In July 2022, Reuters exclusively reported that the United States Department of Justice (DOJ) opened a criminal investigation into Cassava Sciences Inc., over whether the company manipulated research results for its experimental Alzheimer’s drug, simufilam. On its website, Cassava explains that simufilam is an “entirely new approach” to Alzheimer’s treatment and that the medicine does not “seek to clear amyloid out of the brain,” but instead focuses on stabilizing a critical protein in the brain.
Reuters notes that its sources say that the criminal investigation began after a petition was filed with the United States Food and Drug Administration (FDA) in August 2021 by two physicians who were asking the agency to stop clinical trials of simufilam. Jordan Thomas, a New York lawyer representing the two physicians in the filing, said that Cassava’s published studies on simufilam’s clinical trials in various journals contained data misrepresentation and images of experiments that seemed to have been manipulated by photo-editing software.
The FDA denied the petition and allowed the trials to continue. The FDA said that the petition filed by the physicians was not the proper avenue for such a request, as it was a citizen petition and enforcement actions are “expressly excluded from the scope of the FDA’s citizen petition procedures.” The FDA exercises its own discretion on enforcement actions.
According to Reuters, the investigators working on the investigation specialize in looking at whether companies (or individuals) misled or defrauded investors, government agencies, or consumers.
As is the case with any DOJ investigation, it is just an investigation and may or may not ultimately lead to criminal charges being filed.
Cassava Response
Reuters published an emailed statement from Kate Watson Moss, a lawyer representing Cassava, which neither confirmed nor denied the investigation, but did “vehemently” deny “any and all allegations of wrongdoing,” saying that the company “has never been charged with a crime, and for good reason – Cassava Sciences has never engaged in criminal conduct.”
Watson Moss did note, though, that Cassava Sciences did receive confidential requests for information from government agencies, but did not identify which agencies, saying, “Cassava Sciences has provided information in response to these requests in full satisfaction of its legal obligations,” noting that there has been no accusation that the company did anything wrong.
SEC Investigation
This news follows scrutiny from the United States Securities and Exchange Commission (SEC), prompted when the two physicians from outside the company made the aforementioned allegations of data manipulation and misrepresentation involving research for simufilam, the company’s Alzheimer’s drug.