June 17, 2022: In 2018 FDA was concerned about “the numbers of reports of death and other serious adverse events” regarding this drug, which already carries a black box warning that there is “increased mortality in elderly patients with dementia-related psychosis.” To outweigh such serious safety risks, the benefits of this drug would need to be substantial. However, there is no such evidence.
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NCHR’s Testimony to FDA on the Novavax COVID-19 Vaccine
June 7, 2022: While this vaccine demonstrates similar levels of efficacy as compared to vaccines approved for COVID-19, the data suggests additional safety risks. Even if it is not proven to be less safe than the other COVID vaccines, it lacks long-term, placebo-controlled efficacy data and there is very little safety or efficacy data for the most at-risk patients. When we already have vaccines on the market that are FDA approved, and based on much better data, why would the FDA authorize this vaccine?
Read More »NCHR’s Testimony to FDA on End of Induction Response in High-Risk Neuroblastoma
May 12, 2022. Clinical benefits should remain the key endpoints for approval decisions of these treatments. Surrogate endpoints that predict clinical benefits are not yet established and until they are, we are concerned about their use as secondary endpoints unless the primary endpoint is also met.
Read More »Testimony of Dr. Diana Zuckerman About IV Tramadol Before FDA Advisory Committee
February 15, 2022: NCHR testifies against the opioid, tramadol, administered by IV to the FDA Advisory Committee.
Read More »Statement by Dr. Diana Zuckerman on Sintilimab at FDA Advisory Committee on Oncologic Drugs
February 10, 2022: NCHR president Dr. Diana Zuckerman testifies to the FDA Advisory Committee on Oncologic Drugs on Sintilimab.
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