Scientists researching Alzheimer’s drug have errors in leaked report | ET REALITY


A neuroscientist whose studies support an experimental Alzheimer’s drug was “reckless” by failing to preserve or provide original data, a crime that “amounts to significant research misconduct,” an investigation by his university concluded.

The medication, simufilam, is made by Cassava science, a Texas-based pharmaceutical company, and is in advanced clinical trials. 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 cast doubt on.

The City University of New York, of which he is a member, convened a committee to investigate the work, and concluded in a report that Dr. Burns was responsible for errors in some of the articles. But the researchers reserved their harshest criticism for Dr. Wang, chiding him for “egregious and long-standing misconduct in data management and record-keeping.”

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

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

Alzheimer’s disease affects approximately six million Americans. Simufilam has been eagerly awaited by patients and families, and has been fervently supported by a group of investors. Cassava’s stock soared after each round of its trial results, at one point more than 1,500 percent.

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

In August 2021, two scientists presented a citizen petition with the Food and Drug Administration in which they described “serious concerns about the quality and integrity” of the research supporting the purported effectiveness of simufilam.

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

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

Other scientists, including some Alzheimer’s disease experts, also pointed out what they said were irregularities in the results published 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’s research in 2021.

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

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

Committee members fought for months to gain access to Dr. Wang’s files and were unsuccessful until they involved the university president. Still, according to the report, they were “unable to objectively evaluate” 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 found was “highly suggestive of deliberate scientific misconduct by Dr. Wang in 14 of the 31 allegations,” according to the report.

Cassava’s statement noted that the report only criticized failures in internal record-keeping and found no evidence of data manipulation, and said CUNY rejected all requests for information and offers of assistance and did not interview any of its employees.

Mozeleski said CUNY would not comment on those allegations.

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

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

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