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 »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
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 Report on Integrated Pain Management Programs
June 21, 2021. While we agree with the stated objective of a report evaluating the effectiveness and harms of pain management programs in the Medicare population, this report has several serious limitations.
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.
Read More »