July 12, 2017. Given the research design, only one pivotal study, the lack of U.S. patients, and a less than convincing literature review, the data do not support sufficient support for approval. The studies, in our view, do not provide strong evidence that GO is effective and there are still continuing safety concerns.
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NCHR Testimony at FDA Meeting on Pediatric Cancer Drugs
At the FDA Advisory Committee meeting, Dr. Megan Polanin of the National Center for Health Research expressed concerns about inadequate evidence regarding the safety and effectiveness of drugs for rare pediatric cancers, pointing out that it is better to provide experimental drugs for free in a clinical trial rather than approving those drugs based on inadequate preliminary evidence with the knowledge that they will be unaffordable because insurance companies will not pay for drugs that are not proven to work.
Read More »NCHR Testimony to FDA on Victoza to Prevent Cardiovascular Events
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 »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.
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