Cassava’s former execs settled after a fraud indictment about Alzheimer's drug simulfilam. Experts ask whether it's time to stop the clinical trials.
On September 26th, Cassava Sciences’ founder and former CEO Remi Barbier, as well as former vice president Lindsay Burns agreed to pay the Securities and Exchange Commission $40 million to settle charges related to misleading statements they made about Phase 2 clinical trials for Cassava’s experimental Alzheimer’s drug simufilam. The SEC order alleges that Burns cherry-picked data that made it look like participants on the drug improved their memory, when the trial results were actually negative.
Hoau-Yan Wang, the drug’s drug’s co-developer and former paid advisor who was indicted by the Department of Justice for fraud, was also charged by the SEC with manipulating clinical trial results. The SEC alleges that Wang received unblinded data, meaning he knew which participants received the drug and which received the placebo, and fudged the data so it looked like the drug reduced Alzheimer’s biomarkers.
Dr. Matthew Schrag, a neurologist and assistant professor at Vanderbilt University, told Being Patient that continuing these trials is “unethical” given the serious concerns surrounding the underlying data.
“When we violate our ethical responsibilities to these patients, we’re undermining the future of clinical trials in this space,” Schrag said.
In 2021, two neuroscientists filed a petition with the FDA to halt clinical trials alleging that the company’s research was fraudulent. Schrag, whose investigations in scientific misconduct are independent of his work at Vanderbilt University, was one of the experts who helped flag potential issues with the drugmakers’ data in the petition.
The filers of the petition admitted they bet on the company’s stock to go down. The FDA denied the petition, but independent experts continued to flag anomalies in the company’s data, leading to several investigations.
“When we violate our ethical responsibilities to
these patients, we’re undermining the future of
clinical trials in this space.”
Last year, CUNY filed an investigative report to explore allegations of misconduct by Wang. A leaked, incomplete, and unofficial report by investigators allegedly found “egregious misconduct” and the data to be “highly questionable.”
However, because the report was leaked before being finalized, the investigation was put on pause.
Adding to the controversies at hand, Cassava Sciences has filed defamation lawsuits against the scientists who filed the citizen petition, an investment firm that researches and bets against companies they believe are fraudulent, and scientists who have criticized the company’s data online and bet against the company. A judge recently filed a motion to dismiss Cassava’s case.
The company is currently conducting two phase three trials of simufilam, with results expected by the end of the year.
“If the studies were to, by some chance, have a positive outcome, nobody in their right mind could trust the outcome,” Schrag said. Although the data provided by Cassava Sciences’ press releases shows that the drug is safe, he isn’t sure the data can be trusted.
“Any responsible regulatory agency involved in this process should be looking to take steps to protect these patients immediately,” he said.
This article is riddled with inaccurate statements and is heavily biased. Why is that?
Hi William, Our reporting team has been closely following the fraud allegations and indictment throughout the simufilam trial and are dedicated to sharing factual, objective news with our community, many of whom are people affected first-hand by Alzheimer’s. We stand by our reporting. Thanks for reading.
I have been following this company very closely and I found nothing inaccurate or biased in this article. Perhaps you have an invested interest in this company? An honest board and executive team has shut down the trials and now I wait for the class actions that are surely coming.