Cleveland Clinic Cardiologist Says Drug Maker Misled Public About Safety of Diet Drug Contrave
A leading cardiologist from the Cleveland Clinic says a drug company misled patients about the safety of a new weight loss drug. Ideastream’s Anne Glausser has more on the drama that unfolded this week.
Back in September, the FDA approved the new weight loss drug Contrave, but they required the drug maker, Orexigen Therapeutics, to do follow-up studies regarding the impact of the drug on heart health and stroke risk.
The Cleveland Clinic’s chair of cardiology Dr. Steven Nissen was tapped to lead this safety trial and what happened next was, he says, was an "almost unprecedented set of events."
Nissen says Orexigen leaked early data from the study that showed a benefit to heart health. But the 5-year trial was only a quarter of the way complete at the time of the data leak and early results cannot be trusted, he says. "If physicians and patients believe that a drug produces a 41% reduction in things that are really important like heart attack, stroke, and death, then they may prescribe the drug based on a false and misleading impression of a benefit. We did not want patients to be inappropriately treated based on unreliable preliminary information," said Nissen.
Learning of the leak, the Clinic issued a press release showing more data from the study where the heart benefits disappeared.
Now the original safety study has been terminated and will need to be started from scratch.