Scientists Investigating Alzheimer’s Drug Faulted in Leaked Report – US 247 News

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A neuroscientist whose studies undergird an experimental Alzheimer’s drug was “reckless” in his failure to keep or provide original data, an offense that “amounts to significant research misconduct,” an investigation by his university has concluded.

The drug, simufilam, is made by Cassava Sciences, a pharmaceutical company based in Texas, and is in advanced clinical trials. The neuroscientist, Hoau-Yan Wang, a professor at the City College of New York, frequently collaborated with Lindsay H. Burns, the company’s chief scientist, on studies that outside experts and journals have called into question.

A committee was convened by the City University of New York, of which the college is a part, to investigate the work, and it concluded in a report that Dr. Burns was responsible for errors in some of the papers. But the investigators reserved their sharpest criticism for Dr. Wang, reproaching him for “long-standing and egregious misconduct in data management and record keeping.”

The report was obtained and made public by the journal Science on Thursday. Dee Dee Mozeleski, a spokeswoman for City College, declined to comment on the document but said that the school would formally release the report later this month.

Dr. Wang did not respond to a request for comment. Remi Barbier, the founder and chief executive of Cassava, said in a statement that the company would continue its clinical trials. “We remain confident in the underlying science for simufilam, our lead drug candidate,” he said.

Alzheimer’s disease affects roughly six million Americans. Simufilam has been eagerly anticipated by patients and families, and fervidly supported by a group of investors. Cassava’s stock soared after each round of reported results from its trials — at one point by more than 1,500 percent.

But some scientists have been skeptical of the drug’s hypothesized mode of action and of claims of improvements among patients in Cassava’s clinical trials. A few accused the company and Dr. Wang of manipulating the results.

In August 2021, two scientists filed a citizen’s petition with the Food and Drug Administration in which they described “grave concerns about the quality and integrity” of the research that supported simufilam’s purported efficacy.

Mr. Barbier has called the two scientists “bad actors” because they held a short position in Cassava’s stock and profited from its decline.

The release of the new report was preceded by a 40 percent increase in short selling of Cassava stocks, according to the company’s statement. Cassava was once valued at nearly $5 billion, but it was worth about $624 million as of Friday.

Other scientists, including some experts on Alzheimer’s disease, also pointed out what they said were irregularities in the results published by Dr. Wang and Dr. Burns, particularly in images. The Securities and Exchange Commission and the National Institutes of Health began investigating Cassava’s research in 2021 as well.

Some scientific journals that published Dr. Wang’s papers have made their own inquiries. Two of them published “expressions of concern” questioning the integrity and accuracy of the results. Another journal, PLOS One, retracted five papers by Dr. Wang after a five-month investigation.

The committee convened by CUNY also began investigating Dr. Wang’s work and his lab’s funding and spending over nearly 20 years. The group examined 31 allegations described by the Office of Research Integrity, the federal agency that helps universities handle scientific misconduct.

The committee members struggled for months to obtain access to Dr. Wang’s files, and did not succeed until they involved the college’s president. Even so, the report said, they were “unable to objectively assess” the merits of most of the allegations because Dr. Wang had not provided primary data, original images, research notebooks or other records of the experiments.

What the committee did find was “highly suggestive of deliberate scientific misconduct by Dr. Wang for 14 of the 31 allegations,” according to the report.

Cassava’s statement noted that the report faulted only internal record-keeping failures and did not find proof of data manipulation, and said that CUNY turned down all requests for information and offers of assistance and did not interview any of its employees.

Ms. Mozeleski said that CUNY would not comment on those allegations.

According to the report, Dr. Wang said some of his research records were missing because boxes containing them had been discarded during the coronavirus pandemic in response to a request from the college.

“The college did not require any member of our faculty or staff to throw out any items during the pandemic,” Ms. Mozeleski said in an email.