Testimony of Dr. Diana Zuckerman About I-omburtamab FDA Advisory Committee Meeting – 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 Testimony at FDA Advisory Panel on Wound Dressings – 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.
Testimony of Diana Zuckerman at the Meeting of EPA’s National Environmental Justice Advisory Council on September 28, 2022 – 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.
Testimony of Dr. Diana Zuckerman About COPIKTRA FDA Advisory Committee Meeting on September 23, 2022 – Dr. Zuckerman of National Center for Health Research testified at FDA Advisory Committee in September 2022 about Copiktra for CLL and SLL. Compared to another treatment option that is no longer considered effective, Copiktra patients lived 11 months shorter with many serious problems harming quality of life.
Testimony of Dr. Diana Zuckerman About PEPAXTO FDA Advisory Committee Meeting on September 22, 2022 – 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.
Diana Zuckerman Statement on the Role of FDA in Health Inequities Meeting of the National Academy of 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.
Dr. Diana Zuckerman Statement to CDC Advisory Committee On Breast Cancer in Young Women – August 23, 2022: Today I want to mention an issue that hasn’t been talked about: fear. 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.
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.