Following a bombshell report that alleges the most widely referenced study on Alzheimer’s this century includes fabricated and/or duplicated images, a criminal investigation has been launched by the U.S. Department of Justice against Cassava Sciences, the drug manufacturer suspected of presenting the fraudulent research in support of its own development and manufacturing of pharmaceuticals.
The investigation seeks to determine whether Cassava Sciences defrauded investors, government agencies, or consumers, Reuters reported.
Matthew Schrag, a neuroscientist and physician at Vanderbilt University, first discovered the peculiarities upon a study of the data Cassava Sciences used in developing an experimental drug for Alzheimer’s called Simufilam. Schrag had been contacted and hired by an attorney for two investors, both neurologists, who believed the data used in the company’s research might be fraudulent.
Schrag’s investigation led him to a 2006 study published in Nature by neuroscientist Sylvain Lesné of the University of Minnesota (UMN) that “underpins a key element of the dominant yet controversial amyloid hypothesis of Alzheimer’s, which holds that [protein amyloid beta] Aβ clumps, known as plaques, in brain tissue are a primary cause of the devastating illness,” Science Magazine reported.
Kate Watson Moss, a lawyer representing Cassava, would not confirm nor deny the existence of the DOJ’s criminal probe in an email statement to Reuters.
“To be clear: Cassava Sciences vehemently denies any and all allegations of wrongdoing,” Watson Moss said, adding the company “has never been charged with a crime, and for good reason – Cassava Sciences has never engaged in criminal conduct.”
Nevertheless, independent experts alongside Science Magazine’s own investigation concurred with Schrag and cast doubt on hundreds of images, many of which exhibited “shockingly blatant” evidence of image doctoring.
The authors “appeared to have composed figures by piecing together parts of photos from different experiments,” says Elisabeth Bik, a molecular biologist and well-known forensic image consultant. “The obtained experimental results might not have been the desired results, and that data might have been changed to … better fit a hypothesis.”
“The immediate, obvious damage is wasted NIH funding and wasted thinking in the field because people are using these results as a starting point for their own experiments,” said Stanford University neuroscientist Thomas Südhof, a Nobel laureate and expert on Alzheimer’s.
“Even if misconduct is rare, false ideas inserted into key nodes in our body of scientific knowledge can warp our understanding,” Schrag concurred.
The criminal investigation was apparently spurred by a petition from New York attorney Jordan Thomas, the counsel for both of the interested neurologists and the lawyer who hired Schrag to conduct the investigation and help make possible a case against Cassava Sciences. The petition filed in August 2021 with the U.S. Food and Drug Administration sought to halt clinical trials for simufilam, but the FDA denied it and allowed the trials to continue.
Adding to what may turn out to be a massive scandal is the fact that Thomas’ clients are short-sell investors in Cassava, and as such, they are positioned to do well even if the drug company’s stock falls.
Claims by the pair that they no longer have a short position in the company could not be verified by Reuters.
For her part, Watson Moss reiterated, “Cassava Sciences is interested in helping those with Alzheimer’s disease, not an easy payday.”
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