Diet Drug Maker Misled Investors & Patients

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dietA top cardiologist is accusing a drug maker with whom he worked closely of making misleading statements about its weight loss medicine and refusing to release data that would undermine its previous claims.

The pill, Contrave, was prescribed 117,000 times in its first three months on the market, a better launch than any obesity drug in the past decade. Things seemed to get even better in March, when Contrave’s maker, Orexigen Therapeutics OREX -13.7%, released data that claimed that the drug not only helped patients lose weight but also prevented heart attacks, strokes and deaths caused by cardiovascular disease by a stunning 41%, a statistically significant amount.

But Steven Nissen, chair of cardiology at the Cleveland Clinic and the lead researcher on the 9,000-patient study, immediately protested that the result was premature and untrustworthy. So did John Jenkins, the head of the Office of New Drugs at the Food and Drug Administration. Now, via a Cleveland Clinic press release and an interview with Forbes, Nissen, well known for his role in raising alarms about the safety of drugs like Merck ’s Vioxx and GlaxoSmithKline ’s Avandia, has released the data to back up that contention.

The supposed benefit almost disappeared as time passed. As the number of heart attacks, strokes, and cardiovascular deaths increased from 94 to 192, the 41% difference between those getting Contrave and those getting placebo shrank to just 12% and was no longer statistically significant. More evidence it may be meaningless: patients given Contrave were more likely to have chest pain and more likely to die from causes other than heart disease. Many patients who supposedly had a benefit had actually stopped taking the drug.

Read more at FORBES