An investigation by his university found that a neuroscientist whose studies were the basis for an experimental Alzheimer’s drug was “reckless” by failing to preserve or provide original data, an offense that “amounts to significant research misconduct.” .
The drug simufilam is manufactured by Cassava Sciences, 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 had questioned outside experts and journals.
A committee was convened by the City University of New York, of which the college is a part, to investigate the work and concluded in a report that Dr. Burns was responsible for errors in some of the work. But the investigators directed their harshest criticism at Dr. Wang and accused him of “long-standing and blatant misconduct in data management and recording.”
The report was obtained and published Thursday by the journal Science. Dee Dee Mozeleski, a spokeswoman for City College, declined to comment on the document but said the school would officially release the report later this month.
Dr. Wang did not respond to a request for comment. Remi Barbier, Cassava’s founder and chief executive, said in a statement that the company would continue its clinical trials. “We remain confident in the scientific basis for simufilam, our lead drug candidate,” he said.
Alzheimer’s disease affects approximately six million Americans. Simufilam was highly anticipated by patients and families and strongly supported by a group of investors. Cassava’s shares rose after each round of reported results from its experiments – at times by more than 1,500 percent.
However, some scientists were skeptical about the drug’s hypothetical mode of action and claims of improvements in patients in cassava clinical trials. Some blamed the company and Dr. Wang accused of manipulating the results.
In August 2021, two scientists filed a citizens’ petition with the Food and Drug Administration raising “serious concerns about the quality and integrity” of the research supporting simufilam’s purported effectiveness.
Mr. Barbier called the two scientists “bad actors” because they held a short position in the cassava 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 statement. Cassava was once worth nearly $5 billion, but as of Friday it was worth about $624 million.
Other scientists, including some Alzheimer’s disease experts, also pointed to irregularities in Dr. Wang and Dr. Burns published results, especially in pictures. The Securities and Exchange Commission and the National Institutes of Health also began investigating cassava research in 2021.
Some scientific journals that Dr. Those who published Wang’s work conducted their own research. Two of them published “statements of concern” questioning the integrity and accuracy of the results. Another journal, PLOS One, pulled five articles by Dr. Wang back.
The CUNY-convened committee also began recruiting Drs. To examine Wang’s work and his laboratory’s funding and expenses over a period of nearly 20 years. The group investigated 31 allegations from the Office of Research Integrity, the federal agency that helps universities deal with academic misconduct.
Committee members fought for months to gain access to Dr. To obtain Wang’s files, they had no success until they contacted the college’s president. Still, the report says, they were “unable to objectively assess the merits of most of the allegations” because Dr. Wang did not provide any primary data, original images, research notebooks or other records of the experiments.
What the committee actually found, according to the report, “strongly suggested intentional scientific misconduct by Dr. in 14 of the 31 allegations.” Wang there.”
Cassava’s statement noted that the report only criticized internal recording errors and found no evidence of data manipulation. It also said CUNY declined all requests for information and offers of assistance and did not interview any of its employees.
Ms. Mozeleski said CUNY would not comment on these allegations.
The report said some of his research papers were missing because boxes containing them were thrown away at the college’s request during the coronavirus pandemic.
“The College has not required any member of our faculty or staff to throw away any items during the pandemic,” Ms. Mozeleski said in an email.