Diet drug drama reveals how FDA caters to Big Pharma
It’s a diet drug drama that had all the elements of a cheap spy thriller.
Top secret data that was secured in specially locked rooms. Special email accounts to make sure spying eyes wouldn’t see anything. And a signed, 14-page document saying company officials would never, ever let any confidential information be revealed except to a special “regulatory SWAT team.”
And for the finale, a top cardiologist who says we were all cheated and deceived by the entire scenario.
But the fallout over the new weight loss med Contrave is far from over.
That’s because it’ll still be seven years before the FDA knows whether Contrave damages your heart — but it’s still being prescribed to unsuspecting patients. Ones who were just hoping to lose some weight, but instead are somehow in the middle of what may be the oddest and riskiest drug approval ever.
Contrave was approved last year under an FDA loophole that allows potentially dangerous drugs on the market before the clinical trials are completed.
The FDA was worried Contrave could boost your risk of heart attack. But under its bizarre rule, the agency allowed drug maker Orexigen to take a peek at the top-secret, ongoing Contrave heart study data a quarter of the way through the trial.
And, get this — if the drug didn’t more than double the risk of heart attacks and strokes, they could go ahead and file with the FDA to get Contrave approved!
That’s shocking enough. After all, this isn’t a potentially life-saving med for a rare disease. It’s a diet pill. And not even a very good one at that.
But what happened next is even more bizarre and worrisome.
Orexigen got Contrave approved by claiming the early trial results looked surprisingly good and that Contrave was actually good for your heart. And they couldn’t keep the news to themselves.
They patented Contrave as a heart drug. They released the news to their investors. And in the process, Orexigen broke every single contract it signed and all the promises it made to the FDA.
But the biggest problem is that the Contrave data was totally contrived.
What the early results of the trial didn’t disclose is that Contrave may have only benefited patients once they stopped taking it!
That’s because of a tricky part of clinical trials called “intent-to-treat.” Under that standard patients who were assigned to take Contrave (instead of a placebo), but who dropped out were still counted as if they were taking the drug.
And those people – the ones who dropped out – seem to be the ones who cut their heart attack risk.
Plus, there were other problems in the trial that didn’t get disclosed. More Contrave patients were having chest pain (which could be why so many stopped taking it) and more people on the drug were dying from things other than heart attacks.
It’s no wonder Orexigen tried to block the release of the full trial results.
Once the misleading cornflakes hit the fan, the committee in charge of the trial demanded the whole thing be stopped. Lead doctor Steven Nissen from the Cleveland Clinic wasn’t mincing words. He said that “patients were misled” and that he “couldn’t believe” what was going on.
But after all is said and done, the really unbelievable part is how the FDA will bend over backwards to protect drug companies, even if it jeopardizes your health.
Instead of receiving some kind of penalty for what it did, Orexigen simply has to start a new Contrave heart trial from the beginning and wrap it up by 2022.
They get to keep selling Contrave. And they get to keep us in the dark for another seven years.
Sources:
“A top cardiologist says a diet drug maker misled patients and investors” Matthew Herper, May 12, 2015, Forbes, forbes.com
