Who Should You Believe? A critique of the Aesthetic Society’s view of Breast Implant Illness – 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.
Public Comment PDUFA VII Commitment Letter (Docket #FDA-2021-N-0891) From the National Center for Health Research – October 28, 2021: CPTF comments on the proposed PDUFA VII Commitment Letter from the FDA.
Statement by Dr. Diana Zuckerman on Sintilimab at FDA Advisory Committee on Oncologic Drugs – February 10, 2022: CPTF president Dr. Diana Zuckerman testifies to the FDA Advisory Committee on Oncologic Drugs on Sintilimab.
Comments on CMS’s Proposed Decision Memo on Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) – December 17, 2021: We are concerned with several major aspects of CMS’s discussion of Counseling and Shared Decision-Making for lung cancer screening.
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: We urge the FDA to regulate all these neurological devices in question as Class II, and to 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 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 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.
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.
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.
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 – 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.
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.