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# National Center for Health Research

The Voice For Prevention, Treatment and Policy

## Sitemaps

- [XML Sitemap](https://www.center4research.org/sitemap.xml): Contains all public & indexable URLs for this website.

## Posts

- [The FDA Commissioner Is Missing the Point of Advisory Committees](https://www.center4research.org/medpage-oped-biased-expert-panels/) - Diana Zuckerman's oped in MedPage Today says FDA was never perfect but the media and public could see how the agency reviewed risks and benefits when they held public meetings where scientists and public citizens debated controversial medical products. In recent months they've switched to one-sided rubber stamp meetings followed by announcements of their decisions at events that feel like pep rallies. For example, research shows that hormones for menopause can be helpful or harmful, depending on your age and the type of hormones and your personal medical history. They are not safe for everyone, and can cause cancer, strokes, and dementia for many women. But the FDA expert panel focused on the benefits and ignored most of the risks.
- [Can Belly Fat Cause Cancer and Other Serious Diseases?](https://www.center4research.org/can-belly-fat-cause-cancer-heart-disease/) - Belly fat is common among men and women. But did you know that having an “apple” body shape due to belly fat can increases your chances of developing cancer, heart disease, and diabetes even if you are not overweight? Find out why belly fat is dangerous and what you can do to reduce risks.
- [Good News for Coffee Drinkers: The Health Benefits Outweigh the Risks for Most People](https://www.center4research.org/coffee-health-benefits-outweigh-risks/) - Most Americans drink coffee every day. The caffeine in coffee helps us stay alert but also may cause jitteriness and interfere with sleeping. A few studies suggest that decaffeinated coffee also has health benefits, perhaps because of antioxidants or acids in the coffee beans.
- [The FDA removes long-standing warning from hormone-based menopause drugs](https://www.center4research.org/ap-fda-removes-hormone-warning-menopause/) - AP News, November 10, 2025: AP explains FDA decision to delete most black box warnings for hormone therapy for menopause, despite controversies about the risks. NCHR’s Diana Zuckerman says FDA lost credibility for deleting such important warnings without scientific review using FDA Advisory Committee.
- [Coalition follow-up letter to FDA regarding FDA overruling their own scientists](https://www.center4research.org/coalition-follow-up-letter-to-fda-regarding-fda-overruling-their-own-scientists/) - February 5, 2024: The Patient, Consumer, and Public Health Coalition expressed their strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.
- [Coalition follow-up letter to FDA regarding FDA overruling their own scientists](https://www.center4research.org/coalition-follow-up-letter-to-fda-regarding-overruling-own-scientists/) - February 5, 2024: The Patient, Consumer, and Public Health Coalition expressed their strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.
- [What the shutdown’s end means for FDA](https://www.center4research.org/politico-plausible-mechanism-pathway-nejm/) - Politico, November 14, 2025: Politico quotes experts’ questions regarding FDA Commissioner Makary’s plausible mechanism pathway described in NEJM. NCHR Diana Zuckerman doubts insurance would pay for such expensive drugs based on “plausible mechanism” rather than evidence that they are safe and effective.
- [NCHR Comments on Risks and Benefits of Menopause Hormone Therapy](https://www.center4research.org/nchr-fda-comment-hormones-for-menopause/) - In response to a request for public comments, NCHR tells FDA that hormones for menopause have cancer risks and benefits, depending on when women take them and what type of hormones. Menopausal Hormone Therapy (MHT) doesn’t decrease dementia or heart disease. Vaginal hormone creams have short-term benefits but any long-term risks are unknown.
- [NCHR Comments on Coverage of Colorectal Cancer Non-Invasive Biomarker Screening Tests](https://www.center4research.org/comment-cms-coverage-colorectal-cancer-screening/) - NCHR public comment tells CMS that the ColoSense multi-target mRNA stool-based colorectal cancer screening test needs better evidence to qualify for Medicare NCD coverage. The study sample included 3x the average number of smokers in the U.S. and since smoking increases the chances of colon cancer, that may have biased the results to make the test seem more accurate than it really is. Too many false positives or false negatives would make the test much less useful for patients.
- [Dr. Diana Zuckerman Testifies at FDA Advisory Committee on Digital Health](https://www.center4research.org/fda-advisory-committee-digital-mental-health/) - NCHR's Dr. Diana Zuckerman testified at the FDA Advisory Committee meeting on Digital mental health products, expressing concerns about FDA's failure to regulate the Chatbots and other digital products being marketed as "licensed therapists" and used as psychotherapists in ways that can be extremely harmful. She urged better research but acknowledged difficulty of studying devices that are updated frequently
- [NCHR Comments on Development of Non-Opioid Analgesics for Chronic Pain](https://www.center4research.org/fda-public-comment-nonopioid-analgesic-research/) - National Center for Health Research submitted a written public comment to the FDA docket that advised the agency on the kinds of research needed to ensure that non-opioid pain medications are safe and effective for chronic pain and patients can make informed choices. We point out that it would be unethical to conduct studies that compare these products to opioids in clinical trials.
- [STAT: In an unconventional process, FDA reverses a decades-old warning for hormone therapy](https://www.center4research.org/stat-fda-reverses-blackbox-hormone-therapy/) - STAT News describes the diversity of views on the decision to remove black box warnings for menopausal hormone therapy, but the HHS announcement and description of hormone therapy benefits was more PR than science, says NCHR Dr. Diana Zuckerman
- [Helio: HHS revises hormone therapy black box warning for menopause treatment](https://www.center4research.org/healio-fda-hormone-therapy-black-box/) - Healio.com reports Commissioner Makary and HHS Secretary RFK Jr. plans to eliminate black box warnings on menopause hormone therapy but they exaggerate hormone benefits say Drs. Diana Zuckerman, Barbara DePree and Nanette Santoro.
- [Politico Prescription Plus: FDA Removes Black Box HRT Warning](https://www.center4research.org/politico-fda-remove-black-box-hrt/) - Politico, November 11, 2025: FDA Commissioner Marty Makary announces that FDA seeks eliminating most black box warnings from hormone therapy for menopause and accuses “dogma” that scared women. NCHR Diana Zuckerman said risks of cancer and heart disease are well established and claims of incomparable benefits are PR rather than science.
- [US to remove warnings from menopause hormone therapy](https://www.center4research.org/afp-fda-removes-hormone-warning-menopause/) - AFP News, November 11, 2025: France 24 explains FDA decision to delete most black box warnings for hormone therapy for menopause, despite controversies about the risks. NCHR’s Diana Zuckerman says warnings needed to be updated but hormones have serious risks and limited benefits.
- [Inside Health Policy: FDA To Proceed With 'Expert Panels' Amid HRT Conflict Concerns](https://www.center4research.org/inside-health-policy-expert-panels-coi-hrt/) - Inside Health Policy, November 10, 2025: Inside Health Policy describes controversy about FDA “Expert Panels” and quotes NCHR Diana Zuckerman on why these panels have conflicts of interest and eliminating menopausal hormone therapy black box warnings about cancer and heart disease is a mistake.
- [F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause](https://www.center4research.org/nyt-fda-remove-blackbox-hormones-menopause/) - The New York Times, November 10, 2025: This NYT article describes the different data and opinions regarding FDA Commissioner Makary's decision to remove the black box from all hormone therapy products for menopause despite risks of cancer and stroke. NCHR president Dr. Diana Zuckerman explains why this is a step backward for women's health.
- [Kennedy's Ties to Ally Leading Vaccine Lawsuits Raise Ethical Concerns](https://www.center4research.org/nyt-rfk-siri-vaccine-conflicts-of-interest/) - New York Times, Oct. 3, 2025: This NYT investigation shows how RFK Jr’s lawyer and long-time colleague Aaron Siri benefits financially from his influence over RFK and HHS, resulting in vaccine policies and other decisions that harm U.S. patients. NCHR president Diana Zuckerman's experience is included as an example.
- [Alcohol and Cancer](https://www.center4research.org/alcohol-and-cancer/) - The link between alcohol and cancer may surprise you. The American Society of Clinical Oncology (ASCO) reports that drinking alcohol increases the risk of cancer of the mouth and throat, vocal cords, esophagus, liver, breast, and colon. The risks are greatest in those with heavy and long-term alcohol use, but even moderate drinking can add up over a lifetime, increasing the chance of developing cancer.
- [Are Prostate Cancer Screenings Necessary? The Pros and Cons](https://www.center4research.org/are-prostate-cancer-screenings-necessary-the-pros-and-cons/) - Prostate cancer is the second most common cancer in men, so screening seems like an important way to prevent cancer. But there is a hot debate within the medical community: do regular prostate cancer screenings do more harm than good?
- [FDA ‘serious’ about hormone therapy changes](https://www.center4research.org/politico-fda-wants-hormone-black-box-changes/) - Politico, October 28, 2025: Politico predicts FDA will revise black box warnings on hormones for menopause, but it isn’t clear how. NCHR’s Diana Zuckerman explains warnings are needed but require more nuance because the evidence is different for hormone creams compared to pills, and evidence of risks and benefits for pills depend on factors such as the type of hormones and the age, medical history, and other differences in the women.
- [Are Playgrounds In Your Community Safe?](https://www.center4research.org/the-well-zuckerman-oped-playground-surfaces/) - The Well News, October 28, 2025: This oped by Dr. Diana Zuckerman explains why PIP and other rubber playground and play surfaces for young children can cause obesity, early puberty, asthma, learning problems, and eventually cancer because they contain PFAS, other hormone-disrupting chemicals, and lead. She explains why claims that these materials are proven safe are inaccurate, and that most of the chemicals in these products are not publicly reported or tested. Children can be exposed day after day and year after year, and very young children get the residue on their hands and may put pieces of the recycled rubber tire crumb in their mouths, ears, and noses. Engineered wood fiber is the safe, ADA compliant alternative.
- [Glucosamine Supplements: Do They Work and Are They Safe?](https://www.center4research.org/glucosamine-supplements-do-they-work-are-they-safe/) - Glucosamine is one of the most popular supplements for joint pain, but scientific studies show mixed results on whether it truly helps. Since it is a dietary supplement rather than a drug, it is not FDA-approved or inspected, so evidence of safety and effectiveness is not required to sell it. The good news is that new research shows glucosamine does not increase the risk of diabetes and may even slightly lower it. Learn what the latest science says about its effectiveness, safety, and what to consider before taking it.
- [F.D.A. Panel to Reassess Hormone Therapy Warnings](https://www.center4research.org/f-d-a-panel-to-reassess-hormone-therapy-warnings/) - New York Times July 17, 2025: This FDA panel hosted by Commissioner Makary ignores evidence of the serious risks of hormone therapy for menopause, such as breast cancer, endometrial cancer, and stroke. Instead it focuses only on benefits, relying on misleading and erroneous information. The panel wants to remove the "black box" warning that tells women about the risks. No public comment was allowed at the meeting. We would have disagreed strongly, except with the issue of whether hormonal cream used in the vagina should not have the same black box warning as the hormonal pills.
- [FDA Leaders Moving to Abandon Advisory Committee Reviews of Specific New Drugs](https://www.center4research.org/kff-fda-abandons-advisory-committees/) - STAT News, September 12, 2025: FDA seeks to abandon Advisory Committees for specific drugs and use them for bigger issues says CDER head George Tidmarsh. We point out that Expert Panels are also replacing Advisory Committees with one-sided reviews.
- [RFK Jr.’s tough talk on corporate influence isn’t adding up in practice](https://www.center4research.org/ehn-rfk-conflicts-of-interest-remain/) - Environmental Health Network, June 26, 2025: EHN reports that HHS and RFK Jr. claim to stop conflicts of interest, but industry influence and other conflicts remain, as explained by NCHR’s Diana Zuckerman.
- [FDA Panel to Revisit Menopausal Hormone Therapy](https://www.center4research.org/politico-fda-menopause-hormone-therapy-panel/) - Politico; July 15, 2025: This article describes the FDA panel on the risks and benefits of hormone therapy for menopause: breast cancer, heart disease,stroke, dementia. Zuckerman points out that the panel is one-sided, ignoring data on risks and not allowing public comments from patients or experts to ask questions or describe studies indicating cancer and other serious risks.
- [After 10 Years, the FDA Is Still Letting Women Down](https://www.center4research.org/drugwatch-fda-lets-women-down/) - Drugwatch, August 14, 2025: This excellent article explains that FDA lets women down when they approve drugs and devices for cancer and many other serious diseases, which often don’t work well on women and can be harmful. The article quotes Dr. Diana Zuckerman and other experts, and provides examples of specific medical products that you may have used or want to avoid.
- [FDA Panel Urges Caution, More Data on Dermal Filler Use in Decolletage Area](https://www.center4research.org/medscape-fda-panel-caution-dermal-filler-decolletage/) - Medscape, August 14, 2025: Dr. Diana Zuckerman urged the FDA to require better research and quantify risk information at the Aug 2025 FDA Advisory Panel reviewing risks of dermal fillers in decolletage area above the breast. We agreed with panel members concerns that filler could interfere with cancer diagnosis and breastfeeding, and cause a stroke. We also pointed out that this cosmetic procedure can cause pain, swelling, bruising, and lumps could last weeks or months, which will undermine any cosmetic improvement. Panel members also focused on risks of interfering with cancer diagnosis and breastfeeding problems.
- [Stakeholders at odds over FDA’s draft guidance on hernia mesh labeling](https://www.center4research.org/raps-fda-hernia-mesh-risks/) - Regulatory Affairs Professional Society, August 11, 2025: This article published by the Regulatory Affairs Professionals Society provides an excellent summary of key responses to the FDA's request for public comment on regulations for hernia mesh. It clearly shows the conflicting perspectives of the device industry and healthcare experts about patients' need for specific information about the risks and benefits of hernia mesh.
- [The Business of Pet Adoption](https://www.center4research.org/timesjournal-pets-human-health/) - The Times-Journal (Alabama), September 5, 2025: Pets play a leading role in many people's lives. Researchers tell us that companion animals (pets) improve human health and well-being. For example, pets can help lower blood pressure, improve heart health, have fewer sick days, and get more exercise.
- [Some MAHA Supporters Say CNPV Could Lower FDA Standards](https://www.center4research.org/inside-health-policy-maha-fda-standards/) - October 23, 2025: Inside Health Policy quotes a MAHA meeting that criticized industry influence over FDA, the impact of user fees, the inappropriate reliance on surrogate endpoints for cancer screening and Alzheimer’s drugs. The Lever FDA report finding that most new drugs are approved on evidence inferior to the FDA's legal standards. NCHR's Diana Zuckerman is quoted criticizing the FDA's new CNVP program that promises extremely fast priority reviews for high-impact drugs.
- [Heart Disease in Women](https://www.center4research.org/heart-disease-in-women/) - Heart disease is the leading cause of death for U.S. women and men, but it often has different causes, symptoms, and risks for women, especially after menopause. Biological differences and the underrepresentation of women patients in cardiovascular research result in less effective prevention and treatment for women. Learn more about how early screening, exercise, and healthy habits can prevent disease, and the research needed to learn more about treating women with heart disease.
- [Protein Powders May Be Doing More Harm than Good](https://www.center4research.org/protein-powders-more-harm-than-good/) - Protein powders often contain hidden ingredients and dangerous contaminants. Here's what you need to know about the risks.
- [Are Dangerous Chemicals Getting into Your Food from Plastic Containers and Plastic Wrap?](https://www.center4research.org/plastic-wrap-plastic-food-containers-safe/) - With many plastic products claiming that they are “microwave-safe” and health experts warning us to not heat food in plastic containers, what information can you trust?
- [NCHR Testimony at FDA Advisory Committee Meeting on Risks of 3 Heat Sticks And Other IQOS Tobacco Products](https://www.center4research.org/nchr-comment-fda-iqos-tobacco-risks/) - Diana Zuckerman spoke on behalf of NCHR and CPTF at Oct 2025 FDA Tobacco Advisory Committee TPSAC meeting on whether Phillip Morris heat sticks and other IQOS products should continue to be marketed as low risk. We pointed out that these products have evidence of substantial risks in the short-term and long-term risks are likely to be greater.
- [NCHR Letter to Kensington MD About the Dangers of Rubber Playground Surfaces](https://www.center4research.org/nchr-letter-kensington-pip-playgrounds/) - October 8, 2025: NCHR was asked to send information to the Mayor and other officials of Kensington, Maryland for their town meeting to consider whether to install new playgrounds made from PIP, a type of artificial rubber surface that has a layer of recycled tire waste underneath. Our letter explains that the tire waste contains lead and all of the rubber used has chemicals that disrupt a child's hormones. These playground surfaces are also dangerously hot, which is harmful to children and adults supervising them, and to the environment.
- [Oral Testimony of Dr. Diana M. Zuckerman, Examining Policies to Enhance Seniors’ Access to Breakthrough Medical Technologies](https://www.center4research.org/zuckerman-oral-testimony-energy-commerce-2025/) - September 18, 2025, House Energy & Commerce Committee: Dr Diana Zuckerman testified about why Medicare should not be required to pay for all Breakthrough medical devices and multi-cancer diagnostic tests unless they are proven safe, effective, reasonable, and necessary for Medicare age patients.
- [New Blood Tests for Early Cancer Detection Get Some Love From House Members](https://www.center4research.org/medpage-house-health-hearing-zuckerman-testimomy/) - MedPage Today, September 18, 2025: This news article describes Energy & Commerce Health Committee hearing on bills that would require Medicare cover Breakthrough devices and controversial Multi-cancer Screening tests. NCHR president Dr. Diana Zuckerman testified, describing the cancer tests as "not ready for prime time" and explaining that the latest research shows they are very inaccurate, with some having a false positive rate over 90%
- [Everything You Need To Know About The New Weight Loss Drugs](https://www.center4research.org/wegovy-ozempic-weight-loss-drugs/) - Several popular new GLP-1 drugs, including Wegovy, Ozempic, Mounjaro and Zepbound, help lose weight but do they improve health? In addition to unpleasant gastro-intestinal side effects, they can cause serious health problems such as stomach paralysis (gastroparesis), which can cause problems with anesthesia. They may cause thyroid cancer. Most information about the benefits of these drugs is from press releases, but FDA is now investigating some unexpected possible side effects, including substantial hair loss and suicidal thoughts.
- [Breakthrough Devices](https://www.center4research.org/nchr-breakthrough-devices-analysis/) - NCHR analysis of FDA breakthrough devices, their approval pathways, and the evidence available for safety and effectiveness.
- [NCHR Public Comment on Improving the Generic Drug User Fee Act (GDUFA IV)](https://www.center4research.org/nchr-written-comment-gdufa-iv-aug-2025/) - National Center for Health Research's written comment on GDUFA IV urges the FDA to use generic drug user fees to pay for staff and resources that improve generic drug safety and equivalence, not just speedy review. We point out that hundreds of generic drugs that are still for sale have been found to be contaminated, the wrong dosage, or otherwise unsafe or ineffective for patients. To regain the trust of all patients and health professionals, FDA needs to do more testing and inspections and make sure that bad drugs are recalled.
- [NCHR Report on FDA Advisory Committees: Does Approval Mean Safety?](https://www.center4research.org/report-fda-advisory-committees/) - NCHR's research report on FDA Advisory Committee meetings found problems with bandwagon voting and major disparities between voting members' criticisms of evidence and their voting behavior. Some types of Advisory Committee members are more skeptical about the evidence and others tend to support industry claims.
- [FDA Expert Panels Lack Balance in Pursuit of ‘Gold Standard Science’](https://www.center4research.org/biospace-fda-expert-panels-biased/) - BioSpace, September 8, 2025: NCHR's Dr. Diana Zuckerman tells BioSpace that the new FDA expert panels, such as those on SSRI's during pregnancy and hormone therapy for menopause are more biased than FDA Advisory Committees and lack nuance about complicated data. They send a message to industry about what changes FDA wants to make.
- [NCHR Comment on the Reauthorization of MDUFA](https://www.center4research.org/nchr-fda-mdufa-vi-written-comment-2025/) - September 4, 2025: NCHR's written public comment to FDA on MDUFA says user fees should support improvements in safety and effectiveness by paying for salaries for staff to improve premarket review, post-market surveillance and other activities, and inspections of manufacturing facilities. Industry has benefitted from MDUFA's speedier reviews and more meetings with FDA staff, but what patients and consumers need most is safer and more effective medical devices. We deserve clear information about risks and benefits, and we can't get that when 96+% of devices are not studied in clinical trials before being sold.
- [NCHR Written Comments on the Reauthorization of PDUFA](https://www.center4research.org/nchr-pdufa-written-comment-fda-august-2025/) - August 14, 2025: National Center for Health Research written comment urges FDA to use PDUFA user fees to improve drug safety and effectiveness, not just faster approvals. All programs included in Commitment Letter should emphasize the scientific standards and evidence that will ensure that drugs and biologics have meaningful benefits for patients that outweigh any risks.
- [FDA Public Meeting on MDUFA VI: Invited Presentation of Dr. Diana Zuckerman](https://www.center4research.org/mdufa-aug4-fda-nchr-presentation/) - August 4, 2025: Diana Zuckerman presented on behalf of NCHR at FDA's first public MDUFA VI meeting of 2025. She focused on device performance goals that enhance safety, effectiveness, and transparency prior to FDA approval or clearance, and evaluating safety, effectiveness, and information for patients post-market. A major focus was on user fees being used to improve the data needed for informed consent for patients, consumers, and providers.
- [Taking Medication While Pregnant or Breastfeeding](https://www.center4research.org/taking-medications-pregnant-breastfeeding/) - If you are pregnant or breastfeeding and are planning to take a medication or get a vaccine, it is important to learn more about the possible risks and to discuss any potential side effects with your healthcare provider. It is also important to understand that your doctor may not know exactly what the risks are of certain prescription and over-the-counter medications. Some risks associated with medications have not been researched yet or might not be known by most doctors.
- [Testimony of Dr. Diana Zuckerman at the FDA Plastic Surgery Advisory Panel  Meeting  On Dermal Fillers for the Decolletage Area](https://www.center4research.org/nchr-testimony-fda-panel-dermal-filler-decolletage/) - August 13, 2025: Diana Zuckerman testified at the FDA panel meeting about the risks of dermal filler for decolletage. Known risks include pain, lumps, rashes, stroke, and interference with breast cancer screening. We explained that patients and their physicians need specific information about the frequency of these risks so that they can make informed decisions about whether they want this cosmetic procedure.
- [Do Fish Oil Supplements Prevent Heart Attacks or Strokes?](https://www.center4research.org/fish-oil-heart-attack-stroke/) - Fish are a healthy food due to omega-3 fatty acids, but the latest research shows that fish oil supplements have no health benefit for most people and may increase the chances of A-Fib.
- [NCHR Public Comment on the Continued Implementation of the National Youth Tobacco Survey](https://www.center4research.org/nyts-nchr-comment-cdc-fda-2025/) - In our public comment to the CDC, we strongly supported the continued operation of the National Youth Tobacco Survey (NYTS) for the 2026-2028 cycle. NYTS is the cornerstone of public health surveillance in this field and we reminded CDC and FDA that evaluating the youth use of tobacco products is an essential tool of U.S. public health strategies to reduce cancer, heart disease, and chronic diseases that are key to the MAHA movement.
- [PDUFA VIII Statement of Dr. Amanda Berhaupt, Health Policy Director of NCHR](https://www.center4research.org/pdufa-viii-comment-nchr-july-2025/) - July 14, 2025: NCHR presentation at PDUFA July 2025 user fee meeting focuses on including patients and consumers in negotiations with FDA and industry and adding metrics to ensure post-market safety and meaningful clinical outcomes for prescription drugs.
- [NCHR Comment on Hernia Mesh Package Labeling Recommendations](https://www.center4research.org/nhch-hernia-mesh-fda-comment/) - Why are there tens of thousands of reports to FDA of patients harmed by mesh used in hernia repair? NCHR points out that the FDA proposed guidance is unlikely to reduce that harm because it does not point out the many serious risks of mesh. We tell the FDA that mesh labeling should have warnings about frequency of the many adverse events of specific mesh products, and FDA should require research to determine which products are safer and which are more dangerous, and for which patients. Only social media should be: X/Blueky: Why have tens of thousands of patients been harmed by mesh used in hernia repair? FDA's proposed solution will not solve the problem of dangerous mesh complications.
- [Medical device industry says future MDUFA hikes unsustainable](https://www.center4research.org/medtech-mdufa-meeting-august4/) - MedTech Dive, August 5, 2025: NCHR's Diana Zuckerman and Patient, Consumer, and Public Health Coalition's Tess Robertson-Neel are quoted in the MedTech Dive's article about the MDUFA VI meeting at FDA in August 2025. Alex Baum of Coalition member Generation Patient is also quoted. They focused on including patient and consumer stakeholders in MDUFA negotiations and using user fees for post-market safeguards and other efforts to improve the quality of medical devices.
- [NCHR Testimony on Talasoparib at the FDA Advisory Committee](https://www.center4research.org/nchr-testimony-talzenna-hrrm-metastatic-prostate-cancer/) - May 21, 2025: NCHR’s Amanda Berhaupt testified at the FDA Advisory Committee that since the TALAPRO-2 trial shows Talzenna with Xtandi benefits castration-resistant metastatic prostate cancer patients with HRRm tumors but not those without, the FDA should not expand approval to HRRm-negative patients. The FDA Committee agreed.
- [NCHR Comments on AHRQ's Mindfulness-Based Interventions for Mental Health and Wellbeing in Children and Adolescents](https://www.center4research.org/mindfulness-based-interventions-for-mental-health/) - The following written comment was submitted by the Health Policy Director, Dr. Amanda Berhaupt at The National Center for Health Research’ (NCHR) to the Agency of Health Research and Quality (AHRQ). AHRQ requested comments on the protocol for the Mindfulness-Based Interventions (MBI) for Mental Health and Wellbeing in Children and Adolescents: A Systematic Review by
- [GDUFA IV Statement of Dr. Diana Zuckerman, President of NCHR](https://www.center4research.org/gdufa-iv-nchr-comment-july-2025/) - July 11, 2025: NCHR presentation at GDUFA IV July 2025 user fee meeting focuses on including patients and consumer in negotiations with FDA and industry and including metrics to show improved safety and equivalence for generic drugs.
- [NCHR Testimony regarding Front-of-Package Nutrition Information Labeling](https://www.center4research.org/nchr-testimony-front-of-package-nutrition-label/) - July 15, 2025: NCHR submitted written comments to the U.S. Food and Drug Administration in support of the proposed rule on front-of-package nutrition labeling, recommending stronger, clearer labeling requirements, especially for young children. They suggested additional testing to ensure consumers understand and benefit from the labels, including those with limited literacy or English proficiency.
- [NCHR Testimony FDA Advisory Committee on Oncological Drugs on Benrep for Multiple Myeloma](https://www.center4research.org/fda-benrep-advisory-committee-multiple-myeloma/) - July 17, 2025: Dr. Diana Zuckerman testifies for NCHR about GSK study flaws of Benrep at FDA Oncology Drugs Advisory Committee. The very high risks of ocular toxicity outweighs the benefits and other better treatments are available.
- [NCHR Comment at FDA Advisory Committee on Rexulti Used with Zoloft](https://www.center4research.org/fda-adcomm-rexulti-zoloft-ptsd/) - July 18, 2025: We testify at FDA Advisory Committee about the lack of evidence that Rexulti combined with Zoloft treats PTSD better than Zoloft alone. Rexulti wants approval for PTSD to sell more product but it doesn't seem to work, and its side effects include suicidal thoughts and behaviors, weight gain, diarrhea, anxiety, uncontrolled body movements, diabetes, compulsive behaviors, and stroke.
- [High Blood Pressure (Hypertension): What Is It and How Do You Control It?](https://www.center4research.org/high-blood-pressure-hypertension-control/) - High blood pressure is the most commonly diagnosed health problem in this country; it can lead to heart attack, stroke, kidney failure, and death if not detected early and appropriately treated.
- [Inside Health Policy: Prasad Leaves FDA After Sarepta Furor, Conservative Backlash](https://www.center4research.org/prasad-leaves-fda-sarepta/) - Vinay Prasad leaves his key post at the FDA after a conservative backlash from Laura Loomer and WSJ. Sarepta's gene therapy Elevidys has killed 2 patients so Prasad's concerns were appropriate and the opposition is not focused on the evidence. We point out that FDA must require better evidence that Elevidys is safe & effective and should limit access meanwhile in order to restore trust in the FDA and the gene therapy.
- [Which Sunscreen Should You Use?](https://www.center4research.org/which-sunscreen-should-you-use/) - Other than the 15 minutes of sunshine we all need for our daily requirement of vitamin D, staying out of the sun should always be the first choice for skin cancer prevention. However, there are ways to reduce the damage your skin gets from the sun.
- [FDA 'Expert Panels' Raise Concerns of Evading Regulations, Ethics: Do panels cherry pick experts and evidence that align with FDA leadership's views?](https://www.center4research.org/medpage-fda-expert-panels-evade-ethics/) - July 24, 2024 MedPage explains how FDA's new meetings are called expert panels but their "experts" seem to have one thing in common: they agree on one side of controversial issues, such as the safety of hormone therapy despite reported cancer risks, the risks of talc for cancer, and the risks of SSRIs (depression drugs). We tell MedPage that the meeting rooms are small and filled primarily with supporters and no public questions or comments are allowed. The meetings are not announced to the general public and usually only a few days in advance. We explain all the reasons why this is the opposite of the transparency we were promised by HHS.
- [Susan Franklin Wood Obituary](https://www.center4research.org/susan-franklin-wood-obituary-lancet/) - The Lancet, April 19, 2025: We share this obituary in The Lancet medical journal of our friend and former board member, Susan Wood. Susan was loved and admired by many. Her impressive work to improve women's health and the safety of medical products reflected her personal experience and leaves a legacy of inspiring public health advocacy.
- [Biotech pauses trial after second patient death linked to gene therapy](https://www.center4research.org/sarepta-gene-therapy-second-death/) - The Washington Post, June 17, 2025; Sarepta restricts Elevidys gene therapy for non-ambulatory Duchenne muscular dystrophy patients after second death. We point out that FDA flexibility “does no favor” to patients who may die from using a questionable treatment. Elevidys costs $3.2 million per patient.
- [MIT Technology Review: Meet Jim O’Neill, the longevity enthusiast who is now RFK Jr.’s right-hand man](https://www.center4research.org/mit-tech-hhs-jim-oneill-longevity/) - MIT Technology Review July 1, 2025: HHS Deputy Secretary Jim O'Neill wants unproven medical treatments to be very widely available and HHS to focus funding on longevity research so that those who can afford them can live much longer. This could include areas at sea or in states that are not subject to FDA safeguards. What will happen to the millions of Americans who need healthcare for diseases they already have?
- [A Closer Look at HPV](https://www.center4research.org/a-closer-look-at-hpv/) - HPV affects approximately 20 million Americans, with 6 million new infections annually. This common STI has about 130 strains, with some causing warts and others leading to cancer. HPV can be prevented through regular screenings, safe sex practices, and vaccination.
- [NCHR Testimony on Prucalopride for Chronic Idiopathic Constipation](https://www.center4research.org/nchr-testimony-prucalopride-chronic-idiopathic-constipation/) - October 18 2018: At an FDA Advisory Committee, the National Center for Health Research testified about our concerns regarding prucalopride's safety and effectiveness for U.S. patients with chronic idiopathic constipation. They emphasize the need for more patient diversity in the clinical trials and longer-term studies to ensure the drug's suitability for the broader American population.
- [Ask the Expert: Is It Okay to Let My Toddler Use My iPad for Nursery Rhymes?](https://www.center4research.org/ask-expert-okay-let-toddler-use-ipad-nursery-rhymes/) - Irish Independent, August 17, 2016: You should not buy an iPad tablet for your toddler, because toddlers exposed to more screen time are more likely to face delays in learning, have poor sleep, develop behavior problems, and have weaker parent-child interactions. The article recommends the article on National Center for Health Research's website.
- [Letter to FDA Commissioner Re Lack of Public Health and Consumer Perspectives at Drug User Fee Meeting](https://www.center4research.org/letter-fda-commissioner-re-lack-public-health-consumer-perspectives-drug-user-fee-meeting/) - August 18, 2016: The National Center for Health Research wrote to the FDA to criticize the agency for excluding consumer and public health experts at the PDUFA user fee meeting, clearly focused on what industry wants rather than patient safety and public health.
- [NCHR Disappointed in Latest FDA-Drug Industry User Fee Agreement](https://www.center4research.org/nchr-disappointed-latest-fda-drug-industry-user-fee-agreement-focuses-much-speed-drug-approvals-not-enough-safety/) - August 22, 2016 Public Comment to FDA: The National Center for Health Research supports more funding for the FDA through PDUFA but warns that the current process focuses too much on speed over safety, leaving patients at risk and consumers without a strong voice in the process.
- [PDUFA Again: Still Trying to Get It Right](https://www.center4research.org/pdufa-still-trying-get-right/) - MedPage Today, August 20, 2016: The Pharmaceutical Industry and some patient groups praised the latest drug user fee plan (PDUFA), but consumer advocates warned that drug safety is compromised when the focus is on faster approvals.
- [Cushing’s Syndrome: A Tale of Frequent Misdiagnosis](https://www.center4research.org/cushings-syndrome-frequent-misdiagnosis/) - Cushing’s syndrome occurs when the tissues of the body are exposed to high levels of cortisol for an extended amount of time. The symptoms seem distinctive, yet it is often difficult for those with Cushing’s syndrome to get an accurate diagnosis. Read about this frequently misdiagnosed disease!
- [Some Antibiotics are Riskier than Others: What You Should Know about Quinolones](https://www.center4research.org/antibiotics-riskier-others-know-quinolones/) - There are many different classes of antibiotics, grouped by their pharmacological properties and chemical compounds. While all of the approved antibiotics should be capable of treating bacterial infections, different types are often used to treat different types of infections. This article is focused on the risks and benefits of quinolones.
- [RFK Jr.’s Planned Assault on Corporate Influence Is Clashing With Reality](https://www.center4research.org/notus-rfk-jr-corporate-influence-fda/) - June 26, 2025: NOTUS news article gives numerous examples from experts who agree with RFK Jr and Makary criticisms of corporate influence on health, but say HHS plans to reduce conflicts of interest are ineffective and FDA remains overly influenced by industry.
- [Which Common Medications May Cause Dementia Symptoms?](https://www.center4research.org/which-common-medications-are-linked-to-dementia/) - You may have heard the media coverage that common medications may increase the risk for dementia. What do these drugs all have in common, what do you need to know about them, and are there really risks to taking them?
- [Safe Teething for Your Baby:  Doctors say no to Orajel and Lidocaine](https://www.center4research.org/safe-teething-baby-doctors-say-no-orajel-lidocaine/) - The Food and Drug Administration (FDA) warns parents that benzocaine and lidocaine should not be used on infants and young children to soothe teething pain. Luckily, there are still safe options for teething babies in pain.
- [Can Listening to Music Improve Your Workout?](https://www.center4research.org/can-listening-music-improve-workout/) - Listening to music while exercising can help improve the quality of your workout by increasing your stamina and putting you in a better mood.
- [Child Abuse and Father Figures: Which Kind of Families Are Safest to Grow Up In?](https://www.center4research.org/child-abuse-father-figures-kind-families-safest-grow/) - Some studies show that children with a father surrogate living at home are more likely to be reported for maltreatment—abuse and neglect—than those with a biological father at home or, as some research shows, no father figure at all.
- [The Benefits of Pets for Human Health](https://www.center4research.org/benefits-pets-human-health/) - Animals play an important role in many people’s lives. In addition to seeing-eye dogs and dogs that can be trained to detect seizures, animals can also be used in occupational therapy, speech therapy, or physical rehabilitation to help patients recover. Aside from these designated therapeutic roles, animals are also valued as companions. Learn more about the possible benefits of that companionship.
- [Can Wearing a Bra Cause Breast Cancer?](https://www.center4research.org/can-wearing-bra-cause-breast-cancer/) - There are several persistent myths about things that cause breast cancer. One of the most common is that wearing a bra - or wearing an underwire bra - causes the disease.
- [Do Lemons Prevent Cancer?](https://www.center4research.org/lemons-prevent-cancer/) - A widely circulating e-mail claiming to be from the Institute of Health Sciences in Baltimore states that lemons are a "proven remedy against cancers of all types" and that lemons are 10,000 times stronger than chemotherapy. The claims this e-mail makes are not correct. Although lemons have many health benefits, no study has ever been done that would compare the effectiveness of a lemon to chemotherapy.
- [Risks of Splenda: Too Risky to Use?](https://www.center4research.org/risks-splenda-risky-use/) - If you’re a coffee or tea drinker, you probably have tried Splenda, the brand name for sucralose, a sugar-free, no-calorie synthetic sweetener. It’s in the yellow packets, and is one of the most popular no-calorie sweeteners in the US. But new research suggests it might not be as safe as everyone thought.
- [Do Cell Phone Radiation Shields Work?](https://www.center4research.org/cell-phone-radiation-shields-work/) - You may have seen cell phone radiation blockers or radiation shields advertised on the internet. Many of these products are scams to prey on real concerns about the long-term risks of cell phone radiation.
- [The Cycle of Domestic Violence](https://www.center4research.org/the-cycle-of-domestic-violence/) - Domestic violence is a serious public health issue that affects both men and women. Victims suffer physical and mental health consequences. Learn more about the repeating cycle of domestic violence and why it is hard for victims to leave abusive relationships.
- [Benadryl and Other Common Medications are Linked to Dementia in Men and Women](https://www.center4research.org/benadryl-and-other-common-medications-are-linked-to-dementia-in-men-and-women/) - Many people turn to over-the-counter medicines when they need relief from allergy and cold symptoms. They also turn to them if they have trouble falling or staying asleep. This is concerning since recent studies show that one of the most common of those drugs—Diphenhydramine, the active ingredient in Benadryl—could lead to serious health problems, including dementia.
- [Violent Video Games and Aggression](https://www.center4research.org/violent-video-games-can-increase-aggression/) - The American Psychological Association (APA) considers violent video games a risk factor for aggression. It is important to keep in mind that violent video game exposure is only one risk factor of aggressive behavior. For example, mental illness, adverse environments, and access to guns are all risk factors of aggression and violence.
- [Social Media and Adolescents’ and Young Adults’ Mental Health](https://www.center4research.org/social-media-affects-mental-health/) - Most teens and young adults use social media, and experts are asking if this use can harm mental health. Here’s what you need to know.
- [NCHR signed on to letter urging the OSTP to provide public comment opportunities](https://www.center4research.org/letter-ostp-guidance-public-comment-opportunities/) - June 20, 2025: NCHR and other non-profit organizations sent a letter to the director of the Office of Science Technology Policy urging them to uphold scientific integrity and explaining that opportunities to provide input will increase public trust in scientific decisions.
- [FDA Questions Effect of Abuse-Deterrent Opioids](https://www.center4research.org/fda-questions-effect-abuse-deterrent-opioids/) - June 13 2017: The NCHR cautions that opioids labeled as "abuse-deterrent" might not actually stop misuse and can still be abused, giving a false sense of safety. They urge the FDA to ensure that such labels accurately reflect the risks to protect patients from harm.
- [Will a New FDA User Fee Discourage Medical Device Innovation?](https://www.center4research.org/will-new-fda-user-fee-discourage-medical-device-innovation/) - Bloomberg June 12, 2017: The NCHR is warning that a new FDA user fee could make the de novo pathway more appealing by speeding up device reviews, but at the cost of safety. NCHR says this fast-track process often skips clinical trials and lacks solid scientific proof, putting patients at risk.
- [NCHR Public Comments at the FDA’s Safe Use Symposium: A Focus on Outpatient Preventable Adverse Drug Effects](https://www.center4research.org/nchr-public-comments-fdas-safe-use-symposium-focus-outpatient-preventable-adverse-drug-effects/) - Megan Polanin, June 15 2017: At the FDA’s Safe Use Symposium, the National Center for Health Research emphasized the need for better communication between doctors and patients about drug risks, especially regarding side effects, off-label uses, and how medications may affect people differently based on age, gender, or race. They called on the FDA to make drug labels clearer and more useful to help prevent harmful drug reactions.
- [Letter to Secretary Price of HHS Concerning Antimicrobial Resistance](https://www.center4research.org/letter-secretary-price-concerning-antimicrobial-resistance/) - June 21 2017: In a letter signed by 34 health and consumer groups to the HHS, we asked for stronger action against antibiotic resistance by improving tracking, using fewer antibiotics on farms, and supporting research to keep people safe.
- [NCHR Testimony at the FDA about a Vaccine for Respiratory Syncytial Virus (RSV)](https://www.center4research.org/nchr-testimony-fda-vaccines-related-biological-products-advisory-committee-meeting/) - Megan Polanin May 17 2017: The NCHR advises the FDA to be cautious when approving RSV vaccines, emphasizing the need for strong evidence of safety and effectiveness, especially before giving them to infants who have never had RSV.
- [NCHR Testimony to FDA About L-Glutamine for Sickle Cell Crisis](https://www.center4research.org/nchr-comments-fda-l-glutamine-sickle-cell-crisis/) - Stephanie Fox-Rowlings May 24 2017: FDA should only approve new treatments when there is clear proof they are safe and helpful. If many people drop out of the study, it’s hard to know if the drug really works, and the FDA should not approve it without strong evidence.
- [Misplaced Trust: Why FDA Approval Doesn’t Guarantee Drug Safety](https://www.center4research.org/misplaced-trust-fda-approval-doesnt-guarantee-drug-safety/) - Drugwatch May 8 2017: Many people think FDA-approved drugs are always safe, but that's not true. This article explains how some medicines get approved too quickly, why drug companies have a big say in the process, and how patients can protect themselves by asking the right questions.
- [NCHR Remarks to the FDA Science Board on Patient Engagement](https://www.center4research.org/nchr-remarks-fda-science-board-patient-engagement/) - The National Center for Health Research tells the FDA it’s important to hear from real patients, not just those backed by drug companies, so that decisions about new medicines and treatments are safer and more fair.
- [NCHR Testimony to FDA About Neratinib to Prevent Breast Cancer Reccurance](https://www.center4research.org/nchr-comments-fda-neratinib-prevent-breast-cancer-reccurance/) - The National Center for Health Research advises the FDA to delay approval of neratinib for early-stage HER2-positive breast cancer, highlighting that the drug offers only a slight improvement in preventing cancer recurrence while causing serious side effects like severe diarrhea and fatigue, which led many patients to stop treatment.
- [Trump budget would cut $636 billion from HHS agencies](https://www.center4research.org/trump-budget-cut-636-billion-hhs-agencies/) - The Trump administration's proposed budget includes a $636 billion reduction to the Department of Health and Human Services, prompting worries about potential impacts on healthcare services, medical research funding, and essential public health programs that many Americans rely on.
- [Letter to Pruitt Concerning Beck Hiring for Senior Position at EPA](https://www.center4research.org/letter-pruitt-concerning-beck-hiring-senior-position-epa/) - The National Center for Health Research and 24 other organizations have expressed concern over Dr. Nancy Beck's appointment to a senior position at the EPA, highlighting her previous role at the American Chemistry Council and potential conflicts of interest that could influence the agency's chemical safety policies.
- [NCHR Comments to FDA Advisory Committee on Organ Care System-Lung](https://www.center4research.org/nchr-comments-fda-advisory-committee-organ-care-system-lung/) - The National Center for Health Research recommends the FDA postpone approval of the Organ Care System (OCS) Lung due to significant flaws in the INSPIRE trial, including design and implementation issues. These compromise the reliability of its findings and pose risks to patient safety.
- [NCHR Comments to EPA on Methylene Choloride and N-Methylpyrrolidone Use in Paint Remover](https://www.center4research.org/nchr-comments-epa-methylene-choloride-n-methylpyrrolidone-use-paint-remover/) - The NCHR asks the EPA to stop the use of methylene chloride and NMP in paint removers because they can cause serious health problems, including death. They believe that warning labels aren't enough and that banning these chemicals is the best way to keep people safe.
- [NCHR Comment to EPA on Procedures for Prioritization of Chemical for Risk Evaluation](https://www.center4research.org/epa-chemical-prioritization-nchr-comment/) - Stephanie Fox-Rawlings, March 20 2017: The National Center for Health Research is advising the EPA to be careful when deciding which chemicals are low-risk. They emphasize that without enough information, some substances might be wrongly considered safe, potentially putting people's health at risk.
- [FDA Proposal Would Lower Requirements for Some Moderate-Risk Devices](https://www.center4research.org/fda-proposal-lower-requirements-moderate-risk-devices/) - Bloomberg, March 24 2017:The FDA wants to remove safety checks for more than 300 moderate-risk medical devices, like surgical clamps and dentures. Health experts worry this could let unsafe products reach patients without proper testing.
- [Amy Reed, MD, Morcellator Opponent, Dies of Uterine Cancer](https://www.center4research.org/amy-reed-morcellator-opponent-dies-uterine-cancer/) - Medscape, May 25 2017: Dr. Amy Reed, a mother of six and physician, died at 44 after her cancer spread during a routine surgery using a power morcellator. She and her husband led a campaign that prompted the FDA to warn against the device's use, aiming to protect other women from similar harm.
- [NCHR Testimony to FDA in Preparation for the 2017 International Cooperation on Cosmetics Regulation (ICCR) Meeting](https://www.center4research.org/nchr-testimony-fda-preparation-2017-international-cooperation-cosmetics-regulation-iccr-meeting/) - Megan Polanin, May 25 2017: The National Center for Health Research is asking the FDA and international cosmetic regulators to take action on harmful chemicals in beauty products. They point out that substances like phthalates and parabens, found in everyday items like lotions and toothpaste, can affect hormones and may harm children's development.
- [Study Explains Why So Many Cancer Drugs Don’t Work](https://www.center4research.org/new-study-explains-many-cancer-drugs-dont-work/) - Diana Zuckerman November 29 2016: A new study reveals that many cancer drugs don’t work as well as expected because they’re often approved based on weak evidence, leading to false hope, wasted money, and serious health risks for patients.
- [NCHR Testimony at FDA Meeting on Developing Antibiotics for Bacteria That Rarely Cause Infection](https://www.center4research.org/nchr-testimony-fda-meeting-developing-antibiotics-bacteria-rarely-cause-infection/) - Stephanie Fox-Rawlings, April 13 2017: At an FDA meeting, NCHR explained that developing new antibiotics for rare, low-risk bacteria could do more harm than good by exposing patients to unnecessary side effects, increasing the chances of drug-resistant infections, and diverting resources away from treatments that are truly needed.
- [NCHR Public Comment to CDC Safety Office on COVID Vaccine Research and Communications](https://www.center4research.org/nchr-public-statement-nasem-2024-cdc-covid-vaccines/) - October 11, 2024: We presented our public comment at the NASEM Review of CDC COVID-19 Vaccine Safety Research and Communications Meeting 3 on how CDC could improve research and communications regarding COVID-19 vaccines. We said CDC needs to be clear on what is known and not known and needs to quantify what is known about adverse events and complications from vaccines.
- [Are Bisphenol A (BPA) Plastic Products Safe?](https://www.center4research.org/bisphenol-bpa-plastic-products-safe/) - Bisphenol A (BPA) is a chemical used to make plastics. It is frequently used in sports equipment, water bottles, medical devices, as a coating or lining in food and beverage cans, and in credit card receipts. While early concerns about BPA's health effects were based primarily on animal studies and research on cells, there is increasing evidence from studies in humans that BPA can cause serious harm, such as increased risk of heart disease, diabetes, obesity, and sexual dysfunction.
- [Featured Presentation by Diana Zuckerman at the CDC Childhood Lead Poisoning Prevention Program Annual Meeting](https://www.center4research.org/zuckerman-speech-cdc-clppp-2023-meeting/) - December 5, 2023: Dr. Diana Zuckerman was the featured speaker at the CDC’s annual childhood lead prevention (CLPPP) meeting in Atlanta, explaining the risks of lead in artificial turf, playground surfaces, recycled rubber tiles, and rubber mulch for plants. Here is her presentation with the photos from her slides.
- [Right Diagnosis, Wrong Prescription: Experts Weigh In on RFK, Jr’s Food Safety and Nutrition Policies](https://www.center4research.org/medscape-rfk-food-safety-debate/) - Medscape, June 4, 2025: NCHR and other experts agree that RFK Jr plans to improve food safety deserve attention, but debate whether these plans benefit nutrition or will be defeated by anti-regulatory pressure from the White House and Republicans in Congress.
- [FDA Approved — And Ineffective](https://www.center4research.org/lever-part-2-fda-approved-ineffective/) - June 5, 2025: New report in The Lever shows that most drugs approved by the FDA do not meet the standards of evidence required by law and we say that the FDA's standards are the lowest ever
- [Risks of Benzodiazepines](https://www.center4research.org/fda-black-box-warnings-benzodiazepines-miscarriages/) - New research shows benzodiazepines can cause miscarriages in addition to FDA black box warnings about the risks of addiction, dependence, withdrawal, misuse, and abuse. There are safer alternatives to reduce stress and anxiety.
- [How Much Fluoride Is Too Much? Balancing Dental Health and Potential Risks](https://www.center4research.org/fluoride-benefits-risks-research/) - Fluoride in drinking water has benefits for dental health but also potential risks with overexposure. This article explores the latest research, health guidelines, and why continued research and unbiased information is the key to families and communities making informed decisions for all ages.
- [NCHR Testimony on Glofitamab-gxbm at the FDA Oncology Drugs Advisory Committee](https://www.center4research.org/nchr-testimony-fda-glofitamab-confirmatory-trial/) - May 20, 2025: NCHR’s Amanda Berhaupt testified at the FDA Advisory Committee that since Glofitamab trial shows Asian patients with Diffuse Large B Cell Lymphoma patients do well but US and European patients do poorly and STARGLO had too few US patients to generalize results, the Genentech trial does not confirm safety and efficacy for DLBCL patients. The FDA Committee agreed.
- [NCHR Follow-up to DC Council Environmental Health Hazards Roundtable](https://www.center4research.org/nchr-2025-dc-council-artificial-turf-hearing-record/) - May 19, 2025: NCHR submitted a letter for the hearing record for the D.C. Council roundtable about environmental and safety hazards in DC parks and playgrounds. Our letter provided the requested information in response to questions about whether artificial turf is recycled and shared additional information about research indicating the presence of heavy metals on rubber playground surfaces.
- [Trump's diversity purge freezes hundreds of millions in medical research at universities across the country](https://www.center4research.org/cnn-diversity-purge-cuts-key-us-medical-research/) - CNN reports how cuts in university research projects harm important efforts to improve health and save lives in red and blue states. NCHR says researchers are scared about the future of their work and explains how important it is to study differences in how patients develop diseases and which treatments are most effective. We suggest that studies using terms like diversity could be funded if described accurately but with different wording.
- [Letter to Secretary Perdue of USDA Concerning Antimicrobial Resistance](https://www.center4research.org/letter-secretary-perdue-usda-antimicrobial-resistance/) - June 21 2017: In a letter signed by 34 health and consumer groups to the USDA, we asked for stronger action against antibiotic resistance by improving tracking, using fewer antibiotics on farms, and supporting research to keep people safe.
- [NCHR Testimony to FDA on Victoza to Prevent Cardiovascular Events](https://www.center4research.org/nchr-testimony-fda-victoza-prevent-cardiovascular-events/) - June 20 2017: Dr. Stephanie Fox-Rawlings of the National Center for Health Research told the FDA Advisory Committee that Victoza shouldn’t be approved to prevent heart problems in patients with type 2 diabetes unless better research is done on American patients to prove it works for them.
- [NCHR Testimony at FDA Meeting on Pediatric Cancer Drugs](https://www.center4research.org/nchr-testimony-fda-pediatric-oncology-subcommittee-oncologic-drugs-advisory-committee-meeting/) - At the FDA Advisory Committee meeting, Dr. Megan Polanin of the National Center for Health Research expressed concerns about inadequate evidence regarding the safety and effectiveness of drugs for rare pediatric cancers, pointing out that it is better to provide experimental drugs for free in a clinical trial rather than approving those drugs based on inadequate preliminary evidence with the knowledge that they will be unaffordable because insurance companies will not pay for drugs that are not proven to work.
- [It’s Not Safe in Soap, But You Touch It Everyday](https://www.center4research.org/not-safe-soap-touch-everyday/) - Marketwatch, June 21 2017: Some soaps contain triclosan and other chemicals that can disrupt hormones and be harmful to health. Experts say these ingredients offer little benefit and pose risks. The FDA has banned certain antibacterial agents in soaps, but these chemicals are still found in other products, raising concerns about daily exposure.
- [FDA Documents Reveal Depths of Internal Rancor Over Drug’s Approval Process](https://www.center4research.org/fda-documents-reveal-depths-internal-rancor-drugs-approval-process/) - August 2 2017: FDA emails show disagreements about a drug called eteplirsen. Some experts said it didn’t work well enough, but it was approved anyway, raising safety concerns. The National Center for Health Research says this shows the need for better rules to protect patients.
- [Letter from NCHR about Dangerous Playgrounds and Athletic Fields to the Mayor and City Council of Washington, DC](https://www.center4research.org/letter-nchr-dangerous-playgrounds-athletic-fields-mayor-city-council-washington-dc/) - August 28 2017: The National Center for Health Research (NCHR) is calling on D.C. leaders to halt the use of artificial turf and rubber playground surfaces. They highlight dangers such as lead exposure, excessive heat, and increased injury risks, emphasizing the need for safer, natural alternatives to protect children's health.
- [FDA Eases Notice Requirement on More Than 1,000 Medical Devices](https://www.center4research.org/fda-eases-notice-requirement-1000-medical-devices/) - Bloomberg, July 10 2017: The FDA removed evidence requirements for over 1,000 moderate-risk medical devices. This has pleased AdvaMed and other companies but it means even less information for patients, and we agree that it could result in less safe medical devices.
- [The Battle Over Essure](https://www.center4research.org/the-battle-over-essure/) - The Washington Post, July 26, 2017: Essure was marketed as an easy, non-invasive permanent contraception (sterilization), but many women reported pain, serious harm requiring surgery, and pregnancies. It wasn't until patients and public health experts like NCHR met with FDA officials that the agency added warnings. Some women needed surgery to remove the device, and lawsuits claimed FDA approved Essure based on poorly conducted clinical trials.
- [Cigarette Maker Stocks Plunge on FDA Announcement, But Health Experts Are Skeptical](https://www.center4research.org/fda-news-nicotine-reduction-cigarette-stocks/) - Marketwatch, July 28 2017: The FDA proposed lowering nicotine in cigarettes to make them non-addictive. Stocks fell, but experts worry about delays in regulating e-cigarettes, cigars, and other tobacco products. Health advocates are concerned that postponing the planned reviews for these products could keep harmful items on the market longer, harming public health.
- [Breast Implants and Cancer of the Immune System (ALCL): A History of Who Knew What When](https://www.center4research.org/breast-implants-cancer-immune-system/) - August 15 2017: Breast implants can cause a rare cancer of the immune system called BIA-ALCL. Plastic surgeons and the FDA knew the risks years before the FDA officially warned the public in 2017. The National Center for Health Research explains how delayed warnings kept that important information about the risks from many women who had breast implants as well as many who were considering getting breast implants.
- [New CDC Head Fitzgerald Peddled Controversial 'Anti-Aging Medicine' Before Leaving Private Practice](https://www.center4research.org/new-cdc-head-fitzgerald-peddled-controversial-anti-aging-medicine-leaving-private-practice/) - Forbes, July 9 2017: Dr. Brenda Fitzgerald, the new CDC director, previously promoted unproven anti-aging treatments, raising concerns about her commitment to science-based medicine. NCHR and other health experts question whether her qualifications align with the CDC's mission to rely on credible scientific evidence for public health decisions.
- [Special Report: Many Expensive New Cancer Drugs Are Useless (or Worse)](https://www.center4research.org/special-report-many-expensive-new-cancer-drugs-useless-worse/) - Bottom Line, July 3 2017: Many new cancer drugs are costly but aren't proven to help patients live longer or improve their quality of life. We and other experts worry that fast FDA approvals are based on questionable evidence. Some drugs have serious side effects and don't improve survival, yet they remain on the market for years, harming patients and costing patients and our healthcare system billions of dollars.
- [NCHR Comments on NTP's Crumb Rubber Research Program Update](https://www.center4research.org/nchr-comments-ntps-crumb-rubber-research-program-update/) - June 29, 2017: Crumb rubber used in playgrounds and artificial turf fields contain harmful chemicals that get on children's skin and in the air we all breathe. Experts urge better studies to understand all the health risks for children and athletes. The National Center for Health Research emphasizes the need for thorough research to ensure safety in these common play areas, because many children and adults are exposed day after day and week after week.
- [Morcellator Cancer Reports Drop, Essure Reports Rise](https://www.center4research.org/morcellator-cancer-reports-drop-essure-reports-rise/) - Drugwatch, June 20, 2017:Reports of cancer that was spread by power morcellators have decreased, while injuries from Essure sterilization (permanent birth control) devices have increased. We join other experts who are concerned about FDA's reporting system and emphasize our support of the Medical Device Safety Act, which would improve the safety of medical devices
- [Foremother and Health Policy Hero Awards Luncheons](https://www.center4research.org/foremother-health-policy-hero-awards/) - Our annual Foremother and Health Policy Hero Awards Luncheon information for this year.
- [NCHR Comment on Medicare Coverage for Tricuspid Valve Transcatheter Edge-to-Edge Repair](https://www.center4research.org/nchr-cms-tter-ced-comment-2025/) - May 2, 2025: The National Center for Health Research questions CMS’s proposed Coverage with Evidence Development for Tricuspid Valve Transcatheter Edge-to-Edge Repair (T-TEER), because it is not proven to save lives or reduce overall hospitalizations. We are also concerned about adverse events and problems with the research evidence used to support approval and coverage.
- [Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER ](https://www.center4research.org/pink-sheet-prasad-appointment-cber-fda/) - We agree with other experts who expect that as head of CBER at FDA, Vinay Prasad will improve FDA approval standards by making it harder for unproven drugs to get FDA approval. Patients deserve to be able to rely on FDA to make sure drugs and biologics being sold in the US are safe and effective. Patients and physicians can't make well-informed decisions if companies don't do the research needed to provide clear evidence that a medical product is safe and effective.
- [This Popular Implant Prevents Pregnancy for Years. It Could Also Go Missing in Your Body.](https://www.center4research.org/nexplanon-prevents-pregnancy-goes-missing/) - Circa Investigation, October 8 2018: Nexplanon birth control implants can migrate from the arm to dangerous areas like the lungs, raising safety concerns and making it difficult or impossible to remove them. We explained to the reporter that changes were made to the product to make it easier to find when it migrates, but FDA needs to do more to ensure women's safety.
- [EpiPen Failures Cited in Seven Deaths This Year, FDA Files Show](https://www.center4research.org/epipen-failures-cited-seven-deaths-year-fda-files-show/) - Bloomberg News, November 2 2017: FDA reports reveal that EpiPen failures have been associated with seven deaths and 35 hospitalizations, highlighting serious concerns about the device's reliability. The National Center for Health Research emphasized the urgent need for thorough investigations and improved safety measures to ensure the effectiveness of this critical allergy treatment.
- [Comments to FDA on Proposed Delay of Compliance Date for Nutrition Rule and Serving Size Rule](https://www.center4research.org/comments-fda-proposed-delay-compliance-date-nutrition-rule-serving-size-rule/) - November 1, 2017: The National Center for Health Research (NCHR) strongly opposes the FDA's proposed delay in implementing updated Nutrition Facts and Serving Size labels. They emphasized that postponing these changes hinders Americans' ability to make informed dietary choices, particularly concerning added sugars and realistic serving sizes, which are crucial for managing health conditions like obesity, diabetes, and heart disease.
- [NCHR Testimony at D.C. Council Public Oversight Roundtable on Environmental and Safety Hazards on DPR Properties](https://www.center4research.org/nchr-testimony-dc-council-artificial-turf/) - May 05, 2025: NCHR’s Tess Robertson-Neel testified at a D.C. Council roundtable about environmental and safety hazards in DC parks and playgrounds. We highlighted concerns about heat-related injuries, other injuries and serious harms, and the presence of lead, PFAS and other harmful chemicals and metals in artificial turf and playground surfaces. Artificial turf and rubber playground surfaces have serious risks that can endanger children's health. We urged the D.C. council to invest in safer, healthier alternatives.
- [Statement of Dr. Diana Zuckerman before the FDA Advisory Committees on Safety and Risk Management and Anesthetic and Analgesic Drug Products  On Behalf of the National Center for Health Research](https://www.center4research.org/zuckerman-testimony-fda-advisory-committee-opiods-may-2025/) - May 5, 2025: NCHR president Dr. Diana Zuckerman testified at the FDA joint meeting of the Safety and Risk Management and Anesthetic and Analgesic Drugs Advisory Committee to discuss the OPC industry consortium new research results on the safety of extended release and long-term opioids. We criticized the biased definition of opioid use disorder (OUD) created by the industry consortium, which resulted in making long-term opioid use seem safer than it really is. We also criticized the labeling on all opioids for not accurately stating that opioids are not proven safe or effective for long-term use.
- [Cervical Cancer Screening Options: What Is Best For You?](https://www.center4research.org/cervical-cancer-screening-options/) - Varuna Srinivasan, MBBS, MPH & Jared Hirschfield, National Center for Health Research Cervical cancer is cancer in the cells lining the cervix, the narrow passage between the uterus and vagina. This cancer is usually diagnosed in women between the ages of 35 and 44.1 Each year approximately 13,000 women in the United States are diagnosed
- [NCHR Comment on USPSTF Draft Recommendation Statement for Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Preventive Medication](https://www.center4research.org/nchr-comments-uspstf-draft-recommendation-statement-ocular-prophylaxis-gonococcal-ophthalmia-neonatorum-preventive-medication/) - In order for the U.S. to follow in the footsteps of Canada and other countries that have stopped universal prophylaxis, we recommend that USPSTF encourage physicians to have conversations or conduct counselling on STD's and give pregnant mothers the option to opt out of neonatal prophylaxis.
- [In Vague Announcement, FDA Says It Will Cut Ad Comm Conflicts](https://www.center4research.org/ihp-fda-unclear-conflict-of-interest-policy-2025/) - IHP News, April 17, 2025: Inside Health Policy reports FDA‘s new conflict of interest policy looks like its old conflict of interest policy. NCHR’s Diana Zuckerman and Public Citizen’s Michael Abrams ask how is this new policy different from the existing policy? Industry representatives are already not allowed to vote on FDA advisory committees.
- [NCHR Testimony at the FDA's Pediatric Advisory Committee Meeting](https://www.center4research.org/nchr-testimony-fdas-pediatric-advisory-committee-meeting/) - September 20 2018. At an FDA Advisory Committee meeting, NCHR challenges FDA's safety conclusions about psychiatric drugs for children, arguing Lexapro lacks evidence for kids under 12 and Intuniv causes serious side effects. Despite NCHR's concerns, the Pediatric Advisory Committee voted 11-1 to continue current monitoring rather than requiring stronger warnings or additional research.
- [NCHR Comments on the FDA's Post-Marketing Pediatric-Focused Product Safety Reviews](https://www.center4research.org/nchr-comments-fdas-post-marketing-pediatric-focused-product-safety-reviews/) - September 28 2018. In its public comment, NCHR calls for better monitoring of children's drug side effects, stronger warning labels, and parent-friendly information about risks of ADHD drugs and medical devices. The FDA's current reporting system misses many adverse reactions due to under-reporting, and psychiatric risks from ADHD medications need more prominent warnings.
- [FDA approves new female Viagra despite skepticism](https://www.center4research.org/fda-approves-new-female-viagra-despite-skepticism/) - Washington Post: June 21 2019. FDA approves Vyleesi, a new drug for women with low sexual desire, but health experts worry about its safety and effectiveness compared to placebo. Diana Zuckerman points out there is "skimpy peer-reviewed data and a complete lack of long-term safety information" for the self-administered injection.
- [FDA Releases Millions of Records of Incidents Involving Medical Devices](https://www.center4research.org/fda-releases-millions-of-records-of-incidents-involving-medical-devices/) - June 21 2019. The FDA has made public 6 million previously hidden reports of injuries and malfunctions linked to medical devices such as implants and defibrillators. This move ends a secretive reporting program and helps patients and doctors make safer, more informed decisions.
- [Rethinking "Antimicrobial Resistance" : Focusing on Patients instead of Pathogenic Organisms](https://www.center4research.org/rethinking-antimicrobial-resistance-focusing-on-patients-instead-of-pathogenic-organisms/) - Everyone knows about antibiotic resistance. In fact, the term "antimicrobial resistance" even has its own acronym: AMR. With all the attention and new antibiotics being developed, why are the number of deaths from infections still the same year after year? Our commentary was just published in an international medical journal, and we explain that the
- [NCHR Comments on FDA's Guidance on Post-Approval Pregnancy Safety Studies](https://www.center4research.org/nchr_comments_fdas_guidance_post-approval_pregnancy_safety_studies/) - June 28, 2019: NCHR public comment urges FDA to require safety studies of drugs taken during or after pregnancy that include women of all races, ethnicities and access to insurance. FDA should require better tracking of medication risks, and ensuring that research represents all races, ethnicities, and insurance types (including uninsured women and those on Medicaid). With 9 out of 10 pregnant women taking medications, we need better safety data to protect both mothers and babies.
- [The Breast Implant Working Group’s Breast Implant Black Box Warning and Patient Checklist](https://www.center4research.org/blackbox-and-patient-checklist/) - Black Box Warnings are the FDA’s strongest alerts about dangerous complications and side effects of drugs or medical devices. This article explains the Black Box warning about breast implants and includes a simple checklist of possible risks that women should be aware of and discuss with their surgeon before deciding whether to get breast implants, to stay safe and make informed choices.
- [Sample Vaping Letter](https://www.center4research.org/sample-vaping-letter/) - E-cigarette ads use fun flavors and cool designs to attract kids, putting them at risk of nicotine addiction and health problems. This sample letter helps parents, teachers, and community members urge schools to take action against teen vaping by banning e-cigarettes and teaching students about the dangers.
- [NCHR Comment on FDA's Draft Guidance to Industry on Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy](https://www.center4research.org/nchr-comment-on-fdas-draft-guidance-to-industry-on-establishing-effectiveness-and-safety-for-hormonal-drug-products-intended-to-prevent-pregnancy/) - September 10, 2019: In response to FDA's request for public comments, we stated that the agency should require better testing of hormonal birth control pills and patches. Current studies don't include enough women with higher BMIs or track blood clot risks properly. Our comments push for stronger safety standards that test hormonal contraceptives on women of all weights, especially since some birth control methods may be less effective or more dangerous for larger women.
- [Massive Marketing Muscle Pushes 3D Mammograms, Despite No Evidence They Save More Lives, Investigation Shows](https://www.center4research.org/massive-marketing-muscle-pushes-3d-mammograms-despite-no-evidence-they-save-more-lives-investigation-shows/) - An investigation shows that while 3D mammograms are marketed with claims that they are better for detecting breast cancer, research has not proven they save more lives or find more deadly cancers than 2D mammograms. The report also raises concerns about hospitals and manufacturers promoting expensive 3D tests without enough scientific evidence to back up the claims.
- [Facts About 6 Common STIs](https://www.center4research.org/facts-about-6-common-stis/) - NCHR explains six common sexually transmitted infections—chlamydia, gonorrhea, hepatitis B, herpes, HPV, and HIV—including how they spread, their symptoms, treatments, and ways to prevent them so everyone can stay informed and healthy.
- [Wearable Health Devices and Personal Health Trackers: What You Need to Know](https://www.center4research.org/wearable-medical-devices-risks-fitbit/) - Wearable medical devices such as the FitBit or other SmartWatches are electronic devices that you wear to track personal health data, such as how many steps you have taken today or your heart rate. We explain how wearable devices are regulated, are they accurate, and what are the risks of relying on them?
- [NCHR Comments on Adverse Events Program for Medical Devices, Medical Product Safety Network ("MedSun")](https://www.center4research.org/nchr-comments-adverse-events-program-medical-devices-medical-product-safety-network-medsun/) - We need better ways to track when medical devices hurt patients. Our comments show how to improve the system that collects reports about device problems. Having a better reporting system would help doctors and patients learn about unsafe devices sooner, preventing injuries and saving lives.
- [Thousands of Deaths Linked to Weak US Air Pollution Rules](https://www.center4research.org/thousands-of-deaths-linked-to-weak-us-air-pollution-rules/) - Studies show that dirty air kills thousands of Americans each year. Our current air pollution rules are too weak to protect people, especially in poorer communities. The research also shows that Black and low-income communities are especially at risk, highlighting the need for stricter pollution rules to protect public health.
- [Canadians could lose vital safety information amid deep cuts to the U.S. FDA, experts warn](https://www.center4research.org/ctv-fda-cuts-hurt-canada/) - CTV News, April 13, 2025: Canadian and U.S. experts explain how huge cuts in FDA staff made by the Trump Administration can harm public health in U.S. and Canada, especially by delaying recalls in unsafe medical products and food.
- [NCHR Report: Breast Implant Illness -- What's the Evidence?](https://www.center4research.org/breast-implant-illness-bii-evidence/) - The National Center for Health Research report on Breast Implant Illness (BII) reviews decades of research before and after the term Breast Implant Illness became popular. Whether referred to as autoimmune symptoms, neurological symptoms, connective tissue disease, neurological symptoms, or BII, we find clear evidence of an increase in symptoms associated with breast implants, compared to women who do not have breast implants. We provide specific examples of how research that dismissed the evidence was poorly designed, often focusing on specific autoimmune diseases, only evaluated hospitalization as evidence of disease, studied women who had breast implants for a short period of time, or had other major flaws.
- [NCHR Report: The Health Risks of MRIs with Gadolinium-Based Contrast Agents](https://www.center4research.org/health-risks-of-gbcas/) - Gadolinium-based contrast agents can improve the diagnostic accuracy of MRIs, however gadolinium can stay in the body for months or years. There are many unanswered questions about who develops health problems related to gadolinium, how to determine if symptoms are due to gadolinium, and how to prevent or treat gadolinium-related conditions.
- [Is TMS Proven Effective for Depression?](https://www.center4research.org/is-tms-proven-effective-depression/) - This report will examine how TMS became a frequently used treatment for depression in the United States despite what the research of the last decade shows about its very questionable effectiveness.
- [National Center for Health Research Public Comment Regarding FDA Draft Guidance for Industry: “Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction” (Docket No. FDA-2007-D-0435)](https://www.center4research.org/nchr-fda-obesity-guidance-comment-2025/) - NCHR supports FDA’s draft guidance on studies needed for drugs intended to help adults and children with obesity or overweight with serious health problems, but we urge the FDA to require studies of 3 years rather than 1 year to ensure that the drugs are effective attaining and maintaining weight loss. In our written public comment, we also recommended that FDA require the research to include possible side effects and complications of long-term use or of discontinuation of use; require prior non-drug interventions before enrollment in a study of a weight loss drug (especially for children), and more rigorously analyze dropout data to determine the causes and analyses of missing data. These changes are crucial to ensure that patients and clinicians have the evidence they need to make informed, safe, and effective decisions.
- [NCHR Public Comment Regarding the FDA’s Draft Guidance for the Study of Sex Differences in the Clinical Evaluation of Medical Products](https://www.center4research.org/nchr-comment-fda-sex-differences/) - April 7, 2025: NCHR responded to FDA’s request for public comments regarding its guidance on sex differences in studies used as the basis for FDA approval. We strongly support most of the FDA’s proposed guidance, but we note that the agency’s has never required adequate representation of both sexes and so has failed to ensure that all drugs and devices approved for males and females are proven to have benefits that outweigh the risks for both males and females. If products are not adequately tested on a meaningful number of females and males, they should not be approved for females and males.
- [Free patient booklet on ductal carcinoma in situ (DCIS)](https://www.center4research.org/free-patient-booklet-on-ductal-carcinoma-in-situ-dcis/) - Our patient booklet, DCIS: What You Need to Know, helps women diagnosed with DCIS understand the difference between DCIS and Stage 1 breast cancer, and discuss treatment options with their doctor. It was funded by a grant from the DC Cancer Consortium through the Department of Health, Government of the District of Columbia, with additional support from the Jacob and Hilda Blaustein Foundation.
- [NCHR’s Testimony to FDA Regarding Reclassification of 4 Medical Devices](https://www.center4research.org/nchrs-testimony-to-fdas-orthopaedic-and-rehabilitation-devices-panel-of-the-medical-devices-advisory-committee-regarding-reclassification-of-devices/) - September 8, 2020: NCHR’s Dr. Meg Seymour expressed concern about the lack of sufficient public information available to evaluate the reclassification of four medical devices. Her testimony emphasized that FDA executive summaries provide minimal details about study design, patient demographics, and clinical endpoints, making it impossible to determine if the proposed special controls would adequately mitigate risks.
- [Open Letter to Stephen M. Hahn, M.D., Commissioner of the Food and Drug Administration: #ProtectTheFDA](https://www.center4research.org/open-letter-to-stephen-m-hahn-m-d-commissioner-of-the-food-and-drug-administration-protectthefda/) - In September 2020, medical and public health experts wrote to the FDA Commissioner to express concern about political influence on FDA's COVID-19 vaccine decision-making, saying it could potentially compromise scientific integrity and public trust. The open letter called on Commissioner Hahn to ensure vaccine approvals remain independent, transparent, data-driven, and free from partisan pressure, urging actions like consulting with other scientific bodies before issuing emergency authorizations.
- [NCHR Comments on Hearing Loss Screening in Older Adults](https://www.center4research.org/nchr-comments-on-hearing-loss-screening-in-older-adults/) - October 5, 2020: The National Center for Health Research agrees with the United States Preventive Services Task Force's conclusion that there is insufficient evidence of the benefits or harms of screening asymptomatic adults aged 50 and older.
- [Feeding Your Pet A Raw Meat Diet Can Be Harmful To Your Health](https://www.center4research.org/feeding-your-pet-a-raw-meat-diet-can-be-harmful-to-your-health/) - Feeding pets raw meat-based diets can harbor harmful bacteria that transmit to humans through food preparation, pet contact, or environmental contamination, potentially causing serious illness.
- [Ways to Help Prevent Breast Cancer](https://www.center4research.org/ways-to-help-prevent-breast-cancer/) - Here’s good news about how to help prevent breast cancer with 7 effective strategies. These include managing your weight, avoiding hormone therapy for menopause, avoid hormone-disrupting chemicals in plastic, reducing your stress, a healthy diet, breast feed, avoid smoking and drink less alcohol.
- [Can Children Get Exercise Through Video Games? (“Exergaming”?)](https://www.center4research.org/can-children-get-exercise-through-video-games-exergaming/) - Explore whether exergaming provides adequate exercise for children. Researchers suggest that exergames should be used as a supplement to more traditional forms of physical activity, rather than a replacement.
- [NCHR's Testimony to FDA on the TransMedics® Organ Care System™ (OCS) Liver System](https://www.center4research.org/nchrs-testimony-to-fda-on-the-transmedics-organ-care-system-ocs-liver-system/) - NCHR Fellow Dr. Meg Seymour testified at an FDA Advisory Committee regarding concerns about the TransMedics Organ Care System (OCS) Liver System. While the device showed superiority on a surrogate endpoint, it did not improve survival compared to traditional cold storage and introduced additional risks caused by device malfunction and organ damage.
- [NCHR's Testimony to FDA on the TriGUARD 3 Device](https://www.center4research.org/nchrs-testimony-to-fda-on-the-triguard-3-device/) - NCHR’s Dr. Meg Seymour testified at an FDA Advisory Committee about why the TriGUARD 3 device is not substantially equivalent to its predicate device, Sentinel. She explained that TriGUARD 3 failed to meet its primary effectiveness endpoint, with patients twice as likely to have a stroke compared to the control group.
- [Training Journalists and Researchers to Communicate Key Healthcare Findings](https://www.center4research.org/training-journalists-and-researchers-to-communicate-key-healthcare-findings-2/) - The National Center for Health Research's "Spreading the Word" project (2018-2021) connected journalists, researchers, and medical experts to effectively explain and disseminate important medical research information from new studies. This PCORI-funded initiative included workshops, teleconferences, and training webinars designed to improve communication of clinical effectiveness research (CER).
- [Safely Dispose of Leftover Pills and Keep Drugs out of Drinking Water](https://www.center4research.org/safe-pill-disposal/) - Do you know how to properly dispose of your unused medications in a way that is safe for your family and for your community? While the FDA recommends flushing certain dangerous drugs, research shows these pharmaceuticals can contaminate drinking water and potentially harm humans and wildlife. Learn about safer alternatives.
- [NCHR's Letter to Elmsford NY Superintendent and District Clerk](https://www.center4research.org/nchrs-letter-to-elmsford-superintendent-and-district-clerk/) - NCHR President Dr. Diana Zuckerman warns Elmsford NY officials about the risks of artificial turf and rubber playground surfaces, citing research on lead, PFAS, and hormone-disrupting chemicals that threaten children's health.
- [NCHR Public Comment on AHRQ Draft Review on Partial Breast Irradiation and Whole Breast Irradiation for Breast Cancer](https://www.center4research.org/nchr-comment-ahrq-review-partial-breast-irradiation-and-whole-breast-irradiation-for-breast-cancer/) - The National Center for Health Research supports AHRQ's draft review finding that partial breast irradiation (PBI) is effective for select early-stage breast cancer patients, with most outcomes comparable to whole breast irradiation (WBI) at 5-10 years. NCHR emphasizes the need for additional research on different PBI types and long-term outcomes at 15-20 years, particularly across diverse patient populations.
- [Patient, Consumer, and Public Health Coalition Letter to Senator Braun Regarding the Promising Pathways Act](https://www.center4research.org/coalition-letter-promising-pathways-act/) - NCHR and the Patient, Consumer, and Public Health Coalition oppose the Promising Pathways Act, which would allow FDA to approve drugs that aren’t proven to work and then to remain on market for up to 8 years without proof of effectiveness. The bill is supposed to help provide treatment for the most serious diseases, but is poorly written, providing false hope, huge financial burdens for patients and Medicare, and undermining existing FDA pathways that are more targeted to urgently needed treatments.
- [Americans Are Paying Billions to Take Drugs That Don’t Work ](https://www.center4research.org/americans-are-paying-billions-to-take-drugs-that-dont-work/) - Bloomberg, April 15, 2024: Since 2014, pharmaceutical companies have made over $3.6 billion from FDA-approved drugs that were later withdrawn or proven ineffective. This news article explores how fast-track approvals may prioritize speed over efficacy, wasting your money and not helping you fight serious diseases.
- [NCHR Comment on EPA's New Chemical Review Program](https://www.center4research.org/nchr-comment-epas-new-chemical-review-program/) - January 17, 2017. As a think tank focused on public health, we strongly agree that chemicals should be carefully evaluated before they are sold, as well as afterwards. People who work around new chemicals should be informed of the risks and the appropriate protections. Thorough evaluations of new chemicals by the EPA can reduce the risks of many new chemicals, saving lives and improving the health of people who live and work in the United States.
- [Sientra’s Silimed Brand "Gummy Bear" Silicone Gel Breast Implants Pose Safety Questions](https://www.center4research.org/sientras-silimed-brand-gummy-bear-silicone-gel-breast-implants-pose-safety-questions/) - In December 2012, the FDA approved Sientra’s “Silimed silicone gel breast implants.” These implants are also called “gummy breast implants” because they are made of a thicker gel that is said to resemble candy gummy bears. But are they safe?
- [NCHR Testimony to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria](https://www.center4research.org/testimony-presidential-advisory-council-combating-antibiotic-resistant-bacteria/) - January 25, 2017. NCHR’s Dr. Stephanie Fox-Rawlings spoke at this meeting about effective strategies to reduce antibiotic resistance.
- [Trump’s Proposed Changes Gut FDA While Targeting Drug Prices](https://www.center4research.org/trumps-proposed-changes-gut-fda-targeting-drug-prices/) - Legal Reader, February 2, 2017. In a study published on the JAMA Network, Dr. Zuckerman and her co-author, Tracy Rupp, looked at certain new – and expensive – cancer drugs. They found that many of these drugs failed to improve patient quality of life or extend patient life.
- [Letter to Senators Opposing Nomination of Scott Pruitt to Head the EPA](https://www.center4research.org/letter-senators-opposing-nomination-scott-pruitt-head-epa/) - February 15, 2017. We joined 233 other organizations in signing this letter to Senators opposing the nomination of Scott Pruitt to head the EPA.
- [Drug Companies Are Exploiting This Law to Keep Prices High](https://www.center4research.org/drug-companies-exploiting-law-keep-prices-high/) - Attn, March 8, 2017. Pharmaceutical companies are exploiting a Food and Drug Administration (FDA) policy to undermine competitors and maintain monopolies on their products.
- [NCHR Testimony on Use of the Term "Healthy" in Food Labeling](https://www.center4research.org/nchr-testimony-use-term-healthy-food-labeling/) - March 9, 2017. NCHR feels that labeling foods with the term "healthy" can become a powerful marketing tool that is easily misused and abused.
- [Trump’s FDA Nominee Spurs Concerns About Drug Approvals, Off-Label Promotion](https://www.center4research.org/trumps-fda-nominee-spurs-concerns-drug-approvals-off-label-promotion/) - Bloomberg BNA, March 14, 2017. President Donald Trump’s pick to head the FDA is spurring concerns about drug approvals and off-label promotion.
- [NCHR Comment to EPA on Regulation of Certain Uses of Trichloroethylene](https://www.center4research.org/nchr-comment-epa-regulation-trichloroethylene/) - March 15, 2017. In summary, the use of TCE for aerosol degreasing and dry cleaning spot removal represent unreasonable health risks to workers, consumers, and bystanders that cannot be appropriately mitigated. Our scientific analysis agrees with the EPA decision that these uses should be prohibited.
- [NCHR Comment to EPA Regarding Risk Evaluation Scoping Effort Under TSCA for Ten Chemical Substances](https://www.center4research.org/nchr-comment-epa-regarding-risk-evaluation-scoping-effort-tsca-ten-chemical-substances/) - March 15, 2017. We strongly support efforts of the Environmental Protection Agency (EPA) to improve chemical review, as required by the 2016 Frank H. Lautenberg Chemical Safety for the 21st Century Act. These first 10 chemical evaluations will set a precedent for future evaluations under this law. Therefore, it is imperative that the EPA adequately and appropriately evaluate these chemicals using sufficient, high quality information on harms, exposure, and conditions of use to evaluate the risks these chemicals pose to health.
- [NCHR Testimony on Labeling and Misuse of Peroxide-Based Contact Lens Products](https://www.center4research.org/nchr-testimony-labeling-misuse-peroxide-based-contact-lens-products/) - March 17, 2017. NCHR feels that the only way to avoid misuse and accidents with peroxide-based contact lens solution is to only make these products available behind the counter.
- [Perspectives on Mental Health for Long COVID Patients Webinar](https://www.center4research.org/webinar-5-long-covid-mental-health/) - January 23, 2023: In the final installment of the Long Covid Teleconference, NCHR Presents ‘Perspectives on Mental Health for Long COVID Patients’ featuring Dr. Jennifer Olsen from the MedStar National Rehabilitation Network, Dr. Helen Lavretsky of UCLA, and Professor Leonard Jason from DePaul University.
- [Perspectives of Physical Therapy for Long COVID Webinar](https://www.center4research.org/webinar-4-long-covid-physical-therapy/) - December 1, 2022: In the 4th installment of the Long Covid Teleconference, NCHR presents ‘Perspectives on Physical Therapy for Long Covid’ featuring Alana Patrick, DPT GCS from the Minneapolis VA Med Center, John Barry DPT OCS of U Penn, and patient advocate Rachel Robles.
- [Multidisciplinary Assessment and Treatment Models for Long COVID Webinar](https://www.center4research.org/webinar-3-long-covid-multidisciplinary-assessment-and-treatment-models/) - June 30, 2022: In the 3rd installment of the Long Covid Teleconference, NCHR Presents ‘Multidisciplinary Assessment and Treatment Models for Long COVID’ featuring Dr. Benjamin Abramoff from UPenn, Dr. Alba Azola from Johns Hopkins, and patient advocate Rachel Robles.
- [Mind-Body Integrative Approaches to Long COVID Webinar](https://www.center4research.org/webinar-2-long-covid-mindbody-integrative-approaches/) - April 21, 2022: In the 2nd installment of the Long Covid Teleconference, NCHR Presents ‘Mind-Body and Integrative Approaches to Long COVID’ featuring Dr. Michelle Simon of the Institute for Natural Medicine, Christine Kaiser, DACM of the University Hospital in Cleveland, and Dr. Helen Lavretsky of UCLA.
- [Long COVID and Disability Benefits Webinar](https://www.center4research.org/webinar-1-long-covid-disability/) - February 8, 2022: In the first installment of the Long Covid Teleconference, NCHR presents ‘Long COVID and Disability Benefits: What You Need to Know’ featuring Barbara B. Comerford, Esq. who shares her expertise on long-term disability insurance claims.
- [Guest Lecture by Diana Zuckerman for Georgetown University Grad Students](https://www.center4research.org/guest-lecture-by-diana-zuckerman-for-georgetown-university-grad-students/) - April 10, 2024: NCHR president Diana Zuckerman gave a guest lecture to Georgetown University grad students discussing the lead, PFAS, EDCs, and other carcinogens and toxic materials in artificial turf, rubber playground surfaces, and recycled tire tiles & mulch that are used at homes, schools, and daycare centers. This is the text of that lecture, with photos from the PowerPoint slides.
- [ADHD Drugs Under Scrutiny by RFK Jr.'s Make America Healthy Again (MAHA) Commission](https://www.center4research.org/adhd-new-maha-commission-news/) - Everydayhealth.com, March 17, 2025: President Trump's executive order will create a MAHA Commission to examine the use of ADHD and psychiatric drugs for children. This news article focuses on whether access to ADHD drugs will harm children. NCHR reassures parents that access is unlikely to be harmed. We view the Commission as a good idea, but those views were not included in the article.
- [‘Operation Stork Speed’: HHS, FDA Launch Plan for More Testing, Scrutiny of Infant Formula Ingredients](https://www.center4research.org/defender-operation-stork-speed-infant-formula/) - The Defender, March 19, 2025: Operation Stork Speed will require increased testing for heavy metals and other contaminants in infant formula and will review nutrients. NCHR points out that a new Consumer Reports investigation found arsenic, lead, and PFAS in several types of infant formula, which confirms that this effort is long overdue.
- [Is Vaping Safer than Smoking Cigarettes?](https://www.center4research.org/vaping-safer-smoking-cigarettes-2/) - Don’t be fooled. E-cigarettes and vapes are very addictive, contain cancer-causing chemicals, may cause stroke and may cause DNA damage. They are not safe.
- [RFK Jr. brings FDA under tighter control with HHS workforce cuts](https://www.center4research.org/statnews-fda-3500-staff-cuts/) - STAT News, March 27, 2025: We explain why RFK Jr's plan to cut 3,500 FDA staff will be "extremely disruptive and not productive" for at least a few years. Reviewers and inspectors' productivity will be hurt even if they are not cut and as a result patients and industry will be harmed because new drugs and devices will not be reviewed as quickly or as carefully. RFK's plans to improve infant formula and food safety more generally will require more staff, not fewer. Why were these cuts decided before the new FDA Commissioner was in place at the FDA and had the opportunity to decide what would be best for the agency and the public?
- [NCHR's FDA Advisory Committee Testimony on Carbetocin Nasal Spray for Hyperphagia in Prader Willi Syndrome](https://www.center4research.org/nchrs-testimony-on-carbetocin-nasal-spray-for-hyperphagia-in-prader-willi-syndrome/) - November 4, 2021. NCHR agrees with FDA criticisms of the evidence. Families urgently need help, but the company should spend a few more months to establish whether this drug is effective and safe for more than 8 weeks – BEFORE FDA considers approving it.
- [ADHD Treatment: Medications and Alternatives](https://www.center4research.org/adhd-treatment-medications-and-alternatives/) - ADHD is a frequently diagnosed condition, and many children and adults take medication to help control the symptoms. But the medication can have serious side effects, there are concerns that ADHD is overdiagnosed and the medications are misused or abused, and there are alternative treatments. This article explains the risk and benefits of medications and includes alternatives that can reduce dosage or replace medications.
- [The FDA’s misguided thinking on antibiotics](https://www.center4research.org/the-fdas-misguided-thinking-on-antibiotics/) - STAT, February 10, 2025: Why are so many people dying from infections? In this op-ed, Diana Zuckerman and John Powers discuss that the main problem isn't antimicrobial resistance; the problem is the way antibiotics are studied and approved. Research shows we can save lives with better studies and FDA approval standards that focus on patients and not bugs.
- [Letter to Santa Clara Officials on Artificial Turf and Playground Surfaces](https://www.center4research.org/nchr-letter-artificial-turf-santa-clara-ca/) - Letter from NCHR President Dr. Diana Zuckerman to public health officials in Santa Clara, California about the dangers of artificial turf and playground surfaces including extreme heat and toxic exposure.
- [Children and Athletes at Play on Toxic Turf and Playgrounds](https://www.center4research.org/children-athletes-play-toxic-turf-playgrounds/) - Is your child playing on rubber instead of grass at the playground? The use of human-made surfaces on playgrounds has increased dramatically over the years. Developed during the 1960s primarily for athletic fields, these artificial surfaces were also part of a strategy to provide children with more opportunities for outdoor physical activity, particularly in the inner city where outdoor playgrounds were scarce.The first artificial turf (marketed as “Chemgrass”) was made of plastic, yet looked a lot like natural grass.
- [A documentary about menopause has ‘misinformation’ and shouldn’t be used to educate docs, critics say](https://www.center4research.org/stat-menopause-documentary-fsmb/) - STAT News, November 21, 2024: We joined other experts in criticizing the Federation of State Medical Boards (FSMB) for their documentary on menopause, which includes several inaccurate claims that hormone therapy has health benefits (such as preventing dementia and heart disease) that are not supported by research.
- [Public Comment of National Center for Health Research Regarding Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway](https://www.center4research.org/nchr-fda-confirmatory-trial-underway-comment-draft-guidance/) - March 10, 2025: National Center for Health Research supports FDA's decision to require that a confirmatory trial is "underway" before granting accelerated approval, but the definition of underway needs to be defined stringently and clearly. In our written public comment, we recommended setting specific benchmarks and stronger oversight to ensure timely trial completion so that patients and physicians can make informed medical decisions about products approved under the accelerated program. We also state that the closer to completion the confirmatory trial is at the time of accelerated approval, the more useful the research evidence is likely to be. We also urge that no exceptions be made to the requirement.
- [NCHR's Public Comment on Early Alzheimer's Disease: Developing Drugs for Treatment; Draft Guidance for Industry](https://www.center4research.org/nchr-comment-early-alzheimers-drug-development/) - June 10, 2024: NCHR disagrees with assumptions made in FDA guidance aimed at developing drugs for treatment of early stages of Alzheimer's dementia.
- [The Deadly Secrets Behind “Breakthrough” Alzheimer’s Drugs](https://www.center4research.org/lever-alzheimers-drugs-expose/) - The Lever, January 28, 2025: We are working with a consortium of experts to expose problems with FDA approvals. Our first article published in The Lever focuses on the clear risks and questionable benefits of drugs for early cognitive impairment caused by Alzheimer's and how conflicts of interest resulted in approval.
- [As Trump Administration Probes Long-Approved Medications, Could FDA Revoke Approvals?](https://www.center4research.org/medscape-maha-commission-psychiatric-adhd-drug-safety-kids/) - Medscape March 6, 2025: MAHA Commission will study psychiatric, ADHD, and weight loss drugs' impact on children. NCHR’s Diana Zuckerman agrees we need better evidence that the benefits of these drugs outweigh the risks.
- [Letter to Wethersfield CT Officials on Artificial Turf](https://www.center4research.org/wethersfield-ct-nchr-letter-arpa-turf/) - October 17, 2024: NCHR President Dr. Diana Zuckerman wrote a letter to Wethersfield CT officials raising concerns about the use of ARPA funds for artificial turf with PFAS and other EDCs.
- [FDA Reviews Medical Device Approval Process](https://www.center4research.org/cbs-fda-medical-device-approval-process/) - CBS News, February 14, 2011. Dr. Diana Zuckerman and Dr. Steven Nissen agree: the FDA needs to enforce more stringent standards for medical devices to ensure that they are safe before they can be sold in the US, instead of after they are causing harm.
- [Institute of Medicine Report: Medical Devices Lack Evidence of Safety and Effectiveness](https://www.center4research.org/report-medical-devices-lack-evidence-safety-effectiveness/) - July 29, 2011. The prestigious Institute of Medicine (IOM) released a report on the Food and Drug Administration's 510(k) medical device clearance process stating the system is "flawed" and should be revised. The report echoes the National Research Center for Women & Families' concerns about the lack of evidence that these devises actually work and are safe.
- [Testimony of of Dr. Diana Zuckerman at Senate Special Committee on Aging Hearing on Medical Devices](https://www.center4research.org/testimony-dr-diana-zuckerman-phd-senate-special-committee-aging-hearing-medical-devices/) - April 13, 2011: Dr Diana Zuckerman of NCHR testified at a Senate Special Committee on Aging Hearing on medical devices, explaining FDA low standards for approval. She said lives could be saved and patients would spend less time in the hospital if FDA implemented the law as required. Billions of Medicare dollars could be saved.
- [Should You Get a Sentinel Lymph Node Biopsy (SLNB) for Stage Zero Breast Cancer (DCIS)? Or for Very Small Stage 1 Breast Cancer?](https://www.center4research.org/should-you-get-a-sentinel-lymph-node-biopsy-slnb-for-dcis-or-tiny-stage1-breast-cancer/) - Are sentinel lymph node biopsies for DCIS (stage zero breast cancer) or very tiny Stage 1 breast cancer a good way to “be cautious” to prevent breast cancer in the future, or is it overtreatment? The biopsies add to the pain and the cost of surgery, and they almost never find cancer in the lymph nodes, so the evidence shows they don't reduce the chances of developing new cancer in the next 5 years.
- [Understanding the IUD](https://www.center4research.org/understanding-the-iud/) - IUDs are one of the most effective forms of birth control , providing reliable, long-term contraception for women. With hormonal and copper options, IUDs work by preventing sperm from fertilizing the ovum (egg), and they can last from 3 to 10 years. This article explains what you need to know about IUDs, including their benefits, risks, and the latest research
- [Pfizer hires FDA drug regulator Cavazzoni, sparking revolving door debate](https://www.center4research.org/pfizer-hires-fda-cavazzoni-sparking-debate/) - Politico, February 24, 2025: FDA Director of Drug Center (CDER), Cavazzoni, returns to Pfizer, where she worked before going to the FDA. NCHR and other experts say this revolving door undermines trust in the FDA and highlights concerns about the cozy relationship between the FDA and industry that can weaken standards of safety and effectiveness.
- [National Center for Health Research Public Comment on FDA Draft Guidance: Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics](https://www.center4research.org/nchr-comment-accelerated-approval-draft-guidance/) - February 4, 2025: In our written public comment, we urged FDA to improve its draft guidance on the accelerated approval process by requiring and enforcing timely confirmatory trials proving meaningful clinical benefit based on validated measures of overall survival and quality of life.
- [Letter to Washington D.C. officials about importance of maintaining a natural grass field](https://www.center4research.org/nchr-testimony-lafayette-field-turf/) - February 20, 2025: NCHR letter to the Washington D.C. Department of General Services emphasizing the public health importance of maintaining a natural grass field instead of artificial turf at Lafayette Elementary.
- [What are Artificial Turf and Playgrounds Made Of? Can They Cause Cancer? Obesity? Asthma? Lower IQ?](https://www.center4research.org/artificial-turf-playgrounds-made-can-cause-cancer-obesity-asthma/) - There is growing evidence that all artificial fields and playgrounds are made with materials that can be dangerous for children and adults. Our Center has testified before the Washington, D.C. City Council, and we are working with parents across the country who seek our help in convincing their communities to choose grass and avoid artificial turf whenever possible.
- [To Tamiflu or Not to Tamiflu? Are other flu treatments Better?](https://www.center4research.org/tamiflu-not-tamiflu/) - When the flu is hitting hard you may have friends, relatives, or co- workers that are getting sick. Here is the information you need to know about current treatment options for the flu.
- [National Center for Health Research Comment on Medicare Coverage for Transcatheter Tricuspid Valve Replacement](https://www.center4research.org/nchr-cms-ttvr-ced-comment-2025/) - January 18, 2025: National Center for Health Research questioned CMS' proposed Medicare coverage with evidence development (CED coverage) for TTVR because the device isn't proven to save lives or reduce hospitalization. In our written public comment, we said that patients' quality of life is also very important, but it should be evaluated in an unbiased way that does not make a device seem more beneficial than it really is.
- [December 12, 2024: Testimony of Dr. Siddiqui at FDA Vaccines and Related Biological Products Advisory Committee Meeting](https://www.center4research.org/fda-nchr-rsv-vaccine-risks-infants-toddler/) - December 12, 2024: NCHR Postdoctoral fellow Dr. Saman Siddiqui testified at the FDA Advisory Committee meeting about the need for better clinical trials of RSV vaccines for infants and toddlers because of serious risks in that age group.
- [Agent Orange and Serious Diseases including Multiple Myeloma](https://www.center4research.org/agent-orange-serious-diseases-including-multiple-myeloma/) - It has taken many years to determine how Agent Orange exposure during the Vietnam War has harmed the health of those who were exposed. One of the reasons is that it can take decades for cancer to develop after a dangerous exposure.
- [FDA webpages on clinical trial diversity removed after Trump orders](https://www.center4research.org/medtechdive-news-fda-webpages-removed-2025/) - MedTechDive, January 27, 2025: FDA webpages on how to improve diversity in clinical trials and other topics were immediately removed after Trump was inaugurated and ordered numerous federal agencies to pause in communicating with the public. We explain that diversity in clinical trials is not affirmative action, it is needed to ensure that medical products are safe and effective for males and females and for people of all ages and races. The new FDA Commissioner hasn’t been confirmed, so who made these decisions?
- [In debate over obesity medications, FDA shifts toward importance of drugs in subtle ways](https://www.center4research.org/stat-fda-favors-weight-loss-drugs-instead-of-diet-exercise/) - STAT News, January 10, 2025: The FDA's new guidance to Pharma on how to develop weight loss drugs reflects a cultural shift that treats drugs as the first resort instead of the last resort if changing eating habits and exercising doesn't work.
- [Beyond Step Counting: Wearable Tech Promises Medical-grade Data](https://www.center4research.org/barrons-afp-wearable-tech-medical-devices/) - Barron’s, January 8, 2025: Barron's article from AFP News describes the promise of new wearable medical devices for improving health and the criticisms by NCHR’s Diana Zuckerman and other experts regarding the lack of certainty about their accuracy due to low regulatory standards by the FDA. This makes it difficult to know which products are accurate and which ones aren't.
- [FDA Off-Label Drug Guidance: 3 Things to Know](https://www.center4research.org/fda-off-label-drug-guidance/) - Law360, January 7, 2025: FDA Final Guidance on promoting off-label uses of approved drugs will increase sales but we explain it misleads doctors and patients about safety and efficacy because unapproved uses of drugs are not proven to be safe or effective.
- [Inside The U.S. Effort To Boost The Natural Grass Industry](https://www.center4research.org/forbes-usda-boost-natural-grass-industry/) - Forbes, December 22, 2024: This excellent article in Forbes explains how USDA is trying to boost the natural grass industry for its advantages compared to artificial grass and its importance to the economy. NCHR agrees that natural grass is safer than plastic grass and explains why.
- [NCHR Public Comment on Communications From Firms to Healthcare Providers Regarding Scientific Information on Unapproved Uses of Approved Medical Products](https://www.center4research.org/nchr-comment-fda-siuu-draft-guidance-unapproved-uses-promotion/) - NCHR comment to FDA draft guidance about limits on scientific info SIUU that companies can give to doctors about the unapproved uses of approved drugs & devices
- [NCHR Agrees with CDC Draft Recommendation to Remove Liraglutide and Pertuzumab from the National Institute for Occupational Safety and Health Hazardous Drugs in Healthcare Settings List](https://www.center4research.org/nchr-comment-cdc-draft-recommendation-liraglutide-pertuzumab-niosh-list/) - February 15th, 2024: NCHR supports the CDC recommendation to remove Liraglutide and Pertuzumab drugs from the NIOSH List of Hazardous Drugs in Healthcare Settings. We agree that due to the to the drugs' low bioavailability and limited risk of occupational exposures these drugs are unlikely to pose a harm to healthcare workers.
- [National Center for Health Research Comment on USPSTF Draft Recommendations on Cervical Cancer Screening](https://www.center4research.org/nchr-public-comment-uspstf-cervical-cancer-screening-2025/) - January 13, 2025: Our public comment on the USPSTF draft recommendation for cervical cancer screening emphasized the need for balanced screening strategies. We highlighted the importance of integrating cytology as a triage step after HPV-positive results, addressing follow-up care, and ensuring equitable access to minimize overtreatment and psychological distress.
- [NCHR Comment on Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Falls and Fractures in Community-Dwelling Adults](https://www.center4research.org/nchr-comment-vitamin-d-calcium-primary-prevention-falls-fractures/) - January 21, 2025: NCHR written public comment supporting the conclusions drawn by the USPSTF and providing suggestions for improvements of their draft recommendation about Calcium, Vitamin D, and combined supplementation to prevent falls and fractures.
- [Letter to Sunnyvale, CA City Council on Artificial Turf and Playground Surfaces](https://www.center4research.org/letter-to-sunnyvale-ca-city-council-on-turf-and-playground-surfaces/) - August 25, 2024: Letter from NCHR President Dr. Diana Zuckerman to officials in Sunnyvale, CA to support the proposed ban of artificial turf for city-owned property and explain the health impacts of turf and playground surfaces.
- [LA California Public Comment Submission on Artificial Turf](https://www.center4research.org/nchr-public-comment-la-california-on-artificial-turf/) - September 16, 2024: NCHR president Dr. Diana Zuckerman submitted a public comment to City of Los Angeles Officials on the dangers and potential health impacts of artificial turf.
- [Letter to Recreation Commission in Hingham, Massachusetts About PIP Playgrounds](https://www.center4research.org/nchr-letter-artificial-turf-hingham-ma/) - October 11, 2024: Letter from NCHR President Dr. Diana Zuckerman to officials in Hingham, Massachusetts explaining the dangers and potential harms of poured-in-place playground surfaces.
- [Letter to PA Officials on installation of Artificial Turf at FDR Park](https://www.center4research.org/nchr-letter-artificial-turf-pa/) - November 18, 2024: NCHR president Dr. Diana Zuckerman wrote a letter to PA officials explaining the harm to community members that would be caused by installing artificial turf in FDR Park in Philadelphia, PA.
- [What You Need to Know About Alzheimer’s Disease and Other Dementias](https://www.center4research.org/what-you-need-to-know-about-alzheimers-disease/) - Alzheimer’s Disease is one of the leading causes of death for Americans ages 65 and older. It is the most common cause of dementia (as much as 60-80% of dementia cases are caused by Alzheimer’s Disease), and 11% of Americans ages 65 and older are estimated to have dementia caused by Alzheimer’s Disease
- [Invited Panel Presentation of Dr. Diana Zuckerman at FDA OMUFA Meeting](https://www.center4research.org/omufa-nchr-2024-invited-presentation/) - November 20, 2024: We were invited to present at the FDA OMUFA November 2024 meeting on the OTC user fee program commitment letter. We appreciate the priority given to safety OMORs (Monograph revisions) but are concerned that the funding is focused on speed of reviews and industry access to FDA staff, not to pay for staff to conduct FDA safety reviews of OTC medications being sold for years without evidence of safety and effectiveness. OTC products will be safer if consumers and public health experts are present when negotiations take place.
- [NCHR Public Comment on FDA Voluntary Sodium Reduction Goals](https://www.center4research.org/fda-sodium-guidance-nchr-comments/) - January 13, 2025: FDA has drafted new targets to reduce the high levels of sodium (salt) in Americans' diet. NCHR urged the FDA to lower voluntary sodium targets for restaurants and food companies so that they meet the recommended maximum daily consumption. If voluntary targets aren't met, NCHR told the FDA that targets should be mandatory in order to save lives.
- [NCHR Public Comment Regarding Device Trial Participation Snapshots](https://www.center4research.org/fda-device-snapshots-comments-nchr/) - January 13, 2025: In response to FDA's draft of medical device Snapshots, NCHR urged FDA to add more information about risks and benefits in wording that is easy to understand. The information should also quantify the risks and benefits and explain the implications of the strengths and weaknesses of the evidence. The SnapShots should be brief but should include the information that helps patients and physicians make important decisions about whether the device has benefits that outweigh the risks for patients.
- [Diana Zuckerman Comments on the U.S. Consumer Product Safety Commission Priorities for FY2025/2026](https://www.center4research.org/nchr-cpsc-priorities-2025-2026/) - May 8, 2024: NCHR recommended that Consumer Product Safety Commission FY 2025-26 priorities include reducing exposures to PFAS and other chemicals, lead, and heavy metals in tire crumb used in homes, backyards, daycare, playgrounds, and artificial turf fields.
- [Testimony of Dr. Diana Zuckerman, House of Representatives Small Business Committee](https://www.center4research.org/zuckerman-testimony-small-business-committee-2/) - May 8, 2024: On behalf of NCHR, Diana Zuckerman's testimony at the House Small Business Committee explains that FDA regulations save lives and saves patients' financial security and do not interfere with innovation in healthcare.
- [NCHR's Comments on USPSTF's Draft Recommendation Regarding Vitamin D Screening](https://www.center4research.org/nchrs-comments-uspstfs-draft-recommendation-statement-regarding-vitamin-d-screening/) - The available evidence is still insufficient to assess the benefits and harms of vitamin D screening for asymptomatic adults.
- [Vivek Ramaswamy’s crusade to change FDA could boost biotech, and himself](https://www.center4research.org/washington-post-ramaswamy-conflicts-of-interest-doge/) - The Washington Post, November 25, 2024: This news article quotes NCHR and other experts explaining that Vivek Ramaswamy is a former biotech executive who is very critical of the FDA in ways that reflect his extensive conflicts of interest. If Donald Trump follows Ramaswamy's advice, Ramaswamy is likely to greatly increase his wealth and patients will be harmed by paying for expensive new medications that do not work.
- [NCHR Signed On to Letter Urging Greater Appropriations for the Consumer Product Safety Commission](https://www.center4research.org/letter-increase-consumer-product-safety-commission-funding/) - NCHR and other non-profit organizations sent a letter urging increased FY 2025 appropriations for the Consumer Product Safety Commission. CPSC funding should not be subject to cuts or restrictions that would further undermine its ability to protect the public from hazardous consumer products.
- [Dr. Diana Zuckerman Testimony at the House Small Business Committee Hearing](https://www.center4research.org/zuckerman-testimony-small-business-committee/) - May 8, 2024: On behalf of NCHR, Diana Zuckerman's testimony at the House Small Business Committee explains that FDA regulations save lives and saves patients' financial security and do not interfere with innovation in health care.
- [NCHR Testifies at the Pediatric Oncology Subcommittee Meeting](https://www.center4research.org/nchr-testimony-pediatric-oncology/) - May 22, 2024: NCHR provided public testimony at the pediatric oncology subcommittee meeting regarding Section 504 of the 2017 FDA Reauthorization Act. We expressed concern that efforts to increase availability of new treatments for pediatric cancer have resulted in more planned studies but not in more treatments. We recommended sponsors prioritize engaging with key stakeholders such as the EMA Paediatric Committee, FDA Pediatric Review Committee, FDA Oncology Subcommittee of the Pediatric Review Committee, the Oncology Center of Excellence, and the use of independent Pediatric Expert Groups.
- [NCHR Testifies at the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting on Shield Guardant Health](https://www.center4research.org/nchr-testimony-molecular-clinical-genetics-panel-medical-devices-advisory-committee-shield-guardant-health/) - May 23, 2024: NCHR provided public testimony at the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting regarding the safety and effectiveness of Shield Guardant blood test for colorectal cancer screening. We advised more research was needed prior to approving the test due to the low sensitivity in detecting colorectal cancer at the earliest stages.
- [Trump's pick for FDA to test 'due diligence' of Agency's science](https://www.center4research.org/bloomberg-law-makary-fda-commissioner/) - Bloomberg Law, November 25, 2024: Dr. Marty Makary has been named by Donald Trump to lead the FDA. The Johns Hopkins surgeon has been an outspoken critic of FDA’s relationships with industry and his appointment could shake up the status quo. NCHR and other experts are optimistic that Dr. Makary will encourage the agency to reduce conflicts of interest and hold industry to a higher standard for FDA approval of medical products and food safety.
- [Testimony of Diana Zuckerman at the FDA Antimicrobial Drugs Advisory Committee Meeting on Sulopenem](https://www.center4research.org/fda-sulopenem-antibiotiv-uti-adcom/) - September 9, 2024: NCHR's Dr. Diana Zuckerman tells FDA Advisory Committee that sulopenem antibiotic is not proven to benefit patients with uncomplicated UTI compared to amoxicillin or Cipro. It should be evaluated in terms of alleviating symptoms, not in terms of bacteria in the urine, and definitely should not be considered a first line treatment.
- [Testimony of Diana Zuckerman at the FDA Gastrointestinal Drugs Advisory Committee Meeting on Ocaliva](https://www.center4research.org/fda-ocaliva-liver-disease-adcom/) - September 13, 2024: NCHR’s Dr. Diana Zuckerman tells FDA Advisory Committee that the data presented on Ocaliva for a rare liver disease does not meet the FDA’s standard of evidence to keep it on the market and that the results do not prove that OCA prevents death or prevents the need for a liver transplant.
- [Testimony of Dr. Zuckerman at FDA Joint Advisory Committees Meeting on Clozapine REMS for Neutropenia](https://www.center4research.org/fda-adcom-clozapine-rems/) - November 19, 2024: We testified at the FDA Advisory Committees joint meeting that the REMS to prevent neutropenia in Clozapine patients is essential to save lives, but that some barriers to patient access should be reduced. Clozapine can cause a dangerous reduction in an important type of white blood cells, making patients vulnerable to infections that require hospitalization and can be fatal.
- [Should I Get the Flu Shot?](https://www.center4research.org/should-i-get-flu-shot/) - It’s that time of year again — time to get your flu shot! Everyone aged 6 months or over and without any restrictive health conditions is encouraged to get the flu shot, not the nasal spray, every year.
- [What Trump’s election win could mean for AI, climate and health](https://www.center4research.org/nature-trump-election-health/) - Nature, November 8, 2024: Nature magazine news article on the impact of Trump election includes views regarding health programs. NCHR asks if RFK Jr. stated plans to "reduce corporate greed" will be implemented, given the close ties between the first Trump Administration and the pharmaceutical industry.
- [Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic.](https://www.center4research.org/medtech-news-tarver-cdrh-director/) - MedTech Dive, October 31, 2024: Article quotes industry officials and NCHR and other patient and consumer advocates about new CDRH director Michelle Tarver and hopes for greater respect for patients, consumers, and researchers during user fee negotiations and FDA decision-making regarding the safety and effectiveness standards for medical devices.
- [Statement of Dr. Diana Zuckerman At the FDA General and Plastic Surgery Devices Advisory Panel on ProSense Cryoablation System](https://www.center4research.org/fda-advisory-panel-zuckerman-testimony-cryoablation-breast-cancer/) - November 7, 2024: We testified at an FDA Advisory Panel meeting to advise FDA whether ProSense Cryoablation can replace lumpectomy for older women with very early, low-risk breast cancer. This technique can freeze and destroy a tumor in a few minutes but the research was not well-designed to determine if it is as safe as lumpectomy, and if so, for which types of patients.
- [What Causes Autism Spectrum Disorder and Why Are More and More Kids Being Diagnosed with It?](https://www.center4research.org/what-causes-autism-spectrum-disorder-and-why-are-more-and-more-kids-being-diagnosed-with-it/) - ASD diagnoses have more than tripled from 1 in 150 (for children born in 1992) to 1 in 44 for children born in 2010 .This article discusses what we know about the causes of this disorder and why more and more children are diagnosed with ASD.
- [Breastfeeding and Rickets](https://www.center4research.org/breastfeeding-and-rickets/) - Breastfeeding is very good for babies, but a 2003 report released by the American Academy of Pediatrics has recommended that breastfeeding babies be given vitamin D supplements to prevent them from developing rickets or vitamin D deficiency.
- [Testimony of Laura Lytle at the FDA Patient Engagement Device Advisory Committee Meeting](https://www.center4research.org/fda-informed-consent-nchr-testimony/) - October 30, 2024: NCHR’s Laura Lytle testified at the FDA Patient Engagement Device Advisory Panel meeting in support of the FDA’s proposed guidance for informed consent, but suggested 4 key areas for improvement: using a short, simple checklist to ensure that patients understand the risks; focusing on informed consent as a process not a document; simple summaries of key information; and ensuring patient privacy.
- [Testimony of Patient, Consumer, and Public Health Coalition at Patient Engagement Device Advisory Committee Meeting](https://www.center4research.org/pcph-coalition-testimony-fda-informed-consent/) - October 30, 2024: Tess Robertson Neel testified at the FDA Patient Engagement Device Advisory Panel on behalf of the Patient, Consumer, and Public Health Coalition regarding informed consent. We support the FDA's proposed improvements, suggests a short, easy to read checklist format to improve fully informed consent, and highlights the need to enforce FDA recommendations or improve incentives for compliance.
- [NCHR Comment on FDA Proposed Rule on the Protection of Human Subjects and Institutional Review Boards(IRB)](https://www.center4research.org/nchr-supports-fda-irbs-proposed-rule/) - December 28, 2022: NCHR public comments on FDA’s proposed rule supports a single IRB for all U.S. centers in multi-center clinical trials and greater diversity among IRB members. We urge the FDA to require more explicit improvements to address known weaknesses in oral and written informed consent procedures and address demographic differences in efficacy and safety of treatments studied clinical trials.
- [F.D.A. names a new chief of medical devices](https://www.center4research.org/nyt-tarver-chief-cdrh/) - New York Times, Oct 22, 2024: Michelle Tarver is the new director of CDRH, FDA medical device center, promoted from within the agency. We are hopeful that she will move CDRH to focus more on ensuring safe and effective medical devices, reversing the bias of former director Jeff Shuren. But given her expertise, why has the agency failed to warn Lasik patients as promised?
- [Letter to Representative Waxman Expressing Concerns About Speeding Up the Development of New Antibiotic Drugs (ADAPT Act)](https://www.center4research.org/letter-rep-waxman-expressing-concerns-speeding-development-new-antibiotic-drugs-adapt-act/) - September 18, 2014. We are writing to express our strong concerns about proposed legislation to speed the development of new antibiotic drugs, H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013. Antibiotic resistance is of grave concern, but this legislation will create more problems than it will solve.
- [Do Antidepressants Increase Suicide Attempts? Do They Have Other Risks?](https://www.center4research.org/antidepressants-increase-suicide-attempts-risks/) - Research shows that antidepressants can increase suicide risk in people. When depressed people become somewhat less depressed, they feel less hopeless and more able to attempt suicide. But there is evidence that antidepressants may also increase the risk of suicide for other reasons, such as akathisia. Other risks from antidepressants include blood clots and birth defects. Antidepressants also have a “placebo effect” that makes the drugs seem more effective than they really are. Safe and effective alternatives include cognitive behavioral therapy and physical activity.
- [High Levels of Toxic Flame Retardants Found in Toys, Kitchen Utensils Made From Black Plastic](https://www.center4research.org/contaminated-plastic-recycling-toxic-black-plastic/) - The Defender, October 2, 2024: Researchers found toxic flame retardants in everyday items made from contaminated recycled black plastic food containers, kitchen utensils, and toys. These toxins are linked to cancer, endocrine disruption, neurotoxicity, and reproductive harm. Plastic recycling is to blame. It is time to come to terms with the misinformation about plastic recycling and demand that FDA and EPA ban unsafe recycled plastic products.
- [NCHR Public Comment on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies](https://www.center4research.org/nchr-comment-diversity-action-plans-draft-guidance/) - September 26, 2024: NCHR appreciates the improvements made in the 2024 FDA draft guidance for Diversity Action Plans but the draft lacks incentives to encourage companies to comply. The indication and label should reflect the evidence for sex, race, ethnicity, and ages of patients studied. Approval should only be for patients for whom clear evidence of safety and effectiveness was provided.
- [National Center for Health Research’s Public Comments on FDA’s Proposed Inclusion of Older Adults in Cancer Clinical Trials Guidance for Industry](https://www.center4research.org/national-center-for-health-researchs-public-comments-on-fdas-proposed-inclusion-of-older-adults-in-cancer-clinical-trials-guidance-for-industry/) - May 4, 2020: We strongly support FDA's efforts to improve the diversity of clinical trials and analyses of demographic subgroups, but have been disappointed that these efforts have not been enforced in a meaningful way.
- [NCHR Comment on Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products](https://www.center4research.org/nchr-comment-fda-race-ethnicity-data-collection/) - April 29, 2024: NCHR backs FDA's proposed guidance to collect standardized race/ethnicity data in clinical trials, which is crucial for addressing safety and efficacy disparities. We also urge a new category, mandatory implementation, and improved diversity to ensure accurate representation and meaningful efficacy and safety data
- [Why are Youth Suicides Increasing?](https://www.center4research.org/why-are-youth-suicides-increasing/) - The last 20 years has seen a troubling spike in suicides in the U.S., including youth suicides. Potential causes include isolation and depression during the COVID-19 pandemic, the influence of social media, and access to firearms and lethal pills. Further research is essential to determine how to best support vulnerable groups and youth mental health in ways that prevent suicides.
- [FDA to launch ‘active’ monitoring system to improve medical device safety](https://www.center4research.org/ahcj-fda-monitor-device-safety/) - Association of Health Care Journalists, September 18, 2024: AHCJ questions the usefulness of FDA's new active monitoring system to improve medical device safety and NCHR and other experts do too. The FDA plans to start by monitoring two types of devices in the first year but there are thousands of devices that were never studied for safety or effectiveness so that is not going to keep patients safe anytime soon.
- [He Regulated Medical Devices. His Wife Represented Their Makers.](https://www.center4research.org/nyt-shuren-fda-conflicts-of-interest/) - The New York Times, August 20, 2024: Ever wonder why there are so many ineffective and unsafe implants and diagnostic tests and other medical devices harming patients? This NYT investigation explains how FDA official Jeff Shuren was involved in decisions that benefited his wife — who worked for Theranos and other major device companies. Why did FDA allow that to happen year after year?
- [The untold trauma of thousands of women suffering from 'Breast Implant Illness', leaving them in agony for years... yet some doctors refuse to accept it is real](https://www.center4research.org/dailymail-breast-implant-illness-medical-skepticism/) - The Daily Mail, September 9, 2024: After making the decision to decrease her cancer risk by removing her breasts and getting implants, one woman discovered a community of women suffering from breast implant illness. Celebrities describe similar health problems from implants and recovery after implants are removed. Despite popularity of explant surgery and mounting evidence of BII, many doctors continue to dismiss breast implant illness, leaving women dependent on online support groups for information. FDA has not ensured accurate information for patients.
- [NCHR Testimony at the FDA Listening Session on Advisory Committee Meetings](https://www.center4research.org/nchr-fda-listening-session-advisory-committees/) - June 13, 2024: NCHR testified at the FDA listening session on Advisory Committee reform. We expressed concerns with the miscategorization of Consumer Representatives on AdComs and the ability of individuals with prior financial ties to industry to serve on these committees.
- [Health Risks of Not Enough Sleep: Why Z’s Matter!](https://www.center4research.org/health-risks-not-enough-sleep-zs-matter/) - How often do you get a good night’s sleep and wake up feeling totally rested? It’s hard to disconnect from work and technology, and it just seems like there aren’t enough hours in the day to get everything done. As a result, sleep rarely makes our “to-do” list, but it is more important than you may realize.
- [Stress and Binge Eating: Why We Do It and How to Avoid It](https://www.center4research.org/stress-binge-eating-avoid/) - Eating is a common coping mechanism for stress, but studies have shown it does nothing to decrease stress levels and can lead to serious weight gain.
- [Suicide Awareness and Prevention](https://www.center4research.org/suicide-awareness-prevention/) - Suicide is the 10th leading cause of death in the United States among all people over 10 years old, and rates are on the rise. Understanding the warning signs and risk factors can help prevent suicides.
- [Violent Songs](https://www.center4research.org/violent-songs/) - Previous studies have found that enjoying or listening to music with violent messages correlates with hostile attitudes, negative attitudes toward women, lower academic performance, behavior problems in school, drug use and arrests.
- [Can Cell Phones Harm Our Health?](https://www.center4research.org/can-cell-phones-harm-health/) - The extensive use of cell phones is a relatively recent phenomenon, and since cancers usually take at least 10-20 years to develop, it will be years before research is likely to conclude whether cell phones cause cancer or not. However, the evidence indicates possible cause for concern.
- [Do Cognitive Enhancing Drugs Improve Memory and Thinking in Older Adults?](https://www.center4research.org/cognitive-enhancing-drugs-mci-impairment/) - About 1 in 5 adults who are 71 years old or older have Mild Cognitive Impairment (MCI), which means they have more trouble thinking and remembering than most other people their age, but their condition is not severe enough to be considered dementia or Alzheimer’s. What are the outcomes of screenings and drug therapy?
- [Does Gun Control Really Work?](https://www.center4research.org/does-gun-control-really-work/) - More research is needed to conclude which policies are most important at preventing firearm-related deaths, but the results suggest that stricter gun-control laws may help.
- [Do Virginity Pledges Delay Teen Sex?](https://www.center4research.org/virginity-pledges-delay-teen-sex/) - Do virginity pledges make a difference in whether or when teens have sex?
- [Early Morning Classes, Sleepy Students, and Risky Behaviors](https://www.center4research.org/early-morning-classes-sleepy-students-risky-behaviors/) - In the 1950's and 1960's, most schools started between 8:30-9:00 and many students barely stayed awake all day. Today, many high schools start at 7:30 or earlier, and a growing number of studies show that these early school schedules can undermine teenagers' ability to learn, to drive safely, and to get along with others. They can even increase the likelihood of smoking, drug abuse, and teen pregnancy.
- [Are Women Who Work Night Shifts at a Higher Risk for Developing Breast Cancer?](https://www.center4research.org/women-work-night-shifts-higher-risk-developing-breast-cancer/) - Night shift work may seem like an odd thing to link to breast cancer. Nevertheless, scientists found that women who work night shifts for many years are more likely to get breast cancer than other women. This includes nurses and flight attendants who work overnight. The International Agency for Research on Cancer, which is a part of the World Health Organization, reported that shift work is a likely risk factor for certain cancers, just as diet can increase or decrease the risks. Researchers found that night shift work links to breast cancer because it can change a person's sleep-wake cycle. This has a lot to do with artificial light.
- [Purchasing Prescriptions: Is Saving Money Risky?](https://www.center4research.org/purchasing-prescriptions-saving-money-risky/) - Who doesn't want to save money on prescriptions? Health problems that require prescription medication can be expensive. In order to alleviate this, consumers are going online to find savings they may not find in stores. BUT, proceed with caution! Look for these key things before purchasing medications online.
- [Blood Pressure Medications Can Lower the Risk of Dementia for Those with High Blood Pressure](https://www.center4research.org/blood-pressure-medications-dementia/) - For those with high blood pressure, medications that lower blood pressure can help lower the likelihood of developing dementia.
- [Teen Jobs and Drug Use](https://www.center4research.org/teen-jobs-drug-use/) - Youths who worked either part-time or full-time were more likely to smoke, drink or use illegal drugs than those who did not have jobs.
- [Palliative Care for Serious Diseases](https://www.center4research.org/palliative-care-serious-diseases/) - Palliative care is often misunderstood as meaning a patient will not get “real treatment.” That is not accurate. Instead, palliative care offers a different type of treatment. Rather than focusing on curing a disease and exposing patients to aggressive treatment and therapy, palliative care focuses on improving the quality of life and relieving patients’ pain. Many patients receive both palliative and curative care at the same time, and benefit from the combination of treatment types.
- [The Unknown Health Risks of Air Pollution](https://www.center4research.org/unknown-health-risks-air-pollution/) - Air pollution is a hot topic in the media. Here is what you need to know about the causes of air pollution and how it affects the health of adults and children.
- [What are the risks and benefits of cannabis (smoking and non-smoking versions)?](https://www.center4research.org/what-are-the-risks-and-benefits-of-cannabis-smoking-and-non-smoking-versions/) - Cannabis use has become more common in the last few years. There are many different reasons people use cannabis, and edible marijuana. Despite being used by many people for medical purposes, only one cannabis product, Epidiolex, is FDA approved. This article explains the risks and benefits of smoking and non-smoking cannabis.
- [The Patient, Consumer, and Public Health Coalition Testified at an FDA Listening Session on Advisory Committees](https://www.center4research.org/fda-listening-session-advisory-committees/) - June 13, 2024: The Patient, Consumer, and Public Health coalition testified at the FDA listening session on Advisory Committee reform. We expressed concerns with the miscategorization of Consumer Representatives on AdComs, the inherent conflicts of interests of committee members, and inadequate training provided to appointees.
- [Jeff Shuren stabilized the FDA’s medical devices center, winning over industry but not all patients](https://www.center4research.org/statnews-shuren-leaves-fda/) - STAT News, August 6, 2024: STAT News article on Jeff Shuren leaving the FDA quotes praise from industry and concerns from physicians, researchers, patients, and public health experts who criticize how many devices are not proven to work.
- [Can Sugar-Sweetened Beverage Taxes Reduce Obesity?](https://www.center4research.org/can-sugar-sweetened-beverage-taxes-reduce-obesity/) - Sugar-sweetened beverages are affordable and easily accessible. Would a sugar-sweetened beverage tax help decrease consumption and help people make healthier choices?
- [How Good Is Wegovy's Heart Benefit?  -- Experts put SELECT trial findings in context](https://www.center4research.org/medpage-wegovy-heart-benefit/) - MedPage Today, August 1, 2024: When the company that makes Wegovy weight loss drugs say it reduces major cardiovascular events by 20% they really mean it reduces that risk by 1.5% for each patient. That's because only 8% of the placebo group had major cardiovascular events, compared to 6.5% of the Wegovy patients. Isn't that misleading? We explain why most weight loss patients will not benefit in terms of heart disease, because the benefit is small and requires staying on Wegovy for almost 3 years.
- [What’s A Woman to Eat?](https://www.center4research.org/whats-woman-eat/) - The Women’s Health Initiative (WHI) began in 1992 as a long term national health research effort focused on disease prevention among postmenopausal women. Over 161,000 women have participated in this research, which has provided information that has saved lives of women across the country.
- [The Dangers of Juuling](https://www.center4research.org/the-dangers-of-juuling/) - The popularity of a brand of e-cigarettes called "Juuls" is now exposing adolescents to high levels of nicotine, which can have harmful effects on their health and well-being.
- [Open Letter to the FDA: You’re Protecting the Wrong People](https://www.center4research.org/medshadow-fda-protecting-the-wrong-people/) - MedShadow, July 23, 2024: We agree with Medshadow that it is outrageous that the FDA is warning companies about fraudulent tests that mean their medications may not be safe or effective but are not warning patients who are buying these medications.
- [NCHR and Consumer Groups Applaud Decision to Hold Amazon Responsible for Certain Hazardous Products](https://www.center4research.org/cpsc-amazon-responsible-illegal-sales-distributor/) - July 30, 2024: NCHR and other consumer groups' joint press release expresses their support for the CPSC decision to hold Amazon responsible for certain hazardous products sold by third parties on their website. According to the Decision and Order, Amazon is a “distributor” of certain defective or non-compliant products and is therefore responsible for the illegal sale of those products. Amazon must submit plans to notify consumers about specific hazardous products and offer incentives to return or destroy the products.
- [Testimony of Grace Drew at the FDA Advisory Committee Meeting on Imfinzi for Resectable Non-Small Cell Lung Cancer](https://www.center4research.org/fda-adcom-imfinzi-lung-cancer/) - July 25, 2024: At the FDA Advisory Committee meeting on a new indication for Imfinzi (durvalumab), NCHR pointed out that the AEGEAN clinical trial did not assess if Imfinzi is necessary both before and after lung tumor surgery. We strongly support the FDA scientists who stated that the trials need to be redesigned to determine whether Imfinzi both before and after surgery is more beneficial compared to Imfinzi either before or after surgery.
- [NCHR Letter for the Record for Hearing on the Consumer Product Safety Commission Budget](https://www.center4research.org/nchr-cpsc-letter-for-record/) - July 22, 2024: NCHR's letter for the record for the House hearing: "The Fiscal Year 2025 Consumer Product Safety Commission Budget" describes the accomplishments of the CPSC and urges Congress to support CPSC's life-saving work evaluating consumer products, especially those for children, in order to keep all of us safe.
- [Patient, Consumer, and Public Health Coalition Public Comment to CMS on Transcatheter Tricuspid Valve Replacement Coverage](https://www.center4research.org/cms-comment-ttvr-coverage/) - July 19, 2024: FDA approval of TTVR was premature and the data are inadequate to support the safety and effectiveness of TTVR for the Medicare population. The Patient, Consumer, and Public Health Coalition urges CMS to conduct a thorough MEDCAC review prior to making a coverage decision.
- [NCHR Comments on FDA’s Proposed Rule “Medication Guides: Patient Medication Information”](https://www.center4research.org/nchr-comment-fda-patient-medical-information-guide/) - November 29, 2023: In response to FDA’s draft guidance on patient medication information guides, NCHR recommends that the FDA includes information on important drug interactions and develops a strategy to ensure the materials meet the average health literacy of the population.
- [NCHR Joint Comment to the Consumer Product Safety Commission on the Advance Notice of Proposed Rulemaking on Electric Bicycles](https://www.center4research.org/nchr-joint-comment-e-bikes/) - May 14, 2024: NCHR collaborated with CFA and KID to provide public comments to CPSC to improve e-bike safety. We emphasized the importance of improving definitions of e-bikes to reflect market realities, implementing specific regulations for children's e-bikes, the importance of further research, and reducing the potential risks associated with speed hacking.
- [NCHR Comment on Petition Requesting Rulemaking To Mandate Testing and Labeling Regarding Slip Resistance of Flooring, Floor Coatings and Treatments, Floor Cleaning Agents, and Footwear](https://www.center4research.org/nchr-comment-labelling-testing-standards-flooring/) - April 22, 2024: NCHR supports CPSC's slip resistance testing proposal for flooring but urges more comprehensive safety standards that also evaluate exposure to dangerous chemicals and heavy metals, such as those in rubber flooring.
- [Revolving door: You are free to influence us “behind the scenes,” FDA tells staff leaving for industry jobs](https://www.center4research.org/bmj-fda-revolving-door-2024/) - BMJ, July 1, 2024: BMJ investigation reveals how revolving door and FDA Ethics office allow former FDA staff to lobby for industry and Dr. Diana Zuckerman explains how this creates conflicts of interest that undermine FDA decision-making.
- [Feds declare turf, rubber playgrounds "generally safe'](https://www.center4research.org/ee-news-epa-artificial-turf-generally-safe/) - Politico E&E NEWS, April 18, 2024: EPA released its 2024 report on artificial turf, which says it contains dangerous chemicals but that the exposures are "generally safe.' NCHR's Dr. Diana Zuckerman asks what does that mean? If it is generally safe that means it isn't safe for everyone, but EPA doesn't explain how many will be harmed and doesn't explain what is known and not known. It's not credible.
- [Readers respond to mothers in treatment for opioid use disorder, pandemic models, and more](https://www.center4research.org/stat-letter-editor-antipsychotic-dementia/) - STAT, June 8, 2024: Our Letter to the Editor at STAT News disagreed with the first Opinion commentary urging more use of antipsychotics for dementia patients. We explain that these drugs too often kill older patients or serve as chemical straight jackets,
- [Advisory Committee Consumer Reps Often Fail To Represent Consumer Interests, Groups Tell US FDA](https://www.center4research.org/nchr-listening-session-fda-advisory-committee-reform/) - Pink Sheet, June 13, 2024: NCHR quoted from FDA listening session on optimizing the advisory committee process.
- [Patient, Consumer, and Public Health Coalition Letter to Congress on CMS Limited Coverage for Newly Approved Alzheimer’s Drugs](https://www.center4research.org/pcph-coalition-congress-letter-cms-limited-coverage-support-alzheimers-treatments/) - February 27, 2023: NCHR urges Congress to support the decision by the Centers for Medicare and Medicaid Services (CMS) to limit the coverage of newly approved Alzheimer’s drugs until the treatments have been shown to have a meaningful, clinical benefit that outweighs the risks for the Medicare population.
- [Aduhelm for the Treatment of Mild Alzheimer’s disease: Controversies and Policies](https://www.center4research.org/aduhelm-for-the-treatment-of-mild-alzheimers-disease-controversies-and-policies/) - This article will provide an overview of the controversial drug Aduhelm (generic name aducanumab) that was approved by the Food and Drug Administration (FDA) as a treatment for Alzheimer’s disease for patients with mild cognitive impairment due to Alzheimer's.
- [Testimony of Dr. Diana Zuckerman at the Tobacco Products Scientific Advisory Committee Meeting on General Snus](https://www.center4research.org/fda-advisory-committee-general-snus-2024/) - June 26, 2024: NCHR testified at the FDA Advisory Committee about the problems with safety data for General Snus smokeless tobacco and questioned whether they deserve to be labeled as safer than cigarettes.
- [“Why Doesn’t She Just Leave?” Barriers to Getting out of Abusive Relationships](https://www.center4research.org/why-doesnt-she-leave-abusive-relationship/) - Domestic violence is a fact of life in the U.S. for approximately 35% of women and 28% of men. When we learn someone is in an abusive relationship, the first question many people ask is “Well, why doesn’t she just leave?” However, getting out of the situation is not as easy as people like to think.
- [NCHR Comment on Proposed Information Collection Request; Comment Request; POTW Influent PFAS Study Data Collection](https://www.center4research.org/nchr-comment-epa-pfas-data-collection/) - May 28, 2024: NCHR supports the EPA’s proposed plan to collect data on PFAS contaminants in public water sources but urges EPA to protect public health by expanding the plan to test for many more PFAS chemicals and at more testing plants.
- [Representatives ponder balance of regulation, innovation in health care](https://www.center4research.org/medical-economics-house-small-business-hearing/) - Medical Economics, May 9, 2024: House Small Business Committee hearing focused on when government regulations undermine medical innovation and services but also agreed on the need to ensure safe and effective medical products.
- [NCHR Letter to Officials in Tucson AZ: A Call for Health-Conscious Decisions on Playground Surfaces and Artificial Turf](https://www.center4research.org/nchr-letter-tucson-tire-mulch-playgrounds-artificial-turf/) - At the request of Tucson residents, in April 2024 Diana Zuckerman of the National Center for Health Research sent a letter to Tucson officials to explain why PFAS, lead, and other toxic chemicals and heavy metals in tire mulch used in rubber playground surfaces, artificial turf, and plastic grass are dangerous for kids.
- [Treating Prostate Cancer: Options to Consider](https://www.center4research.org/treating-prostate-cancer-options/) - Men who are diagnosed with prostate cancer are faced with the difficult decision of deciding what to do next, since treatment is not always necessary, and each treatment option has advantages and disadvantages. The more that patients understand about the options, the more likely that they will make the decision that is right for them. That is the goal of this article.
- [Smoking Cessation Aids: What Are Your Options?](https://www.center4research.org/smoking-cessation-aids/) - It is important to address the reasons why you smoke through therapy in order to properly quit instead of turning to e-cigarettes or medication.
- [Weight and Cancer: What You Need to Know](https://www.center4research.org/weight-cancer-risk/) - Research shows that the being overweight or obese can increase the risk of developing certain types of cancer, and exercise and eating certain foods and beverages (and avoiding others) decrease the risk. Here’s what you need to know to prevent cancer and prevent recurrence.
- [Liver Cancer: What is it and how to prevent it](https://www.center4research.org/liver-cancer-prevention-asian-american-hepatitis-vaccine/) - This article explains the signs and symptoms of liver cancer and the steps you can take to prevent it. The best way to prevent it is to be tested for Hepatitis C, get vaccinated for Hepatitis B, and if diagnosed with either, get treated. Reducing smoking and alcohol consumption also helps prevent liver cancer.
- [FDA Brings Lab Tests Under Its Oversight](https://www.center4research.org/medpage-fda-regulates-lab-tests/) - MedPage Today, April 29, 2024: FDA issues the final rule for lab-developed tests (LDTs) and we explain that the rule has a giant deadly loophole allowing thousands of diagnostic tests and genetic tests for cancer and other deadly diseases to be sold without evidence they are accurate.
- [Patient, Consumer, and Public Health Coalition Letter to Rep. Pallone in Support of the Ban Water Beads Act (H.R. 6468)](https://www.center4research.org/letter-support-ban-water-beads/) - May 1, 2024: We strongly support H.R. 6468 which would expedite the removal of water beads from the market to prevent severe injuries and fatalities due to these products.
- [Statement from Dr. Diana Zuckerman Regarding the FDA Final Rule on Regulation of Lab Developed Tests](https://www.center4research.org/statment-lab-developed-tests-rule/) - April 29, 2024: We strongly support today’s FDA's decision to regulate lab-developed tests. Unfortunately, FDA’s final rules has compromised on the critical issue of grandfathering thousands of tests on the already on the market.
- [NCHR Provides Oral Testimony at the FDA Pulmonary Allergy Advisory Committee Meeting on Gefapixant](https://www.center4research.org/nchr-fda-pulmonary-allergy-advisory-committee-meeting-gefapixant/) - November 17, 2023: NCHR provided testimony at the FDA Pulmonary Allergy Advisory Committee Meeting on a new treatment for refractory or unexplained cough, Gefapixant. We reviewed the research which showed Gefapixant had a modest difference in cough frequency (
- [NCHR Provides Testimony at the Presidential Advisory Council Meeting on Combating Antimicrobial Resistance](https://www.center4research.org/nchr-presidential-advisory-committee-meeting-antimicrobial-resistance/) - March 15, 2024: NCHR provided testimony at the Presidential Advisory Council Meeting on Combating Antimicrobial Resistance. We advised that AMR research should move away from using pathogen-specific metrics and focus on patient-centered metrics. This will help to improve our current understanding of the clinical significance of resistant and nonresistant bacterial infections.
- [NCHR testimony at the FDA Oncologic Drugs Advisory Committee meeting regarding the dangling accelerated approvals of pralatrexate and belinostat for peripheral T-cell lymphoma](https://www.center4research.org/testimony-pralatrexate-belinostat-lymphoma/) - November 16, 2023: We believe it necessary for FDA to rescind approval until a trial is completed that confirms meaningful clinical benefits
- [NCHR Comment on Labeling and Advertising of Beverages with Alcohol Content](https://www.center4research.org/nchr-comment-ttb-alcohol-label/) - April 4, 2024: NCHR advocates for mandatory labeling of alcohol beverages that includes portion size information about alcohol content, calories, allergens, and other ingredients. We explain why voluntary standards are inadequate and that consumers need and deserve the information that would enable them to make safe and healthy decisions.
- [NCHR Comments on CMS' Proposed Rule On Strengthening the Oversight of Accrediting Organizations and Preventing Conflict of Interests, and Related Provisions](https://www.center4research.org/nchr-comment-cms-strengthening-oversight-medicare-accrediting-organizations/) - April 16th, 2024: NCHR supports CMS’ proposed rule and policies to increase oversight of Medicare accrediting organizations by addressing conflicts of interest; establishing standards, processes, and definitions for state surveys and unannounced surveys; and revising the validation survey program. We provide four key recommendations to bolster CMS' proposal.
- [Letter to Sen. Sanders in Support of the Childhood Diabetes Reduction Act](https://www.center4research.org/letter-support-diabetes-bill/) - April 12, 2024: This bill takes important steps to adequately inform consumers about the known risks of foods marketed to children and often consumed by all family members
- [Helping Your Child Develop a Healthy Microbiome](https://www.center4research.org/helping-your-child-develop-a-healthy-microbiome/) - Research is underway about how the microbiome develops in children. Research suggests that babies born vaginally have different microbiomes compared to babies born via caesarean section (C-section). This article focuses on ways to promote microbiome development in children, describing when there is good research evidence (such as breastfeeding) and when we don’t yet have enough research evidence (such as fecal matter transfers and vaginal seeding procedures).
- [Scientists urge FDA to rescind approval of test for opioid addiction risk](https://www.center4research.org/scientists-urge-rescind-approval-avertd-no-cms-coverage/) - Washington Post, April 5, 2024: NCHR president is one of 31 scientists urging FDA to rescind approval of AvertD DNA test that purports to predict risk of opioid addiction and urging CMS to refuse to pay for the test because it does not work and can do more harm than good.
- [10 doctors on FDA panel for Abbott heart device had financial ties to the company. The FDA didn’t disclose the payments.](https://www.center4research.org/nbc-triclip-fda-conflicts-of-interest/) - NBC News and Kaiser Health News, April 6, 2024: NBC News reported the Kaiser Health News investigation showing that 10 doctors who advised FDA about Abbott's heart device TriClip had financial ties to the company that weren't disclosed. Their votes almost unanimously supported approval. We explain that FDA conflict of interest rules are too loose.
- [Joint Comments to the Consumer Product Safety Commission on the Notice of Proposed Rulemaking: “Safety Standard for Infant Support Cushions”](https://www.center4research.org/consumer-comment-cpsc-infant-support-cushions/) - March 18, 2024: NCHR was one of 6 Consumer Safety groups submitting joint comments to the Consumer Product Safety Commission (CPSC) for its Proposed Rule for Safety Standards for Infant Support Cushions
- [Failure of ALS drug puts a spotlight on controversial FDA approvals](https://www.center4research.org/relyvrio-als-ineffective-2024/) - Washington Post, March 16, 2024: New study results showing that the ALS drug Relyvrio does not work raises important questions about FDA’s decision to be flexible about approval even when the scientific evidence is lacking. We explain that the pendulum has swung too far and each questionable approval results in more pressure on FDA to make more questionable approvals.
- [OTC Birth Control Pill Headed to US Pharmacies: What Your Patients Should Know](https://www.center4research.org/medscape-otc-opill-contraceptive-available/) - Medscape March 14, 2024: What patients should know about OTC birth control pill Opill, which will be available in March 2024. How can we make sure patients know the risks and use it correctly and we point out that patients shouldn't assume that just because it doesn't require a prescription doesn't mean it doesn't have risks.
- [NCHR Comment on Classification of Certain Wound Dressings](https://www.center4research.org/nchr-comment-wound-dressings/) - NCHR supports the proposed FDA rule, which aims to reclassify wound dressings and liquid wound washes containing antimicrobials based on their level of antimicrobial resistance (AMR), with higher-risk products categorized as Class III. This change is crucial for mitigating the public health threat posed by AMR, ensuring the appropriate use of these medical devices, and ultimately improving patient outcomes.
- [Why journalists should scrutinize the FDA’s accelerated drug approval process](https://www.center4research.org/ahcj-journalists-accelerated-approval-pepaxto/) - March 7, 2024 article by Association of Health Care Journalists explains the problems with the FDA accelerated approval process and gives advice on how to cover the evidence accurately. NCHR’s Diana Zuckerman explains that when FDA rescinded approval of the cancer drug Pepaxto, it was an easy call because the company took it off the market 2 years ago because of the higher death rate in a clinical trial.
- [Statement of Dr. Diana Zuckerman on Behalf of the National Center for Health Research  FDA Advisory Committee Meeting on AMX0035 for ALS](https://www.center4research.org/amylyx-als-drug-fda-september-advisory-committee-zuckerman-statement/) - September 7, 2022 Diana Zuckerman testified on behalf of NCHR at the FDA Advisory Committee hearing about the poor evidence foe Amylyx drug AMX0035 for the treatment of ALS, and how approving this drug would undermine other ALS clinical trials that are underway.
- [Accelerated Approval Withdrawal Offers Hints On New FDA Approach](https://www.center4research.org/fda-rescind-accelerated-approval-pepaxto/) - Inside Health Policy, March 4, 2024: NCHR was interviewed regarding the FDA rescinding accelerated approval for Pepaxto for multiple myeloma. We explain that the FDA’s new “’streamlined’ path to reverse approval decisions still takes years even after there is proof that patients taking the drug are more likely to die.
- [What’s the Deal with Keratin Treatments and Other Hair Straighteners?](https://www.center4research.org/whats-deal-keratin-treatments/) - Have you ever gotten a keratin treatment? A Brazilian Blowout? Maybe you’ve heard that they make hair silky smooth and relaxed and cost about $400. Or maybe you’ve heard that they can cause cancer. But which is true?
- [The Evidence Behind Clinical and Self-Breast Exams](https://www.center4research.org/nchr-self-breast-exam/) - We review the conflicting advice from healthcare professionals on performing self-breast exams so that you and your doctor can make the best decision for you.
- [Comments of National Center for Health Research on USPSTF Draft Research Plan for BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing](https://www.center4research.org/ncrh-comments-uspstf-brca-research-plan/) - February 14, 2024: NCHR supports USPSTF BRCA-Related Cancer research plan but recommends evaluating the impact of how risk information is explained in genetic counseling & treatment options. Our primary concern is providing short-term and long-term risk information and absolute risk and benefit statistics as well as relative risks and benefits.
- [NCHR Testimony in Support of HB1147 for the Maryland House of Delegates Environment and Transportation Committee](https://www.center4research.org/nchr-testimony-maryland-hb1147-playground-prohibitions/) - February 28, 2024: NCHR provided written testimony to the Maryland House of Delegates Environment and Transportation Committee in support of HB1147, a bill to prohibit the sale and installation of playground surfaces that contain levels of lead, PFAS, or PAH chemicals.
- [NCHR Written Testimony in Support of HB457 for the Maryland House of Delegates Environment and Transportation Committee](https://www.center4research.org/nchr-testimony-maryland-hb457-chain-of-custody-2024/) - February 16, 2024: NCHR provides written testimony to the Maryland House of Delegates Environment and Transportation Committee to support HB457, which requires transparency regarding all new artificial turf and infill installation, use, reuse, recycling, and disposal. This information would enable communities to make informed decisions about artificial turf that take into account how long it lasts and its impact on the environment.
- [NCHR Comment- Menu Labeling: Supplemental Guidance for Industry (Edition 2)](https://www.center4research.org/nchr-comment-fda-restaurant-proposed-rule/) - The FDA recommends that chain restaurants publish information on calories and added sugars on standard menus and also on third-party platforms such as Grubhub and Ubereats. NCHR agrees with FDA's plan to improve info available to consumers but urges the agency to make these recommendations mandatory to ensure the compliance needed to provide useful health information to consumers.
- [A Closer Look at Aduhelm, CTE, and the Super Bowl: Insights from STAT Readers](https://www.center4research.org/medtriva-aduhelm-fda-approval-nchr-commentary/) - February 11, 2024: NCHR was quoted in Medriva regarding our commentary on the evidence FDA should require to prove safety and efficacy of treatments used by older patients, which was also discussed in Letters to the Editor and comments to STAT.
- [Medicare has different standards than the FDA. That’s how it should be](https://www.center4research.org/zuckerman-stat-commentary-cms-fda/) - STAT News, February 2, 2024: NCHR’s Diana Zuckerman’s commentary in STAT News explains why Medicare should not pay for every medical product that FDA approves, since some are more likely to harm rather than help Medicare patients. She points out that FDA does not require diversity in clinical trials and rarely includes enough older and less healthy patients that tend to rely on Medicare.
- [NCHR's Comment on EPA’s Proposed Lead and Copper Rule Improvements (LCRI)](https://www.center4research.org/nchr-comment-epa-lead-copper-pipes-proposed-rule/) - February 2024: In its public comment, NCHR supported EPA’s proposed lead and copper rule improvements (LCRI) and suggested strengthening safeguards such as lowering the action lead level to 5 ppb or less, more attention to schools, daycares, and afterschool facilities, better enforcement, and not replacing lead pipes with PVC or other dangerous pipes.
- [How to Recover from Trauma and PTSD](https://www.center4research.org/how-to-recover-from-trauma-and-ptsd/) - Several types of therapy have been shown to be effective for helping people recover from trauma and PTSD, and this article will explain them to you.
- [Deep flaws in FDA oversight of medical devices — and patient harm — exposed in lawsuits and records](https://www.center4research.org/fda-approval-medical-devices-patient-harm/) - CBS News, December 20, 2023: CBS News article dives into the lack of FDA oversight within the medical device industry. Increased patient harm is exposed in lawsuits and records.
- [Coping with Stress](https://www.center4research.org/coping-with-stress/) - Can stress make you sick? Yes. Find out what stress is, how it affects your body, and what you can do about it.
- [ NCHR Provides Recommendations for the Public Meeting Agenda to Reduce Added Sugar Consumption in the United States](https://www.center4research.org/nchr-comment-reducing-added-sugar-consumption/) - January 22, 2024: NCHR recommends that FDA policies are discussed as a key strategy to reduce added sugar consumption at the national public meeting on hunger. The FDA should require targets for added sugar amounts in packaged food, hold restaurants accountable for disclosing added sugar content, and regulate food with artificial sweeteners.
- [How Safe is CBD?](https://www.center4research.org/how-safe-is-cbd/) - Cannabidiol (CBD) is an ingredient in cannabis and hemp that has taken the public by storm. But is CBD safe? There is currently no concrete, scientific evidence of its benefits besides treating pediatric epilepsy.
- [What You Can Do to Improve Your Sleep and Your Health](https://www.center4research.org/what-you-can-do-to-improve-your-sleep-and-your-health/) - Many children and adults are not getting enough sleep. There are always good excuses – Too much work to do! I just got an email or text message that I need to respond to! – but the bottom line is you need more sleep and it’s much better to find ways to fall asleep naturally than to rely on sleeping pills.
- [Is Belsomra a Magic Sleep Pill? Or a Dangerous One?](https://www.center4research.org/belsomra-magic-sleep-pill-dangerous-one/) - Most of us have experienced sleepless nights that leave us so tired and miserable the next day that we’ll try almost anything that claims to be helpful. The newest sleep medication, called Belsomra, claims to be just the answer. But, the truth is that Belsomra doesn’t actually improve your sleep that much.
- [Buy a Sleep Mask! It's an Investment in Your Health](https://www.center4research.org/buy-nice-sleep-mask-investment-health/) - Research shows that sleeping in total darkness allows your body to produce as much of the hormone melatonin as possible. This is good because when your production of melatonin drops, you are at greater risk of breast and/or colorectal cancer and other health risks.
- [Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions](https://www.center4research.org/510k-devices-clinical-data-coalition-comment/) - December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to rely more on scientifically credible types of clinical data for 510(k) to ensure patients’ health and safety.
- [NCHR Comments on USPSTF Draft Recommendations on Interventions for Adolescents with a High Body Mass Index](https://www.center4research.org/nchr-comment-uspstf-interventions-adolescents-high-bmi/) - January 16, 2024: NCHR strongly supports USPSTF’s draft recommendation on using behavioral interventions to manage unhealthy weight gain in adolescents over six years of age with a body mass index at the 95th percentile for their age and sex. More research is needed to clearly show the safety and efficacy of weight loss medications in this patient population.
- [Artificial Sweeteners: Do They Help You Lose Weight or Gain it? Are they Safe?](https://www.center4research.org/artificial-sweeteners-weight-safety/) - When people want to treat themselves to something sweet without having to treat themselves to a larger pants size too, they often reach for low-calorie, artificial sweeteners. But do artificial sweeteners actually help you lose weight? The answer is apparently not -- and there are concerns about their safety if consumed in large quantities.
- [Are Some Birth Control Pills Too Risky?](https://www.center4research.org/birth-control-pills-risky/) - YAZ, Yasmin, Beyaz, and other drospirenone hormonal birth control pills have been found to have an increased risk of serious blood clots. However, the FDA has not taken the pills off the market or demanded a black box warning.
- [Will Pills, Creams, or Other Products Increase Breast Size?](https://www.center4research.org/will-pills-creams-increase-breast-size/) - Question: I got an email about a cream that will make my breasts grow. Then I saw an ad for a different cream in a magazine. My mother says that those products don't really work. Is that true? Why are they allowed to sell them if they don't work?
- [NCHR Comment on CPSC Proposed Investigation of Smart Toys and Additional Toys Through Child Observations Response](https://www.center4research.org/nchr-comment-cpsc-response-toy-study/) - NCHR submitted the only comment to CPSC about their proposed study of young children’s effective use of smart toys. CPSC responded to our previous comment and released a revised request for public comments, clarifying that the study was exploratory. We responded by again urging CPSC to study a larger number of children who are more representative of the U.S. population, to better guide future guidelines for these toys.
- [NCHR's Comments on the CPSC's Proposed Guidelines on Safety Standard for Infant and Infant/Toddler Rockers](https://www.center4research.org/nchr-comment-cpsc-infant-rockers/) - NCHR supports the CPSC's new proposed guidelines for infant rockers that will help to strengthen safety standards for such products. We offered suggestions to the rule, including adding a minimum age of use of at least 4 months old, more strongly discouraging the use of rockers for sleeping, and making physical changes that minimize the use for sleeping and the risk of injury. We also urged the CPSC to strengthen warning/labeling requirements, prevent stockpiling of rockers that don’t meet the new requirements, and support future research into the safety of rockers and related products.
- [FDA Reviews Breast Implant Safety as Women Raise Concerns](https://www.center4research.org/fda-reviews-breast-implant-safety/) - FoxNews interviews a woman with breast implants who is getting them removed to improve her health, and we are interviewed explaining that some implants are probably safer than others and some women more likely to be harmed. FDA keeps saying there isn’t enough evidence, but whose fault is that?
- [NCHR Comments On FDA's Draft Guidance Regarding the Confirmatory Evidence Needed to Demonstrate A Drug's Effectiveness](https://www.center4research.org/nchr-comment-fda-confirmatory-evidence-clinical-effectiveness/) - December 18, 2023: NCHR urged the FDA to institute stronger scientific standards to confirm that a new drug is effective, preferably two randomized, double-blind, clinical control trials. Patients deserve drugs that are proven to work, not drugs that possibly work.
- [NCHR Comments On the FDA's Draft Guidance Regarding the Development of Novel Drugs for Diabetic Foot Infections](https://www.center4research.org/nchr-comment-fda-diabetic-foot-infections-antimicrobial-resistance/) - December 18, 2023: NCHR urges the FDA to oppose using non-inferiority trials as evidence for new antibiotic treatments for diabetic foot infections. FDA defines “non-inferior” to include “slightly worse” but new antibiotic treatments should be better than standard treatments. Otherwise they don’t benefit patients and worsen antimicrobial resistance.
- [Trump Covid Report Stirs Calls for FDA to Rebuild Public Trust](https://www.center4research.org/trump-covid-report-fda/) - Bloomberg Law, August, 26, 2022 A House report detailing coordinated attempts by Trump White House officials to influence the FDA’s pandemic response underscores the need for more transparency at an agency that’s facing historically low public trust, health policy analysts say. The House Select Subcommittee on the Coronavirus Crisis said this week that advisers to former President Donald
- [Public Comment of the National Center for Health Research on USDA Proposed Rule on New Program on Natural Grass and Sod Products, Docket AMS-LP-21-0028](https://www.center4research.org/nchr-usda-comment-grass-research/) - December 15, 2023: In response to a request for public comment, NCHR submitted a comment in support of the USDA proposed rule to establish a promotion, research, and information program for natural grass sod products. We believe this will provide important information that will help reduce the proliferation of artificial turf, which endangers the health of children and adults as well as harming the environment.
- [NCHR's Comment on the ATF's Proposed Rule on the Definition of "Engaged in the business"](https://www.center4research.org/nchr-atf-gun-control-proposed-rule/) - December 5, 2023: NCHR supports the ATF's proposed rule that will implement an updated definition of "engaged in business" so that anyone engaged in selling firearms "for profit" will be deemed as sellers required to do background checks on their patrons. This new rule will require trade shows and online retailers to be regulated the same as brick-and-mortar establishments.
- [NCHR Comments on FDA's Proposed Rule Regarding Canned Tuna Standard of Identity and Standard of Fill of Container](https://www.center4research.org/nchr-comment-tuna-mercury/) - November 24, 2023: NCHR urges the FDA to address the issue of methylmercury exposure to children and pregnant women through canned tuna. We urge the FDA to reevaluate current standards and utilize clear labeling to inform consumers of the risk.
- [NCHR's Comments on FDA's Draft Guidance for Medical Devices with Indications Associated with Weight Loss](https://www.center4research.org/nchr-comment-weight-loss-devices-fda-draft-guidance/) - November 14, 2023: Medical Devices with indications associated with weight loss that are affected by this FDA draft guidance have many implications for the health and quality of life of many individuals. For this reason, it is vital for FDA guidance to be based on large sample sizes, stringent controls, and extensive follow-up to ensure the safety and efficacy of such medical devices.
- [Patient, Consumer, and Public Health Coalition Comments to FDA on their Guidance for Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission](https://www.center4research.org/510k-best-predicate-devices-coalition-comment/) - December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition told FDA that if a predicate device for 510(k) review does not align with the best practices identified in the FDA guidance, the device should be submitted to De novo or PMA instead.
- [Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for Evidentiary Expectations for 510(k) Implant Devices](https://www.center4research.org/510k-implant-devices-evidence-coalition-comment/) - December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to institute stronger standards to determine clinically meaningful substantial equivalence for 510(k) clearance.
- [Patient, Consumer, and Public Health Coalition Comments on the FDA Proposed Rule Regarding Laboratory Developed Tests](https://www.center4research.org/coalition-lab-developed-tests-guidance/) - December 4, 2023: The PCPH Coalition supported the FDA proposed rule on lab-developed tests (LDTs) to diagnose diseases and genetic issues, with the exception of FDA’s proposed increased use of third-party reviewers.
- [NCHR Comments on Consumer Product Safety Commission Scientific Integrity Policy](https://www.center4research.org/scientific-integrity-policy-cpsc-consumer-products/) - December 4, 2023: NCHR urged CPSC to strengthen protections for scientists against retaliation and instill consequences for violations of the scientific integrity policy.
- [FDA Warned of Overstepping Authority With Lab Test Rule Proposal](https://www.center4research.org/bloomberg-ldts-fda-public-comments/) - Bloomberg Law, December 7: Bloomberg Law news article describes the strong opposition to FDA’s plan to regulate lab-developed tests (LDTs). We explain why patients can’t trust the results of these diagnostic tests unless FDA makes sure they are accurate.
- [FDA’s Janet Woodcock to retire early next year](https://www.center4research.org/woodcock-retire-fda-2024/) - STAT News, November 16, 2023: Principal Deputy FDA Commissioner Janet Woodcock will retire from the FDA in early 2024 after almost 40 years at the agency, many as a powerful and controversial leader. We explain how her legacy has tarnished the FDA’s reputation.
- [FDA Accelerated Approval Pathway: Controversies and Reform](https://www.center4research.org/accelerated-approval-pathway-summary/) - Recent controversies of drugs granted accelerated approval have raised important questions about the evidence needed to determine whether the benefits outweigh the risks in the short-term or the long-term, and what can be done to improve the pathway.
- [NCHR Comments on FDA Proposed Guidance "Stimulant Use Disorders: Developing Drugs for Treatment"](https://www.center4research.org/nchr-comment-fda-proposed-guidance-stimulant-use-disorders-drugs-treatment/) - December 4, 2023: NCHR expressed concerns that accelerated approval for stimulant addiction treatment will jeopardize patient safety and drug effectiveness. We also recommended the study design include a diverse patient population to best reflect the intended patient population, and improving study end-points to be more reflective of real-world practice.
- [NCHR Comments on Health and Human Services' Proposed Healthy People 2030 Objectives](https://www.center4research.org/nchr-comments-healthy-people-2030-objectives/) - November, 2023, NCHR supports HHS' proposed healthy people 2030 objectives and the inclusion of social determinants of health as key measurable objectives. To strengthen HHS’ goal of improving community health and achieving health equity, we recommended including individual and organizational health literacy objectives and forming inclusive, diverse stakeholder committees.
- [Can Eating Fish Be Dangerous? The Facts About Methylmercury](https://www.center4research.org/can-eating-fish-dangerous-facts-methlymercury/) - Mercury is a mineral that exists naturally in the environment. Bacteria and natural processes can transform mercury into the organic mercury compound methylmercury, which is a poisonous substance. Unfortunately, this toxin is in the fish we eat.
- [Patient, Consumer, and Public Health Coalition Letter to FDA Regarding Consumer Representatives in Advisory Committees](https://www.center4research.org/coalition-consumer-representatives-fda/) - November 20, 2023: The Coalition expressed concerns that patients, health professionals, and industry-affiliated individuals are erroneously categorized as Consumer Representatives on FDA Advisory Committees.
- [Questions remain about new drug for hot flashes](https://www.center4research.org/fda-hot-flashes-veozah-menopause/) - Leaps. Org, Jul 27, 2023: This news story discusses the May, 2023, FDA approval of fezolinetant (brand name Veozah™) to treat hot flashes caused by menopause. While the drug was shown to slightly reduce the frequency and severity of hot flashes per day, NCHR and other experts question if these changes are sufficient to justify any risks and the high cost. We also suggest possible alternative strategies to deal with hot flashes.
- [NCHR Comment on CPSC's Proposed Study of Toddlers Using Smart Toys](https://www.center4research.org/nchr-comment-cpsc-toy-study/) - October 6, 2023: The Consumer Product Safety Commission is responsible for ensuring that consumer products are safe. One of their jobs is to make sure toys are labeled to indicate the age of children for which they are safe and age-appropriate. In October 2023, NCHR reviewed a proposed CPSC study of new toys intended for ages 2-4 and expressed concerns that there were too few children in the proposed study to provide reliable, generalizable information about the use and safety of these toys for a diverse group of U.S. children.
- [Are PIP rubber playgrounds safe for Kingston?](https://www.center4research.org/pip-playgrounds-danger-kingston-ny/) - Kingston Wire, October 23, 2023: NCHR president Diana Zuckerman’s oped in the Kingston (NY) Wire explains the risks to children of lead and other toxic chemicals in PIP rubber playground surfaces and artificial turf in Kingston and other communities.
- [Biden’s Crackdown on 'Junk' Plans: Minimal Impact on Payers](https://www.center4research.org/biden-restricts-junk-health-insurance-policies/) - Health Payer Specialist, July 14, 2023: The White House proposes restricting “junk” health insurance policies to 3-4 months for emergencies, instead of 3 years. These health insurance policies are supposed to be for short-term emergency coverage, not to replace comprehensive health insurance. We explain that these inexpensive policies result in patients paying much more if they have any medical needs – or going without important medical care. Don’t be fooled by misleading ads for cancer coverage or other limited coverage.
- [NCHR Public Comment on HHS Draft Framework to Support and Accelerate Smoking Cessation](https://www.center4research.org/hhs-draft-framework-smoking-cessation-2023/) - July 30, 2023: HHS released a draft framework to support and accelerate smoking cessation. NCHR provided a public comment with recommendations to improve the framework, with a focus on evaluating the impact of demographic differences on the safety and efficacy of different smoking cessation strategies.
- [Letter from Experts to CMS and HHS Regarding Data Sharing in Leqembi Registries](https://www.center4research.org/data-sharing-experts-letter-leqembi-registry/) - July 27, 2023: In a letter to CMS and HHS, policy experts and bioethicists urge CMS to require that registries that make Medicare patients eligible for Leqembi coverage share data with CMS, FDA, and independent researchers to ensure accurate and unbiased data.
- [Letter to NJ officials in Montclair and Essex County Regarding Harms from Artificial Turf](https://www.center4research.org/nchr-letter-montclair-essex-county-nj-turf-playgrounds/) - October 30, 2023: NCHR president Dr. Diana Zuckerman wrote a letter to NJ officials in Montclair and Essex County explaining why lead, PFAS, and other chemicals in artificial turf and rubber playground surfaces harm children’s health and safety.
- [Testimony of Dr. Diana Zuckerman On Bill H.3948](https://www.center4research.org/massachusetts-bill-h3948-artificial-turf/) - July 26, 2023: We provided written testimony in support of Massachusetts bill H 3948, which would prohibit state and municipal contracts to install artificial turf fields. In October, the bill was reported favorably.
- [Letter to Officials in Kingston, NY Regarding Lead, PFAS, and Other Chemicals in Artificial Turf and PIP Rubber Playground Surfaces Causing Harm to Children’s Health and Safety](https://www.center4research.org/slug-nchr-letter-kingston-ny-turf-pip-playgrounds/) - October 18, 2023: NCHR president Dr. Diana Zuckerman wrote a letter to officials in Kingston, NY explaining why lead, PFAS, and other chemicals in artificial turf and PIP rubber playground surfaces harm children’s health and safety.
- [After Drug Trial Fizzles, Sarepta Still Seeks Broad Approval](https://www.center4research.org/bloomberg-sarepta-elevidys-failed-confirmatory-trial/) - Bloomberg News, November 1, 2023: Sarepta’s gene therapy Elevidys failed to confirm efficacy for Duchenne Muscular Dystrophy. Will FDA convert accelerated approval to full approval anyway? We explain why that would be ridiculous, but not impossible. But who will pay for an unproven treatment that costs $3.2 million per patient?
- [Testimony of Diana Zuckerman at FDA Advisory Panel on Blood Irradiators](https://www.center4research.org/fda-nchr-blood-irradiators-cancer/) - November 7, 2023: Blood irradiator devices have been used for decades on cancer patients to try to prevent metastasis. NCHR agrees with FDA there is no evidence that they benefit patients and it is clear the radiation can be harmful. At an FDA Advisory Committee meeting in November 2023, we urged FDA to finally require scientific studies if companies want to continue to sell these devices.
- [NCHR Comments On FDA's Requirements for Tobacco Product Manufacturing Practices](https://www.center4research.org/nchr-comment-fda-tobacco-product-manufacturing-practices/) - October 6, 2023, in response to FDA's draft guidance on tobacco manufacturing practices, NCHR recommends that the FDA requires manufacturers to accurately reflect the nicotine concentration of their products using clear labeling, restrict flavor additives, and impose maximum nicotine levels. We also urge FDA to exercise its full authority for manufacturer violations to improve incentive for compliance.
- [What Are PFAS Chemicals and Why Are They Dangerous?](https://www.center4research.org/what-is-pfas-health-risks/) - This article explains where PFAS chemicals are found, the types of medical problems they cause, and how you can reduce your exposure to them
- [NCHR's Comments on Proposed Supplemental Guidance for CPSC Chronic Hazard Guidelines](https://www.center4research.org/cpsc-chronic-hazards-guidelines-nchr-comment/) - NCHR criticizes CPSC’s revised proposal for chronic hazard guidelines for focusing on linear modeling that is not appropriate for endocrine disrupting chemical and for including a loophole that enables companies to do whatever they think is scientifically appropriate. We urge the CPSC to produce more explicit, rigorous guidelines based on sound science, since that is essential for the safety of consumers.
- [Experts fear FDA push to get neurological drugs to market faster shortchanges patients](https://www.center4research.org/politico-neurological-drugs-accelerated-approval/) - Politico Pro, October 20, 2023: Politico news story explains that FDA’s accelerated approval of neurological drugs shortchanges patients who have lobbied for it because these very expensive drugs aren’t proven to work
- [Dr. Diana Zuckerman's Testimony at the FDA Advisory Committee on NurOwn for ALS Treatment](https://www.center4research.org/zuckerman-testimony-fda-nurown-als-2023/) - September 27, 2023: NCHR’s Diana Zuckerman’s testified at FDA’s Advisory Committee meeting on September 27, 2023 about tripling of deaths and no benefits of NurOwn treatment for ALS. Improvements were identical for placebo compared to NurOwn treatment, and patients should not have to pay for unproven treatment. Experimental treatment should be free through clinical trials or expanded access.
- [Inside the NFL turf debate: Injuries, safety measures, problems](https://www.center4research.org/espn-turf-nfl-debate/) - ESPN, October 11, 2023: This comprehensive ESPN news article explains the NFL injury rate and players’ concerns comparing grass fields to artificial turf. Diana Zuckerman tells ESPN reporters about biased info from artificial turf industry.
- [NCHR Comments on the Proposed Data Collection Submitted for Public Comment and Recommendations for Thermal Spray Coating](https://www.center4research.org/nchr-comment-cdc-data-collection-thermal-spray-coating/) - October 6th, 2023, in response to CDC's draft guidance on information collection regarding thermal spray coating, NCHR recommends that the CDC improves the language of the survey questions to enhance study design and better inform occupational health standards.
- [Circumcision: The Health Benefits and Risks](https://www.center4research.org/circumcision-health-benefits-risks/) - Parents can decide whether to circumcise their sons based on culture, religion, or family tradition, since medical experts say health benefits and risks are quite minor. Previous recommendations stating that the benefits outweigh the risks have been replaced with a focus on educating parents so that they can decide what they want to do.
- [Less Radical Surgery Is a Healthier Choice for Women with Breast Cancer](https://www.center4research.org/breast-cancer-mastectomy-lumpectomy-better-survival/) - Experts agree that lumpectomy patients live longer than mastectomy patients with better quality of life. BCT is superior to more radical surgery. Bilateral mastectomy has no survival benefit.
- [NCHR Comments on FDA's Draft Guidance on QTc Information in Human Prescription Drug and Biological Product Labeling](https://www.center4research.org/nchr-comment-fda-qtc-guidance-labeling/) - October 10, 2023, in response to FDA's draft guidance on QTc product labeling to correctly measure heartbeat contraction and relaxation, NCHR recommends that FDA specify a preferred method of calculating the QTc, provide methods for to improve study design, and require studies of the impact of drug-drug and drug-disease interactions. These changes to the guidance are needed to encourage industry to do the research needed to ensure the safety and effectiveness of their products.
- [Do Heartburn Medications Cause Kidney Disease? Dementia?](https://www.center4research.org/heartburn-medications-cause-kidney-disease-dementia/) - New research shows that people who take popular heartburn medications are more likely to develop dementia as well as serious kidney disease. These include Prilosec, Nexium Prevacid, Kapidex, Aciphex and Protonix, which are all a type of drugs called Proton Pump Inhibitors (PPI).
- [Consumer and Public Health Groups Support FDA Proposal to Ensure Accuracy of Lab-Developed Medical Tests](https://www.center4research.org/lab-developed-tests-regulation/) - September 29, 2023: A coalition of consumer advocacy groups is welcoming a proposed rule released today by the Food and Drug Administration to regulate laboratory-developed tests (LDTs), a category of diagnostic tests developed and used in a single lab.
- [NCHR Testimony at the Meeting of the Nonprescription Drugs Advisory Committee Concerning Oral Phenylephrine (PE) as a Nasal Decongestant](https://www.center4research.org/testimony-oral-phenylephrine-decongestant/) - September 11, 2023: Orally administered phenylephrine (or PE) as a nasal decongestant should not be on the market because it has not been shown to work. Millions of dollars have been wasted by consumers on a product that has been shown in research to act similar to a placebo.
- [NCHR Comments on the FDA Draft Guidance for Industry Concerning Dietary Guidance Statements in Food Labeling](https://www.center4research.org/comment-dietary-guidance-statements-fda/) - September 25, 2023: NCHR supported the use of Dietary Guidance Statements to reduce nutrition-related chronic diseases and advance health equity. We made recommendations regarding dietary statements for products that exceed recommended amounts, or contain fruit juice, whole grains, and alcohol.
- [POSTPONED- Journalists:  Apply for a Free Health Research Training Workshop on March 19 and 20, 2020 in Washington, D.C.](https://www.center4research.org/health-research-training-workshop-2019/) - Are you a journalist or medical writer who wants to better understand medical and healthcare research? See our free workshop details.
- [NCHR Comments on USPSTF Draft Recommendation Statement Regarding Screening for Hypertensive Disorders of Pregnancy](https://www.center4research.org/nchr-uspstf-screening-for-hypertensive-disorders-of-pregnancy/) - March 6, 2023: We strongly support the US Preventive Services Task Force draft recommendations that all asymptomatic pregnant women be screened for high blood pressure throughout pregnancy. We appreciate the agency considering how screening will help prevent medical problems for mothers and babies that could be caused by hypertensive disorders of pregnancy.
- [NCHR Comments on the Proposed Framework from Ranking Member Cassidy to Regulate Artificial Intelligence (AI) in Healthcare](https://www.center4research.org/comment-ai-medical-devices-healthcare/) - September 22, 2023: NCHR urged the need to reform the 510k clearance pathway for AI/machine learning (ML) devices, promote diversity in the data used for AI, and the need to routinely test effectiveness of updated systems, including post market surveillance.
- [Who gets to decide who receives experimental medical treatments?](https://www.center4research.org/mit-experimental-treatments-duchenne-cancer-accelerated-approval/) - MIT Technology Review, August 10, 2023: This excellent news article by MIT Technology Review asks “Who decides who receives experimental medical treatments” and are FDA’s standards for accelerated approval too low for Duchenne Muscular Dystrophy, cancer, and other diseases. We call accelerated approval a disaster.
- [Injuries Related to Artificial Turf](https://www.center4research.org/injuries-related-to-artificial-turf/) - Artificial turf is used all over the U.S. for sports fields instead of natural grass. However, the risks to human health and injuries include abrasions, concussions, and musculoskeletal injuries, and the risks to the environment are also increasingly obvious.
- [NCHR Comments to FDA on the Draft Guidance Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act](https://www.center4research.org/nchr-comments-good-practice-pmr/) - September 12, 2023: Noncompliance with required post-market studies (PMRs) is a serious problem that undermines FDA’s authority and the public trust in FDA decision-making.NCHR supports the process described in the guidance for applicants to correct circumstances that led to non-compliance with the agreed upon PMRs; however, we urge that the description of the actions taken by the applicant to address these issues be more explicit and less subjective.
- [NCHR Comments on Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development](https://www.center4research.org/nchr-comment-fda-draft-guidance-inborn-errors-of-metabolism-clinical-trial-design/) - September 11, 2023, NCHR supports the FDA’s draft guidance with key recommendations. NCHR urges the FDA to add standardized protocols for instances of participant non-adherence, disease flair up, and acute illness. NCHR also recommends including specific guidance for crossover clinical trial design and more objective measures for dietary compliance rather than food diaries to strengthen the quality of the clinical trials performed among the IEM patient population, reduce confounding, and improve data interpretability.
- [NCHR Comments on Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination FDA Draft Guidance](https://www.center4research.org/nchr-comment-tattoo-ink-risks-fda-draft-guidance/) - September 11, 2023: Tattoos are common in the U.S. and almost half tattoo inks are contaminated. NCHR supports FDA's draft guidance to improve the safety of tattoo ink and recommends that labels describing the links be available to consumers and sterile dilution techniques should be required and explained. NCHR urges FDA to develop an information toolkit to increase consumer awareness about reporting any adverse reactions to tattoos.
- [NCHR Comments on the FDA Proposed Guidance Regarding the Registration and Listing of Cosmetic Product Facilities and Products](https://www.center4research.org/nchr-comment-cosmetics-regulation-fda/) - September 7, 2023: NCHR provided comments on the FDA guidance regarding the registration and listing of cosmetic product facilities and products required in the Modernization of Cosmetics Regulation Act of 2022. We support these requirements and provide recommendations to improve the guidance.
- [NCHR Comments on The E6(R3) Guideline for Good Clinical Practice and International Council for Harmonisation Draft Guidance](https://www.center4research.org/nchr-comment-good-clinical-practice-international-harmonisation/) - September 5, 2023: We support the overall goals of the Good Clinical Practices International Council Harmonisation guidance. But we recommend strengthening diversity criteria and providing objective trial oversight while leveraging stakeholder engagement committees to improve study quality and participant safety.
- [Dr. Diana Zuckerman's Testimony at the FDA Advisory Committee Meeting on Microbiology Devices on HBV Assays](https://www.center4research.org/fda-2023-advisory-meeting-microbiology-devices/) - September 7, 2023: We testified that FDA’s plan to reclassify hepatitis B (HBV) assays from high risk (Class III) to moderate risk (Class II) would mean lack of evidence of accuracy. Why do that when there are already accurate assays available? Lowering the standards would harm patients by resulting in inappropriate treatments.
- [Everything You Need To Know to Choose Safe Cosmetic Products](https://www.center4research.org/cosmetics-safety-regulations-law-tips/) - Cosmetics, including shampoo and other products we all use, will cost U.S. consumers $92 billion this year. They contain various chemicals, often including harmful substances like parabens and phthalates. These products can also harm the environment and pose greater risks to salon workers. His article helps consumers read labels, reduce exposures to unsafe ingredients, and choose eco-friendly cosmetics for safety.
- [NCHR Comments on the CMS Notice on Transitional Coverage for Emerging Technologies (TCET).  ](https://www.center4research.org/nchr-tcet-cms-coverage/) - August 28, 2023: We support the overall goals of the TCET program, but we see an enormous disconnect between the types of evidence that FDA requires for breakthrough devices and the CED standards that CMS requires for coverage.
- [NCHR Comment on the CMS National Coverage Analysis Evidence Review Proposed Guidance](https://www.center4research.org/nchr-comment-nca-cms/) - August 21, 2023: We support the methodological attributes of clinical studies that are described in the NCA guidance. We also strongly agree with CMS’s priorities that emphasize evidence of meaningful health outcomes, particularly morbidity and mortality, since those can be evaluated more objectively.
- [NCHR Comments on the CMS Coverage with Evidence Development Proposed Guidance Document](https://www.center4research.org/nchr-comment-ced-cms/) - August 21, 2023: We support the refinements to the proposed new criteria regarding the need for proper control groups and blinding in CED studies. However, we have minor suggestions that would strengthen these changes.
- [NCHR Comments on the CMS proposal to Remove the National Coverage Determination (NCD) for Beta-amyloid Positron Tomography (PET Aß) in Dementia and Neurodegenerative Disease](https://www.center4research.org/nchr-comment-amyloid-pet-scan/) - August 16, 2023: NCHR supported expanded coverage for PET Aß under very limited circumstances, to determine if a patient is eligible for Medicare coverage of an amyloid targeting drug that has FDA approval.
- [NCHR Comments on the Food and Drug Administration In-Home Disposal Systems for Opioid Analgesics](https://www.center4research.org/nchr-comment-fda-in-home-opioid-disposal-systems/) - August 28, 2023 The FDA is assessing whether in-home disposal products can reduce opioid nonmedical use and overdose. We recommend user-friendly, accessible in-home disposal systems that rely on deactivation rather than incineration.
- [Testimony at the FDA Advisory Committee Meeting on the Recor Paradise Ultrasound Renal Denervation System](https://www.center4research.org/fda-advisory-meeting-hyptersion-paradise-ultrasound-renal-denervation/) - August 22 2023, we testified at the FDA Advisory Meeting on the Paradise Ultrasound Renal Denervation (uRDN) System used to treat hypertension, we attested that the hypertensive efficacy of the Paradise uRDN system is insufficient to justify its use as an adjunct therapy for hypertension.
- [NCHR Comments on FDA's Bioequivalency for Generic Drug Formulations Draft Guidance](https://www.center4research.org/fda-bioequivalency-guidance-generic-drugs-2023/) - July 18, 2023: FDA draft guidance on bioequivalency is intended to streamline generic drug development and speed up patients’ access to generic medications. But some shortcuts that FDA proposes could result in unsafe generic medications that were not adequately tested. We highlight research standards that will help keep patients safe.
- [NCHR Comments on the FDA's Use of Generally Accepted Medical Knowledge Draft Guidance](https://www.center4research.org/fda-generally-accepted-medical-knowledge-guidance-product-safety-2023/) - July 24, 2023: The FDA proposed a draft guidance on using generally accepted medical knowledge (GASK) when conducting nonclinical studies to help streamline product development, decrease costs, and hasten new product approval time. We do not recommend using GASK as the sole source of nonclinical data in new drug applications or biologic license applications as this could jeopardize the safety, toxicology, and efficacy of the product.
- [NCHR Comments on CMS's Proposed Decision Regarding Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery](https://www.center4research.org/nchr-comments-cms-pta-draft-decision-2023/) - August 10, 2023: CMS released a draft decision to cover an experimental procedure for stroke prevention on populations who are normally too low-risk to be considered for surgical intervention. There is no evidence that this experimental procedure, a Percutaneous Transluminal Angioplasty (PTA), is a beneficial treatment over optimal medical (non-surgical) care in patients with moderate narrowing of their carotid arteries. Yet, there are many documented risks to this procedure and we are concerned that covering this experimental procedure in a lower-risk stroke population will cause real harm to Medicare patients and increase the cost of medical care.
- [Testimony at FDA on Eteplirsen for Duchenne Muscular Dystrophy](https://www.center4research.org/eteplirsen-duchenne-muscular-dystrophy-statement-fda-april-25-2016/) - April 25, 2016. U.S. law requires evidence of safety and effectiveness. The burden of proof lies with Sarepta. If this drug actually works, then Sarepta has failed itself, the patients, and their families, by not conducting a better study that could provide convincing evidence showing that it works.
- [When You Eat Can Affect Your Weight](https://www.center4research.org/eat-just-important-eat/) - This article will explain the research on how the timing of meals can make a difference for those trying to lose weight.
- [NCHR Comments on FDA Notice of Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health](https://www.center4research.org/regulatory-misconduct-cdrh-nchr-comment/) - August 9, 2023: NCHR supports FDA’s proposed online form for allegations of potential regulatory misconduct pertaining to medical devices. We recommended revisions to preserve anonymity and make the form easier to complete.
- [The real costs of the new Alzheimer's drug, Leqembi — and why taxpayers will foot much of the bill](https://www.center4research.org/cbs-leqembi-costs-taxpayers-billions/) - KFF Health News/CBS News, Aug 1, 2023: CBS News says that the drug Leqembi for mild cognitive impairment and early Alzheimer’s is likely to cost taxpayers billions of dollars. We are among the policy experts who tell Medicare that all registry data need to be public to see if it is safe or effective. Will that happen?
- [Medicare’s Registry Plans For Leqembi Prompt New Calls For Transparency, Rigor](https://www.center4research.org/leqembi-registries-letters-cms/) - Pink Sheet, August 2, 2023: This news article extensively describes 2 letters sent to CMS about the Leqembi registries: one from policy experts and one from 20 members of the Patient, Consumer, & Public Health Coalition. The article explains what these experts are asking Medicare to require of private registries for patients with mild cognitive impairment caused by early Alzheimer’s.
- [Patient, Consumer, and Public Health Coalition Letter to CMS and HHS Regarding the CMS Requirements for Alzheimer's Treatment Registries](https://www.center4research.org/coalition-letter-cms-hhs-registry-alzheimers/) - August 2, 2023: The coalition urged CMS that all data collected by any of the registries are made publicly available for research purposes, and available to the public.
- [When Should Women Start Regular Mammograms? 40? 50? And How Often is "Regular"?](https://www.center4research.org/2016-update-when-should-women-start-regular-mammograms-40-50-and-how-often-is-regular/) - In recent years, there has been a growing concern that annual mammograms starting at age 40 may do more harm than good for many women. That is why the U.S. Preventative Services Task Force, an expert group that reviews the latest research findings, recommends that mammography screening for most women start at age 50 rather than 40, and that the frequency be every two years (instead of annually) through the age of 74.
- [NCHR Comments on FDA Guidance Regarding Decentralized Clinical Trials for Drugs, Biological Products, and Devices](https://www.center4research.org/decentralized-clinical-trials-guidance-fda-comment/) - August 1, 2023: We asked FDA and those conducting DCTs to recognize how they could inadvertently reduce the enrollment of diverse populations when relying on digital health technologies (DHTs). NCHR then provided strategies and considerations to FDA for implementing decentralized clinical trials, including those that use DHTs.
- [Testimony of Diana Zuckerman at the CMS Meeting Regarding Transitional Coverage for Emerging Technologies](https://www.center4research.org/testimony-zuckerman-cms-transitional-coverage-emerging-technology/) - August 1, 2023: Dr. Zuckerman urged CMS to uphold its standard for coverage based on evidence that medical products are proven reasonable and necessary for Medicare patients.
- [Policy experts call on Medicare to ensure data from Alzheimer’s drug registries is shared publicly](https://www.center4research.org/stat-experts-urge-cms-alzheimers-registries-public-data/) - STAT, July 27, 2023: Prestigious health policy experts and ethicists sent a letter to CMS to urge Medicare to require all Alzheimer’s drug registries to share their de-identified data publicly to allow statistical analyses by CMS and others. NCHR explains why that is important, but Alzheimer’s Association and Beth Israel Hospital don’t plan to comply.
- [NCHR Comments on the FDA Notice Regarding Changes to Third-Party Vendors for Risk Evaluation and Mitigation Strategies (REMS)](https://www.center4research.org/fda-notice-rems-changes-third-party/) - July 19, 2023: NCHR urged FDA to require drug sponsors and their REMS administrators to test proposed changes to REMS systems prior to implementation. FDA should also require stakeholder input from prescribers in all stages of developing, implementing, and tracking a REMS modification.
- [US Mammogram Update Sparks Concern, Reignites Debates](https://www.center4research.org/medscape-new-mammogram-guidelines-uspstf/) - Medscape, July 9, 2023:Medscape quotes experts disagreeing about what age (40? 50? to start mammograms and we point out that the science suggests different guidelines based on race and risk. Radiologists suggest Black women start at age 35, which would means $$$ for the radiologists but would do more harm than good for most women. USPSTF recommendations raise concerns about costs, accuracy, timing, and ensuring that abnormal mammograms result in biopsies to learn if treatment is needed.
- [Fast Food Calorie Count Cheat Sheet](https://www.center4research.org/fast-food-menu-nutrition-calories/) - NCHR gives you the skinny on the calorie counts for many menu choices offered by some of the most popular fast food chains. Take a look -- you may be surprised!
- [NCHR Comments on USPSTF Draft Recommendation on Breast Cancer Screening](https://www.center4research.org/uspstf-breast-cancer-screening-2023/) - June 6, 2023: The U.S. Preventive Services Task force has changed its recommendations for mammography to start at age 40 instead of 50. However, they still recommend mammograms every 2 years instead of every year. We point out that there are racial differences in cancer risk and that mammography guidelines should reflect those racial differences. One size does not fit all.
- [Low T: Are Testosterone Treatments Safe and Effective for Men?](https://www.center4research.org/low-t-testosterone-treatments-safety-concerns/) - Testosterone therapy can be beneficial for Low-T but has serious risks. Testosterone is a controlled substance and should not be used in an effort to “stay young.” Many men are getting treatments that can harm them, especially if getting drugs online.
- [No more FDA adcomm votes? Reforms brew as new research highlights decline in meetings](https://www.center4research.org/endpoints-fda-adcomms-conflicts/) - Endpoints News, July 7, 2023: FDA wants to revamp its Advisory Committee meetings but will they make them better or worse? The votes aren’t the problem. We explain that the conflicts of interest of committee members is “outrageous.”
- [Alzheimer’s Drug Safety Hinges on Doctors Heeding FDA Warning](https://www.center4research.org/bloomberg-leqembi-fda-blackbox-warnings/) - Bloomberg Law News, July 12, 2023: NCHR says the FDA black box warnings about brain swelling and bleeding and other cautions about who is most likely to be harmed by Alzheimer’s drug Leqembi will help protect patients with mild cognitive impairment, but only if their doctors pay attention and accurately discuss the risks vs. uncertain benefits with patients and family members.
- [Patient, Consumer, and Public Health Coalition Letter to FDA Commissioner Califf Regarding FDA Advisory Committee Meetings](https://www.center4research.org/coalition-letter-fda-commissioner-advisory-committee/) - July 7, 2023: The Coalition expressed our strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.
- [NCHR Comments on FDA's Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising](https://www.center4research.org/drug-advertising-survey-comprehending-risks-benefits/) - June 26, 2023: In our public comment, NCHR supports the FDA's survey on evaluating patients' understanding of quantitative information provided in prescription drug advertising. We strongly recommend adding an assessment of comprehension for factors such as relative risk, absolute risk, relative benefit, and absolute benefit of drugs. We urge the FDA to include a diverse demographic of participants in the one-on-one interview informing the survey and provide details about the number of interviews OPDP plans to conduct.
- [Cambridge biotech Sarepta wins fast-track approval for the first muscular dystrophy gene therapy](https://www.center4research.org/sarepta-accelerated-approval-gene-therapy/) - The Boston Globe, June 22, 2023: FDA has approved Sarepta’s gene therapy for Duchenne muscular dystrophy, which will cost $3.2 million per patient. FDA’s Peter Marks praises the drug as if he is a Sarepta salesman, and NCHR explains why this political compromise is harmful to patients.
- [NCHR Comments on FDA's Patient-Focused Drug Development Draft Guidance](https://www.center4research.org/fda-patient-focused-drug-development-coa-endpoint/) - July 5, 2023: NCHR supports the FDA's efforts to increase patient engagement in medical product development and emphasizes the need for diverse and representative samples, the importance of transparency in data analysis, and the use of COA-based endpoints in regulatory decision-making and drug labeling.
- [Pricey Alzheimer’s Drug Coverage Hinges on FDA Decision](https://www.center4research.org/bloomberg-leqembi-alzheimers-registry/) - Bloomberg News, June 15, 2023: If Leqembi is approved, it will take time for doctors to arrange for patients to be tested for mild cognitive impairment and amyloid plaques on the brain, get the Leqembi infusions, and sign up patients for a registry. NCHR praises the CMS Registry as a good choice, but industry-funded groups complain.
- [National Center for Health Research National Long COVID Conference on October 3, 2022](https://www.center4research.org/long-covid-conference/) - October 3, 2022: NCHR’s National Long COVID conference was held in Washington, DC. Topics included autoimmunity, ME/CFS, Caregiving, Children and Teens, Dept of Veterans Affairs, and Research.
- [Mastectomy v. Lumpectomy: Who Decides?](https://www.center4research.org/mastectomy-v-lumpectomy-who-decides/) - Diana Zuckerman, PhD, National Center for Health Research Approximately 230,000 women in the U.S. will be diagnosed with breast cancer this year. Over the last two decades, research has regularly provided new evidence that breast cancer patients can live just as long – or even longer – with less radical treatment. In the 1990s, research
- [Novo Nordisk bought prescribers over 450,000 meals and snacks to promote drugs like Ozempic](https://www.center4research.org/novo-nordisk-gave-doctors-450000-meals-ozempic/) - STAT News, July 5, 2023: Novo Nordisk gave doctors 450,000 free restaurant meals and snacks in 2022 while promoting drugs like Ozempic for weight loss. One doctor got 183 meals. Some got free trips to Paris or Hawaii. Can those doctors be objective about the risks and benefits of the drugs?
- [Alzheimer’s Patient Registry Raising Questions as Drug OK Nears](https://www.center4research.org/bloomberg-june-29-cms-registry-leqembi/) - Bloomberg News, June 29, 2023: If Leqembi is approved for very early Alzheimer’s, CMS and NCHR explain how the Medicare registry will help patients make informed decisions about whether the benefits are likely to outweigh the risks for them for this expensive and risky treatment. But PhRMA and aligned patient groups complain.
- [US FDA adcom supports Leqembi for full approval](https://www.center4research.org/bioworld-fda-leqembi-alzheimers/) - BioWorld, June 9, 2023: BioWorld news explains that FDA Advisory Committee supports Leqembi for Mild Cognitive Impairment (MCI) caused by Alzheimer’s and quotes our statement that MCI can go away without drugs, which means that Leqembi’s risks of brain swelling and bleeding will often greatly outweigh the potential benefits.
- [NCHR Comments on the Filing of Color Additive Petition to FDA from the Center for Science in the Public Interest](https://www.center4research.org/nchr-comment-fda-color-additive-petition/) - May 18, 2023: We support the request that the FDA ban the use of FD&C Red No. 3 in foods, drugs, and dietary supplements. We find it unacceptable that the FDA has known for more than 30 years that Red 3 can cause cancer and yet still allows the dye to be used in foods, drugs, and supplements.
- [NCHR Testimony at the FDA Oncologic Drugs Advisory Committee Meeting on Pediatric Dosage for Cancer Drugs, June 16, 2023](https://www.center4research.org/pediatric-cancer-drugs-dosage-safety/) - June 16, 2023: NCHR testified on how to choose dosages for pediatric cancer drugs, stating that variables such as weight, age, sex, race, and organ impairment should be studied to identify differences in safety or effectiveness for subpopulations. We also strongly support the specifications about drug safety and tolerability, requiring factors such as duration of exposure and adverse events to be compared across varying dosages.
- [NCHR Comments on USPSTF Draft Recommendation for Oral Health in Adults](https://www.center4research.org/oral-health-screening-adults/) - June 20, 2023: In our public comment, NCHR agrees with USPSTF that there is insufficient evidence to recommend routine oral health screening of adults by primary care clinicians. We urged that new research be conducted to determine the benefits and harms of screening, primary care counseling, dental referral, and oral health preventive interventions administered in primary care settings for adults.
- [NCHR Comments on USPSTF Draft Recommendation for Oral Health in Children and Adolescents](https://www.center4research.org/oral-health-screening-kids/) - June 20, 2023: In our public comment, NCHR agrees with USPSTF that there is insufficient evidence to recommend routine oral health screening by primary care clinicians in children ages 5 to 17 years. Available research evidence is limited to studies assessing oral health preventive interventions that were administered by dental professionals or in supervised school settings, but not in primary care settings. We strongly recommend that well-designed research be conducted to fill these gaps.
- [Medicare outlines plan to expand coverage for costly new Alzheimer’s drugs](https://www.center4research.org/medicare-announces-registry-coverage-alzheimers-drugs/) - Washington Post, June 1, 2023: CMS announces that Medicare will cover FDA fully approved Alzheimer’s treatments for patients in a registry that will evaluate safety and efficacy. NCHR explains why this is essential to learn which patients are most likely to benefit and which are most likely to be harmed.
- [NCHR Comments on the FDA Draft Guidance Evaluating the Safety of Antimicrobial New Animal Drugs](https://www.center4research.org/nchr-comment-antimicrobial-new-animal-drugs/) - May 19, 2023: NCHR supports the proposed criteria for ranking antimicrobial new animal drugs according to their importance to human medicine; however these criteria need to be applied correctly. FDA should classify bacitracin as medically important and should almost always give antibiotics belonging to the same drug class the same rankings of medical importance.
- [Patient, Consumer, and Public Health Coalition Comment to CMS on CT Quality Measures Included in the Proposed Rule for the Hospital Inpatient Quality Reporting (IQR) Program](https://www.center4research.org/coalition-ct-quality-inpatient-rule/) - June 9, 2023: We support this CT quality measure because it establishes a floor and a ceiling to provide an optimal level of radiation exposure for imaging for numerous different conditions, without reducing the diagnostic benefits of those scans.
- [NCHR Comments on EPA Per- and Polyfluoroalkyl Substances National Primary Drinking Water Regulation](https://www.center4research.org/epa-pfas-national-standards/) - May 30, 2023: We agree that this proposed rule will improve public health, reducing cancer, heart disease, stroke, low birth weight, and other harms to adults and children. However, we have several recommendations to improve the proposed rule. The PFAS limit should be changed to 2 parts per trillion (ppt) and the EPA needs more explicit limits to prevent a weakening of these regulations. Finally, companies that produce PFAS should bear the financial burden.
- [NCHR Comments on the FDA Draft Guidance on Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics](https://www.center4research.org/nchr-comment-clinical-trial-oncology/) - May 26, 2023: FDA draft guidance contained numerous recommendations that would improve the quality of research submitted in support of accelerated approval for oncology drugs. However, we recommended the FDA explicitly specify that studies need to have a majority of patients enrolled prior to receiving accelerated approval and that they advise against the use of single-armed trials.
- [NCHR Comments on CPSC Priorities for FY2021/2022](https://www.center4research.org/nchr-comments-on-cpsc-priorities-for-fy2021-2022/) - April 2020. We want to start by emphasizing two issues involving chemicals in products that affect our and our children’s health, (1) artificial turf and playground surfaces and equipment, and (2) organohalogen flame retardants. We will also briefly discuss sport and recreational helmets, sleep-related products for infants, furniture stability, home elevators, and liquid nicotine packaging. All these issues should be CPSC priorities.
- [Are DC Playgrounds Safe? One Report Finds High Levels of Lead](https://www.center4research.org/dc-playgrounds-high-lead-levels/) - WUSA9 News: May 6, 2019. At Janney Elementary School in Washington DC, testing revealed high levels of lead. Are children being harmed?
- [Parents Demand Answers on Playground Lead in DC](https://www.center4research.org/parents-demand-answers-on-playground-lead-in-dc/) - WUSA-TV, October 2, 2019. Local parents attended a "Community Forum on the Safety of Playgrounds and Artificial Turf Fields in D.C.," sponsored by the Park View UNC and D.C. Safe Healthy Playing Fields on Wednesday.
- [Toxic chemicals lurk at playgrounds](https://www.center4research.org/toxic-chemicals-lurk-at-playgrounds/) - E&E News, July 8, 2022: The sight of rubber surfaces on playgrounds concerns Dr. Diana Zuckerman, “because as president for the National Center for Health Research she has testified in front of multiple municipal and even state governments about the toxic chemicals that can lurk on those playground surfaces.” They look very pretty and feel spongy if a child falls, but the evidence shows the toxic chemicals in these surfaces can be harmful to children.
- [Nearly a Dozen Artificial Turf Fields in DC Failed Last Round of Safety Tests](https://www.center4research.org/nearly-dozen-artificial-turf-fields-dc-failed-last-round-safety-tests/) - Fox 5 News, September 18, 2017. 11 artificial turf fields in the District have failed their most recent round of testing, leading to closures and replacements, and igniting another debate over the safety of synthetic turf.
- [Risks of Head Injuries on Artificial Turf Fields in Washington, D.C.](https://www.center4research.org/risks-head-injuries-artificial-turf-fields-washington-d-c/) - Professional athletes don’t like artificial turf for many reasons, and many parents feel the same way about artificial turf playgrounds and athletic fields. Artificial turf is made with chemicals that can harm children and adults, the fields also are much hotter than grass, and bacteria can grow in them. Some fields are also so hard that if people fall on them they are at an increased risk of getting a head injury.
- [Municipal and Schools Budgets Proposed for FY ’19-20, Public Comments Focus on Turf, Ice Rink](https://www.center4research.org/municipal-schools-public-comments-focus-turf/) - Greenwich Free Press: January 25, 2019. NCHR's president, Dr. Zuckerman, traveled to Connecticut to present information on artificial turf fields.
- [NCHR Comments on EPA Greenhouse Gas Emission Standards for Heavy-Duty Vehicles](https://www.center4research.org/nchr-comment-epa-greenhouse-gas-emission-standards-for-heavy-duty-vehicles/) - June 16, 2023: NCHR responds to EPA’s request for public comments on the new emission standards for heavy-duty vehicles. We strongly urge the EPA to strengthen the proposed standards by requiring 100% zero-emission sales by 2035 in the final rule to protect public health and set the United States on a path to a zero-emissions future.
- [NCHR Comment on USPSTF Draft Research Plan on Weight Loss Intervention](https://www.center4research.org/nchr-uspstf-obesity-treatments-health-benefits/) - June 14, 2023: Obesity affects nearly half of US adults (42%) and is extremely costly to the US healthcare system, costing $173 billion in 2019. We responded to USPSTF's request for public comments regarding their research plan, which is aimed at evaluating which pharmaceutical and behavioral treatments for obesity are proven to improve the health of adults, as well as any risks associated with those interventions.
- [Press Release: After Less than 1 Year, Artificial Turf Field at DC Elementary School is Falling Apart — And It's HOT!](https://www.center4research.org/press-release-less-1-year-artificial-turf-field-dc-elementary-school-falling-apart/) - Press release by Dr. Diana Zuckerman regarding the dangers of artificial turf like increased temperatures, chemical release, and more.
- [Written Statement to the First Selectman’s Capital Improvement Program's Public Hearing Regarding Dangers of Artificial Turf](https://www.center4research.org/first-selectmans-dangers-of-artificial-turf/) - January 9, 2020. Officials in communities all over the country have been misled by artificial turf salespeople. They were erroneously told that these products are safe. But on the contrary, there is clear scientific evidence that these materials are potentially harmful. The only question is how harmful and how much exposure is likely to be harmful? We should not be willing to take such a risk. Our children deserve better.
- [Letter to the Editor: Why Expose Children to the Danger of Artificial Turf Fields](https://www.center4research.org/letter-to-the-editor-why-expose-children-to-the-danger-of-artificial-turf-fields/) - Woodbridge Town News, April 22, 2021. Dr. Zuckerman writes about her concerns for children regarding artificial turf. Currently no tests for the impact of turf on human health are required before getting the product on the market.
- [Opinion: Are Turf Fields a Safe Place for Kids to Play in Westfield?](https://www.center4research.org/turf-fields-safe-place-kids-play-westfield/) - Dr. Diana Zuckerman, PH.D, Tap into Westfield: September 12, 2022 As a mother, I used to think that artificial turf and rubber playground surfaces were a clever and attractive alternative to grass fields. As a scientist, however, I learned that my children were being exposed to unsafe chemicals without my knowledge or consent. I recently wrote
- [NCHR Statement Supporting Maryland House Bill to Ban State Funds for Artificial Turf and Playgrounds](https://www.center4research.org/nchr-statement-supporting-maryland-house-bill-to-ban-state-funds-for-artificial-turf-and-playgrounds/) - March 5, 2020. Officials in communities all over the country have been misled by artificial turf salespeople. They were erroneously told that these products are safe. But on the contrary, there is clear scientific evidence that these materials are harmful. The only question is how much exposure is likely to be harmful to which children? We should not be willing to take such a risk. Our children deserve better.
- [Lilly battling rivals for breast-cancer patients](https://www.center4research.org/drug-companies-compete-breast-cancer/) - Indianapolis Business Journal, June 9, 2023: We explain to the Indianapolis Business Journal that 3 drug companies are spending $millions to persuade breast cancer patients that their drug is best despite risky side effects. Their ads are confusing and misleading.
- [NCHR Testimony at the FDA about Type 2 Diabetes Drug, Semaglutide](https://www.center4research.org/nchr-testimony-fda-type-2-diabetes-drug-semaglutide/) - October 18, 2017. In summary, we urge this Committee to recommend that the sponsor re-analyze the existing data to determine whether the benefits outweigh the risks for women of color, white women, men and women over 65, and other major demographic groups. We also recommend a longer follow-up of patients in the studies to determine safety, including appropriate evaluation of diabetic retinopathy. If there are too few patients in major subgroups to meaningfully evaluate risks and benefits, the sponsor should be required to add patients prior to FDA making a decision about approval. We urge this Committee to consider the safety and efficacy of Semaglutide within demographic subgroups and not subject patients to uncertain risk.
- [Eating Habits That Improve Health and Help with Weight Loss and BMI](https://www.center4research.org/eating-habits-improve-health-help-weight-loss-bmi/) - More and more research studies are confirming the importance of keeping body mass index (BMI) and waistline measurements under control in order to reduce the risk of disease and premature death. Keeping track of calories and fat percentages can be confusing, and the nutrition labels on the foods we buy aren't always that helpful. How are consumers supposed to figure out which diet advice is just hype - that ultimately don't contribute to better health - and which advice offers good, medically sound information?
- [Parkinson's Disease: News on Causes, Prevention, and Treatment](https://www.center4research.org/parkinsons-disease-causes-treatment-2/) - Studies have shown that people with traumatic brain injuries (TBI) and people exposed to pesticides or the common chemical trichloroethylene (TCE), are more likely to develop Parkinson's. Although there is no cure, various treatments are available to lessen or delay symptoms.
- [Parkinson's Disease: News on Causes, Prevention, and Treatment](https://www.center4research.org/parkinsons-disease-causes-treatment/) - Studies have shown that people with traumatic brain injuries (TBI) and people exposed to pesticides or the common chemical trichloroethylene (TCE), are more likely to develop Parkinson's. Although there is no cure, various treatments are available to lessen or delay symptoms.
- [Could new drugs for early Alzheimer's really signal the end of dementia? These women say ‘breakthrough’ medicines have halted their mental decline. But do side-effects – and cost – outweigh the benefits...](https://www.center4research.org/daily-mail-alzheimers-drugs-uk-concerns/) - Daily Mail, May 30, 2023: The Daily Mail reports on new Alzheimer’s drugs that are approved in the US but not in the UK. Dr. Zuckerman & other experts ask: Are they worth the costs or the risks? Patients want access but do these drugs really work? Mild cognitive impairment can change daily without treatment – we all have good days and bad days.
- [Comments of the Patient, Consumer, and Public Health Coalition on the Proposed Vaccine Information Materials for HPV (Human Papillomavirus) Gardasil®-9 Vaccine](https://www.center4research.org/comments-patient-consumer-public-health-coalition-proposed-vaccine-information-materials-hpv-human-papillomavirus-gardasil-9-vaccine/) - December 21, 2015. It is important that the statement concisely describe the benefits and risks associated with the vaccine. But it is equally important that the statement provide all the essential information about the vaccine.
- [NCHR Testimony on Gardasil](https://www.center4research.org/nchr-testimony-gardasil/) - December 7, 2010. The FDA approved Gardasil on the basis of short-term research, and we don't yet know how long Gardasil provides protection or when a booster shot will be needed.
- [Coalition Letter to FDA Commissioner Hamburg About Approving Cobas HPV Test Alone (Without Pap Smear) and FDA Response](https://www.center4research.org/coalition-letter-fda-commissioner-hamburg-approving-cobas-hpv-test-alone-without-pap-smear-fda-response/) - April 11, 2014. We are writing as members of the Patient, Consumer, and Public Health Coalition and other interested experts to express our grave concerns about the March 12, 2014 FDA meeting of the Microbiology Medical Devices Panel of the Medical Devices Advisory Committee. Under consideration was the premarket approval of a new indication for the Cobas HPV test, as a first-line primary screening tool for cervical cancer in women aged 25 and older.
- [NCHR Comment on the USPSTF’s Draft Recommendations for Cervical Cancer Screening](https://www.center4research.org/nchr-comment-uspstfs-draft-recommendations-cervical-cancer-screening/) - The National Center for Health Research is dedicated to improving the health and safety of adults and children by scrutinizing medical and scientific research. Based on our detailed analysis of currently available data, the Center strongly supports the existing USPSTF guidelines on cervical cancer screening which recommend Pap smears every 3 years starting at age
- [NCHR Comments on the USPSTF's Draft Recommendation Statement, Evidence Review, and Modeling Report on Cervical Cancer Screening](https://www.center4research.org/nchr-uspstf-cervical-cancer-screening/) - October 9, 2017. The USPSTF proposes new cervical cancer screening recommendations. Surprisingly, the USPSTF proposes eliminating co-testing (pap and HPV test together) as a preferred screening approach in favor of the HPV test alone. Do the proposed recommendations deserve an "A" rating? Read our comments to find out.
- [NCHR Testimony on the Evaluation for High-Risk HPV Detection Devices](https://www.center4research.org/nchr-testimony-hpv-screening/) - March 8, 2019. NCHR testified on March 8th, 2019 at the Microbiology Advisory Committee urging panel members to consider increasing the screening age from 25 to 30.
- [The HPV Vaccine](https://www.center4research.org/effectiveness-safety-access-hpv-vaccine-3-doses/) - Megan Cole, Diana Zuckerman, PhD, Brandel France de Bravo, MPH, and Janet A. Phoenix, MD, MPH, Cindy Min, MPH, National Center for Health Research What is a HPV Vaccine? The human papillomavirus virus, also known as HPV, is the most common sexually transmitted infection in the world. It can cause various different type of cancer
- [How Safe are Dietary Supplements?](https://www.center4research.org/examining-safety-dietary-supplements/) - In their quest for health and beauty, many American adults take dietary supplements to solve all sorts of problems. But do these products really work, and are they safe? Many aren’t. Don’t trust the claims that companies make about either the effectiveness or safety of their products. Even brand name products may not contain what they say they contain, so let the buyer beware.
- [Under pressure from patients, FDA faces tough choices on experimental gene therapy](https://www.center4research.org/boston-globe-fda-duchenne-gene-therapy/) - Boston Globe, May 22, 2023: Boston Globe quotes NCHR and other experts explaining why we are concerned that Sarepta’s gene therapy for Duchenne Muscular Dystrophy isn’t proven to work and has substantial risks. If it doesn’t work, patients who use it will not be able to try other, potentially better gene therapies in the future.
- [FDA advisers recommend accelerated approval of a Sarepta gene therapy](https://www.center4research.org/boston-globe-sarepta-dmd-gene-therapy/) - Boston Globe, May 12, 2023: FDA advisers recommended accelerated approval of Sarepta gene therapy for Duchenne Muscular Dystrophy, despite questionable results and worrisome risks. We testified that lowering FDA standards harms all families, and that Duchenne patients deserve free access to affordable treatments until drugs are proven to work.
- [NCHR Comments on AHRQ Systematic Review of Peripheral Nerve Blocks (PNB) for Postoperative Pain Management](https://www.center4research.org/ahrq-comment-peripheral-nerve-blocks/) - May 19, 2023: NCHR commented on the AHRQ Systematic Review of Peripheral Nerve Blocks (PNB) for Postoperative Pain Management. Helping patients avoid opioids in the postoperative period may prevent pain conversion from acute to chronic pain, and also avoid opioid addiction. In order to achieve these two goals, opioid-sparing pain medications must be safe and effective in the postoperative period. Peripheral nerve blocks (PNB) have the potential to reduce perioperative opioid use and its associated adverse effects.
- [NCHR Comments on the FDA Filing of Color Additive Petition Concerning Red No. 3](https://www.center4research.org/nchr-comment-red-dye-petition-fda/) - May 18, 2023: NCHR strongly supports the petition from the Center for Science and the Public Interest urging an FDA ban on the use of FD&C Red No. 3 in foods, drugs, and dietary supplements. We find it unacceptable that the FDA has known for more than 30 years that Red 3 can cause cancer and yet still allows the dye to be used in these products.
- [Unproven Drugs Reap Billions for Years After Taking FDA Shortcut](https://www.center4research.org/bloomberg-fda-sarepta-reap-billions/) - Bloomberg News, May 12, 2023: Accelerated approval of Sarepta drugs for Duchenne muscular dystrophy makes billions of dollars for the company even though the drugs aren’t proven to work. We call Sarepta decisions a poster child for inexcusable FDA lack of oversight or enforcement.
- [NCHR Testimony at the FDA Advisory Committee Hearing on OTC Access to Norgestrel (OPill)](https://www.center4research.org/nchr-testimony-fda-otc-birth-control/) - May 9, 2023: NCHR testified on the proposed first-in-class prescription-to-nonprescription switch of OPill (norgestrel) tablet, a progestin-only oral contraceptive pill (POP), and expressed concerns that the data demonstrated that a substantial minority of consumers did not understand written information about how to use the pill safely if they were not instructed by their physician.
- [Testimony of Diana Zuckerman on the Treatment of Duchenne Muscular Dystrophy before the Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee](https://www.center4research.org/nchr-comment-fda-sarepta-duchenne-2023/) - We testified at the May 2023 FDA Advisory Committee that Sarepta’s new treatment for Duchenne Muscular Dystrophy isn’t proven to work or to be safe, and that the company’s 3 previously approved DMD treatments are still not proven to work and have not submitted confirmatory trials as required.
- [EPA Public Meeting on Proposed Rule to Reduce PFAS in Water](https://www.center4research.org/epa-rule-reduce-pfas-water/) - May 4, 2023: We provided a public comment at an EPA public meeting to support their proposed rule to reduce PFAS in water and suggested ways to strengthen the rule to save more lives by reducing limits on these carcinogenic chemicals.
- [Alzheimer’s drug donanemab: what promising trial means for treatments](https://www.center4research.org/alzheimers-donanemab-lilly-nature-nchr/) - Nature, May 4, 2023: Nature news article quotes Eli Lilly’s press release claiming donanemab delays cognitive decline from Alzheimer’s Disease, but we ask if the small benefit is meaningful to patients with mild cognitive impairment compared to the risk of death or brain swelling or bleeding.
- [Getting Up on the Wrong Side of the Bed: Sleepiness, Behavior Problems, and Obesity in Children and Teens](https://www.center4research.org/sleep-deprivation-behavior-problems-obesity-children-teens/) - Sleep is essential for the renewal and restoration of the body. But is your child getting enough? Research indicates that children who do not get the recommended 10 to 12 hours of sleep per night may be more likely to have conduct problems at home and in the classroom, as well as suffer from many health problems now and in the future.
- [NCHR comments on the FDA Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Draft Guidance](https://www.center4research.org/nchr-comment-fda-externally-controlled-trial/) - May 2, 2022: NCHR supports FDA’s draft guidance’s research design considerations to reduce bias in externally controlled trials. However, FDA should be much more explicit about the criteria that must be met to ensure that externally controlled trials are only used when absolutely necessary.
- [Surgery Studies Rarely Use Females](https://www.center4research.org/scientist-clinical-trial-nchr/) - The Scientist, August 28, 2014: The Scientist article on lack of women in clinical trials quotes NCHR telling MedPage Today that FDA must increase incentives for companies to include more women, older patients, and people of color in clinical trials. The FDA urges diversity but approves drugs and implants that have not been evaluated on all the types of patients who will want to use the product.
- [FDA is Chastised Over its 'Action Plan' to Diversify Clinical Trial Participation](https://www.center4research.org/wsj-fda-diversity-plan-nchr/) - The Wall Street Journal, August 28, 2014: NCHR explains to WSJ that the FDA Diversity Action Plans lacks incentives for companies to study their medical products in a diverse group of patients, including sex, age, and race/ethnicity. The FDA urges diversity but approves drugs and implants that have only been evaluated on mostly white patients under 65.
- [When it comes to clinical trials, healthcare’s diversity problem is standing in the way of medical advancement](https://www.center4research.org/fortune-diversity-medical-advancement/) - Fortune, November 5, 2021: The lack of diversity in clinical trials is standing in the way of medical advancement. NCHR president Dr. Diana Zuckerman explains how that delayed progress in treating triple negative breast cancer, which is more common among Black women.
- [NCHR Comments on Recommended Diversity Plan to Improve Enrollment of Racial and Ethnic Minorities in Clinical Trials](https://www.center4research.org/nchr-comment-fda-diversity-plan-clinical-trials/) - June 13, 2022. We strongly support FDA’s proposed recommendations which provide specific, actionable guidance for sponsors to develop a meaningful Race and Ethnicity Diversity Plan. For too long, clinically meaningful disparities in the efficacy of drugs or therapies in minority populations have been hidden by a lack of data. However, this draft proposal should go further by providing meaningful incentives for sponsors to follow the recommendations.
- [NCHR’s Comments on AHRQ’s Draft Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain and Subacute Pain](https://www.center4research.org/ahrq-cannabis-systematic-review-comment/) - April 20, 2023: NCHR supports the goals of the review and agrees that there is a need for a systematic review of the effects of cannabis and other plant-based treatments for chronic pain. However, there are several important limitations of the report that were either not adequately addressed.
- [Public Comment of Dr. Diana Zuckerman, President National Center for Health Research  At the FDA Advisory Committee meeting on Rexulti for Alzheimer’s patients  April 14, 2023](https://www.center4research.org/rexulti-dementia-agitation-fda-nchr-testimony/) - April 14, 2023: Rexulti is already FDA approved as an atypical antipsychotic and FDA held an Advisory Committee meeting in April 2023 to consider approving it for agitation in dementia patients, many of whom are in nursing homes. We expressed concerns about Rexulti’s well-known risks of death for dementia patients. Why isn’t FDA more concerned about safety?
- [FDA’s new plan to study opioids’ effectiveness faces resistance](https://www.center4research.org/stat-fda-study-opioids-nchr/) - STAT, April 19, 2023: An FDA proposal to study whether opioids are effective as a chronic pain treatment is facing major resistance from addiction and pain care experts who are not paid by industry. We told STAT that the proposed clinical trial is unethical because it will provide no new information and would make some patients more dependent on opioids.
- [Testimony of Diana Zuckerman at the FDA Advisory Committee Meeting on Extended-Release/Long-Acting Opioid Analgesics Post-marketing  Requirements](https://www.center4research.org/opioid-research-nchr-fda-testimony/) - April 19, 2023: FDA has worked with industry to propose a clinical trial to determine safety and efficacy of extended release (ERLA) opioids for chronic pain. We criticized the proposed study due to bias, poor study design, and ethical considerations for patients who could be harmed by the study. We urge the FDA to revise the labels to restrict the use of these opioids for chronic pain, based on current data and not wait for what could be an inevitably flawed study to be completed.
- [Do Vitamin D Supplements Prevent Health Problems? What the Research Says](https://www.center4research.org/do-vitamin-d-supplements-prevent-health-problems/) - Do vitamin D supplements prevent health problems? Research is examining whether taking vitamin D can help to prevent cancer, heart problems, or Alzheimer’s.
- [NCHR Comments on the CMS Inflation Reduction Act Initial Program Guidance](https://www.center4research.org/cms-inflation-reduction-act-guidance/) - April 14, 2023: NCHR comment on the CMS plan to fully implement the authorities provided by Congress in the Inflation Reduction Act (Pub. L. 117-169) to lower the costs of prescription drugs for beneficiaries through drug price negotiations.
- [NCHR addresses proposed changes to acne medicine iPLEDGE program](https://www.center4research.org/nchr-change-acne-med-ipledge-rems/) - March 29, 2023: NCHR testimony at an FDA advisory committee recommends changes to the iPLEDGE REMS (risk reduction) program for patients taking the acne medication isotretinoin, which causes birth defects. We recommend eliminating unnecessary barriers for women who are unable to become pregnant and strengthening contraceptive requirements for adolescents.
- [NCHR Comments on CPSC Proposed Rulemaking on Safety Standards for Non-full-size (NFS) Baby cribs. ](https://www.center4research.org/cpsc-safety-standard-non-full-size-cribs/) - April 5, 2023: NCHR supports the additional standards to improve the safety of non-full-size cribs by regulating cords and straps that form a loop and the addition of language to prevent exemptions for cribs intended for playing. However, we also recommend revision to the proposal exempting certain products from including a mattress.
- [NCHR testifies for FDA Advisory Committee about withdrawing approval of Makena, to prevent preterm birth](https://www.center4research.org/nchr-testifies-for-fda-advisory-committee-about-withdrawal-of-approval-for-preterm-labor-drug/) - October 17, 2022: In OB/GYN, preterm delivery is one of our most difficult challenges. The causes are complicated and not well-understood. But the associated harms are clear and devastating. We all want an effective intervention that will reduce the number of babies delivered too early and lead to better maternal and fetal outcomes. Unfortunately, current data do not indicate that Makena is the solution we have been seeking.
- [NCHR Comments on FDA Guidance for Lead Levels in Food for Babies and Young Children](https://www.center4research.org/nchr-comments-lead-baby-food/) - March 27, 2023: NCHR comments on the new FDA standards for lead in food for babies and young children. Standards must be implemented as soon as possible and should be enforced.
- [NCHR Letter to Members of the Board of the Los Gatos Union School District on Artificial Turf and Playgrounds](https://www.center4research.org/nchr-letter-to-members-of-the-board-of-the-los-gatos-union-school-district-on-artificial-turf-and-playgrounds/) - April 18, 2022: NCHR Letter to Superintendent Paul Johnson and Members of the Board of the Los Gatos Union School District regarding the health risks posed by artificial turf and playground surfaces.
- [NCHR Comment on USPSTF Draft Research Plan on Interventions to Prevent Perinatal Depression](https://www.center4research.org/nchr-uspstf-prevent-perinatal-depression/) - We appreciate efforts by the US Preventive Services Task Force to reduce perinatal depression, which is one of the most common complications of pregnancy. Perinatal depression contributes significantly to maternal mortality and adverse neonatal, infant, and child outcomes. We agree that developing effective interventions to prevent perinatal depression is essential to reduce the U.S. maternal mortality rate.
- [NCHR Comment On USPSTF Draft Recommendation On Folic Acid Supplementation To Prevent Neural Tube Defects](https://www.center4research.org/nchr-uspstf-folic-acid-supplementation-neural-tube-defects/) - Neural tube defects are among the most common causes of childhood mortality and disability. In its new draft recommendation, the US Preventive Services Task Force reaffirms that folic acid supplementation provides a substantial benefit for reproductive-aged women in reducing the risk of neural tube defects. The task force also highlights areas that require further study, including disparities in the prevalence of neural tube defects. We agree.
- [NCHR Comments on the Use of Medical Device User Fees Collected by FDA](https://www.center4research.org/nchr-fda-user-fee-funding-rwe/) - March 20, 2023: In a public comment, we explain our concerns about FDA’s plan to distribute user fee funding to non-governmental organizations to support premarket real world evidence (RWE).
- [For Canadian Patients, Therapeutic Psychedelics Beset by Red Tape](https://www.center4research.org/canadian-red-tape-psychedelic-therapy/) - Undark, March 8, 2023: Undark article reviews the red tape in Canada vs. U.S. for access to psychedelics for cancer patients and other depressed patients. In this news article, we explain FDA expanded access program, which tends to make access easier if companies agree to help patients.
- [Can Daily Aspirin Prevent Both Heart Disease and Cancer?](https://www.center4research.org/baby-aspirin-cancer-heart-disease-prevention/) - Daily low-dose aspirin used to be widely recommended to prevent heart attacks but is now only recommended for patients who already have had heart attacks or other serious cardiovascular problems. It is not recommended for people with high blood pressure because it can cause serious bleeding complications that outweigh any benefits for heart disease or cancer. That’s why experts recommend safer options to help prevent heart disease in low-risk patients.
- [Statement of Dr. Diana Zuckerman, President, National Center for Health Research,  March 8, 2023](https://www.center4research.org/zuckerman-breast-implants-squamous-cell-carcinoma/) - Today the FDA announced that 19 women were reported in medical publications who developed squamous cell carcinoma (SCC) in the capsule around breast implants. This is more than the 10 women that FDA reported in September. Several of the women died. It is important to know that 24 cases of SCC have been reported to
- [NCHR comments on AHRQ draft review on the management of postpartum hypertensive disorders of pregnancy](https://www.center4research.org/nchr-ahrq-review-postpartum-hypertensive-disorders-of-pregnancy/) - NCHR agrees with AHRQ draft review designed to enhance care for women with postpartum hypertensive disorders of pregnancy. We are encouraged by the focus on the important issue of maternal mortality and look forward to seeing a meaningful response by policymakers.
- [NCHR Comments on EPA Request for Information on Better Indoor Air Quality (IAQ) Management to Help Reduce COVID-19](https://www.center4research.org/nchr-epa-comment-iaq-air-quality/) - December 5, 2022: Current IAQ standards are insufficient and poorly regulated at state and local levels to keep the public safe from increased COVID-19 transmission and other respiratory illnesses. Federal mandates would ensure that all indoor public spaces are properly assessed to improve ventilation rates. In the absence of greater regulation, the EPA must promote alternative methods of air filtration such as the Corsi-Rosenthal Box.
- [Meeting of Patient, Consumer, and Public Health Coalition with Commissioner Califf and Key FDA Officials](https://www.center4research.org/patient-consumer-public-health-coalition-meeting-commissioner-califf/) - March 1, 2023: As a leader of the Patient, Consumer, and Public Health Coalition, the National Center for Health Research scheduled a meeting at the FDA with Commissioner Califf and other key FDA officials to discuss accelerated approval, lab developed diagnostic tests, and improvements to FDA Advisory Committees.
- [FDA could widen path for OTC birth control, statins](https://www.center4research.org/roll-call-conditional-nonprescription-rule/) - Roll Call, March 2, 2023: Roll Call explains that FDA proposes broadening access to some common medications that currently require a doctor’s prescription. FDA suggests replacing prescriptions with a short quiz for over-the-counter access. We ask if patients will be careful enough to safely use these products.
- [The Obesity Revolution](https://www.center4research.org/stat-obesity-revolution-med-students/) - STAT, March 5, 2023: Novo Nordisk makes a popular weight loss drug and they want doctors to prescribe it. They have paid for materials to teach medical students that weight loss drugs are effective, and we tell STAT that med students are a captive audience and shouldn’t be taught by a company that sells the drugs that they are learning about. That doesn’t just push the envelope, it shreds it.
- [Lawmakers, advocates press for diversity in clinical trials](https://www.center4research.org/lawmakers-advocates-diversity-clinical-trials/) - National Journal, February 15, 2023: NCHR joins lawmakers and other advocates in urging FDA and NIH to improve diversity in race/ethnicity, age, and sex in clinical trials as a way to improve medical care for everyone. So far, enforcement is lacking.
- [NCHR Comments on FDA update to “healthy” food label criteria](https://www.center4research.org/nchr-fda-healthy-food-claims/) - NCHR supports FDA’s updated criteria for the “healthy” food label focused on foods with high nutritional value and healthy eating patterns, rather than specific nutrients. However, we urge the agency to ensure the "healthy" label isn’t on foods that are highly processed, contain artificial sweeteners or are high in saturated fats. The revised definition will help consumers make informed food choices that will benefit their health.
- [Testimony of Dr. Diana Zuckerman before the House of Delegates Environment & Transportation Committee For HB 299](https://www.center4research.org/nchr-maryland-chain-of-custody-turf-bill/) - February 15, 2023: NCHR testified before the Maryland House Environment Committee to support HB299, which would require transparency about the use and disposal of artificial turf and infill. That will enable communities to make informed decisions about the environmental and health impact of these materials.
- [Many pediatric drug study results were never posted to a U.S. government database](https://www.center4research.org/pediatric-clinical-trial-results-missing/) - STAT News, January 24, 2023: Results of 43 clinical trials involving thousands of children were never reported to clinicaltrials.gov or published in a medical journal or otherwise made publicly available, as required by law. We explain how this harms children and families.
- [American women still can’t get birth control pills without a prescription. This company has been trying for nine years to change that](https://www.center4research.org/birth-control-pills-without-prescription/) - FORTUNE, February 10, 2023: A company wants their birth control pill to be available over the counter. Is it safe enough to use without a prescription? It is safer than most hormonal contraceptives, but would this set a dangerous precedent for less safe contraceptives?
- [Testimony of Dr. Diana Zuckerman at CMS MEDCAC Meeting On Coverage with Evidence Development](https://www.center4research.org/nchr-cms-medcac-medicare-ced/) - February 13, 2023: In testimony before CMS MEDCAC, NCHR strongly supported the new proposals to improve the quality of research needed to decide Medicare coverage evidence. We especially appreciate the focus on clinically meaningful benefits for patients that are representative of Medicare beneficiaries
- [NCHR Comments on the CDC proposed new Recommendations for Hepatitis C Testing Among Perinatally Exposed Infants and Children](https://www.center4research.org/nchr-cdc-comment-infant-hepatitis-testing/) - January 27, 2023: Hepatitis C infections have dramatically increased among pregnant women, which exposes babies during birth. National Center for Health Research supports CDC's recommendations for HCV testing of all infants and children born to pregnant mothers with confirmed or probable HCV.
- [NCHR Comments on the Consumer Product Safety Commission’s Proposed Ruling of Safety Standards for Adult Portable Bed Rails](https://www.center4research.org/comment-cpsc-proposed-ruling-safety-standards-adult-portable-bed-rails/) - January 9, 2023: NCHR strongly agrees with CPSC’s proposed ruling that APBR has an “unreasonable risk of injury and death associated with entrapment hazards” and enthusiastically supports CPSC’s plan to make the voluntary safety standards mandatory, include new requirements for testing and labeling, and consider banning the products if the new standards do not substantially improve their safety. It is important to consider alternatives to APBR’s if it becomes necessary to ban them, and alternatives can be bed trapezes, adjustable beds, nonslip mattress pads, and bed exit alarms.
- [NCHR Testimony on Non-Prescription Nicotine Mouth Spray](https://www.center4research.org/nchr-testimony-on-non-prescription-nicotine-mouth-spray/) - September 18, 2019: This nicotine mouth spray has already been approved in several other countries, but that doesn’t mean that it is good product for the U.S. If we’ve learned anything from the Juul and vaping epidemic, it is that anything that delivers nicotine over the counter or online can be misused.
- [Testimony of Dr. Diana Zuckerman About Jemperli (Dostarlimab) FDA Advisory Committee Meeting](https://www.center4research.org/fda-testimony-zuckerman-jemperli-rectal-cancer/) - February 9, 2023: Dr. Diana Zuckerman of NCHR urges the FDA Oncology Advisory Committee to require randomized trials of Jemperli for rectal cancer instead of single arm trials, so that patients and physicians can make informed decisions about the best treatment.
- [NCHR Comments on the FDA Preliminary Assessment of Potential Non-prescription Naloxone Products](https://www.center4research.org/nchr-supports-fda-naloxone-otc/) - January 17, 2023: NCHR agrees with the FDA’s assessment that certain types of naloxone drug products could be safe and effective for non-prescription use but training is needed to use it correctly in urgent situations. We also support FDA's request for more research to determine how to provide the most effective instructions and labeling for non-prescription naloxone products.
- [Fibromyalgia](https://www.center4research.org/fibromyalgia-symptoms-causes-treatment/) - Fibromyalgia causes pain and suffering that is difficult to correctly diagnose or to fix. Here’s how to know if you might have fibromyalgia, and what is known about treatment options.
- [Improving Outcomes for Long COVID-19 Patients](https://www.center4research.org/nchr-long-covid-teleconferences-national-conference-project/) - The project “Engaging Stakeholders in Patient-Centered Outcomes Research and Clinical Effectiveness Research to Improve Outcomes for Post-Acute COVID-19 Patients” aims to strengthen collaboration among healthcare providers, patients, disability experts, payers, and employers.
- [NCHR Comments on USPTO-FDA Collaboration and Engagement](https://www.center4research.org/nchr-comments-uspto-fda-collaboration/) - February 6, 2023: NCHR's public comments strongly support FDA's decision to prioritize USPTO-FDA collaboration. Access to generic drugs and biosimilars is critically important and abuse of the patent system remains a major barrier. We are hopeful that meaningful collaboration between the FDA and the USPTO will result in substantial improvements.
- [FDA approves Alzheimer’s drug lecanemab amid safety concerns](https://www.center4research.org/fda-accelerated-approval-lecanemab-alzheimers/) - Nature, January 7, 2023: FDA approved Alzheimer’s drug lecanemab (Leqembi) under the accelerated approval pathway, despite safety concerns. 3 patients died. It has serious risks, is not proven to work, and will cost $26,500/year. Dr. Zuckerman points out that those risks may outweigh the benefits for people with mild impairment who are still functioning well.
- [An FDA pathway to clear medical devices puts patients at risk, research suggests](https://www.center4research.org/fda-medical-devices-risks/) - Stat News, January 10, 2023: When FDA clears medical devices based on similar “predicate” devices that were previously recalled, that puts patients’ lives at risk. It’s easy to fix: Don’t allow recalled predicates!
- [Medicare, patient advocates at odds over coverage for an expensive new Alzheimer’s therapy](https://www.center4research.org/medicare-coverage-alzheimers-leqembi-advocates-disagree/) - PoliticoPro, January 18, 2023: Public health and patient advocates disagree on whether Medicare should cover Leqembi, a questionable new treatment for Alzheimer’s Disease. We express doubts that the benefits outweigh the risks and the Patient, Consumer and Public Health Coalition urges Medicare to restrict coverage to clinical trials as they do for Aduhelm.
- [NCHR Comments on HHS Proposed Rule Regarding Confidentiality of Substance Use Disorder (SUD) Patient Records](https://www.center4research.org/nchr-comment-hhs-confidentiality-substance-use-sud/) - January 31, 2023: NCHR’s public comment criticizes the HHS plan to align privacy standards with HIPAA instead of Part 2. We are concerned that loss of privacy for patients with substance abuse disorder (SUD) could stigmatize them or discourage them from seeking treatment.
- [Exercising During Pregnancy: Anything Goes?](https://www.center4research.org/exercising-pregnancy-anything-goes/) - In general, staying physically active during pregnancy is good for you: it lowers your risk of heart disease, helps keep you from gaining too much weight, and it makes you feel good!
- [NCHR Comments on EPA's Draft for Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)](https://www.center4research.org/nchr-comments-on-epas-draft-for-reporting-and-recordkeeping-requirements-for-perfluoroalkyl-and-polyfluoroalkyl-substances-pfas/) - December 27, 2022: NCHR public comments on EPA's proposed draft supports the need for recordkeeping and reporting as they are vital steps toward managing perfluoroalkyl and polyfluoroalkyl substances (PFAS). However, there are accountability loopholes identified in this proposed draft that could allow manufacturers to take advantage of the system, ie. making it optional to register an unknown chemical with a CASRN or other identifier and not required. It is for reasons like this that we believe the draft does not go far enough.
- [Patient, Consumer, and Public Health Coalition Letter to CMS on Lecanemab Approval](https://www.center4research.org/pcphc-letter-cms-lecanemab-coverage-decision/) - January 6, 2023: We applaud your National Coverage Determination that made the wise decision to limit coverage of this class of drugs solely to patients participating in clinical trials following the approval of aducanamab (Aduhelm) by the FDA. The FDA approved Biogen and Eisai’s lecanemab today, and we urge you to hold firm to your decision to prioritize patient safety and the scientific credibility of CMS’s coverage decisions.
- [NCHR Comments on EPA's Proposed Finding that Lead Emissions from Aircraft Engines using Leaded Fuel May Endanger Public Health](https://www.center4research.org/nchr-epa-comment-leaded-fuel-aircraft-effect-public-health/) - January 17, 2023: The presence of lead in aircraft engines has a significant, negative effect on public health, and we enthusiastically agree with the proposed EPA finding in support of these conclusions. These findings should be finalized as soon as possible to give EPA the authority to set aircraft emission standards for lead under section 231 of the Clean Air Act.
- [NCHR Statement on Transparency of Children's Clinical Trials](https://www.center4research.org/nchr-statement-on-transparency-of-childrens-clinical-trials/) - January 24, 2023: A new report finds that 3,627 American children participated in clinical trials whose results remain hidden. This is not ‘only’ unethical – it’s illegal.
- [Reassuring Safety Inquiry But Botched Comms Leads To Mixed Headlines For Pfizer Bivalent Vax](https://www.center4research.org/fda-cdc-risks-pfizer-vaccine/) - Pink Sheet, January 16, 2023: FDA and CDC failed to be transparent regarding their analysis of whether the Pfizer bivalent COVID vaccine increase strokes in older patients. There seems to be disagreement about how to explain the findings and the bottom line is that the agencies “don’t want to be asked questions” by experts in public.
- [National Center for Health Research Comment on Safety Standards for Gates and Enclosures to the Consumer Product Safety Commission](https://www.center4research.org/gates-enclosures-safety-standards/) - December 14, 2022: NCHR supports CPSC’s plan to revise section ASTM F1004-22 of the mandatory standards for safety gates and enclosures to include a specific warning about the installation of wall cups. Gates and enclosures that use wall cups for mounting can break or unlatch if not installed properly which can result in falls, choking, and strangulations. A mandatory warning label that specifically addresses these concerns will alert parents to the need for proper installation of these gates and enclosures but we urge CPSC to make this mandatory label also present on the outside packaging of gates and enclosures.
- [NCHR Comments on FDA Updates to the Breakthrough Devices Program to Reduce Disparities in Health Care](https://www.center4research.org/nchr-comment-breakthrough-devices-updates-health-disparities/) - December 20, 2022: We disagree with the guidance because of the enormous loophole it represents. Altering the eligibility criteria for the breakthrough pathway to include certain devices that have the “potential” to benefit certain populations is too vague. FDA must Improve the standards of evidence required to authorize Breakthrough medical devices prior to focusing on equity issues.
- [NCHR Comments on FDA Ethical Considerations for Clinical Investigations of Medical Products Involving Children](https://www.center4research.org/nchr-comments-ethical-children-clinicl-trials-medical-products/) - December 27, 2022: We address suggestions of how to improve this guidance to promote safety and efficacy in clinical investigations of medical products involving children. Many new medical products that are used by children are never actually tested on them or approved for them prior to entering the market. Many children are either left with no treatment options or given products “off label” that have not been tested for safety, effectiveness, or dosage requirements in patients of their age, size, or weight.
- [NCHR Comments on HHS and FDA's Request for Information on Ortho-phthalates for Food Contact Use](https://www.center4research.org/nchr-comment-phthalates-food-contact-use/) - December 27, 2022: NCHR strongly urges the FDA to ban the remaining phthalates from materials that have contact with food, and to rigorously enforce this ban. Phthalates are endocrine disrupting chemicals that have potential adverse effects for children and adults, such as fertility issues and obesity, and can be detrimental even at low levels of exposure. These toxins are found in many items used in food preparation, contact, and packaging, and can leach out of these products where they can be consumed or inhaled.
- [A Guide to Selecting Safe Medical Contraception](https://www.center4research.org/guide-selecting-safe-medical-contraception/) - Based on your health history, certain types of contraceptives may be safer or more effective than others. Use this guide to look up the conditions that apply to your current and past health history, to ensure that you select or are using the best medical contraceptive for YOU.
- [Lasik Patients Should Be Warned of Complications, F.D.A. Draft Says](https://www.center4research.org/nytimes-lasik-patients-risks-fda-warning/) - New York Times, December 7, 2022: FDA says many Lasik surgery patients develop double vision, dry eyes, difficulty driving at night and some have persistent eye pain. Diana Zuckerman says these FDA warnings should be required.
- [Fitness Tracking Apps and Eating Disorders](https://www.center4research.org/fitness-tracking-apps-eating-disorders/) - Belinda Gorsuch, National Center for Health Research December 15, 2022 It seems there is an app for everything. About 69% of adults track health indicators, such as steps, calories, and hydration [1]. But, has fitness tracking technology gone too far? Some believe our phones can help us improve our diet and exercise routines. Others claim
- [What to do About the Flu?](https://www.center4research.org/do-this-if-you-have-flu/) - The flu is a very contagious respiratory virus that can cause mild to severe illness. Learn more about what to do if you have the flu.
- [Long COVID National Conference Agenda](https://www.center4research.org/nchr-long-covid-conference-agenda/) - Monday, October 3rd, 2022 9:00 am to 9:15 am Welcome from Dr. Diana Zuckerman, President of National Center for Health Research, and Dr. Monica Verduzco-Gutierrez, Chair of Rehabilitation Medicine at Long School of Medicine at UT Health Science Center 9:15 am to 10:15 am Panel I: Autoimmunity and Long COVID: Dr. Rasika Karnik, Assistant
- [National Center for Health Research Comment on Proposed Labeling Recommendations for Patients Considering LASIK](https://www.center4research.org/fda-lasik-2022-guidance-weak/) - November 25, 2022: NCHR does not support nonbinding FDA LASIK guidance saying it is not enforceable and does not protect patients. We strongly urge the FDA to require patients to be provided with short, easy-to-understand labeling prior to scheduling surgery, and that the FDA improve their example of a LASIK Patient Checklist to provide more balanced information about risks.
- [National Center for Health Research (NCHR) Comment on FDA proposed ruling for ACNU Nonprescription Drug Products](https://www.center4research.org/nchr-rejects-fda-acnu-nonprescription-drugs-proposal/) - November 25, 2022: We appreciate the FDA’s interest in establishing requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). However, the FDA has not identified a mechanism to ensure appropriate use. Based on our experience with patients across the country, we believe it would be impossible to do so. For that reason, we do not support the proposed ruling.
- [Fecal Matter Transplants - What You Need to Know](https://www.center4research.org/fecal-matter-transplants-risks-safety-rebyota-2/) - Fecal Matter Transplants can only be used in a medical setting as an investigational treatment for c. diff or in research studies for patients with other conditions.
- [NCHR's Testimony on Elivaldogene Autotemcel](https://www.center4research.org/nchrs-testimony-on-elivaldogene-autotemcel/) - June 9, 2022. We agree with FDA scientists in their summary that “The uncertainty regarding efficacy at 24 months following treatment is particularly problematic in the context of the recent discovery of a serious safety concern, the development of MDS, a life-threatening malignancy which occurred in 3 subjects.” We share the concerns of the FDA that two of the events are definitely related to the product and the third is highly likely to be related.
- [Are Mastectomies Necessary for Women with BRCA1 or BRCA2? What About for Women Without the Breast Cancer Gene?](https://www.center4research.org/prophylactic-mastectomy-to-prevent-breast-cancer-brca/) - When Angelina Jolie publicly announced her double mastectomy in 2013, she was praised for possibly saving many women’s lives. But we know more today than we did then and experts now agree that too many women are undergoing unnecessary mastectomies. Here are the facts.
- [NCHR Testifies Before Cardiovascular and Renal Drugs Advisory Committee on Heart Failure Drug](https://www.center4research.org/nchr-2022-testimony-fda-reject-om-heart-failure/) - Dr. Ealena Callender of National Center for Health Research tells Dec. 2022 FDA Advisory Committee to require better research on OM heart failure drug due to lack of evidence of efficacy and concerns about safety due to toxicity.
- [NCHR encourages WSPI to do more to prevent long-term impact of diabetes in pregnancy](https://www.center4research.org/nchr-supports-wspi-postpartum-diabetes-screening/) - December 8, 2022: The National Center for Health Research (NCHR) agrees with the Women's Preventive Services Initiative (WPSI) 2022 recommendations for diabetes screening after pregnancy. WPSI encourages continued diligence during the postpartum period in patients who were diagnosed with diabetes mellitus during pregnancy. That’s important because gestational diabetes increases a patient’s chances of developing type 2 diabetes.
- [Does Media Coverage Inspire Copy Cat Mass Shootings?](https://www.center4research.org/copy-cats-kill/) - Decreasing media contagion could reduce the number of mass shootings, but other public health steps are needed like making it more difficult to obtain guns
- [Does Infrared Light Therapy Work for Weight Reduction?](https://www.center4research.org/infrared-light-therapy-work-weight-reduction/) - Infrared light therapy has been advertised as a means for weight loss, but what evidence is there in support? This therapy might not help in the long run.
- [Football and Brain Injuries: What You Need to Know](https://www.center4research.org/football-brain-injuries-need-know/) - There are many hidden dangers of contact sports like football, but new rules emphasizing safety over entertainment may help to reduce risks.
- [Bacteria: the Good, the Bad, and the Ugly](https://www.center4research.org/bacteria-good-bad-ugly/) - Bacteria are everywhere, including your entire body. The bacteria in our body weighs as much as our brain--3 lbs!
- [ALS patients contend with $158K price tag on new drug](https://www.center4research.org/als-lou-gehrig-158k-amazon-relyvroo-zuckerman/) - AP, December 18, 2022: Patients with ALS (also called Lou Gehrig’s disease) celebrated when FDA approved Relyvrio in 2022. But it costs $158k despite combining two old ingredients, the benefits are unclear, and the effective ingredient may be the one sold by Amazon for $1/day. Important research is underway to find out if the ingredient available on Amazon is equally or more effective, says Dr. Diana Zuckerman of National Center for Health Research.
- [NCHR criticism of drug for chronic kidney disease at FDA Advisory Committee Meeting](https://www.center4research.org/fda-advisory-committee-considers-new-drug-for-esrd-patients/) - November 16, 2022: Elevated phosphorus is a serious complication encountered by the majority of patients with chronic kidney disease on dialysis. Tenapanor represents a novel approach to this major problem. Still, we are concerned about this product because the data do not show it to be more effective than current options, and the significant side effects may lead to poor patient compliance.
- [NCHR urges FDA to require more diversity in trials to improve accuracy of pulse ox devices](https://www.center4research.org/pulse-ox-inaccurate-on-pigmented-skin/) - December 2, 2022: NCHR testified at an FDA meeting that there is strong evidence that commonly-used pulse oximeters are less reliable for patients with pigmented skin. The FDA’s current guidelines do not require product labeling to address the impact of skin pigmentation on pulse oximetry. While labeling is important to alert users to possible inaccuracies, it does not diminish the importance of developing devices that are effective for everyone.
- [Comments of National Center for Health Research Regarding the USPSTF Draft Evidence Review: Screening for Depression and Suicide in Adults](https://www.center4research.org/comments-uspstf-screening-depression-suicide-adults/) - October 17, 2022: We are concerned screening for asymptomatic depression and suicide has more risks than benefits. Further research is needed to find methods that accurately identify at-risk patients.
- [NCHR Letter to Senate HELP and House Energy & Commerce Committees Regarding the VALID Act](https://www.center4research.org/senate-help-energy-commerce-letter-valid-act/) - December 14, 2022: We strongly support the inclusion of the VALID Act in the year-end omnibus spending package. This important bill will provide the FDA with the authority and resources necessary to ensure that the highest-risk diagnostic tests are valid and reliable.
- [NCHR's Comment for the Clinical Laboratory Improvement Advisory Committee](https://www.center4research.org/nchr-commentt-clinical-laboratory-improvement-advisory-committee/) - November 7, 2022: NCHR urges CLIAC to amend its Clinical Laboratory Improvement Amendments (CLIA) of 1988 because CLIA needs to better reflect the advancements in science and technology that occurred over the past two decades. Current CLIA standards have numerous limitations and deficiencies that must be addressed. Two examples include the accuracy of lab-developed diagnostic tests and the electronic health records and software prompts used by physicians across the country.
- [NCHR's Comment on the Draft IRIS Assessment Plan and Protocol for Assessing Cancer Risk from Inhalation Exposure to Cobalt and Cobalt Compounds](https://www.center4research.org/iris-iap-protocol-cobalt/) - NCHR supports the EPA’s decision to assess the risk for cancer from inhalation exposure to cobalt and cobalt compounds. Other health organizations recognize that cobalt is a likely human carcinogen based on animal studies, and it is important for the EPA to investigate if the same link extends to humans as well. An analysis of the evidence is needed to understand the upper-dose limit and how to prevent dangerous exposures to cobalt and cobalt compounds. By providing these results, we hope organizations create guidelines and requirements that the industry must follow to protect worker's health and well-being of the public.
- [NCHR's Comment on Topics Discussed in the Advancing Premarket Safety Analytics Workshop ](https://www.center4research.org/nchr-comment-advancing-premarket-safety-analytics-workshop/) - NCHR had the opportunity to share our views with the Food and Drug Administration (FDA) about topics brought up in the Advancing Premarket Safety Analytics Workshop, including our support of the FDA Medical Queries as we believe it would better quantify adverse events. Additionally, we agree that the FDA should be transparent in providing their methods for the standard safety tables and figures via their integrated guide to the public and urge them to make these guidelines mandatory so that everyone is held to the same standard.
- [What You Need to Know About Preventing and Treating Monkeypox (Mpox)](https://www.center4research.org/prevent-monkeypox-risks-vaccines-treatment/) - Monkeypox can infect anyone. It is important to know how to protect yourself and your family. Here is information symptoms, how to prevent infection, vaccines and treatments, and the research showing they are safe and effective.
- [Testimony of Dr. Diana Zuckerman About PEPAXTO FDA Advisory Committee Meeting on September 22, 2022](https://www.center4research.org/dr-zuckerman-testimony-pepaxto-fda/) - We testified before the FDA Advisory Committee that Pepaxto should no longer be approved for multiple myeloma because new research shows that patients taking it died 5 months sooner than patients taking a different treatment.
- [Testimony of Dr. Diana Zuckerman About I-omburtamab FDA Advisory Committee Meeting](https://www.center4research.org/fda-cancer-advisory-committee-october-2022-i-omburtamab-nchr/) - October 28, 2022: Dr. Diana Zuckerman testified at the FDA Advisory Meeting on I-omburtamab, a drug for children’s brain cancer (relapsed neuroblastoma). She agreed with the FDA that the company’s studies had no adequate control group, making it impossible to determine if the treatment worked better than placebo. Therefore, despite the urgent unmet need, the drug does not meet the required standard of evidence for FDA approval. We hope the company will make the drug available for free through the FDA’s Expanded Access program for experimental drugs.
- [NCHR Comments On Emergency Authorization for New COVID-19 Drug](https://www.center4research.org/nchr-comments-authorization-covid-treatment-eua/) - November 9, 2022: FDA Advisory committee considers EUA emergency authorization of new COVID-19 treatment. NCHR says study is small and flawed and additional data are needed and FDA advisors agree.
- [What You Need to Know about Coronavirus (COVID-19)](https://www.center4research.org/what-you-need-to-know-about-coronavirus-covid-19/) - The coronavirus can infect anyone, young or old, healthy or frail. Here’s what you need to know.
- [A Tiny Lab Finds Danger on Drugstore Shelves While the FDA Lags Behind](https://www.center4research.org/valisure-zantac-sunscreen-dry-shampoo-fda-impurity-2/) - Bloomberg News, November 9, 2022: Valisure is a small lab that found carcinogens in Zantac, sunscreen, shampoo, sanitizers, and other products. NCHR asks: Why isn’t FDA doing these routine impurity tests? Too cozy with industry?
- [FDA Warns Against Dental Amalgam Fillings for Children and Many Adults](https://www.center4research.org/dental-amalgam-fillings-fda-warning-mercury-problems/) - Since the 1990s, patients with amalgam fillings have reported health problems that they believe are caused by their exposure to mercury. The amalgam is known to release small amounts of mercury over time, and while low levels of mercury vapor is not known to be harmful for most people, the long-term health risks of mercury inhalation are not clear.
- [Digital screens can cause eye strain for children and adults. Are blue light glasses the solution?](https://www.center4research.org/digital-screens-eye-strain-blue-light-glasses/) - People are spending more time in front of screens than ever before, and many of them are experiencing digital eye strain. While many eyewear companies are marketing blue light glasses as the solution, do these glasses really work? Read our article to see what the latest research says about blue light glasses and proven ways to reduce digital eye strain.
- [The Number Of Women Having Their Breast Implants Removed Is On The Rise](https://www.center4research.org/more-women-removing-breast-implants/) - Women's Health, August 8, 2020. A growing number of women, especially athletes, are having their breast implants removed to alleviate symptoms of breast implant illness.
- [NCHR Testimony at FDA Advisory Panel on Wound Dressings](https://www.center4research.org/wound-dressing-fda-safety-effectiveness-nchr/) - October 26, 2022: Dr. Diana Zuckerman testified at the FDA Advisory Meeting on Wound Dressings. She pointed out that data on safety and effectiveness is lacking for these products even though they have been used for decades. Thousands of adverse event reports to FDA indicate contamination and problems with sterile packaging. FDA should classify them as Class III and require clinical trials and inspections.
- [What You Need to Know About Breast Implants](https://www.center4research.org/breast-implants/) - Research clearly shows that implants are associated with significant health, cosmetic, and economic risks within the first few years and these risks increase over time. Unfortunately, long-term risks remain unknown because of a lack of careful scientific studies. FDA has required implant manufacturers to conduct additional research to determine why implants break, how long they can be expected to last, and what the longer-term health consequences of broken and leaking breast implants might be. Those studies, however, have not yet been made public.
- [NCHR Speaks out on the Dept. of Veteran's Affairs' decision to cover abortion and abortion counseling](https://www.center4research.org/nchr-speaks-out-on-the-dept-of-veterans-affairs-decision-to-cover-abortion-and-abortion-counseling/) - October 11, 2022: Women veterans number about two million and make up the fastest-growing group of veterans in the U.S. today. We commend the Department of Veterans Affairs for its decision to expand healthcare coverage for women veterans to include abortion and abortion counseling. This action will help ensure that veterans and their beneficiaries have access to a full complement of reproductive healthcare regardless of where they live.
- [Comments of National Center for Health Research The USPSTF Draft Evidence Review: Screening for Anxiety in Adults](https://www.center4research.org/comments-uspstf-screening-anxiety-adults/) - October 17, 2022: We are concerned the USPSTF recommended anxiety screening does not have enough supporting evidence, and the resulting treatments come with serious risks.
- [NCHR Comment on CPSC Adoption of Mandatory Safety Standard for Infant Bouncer Seats](https://www.center4research.org/nchr-comment-infant-bouncer-seats/) - October 5, 2022: "The updated warning gives parents clear advice on how to avoid the possible hazards of using bouncer seats. In addition, making the safety standard mandatory will help ensure widespread compliance by manufacturers."
- [A Special Report: Can Breast Implants Cause Chronic Disease?](https://www.center4research.org/breast-implant-illness-lymphoma-healthcentral-zuckerman/) - HealthCentral, October 25, 2022: This excellent review from HealthCentral.com quotes breast implant patients, NCHR and other experts responding to new FDA warnings and troubling research. We explain the research evidence of risks of breast implant illness and lymphoma and point out the misleading denials of risk by plastic surgeons.
- [Heart CT Scans: New Heart Disease Test May Cause Cancer](https://www.center4research.org/ct-scans-heart-disease-test-cancer/) - Heart disease is the leading cause of death among adults in the U.S., so some doctors have recently started using a "CAT scan" (or CT scan) to detect blockages in the heart's arteries. Unfortunately, a CT scan uses relatively large doses of radiation, which could ultimately lead to many new cases of cancer from increased exposure to radiation. Although heart CT scanning may be a useful tool in detecting blockages in heart arteries, there is not enough evidence to show that this test is worth the risks and is therefore not recommended for screening for heart disease at this time.
- [My breast implants are making me sick — and I’m not alone](https://www.center4research.org/breast-implants-make-women-sick/) - Salon, June 20, 2021: It's not in our heads: More women are speaking up about how their breast implants are making them sick. And Healing Breast Implant Illness Society of North America and National Center for Health Research are making sure women know they are not alone.
- [Costly Alzheimer’s treatment is spreading around the world, with virtually no science to back it up](https://www.center4research.org/expensive-ineffective-shockwave-neurolith-tps-alzheimer-therapy/) - Stat News, June 1, 2022: Thousands of patients have undergone a type of “shockwave therapy” called transcranial pulse stimulation (TPS) for Alzheimer’s disease and other conditions. The Neurolith device costs patients thousands of dollars but isn’t proven to work. It is not FDA approved for use in the U.S. but Boris Kawliche, a Florida psychiatrist, has been offering TPS at Brandon TMS and Psychiatry clinic since November. Snake oil or treatment?
- [Early Puberty in Girls](https://www.center4research.org/early-puberty-girls-causes-harms/) - Ten years ago, shocking new guidelines for pediatricians advised that girls who start to develop breasts and pubic hair at age six or seven are not necessarily "abnormal." In fact, by age eight, 48 percent of African American girls and 15 percent of white girls are showing clear signs of puberty.
- [Writing to Policy Makers](https://www.center4research.org/writing-policy-makers/) - Elected officials at all levels are responsible for representing the interests of their constituents. Write to your elected officials to make sure they hear from you!
- [Visiting Policy Makers](https://www.center4research.org/visiting-policy-makers/) - Elected officials at all levels are responsible for representing the interests of their constituents. Visit your elected officials so they can hear from you!
- [Calling Policy Makers](https://www.center4research.org/calling-policy-makers/) - Elected officials at all levels are responsible for representing the interests of their constituents. Your elected officials must hear from you!
- [ALS drug gets rare second review](https://www.center4research.org/als-drug-rare-second-review/) - Matthew Perrone, AP: September 7, 2022 (This AP article was published in numerous newspapers and media outlets across the country) A closely watched experimental drug for Lou Gehrig’s disease got an unusual second look from U.S. regulators on Wednesday, following intense pressure to approve the treatment for those with the fatal illness. Patients and their
- [Patient, Consumer, and Public Health Coalition Letter to Senate HELP and Energy and Commerce Committee Regarding User Fee Reauthorization Legislation](https://www.center4research.org/letter-senate-house-reauthorize-user-fee-programs/) - September 22, 2022: It is critically important that House and Senate committees work together to consolidate differences between the Food and Drug Amendments Act (H.R. 7667), which passed the House of Representatives on June 8, and the Food and Drug Administration Safety and Landmark Advancements Act (S. 4348), which passed the Senate Health, Education, Labor, and Pensions (HELP) Committee on June 15.
- [Patient, Consumer, and Public Health Coalition Letter on FDASLA Act of 2022](https://www.center4research.org/patient-consumer-and-public-health-coalition-letter-on-fdasla-act-of-2022/) - May 22, 2022: We appreciate the opportunity to submit comments and feedback on the draft legislation, the Food and Drug Administration Safety and Landmark Advancement Act of 2022, which will reauthorize the Food and Drug Administration (FDA) user fee programs.
- [Patient, Consumer, and Public Health Coalition Letter to Senate HELP on the Updated Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA)](https://www.center4research.org/patient-consumer-and-public-health-coalition-comments-on-the-updated-food-and-drug-administration-safety-and-landmark-advancements-act-of-2022-fdasla/) - June 13, 2022: While pleased with many of the changes in the updated bill introduced on May 26, we continue to have serious concerns regarding a number of provisions, including: lack of sufficient post-market surveillance of medical devices; several weaknesses regarding accelerated approval reform; lack of bill language to improve the diversity of patients in clinical trials used as the basis of FDA approval decisions; and the lack of post-market surveillance activities in the VALID Act.
- [Letter to the Editor: Asphalt playgrounds are bad for kids. So is artificial grass](https://www.center4research.org/asphalt-playgrounds-turf-bad-for-kids/) - Los Angeles Times and Yahoo News, September 7, 2022 To the editor: It’s frightening that L.A. schoolchildren are playing on sizzling asphalt, but the commentary and reporting on it miss an important part of the story. Years of research show that the school playground surfaces that are even hotter than pavement are made from artificial turf or colorful rubber. On
- [Patient, Consumer, and Public Health Coalition Letter to Senate HELP and Energy and Commerce Committee Regarding User Fee Reauthorization Legislation](https://www.center4research.org/patient-consumer-public-health-coalition-letter-energy-and-commerce-committee-regarding-user-fee-reauthorization-legislation/) - July 12, 2022: We write to urge you to expeditiously consolidate the two pieces of legislation to reauthorize the Food and Drug Administration (FDA) user fee programs for medical products. We request your consideration on reform to the accelerated approval pathway, clinical trial diversity, and new oversight of dietary supplements, cosmetics, and lab-developed diagnostic tests.
- [NCHR Letter to Democratic Congressional Leadership on Drug Pricing Reform](https://www.center4research.org/nchr-letter-democratic-congressional-leadership-drug-pricing-reform/) - July 26, 2022: We write to urge you to quickly pass a budget reconciliation bill that includes meaningful drug pricing reforms. The provisions included in the reconciliation bill to combat high drug prices are a step in the right direction and we applaud all of your hard work. There is still much to be done to lower the launch prices of new drugs, promote pricing that accurately reflects the value of a prescription, and to instill competition into a highly controlled drug market.
- [NCHR Letter to Sen. Smith in Support of Women's Health Legislation](https://www.center4research.org/letter-smith-support-women-health-legislation/) - September 22, 2022: Two bills led by Sen. Smith take critical steps to help protect access to safe and effective reproductive health care products. We at NCHR are appreciative of her work to act in the face of the many challenges presented following the Dobbs decision.
- [NCHR Letter to Senate Finance Committee on Telehealth Legislation](https://www.center4research.org/nchr-letter-telehealth-legislation/) - August 22, 2022: We urge you to act quickly to introduce and advance your telehealth legislation building on the strengths of H.R. 4040. We strongly urge that your legislation increase coverage and access to telehealth for the Medicare population, while continuing to address the underlying barriers faced by rural and underserved communities.
- [FDA approves first ALS drug in 5 years after pleas from patients](https://www.center4research.org/fda-approves-als-drug-lou-gehrig-questionable-effectiveness/) - Washington Post, September 29, 2022: FDA approves new ALS drug for Lou Gehrig’s disease despite NCHR and other experts’ criticisms that the drug’s effectiveness is questionable and FDA evidence standards should be higher.
- [NCHR Comments for Advisory Board on Radiation and Worker Health](https://www.center4research.org/nchr-comment-abrwh/) - October 12th, 2022: NCHR strongly recommends that ABRWH encourages NIOSH to reevaluate the risk of radiation exposure to TSA baggage screeners and to take into consideration what workers typically wear during the time of possible exposure for dose reconstruction.
- [NCHR’s Comments on the EPA’s Draft Revision for TSCA Risk Determination on Carbon Tetrachloride](https://www.center4research.org/nchr-comment-epa-risk-determination-carbon-tetrachloride/) - September 28, 2022: NCHR strongly supports the EPA’s reconsideration of risk evaluations of carbon tetrachloride using a whole chemical approach. We also strongly endorse the EPA’s decision to exclude the assumption of Personal Protective Equipment (PPE) usage when considering the unreasonable risk of carbon tetrachloride.
- [Comment Regarding AHRQ's Analysis of Requirements for Coverage with Evidence Development (CED) – Topic Refinement](https://www.center4research.org/nchr-comment-ahrq-analysis-requirements-coverage-evidence-development/) - September 28, 2022: NCHR support AHRQ’s overall report and recommendations for the Centers for Medicare and Medicaid Services (CMS) to update their CED requirements.
- [Comment of the National Center for Health Research Submitted to the EPA on the Designation of PFOA and PFOS as CERCLA Hazardous Substances, October 6, 2022](https://www.center4research.org/nchr-comment-epa-pfoa-pfos-cercla-hazardous-substances/) - October 6, 2022: In our public comment to the EPA, the National Center for Health Research agrees with EPA’s proposed designation of PFOA and PFOS as CERCLA hazardous substances. Holding companies accountable for these toxic chemicals, and other PFAS chemicals, will improve human health.
- [National Center For Health Research Comments on Consumer Product Safety Standards for Frame Child Carriers](https://www.center4research.org/nchr-comments-frame-child-carriers/) - September 29, 2022 We are writing to express our strong support for the Consumer Product Safety Commission (CPSC) plan to adopt a mandatory standard for frame child carriers to improve safety by including more stringent requirements and test conditions. The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and
- [Testimony of Diana Zuckerman at the Meeting of EPA’s National Environmental Justice Advisory Council on September 28, 2022](https://www.center4research.org/zuckerman-nchr-testimony-epa-environmental-justice-advisory-council/) - September 28, 2022: I want to comment very briefly on the PFAS recommendations, since that’s an issue we’ve worked on for years. Let me add that we are very concerned about all endocrine disrupting chemicals not just PFAS.
- [NCHR Comments on the Office of Dietary Supplements (ODS) Proposed Draft of Their Strategic Plan (2022-2026)](https://www.center4research.org/nchr-comment-office-dietary-supplements-plan/) - August 31, 2022: NCHR supports the efforts to improve research in the ODS proposed strategic plan but recommends several revisions, primarily focusing on the “Addressing Health Disparities and Advancing Health Equity".
- [NCHR Comments on the Calendar Year 2023 Medicare Physician Fee Schedule](https://www.center4research.org/nchr-comments-2023-medicare-physician-fee-schedule/) - September 8, 2022: We are encouraged to see policies in this Proposed Rule that would increase access to quality healthcare for millions of vulnerable Americans. NCHR supports the proposal for continued expansion of coverage for telemental health services. We also support the provision to cover substance use disorder (SUD) for Medicare beneficiaries.
- [NCHR Comments on the CMS National Coverage Analysis of Seat Extenders for Wheelchairs](https://www.center4research.org/nchr-comments-national-coverage-analysis-wheelchairs/) - September 14, 2022: We strongly support the coverage of wheelchair seat extender systems through Medicare and encourage CMS quickly act on this decision. There are numerous direct medical benefits from the use of power seat elevation systems in power wheelchairs. Many preventable complications and secondary conditions are common among individuals who spend long periods of time unable to stand or walk, restricted to a bed, chair, or wheelchair.
- [Bipartisan bill on antibiotics faces crucial stretch](https://www.center4research.org/bipartisan-bill-antibiotics-crucial-stretch/) - The Hill, August 1, 2022: A health care bill is facing criticism from some experts who say it could lead to huge spending on new antibiotic drug development that may not improve patient outcomes in the long run. We point out that it could increase antibiotic resistance rather than solve the problem.
- [Science says later school start times are healthier. Some High Desert schools aren't so sure](https://www.center4research.org/later-school-start-times-healthier/) - Daily Press, August 1, 2022: Science says later school start times are healthier. We explain that “If you were designing something to make it very difficult for high school students to learn and concentrate, starting classes at 8 or earlier is what you would design.” But some students disagree.
- [NCHR Comments on Broadening Coverage for Cochlear Implants](https://www.center4research.org/nchr-broadening-coverage-cochlear-implants/) - August 4, 2022. We agree that cochlear implants have been shown to improve sentence recognition, thus helping affected adults communicate better and reducing feelings of isolation. However, there are several issues that we strongly urge CMS to consider before deciding whether to broaden the national coverage.
- [Dr. Diana Zuckerman Statement to CDC Advisory Committee On Breast Cancer in Young Women](https://www.center4research.org/cdc-advisory-committee-breast-cancer/) - August 23, 2022: Research shows that many young women are disproportionately afraid of breast cancer and that young breast cancer survivors are more afraid of recurrence than older survivors. I encourage you to think of what we can do together to help reduce that fear so that young women don’t let their fear overwhelm them as they become aware of and educated about their risks as well as their prevention and treatment options.
- [Diana Zuckerman Statement on the Role of FDA in Health Inequities Meeting of the National Academy of Medicine](https://www.center4research.org/health-inequities-national-academy-medicine/) - July 26, 2022: The National Center for Health Research testified before a meeting of the National Academy of Medicine in July 2022 regarding federal policies that could improve health equity and decrease racial and ethnic disparities. There are many reasons for health inequities, but we focused on federal laws regarding diversity in clinical trials. The U.S. Department of Health and Human Services requires research studies to include people representing diverse racial and ethnic backgrounds. NIH, CDC, SAMHSA and other federal health agencies make an effort to abide by this law. The one exception among federal public health agencies is the Food and Drug Administration (FDA), which encourages but does not require diversity in clinical trials. The agency’s justification is American taxpayers don’t pay for the studies – the companies that make the products pay for the studies. However, taxpayers pay for FDA staff that regulate these products, and taxpayers also pay for the products themselves.
- [NCHR supports mandatory safety standards for sling baby carriers](https://www.center4research.org/safer-sling-baby-carriers/) - September 15, 2022: We are writing to express our views on the Consumer Product Safety Commission’s adoption of a mandatory safety standard for infant sling carriers. We enthusiastically support the plan to make the current CPSC voluntary safety standards – which address product test methods, performance requirements, labeling and instructional literature –mandatory for manufacturers in
- [NCHR Public Comment on Genital Herpes Screening](https://www.center4research.org/genital-herpes-screening/) - September 12, 2022: We are writing to express our views on the USPSTF updates to its recommendations regarding asymptomatic serum screening for genital herpes (HSV-2). The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention
- [Breast Implants: A Research and Regulatory Summary](https://www.center4research.org/breast-implants-research-regulatory-summary/) - In the past decade, there has been a dramatic increase in breast implant surgery, yet this does not necessarily mirrored by a similar increase in the number of women with breast implants. Many women are replacing old implants that have broken or caused problems. This summary examines the role of the FDA in safety research, the types of breast implants, the frequency of local complications, increased risk of autoimmune and connective tissue diseases, cancer, lung disease, and suicide, impact on general health and quality of life, and the hidden costs associated with breast implants.
- [FDA official bolting to Big Tobacco shines a light on the agency’s revolving-door problem](https://www.center4research.org/fda-official-bolting-big-tobacco/) - Grid News, August 3, 2022: An FDA official leaving FDA’s Tobacco Science Office to work for Big Tobacco shines a light on the agency’s revolving-door problem. We explain why this undermines FDA’s authority.
- [NCHR's Testimony on the FDA's Proposed Reclassification of Computer-Aided Devices which Provide Adjunctive Diagnostic Information about Lesions Suspicious for Melanoma from Class III Devices to Class II Devices](https://www.center4research.org/nchrs-testimony-fda-reclassification-of-computer-aided-devices-which-provide-adjunctive-diagnostic-information-about-lesions-suspicious-for-melanoma/) - July 29, 2022. We do not support the proposed reclassification of the two skin lesion analyzers, MelaFind and Nevisense, from Class III to Class II. We have 2 major concerns: There is no guarantee that newly developed devices cleared through the 510(k) process would be as accurate as those currently on the market. For that reason, newly developed devices should be reviewed through the PMA process and there is a clear risk of false positive and false negative results, misuse, and device failure, and the FDA has not provided adequate evidence that these risks can be adequately mitigated with the Class II special and general controls listed in the executive summary. As described, FDA cannot ensure that there will be reasonable assurance of safety or effectiveness over the lifespan of the newly submitted devices.
- [Children and Cell Phones: Is Phone Radiation Risky for Kids?](https://www.center4research.org/children-cell-phones-phone-radiation-risky-kids/) - Children use cell phones to watch TV, play games, make phone calls, and send text messages. But are there risks to such frequent use by children, and if so is that different than the risks for adults?
- [NCHR Comments On Dietary Supplements Subject to the Requirement for Premarket Notification](https://www.center4research.org/nchr-comments-on-dietary-supplements-subject-to-the-requirement-for-premarket-notification/) - July 19, 2022. We support the proposed policy as a positive step to increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace and to promote risk-based regulation. Having data is essential; reducing manufacturers’ fear of reprisal for submitting late data creates an incentive to provide that information. However, we support greater monitoring and enforcement of premarket notifications to reduce late submissions in the future, and to reduce manufacturers’ failure to submit NDIs in a timely manner.
- [NCHR Comments to CMS on Beta Amyloid Positron Tomography in Dementia and Neurodegenerative Disease](https://www.center4research.org/nchr-comment-to-cms-on-beta-amyloid-positron-tomography-in-dementia-and-neurodegenerative-disease/) - July 15, 2022: We agree that there is evidence that PET Aß imaging is a useful tool to support a diagnosis of Alzheimer’s Disease as part of a clinical trial protocol. However, there are conflicting data regarding its usefulness to determine the effectiveness of Alzheimer’s Disease treatment strategies.
- [NCHR Comments on Fostering Medical Device Improvement](https://www.center4research.org/nchr-comments-on-fostering-medical-device-improvement/) - July 5, 2022: This proposed draft guidance on Fostering Medical Device Improvement aligns closely with the needs of medical device companies, but not with the needs of patients and consumers. NCHR has many concerns about the proposed program.
- [NCHR’s Public Comment on Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient Setting](https://www.center4research.org/nchrs-public-comment-on-providing-mail-back-envelopes-and-education-on-safe-disposal-with-opioid-analgesics-dispensed-in-an-outpatient-setting/) - June 21, 2022: While we agree that these potential modifications are a great step forward in ensuring that unused medications are properly disposed of, overprescribing continues to be a major problem in the U.S. There should be continued efforts to educate physicians and pharmacists on reducing the number of opioids prescribed and providing alternatives to opioid analgesic prescriptions...
- [NCHR Testimony on NUPLAZID for the Treatment of Alzheimer's Disease Psychosis](https://www.center4research.org/nchr-testimony-on-nuplazid-for-the-treatment-of-alzheimers-disease-psychosis/) - June 17, 2022: In 2018 FDA was concerned about “the numbers of reports of death and other serious adverse events” regarding this drug, which already carries a black box warning that there is “increased mortality in elderly patients with dementia-related psychosis.” To outweigh such serious safety risks, the benefits of this drug would need to be substantial. However, there is no such evidence.
- [Over-the-counter birth control? Drugmaker seeks FDA approval](https://www.center4research.org/over-the-counter-birth-control-drugmaker-seeks-fda-approval/) - Associated Press, July 11, 2022: For the first time, a pharmaceutical company has asked for permission to sell a birth control pill over the counter in the U.S. Birth control pills are safer than pregnancy, but they are sometimes taken for other reasons.
- [These machines to help people breathe were recalled a year ago. Many still use them](https://www.center4research.org/these-machines-to-help-people-breathe-were-recalled-a-year-ago-many-still-use-them/) - Los Angeles Times, June 23, 2022: CPAP, BiPAP, and other ventilators made by Philips that help people stay alive were recalled more than a year ago. But patients haven’t been informed and others can’t live without them unless there is a replacement device that they can afford. FDA is now pressuring Philips to replace them.
- [When Do At-Home COVID-19 Tests Expire?](https://www.center4research.org/when-do-at-home-covid-19-tests-expire/) - The FDA has recently given emergency authorization to extend the shelf-life of at-home test kits, adding an additional 3-6 months to the expiration date printed on the box.
- [What is Vulvodynia?](https://www.center4research.org/what-is-vulvodynia/) - One of the most common causes of chronic pelvic pain in women is vulvodynia. This is defined as vulvar pain of unknown cause that’s lasted for at least three months.[1,2] This disorder is experienced by an estimated 10% to 28% of reproductive-age women.[1,2] Although less common, it can affect postmenopausal women as well. The pain can sometimes be described as a burning, irritation, stinging, or sharp pain in the vulva, the area outside the vagina. This area includes the labia and the entrance to the vagina. This pain can be brought on by touch, pressure, and vaginal intercourse (attempted or completed). Because of the pain, it can wreak havoc on a patient’s intimate relationships and everyday life...
- [NCHR Comments on Regulating Menthol in Tobacco Products](https://www.center4research.org/nchr-comments-on-regulating-menthol-in-tobacco-products/) - June 6, 2022. We strongly support the proposed tobacco product standards that would prohibit menthol in cigarettes and prohibit characterizing flavors in all cigars. While the proposed product standards are an important first step, we also urge FDA to prohibit menthol in all e-cigarettes and related products, in addition to enforcing efforts to prohibit fruit, dessert, and some other flavored cartridge-based sales. Through such efforts, there is a significant opportunity to reduce nicotine addiction in the United States, particularly among young people who increasingly suffer from that addiction as they grow older.
- [Patient, Consumer, and Public Health Coalition Letter to Congresswoman Dingell Thanking Her for Requesting a GAO Report on Post-market Surveillance of Medical Devices](https://www.center4research.org/patient-consumer-and-public-health-coalition-letter-to-congresswoman-dingell-thanking-her-for-requesting-a-gao-report-on-post-market-surveillance-of-medical-devices/) - June 7, 2022: We write to express our gratitude as you work to protect patients by promoting post-market review of approved medical devices. Specifically, we greatly appreciate and value your leadership requesting that the Government Accountability Office (GAO) evaluate the current landscape of post-market surveillance of medical devices.
- [Why isn’t there a cure for Alzheimer’s Disease or Dementia?](https://www.center4research.org/why-isnt-there-a-cure-for-alzheimers-disease-or-dementia/) - We reviewed a proposed 2015 controversial health law that would have had a terrible impact on the lives of Alzheimer’s patients and their families, who would have spent billions on medications that don’t work and can cause cancer.
- [NCHR's Testimony to FDA on Lorcaserin Hydrochloride (BELVIQ)](https://www.center4research.org/nchrs-testimony-to-fda-on-lorcaserin-hydrochloride-belviq/) - June 8, 2022. FDA announced that the risks of BELVIQ outweigh any potential benefits and withdrew the drug “from sale for reasons of safety or effectiveness” in March 2021 and yet, this drug has not been added to the “Withdrawn or Removed List”. Delaying the inclusion of unsafe drug products poses an entirely avoidable risk for patients. An inclusion on the list at the same time as the product is withdrawn from the market is necessary to protect the public health.
- [NCHR's Testimony to FDA on the Novavax COVID-19 Vaccine](https://www.center4research.org/nchrs-testimony-to-fda-on-the-novavax-covid-19-vaccine/) - June 7, 2022: While this vaccine demonstrates similar levels of efficacy as compared to vaccines approved for COVID-19, the data suggests additional safety risks. Even if it is not proven to be less safe than the other COVID vaccines, it lacks long-term, placebo-controlled efficacy data and there is very little safety or efficacy data for the most at-risk patients. When we already have vaccines on the market that are FDA approved, and based on much better data, why would the FDA authorize this vaccine?
- [Who Should You Believe? A critique of the Aesthetic Society’s view of Breast Implant Illness](https://www.center4research.org/who-should-you-believe-a-critique-of-the-aesthetic-societys-view-of-bii/) - A 2022 article in the Aesthetic Surgery Journal makes it clear that Aesthetic Society plastic surgeons are encouraging their members to pretend to share patients’ concerns about breast implant illness (BII) while persuading patients that BII is not real and therefore BII patients do not need explant surgery. A review of their poorly researched article explains which BII studies it ignored or misrepresented and raises questions about bias and gaslighting.
- [NCHR's Comments to AHRQ on Breast Reconstruction After Mastectomy](https://www.center4research.org/nchrs-comments-to-ahrq-on-breast-reconstruction-after-mastectomy/) - We have identified a number of shortcomings of the report on breast reconstruction after mastectomy, which we urge AHRQ to address before the report is finalized.
- [Scientific Coalition Letter on Aduhelm to HHS Inspector General, CMS, and Congress](https://www.center4research.org/scientific-coalition-letter-on-aduhelm-to-hhs-inspector-general/) - July 7, 2021. As organizations working to promote and protect science for the public good, we are writing to express our concern about the lack of scientific evidence to support the FDA’s recent accelerated approval of Biogen’s Aduhelm (aducanumab) as a drug intended to slow cognitive damage caused by Alzheimer’s disease.
- [NCHR’s Comment on Class I Surgeon's and Patient Examination Gloves](https://www.center4research.org/nchrs-comment-on-class-i-surgeons-and-patient-examination-gloves/) - May 17. 2021. We enthusiastically support the proposal to withdraw the January exemption for the Class 1 gloves noted above, returning the requirement for a report under section 510(k) of the FD&C Act.
- [NCHR’s Comments on Screenings for Atrial Fibrillation in Asymptomatic Adults](https://www.center4research.org/nchrs-comments-on-screenings-for-atrial-fibrillation-in-asymptomatic-adults/) - May 17, 2021. We support the “I” rating that there is insufficient evidence to assess the benefits and harms of screening for atrial fibrillation in asymptomatic adults ages 50 and over.
- [NCHR Comments on USPSTF's Draft Recommendation on Aspirin Use to Prevent Cardiovascular Disease](https://www.center4research.org/nchr-comments-on-uspstfs-draft-recommendation-on-aspirin-use-to-prevent-cardiovascular-disease/) - November 8, 2021. Based on the data, we strongly support the “C” grade recommendation for patients 40 to 59 years old with a 10% or more risk of developing CVD, as well as the “D” grade recommendation for patients 60 and older. However, we urge the USPSTF to include additional information to their recommendation.
- [Public Comment PDUFA VII Commitment Letter (Docket #FDA-2021-N-0891) From the National Center for Health Research](https://www.center4research.org/public-comment-pdufa-vii-commitment-letter-docket-fda-2021-n-0891-from-the-national-center-for-health-research/) - October 28, 2021: NCHR comments on the proposed PDUFA VII Commitment Letter from the FDA.
- [NCHR Comments on EPA truck pollution standards](https://www.center4research.org/nchr-comments-on-epa-truck-pollution-standards/) - May 16, 2022. NCHR agrees with the Environmental Protection Agency (EPA) that the proposed truck pollution standards, which would reduce emissions of smog- and soot-forming nitrogen oxides, are a crucial step towards EPA’s commitment to climate, clean air and environmental justice. However, in light of the ongoing health and climate crisis, the proposed standards fall short of a zero-emission transportation future, and we urge EPA to further strengthen the proposed standards. This has also long been requested by environmental justice communities across the country, because while truck pollution has been devastating the health of communities across the country, it has a disproportionate impact on communities of color.
- [NCHR Comments on the Proposed 2022 Center for Disease Control (CDC) Clinical Practice Guideline for Prescribing Opioids](https://www.center4research.org/nchr-comments-on-the-proposed-2022-center-for-disease-control-cdc-clinical-practice-guideline-for-prescribing-opioids/) - April 11, 2022: We commend the CDC for their continued efforts to reduce opioid use. However, we are very concerned that the impact of the Box 1 Guideline as currently written will be very harmful to patients.
- [Patient, Consumer, and Public Health Coalition Letter on FDA Amendments Act H.R. 7667](https://www.center4research.org/patient-consumer-and-public-health-coalition-letter-on-fda-amendments-act/) - May 17, 2022: We are writing to express our strong support for several provisions in The Food and Drug Amendments Act (H.R. 7667), and our concerns about other provisions that could be improved. There are numerous important provisions in the FDA Act, but in this letter we will focus on two major issues: accelerated approval and contrast imaging agents.
- [COVID-19 Tests: How surprise billing affects patients across the country](https://www.center4research.org/covid-19-tests-how-surprise-billing-affects-patients-across-the-country/) - Approximately one million Americans a day receive a COVID-19 test, often with the expectation the test will be free. However, many have found coverage is not guaranteed through private insurance, resulting in surprise bills ranging from $50 to as much as $2,000. Fortunately, there are steps you can take to protect yourself.
- [NCHR Comments on Quality System Regulation Amendments for Medical Devices](https://www.center4research.org/nchr-comments-on-quality-system-regulation-amendments-for-medical-devices/) - May 24, 2022. We recognize that the proposed harmonization with international consensus standard for devices would allow companies to have a single quality management system. However, the proposal ignores several issues of great importance to patients and consumers, and these issues deserve more attention as FDA considers changes to the proposed rule.
- [STAT Report : The need for speed and safety: A primer on the FDA's drug approval pathways](https://www.center4research.org/stat-report-the-need-for-speed-and-safety-a-primer-on-the-fdas-drug-approval-pathways/) - This STAT report provides an excellent primer on FDA’s drug approval pathways, and the controversies about whether patients can be harmed when FDA standards get too lose. Dr. Diana Zuckerman describes the need for the FDA Commissioner to restore the public’s trust.
- [NCHR Comments on Hormone Therapy in Postmenopausal Women for the Primary Prevention of Chronic Conditions](https://www.center4research.org/nchr-comments-on-hormone-therapy-in-postmenopausal-women-for-the-primary-prevention-of-chronic-conditions/) - May 16, 2022. The currently available evidence on hormone therapy is very clear: Whether combination therapies of estrogen and progestin or treatments with estrogen alone, the risks by far outweigh the limited benefits for postmenopausal women. We thus strongly support USPSTF’s “D” grade recommendation against the use of combined estrogen and progestin for the primary prevention of chronic conditions such as cardiovascular disease, types of cancer, and osteoporotic fractures in postmenopausal persons, as well as the “D” grade recommendation against the use of estrogen alone in postmenopausal persons who have had a hysterectomy.
- [Will the FDA change how it vets drugs following the Alzheimer's debacle?](https://www.center4research.org/will-the-fda-change-how-it-vets-drugs-following-the-alzheimers-debacle/) - Nature, May 13, 2022: Nearly a year after the FDA approved a controversial drug to treat Alzheimer’s disease, Congress is attempting to amend the accelerated process that led to its approval and also the approval of many cancer drugs that have not been proven to work.
- [NCHR's Testimony to FDA on End of Induction Response in High-Risk Neuroblastoma](https://www.center4research.org/nchrs-testimony-to-fda-on-end-of-induction-response-in-high-risk-neuroblastoma/) - May 12, 2022. Clinical benefits should remain the key endpoints for approval decisions of these treatments. Surrogate endpoints that predict clinical benefits are not yet established and until they are, we are concerned about their use as secondary endpoints unless the primary endpoint is also met.
- [NCHR Comments on Screening for Depression and Suicide Risk in Children and Adolescents](https://www.center4research.org/nchr-comments-on-screening-for-depression-and-suicide-risk-in-children-and-adolescents/) - May 9, 2022. The currently available evidence on the accuracy of screening tools as well as the potential benefits and harms associated with screening and treatment for major depressive disorder (MDD) and suicide risk are insufficient. For this reason, we agree with the USPSTF “I” grade recommendation for MDD screening in asymptomatic children age 11 years or younger and the “I” grade recommendation for screening for suicide risk in asymptomatic children and adolescents of all ages.
- [NCHR Comments on Screening for Anxiety in Children and Adolescents](https://www.center4research.org/nchr-comments-on-screening-for-anxiety-in-children-and-adolescents/) - May 9, 2022. We agree with USPSTF’s “I” grade recommendation regarding anxiety screening for children 7 years or younger, since there is not sufficient evidence on the benefits and harms of screening for this age group, or to determine the impact of treatments for anxiety in children in this age group. However, regarding screening for anxiety in asymptomatic children between the ages of 8 and 18, we do not agree with USPSTF’s “B” grade recommendation, because of the lack of direct evidence to support USPSTF’s recommendation.
- [Nonprofit Consumer and Public Health Organization’s Letter To FDA Regarding Transparency Of The MDUFA V Reauthorization Process](https://www.center4research.org/nonprofit-consumer-and-public-health-organizations-letter-to-fda-regarding-transparency-of-the-mdufa-v-reauthorization-process/) - March 4, 2022: We write today to follow up on your response to several requests for information at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Medical Device User Fee Amendments (MDUFA V) stakeholders meeting on February 28, 2022.
- [Danica Patrick reveals she had breast implants removed after suffering complications](https://www.center4research.org/danica-patrick-reveals-she-had-breast-implants-removed-after-suffering-complications/) - Good Morning America, May 2, 2022: Former NASCAR driver Danica Patrick revealed she had her breast implants removed after suffering medical complications she believes were caused by the implants. We explain that her symptoms of breast implant illness were typical of breast implant illness, and she immediately felt better after the implants were removed.
- [NCHR Comments on Screening for Obstructive Sleep Apnea in Adults](https://www.center4research.org/nchr-comments-on-screening-for-obstructive-sleep-apnea-in-adults/) - April 25, 2022. Despite the recent increase in obstructive sleep apnea (OSA), we agree with the “I” grade recommendation for OSA screening in asymptomatic adults or those with unrecognized symptoms, as there is currently insufficient evidence to assess the benefits and harms of screening.
- [NCHR Comments on the MDUFA V Commitment Letter](https://www.center4research.org/nchr-comments-on-the-mdufa-v-commitment-letter/) - April 21, 2022: NCHR would like to express our substantial concerns with the overall process as well as the shortcomings of the Commitment letter.
- [Narrow Aduhelm Coverage Sparks Debate Over Viability of Future Treatments](https://www.center4research.org/narrow-aduhelm-coverage-sparks-debate-over-viability-of-future-treatments/) - Politico, April 9th, 2022. The Biden administration’s contentious decision to only partially cover Aduhelm could reach well beyond the world of Alzheimer’s drugs, potentially affecting efforts to develop treatments for devastating diseases. "it was a defining moment for the White House and they passed with flying colors,” said Diana Zuckerman, the president of the National Center for Health Research. It “has sent a message to industry and to patient groups, and also to the FDA, that the standards had gotten too loose.”
- [Covid Booster Costs Spur Calls to Shift From Free Jabs for All](https://www.center4research.org/covid-booster-costs-spur-calls-to-shift-from-free-jabs-for-all/) - Bloomberg Law, April 11, 2022. The U.S. Covid-19 vaccine funding may have to shift from a model of free shots for all to one in which the government only subsidizes boosters for targeted populations, public health analysts say. Annual Covid-19 boosters for all Americans , would cost billions of dollars each year .“Given the much greater expense of Covid boosters compared to flu shots and the time needed to revise and manufacture Covid vaccines, we need to hope we won’t need annual shots,” said Diana Zuckerman, founder and president of the National Center for Health Research.
- [NCHR Comments on the Development of Non-Opioid Analgesics for Acute Pain](https://www.center4research.org/nchr-comments-on-the-development-of-non-opioid-analgesics-for-acute-pain/) - April 11, 2022. In light of the ongoing opioid epidemic, we commend FDA’s goal of fostering the development of non-addictive alternatives to opioids for managing acute pain, and thereby decreasing exposure to opioids and preventing new addiction.
- [NCHR Testimony by Dr. Diana Zuckerman about AMX0035 for ALS at FDA Advisory Committee](https://www.center4research.org/testimony-of-dr-diana-zuckerman-about-amx0035-for-als-at-fda-advisory-committee/) - March 30, 2022. ALS is a devastating disease and all of us want better treatments to be available as soon as possible. But NCHR agrees with FDA that “The secondary endpoint results are not compelling or supportive of the primary endpoint.”
- [FDA advisers to discuss ALS drug at Wednesday meeting](https://www.center4research.org/fda-advisers-to-discuss-als-drug-at-wednesday-meeting/) - Politico, March 29, 2022. On March 30, FDA holds a highly anticipated advisory committee on neurological drugs to discuss a drug from Amylyx that aims to treat amyotrophic lateral sclerosis (ALS). Dr. Diana Zuckerman told Politico: “Did the FDA schedule an advisory committee meeting to placate patient advocates and other political pressure in the hope that the advisory committee would vote against it? Or is the FDA really considering approving it?”
- [Phthalates and Children's Products](https://www.center4research.org/phthalates-childrens-products/) - The ban on phthalates is the result of a law passed in 2008, the Consumer Product Safety Improvement Act. The law permanently bans BBP, DBP and DEHP from toys and child care products, and temporarily bans DIDP, DINP and DnOP until a scientific board (the Chronic Hazard Advisory Panel) determines for the Consumer Product Safety Commission (CPSC) whether or not they are safe. A few months before the bill passed, major retailers such as Wal-Mart, Target, and Babies "R" Us promised to remove or severely restrict children's products containing phthalates by the end of 2008. But children and adults in the U.S. are STILL EXPOSED to phthalates in many other products, including shampoo, soap, lotions, and food packaging.
- [What Are Phthalates and How Do They Affect Your Health?](https://www.center4research.org/what-are-phthalates/) - Phthalates are synthetic chemicals used to make plastics flexible and to make products smell good. This article will explain some of the harm caused by phthalates as well as how to reduce your exposure to them.
- [NCHR Comments On Transitional Standards for Milk, Whole Grains, and Sodium](https://www.center4research.org/nchr-comments-on-transitional-standards-for-milk-whole-grains-and-sodium/) - March 24, 2022. Nutrition standards that ensure that children receive healthy food alternatives in their school meals are of utmost importance. For this reason, we agree that USDA’s proposed transition standards, which will reduce sodium and increase whole grains, are a much-needed improvement to Child Nutrition Programs.
- [Bella Hadid regrets getting a nose job at 14. How young is too young for plastic surgery?](https://www.center4research.org/bella-hadid-regrets-getting-a-nose-job-at-14-how-young-is-too-young-for-plastic-surgery/) - USA Today, March 21, 2022: Model Bella Hadid regrets getting a nose job at 14. USA Today asks NCHR’s Dr. Diana Zuckerman how young is too young for plastic surgery, and we explain how it depends on the situation but that teenagers are unlikely to make the best decisions and parents need help from surgeons to say “let’s wait.”
- [NCHR Comments on Statin Use for the Primary Prevention of Cardiovascular Disease](https://www.center4research.org/nchr-comments-on-statin-use-for-the-primary-prevention-of-cardiovascular-disease/) - March 21, 2022. We generally agree with the USPSTF’s recommendations for preventive statin use, but suggest several improvements. For example, the studies included in the review varied greatly in the types of patients studied and the outcomes measured, and it seems premature to assume the risks are small, especially since even rare risks can be very serious for some patients. We thus urge the USPSTF to recommend that physicians emphasize other strategies to lower cholesterol, such as changes to lifestyle and diet.
- [Which Blood-Thinning Medication Is Right for You?](https://www.center4research.org/atrial-fibrillation-pradaxa-xarelto-better-worse-coumadin-warfarin/) - This article will describe the benefits and risks of different blood thinning medications for reducing the chance of stroke for those with atrial fibrillation.
- [Drowsy Driving: How to Stop Falling Asleep at The Wheel](https://www.center4research.org/drowsy-driving-stop-falling-asleep-wheel/) - Drowsy driving is a major problem. Experts estimate that the cost of automobile accidents related to sleep issues are somewhere between $29.2 to 37.9 billion. While distracted driving gets most of the public’s attention, there is very limited understanding of what drowsy driving is, what the warning signs are, and how to prevent it.
- [NCHR Comments on AHRQ's Review on Schedule of Visits and Televisits for Routine Antenatal Care](https://www.center4research.org/nchr-comments-on-ahrqs-review-on-schedule-of-visits-and-televisits-for-routine-antenatal-care/) - March 15, 2022. We agree with the review that the overall assessment of the available evidence is inconclusive regarding the adequacy of a reduced number of antenatal visits or replacing some routine antenatal visits with telehealth appointments.
- [NCHR Comments on USPSTF's Draft Recommendation on Screening for Syphilis Infection in Nonpregnant Adolescents and Adults](https://www.center4research.org/nchr-comments-on-screening-for-syphilis-infection-in-nonpregnant-adolescents-and-adults/) - March 14, 2022. We support the reaffirmation of the previous “A” recommendation of syphilis screening in persons who are at increased risk for infection. However, we urge USPSTF to provide as much guidance as possible to ensure that healthcare providers do not base their decisions on personal or widely held stereotypes pertaining to age, race, ethnicity, social class, or appearance.
- [NCHR Comments on AHRQ's Review on Effectiveness of Telehealth for Women’s Preventive Services](https://www.center4research.org/nchr-comments-on-ahrqs-review-on-effectiveness-of-telehealth-for-womens-preventive-services/) - March 9, 2022. We support the objective of this report, however, we agree with the report's assessment that the “systematic review demonstrates a paucity of data to inform the effectiveness,” and there are several limitations in the data that are particularly problematic.
- [“Study Drug” Abuse by College Students: What You Need to Know](https://www.center4research.org/study-drug-abuse-college-students/) - Approximately 2.5 million Americans are prescribed prescription stimulants such as Adderall or Ritalin to treat Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a brain disorder that makes it difficult to concentrate and increases impulsive behavior. Prescription stimulants help to reduce these symptoms. However, many people use these drugs for non-medical purposes and without a prescription, especially college students who buy them from a friend with a prescription.
- [High Praise, Condemnation for CMS Aduhelm Coverage Plan](https://www.center4research.org/high-praise-condemnation-for-cms-aduhelm-coverage-plan/) - Medscape Medical News, February 16, 2022: Medicare has received a key endorsement and considerable support for its plan to restrict payment for the controversial Alzheimer’s disease drug aducanumab (Aduhelm) — but also drew pleas from other groups for more generous reimbursement of the drug.
- [Califf heads to Capitol Hill for FDA confirmation hearing](https://www.center4research.org/califf-heads-to-capitol-hill-for-fda-confirmation-hearing/) - Politico, December 14, 2021: FDA Commissioner nominee Dr. Robert Califf makes his case for the job before the Senate health panel. We ask: What will he do about accelerated approval of ineffective medical treatments?
- [She's the reason Arizona has a law requiring surgeons to warn patients about the dangers of breast implants](https://www.center4research.org/shes-the-reason-arizona-has-a-law-requiring-surgeons-to-warn-patients-about-the-dangers-of-breast-implants/) - Arizona News 12 NBC, February 22, 2022: Will this new law help women considering breast implants make informed medical decisions? The FDA took a step in the right direction but will doctors accurately inform their patients?
- [Testimony of Dr. Diana Zuckerman About IV Tramadol Before FDA Advisory Committee](https://www.center4research.org/testimony-of-dr-diana-zuckerman-about-iv-tramadol-before-fda-advisory-committee/) - February 15, 2022: NCHR testifies against the opioid, tramadol, administered by IV to the FDA Advisory Committee.
- [Statement by Dr. Diana Zuckerman on Sintilimab at FDA Advisory Committee on Oncologic Drugs](https://www.center4research.org/statement-by-dr-diana-zuckerman-on-sintilimab-at-fda-advisory-committee-on-oncologic-drugs/) - February 10, 2022: NCHR president Dr. Diana Zuckerman testifies to the FDA Advisory Committee on Oncologic Drugs on Sintilimab.
- [Less Adderall, More Weed](https://www.center4research.org/less-adderall-more-weed/) - Chronicle of Higher Education, February 28, 2022: Adderall, a stimulant medication often prescribed to treat attention deficit hyperactivity disorder, has been misused as a “study drug” on college campuses for years. According to the latest available annual national study, medications such as Adderall reached a 10-year low among college students in 2020.
- [NCHR's Testimony to FDA on Bardoxolone for Kidney Failure from Alport Syndrome](https://www.center4research.org/nchrs-testimony-to-fda-on-bardoxolone-for-alport-syndrome/) - December 8, 2021: We agree with FDA scientists that bardoxolone does not demonstrate effectiveness at slowing the loss of kidney function and reducing the risk of progression to kidney failure, which are the outcomes that matter most to patients.
- [Nonprofit Consumer and Public Health Organization's Letter on MDUFA reauthorization to FDA and CDRH](https://www.center4research.org/nonprofit-consumer-and-public-health-organizations-letter-on-mdufa-reauthorization-to-fda-and-cdrh/) - February 22, 2022: We strongly urge the FDA to hold firm in the demands to strengthen pre- and post-market safety performance measures and surveillance as part of the MDUFA Commitment Letter as you enter into final negotiations with industry. MDUFA performance goals should include metrics regarding safety, and not just speed of review.
- [Are Pesticides, Roundup, and Cancer in Children Connected?](https://www.center4research.org/pesticides-roundup-cancer-children-connected/) - Pesticides have long been known to cause birth defects and poisoning if ingested. Now research is showing that even small quantities of rodent and insect killing pesticides can be toxic over time to children.
- [Scientific Coalition Comment on CMS's Proposed Decision Memo on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease](https://www.center4research.org/scientific-coalition-letter-on-cmss-proposed-decision-memo-on-monoclonal-antibodies-directed-against-amyloid-for-the-treatment-of-alzheimers-disease/) - February 10, 2022: We strongly support the CMS proposed decision to limit the coverage of these Alzheimer’s drugs to patients participating in clinical trials, as a way to determine if the drug is safe and effective for Medicare patients before covering the cost for millions of patients. This will provide the scientific evidence needed so that patients and family members can make informed decisions based on unbiased information.
- [Patient, Consumer, and Public Health Coalition Comment on CMS's Proposed Decision Memo on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease](https://www.center4research.org/patient-consumer-and-public-health-coalition-comment-on-cmss-proposed-decision-memo-on-monoclonal-antibodies-directed-against-amyloid-for-the-treatment-of-alzheimers-disease/) - February 10, 2022: As members of the Patient, Consumer, and Public Health Coalition, we strongly support the CMS proposed decision to limit the coverage of these drugs to patients participating in clinical trials, because it will provide the evidence needed regarding safety and effectiveness for the Medicare population.
- [NCHR's Comments on USPSTF's Draft Recommendation Statement on Behavioral Counseling to Reduce Cardiovascular Disease in Adults Without Known Risk Factors](https://www.center4research.org/nchrs-comments-on-uspstfs-draft-recommendation-statement-on-behavioral-counseling-to-reduce-cardiovascular-disease-in-adults-without-known-risk-factors/) - February 14, 2022: Given the lack of evidence of a more meaningful benefit, we support the “C” grade recommendation that clinicians make decisions for these individual patients about whether to offer or refer them to behavioral counseling.
- [NCHR Testimony at the Public Meeting on Prescription Drug User Fee Act (PDUFA) Reauthorization](https://www.center4research.org/statement-dr-diana-zuckermanphd-public-meeting-prescription-drug-user-fee-act-pdufa-reauthorization/) - October 5, 2011. "Everyone in this room agrees that we want safe and effective drugs to be on the market in the U.S. as soon as possible. Where we don’t always agree, however, is what is appropriate evidence of what is safe or effective, and how to weigh the potential risks and potential benefits."
- [NCHR Comments on CMS's Proposed Decision Memo on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease](https://www.center4research.org/nchr-comments-on-cmss-proposed-decision-memo-on-monoclonal-antibodies-directed-against-amyloid-for-the-treatment-of-alzheimers-disease/) - February 10, 2022: We strongly support the CMS proposed decision to limit the coverage of this class of drugs while requiring additional clinical trials to ensure safety and effectiveness for the Medicare population.
- [FDA's agenda in limbo as Biden's nominee stalls in Senate](https://www.center4research.org/fdas-agenda-in-limbo-as-bidens-nominee-stalls-in-senate/) - Fox13, February 9, 2022: President Joe Biden's pick to lead the Food and Drug Administration has stalled in the narrowly divided Senate, an unexpected setback that could delay decisions on electronic cigarettes and other high-profile health issues. Will all the publicity help Califf get confirmed, given the alternatives?
- [Do Beauty Products Affect Hormones, Early Puberty, Birth Defects, and Other Health Problems?](https://www.center4research.org/beauty-products-affect-hormones-early-puberty-birth-defects-health-problems/) - There is mounting evidence that suggests harmful chemicals in personal care products could be a potential cause of early puberty and other health issues.
- [Biden’s ‘Cancer Moonshot’ Turns Toward Pollution](https://www.center4research.org/bidens-cancer-moonshot-turns-toward-pollution/) - E&E News, February 3, 2022: President Biden made an emotional pledge to “end cancer as we know it” by reinvigorating the Cancer Moonshot Initiative he first launched in 2016, just one year after his son Beau succumbed to the disease. But experts, including us, point out that there isn’t enough focus on environmental causes of cancer.
- [Menopause and Hormones](https://www.center4research.org/menopause-and-hormones/) - A closer look at frequently asked questions about menopause and the use of hormones for menopause.
- [Hormone Therapy and Menopause](https://www.center4research.org/hormone-therapy-menopause/) - The experts at the U.S. Preventive Services Task Force issued a clear recommendation: post-menopausal women should NOT take hormones to prevent chronic health conditions, such as increasing bone strength to avoid fractures. The reason is that the risks of these hormones outweigh the benefits. In addition, hormone therapy for menopause increases the risk of breast cancer and the recurrence of breast cancer.
- [NCHR Comments on FDA’s Draft Guidance for Industry on Using RND to Support Regulatory Decision-Making](https://www.center4research.org/nchr-comments-on-fdas-draft-guidance-for-industry-on-using-rnd-to-support-regulatory-decision-making/) - January 24, 2022. Although well-designed RWD and RWE studies can provide useful information about drug safety and even effectiveness, there are major shortcomings if RWD and RWE studies replace rather than supplement data from well-designed clinical trials. We therefore strongly encourage the FDA to make it clear that studies based on RWE should only be considered to provide supplemental evidence that can support regulatory decision-making for drugs and biological products.
- [NCHR's Comments on Prediabetes and Type 2 Diabetes Screening for Children and Adolescents](https://www.center4research.org/nchrs-comments-on-prediabetes-and-type-2-diabetes-screening-for-children-and-adolescents/) - January 18, 2022: We support the “I” recommendation against screening for either prediabetes or type 2 diabetes in asymptomatic children aged 18 years or younger.
- [What’s Wrong with the FDA?](https://www.center4research.org/whats-wrong-with-the-fda/) - Washington Monthly, January 20, 2022: If Robert Califf, the White House nominee for commissioner of the FDA, is confirmed by the Senate, he’ll take the reins of an agency with its reputation in tatters. Once revered as the global leader in drug regulation, the FDA has approved one bad drug and medical device after another over the past 30 years, leaving staff demoralized and overseas regulators scratching their heads. NCHR and other experts provide recommendations for improvements.
- [NCHR FDA Testimony on Remoxy as an Abuse-Deterrent Opioid](https://www.center4research.org/opioid-abuse-remoxy-fda/) - June 26, 2018: To reduce the opioid epidemic, the FDA must hold pharmaceutical companies to a high and truthful standard. Remoxy did not meet the FDA’s standards for oral abuse, and it remains unclear whether it can be abused intravenously. The safety of the excipient is also in question. Please carefully consider the risks of putting another drug with abuse-deterrent labeling on the market that could result in misuse and abuse in the real world. We urge this Advisory Committee to vote that the benefits of this drug do not outweigh its risks.
- [Biogen Alzheimer’s Drug Coverage Threatens Minorities’ Access](https://www.center4research.org/biogen-alzheimers-drug-coverage-threatens-minorities-access/) - Bloomberg Law, January 13, 2022: Minority groups could have a harder time accessing Aduhelm, Biogen Inc.’s Alzheimer’s drug, under Medicare’s preliminary decision to limit coverage to patients enrolled in clinical trials, policy analysts say. But we explain that it will ensure that patients understand that the drug is experimental, with proven risks but no proven benefits.
- [Statement of Dr. Diana Zuckerman Regarding the January 11, 2022 CMS Decision about Aduhelm](https://www.center4research.org/statement-of-dr-diana-zuckerman-regarding-the-january-11-2022-cms-decision-about-aduhelm/) - January 11, 2022: Dr. Diana Zuckerman, president of NCHR, speaks in favor of CMS decision to limit coverage of the Alzheimer's drug, Aduhelm.
- [NCHR Comments on CMS's Proposed Decision Memo on Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)](https://www.center4research.org/nchr-comments-on-cms-proposed-decision-memo-on-screening-for-lung-cancer-with-low-dose-computed-tomography-ldct/) - December 17, 2021. We agree that former smokers would benefit from a higher rate of LDCT screening. However, we are concerned with several major aspects of the Proposed Decision Memo’s discussion of Counseling and Shared Decision-Making.
- [Breast Augmentation and Plastic Surgery Are on the Rise - What Are the Risks?](https://www.center4research.org/breast-augmentation-and-plastic-surgery-are-on-the-rise-what-are-the-risks/) - Honeysuckle Magazine, December 29, 2021: There has been a 33 percent increase in cosmetic surgery for women between 2000 and 2020. However, the measures meant to guarantee their safety are disputed among experts such as the National Center for Health Research.
- [Pfizer Covid Pill’s Fast Signoff Spurs Row Over Skipped Step](https://www.center4research.org/pfizer-covid-pills-fast-signoff-spurs-row-over-skipped-step/) - Bloomberg Law, December 22, 2021: The FDA authorized Pfizer Inc.'s pill to treat Covid-19 without first getting input from an expert advisory panel. We explain why that could further undermine trust in an agency already facing scrutiny over its rapid decision-making during the pandemic.
- [FDA Issues Black Box Warnings for Four Arthritis Drugs](https://www.center4research.org/fda-issues-black-box-warnings-for-four-arthritis-drugs/) - The FDA has issued black box warnings for four drugs used to treat different types of arthritis. This article will explain which medications have warnings and why.
- [NCHR's Testimony to FDA on the BrainsGate Ischemic Stroke System](https://www.center4research.org/nchrs-testimony-to-fda-on-the-brainsgate-ischemic-stroke-system/) - December 10, 2021. We agree with the FDA reviewers that the data presented today do not support the claim that the specific device that the company plans to market is either reasonably safe or reasonably effective.
- [NCHR Comments on USPSTF’s Draft Recommendation on Screening for Chronic Obstructive Pulmonary Disease](https://www.center4research.org/nchr-comments-on-uspstfs-draft-recommendation-on-screening-for-chronic-obstructive-pulmonary-disease/) - December 6, 2021. We strongly support the “D” grade reaffirmation of the 2016 recommendation against screening for COPD in asymptomatic adults. There is simply not sufficient evidence that screening for COPD in asymptomatic adults (or treatments for asymptomatic adults) reduce morbidity or mortality or improve health-related quality of life.
- [Equal Access to Merck Covid Pill Imperiled by Prescribing Rules](https://www.center4research.org/equal-access-to-merck-covid-pill-imperiled-by-prescribing-rules/) - Bloomberg Law, December 2, 2021: Merck’s antiviral drug molnupiravir—if authorized by the agency—would offer for the first time in the U.S. an at-home treatment option for patients with mild to moderate Covid-19 who are at risk of severe disease.
- [NCHR Comments on AHRQ's draft review on Maternal and Child Outcomes Associated with the Special Supplemental Nutrition Program](https://www.center4research.org/nchr-comments-on-ahrqs-draft-review-on-maternal-and-child-outcomes-associated-with-the-special-supplemental-nutrition-program/) - November 2, 2021: NCHR endorses the systematic review of WIC, an important program that aims to safeguard the health of low-income, nutritionally at-risk pregnant and postpartum women and children under the age of 5 years old.
- [NCHR's Testimony to FDA About Molnupiravir for COVID-19](https://www.center4research.org/nchrs-testimony-to-fda-about-molnupiravir-for-covid-19/) - November 30, 2021: For molnupiravir, the balance of benefits and risks may differ between different types of patients, and not all types of patients were studied.
- [Biden’s Drug Agency Nominee Returns With Deeper Industry Ties](https://www.center4research.org/bidens-drug-agency-nominee-returns-with-deeper-industry-ties/) - Bloomberg Business, November 23, 2021: President Biden’s choice to lead the FDA made millions of dollars from health and drug companies since his last stint in government, raising new questions about his ties to firms the agency oversees.
- [FDA Panels: Too Many Conflicts or Too Little Expertise?](https://www.center4research.org/fda-panels-many-conflicts-little-expertise/) - Pharmalive.com, June 12, 2013. Should FDA Advisory Committee members be allowed to have financial conflicts of interest regarding the approval of medical products? Diana Zuckerman discusses how financial ties to pharmaceutical companies can influence the voting and discussion on drug and medical device approvals, and how misunderstandings of statistics and the value of clinical trials can lead to the approval of dangerous products.
- [Pharmaceutical industry, under scrutiny for prices, has history of big political wins](https://www.center4research.org/pharmaceutical_industry_scrutiny_prices/) - Center for Responsive Politics, October 2, 2015. Soaring drug prices already had customers unhappy. The pharmaceutical industry hardly needed a new poster boy to add volume and passion to the complaints.
- [GDUFA III Statement of Dr. Diana Zuckerman, President of the National Center for Health Research](https://www.center4research.org/gdufa-iii-statement-of-dr-diana-zuckerman-president-of-the-national-center-for-health-research/) - November 16, 2021: There are issues of safety and effectiveness in the GDUFA III Commitment letter.
- [The road ahead for Califf's confirmation](https://www.center4research.org/the-road-ahead-for-califfs-confirmation/) - Axios and Yahoo News, November 15, 2021: Former FDA chief Robert Califf has been nominated to head the agency again. We tell Axios that "The public has been asking if they can trust the FDA to ensure that the benefits outweigh the risks for Alzheimer's drugs, cancer treatments, and implanted devices"
- [NCHR's Comments on USPSTF's Draft Recommendation Statement on Screening for Eating Disorders](https://www.center4research.org/nchrs-comments-on-uspstfs-draft-recommendation-statement-on-screening-for-eating-disorders/) - November 15, 2021: We strongly agree with the USPSTF’s “I” grade recommendation that there is insufficient evidence in order to assess the benefits and risks of universal screening for eating disorders in asymptomatic adolescents and adults.
- [Biden Picks Robert Califf to Head the FDA for a Second Time](https://www.center4research.org/biden-picks-robert-califf-to-head-the-fda-for-a-second-time/) - The Scientist, November 12, 2021: Former FDA Commissioner Robert Califf has been nominated to be the new FDA Commissioner. He has excellent experience, but like all the FDA candidates the White House considered recently, he has close ties to industry.
- [Biden to Choose Robert Califf to Lead F.D.A., Despite Drug Industry Ties](https://www.center4research.org/biden-to-choose-robert-califf-to-lead-f-d-a-despite-drug-industry-ties/) - The New York Times, November 12, 2021: Is Biden nominee Dr. Califf the best choice to head up the FDA. The New York Times describes his pros and cons, and we point out that the White House doesn’t mind his Pharma ties.
- [Biden picks ex-FDA chief Robert Califf to again lead agency](https://www.center4research.org/biden-picks-ex-fda-chief-robert-califf-to-again-lead-agency/) - AP News, November 12, 2021: Robert Califf will be nominated as FDA Commissioner today. We told AP “He knows how the FDA works, and he avoided making any outrageous decisions as commissioner. Those are essential if the FDA is going to regain the public trust.”
- [Biden expected to tap Califf as FDA commissioner](https://www.center4research.org/biden-expected-to-tap-califf-as-fda-commissioner/) - Roll Call, November 12, 2021: Robert Califf will be nominated to again serve as FDA commissioner. We tell Roll Call that he’s a political compromise, close to Pharma but avoiding the controversy that happens when FDA ignores scientific evidence.
- [Biden chooses Robert Califf, former Obama FDA chief, as agency commissioner](https://www.center4research.org/biden-chooses-robert-califf-former-obama-fda-chief-as-agency-commissioner/) - Washington Post, November 12, 2021: President Biden is expected to nominate former FDA Commissioner Robert Califf to return as the agency’s head, and we explain why this political compromise makes sense despite his industry ties.
- [Breast Implants will now come with Black Box Warnings, List Risks](https://www.center4research.org/breast-implants-will-now-come-with-black-box-warnings-list-risks/) - Legal Reader, November 9, 2021: Will FDA’s requirements to warn patients about the cancer risks and other serious risks of breast implants be enough to adequately warn women considering implants? Experts disagree.
- [Testimony of Dr. Diana Zuckerman, NCHR, at the FDA MDUFA Meeting](https://www.center4research.org/testimony-of-dr-diana-zuckerman-nchr-at-the-fda-mdufa-meeting/) - September 30, 2021: Dr. Diana Zuckerman testifies to the FDA regarding the lack of diversity and inclusion in medical device trials pointing out that most medical companies do not adequately study safety and effectiveness in women, older patients, and people of color.
- [More efficacy data needed for Levo’s PWS treatment](https://www.center4research.org/more-efficacy-data-needed-for-levos-pws-treatment/) - BioWorld, November 4, 2021: Prader-Willi syndrome (PWS) is a terrible disease. But Levo Therapeutics research evidence for their nasal spray to prevent uncontrollable eating is among the worst we’ve seen at National Center for Health Research.
- [NCHR's Testimony at FDA's November 3, 2021 Circulatory Systems Devices Advisory Committee Meeting](https://www.center4research.org/nchrs-testimony-at-fdas-november-3-2021-circulatory-systems-devices-advisory-committee-meeting/) - November 3, 2021: We are concerned about the conflicting data on EVAR devices, and the reliance on 5-year studies that include different iterations of a device.
- [NCHR's Comments at EPA's 2021 CHPAC Meeting](https://www.center4research.org/nchrs-comments-at-epas-2021-chpac-meeting/) - November 2, 2021: We strongly urge the EPA to conduct research on how currently used materials for artificial turf and playgrounds can pose risks to the health of the children who play on them, and to develop standards to regulate the safety of these materials.
- [NCHR's testimony about Endologix AFX endovascular graft system (EVAR) at the FDA Advisory Panel](https://www.center4research.org/nchrs-testimony-about-endologix-afx-endovascular-graft-system-evar-at-the-fda-advisory-panel/) - November 2, 2021: The evidence does not support the use of the Endologix AFX EVAR devices, and the AFX2 device should not remain on the market while waiting for longer term data to determine if it is as safe as other EVAR devices.
- [Patients Must Be Warned of Breast Implant Risks, F.D.A. Says](https://www.center4research.org/patients-must-be-warned-of-breast-implant-risks-f-d-a-says/) - The New York Times, October 27, 2021: The FDA has placed black box warnings on breast implant packaging and told manufacturers to sell the implants only to health providers who review the potential risks with patients before surgery, and tell them the risks are even higher for breast cancer patients. The National Center for Health Research asks who will enforce that?
- [Training Researchers to Communicate CER Findings to Journalists](https://www.center4research.org/training-researchers-to-communicate-cer-findings-to-journalists/) - This webinar is part of our "Spreading the Word" project and is designed for researchers who want to better communicate in an interesting and understandable way with journalists (and the public).
- [Psychology Professor: There's little evidence linking entertainment to violence](https://www.center4research.org/psychology-professor-theres-little-evidence-linking-entertainment-to-violence/) - Hot Air, October 20, 2021: The debate over Dave Chappelle’s “The Closer” on Netflix has often centered on the harm his words might do to trans people. Will it lead to violence? NCHR’s president joins the public debate.
- [Netflix's support of Dave Chappelle is setting a dangerous precedent. Here's why.](https://www.center4research.org/netflixs-support-of-dave-chappelle-is-setting-a-dangerous-precedent-heres-why/) - USA Today, October 18, 2021: The growing controversy over Dave Chappelle’s stand-up special, "The Closer," in which he makes jokes about the trans community, has put Netflix on the defensive. NCHR’s president explains why hate speech is infectious and dangerous.
- [Improving the Accuracy of COVID-19 Media Coverage](https://www.center4research.org/improving-the-accuracy-of-covid-19-media-coverage/) - In response to the COVID-19 pandemic, the National Center for Health Research hosted 9 teleconferences featuring COVID-19 researchers as speakers and discussants on different aspects of COVID-19 of importance to journalists. The main goal of this project was to help journalists understand the nuances of often conflicting information about COVID-19 research, to help ensure accurate media coverage.
- [Talcum Powder and Ovarian Cancer](https://www.center4research.org/talc-and-ovarian-cancer/) - While the scientific evidence has shown a consistent link between talcum powder and ovarian cancer, many questions remain. Why take the risk?
- [Testimony of Dr. Diana Zuckerman, NCHR, at the FDA PDUFA Meeting, September 28, 2021](https://www.center4research.org/testimony-of-diana-zuckerman-phd-president-of-the-national-center-for-health-research-at-the-fda-pdufa-meeting-september-28-2021/) - September 28, 2021: After reviewing FDA’s PDUFA VII plans, I have concerns about the performance goals and policies that the FDA has negotiated with industry behind closed doors.
- [FDA continues operating without a Senate-confirmed, permanent leader](https://www.center4research.org/fda-continues-operating-without-a-senate-confirmed-permanent-leader/) - Homeland Preparedness News, September 28, 2021: Should you be concerned about the lack of a permanent FDA Commissioner? NCHR explains why the new Commissioner needs to be someone who cares about public safety and public health.
- [MyPlate: Understanding the Dietary Guidelines for Americans](https://www.center4research.org/my-plate-dietary-guidelines/) - An important goal of the U.S. government is to help guide adults and children to be as healthy as possible. One way to do so has been to make dietary recommendations as visual representations of nutrition guidelines. The most recent update of the Dietary Guidelines came out in 2020, and it uses an updated MyPlate visual model.
- [NCHR's comments on FDA’s Draft Guidance for Industry on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products](https://www.center4research.org/nchrs-comments-on-fdas-draft-guidance-for-industry-on-demonstrating-substantial-evidence-of-effectiveness-for-human-drug-and-biological-products/) - March, 19, 2020: The FDA’s draft guidance describes circumstances under which exceptions can be made to the requirement of two adequately controlled clinical trials. Although the law allows these exceptions under certain circumstances, we have concerns over the frequency with which these exceptions are made.
- [NCHR's Comments on FDA’s Draft Guidance on Levonorgestrel](https://www.center4research.org/nchrs-comments-on-fdas-draft-guidance-on-levonorgestrel/) - March 23, 2020: A diverse participant population is necessary for the results to be relevant to women of different races, ethnicities, and BMI.
- [NCHR's Public Comments on the USPSTF Draft Research Plan on Atrial Fibrillation: Screening With Electrocardiography](https://www.center4research.org/national-center-for-health-researchs-public-comments-on-the-united-states-preventive-services-task-forces-draft-research-plan-on-atrial-fibrillation-screening-with-electrocardiograp/) - April 22, 2020: We commend the assessment of the potential benefits and harms of electrocardiography screening among asymptomatic adults. Furthermore, we applaud the commitment to assessing these potential benefits and harms by subgroups defined by stroke risk, as well as by race/ethnicity, age, and sex.
- [NCHR’s Testimony to FDA on Belantamab Mafodotin](https://www.center4research.org/nchrs-testimony-to-fda-on-belantamab-mafodotin/) - July 14, 2020: Based on the data discussed today, it is difficult to determine how well Belantamab Mafodotin works and whether its effect is clinically meaningful. To approve a treatment for which the benefits do not clearly outweigh the risks creates additional risk for those who are already suffering.
- [NCHR’s Testimony to FDA Regarding Proposed Labeling for TRELEGY ELLIPTA](https://www.center4research.org/nchrs-testimony-regarding-proposed-labeling-for-trelegy-ellipta/) - August 31, 2020: We share the concerns of the FDA scientists that trends shown by the data do not support the claim that TRELEGY improves all-cause mortality.
- [NCHR Public Comments on the AHRQ Draft Systematic Review of Cervical Ripening in the Outpatient Setting](https://www.center4research.org/nchrs-comments-on-the-agency-for-healthcare-research-and-qualitys-draft-systematic-review-regarding-cervical-ripening-in-the-outpatient-setting/) - September 28, 2020: We support the review’s examination of the relative risks and outcomes of cervical ripening in the outpatient compared to the inpatient setting. However, an overarching problem in the review is that it does not examine the role of patient-centered outcomes and satisfaction.
- [NCHR’s Testimony at FDA Advisory Committee Meeting on “Abuse-Deterrent” Amphetamine Sulfate Immediate-Release Oral Capsules](https://www.center4research.org/nchrs-testimony-at-the-fdas-joint-meeting-of-the-psychopharmacologic-drugs-advisory-committee-and-the-drug-safety-and-risk-management-advisory-committee-regarding-a-new-drug-application-for-amphet/) - October 8, 2020: The drug should be labeled with an accurate description of its properties, not “abuse deterrent,” so that patients, family members, and healthcare providers do not erroneously assume the drug is less addictive.
- [NCHR's Statement at FDA Advisory Committee Meeting on Olanzapine and Samidorphan Combination Tablets](https://www.center4research.org/nchrs-testimony-at-fdas-joint-meeting-of-the-psychopharmacologic-drugs-advisory-committee-and-the-drug-safety-and-risk-management-advisory-committee-regarding-new-drug-application-for-olanzapine-a/) - October 9, 2020: Although patients may benefit from olanzapine/samidorphan by experiencing lower weight gain, the risks are too high to justify approval.
- [NCHR Statement by Dr. Diana Zuckerman at FDA Covid Vaccine Advisory Committee October 22, 2020](https://www.center4research.org/nchr-statement-by-dr-diana-zuckerman-at-fda-covid-vaccine-advisory-committee-october-22-2020/) - October 22, 2020: It is FDA’s job to make sure that a vaccine has meaningful benefits for the health and lives of most Americans, and especially those most at risk.
- [NCHR's Testimony at FDA Meeting for Reducer Circulatory System Device](https://www.center4research.org/nchrs-testimony-at-fda-meeting-for-reducer-circulatory-system-device/) - October 27, 2020: The data provided thus far simply do not provide enough evidence that there are benefits outweighing the risks for the Reducer, a permanent device.
- [NCHR Statement at FDA Alzheimer’s Advisory Committee Meeting On Aducanumab](https://www.center4research.org/nchr-statement-at-fda-alzheimers-advisory-committee-meeting-on-aducanumab/) - November 6, 2020: Aducanumab could be promising, but we need better evidence before approving it.
- [NCHR's Comments on Drug Labeling for Geriatric Patients](https://www.center4research.org/nchrs-comments-on-drug-labeling-for-geriatric-patients/) - November 16, 2020: We agree that the FDA should immediately develop clear guidelines for labeling that addresses safety and effectiveness of drugs in the geriatric population.
- [Public Comments Regarding ACIP Meeting on December 1, 2020](https://www.center4research.org/public-comments-regarding-acip-meeting-on-december-1-2020/) - December 1, 2020: We are concerned about the lack of data on the vaccines in patients living in long-term care facilities, or any patients over 65 years of age.
- [Testimony of Dr. Diana Zuckerman of NCHR before the FDA Advisory Committee on Pfizer COVID Vaccine](https://www.center4research.org/testimony-of-dr-diana-zuckerman-of-nchr-before-the-fda-advisory-committee-on-pfizer-covid-vaccine/) - December 10, 2020: We need longer-term data on the Pfizer COVID-19 vaccine to fully understand if benefits outweigh the risks for frail patients and all races/ethnicities, and for everyone else as well. It is essential that FDA ensure the continuation of the randomized controlled trial.
- [NCHR's Comments Regarding Spironolactone for Heart Failure with Preserved Ejection Fraction](https://www.center4research.org/nchrs-comments-regarding-spironolactone-for-heart-failure-with-preserved-ejection-fraction/) - December 16, 2020: What can be done to improve the quality of the data prior to FDA making a decision about whether or not to approve a new indication for spironolactone?
- [Dr. Diana Zuckerman's Testimony on Moderna’s COVID Vaccine Before the FDA Advisory Committee](https://www.center4research.org/dr-diana-zuckermans-testimony-to-the-fda-advisory-committee-on-modernas-covid-vaccine/) - December 17, 2020: We need at least 1 year of blinded, randomized, controlled data. We agree that FDA should delay access to vaccines by members of the placebo group unless they are in priority populations.
- [NCHR's Statement on Keytruda for Early Stage Triple Negative Breast Cancer](https://www.center4research.org/nchrs-statement-on-keytruda-for-early-stage-triple-negative-breast-cancer/) - February 9, 2021: We agree with FDA scientists that Keytruda is not proven to be effective for women with early stage triple negative breast cancer, but can cause serious health problems.
- [Testimony of Dr. Diana Zuckerman at the FDA Advisory Committee on Johnson & Johnson COVID Vaccine](https://www.center4research.org/testimony-of-dr-diana-zuckerman-of-nchr-before-the-fda-advisory-committee-on-j-j-covid-vaccine/) - February 26, 2021: The Johnson & Johnson vaccine seems to be effective, but not proven to be more effective for moderate or severe COVID than the Pfizer or Moderna vaccines. We asked FDA to stop the hype and require studies to continue.
- [Statement of Diana Zuckerman, Ph.D On Behalf of the National Center for Health Research Before the FDA Advisory Panel Convening to Discuss Dermal Fillers](https://www.center4research.org/statement-of-diana-zuckerman-ph-d-on-behalf-of-the-national-center-for-health-research-before-the-fda-advisory-panel-convening-to-discuss-dermal-fillers/) - March 23, 2021: A black box warning is needed, should be prominently displayed, and should include warnings about off-label uses as well as approved indications and well-trained providers.
- [NCHR's Testimony to FDA Regarding Tanezumab for Osteoarthritis](https://www.center4research.org/nchrs-testimony-to-fda-regarding-tanezumab-for-osteoarthritis/) - March 24, 2021: We agree with the FDA’s assessment that the risk mitigation measures proposed for tanezumab are not likely to be feasible or effective, and there are serious risks, even after patients discontinue use.
- [NCHR's Comments to USPSTF on Aspirin to Prevent Morbidity and Mortality from Preeclampsia](https://www.center4research.org/nchrs-comments-to-uspstf-on-aspirin-to-prevent-morbidity-and-mortality-from-preeclampsia/) - March 22, 2021: We support this update, strengthened by new evidence, maintaining the 2014 “B” recommendation that there is moderate certainty of a substantial net benefit for the use of low-dose aspirin as preventive medication after 12 weeks of gestation in women who are at high risk for preeclampsia.
- [NCHR's Testimony at FDA Regarding Donislecel Treatments for Diabetes](https://www.center4research.org/nchrs-testimony-at-fda-regarding-donislecel-treatments-for-diabetes/) - April 15, 2021: We agree with the concerns of the FDA reviewers regarding the benefit-risk profile of donislecel transplant treatments.
- [NCHR Statement at FDA Advisory Committee Meeting on Tecentriq for Triple Negative Breast Cancer](https://www.center4research.org/nchr-statement-at-fda-advisory-committee-meeting-on-tecentriq-for-triple-negative-breast-cancer/) - April 27, 2021: A new randomized controlled trial that includes more Black women is needed to evaluate Tecentriq for Triple Negative Breast Cancer in order to keep FDA approval. The FDA doesn't do patients any favors by continuing to approve a treatment that isn't shown to help and may actually harm them.
- [NCHR's Statement to FDA Advisory Committee Meeting on Neurological Devices](https://www.center4research.org/nchrs-statement-to-fda-advisory-committee-meeting-on-neurological-devices/) - June 3, 2021: We urge the FDA to regulate the neurological devices in question as Class II, and require the kind of meaningful evidence for new devices that we would want for any device that we use as health professionals, as patients, or as consumers.
- [NCHR's Testimony to FDA on Pediatric Covid Vaccines](https://www.center4research.org/nchrs-testimony-to-fda-on-pediatric-covid-vaccines/) - June 10, 2021: We agree with the FDA’s assessment that the lower burden of disease for COVID-19 in pediatric populations warrants more stringent criteria for safety and efficacy of vaccines than for adults.
- [NCHR's Comments on AHRQ’s Draft Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain](https://www.center4research.org/nchrs-comments-on-ahrqs-draft-systematic-review-on-cannabis-and-other-plant-based-treatments-for-chronic-pain/) - June 14, 2021: Although we support the goals of the review and agree that there is a need for a systematic review of the effects of cannabis and other plant-based treatments for chronic pain, there are several important limitations of the report that were either not adequately addressed or were not mentioned.
- [NCHR's Comments to CMS on the 2022 Medicare Physician Fee Schedule](https://www.center4research.org/nchrs-comments-to-cms-on-the-2022-medicare-physician-fee-schedule/) - September 13, 2021: We support the continued funding of telehealth services for mental health appointments, though additional data needs to be collected and patient preferences need to be taken into account.
- [NCHR's Comments on FDA's Information Collection Activities on Abuse Deterrent Formulations](https://www.center4research.org/nchrs-comments-on-fdas-information-collection-activities-on-abuse-deterrent-formulations/) - April 6, 2020: We support FDA’s decision to conduct a comprehensive evaluation of opioid prescribers’ knowledge, attitudes, perceptions, experiences and behaviors related to Abuse Deterrent Formulations (ADF) and agree with the FDA that new language is needed to better describe and explain ADF.
- [NCHR's Public Comments on the Scientific Report of the 2020 Dietary Guidelines Advisory Committee](https://www.center4research.org/nchrs-public-comments-on-the-scientific-report-of-the-2020-dietary-guidelines-advisory-committee/) - August 13, 2020: We support many of the recommendations of the Dietary Guidelines Advisory Committee. However, we also have some concerns.
- [NCHR's Public Comments on the FDA's Draft Guidance Regarding the Development of Anti-Infective Drug Products for the Pediatric Population](https://www.center4research.org/nchrs-public-comments-on-the-fdas-draft-guidance-regarding-the-development-of-anti-infective-drug-products-for-the-pediatric-population/) - August 31, 2020: We have several recommendations regarding the FDA's draft guidance regarding the development of anti-infective drugs for the pediatric population.
- [Diana Zuckerman’s Public Health presentation at FDA MDUFA Meeting, October 27, 2020](https://www.center4research.org/diana-zuckermans-public-health-presentation-at-fda-mdufa-meeting-october-27-2020/) - October 27, 2020: MDUFA performance goals need to be more patient-centered by including specific metrics pertaining to safety and effectiveness, both pre-market and post-market, and improving patients and consumer advocates’ access to meet with FDA decision-making officials. That will help provide the safeguards that patients and consumers deserve.
- [NCHR's Public Comments on Breast Cancer Treatment for Premenopausal Women](https://www.center4research.org/nchrs-public-comments-on-breast-cancer-treatment-for-premenopausal-women/) - December 7, 2020: We strongly recommend that clinical trials on breast cancer treatments should include pre-menopausal women.
- [NCHR's Comments on Modified Risk Tobacco Product Application for Camel Snus](https://www.center4research.org/nchrs-comments-on-modified-risk-tobacco-product-application-for-camel-snus/) - December 30, 2020: We strongly oppose the approval of this modified risk application for six Camel Snus smokeless tobacco products. If Camel Snus are declared to be a MRTP, there is a risk of increased use of these products, due to perceptions of safety as well as the appeal of flavored products.
- [NCHR's Comments on AHRQ's Draft Report on Improving Patient Safety](https://www.center4research.org/nchrs-comments-on-ahrqs-draft-report-on-improving-patient-safety/) - February 16, 2021: Identifying and implementing strategies to improve patient safety and reducing medical errors is of utmost importance, and we strongly support this draft report. However, we have concerns over the limited scope of the report, and the title should be revised to better reflect that scope.
- [Written Statement Regarding Artificial Turf to Woodbridge Ordinance Committee](https://www.center4research.org/written-statement-regarding-artificial-turf-to-woodbridge-ordinance-committee/) - March 16, 2021: Dr. Diana Zuckerman speaks out against the use of artificial turf to Woodbridge Ordinance Committee due to potential harm to children.
- [NCHR Letter to Belvedere City Council Regarding Rubber Playground Surfaces](https://www.center4research.org/nchr-letter-to-belvedere-city-council-regarding-rubber-playground-surfaces/) - March 19, 2021: Dr. Diana Zuckerman's letter to Belvedere City Council regarding the dangers of rubber playground surfaces to children and the community.
- [Letter to California State Assembly Supporting Repeal of Sugary Drink Tax Preemption](https://www.center4research.org/letter-to-california-state-assembly-supporting-repeal-of-sugary-drink-tax-preemption/) - March, 26, 2021: NCHR letter to California State Assembly supports the repeal of the sugary drink tax preemption to allow localities to implement life-saving taxes.
- [NCHR's Comments to FDA on the Remanufacturing of Medical Devices](https://www.center4research.org/nchrs-comments-to-fda-on-the-remanufacturing-of-medical-devices/) - September 22, 2021: We agree with the FDA that clarification is needed of whether or not activities performed on medical devices are considered “remanufacturing” or “servicing,” and we support the draft guidance’s clarity on how to correctly classify a procedure.
- [How Fauci and the NIH Got Ahead of the FDA and CDC in Backing Boosters](https://www.center4research.org/how-fauci-and-the-nih-got-ahead-of-the-fda-and-cdc-in-backing-boosters/) - KHN, September 16, 2021: How did Fauci and the NIH and the White House get ahead of the FDA and CDC in backing boosters? NCHR’s president explains the conflicting perspectives. And when the data are not conclusive, the question is what is the best strategy for you? And to defeat the pandemic? They may not be the same.
- [NCHR's Testimony to FDA Regarding Boosters for Pfizer's COVID-19 Vaccine](https://www.center4research.org/nchrs-testimony-to-fda-regarding-boosters-for-pfizers-covid-19-vaccine/) - September 17, 2021: The data provided for this meeting do not allow us to draw confident conclusions, and a premature decision will make it impossible to do the research necessary to draw scientific conclusions.
- [NCHR’s Public Comments on Transvenous (Catheter) Pulmonary Embolectomy](https://www.center4research.org/nchrs-public-comments-on-transvenous-catheter-pulmonary-embolectomy/) - September 10, 2021. We find the evidence that would support changing the National Coverage Determination inadequate and therefore strongly support maintaining the current non-coverage National Coverage Determination for TPE, and oppose reversing that decision.
- [Health Research Issues 101: The Basics for Health Journalists](https://www.center4research.org/health-research-issues-101-the-basics-for-health-journalists/)
- [Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data](https://www.center4research.org/covid-19-fda-set-to-grant-full-approval-to-pfizer-vaccine-without-public-discussion-of-data/) - BMJ, August 20, 2021: The FDA is being criticized for not holding an advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine. Will it undermine public confidence?
- [NCHR's Comments on Conveying Materials Information About Medical Devices to Patients](https://www.center4research.org/nchrs-comments-on-conveying-materials-information-about-medical-devices-to-patients/) - August 18, 2021. All information about materials should be listed in an understandable and accessible way for all devices – even tiny ones that are not the major focus of a surgical procedure – so that patients can make informed choices about their medical care.
- [Biden yet to nominate new FDA chief even as delta surges](https://www.center4research.org/biden-yet-to-nominate-new-fda-chief-even-as-delta-surges/) - The Hill, August 8, 2021: FDA news a new focus on public health that protects patient safety and ensures strong scientific evidence. We explain to The Hill that making the right choice is as important as making a decision soon.
- [7 things to know about bad COVID-19 tests](https://www.center4research.org/7-things-to-know-about-bad-covid-19-tests/) - CBS 5, July 29, 2021: This CBS 5 investigation about FDA emergency use authorizations (EUAs) for COVID tests will shock you! Thanks to Kris Pickel, you can find out why so many COVID tests and antibody tests were not accurate and how many we still aren’t sure of.
- [Hormones, Menstruation, and Migraines: What’s the Connection?](https://www.center4research.org/hormones-menstruation-and-migraines-whats-the-connection/) - Migraines are known to be more common in women than men. Some research suggests that estrogen and other hormones that fluctuate during menstruation can affect migraine frequency and severity.
- [Beleaguered FDA in talks for drug-company funding](https://www.center4research.org/beleaguered-fda-in-talks-for-drug-company-funding/) - Marketwatch, July 13, 2021: Fees paid by drug companies make up half of the FDA's revenue. Dr. Diana Zuckerman explains how these fees often influence FDA decisions and sacrifice patient safety.
- [Drug Prices Are One Focus of Biden’s Push to Boost Competition](https://www.center4research.org/drug-prices-are-one-focus-of-bidens-push-to-boost-competition/) - Wall Street Journal, July 9, 2021: Drug prices in the US are extremely high with both sides of the aisle advocating for Medicare to be able to negotiate drug prices. Dr. Diana Zuckerman spoke with the WSJ about how President Biden plans to lower drug prices.
- [Emergency Use Authorization vs. Full Approval: What are the Implications?](https://www.center4research.org/emergency-use-authorization-vs-full-approval-what-are-the-implications/) - Contagion Live, June 20, 2021: What is the difference between Emergency Use Authorization and FDA Approval? Dr. Diana Zuckerman addresses the difference between the two and the implications of both.
- [NCHR's Comments on AHRQ's Draft Report on Integrated Pain Management Programs](https://www.center4research.org/nchr-comments-on-ahrqs-draft-report-on-integrated-pain-management-programs/) - June 21, 2021. While we agree with the stated objective of a report evaluating the effectiveness and harms of pain management programs in the Medicare population, this report has several serious limitations.
- [Statement of Dr. Diana Zuckerman on FDA's Approval of Alzheimer's Drug Aduhelm](https://www.center4research.org/statement-of-dr-diana-zuckerman-on-alzheimers-drug-aduhelm/) - June 8, 2021: Dr. Diana Zuckerman, president of NCHR, speaks out against FDA's approval of the ineffective Alzheimer's drug aduhelm.
- [New Alzheimer's drug could be 'devastating' for Medicare](https://www.center4research.org/new-alzheimers-drug-could-be-devastating-for-medicare/) - Politico, June 15, 2021: The controversial approval of the first drug to target Alzheimer’s disease in nearly 20 years has been blasted by many experts, because the drug is not proven to work and will cost $56,000 per year. “You don’t have to be a rocket scientist to know that the impact on Medicare is likely to be devastating,” said Diana Zuckerman, the president of the National Center for Health Research.
- [Alzheimer’s drug approval debacle deepens FDA scrutiny](https://www.center4research.org/alzheimers-drug-approval-debacle-deepens-fda-scrutiny/) - Politico, June 11, 2021: Dr. Diana Zuckerman speaks with Politico on the impact that the newly approved Alzheimer's drug will have on Democratic senators.
- [NCHR Comments on USPSTF's Recommendation Statement Regarding Vitamin Supplementation](https://www.center4research.org/nchr-comments-on-uspstfs-recommendation-statement-regarding-vitamin-supplementation/) - June 1, 2021. We support all 3 of USPSTF’s reissued recommendations. However, we urge the USPSTF to also specify the gap in data caused by the lack of information on race in the research.
- [Racial Differences in Prostate Cancer](https://www.center4research.org/racial-differences-in-prostate-cancer/) - Prostate cancer is a common form of cancer in men and is one of the leading cancer killers. Black men are disproportionately affected. They are often diagnosed at younger ages, with more advanced stages of cancer, with more aggressive cancers, and they may be more likely to need screening. Some of the differences in rates of survival between Black and White men may be due to differences in access to medical care.
- [NCHR's Testimony at FDA Advisory Meeting on Teplizumab to Delay Type 1 Diabetes](https://www.center4research.org/nchrs-testimony-at-fda-advisory-meeting-on-teplizumab-to-delay-type-1-diabetes/) - May 27, 2021. FDA scientists note substantial problems with the study sample. These study shortcomings are even more worrisome since the sample was very small.
- [Postpartum Depression: Brexanolone and Other Treatments](https://www.center4research.org/postpartum-depression-brexanolone-and-other-treatments/) - Postpartum Depression (PPD) affects between 10-15% of new mothers. PPD causes mothers to suffer from a long-lasting depression that, if severe, can put both the mother and the child in danger. Though PPD is common, available antidepressants are not guaranteed to help. A new treatment, brexanolone, offers hope for some mothers but also has severe side effects.
- [Comparison of Acupuncture and Therapy as Treatments for Cancer Survivors with Insomnia](https://www.center4research.org/comparison-of-acupuncture-and-therapy-as-treatments-for-cancer-survivors-with-insomnia/) - Both acupuncture and CBT-I helped reduce insomnia symptoms in cancer survivors. The researchers concluded that CBT-I should be used as the first line of treatment for cancer-related insomnia, but acupuncture is a good alternative.
- [Psychedelic-Assisted Therapy as Treatment for Mental Disorders](https://www.center4research.org/psychedelic-assisted-therapy-as-treatment-for-mental-disorders/) - This article will describe some of the key research on the therapeutic properties of psychedelic drugs when used in a medical setting and their potential risks and benefits for the treatment of specific mental disorders.
- [Taking Propecia or Proscar to Prevent Hair Loss is Associated with Depression, Anxiety, and Sexual Problems](https://www.center4research.org/taking-propecia-or-proscar-to-prevent-hair-loss-is-associated-with-depression-anxiety-and-sexual-problems/) - Finasteride (brand name Propecia or Proscar) has side effects, some of which are serious and can last even after someone stops taking the drug.
- [NCHR Statement Regarding Cancer Drugs that Failed to Confirm Efficacy after Accelerated Approval](https://www.center4research.org/nchr-statement-regarding-cancer-drugs-that-failed-to-confirm-efficacy-after-accelerated-approval/) - April 29, 2021: Patients are being harmed when the FDA does not follow the law pertaining to FDA approval. Drugs must be proven safe and effective, and companies must continue randomized clinical trials that prove the benefits of their drugs outweigh the risks for most patients.
- [NCHR Statement at FDA Advisory Committee Meeting on Keytruda and Tecentriq for Advanced Urothelial Carcinoma](https://www.center4research.org/nchr-statement-at-fda-advisory-committee-meeting-on-keytruda-and-tecentriq-for-advanced-urothelial-carcinoma/) - April 28, 2021: Patients have suffered from taking cancer drugs that aren’t proven to work. Other treatment options are proven to work. Physicians can still choose whatever treatments are on the market, but treatment decisions shouldn’t be based on the mistaken belief that these drugs are proven effective for advanced urothelial carcinoma.
- [NCHR's Testimony at FDA Advisory Committee Meeting on Avacopan](https://www.center4research.org/nchrs-testimony-at-fda-advisory-committee-meeting-on-avacopan/) - May 6, 2021: Although AAV is a serious disease with an unmet need for new treatments, avacopan has not clearly demonstrated that it is more effective than the existing treatments, and it apparently carries more risk for certain adverse events.
- [NCHR Written Statement for North Salem Central School District Board of Education](https://www.center4research.org/nchr-written-statement-for-north-salem-central-school-district-board-of-education-2/) - May 12, 2021: Dr. Diana Zuckerman, president of NCHR, writes to the North Salem Central School District Board of Education on the dangers of artificial turf.
- [NCHR Written Statement for North Salem Central School District Board of Education](https://www.center4research.org/nchr-written-statement-for-north-salem-central-school-district-board-of-education/) - May 12, 2021: Dr. Diana Zuckerman, president of NCHR, writes to the North Salem Central School District Board of Education on the dangers of artificial turf.
- [The Role of Environmental Regulations in the Fight Against Cancer](https://www.center4research.org/18885-2/) - NYC NPR, May 10, 2021: President Biden wants a new agency within NIH to “end cancer as we know it.” Dr. Diana Zuckerman explains to NPR that EPA needs to do more to help prevent cancer.
- [Teens are worried about wrinkles. Here's how Gen Z is helping to fuel a beauty boom](https://www.center4research.org/teens-are-worried-about-wrinkles-heres-how-gen-z-is-helping-to-fuel-a-beauty-boom/) - CNN, May 6, 2021: While teens are increasingly spending time and money to prevent wrinkles, experts are concerned about the premature demand for more invasive treatments.
- [Biden's 'end cancer' pledge begs for environmental oversight](https://www.center4research.org/bidens-end-cancer-pledge-begs-for-environmental-oversight/) - E&E News, May 4, 2021: President Biden pledged last week to "end cancer as we know it," a bold promise focused on boosting funding to the National Institutes of Health for a special Advanced Research Projects Agency-Health. But public health experts who have spent their careers examining environmental causes of cancer say it may not be possible to truly stop cancer without EPA stepping in.
- [Conflicts Galore: Upcoming Accelerated Approval Cancer Panel Includes Many Industry Relationships](https://www.center4research.org/conflicts-galore-upcoming-accelerated-approval-cancer-panel-includes-many-industry-relationships/) - Pink Sheet, April 21, 2021. Six members of the FDA Oncologic Drugs Advisory Committee had conflicts of interest requiring waivers to participate in the agency’s April 2021 meeting to review whether 3 cancer drugs should have their indications for late-stage breast cancer, bladder cancer, and gastric cancer removed from the market due to lack of evidence that they are effective.
- [To Stay: Two More Cancer Indications With 'Dangling Approvals'](https://www.center4research.org/to-stay-two-more-cancer-indications-with-dangling-approvals/) - Medscape News, April 29, 2021: Two more cancer indications that had been granted accelerated approval by the US Food and Drug Administration (FDA) are going to stay in place, at least for now. This was the verdict after the second day of a historic 3-day meeting (April 27–29) and follows a similar verdict from day one.
- [FDA Scrutinizes Pricey Cancer Drugs](https://www.center4research.org/fda-scrutinizes-pricey-cancer-drugs/) - Politico Pulse, April 28, 2021: Will FDA maintain approval for cancer drugs that are proven to not work? We were hoping for a reckoning, but that doesn’t seem likely as the doctors on the FDA Advisory panel tell FDA that they are hopeful that the drugs will eventually be proven to work.
- [Can California’s public universities mandate COVID-19 vaccines?](https://www.center4research.org/can-californias-public-universities-mandate-covid-19-vaccines/) - Monterey Herald, April 26, 2021: Dr. Diana Zuckerman and Robert Kaplan address the possibility of mandatory vaccinations at California public colleges and strategies to ensure policies can withstand legal choices.
- [4 in 10 Adults Over 50 Consult Online Reviews When Picking a Doctor](https://www.center4research.org/4-in-10-adults-over-50-consult-online-reviews-when-picking-a-doctor/) - HealthDay, April 14, 2021. Finding a new doctor can be a daunting task. For help, many older adults turn to online reviews, a new study finds. In fact, many people rate online reviews as highly as they would a recommendation from friends and family when picking a doctor. Dr. Diana Zuckerman, president of the National Center for Health Research, said that choosing a doctor is a complex undertaking.
- [NCHR's Comments on USPSTF's Draft Recommendation for Diabetes Screening](https://www.center4research.org/nchrs-comments-on-uspstfs-draft-recommendation-for-diabetes-screening/) - While we agree that diabetes screening is an important tool, the USPSTF recommendation appears to be not fully rooted in data.
- [What Genentech is doing to fix biotech’s diversity problem](https://www.center4research.org/what-genentech-is-doing-to-fix-biotechs-diversity-problem/) - Fortune, April 7, 2021. There’s a big problem with clinical trials: a lack of diversity. This problem led researchers to believe that Black women did not develop breast cancer as frequently as white women and created a gap in understanding how different treatments work. How can companies like Genentech start increasing diversity in clinical trials?
- [Trying to Get Pregnant or Trying to Avoid it? Now, There Are Apps for Both!](https://www.center4research.org/trying-get-pregnant-trying-avoid-now-theres-app/) - Digital birth control apps are becoming more common. The FDA has now cleared two apps: Natural Cycles and Clue for preventing pregnancy. Read more about why these apps are unreliable for women looking to avoid pregnancy.
- [NCHR's Testimony to NASEM Town Hall on PFAS Testing](https://www.center4research.org/nchrs-testimony-to-nasem-town-hall-on-pfas-testing/) - We urge testing for blood levels of PFAS among those exposed at work, among communities exposed through groundwater, athletes and children who play on artificial turf and playground equipment, pregnant and lactating women, or others exposed to contaminants.
- [NCHR's testimony to FDA on the OCS Heart System](https://www.center4research.org/nchrs-testimony-to-fda-on-the-ocs-heart-system/) - April 6, 2021. The materials presented have not proven that the OSC Heart System is as effective or more effective than the usual standard of care.
- [The FDA Cut Off COVID Vaccine Testing. That Was a Really Bad Idea.](https://www.center4research.org/the-fda-cut-off-covid-vaccine-testing-that-was-a-really-bad-idea/) - Washington Monthly, March 26, 2021: Not since the polio vaccine became available in April 1955 have Americans been so excited about getting a shot. But behind the scenes, there’s a lot we don’t know because of a decision made back in December by the FDA. The agency allowed manufacturers to effectively stop their clinical trials as soon as they were authorized to market their vaccines, making it impossible to learn how long the vaccines work and for whom.
- [NCHR's Comments on USPSTF's Recommendations for Chlamydia and Gonorrhea Screenings](https://www.center4research.org/nchrs-comments-on-uspstfs-recommendations-for-chlamydia-and-gonorrhea-screenings/) - Although we support the reissued “B” grade recommendation for screening for chlamydia and gonorrhea in all sexually active ages 24 and younger, we disagree that women ages 25 and over should only be screened if at high risk. We suggest that a “C” recommendation for men may capture that health care providers should assess patients’ risk factors and suggest screening accordingly.
- [Health Insurance: 2021 Special Open Enrollment Period– Now What?](https://www.center4research.org/health-insurance-open-enrollment-season/) - President Biden has reopened the ACA insurance marketplace to help Americans get health insurance during the COVID-19 pandemic.
- [Is Your Jaw Clicking or Causing Discomfort?  What are Temporomandibular Disorders?](https://www.center4research.org/jaw-clicking-causing-discomfort-temporomandibular-disorders/) - Temporomandibular disorders (TMD), commonly called TMJ, are poorly understood conditions including pain in the jaw joint and limits on jaw movements.
- [Choosing Wisely: Physician Groups Make Recommendations to Improve Health Care and Reduce Costs](https://www.center4research.org/choosing-wisely-physician-groups-make-recommendations-reduce-healthcare-costs/) - Do females under 21 need pap smears? Should a patient with lower-back pain get an MRI? You might be surprised that the answer is usually NO.
- ['Buyer beware': Ads hide PFAS cookware risks](https://www.center4research.org/buyer-beware-ads-hide-pfas-cookware-risks/) - E & E News, March 24, 2021: Consumers trying to avoid toxic chemicals in their nonstick cookware face convoluted advertising claims that can confuse even the most well-informed buyers. Take Diana Zuckerman, who, as president of the National Center for Health Research, is more familiar than the average person with chemistry and toxicology. Still, she said, trying to determine which pans and cookware did not contain PFAS, a class of toxic substances linked to cancer and other health problems, was no easy task.
- [Can Girls Lower their Breast Cancer Risk by Eating Peanut Butter?](https://www.center4research.org/can-girls-lower-breast-cancer-risk-eating-peanut-butter/) - Peanut butter, a favorite food of so many kids and overwhelmed parents, may help ward off abnormal breast conditions linked to cancer.
- [Do Anti-Anxiety Medications Cause Dementia?](https://www.center4research.org/preventing-treating-alzheimers-dementia/) - Exercise was shown to protect against the brain shrinking even if people with a family history of Alzheimer’s disease.
- [Birth Control Apps Show the Contradictions in FDA Device Oversight](https://www.center4research.org/birth-control-apps-show-the-contradictions-in-fda-device-oversight/) - The Verge, March 17, 2021: The FDA has allowed a second digital birth control app to be sold in the U.S. Neither Natural Cycles nor Clue were tested in clinical trials. NCHR asks how safe and effective are they, and are women being misled?
- [NCHR Comments on USPSTF's Draft Recommendation on Gestational Diabetes Screening](https://www.center4research.org/nchr-comments-on-uspstfs-draft-recommendation-on-gestational-diabetes-screening/) - March 15, 2021. We support the USPSTF’s update to the 2014 recommendations for GDM screening in asymptomatic pregnant persons.
- [Avoiding the Subject: On Pfizer Vaccine Quality Control, FDA Says Less than European Counterpart](https://www.center4research.org/avoiding-the-subject-on-pfizer-vaccine-quality-control-fda-says-less-than-european-counterpart/) - Project on Government Oversight, March 19, 2021: The Project on Government Oversight’s new report about the Pfizer COVID Vaccine raises questions about why the FDA did not publicly disclose quality control concerns that were publicly raised in Europe. We ask: Is “adequate” quality control good enough?
- [Beginner's Guide to Developing an Exercise Routine](https://www.center4research.org/beginners-guide-developing-exercise-routine/) - Exercise is one of NCHR's seven recommended ways to maximize your health. If you want to exercise but aren't sure where to begin, we can help! If you feel like your daily life doesn't allow you to get fit (not enough time, no money for a gym membership, etc.), we have some "work-arounds" that may help.
- [Self-Injury Is Increasing in Teenage Girls: What Can Parents Do?](https://www.center4research.org/self-injury-increasing-teenage-girls-can-parents/) - Trends of self-injury on the rise in an alarming rate for adolescent females and still rising in teenage boys. Read about warning signs and get the information you may need to help your child.
- [Compounded Bioidentical Hormone Therapy](https://www.center4research.org/bio-identical-hormone-replacement-therapy-2/) - To avoid the risks of conventional hormone therapy, more and more women are seeking alternatives. But how safe are compounded bioidentical hormones?
- [Preventing Hip Fracture: Do Supplements Help?](https://www.center4research.org/preventing-hip-fracture-do-supplements-help/) - Calcium and vitamin D made headlines in the health world when many new studies on the effectiveness and safety of supplements were released. Read more about these nutrients and why you should or should not take supplements.
- [Will Breast Implants Improve Your Life?](https://www.center4research.org/will-breast-implants-improve-life/) - Despite the claims of plastic surgeons that breast implants improve patients’ self-esteem and quality of life, there is no scientific support for those statements.
- [Drugs to Quit Smoking Can Affect Mental and Physical Health: the Truth About Chantix and Zyban](https://www.center4research.org/drugs-quit-smoking-can-affect-mental-physical-health-truth-chantix-zyban/) - Everyone knows that smoking harms health and that the habit is difficult to quit. Unfortunately, some products that help people stop smoking can also be harmful.
- [Spravato for suicidal veterans? What we know and don’t know](https://www.center4research.org/spravato-suicidal-veterans-what-we-know-and-dont-know/) - Is Spravato safe and effective for suicidal veterans? What we know and don’t know
- [Does Online Therapy Work?](https://www.center4research.org/does-online-therapy-work/) - Research has found that online therapy can be effective at treating anxiety, depression, and trauma.
- [Does Transcranial Magnetic Stimulation Work?](https://www.center4research.org/does-transcranial-magnetic-stimulation-work/) - Although transcranial magnetic stimulation (TMS) is a safe treatment, it is not effective for treating depression.
- [Do Lesbians Need Cervical Cancer Screening? What You Need to Know](https://www.center4research.org/do-lesbians-need-cervical-cancer-screening-what-you-need-to-know/) - Lesbians are less likely to get screened for cervical cancer than heterosexual and bisexual women, but cervical cancer screening is recommended for all women with a cervix, including lesbians.
- [Janet Woodcock revolutionized the way the FDA reviews cancer drugs, inspiring her supporters and raising concerns for detractors](https://www.center4research.org/janet-woodcock-revolutionized-the-way-the-fda-reviews-cancer-drugs-inspiring-her-supporters-and-raising-concerns-for-detractors/) - STAT News, March 1, 2021: The FDA is approving more new cancer drugs than ever before, after FDA’s drug chief Janet Woodcock loosened FDA standards. Now cancer doctors are Woodcock’s most vocal backers in her campaign to be FDA Commissioner. But critics say too many approved cancer drugs aren’t proven to help patients live longer.
- [COVID-19: Myths v. Reality](https://www.center4research.org/covid-19-myths-v-reality/) - There is a lot of misinformation about Covid-19 floating around. Here's what you need to know to separate myth from reality.
- [Opinion: Maryland's reopening, especially of sports stadiums, is too soon](https://www.center4research.org/opinion-marylands-reopening-especially-of-sports-stadiums-is-too-soon/) - The Washington Post Letters to the Editor, March 15, 2021: Gov. Larry Hogan (R) is reopening sports stadiums to 50 percent capacity and consulting Dr. Robert Redfield for his COVID-19 response. Both decisions create an enormous opportunity for the coronavirus to spread.
- [The Differences Between the Vaccines Matter](https://www.center4research.org/the-differences-between-the-vaccines-matter/) - The Atlantic, March 7, 2021: Public-health officials are enthusiastic about all 3 COVID-19 vaccines available in the U.S. For example, Virginia’s vaccine coordinator stated, “A hundred percent efficacy against deaths and hospitalizations? That’s all I need to hear.” But experts, including NCHR, point out that there were too few people with severe COVID in the vaccine studies to draw conclusions.
- [Drug Industry Pushes FDA to Solve Growing Inspection Backlog](https://www.center4research.org/drug-industry-pushes-fda-to-solve-growing-inspection-backlog/) - Politico, March 2, 2021: The FDA is under pressure from the pharmaceutical industry to address the growing backlog of drug inspections — nearly a year after Covid-19 prompted the agency to halt most plant visits. From March through September, FDA inspected just three plants outside the U.S. and 52 within the U.S., well below the 600 and 400, respectively in each of the prior two years. NCHR president reports device inspections have also dropped dramatically
- [J&J COVID-19 Vaccine Wins Unanimous Backing of FDA Panel](https://www.center4research.org/jj-covid-19-vaccine-wins-unanimous-backing-of-fda-panel/) - Medscape Medical News: February 26, 2021. An FDA advisory panel lent their support today to a rapid clearance for Janssen/Johnson & Johnson's COVID-19 vaccine, but several researchers expressed concerns to the panel about the lower standards of EUAs, including NCHR’s president Dr. Diana Zuckerman.
- [What you need to know about J&J's newly authorized one-shot COVID-19 vaccine](https://www.center4research.org/what-you-need-to-know-about-jjs-newly-authorized-one-shot-covid-19-vaccine/) - ScienceNews: February 27, 2021. On February 27, the FDA authorized Johnson & Johnson’s COVID-19 vaccine for use in the U.S. The other two authorized vaccines are made by Pfizer and Moderna. None are FDA approved. All show effectiveness, but there are too few serious COVID-19 cases in any of the studies to conclude how well it prevents hospitalizations or deaths.
- [Who Will Be the Next F.D.A. Chief?](https://www.center4research.org/who-will-be-the-next-fda-chief/) - The New York Times: February 20, 2021. One month into his presidency, President Biden still has not named a candidate to head the Food and Drug Administration, a critical position at a time when new vaccines and coronavirus treatments are under the agency’s review. This has spurred a public lobbying campaign by supporters of the two apparent front-runners, Dr. Joshua Sharfstein, a former high-ranking F.D.A. official and Dr. Janet Woodcock, the acting commissioner.
- [Allergan is trying to track down women with breast implants it recalled nearly a year ago](https://www.center4research.org/allergan-is-trying-to-track-down-women-with-breast-implants-it-recalled-nearly-a-year-ago/) - Fortune, June 3, 2020. Allergan has asked small nonprofit organizations to help inform tens of thousands of women that they have a type of breast implant that has been recalled due to increased cancer risks.
- [NCHR Comment on the USPSTF's Draft Recommendations for Ovarian Cancer Screening](https://www.center4research.org/nchr-comments-uspstfs-draft-recommendation-statement-ovarian-cancer-screening/) - August 10, 2017. We strongly support the USPSTF’s draft recommendation to maintain the “D” grade for ovarian cancer screening, as well as their broader efforts to improve the health of all Americans by making evidence-based recommendations about clinical preventive services. As more high-quality research becomes available, we encourage the provision of additional recommendations about the benefits and harms of using new screening strategies in asymptomatic women who are not known to be at increased risk for ovarian cancer.
- [NCHR’s Statement on the Lutonix 014DCB Device](https://www.center4research.org/nchrs-comments-on-the-lutonix-014dcb-device/) - February 17, 2021. There is no reasonable assurance that the Lutonix 014DCB device is effective and therefore no reasonable assurance that the benefits outweigh the risks.
- [FDA blasts Merck's Keytruda data for new breast cancer indication](https://www.center4research.org/fda-blasts-mercks-keytruda-data-for-new-breast-cancer-indication/) - Stat News, February 5, 2021. The cancer drug Keytruda is a medical and financial juggernaut, but it may not win FDA approval for early-stage triple negative breast cancer. FDA medical reviewers agreed there is a need for new treatments, but Keytruda did not impress them with its small benefit of “questionable clinical meaningfulness” and serious safety issues. NCHR’s Dr. Zuckerman said “This is one of the most negative reviews I’ve ever seen.”
- [Covid-19: Should vaccine trials be unblinded?](https://www.center4research.org/covid-19-should-vaccine-trials-be-unblinded/) - BMJ, December 29, 2020. Volunteers in COVID-19 vaccine studies want the vaccine, not placebos, but stopping studies early could be dangerous.
- [New Trump Administration Policies for FDA Under Fire](https://www.center4research.org/new-trump-administration-policies-for-fda-under-fire/) - Medscape, January 15, 2021. New policies will weaken regulations on medical products if the Trump administration passes them before leaving.
- [Patient Safety Advocate Raises Alarm Over HHS/FDA Push That Could Exempt 80+ Devices From Regulation](https://www.center4research.org/patient-safety-advocate-raises-alarm-over-hhs-fda-push-that-could-exempt-80-devices-from-regulation/) - MedTech Insight: January 19, 2021. HHS plans to waive regulatory review of more than 80 different types of medical devices granted, but advocates have concerns.
- [Patients Continue to Be Inadequately Informed of Risk for Breast Implant-Associated ALCL](https://www.center4research.org/patients-continue-to-be-inadequately-informed-of-risk-for-breast-implant-associated-alcl-2/) - Cancer Therapy Advisor, February 8, 2021. Although the risk for breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) has been well-documented, patients considering breast implants continue to be inadequately informed of the propensity for disease development. Awareness of BIA-ALCL has risen since 2020, but adequate safeguards have not yet been put in place, according to experts in the field, including Dr. Diana Zuckerman of the National Center for Health Research and their Cancer Prevention and Treatment Fund.
- [Coronavirus Relief Act Gives Drug Makers New Sway Over FDA](https://www.center4research.org/coronavirus-relief-act-gives-drug-makers-new-sway-over-fda/) - Pogo, May 5, 2020. Under the $2 trillion coronavirus relief law, makers of over-the-counter drugs will pay the FDA to oversee their products and will gain new sway over the consumer protection agency.
- [Tests for COVID-19: Has the FDA said yes too many times?](https://www.center4research.org/tests-for-covid-19-has-the-fda-said-yes-too-many-times/) - The Hill Opinion Contributors, May 6, 2020. Most tests being sold in the U.S. aren’t proven to be accurate by unbiased scientists. Here’s what you need to know.
- [How Effective Is the Mask You’re Wearing? You May Know Soon](https://www.center4research.org/how-effective-is-the-mask-youre-wearing-you-may-know-soon/) - The New York Times, December 16, 2020. A CDC division is working with an industry standards group to create standards for mask safety and effectiveness.
- [A C.D.C. analysis describes anaphylaxis after people have received the Pfizer-BioNTech vaccine as ‘rare’](https://www.center4research.org/covid-vaccine-anaphylaxis/) - NYT, January 9, 2021. Federal health officials say allergic reactions to coronavirus vaccines are rare, but serious, and every site administration vaccines must be prepared to recognize and treat them.
- [Girls and Sports](https://www.center4research.org/female-athletes/) - The American Academy of Pediatrics Committee on Sports Medicine and Fitness recently published a review of the research and information about female athletes. The article summarizes information about eating disorders, menstrual problems, and bone mineral density.
- [What You Need to Know About the Measles and Vaccines](https://www.center4research.org/need-know-measles-vaccines/) - Measles is in the news, and many parents are wondering if their children are at risk. Here is what you need to know.
- [LASIK Surgery: Eye Opening Information On Patient Risk](https://www.center4research.org/lasik-surgery-eye-opening-information-patient-risk/) - LASIK (Laser-Assisted In Situ Keratomileusis) is a surgical procedure intended to improve a person's vision by changing the shape of the cornea and improving the eye's ability to focus. What are the risks, and how do you know if you're a good candidate for the surgery?
- [Congressman calls for FDA to continue vaccine trials](https://www.center4research.org/congressman-calls-for-fda-to-continue-vaccine-trials/) - ABC, December 29, 2020. Rep. Llyod Doggett of Texas wrote to the FDA urging COVID-19 clinical trials to continue until they have more data.
- [Statement of Dr. Diana Zuckerman, resident of Chevy Chase, Maryland and president of the National Center for Health Research](https://www.center4research.org/statement-of-dr-diana-zuckerman-resident-of-chevy-chase-maryland-and-president-of-the-national-center-for-health-research-re-ab-771-abandonment-of-ellsworth-drive-approve-only-with-condition/) - December 23, 2020. Montgomery County should only approve the abadonment of Ellsworth Dr. if they provide a surface other than artificial turf or other artificial rubber products.
- [NCHR Statement about Entresto at FDA Cardiovascular and Renal Drugs Advisory Committee Meeting](https://www.center4research.org/nchr-statement-at-fda-cardiovascular-and-renal-drugs-advisory-committee-meeting-on-entresto/) - December 15, 2020. FDA should not approve this new indication until an adequate number of Black patients have been studied and the results are conclusive for all patients.
- [NCHR's Comments to EPA's Children's Health Protection Advisory Committee](https://www.center4research.org/nchrs-comments-to-epas-childrens-health-protection-advisory-committee/) - We urge the EPA to dedicate more resources towards studying the chemicals and metals contained in artificial turf and playground surfaces, and focus on ensuring that the materials used are safe for children who will be frequently exposed and/or who might be particularly vulnerable because of other health conditions and other exposures.
- [FDA Panel Reviewing Pfizer Vaccine Leaves Out Some Experts Who Raised Concerns](https://www.center4research.org/fda-panel-reviewing-pfizer-vaccine-leaves-out-some-experts-who-raised-concerns/) - POGO, December 9, 2020. FDA's coronavirus vaccine panel did not include experts who raised concerns about Pfizer's data at a previous meeting.
- [C-Section Birth Associated with Numerous Health Conditions](https://www.center4research.org/c-section-birth-health-risks/) - Numerous recent research studies suggest that babies born via C-section are at higher risk for developing medical conditions. In this article, we will summarize recent research and provide you with information you can use to make informed health decisions.
- [Obesity in America: Are You Part of the Problem?](https://www.center4research.org/obesity-america-part-problem/) - Despite our country's obsession with weight and appearance, most people who are medically overweight don't realize it. What we're talking about isn't "love-handles" or a body that doesn't match the supermodels we see in magazines. Instead, we're talking about a weight that affects your health, well-being, and longevity. Our collective weight problem is so bad that only cigarette smoking causes more preventable deaths in America than obesity does.
- [NCHR’s Comments on Colorectal Cancer Screening in Asymptomatic Adults](https://www.center4research.org/nchrs-comments-on-colorectal-cancer-screening-in-asymptomatic-adults/) - November 23, 2020. We support for the United States Preventive Services Task Force’s (USPSTF) draft recommendation statement regarding colorectal cancer screening in asymptomatic adults.
- [New Research Confirms Breast Implant Illness](https://www.center4research.org/new-research-confirms-breast-implant-illness/) - A new study provides clear evidence that most women with these symptoms will recover dramatically if their implants and scar capsules are carefully removed by an experienced explant surgeon.
- [Do Chemicals in Our Environment Cause Weight Gain?](https://www.center4research.org/chemicals-environment-cause-weight-gain/) - Some chemicals that we are exposed to through our food, water, and the products that we use can interfere with our natural hormones, including our sex hormones. Chemicals can cause the body to "think" that it has to store more fat than it actually does, or they can interfere with the processes our bodies use to make fat cells.
- [NCHR Statement at FDA Medical Devices Advisory Committee Meeting on the VisAbility Micro Insert](https://www.center4research.org/nchr-statement-at-fdas-medical-devices-advisory-committee-meeting-on-visability-micro-insert/) - November 9, 2020. The risks for this device are notable, especially considering that it is unnecessary because other, non-invasive and approved treatments are available.
- [Four ways Trump has meddled in pandemic science — and why it matters](https://www.center4research.org/four-ways-trump-has-meddled-in-pandemic-science-and-why-it-matters/) - Nature, November 3, 2020. Donald Trump’s response to the COVID-19 pandemic looms large in the election. One issue that resonates with the research community, including NCHR, is the extent to which the current president and his administration have meddled with science and scientific advice during the pandemic — often with disastrous results.
- [NCHR Statement about Hydexor at FDA Opioid Advisory Committee Meeting](https://www.center4research.org/nchr-statement-about-hydexor-at-fda-opioid-advisory-committee-meeting/) - There is clear evidence that opioid REMS have not worked in the past, and it is not possible to enforce them. NCHR encourages the committee to encourage the FDA to not approve an opioid that has not even been studied for efficacy compared to non-opioid pain meds, given the unproven ability to enforce REMS compliance.
- [How to Cope with Coronavirus Anxiety](https://www.center4research.org/how-to-cope-with-coronavirus-anxiety/) - Anxiety can be scary, but it is possible to overcome it. If you are feeling like you are spinning out of control with anxiety reading the news about the coronavirus, this article can help.
- [Hahn Says FDA Wants Higher Device User Fees](https://www.center4research.org/hahn-says-fda-wants-higher-device-user-fees/) - Politico Pro, October 27, 2020. FDA to raise user fees for medical device makers, but experts caution against relying too heavily on them.
- [Will Covid-19 vaccines save lives? Current trials aren’t designed to tell us](https://www.center4research.org/will-covid-19-vaccines-save-lives-current-trials-arent-designed-to-tell-us/) - October 21, 2020, BMJ. Current Covid-19 vaccine trials don't give the public enough information on whether the vaccine is safe or will work for everyone.
- [HEALTH CARE BRIEFING: FDA Vaccine Rules Challenged as Weak](https://www.center4research.org/health-care-briefing-fda-vaccine-rules-challenged-as-weak/) - Bloomberg Gov, October 23, 2020. Scientists and advocates challenge coronavirus vaccine testing standards at FDA advisory meeting.
- [FDA Vaccine Rules Challenged as Weak at Advisory Panel Meeting](https://www.center4research.org/fda-vaccine-rules-challenged-as-weak-at-advisory-panel-meeting/) - Bloomberg Business, October 23, 2020. We, with other, scientists and advocates criticize weak Covid-19 vaccine standards at FDA Advisory Panel Meeting.
- [FDA Panel To Lay Regulatory Groundwork For COVID-19 Vaccine](https://www.center4research.org/fda-panel-to-lay-regulatory-groundwork-for-covid-19-vaccine/) - NPR, October 22, 2020. Dr. Diana Zuckerman spoke about making sure vaccines aren't rushed through too quickly to be safe at the FDA advisory meeting on Covid-19 vaccine approval.
- [FDA Promises Strong Safety Standards for Covid-19 Vaccines as It Convenes Advisory Panel](https://www.center4research.org/fda-promises-strong-safety-standards-for-covid-19-vaccines-as-it-convenes-advisory-panel/) - WSJ, October 23, 2020. FDA promises strong safety testing for coronavirus vaccines even as current standards criticized at advisory meeting.
- [Third-Hand Smoke](https://www.center4research.org/third-hand-smoke/) - Third-hand smoke is the residue from cigarette smoke that stays on just about every surface exposed to that smoke. The smoke residue clings to hair and fabrics, including clothing, carpets, drapes, and furniture upholstery, and it can cause serious health problems.
- [NCHR Testimony at the FDA about Antibiotic for Inhalation, Cipro DI](https://www.center4research.org/8104-2/) - January 11, 2018. It is important that any drugs should clearly demonstrate efficacy and a good long-term safety profile before they are approved. Cipro DI has clearly not yet met that standard.
- [Polycystic Ovary Syndrome (PCOS): What is It and What are the Signs?](https://www.center4research.org/polycystic-ovary-syndrome-pcos-signs/) - Monthly changes in hormones affect nearly all women. Some of the symptoms are more bothersome or noticeable than others, and sometimes they signal health problems. Studies show that 8% to 13% of women of reproductive age have a condition called polycystic ovary syndrome (PCOS). It can be difficult to diagnose because it is similar to so many other conditions. What is PCOS, and what are the signs?
- [NCHR’s Public Comments on USPSTF’s Draft Research Plan Regarding Screening for Eating Disorders in Adolescents and Adults](https://www.center4research.org/national-center-for-health-researchs-public-comments-on-united-states-preventive-services-task-forces-draft-research-plan-regarding-screening-for-eating-disorders-in-adolescents-and/) - We commend USPSTF’s intention to include studies that assess both the benefits and harms of the screening process for eating disorders. However, we have several suggestions.
- [Study finds removing breast implants improved symptoms](https://www.center4research.org/study-finds-removing-breast-implants-improved-symptoms/) - AzFamily.com, October 1, 2020. The FDA is finally encouraging better information about the risks of cancer, breast implant illness, and other health problems for women considering breast implants. But we agree with patients that the agency could do so much more.
- [First, Their Breast Implants Made Them Sick. Then They Were Hit with the Bill.](https://www.center4research.org/first-their-breast-implants-made-them-sick-then-they-were-hit-with-the-bill/) - Cosmopolitan, August 18, 2020. Insurance companies rarely cover the costs of breast implant removals, even when they make women really sick.
- [How the Coronavirus Pandemic May Affect Cancer Clinical Trials](https://www.center4research.org/how-the-coronavirus-pandemic-may-affect-cancer-clinical-trials/) - Cancer Therapy Advisor, August 18, 2020. The dangers of Covid-19, especially to cancer patients, are upending access to clinical trials for cancer treatments.
- [FDA Updates Breast Implant Labeling Recommendations to Help Inform Patients About Dangerous Potential Side Effects](https://www.center4research.org/fda-updates-breast-implant-labeling-recommendations-to-help-inform-patients-about-dangerous-potential-side-effects/) - Cure, September 29, 2020. Makers of breast implants should include a black box warning about cancer and other serious risks, along with a patient decision checklist for patients to sign, according to final guidance issued by the FDA.
- [NCHR's Comments on the Petition for Extension of Premarket Tobacco Product Application Filing Deadline from Keller and Heckman LLP](https://www.center4research.org/nchrs-comments-comments-on-the-petition-for-extension-of-premarket-tobacco-product-application-filing-deadline-from-keller-and-heckman-llp/) - We strongly oppose the requested extension of the deadline for premarket tobacco product applications (PMTAs), and we urge the FDA to not grant this requested extension.
- [Breast Implant Illnesses: What's the Evidence?](https://www.center4research.org/breast-implant-illnesses-whats-evidence/) - A large meta-analysis of the current cornerstone breast implant illnesses research studies reveals their weaknesses and highlights what is known.
- [NCHR joins Nonprofits in asking FDA to only allow Covid vaccine distribution after phase 3 trials completed](https://www.center4research.org/nchr-joins-nonprofits-in-asking-fda-to-only-allow-covid-vaccine-distribution-after-phase-3-trials-completed/) - August 10, 2020. Experts urge that COVID-19 vaccines are made widely available only after the Food and Drug Administration (FDA) has been able to evaluate safety and efficacy data from completed Phase 3 clinical trials.
- [NCHR Comments on Asymptomatic Carotid Artery Stenosis Screening](https://www.center4research.org/nchr-comments-on-asymptomatic-carotid-artery-stenosis-screening/) - August 31, 2020. We support the USPSTF’s reaffirmation of the “D” grade recommendation first issued in 2014 against screening for asymptomatic carotid artery stenosis in the general adult population.
- [Summary of: Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide](https://www.center4research.org/summary-breast-implants-self-esteem-quality-life-risk-suicide/) - Women's Health Issues, August 2016. Breast augmentation is the most common cosmetic surgery in the US, but studies have shown that suicide rates are higher for women with implants.
- [Seven Ways to Maximize Good Health](https://www.center4research.org/seven-ways-maximize-good-health/) - Following just seven simple principles can make a big difference in helping us maintain our overall health and lowering the probability of developing many of the diseases that are most debilitating and dreaded, like cancer, heart and lung diseases, stroke, and diabetes.
- [Using informatics to guide public health policy during the COVID-19 pandemic in the USA](https://www.center4research.org/using-informatics-to-guide-public-health-policy-during-the-covid-19-pandemic-in-the-usa/) - There are many conflicting views about how to get the Covid-19 pandemic under control in the U.S. Our study in the Journal of Public Health, published in July 2020, explains how experts can use existing datasets and analytical tools to evaluate the risks of different policies, and determine the resources and policies needed to save lives during this pandemic and any future pandemics
- [Public health experts want rigorous FDA review of Covid vaccine data](https://www.center4research.org/public-health-experts-want-rigorous-fda-review-of-covid-vaccine-data/) - Politico, August 7, 2020. A letter to FDA Commissioner Stephen Hahn argues that FDA should allow the distribution of a future coronavirus vaccine only after evaluating safety and effectiveness data from completed Phase 3 trials.
- [Lyme Disease: The Signs and Symptoms You Need to Know](https://www.center4research.org/lyme-disease-the-signs-and-symptoms-you-need-to-know/) - Lyme disease is a bacterial infection caused by ticks. Lyme disease infects approximately 300,000 people in the United States each year according to the Centers for Disease Control and Prevention (CDC). However, some experts believe that the number is much higher since only 30% of patients develop the bull’s-eye rash that is the well-known early sign of the disease. While most patients recover from Lyme disease with a course of antibiotics, some experience persistent symptoms. Researchers are unsure of why some patients do not fully recover from Lyme disease, making it difficult to treat.
- [NCHR Testimony at FDA on Esketamine for Treatment Resistant Depression](https://www.center4research.org/9850-2/) - February 12, 2019. The data from the clinical trials for esketamine nasal spray are encouraging, but there are still important questions concerning its safety and efficacy.
- [Nips, Tucks, and...Designer Vaginas? Hype or Help?](https://www.center4research.org/nips-tucks-designer-vaginas/) - Variations in the natural female form used to be accepted, even celebrated. Increasingly, however, these variations are seen not as assets, but as problems to be taken care of by plastic surgeons. Amongst many cosmetic surgeries, "genital rejuvenation" is growing in popularity. Does this procedure work, and what does the future hold for such genital plastic surgeries?
- [NCHR's Public Comments on USPSTF's Draft Recommendation Statement Regarding Lung Cancer Screening](https://www.center4research.org/nchrs-public-comments-on-uspstfs-draft-recommendation-statement-regarding-lung-cancer-screening/) - Although we agree that the evidence suggests that the recommended changes in screening ages and pack-year history will lead to fewer lung cancer deaths, we have several suggestions for USPSTF to consider.
- [NCHR joins Nonprofits in criticizing White House blocking CDC from sharing Covid-19 data](https://www.center4research.org/nchr-joins-nonprofits-in-criticizing-white-house-blocking-cdc-from-sharing-covid-19-data/) - July 23, 2020. Nonprofit coalition asks Sec. Azar to rescind guidance to stop reporting coronavirus data to CDC and send it only to HHS.
- [Antibiotic-Resistant Bacteria: MRSA and C. diff](https://www.center4research.org/antibiotic-resistant-bacteria-mrsa-c-diff/) - Janet Phoenix MD MPH, Amanda Bisnath, Megan Peterson, Elizabeth Sack Since the discovery of the first antibiotic, penicillin, in 1928, antibiotics and antimicrobial drugs have been widely used in the United States. Over time, some bacteria have developed ways to survive these drugs. Unfortunately, the widespread use of antibiotics has contributed to the development of
- [What to Know About Transgender Medical Transitioning: Female to Male](https://www.center4research.org/what-to-know-about-transgender-medical-transitioning-female-to-male/) - This article will specifically examine the medical treatment options in the female to male transgender transition process.
- [What to Know About Transgender Medical Transitioning: Male to Female](https://www.center4research.org/what-to-know-about-transgender-medical-transitioning-male-to-female/) - This article will specifically examine the medical treatment options in the male to female transgender transition process.
- [NCHR Comments on USPSTF’s Draft Recommendation Regarding Screening for Hypertension in Adults](https://www.center4research.org/nchr-comments-on-uspstfs-draft-recommendation-regarding-screening-for-hypertension-in-adults/) - July 20, 2020. We support USPSTF’s reaffirmation of the 2015 recommendation statement on screening for high blood pressure in adults based on new scientific evidence and agree with USPSTF’s ‘A’ grade.
- [Can Cleanliness Increase the Risk of Allergies and Asthma?](https://www.center4research.org/can-cleanliness-increase-risk-allergies-asthma/) - Is being too clean bad for your health? Research indicates that some of the products we use to avoid germs may contribute to the development of conditions like asthma and allergies.
- [Rock-a-bye Baby, Chemicals and All: the Health Risks Posed by Crib Mattresses](https://www.center4research.org/rock-bye-baby-chemicals-health-risks-posed-crib-mattresses/) - In recent years, the safety regulations for cribs have increased yet little attention has been given to the safety of crib mattresses. A 2011 study finds that an alarming number of mattresses contain chemicals that may pose serious health risks for infants.
- [Birth Control Pills: What You Need to Know](https://www.center4research.org/birth-control-pills-need-know/) - Understanding how birth control pills work and how the FDA determines whether they are safe and effective can help demystify the process of choosing the birth control pill that is right for you.
- [Swimming Pool Safety: Don’t Pee in the Pool (It’s Worse than Gross!)](https://www.center4research.org/swimming-pool-safety-dont-pee-pool-worse-gross/) - Swimming is a healthful and fun activity that many people enjoy, but a few tips can make swimming safer and healthier for everyone.
- [What Everyone with Type 2 Diabetes Should Know](https://www.center4research.org/everyone-type-2-diabetes-know/) - Talk with your doctor about the blood sugar goal range that is best for you, considering your lifestyle, other health considerations, and preferences. Read this article carefully to educate yourself about the risks of different diabetes medications before you talk with your doctor about the risks and benefits of each choice and how they might affect you. Consider the medical histories of your parents and siblings, since that can influence your health risks as well. Ask questions until you feel confident that you understand all the possible options.
- [Traumatic Brain Injury and Post-Traumatic Stress Disorder in Military Veterans: When Two Problems Collide](https://www.center4research.org/traumatic-brain-injury-post-traumatic-stress-disorder-military-veterans-two-problems-collide/) - Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that can occur as a result of experiencing a traumatic event. The symptoms of PTSD may include being constantly on-edge, frequently having a short temper, reliving the traumatic event through flashbacks or bad dreams, avoiding things related to the traumatic event, or losing interest in previously enjoyable activities. In people with PTSD, these symptoms last for more than a few weeks and become disruptive to the person’s daily living.
- [Treatments for Stress Incontinence in Women](https://www.center4research.org/treatments-stress-incontinence-women/) - While stress incontinence may feel embarrassing or demoralizing, remember that it is a medical condition that affects millions of women, and it can be lessened or cured without invasive surgery. Since Kegel exercises are the simplest, safest, and most effective treatment, it should be tried first, but must be done regularly. In fact, Kegel exercises alone, when performed correctly, daily, and for at least six weeks, are extremely likely to reduce symptoms. In the meantime, you can help reduce your symptoms by scheduling regular bathroom breaks, wearing an absorbent liner, or losing weight if you need to.
- [Should You Consider a Birth Control Patch?](https://www.center4research.org/birth-control-patch/) - When choosing a method of birth control, most women want what is the most effective and convenient. Women who want "hormonal" birth control can choose a pill, patch, injection, or vaginal ring, yet not all of these options have equal risks. In fact, the Patch, Ortho Evra, is now shown to put women at greater risks than birth control pills did by exposing women to high levels of estrogen. But, how does Ortho Evra work, and why is it more dangerous than other forms of birth control?
- [Breast Cancer Patients: Breast Reconstruction Options](https://www.center4research.org/breast-cancer-patients-keeping-reconstructing-breasts/) - FAQs about keeping or restructuring your breasts after breast cancer treatment.
- [Marijuana Use Among Youth](https://www.center4research.org/marijuana-use-among-youth-2/) - Marijuana use
- [Growing Up Too Fast: Premature Sexual Development in Boys](https://www.center4research.org/boys-to-men/) - The early sexual development of girls has received tremendous media attention, but there has been no similar attention to boys. A 2012 study of signs of puberty among boys between 8 and 19 may change that, because it shows that early puberty is also happening among boys.
- [Fracking and Your Health](https://www.center4research.org/fracking-your-health/) - Hydraulic fracturing or “fracking” has boomed in the last few years and is now producing most of the natural gas in the U.S. It is praised as helping the U.S. be more “energy independent” and has lowered the cost of natural gas. But, the controversy is whether it can harm our health, especially for people who live near the drilling sites.
- [Is Play on the Endangered List?](https://www.center4research.org/play-endangered-list/) - Building with blocks, playing house, a game of tag...Most of us have fond childhood memories that include these and similar kinds of play. But unstructured play-the activities, games, and "make-believe" that children themselves come up with and engage in, either alone or in groups, is fast becoming extinct.
- [Less Sex, More Condoms, Fewer Teen Births](https://www.center4research.org/less-sex-condoms-fewer-teen-births/) - According to a report from Child Trends, it really is good news: since the early 1990's teens have been less likely to have sex and more likely to use contraceptives when having sex for the first time.
- [Another Reason to Keep the Weight Off: Knee Pain and the Risk of Surgery](https://www.center4research.org/another-reason-keep-weight-off-knee-pain-risk-surgery/) - When it comes to knees giving out or having problems, it turns out that excess weight is just as bad as or maybe worse than getting older. Changes in diet and exercise can reduce your pain and help you avoid or delay surgery.
- [Steroid Injections May do Harm and do No Good for Joint Pain](https://www.center4research.org/steroid-injections-joint-pain/) - A 2017 study showing that steroid injections are not helpful for joint pain finally confirms what many researchers have been saying for years.
- [Gastric Lap-Bands: What You Need to Know](https://www.center4research.org/gastric-lap-bands-need-know/) - Lap-Bands help many people lose weight rather dramatically - some lose 50-100 pounds in the first 6 months or year. Are Lap-Bands a lasting solution to obesity? Not necessarily. Are they safe? Often they aren't.
- [Can Sleeping Pills Cause Cancer?](https://www.center4research.org/trouble-sleeping-pills-not-safe-solution/) - A compelling 2018 study suggests that people who take sleeping pills are at an increased risk of dying or developing cancer within the next 2 and a half years.
- [Honey: The Sweetest Medicine?](https://www.center4research.org/honey-sweetest-medicine/) - Parents of children who are coughing due to a cold or flu may want to try using honey to relieve their children's symptoms. A 2012 study suggests that giving children honey before bedtime can give them relief and help them (and their parents!) get a good night of sleep.
- [Adolescents, Celebrity Worship, and Cosmetic Surgery](https://www.center4research.org/adolescents-celebrity-worship-cosmetic-surgery/) - A study shows that media portrayals of celebrities influence how adolescents feel about their looks and influence their decisions to undergo cosmetic surgery. Young adults are not just mimicking the clothing and hairstyles of their favorite celebrities, but rather undergoing invasive procedures to feel better about how they look.
- [Exposure to Heavy Metals and Fertility: What a Couple Should Know](https://www.center4research.org/exposure-heavy-metals-fertility-couple-know/) - Are you or someone you love trying to start a family or have another baby? A study suggests that when men or women are exposed to heavy metals in their environment it can make it more difficult for a woman to get pregnant. We should be aware of the ways we come into contact with these metals, and limit our exposure. Taking a few preventative measures today might make it easier to get pregnant and have a healthy baby.
- [Unnecessarily Invasive Breast Biopsies](https://www.center4research.org/unnecessarily-invasive-breast-biopsies/) - A study by physicians at the University of Florida has found that doctors are performing unnecessarily high numbers of open surgical biopsies, instead of biopsy procedures that are as effective but less invasive.
- [When Silence Means Violence](https://www.center4research.org/silence-means-violence/) - Some kids seem like obvious troublemakers, but many youth workers have found out the hard way to also pay attention to quiet kids. Children who were victimized by peers were more likely to have violent fantasies, which in turn predicted aggressive behavior.
- [The NHL moves north for its restart, shifting to Canada as U.S. struggles with pandemic](https://www.center4research.org/the-nhl-moves-north-for-its-restart-shifting-to-canada-as-u-s-struggles-with-pandemic/) - The Washington Post, July 11, 2020. As the NHL tries to resume play and crown a Stanley Cup champion by early October, it is also shifting its operations to Canada.
- [Is Newer and More Expensive Care Better?](https://www.center4research.org/newer-expensive-care-better/) - You get what you pay for, right? Many people assume that more expensive care is superior. However, care that is far less expensive is sometimes just as good or even better.
- [Media, Kids, and Violence](https://www.center4research.org/media-kids-violence/) - Violent media can have negative effects on children. What does the research have to say and what can you do about it?
- [Are Antiperspirants Safe?](https://www.center4research.org/are-antiperspirants-safe/) - A widely circulating e-mail article claims that antiperspirant use causes breast cancer. The e-mail says that since antiperspirants prevent your body from sweating out toxins, the toxins then build up in your lymph nodes and result in breast cancer. However, these claims are NOT correct.
- [Breast Surgery Likely to Cause Breastfeeding Problems](https://www.center4research.org/breast-surgery-likely-cause-breastfeeding-problems/) - According to the Institute of Medicine (IOM), any kind of breast surgery, including breast implant surgery, makes it at least three times more likely that a woman trying to breastfeed will have an inadequate milk supply. A number of studies have revealed this concerning information.
- [Youth Violence in Rural Areas](https://www.center4research.org/youth-violence-rural-areas/) - A study of rural youth violence found important similarities and one important difference in the community characteristics that predict youth violence.
- [Risk Factors and Warning Signs for Youth Suicide: Smoking, Drinking, Marijuana, Family Problems, Sexual Orientation, and School-Performance](https://www.center4research.org/risk-factors-warning-signs-youth-suicide-smoking-drinking-marijuana-family-problems-sexual-orientation-school-performance/) - Why do kids kill themselves and what are some of the warning signs? A 2001 study reveals some predictable findings, and some surprises.
- [Teen Mothers as Targets for Violence](https://www.center4research.org/teen-mothers-targets-violence/) - It is well-known that teen pregnancy puts girls at risk for a lifetime of poverty, but a 2002 study shows that teen mothers are also at high risk of being abused by their boyfriends or husbands in the months after their baby is born.
- [Is There a Youth Violence Epidemic?](https://www.center4research.org/youth-violence-epidemic/) - Youth Today, November 1999 - November 2004. Berkeley professor Franklin Zimring concludes that youth crime is not increasing, and that punitive public policies are based on fears rather than facts.
- [Tale of Two Studies: What Causes Teen Pregnancy, Violence, and Drug Use?](https://www.center4research.org/tale-two-studies-causes-teen-pregnancy-violence-drug-use/) - This study has important implications for all parents and adults who work with youth. To get the whole picture, we describe two versions of the study: one that was published in a public health journal, and another that was aimed at the media and the public.
- [Another Reason Not to Smoke](https://www.center4research.org/another-reason-not-smoke/) - Smokers tell you that smoking calms them down, but a 2000 study finds that adolescents who smoke are more likely to suffer from phobias, panic attacks, and other serious anxiety problems as young adults.
- [Mercury in Your Favorite Snacks?](https://www.center4research.org/mercury-in-your-favorite-snacks/) - There could be mercury in many snacks sweetened with high fructose corn syrup: soft drinks, yogurt, cookies, ice cream, salad dressing, and even soup.
- [Cancer Researchers with Industry Ties Report “Rosier” Results](https://www.center4research.org/cancer-researchers-industry-ties-report-rosier-results/) - With all of the cancer studies being performed today, how can consumers be sure of their accuracy? A study by Dr. Reshma Jagsi at the University of Michigan and her colleagues indicates that cancer studies are more likely to have positive results when the researchers have ties to the company that makes the product being studied. With nearly one-quarter of relevant research articles disclosing a conflict of interest, this causes reason for concern.
- [New study backs breast implant illness claims by patients](https://www.center4research.org/new-study-backs-breast-implant-illness-claims-by-patients/) - International Consortium of Investigative Journalists, July 2, 2020. A study in a leading plastic surgery journal offers more evidence to support the existence of breast implant illness, a malady reported by thousands of women but dismissed as scientifically unproven by many plastic surgeons and some health authorities.
- [Is Fetroja a Good Choice for Treating Complicated Urinary Tract Infections (cUTI)?](https://www.center4research.org/is-fetroja-a-good-choice-for-treating-complicated-urinary-tract-infections-cuti/) - Fetroja is a new antibiotic to treat complicated urinary tract infections (cUTI). However, we have concerns about the drug because FDA approval was based on two clinical trials that raised questions about safety and effectiveness that were not answered.
- [MLB gambled by converting PED lab to coronavirus testing. But will it work?](https://www.center4research.org/mlb-gambled-by-converting-ped-lab-to-coronavirus-testing-but-will-it-work/) - The Washington Post, July 10, 2020. MLB’s testing process has been beset by problems, threatening to undermine players’ confidence in the safety of playing under these trying circumstances.
- [MLB’s return plan mirrors the Bundesliga’s. The key difference? It’s in the U.S., not Germany.](https://www.center4research.org/mlbs-return-plan-mirrors-the-bundesligas-the-key-difference-its-in-the-u-s-not-germany/) - Washington Post, June 3, 2020. There are lots of challenges facing major league baseball’s efforts to avoid the coronavirus. We explain that one of the biggest challenges are the hot spot states where baseball teams are supposed to play.
- [DOT Wants to Weaken Its Own Power to Penalize Airlines Over Consumer Complaints](https://www.center4research.org/dot-wants-to-weaken-its-own-power-to-penalize-airlines-over-consumer-complaints/) - Fair Warning, July 1, 2020. Are airlines doing all they should to make flying safe again? Filling every seat is not a good idea, and that’s just one of many problems that make flying and buying airline tickets risky.
- [Women with Breast Implants Should Not Need to Wait for Safety Information They Urgently Need](https://www.center4research.org/women-with-breast-implants-should-not-need-to-wait-for-safety-information-they-urgently-need/) - Our Bodies, Ourselves, July 1, 2020. In response to the demands of thousands of breast implant patients, the FDA proposed that a black box warning be affixed to all implant packages to inform women and their doctors about the most serious risks of breast implants.
- [We can’t ever go to the doctor with our guard down’: Why Black women are 40% more likely to die of breast cancer](https://www.center4research.org/we-cant-ever-go-to-the-doctor-with-our-guard-down-why-black-women-are-40-more-likely-to-die-of-breast-cancer/) - Fortune Magazine: June 30, 2020 Black Americans are dying from the COVID-19 pandemic at a disproportionately high rate, and are also much more likely to die from many other health problems. Black women are less likely to develop breast cancer but 40% more likely to die from it than White women. The reasons behind this awful disparity are wide-ranging, and include systemic problems both within healthcare and far beyond it.
- [NCHR's Comments on USPSTF’s Draft Recommendation Statement for Tobacco Smoking Cessation in Adults, Including Pregnant Persons](https://www.center4research.org/nchrs-comments-on-uspstfs-draft-recommendation-statement-for-tobacco-smoking-cessation-in-adults-including-pregnant-persons/) - We strongly agree with the USPSTF’s recommendation that all physicians ask their adult patients and pregnant patients about their tobacco use. However, encourage the USPSTF to consider two suggestions that would strengthen this recommendation.
- [Will MLB’s health and safety plan hold up once baseball returns? It’ll be a tough task.](https://www.center4research.org/will-mlbs-health-and-safety-plan-hold-up-once-baseball-returns-itll-be-a-tough-task/) - The Washington Post, June 24, 2020. Major League Baseball’s 2020 operations manual has strict, detailed instructions in the ball park, but Conduct Outside of Club Facilities, "feels vague and potentially problematic," according to multiple public health experts who reviewed the manual.
- [NCHR's Testimony to FDA on Pediatric Development Plans for Oncology Indications](https://www.center4research.org/nchrs-testimony-to-fda-on-pediatric-development-plans-for-oncology-indications/) - When evaluating drugs for pediatric use, doses must be scrutinized cautiously for children of different ages and weights. Even when there are likely benefits for children on average, it is important to minimize risks whenever possible by determining which children are most and least likely to benefit.
- [NCHR's Comments on CPSC's Proposed Safety Standards for Crib Bumpers/Liners](https://www.center4research.org/nchrs-comments-on-cpscs-proposed-safety-standards-for-crib-bumpers-liners/) - We strongly urge the CPSC to ban the sale of crib bumpers and liners. The known risks of crib bumpers far outweigh any potential benefits. While these products have not demonstrated any clear benefits, there is evidence that they can cause serious injury, including death.
- [What Does Research Tell Us about Who is Most Likely to Die from COVID-19?](https://www.center4research.org/what-does-research-tell-us-about-who-is-most-likely-to-die-from-covid-19/) - A study published in May 2020 in the prestigious medical journal, Lancet confirmed that the biggest risk factor for severe illness due to COVID-19 is old age.
- [NCHR’s Comments on USPSTF’s Draft Research Plan for Cardiovascular Disease Prevention](https://www.center4research.org/nchrs-comments-on-uspstfs-draft-research-plan-for-cardiovascular-disease-prevention/) - June 8, 2020. We support the US Preventive Services Task Force’s efforts to update recommendations based on new scientific evidence.
- [New Warnings on Singulair Allergy and Asthma Drug](https://www.center4research.org/new-warnings-on-singulair-allergy-and-asthma-drug/) - Due to its psychiatric side effects, the FDA advises that Singulair should not be the first choice treatment for mild allergies, and healthcare providers should weigh the potential risks and benefits before prescribing Singulair for asthma.
- [CRS: Congress Can Rein In FDA’s Flexible COVID-19 Vaccine Trial Policies](https://www.center4research.org/congress-can-rein-fda-covid19-vaccine-trial-policies/) - Inside Health Policy, June 03, 2020. The Congressional Research Service says Congress could rein in FDA’s COVID-19 policies by passing a law, and NCHR explains why that is a good idea.
- [Hahn Defends Using Less 'Robust' Data During COVID, But Critics Contend It Has Gone Too Far](https://www.center4research.org/hahn-defends-using-less-robust-data-during-covid-but-critics-contend-it-has-gone-too-far/) - Informa Pharma Intelligence, June 04, 2020. NCHR asserts that anecdotes are not data sets, this problematic situation can been seen in new drugs for coronavirus.
- [NCHR's Comments on USPSTF’s Draft Recommendation Statement Regarding Screening for Hepatitis B Virus Infection](https://www.center4research.org/nchrs-comments-on-uspstfs-draft-recommendation-statement-regarding-screening-for-hepatitis-b-virus-infection/) - June 1, 2020. We agree with the “B” grade to recommend hepatitis B virus infection screening in nonpregnant adolescents and adults at an increased risk for infection.
- [NCHR's Public Comments on United States Preventive Services Task Force’s Draft Research Plan on Screening for Depression, Anxiety, and Suicide Risk in Children and Adolescents](https://www.center4research.org/nchrs-public-comments-on-united-states-preventive-services-task-forces-draft-research-plan-on-screening-for-depression-anxiety-and-suicide-risk-in-children-and-adolescents/) - We agree that it is very important to examine whether screening programs for depression, anxiety, and increased risk of suicide accurately identify children and adolescents with those conditions, as well as whether screening leads to improved health outcomes among children and adolescents. We agree that it is equally important to assess the potential harms of screening and treatment. There are, however, three points that we suggest should be re-examined in the draft research plan.
- [Amid conflict-of-interest criticisms, top FDA officials recuse themselves from Covid-19 vaccine approvals](https://www.center4research.org/amid-conflict-of-interest-criticisms-top-fda-officials-recuse-themselves-from-covid-19-vaccine-approvals/) - Stat News, May 19, 2020. Two FDA officials recuse themselves from COVID-19 vaccine approvals because of conflicts of interest.
- [MLB, players’ union are working to salvage season, and the next two weeks are critical](https://www.center4research.org/mlb-players-union-are-working-to-salvage-season-and-the-next-two-weeks-are-critical/) - The Washington Post, May 22, 2020. The MLB & players’ union are working to salvage the baseball season and NCHR explains why the plan is too risky for players.
- [A Patient’s Guide to Telemedicine](https://www.center4research.org/a-patients-guide-to-telemedicine/) - Drugwatch, May 20, 2020. NCHR advises Drugwatch about preparing ahead of time for telemedicine visits in order to make the best out of the appointment.
- [FDA Warns Allergan Over Breast Implant Studies](https://www.center4research.org/fda-warns-allergan-over-breast-implant-studies/) - International Consortium of Investigative Journalists, May 19, 2020. The FDA warns Allergan over failure to complete breast implant studies.
- [How MLB is navigating the coronavirus pandemic to play ball](https://www.center4research.org/how-mlb-is-navigating-the-coronavirus-pandemic-to-play-ball/) - ESPN, May 19, 2020. We explain to ESPN the importance of quarantining and social distancing, even in a time where sporting events will start to reopen.
- [‘They killed her’: Why are breast implants still putting millions of women at risk?](https://www.center4research.org/they-killed-her-why-are-breast-implants-still-putting-millions-of-women-at-risk/) - Fortune, May 18, 2020. Breast implants and the other “medical aesthetics” products that are driving profits are also endangering women’s health.
- [NCHR's Comments on USPSTF’s Draft Recommendation Statement Regarding Screening for High Blood Pressure in Children and Adolescents](https://www.center4research.org/nchrs-comments-on-uspstfs-draft-recommendation-statement-regarding-screening-for-high-blood-pressure-in-children-and-adolescents/) - We agree that screening should not be recommended without sufficient evidence that it helps prevent negative health outcomes.
- [NCHR's Comments on EPA’s Supplemental Notice of Proposed Rulemaking on Strengthening Transparency in Regulatory Science](https://www.center4research.org/nchrs-comments-on-epas-supplemental-notice-of-proposed-rulemaking-on-strengthening-transparency-in-regulatory-science/) - There is no legitimate scientific basis for this proposal. It fails to improve transparency among the broader scientific community or between EPA and the public. We therefore strongly urge the rejection of this proposed rule and its expansions under the supplemental proposal.
- [You Can't Travel, but You Can Vacation at Home](https://www.center4research.org/you-cant-travel-but-you-can-vacation-at-home/) - AARP, May 12, 2020. In times of coronavirus stress, here are ideas for a relaxing home-cation, because everyone needs time off.
- [What You Need to Know About the Malaria Drugs Trump Keeps Touting](https://www.center4research.org/what-you-need-to-know-about-the-malaria-drugs-trump-keeps-touting/) - Politico: April 6, 2020. The Trump administration is pushing ahead with a plan to “surge” the malaria drug hydroxychloroquine to coronavirus hot zones around the country, despite clear harms, including blindness and heart failure, and interactions with common medications.
- [FDA Grants Experimental Coronavirus Drug Benefits For Rare Disease Treatments](https://www.center4research.org/fda-grants-experimental-coronavirus-drug-benefits-for-rare-disease-treatments/) - NPR, March 25, 2020. FDA gives possible new drug to treat coronavirus orphan drug status, despite the fact that more than 200,000 people will ultimately get coronavirus.
- [NCHR Comments on Public Access to Federally Funded Research](https://www.center4research.org/nchr-comments-on-public-access-to-federally-funded-research/) - May 6, 2020. In this comment, we will focus on two issues: 1) Access to peer-reviewed scholarly publications and 2) Access to data for analysis.
- [Are Processed Red Meats More Unhealthy than Other Red Meats? What About Other Processed Foods?](https://www.center4research.org/processed-red-meats-less-healthy/) - Doctors tell you to not eat too much red meat or processed foods, but research shows processed red meats, like bacon and hot dogs, are the biggest problem.
- [NCHR Comments on Laparoscopic Power Morcellators](https://www.center4research.org/nchr-comments-on-laparoscopic-power-morcellators/) - April 27, 2020. We are disappointed that the FDA’s plan to update the 2014 recommendations for the labeling of laparoscopic power morcellators (LPMs) does not adequately strengthen the warnings.
- [National Center for Health Research’s Public Comments on Simplifying Meal Service and Monitoring Requirements in the National School Lunch and School Breakfast Programs](https://www.center4research.org/national-center-for-health-researchs-public-comments-on-simplifying-meal-service-and-monitoring-requirements-in-the-national-school-lunch-and-school-breakfast-programs/) - The recently proposed changes would drastically weaken school nutrition by creating large loopholes in school nutrition requirements. Despite claiming that the goal is to offer “greater ability to offer wholesome, nutritious, and appealing meals to students,” the result of these guidelines would be to seriously harm children's access to healthy food options. Therefore, we strongly disagree with the proposed changes to school nutrition requirements.
- [NCHR Comments on the USPSTF's Draft Recommendation Statement and Evidence Review on Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Fractures in Adults](https://www.center4research.org/nchr-comments-uspstfs-draft-recommendation-statement-evidence-review-vitamin-d-calcium-combined-supplementation-primary-prevention-fractures-adults-2/) - October 23, 2017. After reviewing the available evidence, the USPSTF proposed new recommendations on the use of Vitamin D, Calcium, or combined supplementation for the primary prevention of fractures. The USPSTF proposes that evidence is insufficient to determine the balance of harms and benefits; however, a thorough review of the evidence shows surprising associated harms. Read on to learn more about this most important issue.
- [NCHR Support for IG Removal Protections](https://www.center4research.org/nchr-support-for-ig-removal-protections/) - April 10, 2020. NCHR signed on to this letter to express our grave and urgent concern for the independence of federal inspectors general.
- [Dietary Supplements Before and During Chemotherapy](https://www.center4research.org/dietary-supplements-before-and-during-chemotherapy/) - People think of dietary supplements as a no-risk insurance policy to improve nutrition, but a study published in 2020 shows that supplements can have risks if you are undergoing chemotherapy.
- [How to Practice Social Distancing and Stay Sane Doing It](https://www.center4research.org/how-to-practice-social-distancing-and-stay-sane-doing-it/) - Oprah Magazine, March 18, 2020. We tell Oprah Magazine how to practice social distancing and how to also stay sane during the coronavirus outbreak.
- [Here's how to get a coronavirus test in New York City if you're feeling sick](https://www.center4research.org/heres-how-to-get-a-coronavirus-test-in-new-york-city-if-youre-feeling-sick/) - Business Insider, March 20, 2020. With the rise of coronavirus cases across the United States, the demand for testing is rapidly increasing. Unfortunately, those with more fame and money are more likely to gain access to testing due to this shortage.
- [Celebrities Are Getting Coronavirus Tests Faster Than Everyone Else](https://www.center4research.org/celebrities-are-getting-coronavirus-tests-faster-than-everyone-else/) - Insider, March 13, 2020. We explain why celebrities have been tested for coronavirus before sick patients who need a diagnosis.
- [New FDA Virus-Test Policy Could Boost Availability, But Reduce Reliability](https://www.center4research.org/new-fda-virus-test-policy-could-boost-availability-but-reduce-reliability/) - Wall Street Journal, March 17, 2020. The new FDA virus-test policy could help east shortage of tests, but may lead to inaccurate results.
- ['Bad advice from the president': Trump touts unproven coronavirus drugs](https://www.center4research.org/bad-advice-from-the-president-trump-touts-unproven-coronavirus-drugs/) - Politico: March 20, 2020. We find that the president's suggested programs allowing the administration to get experimental drugs to people quickly outside of clinical trials is bad advice.
- [What Would Impact of 21st Century Cures Act be on Your Healthcare Costs and the Lives of Alzheimer's Patients?](https://www.center4research.org/impact-21st-century-cures-act-healthcare-costs-lives-alzheimers-patients/) - The BMJ, November 23, 2015. A controversial proposed new health law would have had a terrible impact on the lives of Alzheimer’s patients and their families, who would have spent billions on medications that don’t work and can cause cancer.
- [NCHR's Comments on Cyramza for Metastatic Lung Cancer at FDA Oncologic Drugs Advisory Committee Meeting](https://www.center4research.org/nchrs-comments-on-cyramza-for-metastatic-lung-cancer-at-fda-oncologic-drugs-advisory-committee-meeting/) - February 26, 2020. We oppose approval of this indication of Cyramza without evidence that it improves overall survival enough to outweigh the risk for adverse events and reduced quality of life.
- [FDA considers black box warning for all breast implants](https://www.center4research.org/fda-considers-black-box-warning-for-all-breast-implants/) - WCPO Cincinnati, February 09, 2020. The FDA may finally require blackbox warnings for women considering breast implants, due to complications connected to implants after a mastectomy.
- [NCHR's Comments on USPSTF's Draft Research Plan for Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Risk Factors](https://www.center4research.org/nchrs-comments-on-uspstfs-draft-research-plan-for-healthful-diet-and-physical-activity-for-cardiovascular-disease-prevention-in-adults-without-known-risk-factors/) - We support USPSTF’s efforts to update existing recommendations based on new research. Although we applaud many aspects of the draft research plan, it would benefit from including several additional analyses.
- [NCHR Signature on AB 1989 Opposition Letter](https://www.center4research.org/nchr-signature-on-ab-1989-opposition-letter/) - March 11, 2020. We oppose, unless amended AB 1989, the Menstrual Product Right to Know Act of 2020. Unlike cleaning products, less is known about the manufacture, ingredients and potential health impacts of menstrual products. People using menstrual products have the right to avoid exposures that will lead to allergic reactions.
- [What You Need to Know About Acetaminophen](https://www.center4research.org/need-know-acetaminophen/) - Acetaminophen is one of the most commonly used drugs in the United States. It is used as a fever-reducer and as a pain reliever, and can be found in many common over-the-counter (OTC) products, including Tylenol, Alka-seltzer, Nyquil, and many cold and flu medicines. When used as directed, there is little danger. However, taking too much can have serious health consequences, and children in particular are at high risk.
- [NCHR's Comments on the Agency for Healthcare Research and Quality’s Technical Brief on Strategies for Patient, Family, and Caregiver Engagement](https://www.center4research.org/nchrs-comments-on-the-agency-for-healthcare-research-and-qualitys-technical-brief-on-strategies-for-patient-family-and-caregiver-engagement/) - March 2, 2020. While we commend the Technical Brief’s aim to outline the currently available evidence on patient and family engagement strategies for managing chronic conditions, we have several suggestions.
- [NCHR Comments on FDA's OMHHE Strategic Priorities](https://www.center4research.org/nchr-comments-on-fdas_omhhe_strategic_priorities/) - February 28, 2020. Efforts to improve inclusion of racial and ethnic minority populations in clinical trials need to include incentives that are more effective than merely asking companies to do so. Greater diversity would, in turn, improve the generalizability of clinical trial results and provide patients and health care professionals with the information necessary to make an informed decision about which products to use for which patients.
- [VA Will Restrict Use of New Nasal Antidepressant](https://www.center4research.org/va-will-restrict-use-of-new-nasal-antidepressant/) - Lev Facher and Ed Silverman, STAT News; June 21, 2019 WASHINGTON — A Department of Veterans Affairs committee has declined to approve widespread coverage of a new depression treatment that has generated controversy but also received an express endorsement from President Trump. Instead, the drug was approved on a more limited basis. Many experts have
- [No Shortage of Controversies for New FDA Commissioner](https://www.center4research.org/no-shortage-of-controversies-for-new-fda-commissioner/) - The Wall Street Journal, January 29, 2020. New FDA Commissioner Stephen Hahn faces tug of war over controversial issues in health, including e-cigarettes, stem-cell research, and the use of cannabidiol (CBD).
- [NCHR's Testimony to FDA on TOOKAD to Treat Low-Risk Prostate Cancer](https://www.center4research.org/nchrs-testimony-to-fda-on-tookad-to-treat-low-risk-prostate-cancer/) - February 26, 2020. The long-term complications of TOOKAD to treat low-risk prostate cancer are unclear. We believe that better research needs to be completed before approval, especially because the sponsor did not comply with FDA's recommendations for the study.

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- [Products with Health Risks](https://www.center4research.org/preventing-disease-and-staying-healthy/products-with-health-risks/)
- [Workshops](https://www.center4research.org/our-research-training/workshops/)
- [Artificial Turf and Playground Surfaces](https://www.center4research.org/artificial-turf-and-playground-surfaces/)

## Tags

- [Nuplazid](https://www.center4research.org/tag/nuplazid/)
- [opioid](https://www.center4research.org/tag/opioid/)
- [depression](https://www.center4research.org/tag/depression/)
- [Optimizer](https://www.center4research.org/tag/optimizer/)
- [heart failure](https://www.center4research.org/tag/heart-failure/)
- [510(k)](https://www.center4research.org/tag/510k/)
- [safety](https://www.center4research.org/tag/safety/)
- [medical devices](https://www.center4research.org/tag/medical-devices/)
- [breast implants](https://www.center4research.org/tag/breast-implants/)
- [USPSTF](https://www.center4research.org/tag/uspstf/)
- [HIV](https://www.center4research.org/tag/hiv/)
- [PrEP](https://www.center4research.org/tag/prep/)
- [Yaz](https://www.center4research.org/tag/yaz/)
- [software](https://www.center4research.org/tag/software/)
- [type 1 diabetes](https://www.center4research.org/tag/type-1-diabetes/)
- [Sotagliflozin](https://www.center4research.org/tag/sotagliflozin/)
- [colorectal cancer](https://www.center4research.org/tag/colorectal-cancer/)
- [screening](https://www.center4research.org/tag/screening/)
- [hepatitis B](https://www.center4research.org/tag/hepatitis-b/)
- [pregnancy](https://www.center4research.org/tag/pregnancy/)
- [HBV screening](https://www.center4research.org/tag/hbv-screening/)
- [real-world evidence](https://www.center4research.org/tag/real-world-evidence/)
- [FDA](https://www.center4research.org/tag/fda/)
- [esketamine](https://www.center4research.org/tag/esketamine/)
- [treatment resistant depression](https://www.center4research.org/tag/treatment-resistant-depression/)
- [pancreatic cancer screening](https://www.center4research.org/tag/pancreatic-cancer-screening/)
- [cybersecurity](https://www.center4research.org/tag/cybersecurity/)
- [patient experience data](https://www.center4research.org/tag/patient-experience-data/)
- [proposed draft guidances](https://www.center4research.org/tag/proposed-draft-guidances/)
- [product development](https://www.center4research.org/tag/product-development/)
- [FDA regulation](https://www.center4research.org/tag/fda-regulation/)
- [Consumer Product Safety Commission](https://www.center4research.org/tag/consumer-product-safety-commission/)
- [CPSC](https://www.center4research.org/tag/cpsc/)
- [artificial turf](https://www.center4research.org/tag/artificial-turf/)
- [playground surface](https://www.center4research.org/tag/playground-surface/)
- [flame retardants](https://www.center4research.org/tag/flame-retardants/)
- [helmets](https://www.center4research.org/tag/helmets/)
- [sport](https://www.center4research.org/tag/sport/)
- [head injury](https://www.center4research.org/tag/head-injury/)
- [recreation](https://www.center4research.org/tag/recreation/)
- [rabies](https://www.center4research.org/tag/rabies/)
- [monoclonal antibodies](https://www.center4research.org/tag/monoclonal-antibodies/)
- [lead](https://www.center4research.org/tag/lead/)
- [gadolinium](https://www.center4research.org/tag/gadolinium/)
- [gadolinium-based contrast agent](https://www.center4research.org/tag/gadolinium-based-contrast-agent/)
- [GBCA](https://www.center4research.org/tag/gbca/)
- [MRI](https://www.center4research.org/tag/mri/)
- [Gadolinium Deposition Disease](https://www.center4research.org/tag/gadolinium-deposition-disease/)
- [Gadolinium toxicity](https://www.center4research.org/tag/gadolinium-toxicity/)
- [Gadolinium retention](https://www.center4research.org/tag/gadolinium-retention/)
- [Gadolinium deposition](https://www.center4research.org/tag/gadolinium-deposition/)
- [mannitol](https://www.center4research.org/tag/mannitol/)
- [cystic fibrosis](https://www.center4research.org/tag/cystic-fibrosis/)
- [Bronchitol](https://www.center4research.org/tag/bronchitol/)
- [implants](https://www.center4research.org/tag/implants/)
- [recalls](https://www.center4research.org/tag/recalls/)
- [breast-enhancing pills](https://www.center4research.org/tag/breast-enhancing-pills/)
- [menopause](https://www.center4research.org/tag/menopause/)
- [artificial intelligence](https://www.center4research.org/tag/artificial-intelligence/)
- [machine learning](https://www.center4research.org/tag/machine-learning/)
- [alternative reporting](https://www.center4research.org/tag/alternative-reporting/)
- [staple](https://www.center4research.org/tag/staple/)
- [TB](https://www.center4research.org/tag/tb/)
- [tuberculosis](https://www.center4research.org/tag/tuberculosis/)
- [MDR TB](https://www.center4research.org/tag/mdr-tb/)
- [XDR TB](https://www.center4research.org/tag/xdr-tb/)
- [Pretomanid](https://www.center4research.org/tag/pretomanid/)
- [Paclitaxel-coated balloons](https://www.center4research.org/tag/paclitaxel-coated-balloons/)
- [Paclitaxel-eluting stents](https://www.center4research.org/tag/paclitaxel-eluting-stents/)
- [Vyleesi](https://www.center4research.org/tag/vyleesi/)
- [post-approval studies](https://www.center4research.org/tag/post-approval-studies/)
- [registries](https://www.center4research.org/tag/registries/)
- [Abdominal Aortic Aneurysm](https://www.center4research.org/tag/abdominal-aortic-aneurysm/)
- [US Preventative Services Task Force](https://www.center4research.org/tag/us-preventative-services-task-force/)
- [ginkgo](https://www.center4research.org/tag/ginkgo/)
- [biloba](https://www.center4research.org/tag/biloba/)
- [memory](https://www.center4research.org/tag/memory/)
- [Limited Population Pathway for Antimicrobials and Antifungals](https://www.center4research.org/tag/limited-population-pathway-for-antimicrobials-and-antifungals/)
- [antimicrobials](https://www.center4research.org/tag/antimicrobials/)
- [antibiotics](https://www.center4research.org/tag/antibiotics/)
- [antifungals](https://www.center4research.org/tag/antifungals/)
- [LPAD](https://www.center4research.org/tag/lpad/)
- [third-hand smoke](https://www.center4research.org/tag/third-hand-smoke/)
- [smoking](https://www.center4research.org/tag/smoking/)
- [smoke](https://www.center4research.org/tag/smoke/)
- [cigarette](https://www.center4research.org/tag/cigarette/)
- [nicotine](https://www.center4research.org/tag/nicotine/)
- [nintedanib](https://www.center4research.org/tag/nintedanib/)
- [OFEV](https://www.center4research.org/tag/ofev/)
- [SSC-ILD](https://www.center4research.org/tag/ssc-ild/)
- [systemic sclerosis-associated interstitial lung disease](https://www.center4research.org/tag/systemic-sclerosis-associated-interstitial-lung-disease/)
- [opioids](https://www.center4research.org/tag/opioids/)
- [immediate-release opioids](https://www.center4research.org/tag/immediate-release-opioids/)
- [blister packs](https://www.center4research.org/tag/blister-packs/)
- [DASH diet](https://www.center4research.org/tag/dash-diet/)
- [diet](https://www.center4research.org/tag/diet/)
- [blood pressure](https://www.center4research.org/tag/blood-pressure/)
- [hypertension](https://www.center4research.org/tag/hypertension/)
- [belly fat](https://www.center4research.org/tag/belly-fat/)
- [cancer](https://www.center4research.org/tag/cancer/)
- [weight](https://www.center4research.org/tag/weight/)
- [obesity](https://www.center4research.org/tag/obesity/)
- [overweight](https://www.center4research.org/tag/overweight/)
- [BMI](https://www.center4research.org/tag/bmi/)
- [body shape](https://www.center4research.org/tag/body-shape/)
- [clinical trials](https://www.center4research.org/tag/clinical-trials/)
- [diversity](https://www.center4research.org/tag/diversity/)
- [e-cigarette](https://www.center4research.org/tag/e-cigarette/)
- [vaping](https://www.center4research.org/tag/vaping/)
- [juul](https://www.center4research.org/tag/juul/)
- [juuling](https://www.center4research.org/tag/juuling/)
- [nicotine pods](https://www.center4research.org/tag/nicotine-pods/)
- [PCORI](https://www.center4research.org/tag/pcori/)
- [research](https://www.center4research.org/tag/research/)
- [brexanolone](https://www.center4research.org/tag/brexanolone/)
- [Zulresso](https://www.center4research.org/tag/zulresso/)
- [postpartum depression](https://www.center4research.org/tag/postpartum-depression/)
- [Advisory Committee](https://www.center4research.org/tag/advisory-committee/)
- [Illicit drugs](https://www.center4research.org/tag/illicit-drugs/)
- [Birth Control](https://www.center4research.org/tag/birth-control/)
- [Contraceptives](https://www.center4research.org/tag/contraceptives/)
- [peanut allergy](https://www.center4research.org/tag/peanut-allergy/)
- [ar101](https://www.center4research.org/tag/ar101/)
- [palforzia](https://www.center4research.org/tag/palforzia/)
- [peanut allergen powder](https://www.center4research.org/tag/peanut-allergen-powder/)
- [potassium salt](https://www.center4research.org/tag/potassium-salt/)
- [potassium chloride](https://www.center4research.org/tag/potassium-chloride/)
- [U.S. Preventive Services Task Force](https://www.center4research.org/tag/u-s-preventive-services-task-force/)
- [hepatitis C](https://www.center4research.org/tag/hepatitis-c/)
- [montelukast](https://www.center4research.org/tag/montelukast/)
- [singulair](https://www.center4research.org/tag/singulair/)
- [asthma](https://www.center4research.org/tag/asthma/)
- [allergic rhinitis](https://www.center4research.org/tag/allergic-rhinitis/)
- [anxiety](https://www.center4research.org/tag/anxiety/)
- [suicidal](https://www.center4research.org/tag/suicidal/)
- [children](https://www.center4research.org/tag/children/)
- [playgrounds](https://www.center4research.org/tag/playgrounds/)
- [United States Preventive Services Task Force](https://www.center4research.org/tag/united-states-preventive-services-task-force/)
- [Cognitive Impairment](https://www.center4research.org/tag/cognitive-impairment/)
- [Patient-Centered Outcomes Research Institute](https://www.center4research.org/tag/patient-centered-outcomes-research-institute/)
- [cefiderocol](https://www.center4research.org/tag/cefiderocol/)
- [cUTI](https://www.center4research.org/tag/cuti/)
- [complicated UTI](https://www.center4research.org/tag/complicated-uti/)
- [dcis](https://www.center4research.org/tag/dcis/)
- [breast cancer](https://www.center4research.org/tag/breast-cancer/)
- [Mammograms](https://www.center4research.org/tag/mammograms/)
- [High-tech](https://www.center4research.org/tag/high-tech/)
- [preterm birth](https://www.center4research.org/tag/preterm-birth/)
- [neonate](https://www.center4research.org/tag/neonate/)
- [makena](https://www.center4research.org/tag/makena/)
- [drug development](https://www.center4research.org/tag/drug-development/)
- [FDA draft guidance](https://www.center4research.org/tag/fda-draft-guidance/)
- [male breast cancer](https://www.center4research.org/tag/male-breast-cancer/)
- [illicit drug use](https://www.center4research.org/tag/illicit-drug-use/)
- [interventions](https://www.center4research.org/tag/interventions/)
- [reproductive health](https://www.center4research.org/tag/reproductive-health/)
- [sexual health](https://www.center4research.org/tag/sexual-health/)
- [Essure Impant](https://www.center4research.org/tag/essure-impant/)
- [bacterial vaginosis](https://www.center4research.org/tag/bacterial-vaginosis/)
- [preterm delivery](https://www.center4research.org/tag/preterm-delivery/)
- [EPA](https://www.center4research.org/tag/epa/)
- [Carcinogen](https://www.center4research.org/tag/carcinogen/)
- [stis](https://www.center4research.org/tag/stis/)
- [sti](https://www.center4research.org/tag/sti/)
- [sex](https://www.center4research.org/tag/sex/)
- [common](https://www.center4research.org/tag/common/)
- [heart bypass surgery](https://www.center4research.org/tag/heart-bypass-surgery/)
- [stents](https://www.center4research.org/tag/stents/)
- [ISCHEMIA](https://www.center4research.org/tag/ischemia/)
- [Metals](https://www.center4research.org/tag/metals/)
- [Rye City Council](https://www.center4research.org/tag/rye-city-council/)
- [Mayor Cohn](https://www.center4research.org/tag/mayor-cohn/)
- [Rye Mayor](https://www.center4research.org/tag/rye-mayor/)
- [crumb rubber](https://www.center4research.org/tag/crumb-rubber/)
- [recycled tire](https://www.center4research.org/tag/recycled-tire/)
- [Safer Technologies Program](https://www.center4research.org/tag/safer-technologies-program/)
- [clearance](https://www.center4research.org/tag/clearance/)
- [epithelioid sarcoma](https://www.center4research.org/tag/epithelioid-sarcoma/)
- [tazemetostat](https://www.center4research.org/tag/tazemetostat/)
- [post-market studies](https://www.center4research.org/tag/post-market-studies/)
- [post-market clinical trials](https://www.center4research.org/tag/post-market-clinical-trials/)
- [postmarketing](https://www.center4research.org/tag/postmarketing/)
- [draft guidance](https://www.center4research.org/tag/draft-guidance/)
- [tobacco](https://www.center4research.org/tag/tobacco/)
- [tobacco application](https://www.center4research.org/tag/tobacco-application/)
- [pmta](https://www.center4research.org/tag/pmta/)
- [Clinical Decision Support software](https://www.center4research.org/tag/clinical-decision-support-software/)
- [cds](https://www.center4research.org/tag/cds/)
- [patient checklist](https://www.center4research.org/tag/patient-checklist/)
- [black box warning](https://www.center4research.org/tag/black-box-warning/)
- [postmarket](https://www.center4research.org/tag/postmarket/)
- [surveillance](https://www.center4research.org/tag/surveillance/)
- [data sharing](https://www.center4research.org/tag/data-sharing/)
- [rubber](https://www.center4research.org/tag/rubber/)
- [fields](https://www.center4research.org/tag/fields/)
- [Lower Back Pain](https://www.center4research.org/tag/lower-back-pain/)
- [Treatment](https://www.center4research.org/tag/treatment/)
- [SABER-bupivacaine](https://www.center4research.org/tag/saber-bupivacaine/)
- [Posimir](https://www.center4research.org/tag/posimir/)
- [pain](https://www.center4research.org/tag/pain/)
- [surgery](https://www.center4research.org/tag/surgery/)
- [Industry](https://www.center4research.org/tag/industry/)
- [AI](https://www.center4research.org/tag/ai/)
- [Public Awareness](https://www.center4research.org/tag/public-awareness/)
- [ER](https://www.center4research.org/tag/er/)
- [Expensive](https://www.center4research.org/tag/expensive/)
- [Medical Treatments](https://www.center4research.org/tag/medical-treatments/)
- [Plastics](https://www.center4research.org/tag/plastics/)
- [health risks](https://www.center4research.org/tag/health-risks/)
- [Professors](https://www.center4research.org/tag/professors/)
- [Drugs](https://www.center4research.org/tag/drugs/)
- [Bias](https://www.center4research.org/tag/bias/)
- [Health issues](https://www.center4research.org/tag/health-issues/)
- [Schools](https://www.center4research.org/tag/schools/)
- [Risks](https://www.center4research.org/tag/risks/)
- [FDA Advisory Meeting](https://www.center4research.org/tag/fda-advisory-meeting/)
- [Celecoxib](https://www.center4research.org/tag/celecoxib/)
- [Tramadol](https://www.center4research.org/tag/tramadol/)
- [Aximris](https://www.center4research.org/tag/aximris/)
- [Abuse-Deterrent](https://www.center4research.org/tag/abuse-deterrent/)
- [Medicine](https://www.center4research.org/tag/medicine/)
- [smokeless tobacco](https://www.center4research.org/tag/smokeless-tobacco/)
- [snuff](https://www.center4research.org/tag/snuff/)
- [labeling](https://www.center4research.org/tag/labeling/)
- [marketing](https://www.center4research.org/tag/marketing/)
- [risk](https://www.center4research.org/tag/risk/)
- [lung](https://www.center4research.org/tag/lung/)
- [nerlynx](https://www.center4research.org/tag/nerlynx/)
- [neratinib](https://www.center4research.org/tag/neratinib/)
- [e-cigarettes](https://www.center4research.org/tag/e-cigarettes/)
- [stem cell](https://www.center4research.org/tag/stem-cell/)
- [cannabidiol](https://www.center4research.org/tag/cannabidiol/)
- [Phthalates](https://www.center4research.org/tag/phthalates/)
- [Toys](https://www.center4research.org/tag/toys/)
- [Birth Defects](https://www.center4research.org/tag/birth-defects/)
- [blackbox warning](https://www.center4research.org/tag/blackbox-warning/)
- [breast implant](https://www.center4research.org/tag/breast-implant/)
- [Bumper Pads](https://www.center4research.org/tag/bumper-pads/)
- [Public Health](https://www.center4research.org/tag/public-health/)
- [Infants](https://www.center4research.org/tag/infants/)
- [Seroquel](https://www.center4research.org/tag/seroquel/)
- [stent](https://www.center4research.org/tag/stent/)
- [death-rate error](https://www.center4research.org/tag/death-rate-error/)
- [pulmonary artery disease](https://www.center4research.org/tag/pulmonary-artery-disease/)
- [Modified risk tobacco product](https://www.center4research.org/tag/modified-risk-tobacco-product/)
- [adolescent](https://www.center4research.org/tag/adolescent/)
- [Crib Bumpers](https://www.center4research.org/tag/crib-bumpers/)
- [Ban](https://www.center4research.org/tag/ban/)
- [Prostate](https://www.center4research.org/tag/prostate/)
- [race](https://www.center4research.org/tag/race/)
- [ethnicity](https://www.center4research.org/tag/ethnicity/)
- [priorities](https://www.center4research.org/tag/priorities/)
- [inclusion](https://www.center4research.org/tag/inclusion/)
- [informed decision](https://www.center4research.org/tag/informed-decision/)
- [medical products](https://www.center4research.org/tag/medical-products/)
- [subgroup analysis](https://www.center4research.org/tag/subgroup-analysis/)
- [Spravato](https://www.center4research.org/tag/spravato/)
- [suicide](https://www.center4research.org/tag/suicide/)
- [veterans](https://www.center4research.org/tag/veterans/)
- [Agency for Healthcare Research and Quality](https://www.center4research.org/tag/agency-for-healthcare-research-and-quality/)
- [systematic review](https://www.center4research.org/tag/systematic-review/)
- [chronic conditions](https://www.center4research.org/tag/chronic-conditions/)
- [cyramza](https://www.center4research.org/tag/cyramza/)
- [metastatic lung cancer](https://www.center4research.org/tag/metastatic-lung-cancer/)
- [endocrine disruptors](https://www.center4research.org/tag/endocrine-disruptors/)
- [Maryland](https://www.center4research.org/tag/maryland/)
- [menstrual products](https://www.center4research.org/tag/menstrual-products/)
- [Allergic Reactions](https://www.center4research.org/tag/allergic-reactions/)
- [Coronavirus](https://www.center4research.org/tag/coronavirus/)
- [Testing](https://www.center4research.org/tag/testing/)
- [Diagnosis](https://www.center4research.org/tag/diagnosis/)
- [heart disease](https://www.center4research.org/tag/heart-disease/)
- [heart attack](https://www.center4research.org/tag/heart-attack/)
- [vitamin D](https://www.center4research.org/tag/vitamin-d/)
- [Supplements](https://www.center4research.org/tag/supplements/)
- [hip fracture](https://www.center4research.org/tag/hip-fracture/)
- [calcium](https://www.center4research.org/tag/calcium/)
- [osteoporosis](https://www.center4research.org/tag/osteoporosis/)
- [dementia](https://www.center4research.org/tag/dementia/)
- [alzheimer's disease](https://www.center4research.org/tag/alzheimers-disease/)
- [anticholinergic](https://www.center4research.org/tag/anticholinergic/)
- [Alzheimer’s](https://www.center4research.org/tag/alzheimers/)
- [Disease](https://www.center4research.org/tag/disease/)
- [Cure](https://www.center4research.org/tag/cure/)
- [cardiovascular disease](https://www.center4research.org/tag/cardiovascular-disease/)
- [Social Distancing](https://www.center4research.org/tag/social-distancing/)
- [Quarantine](https://www.center4research.org/tag/quarantine/)
- [effectiveness](https://www.center4research.org/tag/effectiveness/)
- [public comments](https://www.center4research.org/tag/public-comments/)
- [non-inferiority](https://www.center4research.org/tag/non-inferiority/)
- [single trial](https://www.center4research.org/tag/single-trial/)
- [Covid-19](https://www.center4research.org/tag/covid-19/)
- [mental health](https://www.center4research.org/tag/mental-health/)
- [sleep](https://www.center4research.org/tag/sleep/)
- [breathing](https://www.center4research.org/tag/breathing/)
- [caffeine](https://www.center4research.org/tag/caffeine/)
- [anxious](https://www.center4research.org/tag/anxious/)
- [Outbreak](https://www.center4research.org/tag/outbreak/)
- [Virus-Test](https://www.center4research.org/tag/virus-test/)
- [access](https://www.center4research.org/tag/access/)
- [IUD](https://www.center4research.org/tag/iud/)
- [levonorgestrel](https://www.center4research.org/tag/levonorgestrel/)
- [IUDs](https://www.center4research.org/tag/iuds/)
- [gilead](https://www.center4research.org/tag/gilead/)
- [orphan drug](https://www.center4research.org/tag/orphan-drug/)
- [frequently asked questions](https://www.center4research.org/tag/frequently-asked-questions/)
- [chemotherapy](https://www.center4research.org/tag/chemotherapy/)
- [hydroxychloroquine](https://www.center4research.org/tag/hydroxychloroquine/)
- [covid19](https://www.center4research.org/tag/covid19/)
- [trump](https://www.center4research.org/tag/trump/)
- [Inspectors General](https://www.center4research.org/tag/inspectors-general/)
- [Protection](https://www.center4research.org/tag/protection/)
- [Policy](https://www.center4research.org/tag/policy/)
- [nutrition](https://www.center4research.org/tag/nutrition/)
- [school lunch](https://www.center4research.org/tag/school-lunch/)
- [breakfast](https://www.center4research.org/tag/breakfast/)
- [food and nutrition service](https://www.center4research.org/tag/food-and-nutrition-service/)
- [ECG](https://www.center4research.org/tag/ecg/)
- [electrocardiography](https://www.center4research.org/tag/electrocardiography/)
- [atrial fibrillation](https://www.center4research.org/tag/atrial-fibrillation/)
- [Morcellator](https://www.center4research.org/tag/morcellator/)
- [uterine cancer](https://www.center4research.org/tag/uterine-cancer/)
- [fibroids](https://www.center4research.org/tag/fibroids/)
- [organohalogen flame retardants](https://www.center4research.org/tag/organohalogen-flame-retardants/)
- [infant sleep products](https://www.center4research.org/tag/infant-sleep-products/)
- [liquid nicotine packaging](https://www.center4research.org/tag/liquid-nicotine-packaging/)
- [older adults](https://www.center4research.org/tag/older-adults/)
- [cancer treatment](https://www.center4research.org/tag/cancer-treatment/)
- [OSTP](https://www.center4research.org/tag/ostp/)
- [public access](https://www.center4research.org/tag/public-access/)
- [federally funded research](https://www.center4research.org/tag/federally-funded-research/)
- [Tests](https://www.center4research.org/tag/tests/)
- [Vacation](https://www.center4research.org/tag/vacation/)
- [Stay at home](https://www.center4research.org/tag/stay-at-home/)
- [transparency](https://www.center4research.org/tag/transparency/)
- [blood pressure screening](https://www.center4research.org/tag/blood-pressure-screening/)
- [adolescents](https://www.center4research.org/tag/adolescents/)
- [Women's Health](https://www.center4research.org/tag/womens-health/)
- [ESPN](https://www.center4research.org/tag/espn/)
- [Sports](https://www.center4research.org/tag/sports/)
- [MLB](https://www.center4research.org/tag/mlb/)
- [Pandemic](https://www.center4research.org/tag/pandemic/)
- [Allergen](https://www.center4research.org/tag/allergen/)
- [Telemedicine](https://www.center4research.org/tag/telemedicine/)
- [Health Care](https://www.center4research.org/tag/health-care/)
- [Virtual](https://www.center4research.org/tag/virtual/)
- [Vaccine](https://www.center4research.org/tag/vaccine/)
- [COVID_19](https://www.center4research.org/tag/covid_19/)
- [Recall](https://www.center4research.org/tag/recall/)
- [Drug](https://www.center4research.org/tag/drug/)
- [Data](https://www.center4research.org/tag/data/)
- [CDC](https://www.center4research.org/tag/cdc/)
- [CVD](https://www.center4research.org/tag/cvd/)
- [diabetes](https://www.center4research.org/tag/diabetes/)
- [behavioral counseling](https://www.center4research.org/tag/behavioral-counseling/)
- [high blood pressure](https://www.center4research.org/tag/high-blood-pressure/)
- [blood pressure medication](https://www.center4research.org/tag/blood-pressure-medication/)
- [crib liners](https://www.center4research.org/tag/crib-liners/)
- [SIDS](https://www.center4research.org/tag/sids/)
- [pediatric oncology](https://www.center4research.org/tag/pediatric-oncology/)
- [clinical trial design](https://www.center4research.org/tag/clinical-trial-design/)
- [Safety Plan](https://www.center4research.org/tag/safety-plan/)
- [reckless behavior](https://www.center4research.org/tag/reckless-behavior/)
- [FMT](https://www.center4research.org/tag/fmt/)
- [Fecal Matter Transplant](https://www.center4research.org/tag/fecal-matter-transplant/)
- [c. diff](https://www.center4research.org/tag/c-diff/)
- [microbiome](https://www.center4research.org/tag/microbiome/)
- [smoking cessation](https://www.center4research.org/tag/smoking-cessation/)
- [inequality](https://www.center4research.org/tag/inequality/)
- [travel safety](https://www.center4research.org/tag/travel-safety/)
- [airlines](https://www.center4research.org/tag/airlines/)
- [breast implant illness](https://www.center4research.org/tag/breast-implant-illness/)
- [breast implant removal](https://www.center4research.org/tag/breast-implant-removal/)
- [explant](https://www.center4research.org/tag/explant/)
- [urinary tract infection](https://www.center4research.org/tag/urinary-tract-infection/)
- [removal](https://www.center4research.org/tag/removal/)
- [NHL](https://www.center4research.org/tag/nhl/)
- [Canada](https://www.center4research.org/tag/canada/)
- [Belantamab Mafodotin](https://www.center4research.org/tag/belantamab-mafodotin/)
- [social media](https://www.center4research.org/tag/social-media/)
- [teens](https://www.center4research.org/tag/teens/)
- [Transgender](https://www.center4research.org/tag/transgender/)
- [Gender dysphoria](https://www.center4research.org/tag/gender-dysphoria/)
- [Hormone Therapy](https://www.center4research.org/tag/hormone-therapy/)
- [eating disorders](https://www.center4research.org/tag/eating-disorders/)
- [antibiotic resistance](https://www.center4research.org/tag/antibiotic-resistance/)
- [bacteria](https://www.center4research.org/tag/bacteria/)
- [mrsa](https://www.center4research.org/tag/mrsa/)
- [cdiff](https://www.center4research.org/tag/cdiff/)
- [HHS](https://www.center4research.org/tag/hhs/)
- [letter](https://www.center4research.org/tag/letter/)
- [lung cancer](https://www.center4research.org/tag/lung-cancer/)
- [cancer screening](https://www.center4research.org/tag/cancer-screening/)
- [vaccines](https://www.center4research.org/tag/vaccines/)
- [BII](https://www.center4research.org/tag/bii/)
- [women's sports](https://www.center4research.org/tag/womens-sports/)
- [dietary guidelines](https://www.center4research.org/tag/dietary-guidelines/)
- [informatics](https://www.center4research.org/tag/informatics/)
- [trauma](https://www.center4research.org/tag/trauma/)
- [PTSD](https://www.center4research.org/tag/ptsd/)
- [post-traumatic stress disorder](https://www.center4research.org/tag/post-traumatic-stress-disorder/)
- [posttraumatic stress disorder](https://www.center4research.org/tag/posttraumatic-stress-disorder/)
- [therapy](https://www.center4research.org/tag/therapy/)
- [pharmacotherapy](https://www.center4research.org/tag/pharmacotherapy/)
- [dialectical behavior therapy](https://www.center4research.org/tag/dialectical-behavior-therapy/)
- [DBT](https://www.center4research.org/tag/dbt/)
- [somatic therapy](https://www.center4research.org/tag/somatic-therapy/)
- [cognitive progressing therapy](https://www.center4research.org/tag/cognitive-progressing-therapy/)
- [CPT](https://www.center4research.org/tag/cpt/)
- [EMDR](https://www.center4research.org/tag/emdr/)
- [Eye Movement Desensitization and Reprocessing](https://www.center4research.org/tag/eye-movement-desensitization-and-reprocessing/)
- [prolonged exposure therapy](https://www.center4research.org/tag/prolonged-exposure-therapy/)
- [self-injury](https://www.center4research.org/tag/self-injury/)
- [self-harm](https://www.center4research.org/tag/self-harm/)
- [bioidentical hormone therapy](https://www.center4research.org/tag/bioidentical-hormone-therapy/)
- [bio-identical hormone therapy](https://www.center4research.org/tag/bio-identical-hormone-therapy/)
- [hormone replacement therapy](https://www.center4research.org/tag/hormone-replacement-therapy/)
- [cBHT](https://www.center4research.org/tag/cbht/)
- [compounding](https://www.center4research.org/tag/compounding/)
- [cervical cancer](https://www.center4research.org/tag/cervical-cancer/)
- [LGBT health](https://www.center4research.org/tag/lgbt-health/)
- [lesbian health](https://www.center4research.org/tag/lesbian-health/)
- [TRELEGY](https://www.center4research.org/tag/trelegy/)
- [COPD](https://www.center4research.org/tag/copd/)
- [all-cause mortality](https://www.center4research.org/tag/all-cause-mortality/)
- [mothers](https://www.center4research.org/tag/mothers/)
- [antidepressants](https://www.center4research.org/tag/antidepressants/)
- [medication](https://www.center4research.org/tag/medication/)
- [stenosis](https://www.center4research.org/tag/stenosis/)
- [Asymptomatic Carotid Artery Stenosis](https://www.center4research.org/tag/asymptomatic-carotid-artery-stenosis/)
- [premarket tobacco product applications](https://www.center4research.org/tag/premarket-tobacco-product-applications/)
- [explants](https://www.center4research.org/tag/explants/)
- [Cosmopolitan](https://www.center4research.org/tag/cosmopolitan/)
- [insurance](https://www.center4research.org/tag/insurance/)
- [plastic surgery](https://www.center4research.org/tag/plastic-surgery/)
- [explant surgery](https://www.center4research.org/tag/explant-surgery/)
- [cervical ripening](https://www.center4research.org/tag/cervical-ripening/)
- [AHRQ](https://www.center4research.org/tag/ahrq/)
- [black box](https://www.center4research.org/tag/black-box/)
- [hearing loss](https://www.center4research.org/tag/hearing-loss/)
- [breast](https://www.center4research.org/tag/breast/)
- [patient groups](https://www.center4research.org/tag/patient-groups/)
- [ADHD](https://www.center4research.org/tag/adhd/)
- [abuse deterrent formulation](https://www.center4research.org/tag/abuse-deterrent-formulation/)
- [schizophrenia](https://www.center4research.org/tag/schizophrenia/)
- [olanzapine](https://www.center4research.org/tag/olanzapine/)
- [samidorphan](https://www.center4research.org/tag/samidorphan/)
- [online therapy](https://www.center4research.org/tag/online-therapy/)
- [teletherapy](https://www.center4research.org/tag/teletherapy/)
- [CBT](https://www.center4research.org/tag/cbt/)
- [cognitive behavioral therapy](https://www.center4research.org/tag/cognitive-behavioral-therapy/)
- [covid](https://www.center4research.org/tag/covid/)
- [covid vaccine](https://www.center4research.org/tag/covid-vaccine/)
- [covid-19 vaccine](https://www.center4research.org/tag/covid-19-vaccine/)
- [coronavirus vaccine](https://www.center4research.org/tag/coronavirus-vaccine/)
- [Reducer](https://www.center4research.org/tag/reducer/)
- [circulatory device](https://www.center4research.org/tag/circulatory-device/)
- [FDA meeting](https://www.center4research.org/tag/fda-meeting/)
- [FDA user fees](https://www.center4research.org/tag/fda-user-fees/)
- [fees](https://www.center4research.org/tag/fees/)
- [benzo](https://www.center4research.org/tag/benzo/)
- [benzodiazepine](https://www.center4research.org/tag/benzodiazepine/)
- [benzos](https://www.center4research.org/tag/benzos/)
- [Covid-19 COVID19](https://www.center4research.org/tag/covid-19-covid19/)
- [myths](https://www.center4research.org/tag/myths/)
- [cov](https://www.center4research.org/tag/cov/)
- [Hydexor](https://www.center4research.org/tag/hydexor/)
- [election](https://www.center4research.org/tag/election/)
- [NIH](https://www.center4research.org/tag/nih/)
- [Fauci](https://www.center4research.org/tag/fauci/)
- [Aducanumab](https://www.center4research.org/tag/aducanumab/)
- [VisAbility Micro Insert](https://www.center4research.org/tag/visability-micro-insert/)
- [presbyopia](https://www.center4research.org/tag/presbyopia/)
- [geriatric](https://www.center4research.org/tag/geriatric/)
- [digital eye strain](https://www.center4research.org/tag/digital-eye-strain/)
- [glasses](https://www.center4research.org/tag/glasses/)
- [blue light](https://www.center4research.org/tag/blue-light/)
- [technology](https://www.center4research.org/tag/technology/)
- [digital device](https://www.center4research.org/tag/digital-device/)
- [computer vision syndrome](https://www.center4research.org/tag/computer-vision-syndrome/)
- [premenopausal](https://www.center4research.org/tag/premenopausal/)
- [breast cancer treatment](https://www.center4research.org/tag/breast-cancer-treatment/)
- [finasteride](https://www.center4research.org/tag/finasteride/)
- [propecia](https://www.center4research.org/tag/propecia/)
- [proscar](https://www.center4research.org/tag/proscar/)
- [hair loss](https://www.center4research.org/tag/hair-loss/)
- [male pattern baldness](https://www.center4research.org/tag/male-pattern-baldness/)
- [Entresto](https://www.center4research.org/tag/entresto/)
- [HFpEF](https://www.center4research.org/tag/hfpef/)
- [spironolactone](https://www.center4research.org/tag/spironolactone/)
- [mask](https://www.center4research.org/tag/mask/)
- [masks](https://www.center4research.org/tag/masks/)
- [Montgomery County](https://www.center4research.org/tag/montgomery-county/)
- [endocrine disrupting chemicals](https://www.center4research.org/tag/endocrine-disrupting-chemicals/)
- [Ellsworth Drive](https://www.center4research.org/tag/ellsworth-drive/)
- [Camel Snus](https://www.center4research.org/tag/camel-snus/)
- [MRTP](https://www.center4research.org/tag/mrtp/)
- [insomnia](https://www.center4research.org/tag/insomnia/)
- [CBT-I](https://www.center4research.org/tag/cbt-i/)
- [acupuncture](https://www.center4research.org/tag/acupuncture/)
- [Pfizer](https://www.center4research.org/tag/pfizer/)
- [anaphylaxis](https://www.center4research.org/tag/anaphylaxis/)
- [allergy](https://www.center4research.org/tag/allergy/)
- [late allergic reactions](https://www.center4research.org/tag/late-allergic-reactions/)
- [TMS](https://www.center4research.org/tag/tms/)
- [transcranial magnetic stimulation](https://www.center4research.org/tag/transcranial-magnetic-stimulation/)
- [gut health](https://www.center4research.org/tag/gut-health/)
- [breastfeeding](https://www.center4research.org/tag/breastfeeding/)
- [probiotics](https://www.center4research.org/tag/probiotics/)
- [Choosing Wisely](https://www.center4research.org/tag/choosing-wisely/)
- [allergies](https://www.center4research.org/tag/allergies/)
- [imaging](https://www.center4research.org/tag/imaging/)
- [LGBT](https://www.center4research.org/tag/lgbt/)
- [lesbian](https://www.center4research.org/tag/lesbian/)
- [Keytruda](https://www.center4research.org/tag/keytruda/)
- [triple negative breast cancer](https://www.center4research.org/tag/triple-negative-breast-cancer/)
- [industry standards](https://www.center4research.org/tag/industry-standards/)
- [BIA-ALCL](https://www.center4research.org/tag/bia-alcl/)
- [ALCL](https://www.center4research.org/tag/alcl/)
- [lymphoma](https://www.center4research.org/tag/lymphoma/)
- [large-cell lymphoma](https://www.center4research.org/tag/large-cell-lymphoma/)
- [FDA approval](https://www.center4research.org/tag/fda-approval/)
- [Merck](https://www.center4research.org/tag/merck/)
- [patient safety](https://www.center4research.org/tag/patient-safety/)
- [arteries](https://www.center4research.org/tag/arteries/)
- [Biden](https://www.center4research.org/tag/biden/)
- [FDA commissioner](https://www.center4research.org/tag/fda-commissioner/)
- [J & J](https://www.center4research.org/tag/j-j/)
- [Janssen](https://www.center4research.org/tag/janssen/)
- [Johnson & Johnson](https://www.center4research.org/tag/johnson-johnson/)
- [j&j](https://www.center4research.org/tag/jj/)
- [health insurance](https://www.center4research.org/tag/health-insurance/)
- [ACA Marketplace](https://www.center4research.org/tag/aca-marketplace/)
- [Affordable Care Act](https://www.center4research.org/tag/affordable-care-act/)
- [Open Enrollment](https://www.center4research.org/tag/open-enrollment/)
- [drug inspections](https://www.center4research.org/tag/drug-inspections/)
- [cancerdrugs](https://www.center4research.org/tag/cancerdrugs/)
- [vaccine trials](https://www.center4research.org/tag/vaccine-trials/)
- [myplate](https://www.center4research.org/tag/myplate/)
- [gestational diabetes](https://www.center4research.org/tag/gestational-diabetes/)
- [reopening](https://www.center4research.org/tag/reopening/)
- [vaccination](https://www.center4research.org/tag/vaccination/)
- [TMD](https://www.center4research.org/tag/tmd/)
- [TMJ](https://www.center4research.org/tag/tmj/)
- [cervical cancer screening](https://www.center4research.org/tag/cervical-cancer-screening/)
- [stop smoking](https://www.center4research.org/tag/stop-smoking/)
- [chantix](https://www.center4research.org/tag/chantix/)
- [zyban](https://www.center4research.org/tag/zyban/)
- [prostate cancer](https://www.center4research.org/tag/prostate-cancer/)
- [prostate cancer screening](https://www.center4research.org/tag/prostate-cancer-screening/)
- [PSA](https://www.center4research.org/tag/psa/)
- [anxiety medication](https://www.center4research.org/tag/anxiety-medication/)
- [anti-anxiety](https://www.center4research.org/tag/anti-anxiety/)
- [cancer risk](https://www.center4research.org/tag/cancer-risk/)
- [exercise](https://www.center4research.org/tag/exercise/)
- [european vaccine](https://www.center4research.org/tag/european-vaccine/)
- [news](https://www.center4research.org/tag/news/)
- [dermal fillers](https://www.center4research.org/tag/dermal-fillers/)
- [FDA Advisory Committee](https://www.center4research.org/tag/fda-advisory-committee/)
- [wrinkle fillers](https://www.center4research.org/tag/wrinkle-fillers/)
- [Juvederm](https://www.center4research.org/tag/juvederm/)
- [PFAS](https://www.center4research.org/tag/pfas/)
- [rubber playground](https://www.center4research.org/tag/rubber-playground/)
- [playground](https://www.center4research.org/tag/playground/)
- [hormone disruptor](https://www.center4research.org/tag/hormone-disruptor/)
- [osteoarthritis](https://www.center4research.org/tag/osteoarthritis/)
- [arthritis](https://www.center4research.org/tag/arthritis/)
- [tanezumab](https://www.center4research.org/tag/tanezumab/)
- [aspirin](https://www.center4research.org/tag/aspirin/)
- [low dose aspirin](https://www.center4research.org/tag/low-dose-aspirin/)
- [preeclampsia](https://www.center4research.org/tag/preeclampsia/)
- [cookware](https://www.center4research.org/tag/cookware/)
- [FTC](https://www.center4research.org/tag/ftc/)
- [toxic pans](https://www.center4research.org/tag/toxic-pans/)
- [nonstick cookware](https://www.center4research.org/tag/nonstick-cookware/)
- [environmental safety](https://www.center4research.org/tag/environmental-safety/)
- [Chlamydia](https://www.center4research.org/tag/chlamydia/)
- [Gonorrhea](https://www.center4research.org/tag/gonorrhea/)
- [heart transplant](https://www.center4research.org/tag/heart-transplant/)
- [OCS Heart System](https://www.center4research.org/tag/ocs-heart-system/)
- [PFAS testing](https://www.center4research.org/tag/pfas-testing/)
- [FDA clearance](https://www.center4research.org/tag/fda-clearance/)
- [FDA device regulation](https://www.center4research.org/tag/fda-device-regulation/)
- [digital birth control](https://www.center4research.org/tag/digital-birth-control/)
- [health apps](https://www.center4research.org/tag/health-apps/)
- [diversity in clinical trials](https://www.center4research.org/tag/diversity-in-clinical-trials/)
- [diabetes screening](https://www.center4research.org/tag/diabetes-screening/)
- [new doctors](https://www.center4research.org/tag/new-doctors/)
- [online medical advice](https://www.center4research.org/tag/online-medical-advice/)
- [doctor recommendations](https://www.center4research.org/tag/doctor-recommendations/)
- [online reviews](https://www.center4research.org/tag/online-reviews/)
- [online ratings](https://www.center4research.org/tag/online-ratings/)
- [finding a doctor](https://www.center4research.org/tag/finding-a-doctor/)
- [donislecel](https://www.center4research.org/tag/donislecel/)
- [Brittle diabetes](https://www.center4research.org/tag/brittle-diabetes/)
- [risk of artificial turf](https://www.center4research.org/tag/risk-of-artificial-turf/)
- [artificial turf and children](https://www.center4research.org/tag/artificial-turf-and-children/)
- [child safety](https://www.center4research.org/tag/child-safety/)
- [sugar](https://www.center4research.org/tag/sugar/)
- [adult health](https://www.center4research.org/tag/adult-health/)
- [kids health](https://www.center4research.org/tag/kids-health/)
- [healthy eating](https://www.center4research.org/tag/healthy-eating/)
- [sugar-sweetened beverages](https://www.center4research.org/tag/sugar-sweetened-beverages/)
- [FDA conflicts](https://www.center4research.org/tag/fda-conflicts/)
- [oncology drugs](https://www.center4research.org/tag/oncology-drugs/)
- [College](https://www.center4research.org/tag/college/)
- [California](https://www.center4research.org/tag/california/)
- [college vaccines](https://www.center4research.org/tag/college-vaccines/)
- [mandatory vaccinations](https://www.center4research.org/tag/mandatory-vaccinations/)
- [fda safety](https://www.center4research.org/tag/fda-safety/)
- [drug safety](https://www.center4research.org/tag/drug-safety/)
- [tecentriq](https://www.center4research.org/tag/tecentriq/)
- [cancer drugs](https://www.center4research.org/tag/cancer-drugs/)
- [expensive cancer drugs](https://www.center4research.org/tag/expensive-cancer-drugs/)
- [environmental toxins](https://www.center4research.org/tag/environmental-toxins/)
- [teenager](https://www.center4research.org/tag/teenager/)
- [wrinkles](https://www.center4research.org/tag/wrinkles/)
- [wrinkle treatment](https://www.center4research.org/tag/wrinkle-treatment/)
- [Gen Z](https://www.center4research.org/tag/gen-z/)
- [cancer prevention](https://www.center4research.org/tag/cancer-prevention/)
- [Biden end cancer](https://www.center4research.org/tag/biden-end-cancer/)
- [toxins](https://www.center4research.org/tag/toxins/)
- [Avacopan](https://www.center4research.org/tag/avacopan/)
- [hormones](https://www.center4research.org/tag/hormones/)
- [Envirofill](https://www.center4research.org/tag/envirofill/)
- [turf](https://www.center4research.org/tag/turf/)
- [turf injuries](https://www.center4research.org/tag/turf-injuries/)
- [sport injuries](https://www.center4research.org/tag/sport-injuries/)
- [psychedelic therapy](https://www.center4research.org/tag/psychedelic-therapy/)
- [psychedelic](https://www.center4research.org/tag/psychedelic/)
- [psychedelics](https://www.center4research.org/tag/psychedelics/)
- [MDMA](https://www.center4research.org/tag/mdma/)
- [LSD](https://www.center4research.org/tag/lsd/)
- [psilocybin](https://www.center4research.org/tag/psilocybin/)
- [Ayahuasca](https://www.center4research.org/tag/ayahuasca/)
- [Teplizumab](https://www.center4research.org/tag/teplizumab/)
- [Quinolones](https://www.center4research.org/tag/quinolones/)
- [racial differences](https://www.center4research.org/tag/racial-differences/)
- [vitamin](https://www.center4research.org/tag/vitamin/)
- [Multivitamin](https://www.center4research.org/tag/multivitamin/)
- [ovarian cancer](https://www.center4research.org/tag/ovarian-cancer/)
- [talc](https://www.center4research.org/tag/talc/)
- [talcum powder](https://www.center4research.org/tag/talcum-powder/)
- [neurological devices](https://www.center4research.org/tag/neurological-devices/)
- [mastectomy](https://www.center4research.org/tag/mastectomy/)
- [lumpectomy](https://www.center4research.org/tag/lumpectomy/)
- [pediatric vaccine](https://www.center4research.org/tag/pediatric-vaccine/)
- [Senate](https://www.center4research.org/tag/senate/)
- [cannabis](https://www.center4research.org/tag/cannabis/)
- [cannabinoid](https://www.center4research.org/tag/cannabinoid/)
- [chronic pain](https://www.center4research.org/tag/chronic-pain/)
- [medicare](https://www.center4research.org/tag/medicare/)
- [aduhelm](https://www.center4research.org/tag/aduhelm/)
- [Pain management](https://www.center4research.org/tag/pain-management/)
- [EUA](https://www.center4research.org/tag/eua/)
- [biogen](https://www.center4research.org/tag/biogen/)
- [drug prices](https://www.center4research.org/tag/drug-prices/)
- [drug negotiation](https://www.center4research.org/tag/drug-negotiation/)
- [regulation](https://www.center4research.org/tag/regulation/)
- [FDA drugs](https://www.center4research.org/tag/fda-drugs/)
- [covid-19 tests](https://www.center4research.org/tag/covid-19-tests/)
- [bad covid tests](https://www.center4research.org/tag/bad-covid-tests/)
- [liver](https://www.center4research.org/tag/liver/)
- [liver transplant](https://www.center4research.org/tag/liver-transplant/)
- [OCS system](https://www.center4research.org/tag/ocs-system/)
- [Triguard 3](https://www.center4research.org/tag/triguard-3/)
- [TAVR](https://www.center4research.org/tag/tavr/)
- [gloves](https://www.center4research.org/tag/gloves/)
- [PPE](https://www.center4research.org/tag/ppe/)
- [AccessGUDID](https://www.center4research.org/tag/accessgudid/)
- [CMS](https://www.center4research.org/tag/cms/)
- [Pulmonary Embolectomy](https://www.center4research.org/tag/pulmonary-embolectomy/)
- [TPE](https://www.center4research.org/tag/tpe/)
- [telehealth](https://www.center4research.org/tag/telehealth/)
- [Pfizer vaccine](https://www.center4research.org/tag/pfizer-vaccine/)
- [booster](https://www.center4research.org/tag/booster/)
- [booster vaccine](https://www.center4research.org/tag/booster-vaccine/)
- [covid booster](https://www.center4research.org/tag/covid-booster/)
- [medical device](https://www.center4research.org/tag/medical-device/)
- [servicing](https://www.center4research.org/tag/servicing/)
- [remanufacturing](https://www.center4research.org/tag/remanufacturing/)
- [PDUFA](https://www.center4research.org/tag/pdufa/)
- [MDUFA](https://www.center4research.org/tag/mdufa/)
- [Long COVID](https://www.center4research.org/tag/long-covid/)
- [PASC](https://www.center4research.org/tag/pasc/)
- [Corona](https://www.center4research.org/tag/corona/)
- [hate speech](https://www.center4research.org/tag/hate-speech/)
- [PFOA](https://www.center4research.org/tag/pfoa/)
- [BPA](https://www.center4research.org/tag/bpa/)
- [PFTE](https://www.center4research.org/tag/pfte/)
- [Phthalate](https://www.center4research.org/tag/phthalate/)
- [endocrine](https://www.center4research.org/tag/endocrine/)
- [webinar](https://www.center4research.org/tag/webinar/)
- [Spreading the Word](https://www.center4research.org/tag/spreading-the-word/)
- [CER](https://www.center4research.org/tag/cer/)
- [WIC](https://www.center4research.org/tag/wic/)
- [Special Supplemental Nutrition Program for Women](https://www.center4research.org/tag/special-supplemental-nutrition-program-for-women/)
- [and Children](https://www.center4research.org/tag/and-children/)
- [Endologix](https://www.center4research.org/tag/endologix/)
- [endoleaks](https://www.center4research.org/tag/endoleaks/)
- [EVAR](https://www.center4research.org/tag/evar/)
- [carbetocin](https://www.center4research.org/tag/carbetocin/)
- [Prader Willi Syndrome](https://www.center4research.org/tag/prader-willi-syndrome/)
- [PWS](https://www.center4research.org/tag/pws/)
- [breast augmentation](https://www.center4research.org/tag/breast-augmentation/)
- [GDUFA](https://www.center4research.org/tag/gdufa/)
- [molnupiravir](https://www.center4research.org/tag/molnupiravir/)
- [MOV](https://www.center4research.org/tag/mov/)
- [unvaccinated](https://www.center4research.org/tag/unvaccinated/)
- [bardoxolone](https://www.center4research.org/tag/bardoxolone/)
- [Alport Syndrome](https://www.center4research.org/tag/alport-syndrome/)
- [kidney disease](https://www.center4research.org/tag/kidney-disease/)
- [Ischemic Stroke](https://www.center4research.org/tag/ischemic-stroke/)
- [Advisory Panel](https://www.center4research.org/tag/advisory-panel/)
- [BrainsGate](https://www.center4research.org/tag/brainsgate/)
- [surprise billing](https://www.center4research.org/tag/surprise-billing/)
- [Califf](https://www.center4research.org/tag/califf/)
- [LDCT](https://www.center4research.org/tag/ldct/)
- [low dose computed tomography](https://www.center4research.org/tag/low-dose-computed-tomography/)
- [toxic](https://www.center4research.org/tag/toxic/)
- [chemicals](https://www.center4research.org/tag/chemicals/)
- [toxic chemicals](https://www.center4research.org/tag/toxic-chemicals/)
- [Xeljanz](https://www.center4research.org/tag/xeljanz/)
- [Xeljanz XR](https://www.center4research.org/tag/xeljanz-xr/)
- [Olumiant](https://www.center4research.org/tag/olumiant/)
- [Rinvoq](https://www.center4research.org/tag/rinvoq/)
- [CBD](https://www.center4research.org/tag/cbd/)
- [THC](https://www.center4research.org/tag/thc/)
- [COVID Pill](https://www.center4research.org/tag/covid-pill/)
- [autism](https://www.center4research.org/tag/autism/)
- [autism spectrum disorder](https://www.center4research.org/tag/autism-spectrum-disorder/)
- [baby aspirin](https://www.center4research.org/tag/baby-aspirin/)
- [stroke](https://www.center4research.org/tag/stroke/)
- [prediabetes](https://www.center4research.org/tag/prediabetes/)
- [type 2 diabetes](https://www.center4research.org/tag/type-2-diabetes/)
- [RWD](https://www.center4research.org/tag/rwd/)
- [RWE](https://www.center4research.org/tag/rwe/)
- [Regulatory decision](https://www.center4research.org/tag/regulatory-decision/)
- [pill disposal](https://www.center4research.org/tag/pill-disposal/)
- [cancer moonshot](https://www.center4research.org/tag/cancer-moonshot/)
- [environmental pollution](https://www.center4research.org/tag/environmental-pollution/)
- [puberty](https://www.center4research.org/tag/puberty/)
- [beauty](https://www.center4research.org/tag/beauty/)
- [teenagers](https://www.center4research.org/tag/teenagers/)
- [early puberty](https://www.center4research.org/tag/early-puberty/)
- [girls](https://www.center4research.org/tag/girls/)
- [testimony](https://www.center4research.org/tag/testimony/)
- [oncology](https://www.center4research.org/tag/oncology/)
- [CMS comment](https://www.center4research.org/tag/cms-comment/)
- [coalition](https://www.center4research.org/tag/coalition/)
- [Patient and consumer](https://www.center4research.org/tag/patient-and-consumer/)
- [prescription](https://www.center4research.org/tag/prescription/)
- [CDRH](https://www.center4research.org/tag/cdrh/)
- [kidney](https://www.center4research.org/tag/kidney/)
- [kidney failure](https://www.center4research.org/tag/kidney-failure/)
- [adderall](https://www.center4research.org/tag/adderall/)
- [stimulant](https://www.center4research.org/tag/stimulant/)
- [study drug](https://www.center4research.org/tag/study-drug/)
- [intimate partner violence (IPV)](https://www.center4research.org/tag/intimate-partner-violence-ipv/)
- [ASD](https://www.center4research.org/tag/asd/)
- [Syphilis](https://www.center4research.org/tag/syphilis/)
- [televisits](https://www.center4research.org/tag/televisits/)
- [antenatal care](https://www.center4research.org/tag/antenatal-care/)
- [weight loss](https://www.center4research.org/tag/weight-loss/)
- [intermittent fasting](https://www.center4research.org/tag/intermittent-fasting/)
- [Coumadin](https://www.center4research.org/tag/coumadin/)
- [warfarin](https://www.center4research.org/tag/warfarin/)
- [pradaxa](https://www.center4research.org/tag/pradaxa/)
- [xarelto](https://www.center4research.org/tag/xarelto/)
- [A-fib](https://www.center4research.org/tag/a-fib/)
- [blood clots](https://www.center4research.org/tag/blood-clots/)
- [Dabigatran](https://www.center4research.org/tag/dabigatran/)
- [Rivaroxaban](https://www.center4research.org/tag/rivaroxaban/)
- [Statin](https://www.center4research.org/tag/statin/)
- [preventive statin use](https://www.center4research.org/tag/preventive-statin-use/)
- [USDA](https://www.center4research.org/tag/usda/)
- [School Meals](https://www.center4research.org/tag/school-meals/)
- [Sodium](https://www.center4research.org/tag/sodium/)
- [Whole Grain](https://www.center4research.org/tag/whole-grain/)
- [ALS](https://www.center4research.org/tag/als/)
- [Amylyx](https://www.center4research.org/tag/amylyx/)
- [AMX0035](https://www.center4research.org/tag/amx0035/)
- [non-opioid analgesics](https://www.center4research.org/tag/non-opioid-analgesics/)
- [guideline](https://www.center4research.org/tag/guideline/)
- [user fee](https://www.center4research.org/tag/user-fee/)
- [commitment letter](https://www.center4research.org/tag/commitment-letter/)
- [fitbit](https://www.center4research.org/tag/fitbit/)
- [devices](https://www.center4research.org/tag/devices/)
- [pedometer](https://www.center4research.org/tag/pedometer/)
- [Sleep Apnea](https://www.center4research.org/tag/sleep-apnea/)
- [obstructive sleep apnea](https://www.center4research.org/tag/obstructive-sleep-apnea/)
- [OSA](https://www.center4research.org/tag/osa/)
- [Major depressive disorder](https://www.center4research.org/tag/major-depressive-disorder/)
- [MDD](https://www.center4research.org/tag/mdd/)
- [Suicide risk](https://www.center4research.org/tag/suicide-risk/)
- [high-risk neuroblastoma](https://www.center4research.org/tag/high-risk-neuroblastoma/)
- [accelerated approval](https://www.center4research.org/tag/accelerated-approval/)
- [pollution](https://www.center4research.org/tag/pollution/)
- [zero-emission](https://www.center4research.org/tag/zero-emission/)
- [combined estrogen and progestin](https://www.center4research.org/tag/combined-estrogen-and-progestin/)
- [user fees](https://www.center4research.org/tag/user-fees/)
- [Quality System Regulation](https://www.center4research.org/tag/quality-system-regulation/)
- [transcranial pulse stimulation](https://www.center4research.org/tag/transcranial-pulse-stimulation/)
- [TPS](https://www.center4research.org/tag/tps/)
- [Senate HELP](https://www.center4research.org/tag/senate-help/)
- [Legislation](https://www.center4research.org/tag/legislation/)
- [Novavax](https://www.center4research.org/tag/novavax/)
- [BELVIQ](https://www.center4research.org/tag/belviq/)
- [lorcaserin hydrochloride](https://www.center4research.org/tag/lorcaserin-hydrochloride/)
- [Elivaldogene Autotemcel](https://www.center4research.org/tag/elivaldogene-autotemcel/)
- [post-market surviellance](https://www.center4research.org/tag/post-market-surviellance/)
- [FDASLA](https://www.center4research.org/tag/fdasla/)
- [Pimavanserin](https://www.center4research.org/tag/pimavanserin/)
- [flushing](https://www.center4research.org/tag/flushing/)
- [overprescribing](https://www.center4research.org/tag/overprescribing/)
- [envelopes](https://www.center4research.org/tag/envelopes/)
- [analgesics](https://www.center4research.org/tag/analgesics/)
- [benadryl](https://www.center4research.org/tag/benadryl/)
- [antidepressant](https://www.center4research.org/tag/antidepressant/)
- [bladder](https://www.center4research.org/tag/bladder/)
- [vulvodynia](https://www.center4research.org/tag/vulvodynia/)
- [intimacy](https://www.center4research.org/tag/intimacy/)
- [pelvic pain](https://www.center4research.org/tag/pelvic-pain/)
- [voluntary program](https://www.center4research.org/tag/voluntary-program/)
- [post-market surveillance](https://www.center4research.org/tag/post-market-surveillance/)
- [PET scan](https://www.center4research.org/tag/pet-scan/)
- [New Dietary Ingredients Notification](https://www.center4research.org/tag/new-dietary-ingredients-notification/)
- [NDI](https://www.center4research.org/tag/ndi/)
- [Drug pricing](https://www.center4research.org/tag/drug-pricing/)
- [Medicare negotiation](https://www.center4research.org/tag/medicare-negotiation/)
- [skin](https://www.center4research.org/tag/skin/)
- [melafind](https://www.center4research.org/tag/melafind/)
- [nevisense](https://www.center4research.org/tag/nevisense/)
- [prostate cancer treatment](https://www.center4research.org/tag/prostate-cancer-treatment/)
- [radiotherapy](https://www.center4research.org/tag/radiotherapy/)
- [prostatectomy](https://www.center4research.org/tag/prostatectomy/)
- [cochlear implants](https://www.center4research.org/tag/cochlear-implants/)
- [national coverage](https://www.center4research.org/tag/national-coverage/)
- [teleheath](https://www.center4research.org/tag/teleheath/)
- [young women](https://www.center4research.org/tag/young-women/)
- [ODS](https://www.center4research.org/tag/ods/)
- [dietary supplements](https://www.center4research.org/tag/dietary-supplements/)
- [Physician fee schedule](https://www.center4research.org/tag/physician-fee-schedule/)
- [substance use](https://www.center4research.org/tag/substance-use/)
- [wheelchair](https://www.center4research.org/tag/wheelchair/)
- [seat extenders](https://www.center4research.org/tag/seat-extenders/)
- [monkeypox](https://www.center4research.org/tag/monkeypox/)
- [prevention](https://www.center4research.org/tag/prevention/)
- [Relyvrio](https://www.center4research.org/tag/relyvrio/)
- [Coverage with Evidence](https://www.center4research.org/tag/coverage-with-evidence/)
- [carbon tetrachloride](https://www.center4research.org/tag/carbon-tetrachloride/)
- [Risk Determination](https://www.center4research.org/tag/risk-determination/)
- [TSCA](https://www.center4research.org/tag/tsca/)
- [CED](https://www.center4research.org/tag/ced/)
- [policy riders](https://www.center4research.org/tag/policy-riders/)
- [NIOSH](https://www.center4research.org/tag/niosh/)
- [ABRWH](https://www.center4research.org/tag/abrwh/)
- [Radiation](https://www.center4research.org/tag/radiation/)
- [Ephedra](https://www.center4research.org/tag/ephedra/)
- [CLIAC](https://www.center4research.org/tag/cliac/)
- [CLIA](https://www.center4research.org/tag/clia/)
- [laboratory](https://www.center4research.org/tag/laboratory/)
- [21st Century Cures Act](https://www.center4research.org/tag/21st-century-cures-act/)
- [bii evidence](https://www.center4research.org/tag/bii-evidence/)
- [Premarket Safety](https://www.center4research.org/tag/premarket-safety/)
- [FMQ](https://www.center4research.org/tag/fmq/)
- [FDA Medical Queries](https://www.center4research.org/tag/fda-medical-queries/)
- [safety assessments](https://www.center4research.org/tag/safety-assessments/)
- [Integrated guide](https://www.center4research.org/tag/integrated-guide/)
- [cobalt](https://www.center4research.org/tag/cobalt/)
- [inhalation exposure](https://www.center4research.org/tag/inhalation-exposure/)
- [IAP](https://www.center4research.org/tag/iap/)
- [OSHA](https://www.center4research.org/tag/osha/)
- [danger](https://www.center4research.org/tag/danger/)
- [gates](https://www.center4research.org/tag/gates/)
- [enclosures](https://www.center4research.org/tag/enclosures/)
- [warning label](https://www.center4research.org/tag/warning-label/)
- [VALID](https://www.center4research.org/tag/valid/)
- [omnibus](https://www.center4research.org/tag/omnibus/)
- [diagnostic test](https://www.center4research.org/tag/diagnostic-test/)
- [IRB](https://www.center4research.org/tag/irb/)
- [human subjects](https://www.center4research.org/tag/human-subjects/)
- [institutional review boards](https://www.center4research.org/tag/institutional-review-boards/)
- [single IRB](https://www.center4research.org/tag/single-irb/)
- [ortho-phthalates](https://www.center4research.org/tag/ortho-phthalates/)
- [Breakthrough](https://www.center4research.org/tag/breakthrough/)
- [perfluoroalkyl](https://www.center4research.org/tag/perfluoroalkyl/)
- [polyfluoroalkyl](https://www.center4research.org/tag/polyfluoroalkyl/)
- [CASRN](https://www.center4research.org/tag/casrn/)
- [recordkeeping](https://www.center4research.org/tag/recordkeeping/)
- [loophole](https://www.center4research.org/tag/loophole/)
- [APBR](https://www.center4research.org/tag/apbr/)
- [adult portable bed rails](https://www.center4research.org/tag/adult-portable-bed-rails/)
- [safety standards](https://www.center4research.org/tag/safety-standards/)
- [proposed ruling](https://www.center4research.org/tag/proposed-ruling/)
- [bed trapezes](https://www.center4research.org/tag/bed-trapezes/)
- [adjustable beds](https://www.center4research.org/tag/adjustable-beds/)
- [nonslip mattress pads](https://www.center4research.org/tag/nonslip-mattress-pads/)
- [bed exit alarms](https://www.center4research.org/tag/bed-exit-alarms/)
- [nalaxone](https://www.center4research.org/tag/nalaxone/)
- [etc](https://www.center4research.org/tag/etc/)
- [over the counter](https://www.center4research.org/tag/over-the-counter/)
- [non prescription](https://www.center4research.org/tag/non-prescription/)
- [public comment](https://www.center4research.org/tag/public-comment/)
- [SAMHSA](https://www.center4research.org/tag/samhsa/)
- [confidentiality](https://www.center4research.org/tag/confidentiality/)
- [patent](https://www.center4research.org/tag/patent/)
- [USPTO](https://www.center4research.org/tag/uspto/)
- [hpv](https://www.center4research.org/tag/hpv/)
- [pap smear](https://www.center4research.org/tag/pap-smear/)
- [Guillain-Barré syndrome](https://www.center4research.org/tag/guillain-barre-syndrome/)
- [gbs](https://www.center4research.org/tag/gbs/)
- [gardasil](https://www.center4research.org/tag/gardasil/)
- [baby](https://www.center4research.org/tag/baby/)

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