The probe will be led by investigators experienced in determining whether or not entities have defrauded consumers, investors or government agencies.
The United States Department of Justice has opened an investigation into the Austin, Texas-based Cassava Sciences regarding allegations that the company falsified data to support simufilam, its drug candidate for Alzheimer’s disease. The probe could swing both ways, leading to criminal charges or end with no resulting lawsuit.
The probe, revealed in an exclusive report by Reuters, will be led by investigators experienced in determining whether or not entities have defrauded consumers, investors or government agencies, according to two unnamed sources.
Cassava, through its lawyer, denies wrongdoing: “To be clear: Cassava Sciences vehemently denies any and all allegations of wrongdoing,” Kate Watson Moss, the company’s representing lawyer, told Reuters in an emailed statement. She added that Cassava “has never been charged with a crime, and for good reason - Cassava Sciences has never engaged in criminal conduct.”
A spokesperson from the DOJ declined to comment on the matter.
Cassava’s woes started in August last year when Labaton Sucharow, a shareholder rights law firm, submitted a citizen’s petition to the U.S. Food and Drug Administration alleging that the company, through its SVP of neuroscience Dr. Lindsay Burns and scientific advisor Dr. Hoau-Yan Wang, fabricated data to support simufilam.
At the time, Jordan Thomas, partner and chair of the whistleblower representation practice at the New York-based law firm, wrote: “The volume of problematic material uncovered in publicly available sources indicates a thorough audit would likely unveil significant additional scientific misconduct and data manipulation.” In line with this, Thomas asked regulatory bodies to stop Cassava’s trials.
In filing the petition to the FDA, Jordan was representing two doctors: Geoffrey Pitt, cardiologist and professor at Weill Cornell Medicine, and David Bredt, former chief of neuroscience research at Eli Lilly and Johnson & Johnson. At the core of the fabrication allegations were Western blot images which the petitioners said bore obvious evidence of photo manipulation.
Three months later, in November, the U.S. Securities and Exchange Commission acted on Thomas’ allegations and opened an investigation into Cassava. In response, the company threw out its own allegations, accusing both Bredt and Pitt of being short-sellers—those who bet on and profit from a drop in stock prices. In February this year, the FDA denied the citizen petition.
Still, Cassava’s simufilam problems continue. In April, a New York Times article brought to light a series of paper retractions by Wang. The studies, published in the peer-reviewed open-access server PLoS One, were flagged by the journal’s staff for having “serious concerns about the integrity and reliability of the results.” Two of these papers were co-written by Burns and focused on a brain protein that simufilam targets.
These retractions set off a series of reviews of Wang’s papers in other journals. While many have found no evidence of tampering, the German multinational publisher Springer ended up pulling another of Wang’s papers over issues surrounding its Western blot images.
Simufilam is an oral small molecule drug that addresses Alzheimer’s by undoing alterations in the shape and function of the brain scaffolding protein filamin A. Scientists have posited that abnormalities in filamin A could compromise normal neuronal function, giving rise to the typical Alzheimer’s pathology.
