June 20 2017: Dr. Stephanie Fox-Rawlings of the National Center for Health Research told the FDA Advisory Committee that Victoza shouldn’t be approved to prevent heart problems in patients with type 2 diabetes unless better research is done on American patients to prove it works for them.
Read More »On Medical Treatments & Products
NCHR Testimony to FDA About L-Glutamine for Sickle Cell Crisis
Stephanie Fox-Rowlings May 24 2017: FDA should only approve new treatments when there is clear proof they are safe and helpful. If many people drop out of the study, it’s hard to know if the drug really works, and the FDA should not approve it without strong evidence.
Read More »NCHR Testimony to FDA About Neratinib to Prevent Breast Cancer Reccurance
The National Center for Health Research advises the FDA to delay approval of neratinib for early-stage HER2-positive breast cancer, highlighting that the drug offers only a slight improvement in preventing cancer recurrence while causing serious side effects like severe diarrhea and fatigue, which led many patients to stop treatment.
Read More »NCHR Testimony at FDA Meeting about Duchenne Muscular Dystrophy Clinical Trial
May 18, 2017. Patients with Duchenne muscular dystrophy and their loved ones deserve the benefits of the most rigorous research available. At the same time, investing in a clinical trial requires significant time and effort, and patients ALWAYS face risks without any guarantee of benefits. Patients and families who are willing to participate in a clinical trial that has the potential to benefit many should be fully informed about the potential risks and benefits of their participation in order to make a decision that is best for them.
Read More »NCHR Testimony at the FDA about a Vaccine for Respiratory Syncytial Virus (RSV)
Megan Polanin May 17 2017: The NCHR advises the FDA to be cautious when approving RSV vaccines, emphasizing the need for strong evidence of safety and effectiveness, especially before giving them to infants who have never had RSV.
Read More »