Caroline Bradford

National Center for Health Research Public Comment on FDA Draft Guidance: Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics

February 4, 2025: In our written public comment, we urged FDA to improve its draft guidance on the accelerated approval process by requiring and enforcing timely confirmatory trials proving meaningful clinical benefit based on validated measures of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.

National Center for Health Research Comment on Medicare Coverage for Transcatheter Tricuspid Valve Replacement

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.

National Center for Health Research Comment on USPSTF Draft Recommendations on Cervical Cancer Screening

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.

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.

He Regulated Medical Devices. His Wife Represented Their Makers.

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?