Allegations of research fraud (Against Cassava Sciences)
Reuters reported on July 27, 2022, that a criminal investigation of Cassava Sciences had been started by the United States Department of Justice (DOJ) over research results related to simufilam.[1] Two anonymous sources told Reuters that the investigation involved allegations that the company had "manipulated research results".[1] A citizen petition attempting to suspend the clinical trials was filed with the Food and Drug Administration (FDA), but the FDA said that the citizen petition "was not a proper avenue" to stop the trials in February 2022. The request that FDA conduct an investigation fell out of the purview of the citizen petition process.[1]
The Wall Street Journal stated in 2021 that the SEC, the NIH, and CUNY were also investigating allegations of manipulated data.[3]
Cassava Sciences has denied any wrongdoing.[2] Kate Moss, attorney, stated via email to Reuters that "Cassava Sciences ... has never been charged with a crime, and for good reason – Cassava Sciences has never engaged in criminal conduct."[1] Piller summarized an email from Barbier as saying Cassava had "hired investigators to review its work, provided 'nearly 100,000 pages of documents to an alphabet soup of outside investigative agencies,' and asked CUNY to investigate ... 'there is no evidence of research misconduct'."[14] In November 2022, Cassava filed a defamation lawsuit against Quintessential Capital, Geoffrey Pitt and David Bredt accusing them of making over 1000 false and defamatory statements about the company.[28]
Other concerns raised[edit]
A New York Times article stated in April 2022 that "many scientists have been deeply skeptical of the company's claims, asserting that Cassava's studies were flawed, its methods opaque and its results improbable".[9] Robert Howard, professor of psychiatry at the University College London, remarked that the lack of placebo and small sample size meant research conclusions were "implausible" at the least.[9] Elisabeth Bik, image-manipulation consultant, agreed to the citizen petition and alleged data errors and inconsistencies in the publications, identifying potential irregularities consistent with instances of copy and paste across different experiments.[3] Thomas C. Sdhof, Nobel laureate neuroscientist at Stanford University, also commented: "The overall conclusions with regard to Alzheimer's disease make no sense to me whatsoever... [The findings of Cassava Sciences] are not in the mainstream of the field, and to me they seem implausible and contrived."[9]
https://en.wikipedia.org/wiki/Cassava_Sciences