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.
NCHR’s Statement to FDA Advisory Committee Meeting on Neurological Devices – June 3, 2021 I’m Dr. Diana Zuckerman, president of the National Center for Health Research. Our center is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. Today I’m speaking from my perspective as a scientist trained in epidemiology and … Continue reading NCHR’s Statement to FDA Advisory Committee Meeting on Neurological Devices
NCHR Statement at FDA Advisory Committee Meeting on Keytruda and Tecentriq for Advanced Urothelial Carcinoma – 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 Statement Regarding Cancer Drugs that Failed to Confirm Efficacy after Accelerated Approval – 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.
Written Statement Regarding Artificial Turf to Woodbridge Ordinance Committee – Dr. Diana Zuckerman speaks out against the use of artificial turf to Woodbridge Ordinance Committee due to potential harm to children.
Statement on Keytruda for Early Stage Triple Negative Breast Cancer – February 9, 2021 The National Center for Health Research is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products. We don’t accept funding from companies that make those products, so we have no conflicts of interest. We welcome the opportunity to provide our views on Merck’s application for approval of Keytruda … Continue reading Statement on Keytruda for Early Stage Triple Negative Breast Cancer
NCHR Statement by Dr. Diana Zuckerman at FDA Covid Vaccine Advisory Committee – October 22, 2020. The study design that FDA agreed to and that the companies are implementing have serious flaws. As a result, we might not know if the vaccines save lives and reduce COVID hospitalizations.
Testimony of Dr. Diana Zuckerman of NCHR before the FDA Advisory Committee on Pfizer COVID Vaccine – December 10, 2020. The 2 month median follow-up is too short, so the randomized controlled trial should be continued. And there are too few people of color among the COVID cases in their study.
Dr. Diana Zuckerman’s Testimony on Moderna’s COVID Vaccine Before the FDA Advisory Committee – 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.
Public Comments Regarding ACIP Meeting on December 1, 2020 – Diana Zuckerman, Ph.D., on behalf of the National Center for Health Research Thank you for the opportunity to express my views on behalf of the National Center for Health Research regarding the priorities for allocation of initial supplies of the COVID-19 vaccines. Our center is a nonprofit think tank that scrutinizes the safety and effectiveness … Continue reading Public Comments Regarding ACIP Meeting on December 1, 2020
NCHR’s Public Comments on FDA’s Proposed Inclusion of Older Adults in Cancer Clinical Trials – 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 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.
CPTF 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.
NCHR’s 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.
National Center for Health Research Written Statement to Greenwich Board of Education – February 19, 2020. We have found many issues with artificial turf, such as lead, high heat issues, and other environmental concerns. We urge communities to protect themselves and their children from these risks.
NCHR Testimony on Low Nicotine Cigarette Claim – February 14, 2020. NCHR strongly opposes the approval of this modified risk application by the 22nd Century Group for their low-nicotine combusted filtered cigarette tobacco products. Evidence is lacking to support the claim that this product significantly reduces harm for smokers. At the same time, it is likely to entice people who have never smoked, especially adolescents, to start smoking.
Coalition Letter Urging Support for the Reversing the Youth Tobacco Epidemic Act – February 4, 2020 See PDF: Coalition Letter Urging Support for HR 2339 2.4.20 U.S. House of Representatives Washington, DC 20515 Dear Representative: We are writing to express our strong support for H.R. 2339, the Reversing the Youth Tobacco Epidemic Act of 2019. This legislation will address the current youth e-cigarette epidemic that is undermining the … Continue reading Coalition Letter Urging Support for the Reversing the Youth Tobacco Epidemic Act
NCHR Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut – January 21, 2020. We strongly oppose the approval of the modified risk application for Copenhagen Snuff Fine Cut with the claim “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer.” This claim may encourage non-smokers to begin using tobacco. Using smokeless tobacco increases the risk of serious health issues.
NCHR’s Comments on the Safer Technologies Program (STeP) for Medical Devices – November 18, 2019. We therefore respectfully urge the FDA to revise the proposed guidance in ways that ensure that all medical devices undergo more rigorous testing prior to being approved or cleared.
NCHR Testimony on Research Needed on Immunological Responses to Metal in Implants – November 13, 2019. Dr. Diana Zuckerman describes the types of research needed to reduce harm from the metal and other substances in implanted devices, including joint replacements, cardiac implants, mesh, reproductive devices, and many other types of implants.