The recent criminal indictment of a medical school professor and former scientific advisor to Cassava Sciences on fraud charges for manipulating images in scientific papers and applications for federal funding is a “rare” outcome for such alleged actions that “sends a very, very powerful message.”
That’s according to lawyers who have worked on research misconduct cases.
While many investigations by the U.S. 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,” as was Hoau-yan Wang.
Wang, a professor of medicine at the City University of New York School of Medicine, has had seven papers retracted, some involving work for Cassava, which is developing a drug to treat Alzheimer’s disease.
CUNY investigated 31 allegations of research misconduct against Wang and found “long-standing and egregious misconduct in data management and record-keeping” by the researcher. Wang did not provide primary data related to any of the allegations, according to an investigation report published by Science.
The U.S. 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 such charges come only when the agency is “really convinced that there has been intentional bad behavior by a scientist squandering public money.”
In 2005, Eric T. Poehlman, a former researcher at the University of Vermont, pleaded guilty to charges brought by the U.S. attorney’s office in Burlington, who alleged Poehlman received nearly $3 million in grants from the NIH and U.S. Department of Agriculture based on applications containing fake data. Anesthesiologist 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 health care 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 $7 million 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 $3 million.
In other cases, the federal government pursues civil action under the False Claims Act to recover grant money paid to the institutions where the scientists worked. In FCA cases, “the government thinks that the institutional processes or systems have completely failed,” and the institution “either knew or should have known about the behavior and didn’t do anything,” said Barnes, who has held high-level research administration positions at multiple institutions.
Last year, Purdue University in Indiana agreed to pay $737,000 in the case of Alice C. Chang, who ORI found faked data in 16 grant applications. Other large settlements include $112.5 million from Duke University in 2019, $10 million from Brigham and Women’s Hospital for the Piero Anversa case in 2017, and $9.5 million from Columbia University in 2016.
According to the indictment, Wang allegedly fabricated Western blots included in Cassava’s grant applications that resulted in $16 million of NIH funding from 2017-2021.
Cassava issued a statement on Wang’s indictment that said his work under these grants was “related to the early development phases of the Company’s drug candidate and diagnostic test and how these were intended to work.”
“Dr. Wang and his former public university medical school have had no involvement in the Company’s Phase 3 clinical trials of simufilam,” Cassava’s experimental Alzheimer’s treatment, the company statement said. Cassava is cooperating with ongoing investigations by the DOJ and Securities and Exchange Commission, the company has disclosed. Wang did not respond to our request for comment.
Attorneys from the main DOJ fraud section are prosecuting Wang’s case, and the Federal Bureau of Investigation’s Washington field office is investigating it, according to DOJ’s press release.
Richard Goldstein, an attorney in Boston who has worked for the government and now represents scientists involved in research misconduct cases, noted the involvement of the DOJ’s main office in D.C., rather than the regional U.S. attorney’s offices that have pursued other cases with less money at stake, fewer instances of fraud, and less clear involvement of the accused scientist. The main fraud division’s handling of the case “puts it into a category of major crimes that makes it similar to other major financial fraud cases,” he said. “This is getting attention at the highest levels of our government.”
The indictment “indicates the seriousness with which the government takes these allegations,” Goldstein said. “It is also indicative of the magnitude of the alleged crimes here, which appear to be very extensive and involve both a public university, a private company, stock issues, and repeated, longstanding acts of alleged fraud.”
Julie Grohovsky, a partner at Cohen Seglias Pallas Greenhall & Furman in Washington, D.C., who represents whistleblowers and previously worked as a federal prosecutor, noted that criminal cases require a higher burden of proof than civil cases – beyond a reasonable doubt.
In Wang’s case, “they seem to have strong evidence of intent (the pharmaceutical money connection) and the length of the scheme, and fairly large damages for these kinds of cases,” Grohovsky said, so they decided to pursue criminal charges.
“I also think some of the run of the mill grant fraud cases could have more sympathetic defendants,” she said, such as researchers who argue they were just trying to apply through a complicated government system. “But this guy is not sympathetic because of his industry connections and the amount of money allegedly stolen.”
Also, Grohovsky said, “the government likes to bring criminal cases where they think they can send a message to other potential fraudsters that they are watching.”
Wang’s indictment “sends a very, very powerful message,” Goldstein said, that scientists should be careful when submitting grant applications. “It suggests that deliberate manipulation of Western blots which result in federal funding can result in a criminal indictment.”
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Name ONE other time this has happened 11 weeks before the end of a P3 that was granted Special Protocol assessment…
The premise of the entire article is that criminal charges are rare.
What exactly is your point? That there’s some conspiracy at the Justice Department against a trial for an Alzheimer’s treatment?
I think the point is the severity of the offense will translate into a complete re-do for Cassava at some point. Everything post Dr. Wang’s involvement is tainted and allowing simufilam to reach the market on fraudulent data would set a dangerous precedent for drug development. jmho.
My comment was in reply to Bob Crain’s “Name ONE other time this has happened….”
I don’t understand why he thinks the timing is a factor. I assume he’s a shareholder.
The only thing more shameful than the lack of scientific integrity is how much money the Government can manage to flush down various toilets.