Cassava Sciences’ experimental Alzheimer’s drug simufilam is under fire again. City University of New York filed an investigative report to explore allegations of misconduct by scientists who developed simufilam, finding the data to be “highly questionable.” As of Oct. 27, investigation itself is now under investigation.
DEVELOPING STORY, updated 30 October, 2023: In August 2021, the biotechnology company Cassava Sciences — makers of simufilam, an experimental Alzheimer drug currently in Phase 3 clinical trials — was accused of scientific misconduct and fraud by a shareholders’ rights law firm. Cassava Sciences’ stock took a tumble after the firm raised concerns about data on the drug via a Food and Drug Administration citizen petition (a public request made by individuals and community organizations to change or alter a health policy). The FDA citizen petition suggested Cassava should suspend simufilam’s clinical trials until new trial data is reviewed and audited. It’s been drama ever since.
At first glance, this story from the US relates to a commercially sponsored clinical trial. Still, it allows us to make some points relevant to human research in all disciplines and methodologies. If work is essential for the reputation and finances of your body (whether commercial, academic, NGO or other), it is not enough to conduct excellent and impactful search, and you need to be perceived as doing that work ethically, with integrity and responsibly. This story highlights severe consequences if there is a perception that you have not done the research in that way.
According to David Vaux, deputy director of scientific integrity and ethics at the Walter and Eliza Hall Institute of Medical Research, the concerns brought up in the 2021 FDA citizen petition were legitimate and troubling. Eventually, the citizen’s petition was denied on a technicality.
But now, an internal report from an investigative committee at the City University of New York (CUNY), leaked to Science Magazine by an unknown source, has accused CUNY faculty member Hoau-Yan Wang — a neuroscientist who worked with Cassava on the development of simufilam — of scientific misconduct.
The 50-page report by this investigative committee — a four-member panel of researchers at the university — calls into question 20 research papers, many of which informed Cassava’s approach to developing simufilam, according to Science.