Wednesday, November 15, 2023

Science: USC neuroscientist faces research integrity questions

Via Derek Lowe, this rather shocking story: 
In 2022, the U.S. National Institutes of Health (NIH) placed a large bet on an experimental drug developed to limit brain damage after strokes. The agency committed up to $30 million to administer a compound called 3K3A-APC in a study of 1400 people shortly after they experience an acute ischemic stroke, a perilous condition in which a clot blocks blood flow to part of the brain.

The gamble seemed warranted. Lab studies, most by a longtime grantee, prominent University of Southern California (USC) neuroscientist Berislav Zlokovic, had generated promising data. A small safety study of the drug, sponsored by a company Zlokovic co-founded called ZZ Biotech, was also encouraging. Analyses of data from the phase 2 trial hinted that the treatment reduced the number of tiny, asymptomatic brain hemorrhages after stroke patients received either surgery to remove the clot, the clot-busting drug tissue plasminogen activator (tPA), or both.

...But a 113-page dossier obtained by Science from a small group of whistleblowers paints a less encouraging picture. The dossier, which they submitted to NIH, highlights evidence from the phase 2 trial that the experimental remedy might have actually increased deaths in the first week after treatment: Six of the 66 stroke patients who received 3K3A-APC died within this period, compared with one among 44 in the placebo group, although the death rate evened out after a month. Patients who received the drug also trended toward greater disability and dependency at the end of the trial, 90 days after treatment....

...But speaking to Science anonymously, four former members of Zlokovic’s lab say the anomalies the whistleblowers found are no accident. They describe a culture of intimidation, in which he regularly pushed them and others in the lab to adjust data. Two of them said he sometimes had people change lab notebooks after experiments were completed to ensure they only contained the desired results. “There were clear examples of him instructing people to manipulate data to fit the hypothesis,” one of the lab members says.

Seems real bad! 

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