Dive Brief:
- Forbes' Matt Herper reported that Dr. Steven Nissen, the chair of cardiology at the Cleveland Clinic and the doctor who oversaw a 9,000-patient study on the obesity med Contrave, is claiming that the drug's maker, Orexigen Therapeutics, misled patients and investors about the therapy and that he has the data to prove it.
- Orexigen got into hot water in March after prematurely releasing data implying that Contrave significantly reduced adverse CVD events like heart attacks and strokes (to the tune of 41%)—particularly staggering for an obesity drug. Officials overseeing the trial and others from the FDA slammed the unauthorized data release and said the results were "unreliable" and "misleading."
- The company and its partner, Takeda, have faced enormous pressure to release the full trial data—but Orexigen stalled, sending out a press release on Tuesday that only said the trial had been stopped. Nissen and the Cleveland Clinic responded by releasing the full trial data without permission from Orexigen/Takeda. And it shows that the ostensible heart benefit vanishes completely over the long-term.
Dive Insight:
Orexigen CEO Mike Narachi responded to the Cleveland Clinic's unauthorized data dump and study overseer Dr. Steven Nissen's claims that the company had "misled" patients and investors on its obesity medication Contrave's heart benefits during the Bank of America Merrill Lynch Healthcare Conference on Tuesday.
"Contrary to allegations cited today by a journalist, Orexigen has never misled patients," said Narachi in a statement, referring to Forbes' Matt Herper. "At the time of the patent issuance in March, we stated plainly and clearly that the effect of Contrave on CV morbidity and mortality has not been established and that a larger number of MACE are required to precisely determine the effect of Contrave on CV outcomes." The data released by the Cleveland Clinic showed the ostensible heart benefits vanished over the long term, as evidenced by a 50% interim analysis.