The fraud charges against City University of New York (CUNY) Professor Hoau-Yan Wang relating to Cassava Sciences’ proposed Alzheimer’s drug Simufilam, have rocked confidence in the science underpinning the company’s claims, and sent a strong message to researchers, say lawyers.
The BMJ reports that Wang is charged with one count of major fraud against the US, which carries a maximum sentence of 10 years; two counts of wire fraud, with a maximum sentence of 30 years; and making false statements, punishable by up to five years.
Wang “made false, fraudulent, and misleading statements about the mechanism by which drug A (Aimufilam) was designed to treat Alzheimer’s disease, and the improvement of certain indicators associated with advanced Alzheimer’s disease neurodegeneration in patients treated with drug A”, the charging document alleges.
Wang had received about $16m in research grants from the National Institutes of Health between 2017 and 2021 and is also accused of manipulating or adding to images of Western blots, the method used by researchers to identify proteins, in his efforts to bolster evidence and help these secure grants.
NBC News reports that Simufilam is currently in a late-stage clinical trial, and some 735 patients had participated as of May 2024, according to a statement from Cassava last month, which said Wang had not participated in this most recent trial: “Wang’s work under these grants was related to the early development phases of the drug candidate and diagnostic test and how these were intended to work.”
Overall, the manipulation of research images and the handling of allegations of research misconduct is a growing concern in the scientific community.
The issue gained particular attention last summer, when then-Stanford President Marc Tessier-Lavigne stepped down from his post after allegations arose that images had been manipulated within his lab. Tessier-Lavigne said he never submitted papers he didn’t think were accurate and noted that a panel investigating his work did not find that he knew of misconduct within his lab.
Then in January, an amateur science sleuth made allegations of research image manipulation by top scientists at the Dana-Farber Cancer Institute, which led to subsequent retractions. Dana-Farber said it took decisive action to correct the scientific record.
Wang’s work has faced questioning for some time, as the journal Science has reported. The journal obtained a report by CUNY that found evidence suggesting research misconduct. The university halted its investigation after Science published the report.
Multiple journal articles on which Wang was an author have been retracted, according to Retraction Watch, which reported lawyers as saying the criminal indictment is a “rare” outcome for such alleged actions that “sends a very, very powerful message”.
While many investigations by the US Office of Research Integrity and other government watchdogs find scientists manipulated data in grant applications to the National Institutes of Health and National Science Foundation, few are charged with “major fraud against the United States”, like Wang.
CUNY had investigated 31 allegations of research misconduct against Wang and found “long-standing and egregious misconduct in data management and record-keeping” by the researcher.
The US Department of Justice “rarely” files criminal indictments against scientists for faking data, said Mark Barnes, a partner at the Boston firm Ropes & Gray, who added that such charges come only when the agency is “really convinced that there has been intentional bad behaviour by a scientist squandering public money”.
In 2005, Eric Poehlman, a former researcher at the University of Vermont, pleaded guilty to charges brought by the US attorney’s office which alleged Poehlman received nearly $3m in grants from the NIH and US Department of Agriculture based on applications containing fake data.
Anaesthesiologist Scott Reuben in 2010 was sentenced to six months in prison, plus three years of supervised release, and ordered to pay fines and restitution, after pleading guilty to healthcare fraud on charges he published studies with falsified research.
In 2015, a judge sentenced Dong-Pyou Han, an Aids vaccine researcher, to nearly five years in prison and ordered him to repay $7m in grant money to the NIH.
The following year, physicist Sean Darin Kinion, formerly of Lawrence Livermore National Laboratory in California, was sentenced to 18 months in prison for faking quantum computing work, and ordered to repay the government more than $3m.
Last year, Purdue University in Indiana agreed to pay $737 000 in the case of Alice C. Chang, after faked data was found in 16 grant applications. Other large settlements include $112.5m from Duke University in 2019, $10m from Brigham and Women’s Hospital for the Piero Anversa case in 2017, and $9.5m from Columbia University in 2016.
Attorney Richard Goldstein, who has worked for the government and now represents scientists involved in research misconduct cases, said Wang’s indictment “sends a very, very powerful message”, that scientists should be careful when submitting grant applications.
“It suggests that deliberate manipulation of Western blots that result in federal funding can result in a criminal indictment.”
See more from MedicalBrief archives:
Alzheimer’s researcher in court for fraud
Leading Alzheimer’s study under investigation over possible manipulation
More allegations against Stanford president’s Alzheimer’s study