A neuroscientist working on an experimental Alzheimer’s disease drug was “reckless” in failing to preserve or provide the original data, a crime that “amounts to serious research misconduct”. A university investigation concluded.
The drug, Simufilam, is manufactured by Cassava Sciences, a Texas-based pharmaceutical company, and is currently undergoing clinical trials. Professor Hoau Yan Wang, a neuroscientist at the City University of New York, frequently collaborated with the company’s chief scientist, Lindsay H. Burns, on research that was questioned by outside experts and journals.
The City University of New York, of which the university is a member, convened a committee to investigate the study and concluded in its report that Dr. Burns was responsible for some errors in the paper. But investigators reserved their sharpest criticism of Dr. Wang, accusing him of “years of gross misconduct in data management and record-keeping.”
The report was obtained and published by the journal Science on Thursday. City College spokeswoman Dee Dee Mozeleski declined to comment on the document, but said the school would formally release the report later this month.
Dr. Wang did not respond to requests for comment. Cassava founder and CEO Rémi Barbier said in a statement that the company will continue its clinical trials. “We remain confident in the basic science of our lead drug candidate, simfilam,” he said.
Alzheimer’s disease affects approximately 6 million Americans. Simufilam has been enthusiastically embraced by patients and families and has received enthusiastic support from a group of investors. Cassava’s stock price soared each time test results were reported, at one point rising more than 1,500 percent.
But some scientists are skeptical about the drug’s hypothesized mechanism of action and claims that cassava improved symptoms in patients in clinical trials. Several people accused the company and Dr. Wang of manipulating the results.
In August 2021, two scientists submitted a national petition to the Food and Drug Administration stating “serious concerns about the quality and integrity” of the research supporting simfilam’s effectiveness.
Barbier called the two scientists “villains” for holding short positions in cassava stocks and profiting from their decline.
Short interest in cassava stocks increased by 40% ahead of the release of the new report, the company said in a statement. Cassava was once worth nearly $5 billion, but as of Friday it was valued at about $624 million.
Other scientists, including Alzheimer’s disease experts, also pointed to irregularities in the results presented by Dr. Wang and Dr. Burns, particularly in the images. The Securities and Exchange Commission and the National Institutes of Health also began investigating cassava research in 2021.
Some scientific journals that published Dr. Wang’s paper conducted their own investigations. Two of them issued an “expression of concern” questioning the completeness and accuracy of the results. Another journal, PLOS One, retracted five papers by Dr. Wang after a five-month investigation.
The committee convened by the City University of New York also began an investigation into Dr. Wang’s research and lab funding and expenditures over nearly two decades. The group investigated 31 allegations reported by the Office of Research Integrity, a federal agency that helps universities address scientific misconduct.
Committee members struggled for months to gain access to Dr. Wang’s file, but were unsuccessful until they involved the university’s president. Still, the report said the validity of most of the claims could not be “objectively assessed” because Dr. Wang did not provide primary data, original images, research notes or other experimental records. Stated.
The report said the committee found “14 of the 31 allegations strongly suggest deliberate scientific misconduct by Dr. Wang.”
Cassava’s statement noted that the report found only deficiencies in internal record-keeping and no evidence of data manipulation, and that the City University of New York has rejected all requests for information and offers of assistance, and that no staff member He also said that he did not have an interview.
Mozeleski said CUNY does not comment on these allegations.
According to the report, Dr. Wang said some of the research records were missing because the boxes containing them were discarded at the request of the university during the coronavirus pandemic.
“The university did not require faculty and staff to dispose of items during the pandemic,” Mozeleski said in an email.