The Food and Drug Administration should halt Cassava Sciences’ ongoing clinical trials in Alzheimer’s disease. That, and other thoughts on the fallout from the City University of New York investigation that raised serious doubts about the science underpinning the company’s experimental drug simufilam.
Patient safety is paramount to the FDA, so stopping Cassava’s two Phase 3 studies is the ethically correct thing to do.The FDA has the power to place clinical holds on experimental drugs when there’s evidence of an unacceptable safety risk to study participants. Simufilam doesn’t appear to be toxic. It’s not causing dangerous side effects. But study participants can also be harmed when they volunteer for a clinical trial based on false or misleading information about a drug’s potential efficacy.
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The CUNY committee charged with investigating Cassava’s principal scientific collaborator, the neuroscientist Hoau-Yan Wang, could not definitively prove that Wang faked simufilam data, but that’s only because he refused to turn over original data and primary research records that the committee had requested to examine. Wang also claimed that boxes of research records relevant to the investigation were thrown away. The investigative report was first made public last week in the journal Science.
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