A federal grand jury has indicted an Alzheimer’s researcher suspected of falsifying records to fraudulently obtain $16 million in federal research funding from the National Institutes of Health to develop a controversial Alzheimer’s drug and diagnostic test.
Hoau-Yan Wang, 67, a professor of medicine at the City University of New York, was a paid associate with Austin, Texas-based pharmaceutical company Cassava Sciences. Wang’s research and publications provided the scientific basis for Cassava’s Alzheimer’s treatment, Simufilam, which is now in Phase III trials.
Simufilam is a small-molecule drug that Cassava claims can restore the structure and function of a scaffolding protein in the brains of people with Alzheimer’s, leading to slower cognitive decline. But outside researchers have long expressed doubts and concerns about the research.
In 2023, the journal Science obtained a 50-page report from an internal investigation at CUNY that looked into 31 allegations of misconduct made against Wang in 2021. According to the report, the investigative committee “found evidence highly suggestive of intentional scientific misconduct by Wang for 14 of the 31 charges,” the report said. The charges centered around altered and fabricated images by Western blotting, an analytical technique used to separate and detect proteins. However, the committee could not conclusively prove that the images were falsified “due to the failure of Dr. Wang to provide basic, original data or research records and the low quality of published images that should have been examined instead.”
Overall, the investigation “found longstanding and egregious misconduct in data management and record keeping by Dr. Wang” and concluded that “the integrity of Dr. Wang’s work remains highly questionable.” The committee also concluded that Cassava’s lead scientist in its Alzheimer’s disease program, Lindsay Burns, who was a frequent co-author with Wang, was also likely to bear responsibility for the misconduct.
In March 2022, five of Wang’s articles published in the journal PLOS One were retracted due to image integrity concerns in the papers. Other documents from Wang have also been withdrawn or had statements of concern attached to them. Further, in September 2022, the Food and Drug Administration conducted an inspection of the analytical work and techniques used by Wang to analyze blood and cerebrospinal fluid from patients in a simufilam trial. The investigation found a number of egregious problems, which were laid out in a “damning” report obtained by Science.
In the indictment last week, federal authorities were clear about the charges, alleging that Wang falsified the results of his scientific research at the NIH “by, among other things, manipulating data and images of Western blots to artificially increase bands [which represent proteins]subtract the bands and vary their relative thickness and/or darkness, and then draw conclusions’ based on those spurious results.
Wang is charged with one count of grand larceny against the United States, two counts of wire fraud and one count of making false statements. If convicted, he faces a maximum sentence of 10 years in prison on the grand larceny charge, 20 years in prison on each count of wire fraud and five years in prison on the false statement count, the Justice Department said in a release. .
In a statement posted on its website, Cassava accepted Wang’s indictment, calling him a “former scientific advisor.” The company also said the main grants for the indictment were “related to the early stages of development of the Company’s drug candidate test and diagnostic test and how it is intended to work.” However, Cassava said Wang “had no involvement in the Company’s Phase 3 clinical trials of simufilam.”
These ongoing trials, which some have called for to be stopped, are estimated to involve over 1,800 patients in several countries.