Thursday, May 14, 2015

Matter of disclosure of drug trial results: Orexigen Therapeutics and Contrave

See the post on Forbes titled -- Did Orexigen Have The Right To File Its Controversial Patent? -- for issues on including drug test results in a patent application.

The first paragraph of the Forbes post:

Shares in Orexigen Therapeutics, the maker of a weight-loss drug called Contrave, have dropped 24% to $5 since Tuesday, when news came out that data that the drug maker had originally presented as showing Contrave prevented heart attacks and strokes were part of a study that, in the end, showed no such thing.

Of relevance to the issue is the text

But Nissen [Steven Nissen of the Cleveland Clinic, who ran the trial ] says it just meant that Orexigen could file for a patent based on excluding a doubling of risk. “It doesn’t mean the exact data in the trial can be published,” Nissen says. “We work with industry with the expectation that there is not an effort to game the system.”

link to Forbes post:

Separately, from within the Medscape post titled -- US Endocrinologists React to Contrave Safety Study Halt --

Dr Michael Gonzalez-Campoy, medical director and CEO of the Minnesota Center for Obesity, Metabolism, and Endocrinology, in Eagan, agrees that the events of this week are regrettable.

"A trial is designed to go from beginning to end. There's a board that monitors safety, and unless there are safety signals, it should not be [disclosed] prematurely.…It's only at the end of the trial that you can make valid analyses of the data," he told Medscape Medical News.

But he believes the decision to halt the trial was the right one. "I think it would be very difficult to justify moving forward on a study where data have been prematurely released. It's really truly unfortunate that it happened. It really does hurt this particular study, and possibly future studies as well."

Link to Medscape article:

from the beginning of the Medscape post:

News that a cardiovascular-safety study of the weight-loss drug Contrave (naltrexone/bupropion, Orexigen/Takeda Pharmaceuticals, marketed as Mysimba in Europe) had to be halted due to early release of data has prompted outrage and concern about the public's perception of the pharmaceuticals industry's drug trial conduct.


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