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.
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NCHR’s 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.
Read More »Scientific Coalition Letter on Aduhelm to HHS Inspector General, CMS, and Congress
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.
Read More »NCHR’s Comments on AHRQ’s 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.
Read More »NCHR’s 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.
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