Cardiologists have accused a small drug company of withholding data from a clinical trial showing that the company’s drug, meant to reduce the risk of heart attacks, increased the risk instead.
The cardiologists said that the company, Anthera Pharmaceuticals, did not turn over data to academic investigators, as it was required to do, for more than a year.
“Despite a contract that required transfer to the academic authors, the company stonewalled every attempt to acquire the data,” Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, said in an email on Tuesday.
Dr. Nissen was the senior author of a report on the data that was published online Monday by The Journal of the American Medical Association and presented at the annual meeting of the American Heart Association in Dallas. In unveiling the results there, the lead investigator, Dr. Stephen Nicholls, publicly admonished the company.
Dr. Colin Hislop, the chief medical officer at Anthera, denied the accusations, saying it simply took time to gather and organize the data. “I don’t think the timeline was particularly protracted, nor were we being difficult,” he said in an interview Tuesday.
Studies and lawsuits have shown that many clinical trial results, particularly negative ones, are not published. Critics say that hampers medical practice and violates an obligation to patients, who try experimental treatments in part to advance knowledge.
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