The next Vioxx scandal: Why the FDA is standing behind a deadly diabetes drug

The next Vioxx scandal:
Why the FDA is standing behind a deadly diabetes drug

I must be having déjà vu, because this scenario seems a little too familiar to me: Drug gets pushed through approval process; drug is linked to deaths; drug scandal is uncovered; FDA finally removes drug from the market. And everyone lived happily ever after (except for those people who were subjected to the drug before the FDA stepped in, but I’m trying to look on the bright side here).

That’s the Vioxx story in a nutshell. The Avandia story has the same plot line, but a slightly different ending. And it’s not a happy one.

Because despite the side effects, despite the hidden test data, and despite being linked to heart attacks, an FDA advisory panel has voted to keep this controversial diabetes drug on the market. And by controversial, I mean ineffective and potentially deadly.

You would think that there must be a silver lining to this cloud in order for the panel to recommend keeping it on the market. But it turns out it’s not a silver lining——it’s a gold one.

Avandia brings in over $1.1 billion every year——and that’s after taking a hit from a devastating study that was released in 2007 (I’ll tell you more about that in a minute). In its heyday, it was raking in a whopping $3 billion every year. Imagine the rounds of golf you could play with that kind of cash floating around——not to mention the money you could dedicate to advertising (in 2007, GSK spent nearly $2.5 billion on advertising alone), “research,” and, of course, the lawsuits.

Incidentally, just days before the FDA advisory panel voted to keep Avandia on the market, GSK paid out $460 million to settle more than 10,000 lawsuits alleging that the drug caused heart attacks and stroke. That’s a lot of money to fork over for something the company still claims is perfectly safe.

So what’s all the fuss about?

The study that opened this can of worms was conducted in 2007 by Dr. Steven Nissen, and it showed that…

This diabetes drug causes a 43% increase in the risk of heart attack

Of course, GSK did its best to keep this study quiet, but a lawsuit forced the company to post the results of this study on the website.

That’s when this golden egg began to crack. This study led to the FDA’s strongest safety warning, the black box warning, and successfully knocked Avandia from its spot as the world’s best-selling diabetes drug. It was then that officials grudgingly admitted they had known of Avandia’s heart risks since 2005. That was bad enough, but that wasn’t the whole story, either.

Emails have since surfaced showing that GSK executives intentionally hid the study’s results showing that the company kept the drug’s heart dangers hidden for more than a decade.

When Avandia made its debut in 1999, GlaxoSmithKline was a struggling drug company (they went by the name of SmithKline Beecham then) with no major drugs to its name. To say that the company was putting all of its eggs in one basket is an understatement. This golden egg was GSK’s only egg. The last thing they needed was a study to cast a negative light——much less a study that the company itself conducted.

Yet that’s exactly what happened.

Before this drug was even out of the gate, GSK had conducted a trial to compare Avandia to one of its biggest competitors at the time, a diabetes drug called Actos. That’s when this promising new drug should have been sent packing. Instead, after finding out that Avandia was no better than Actos——and that it led to more heart problems than Actos——GSK’s executives dutifully brushed this study under the rug.

“This was done for the U.S. business, way under the radar,” Dr. Martain I. Freed, a SmithKline executive wrote in an email from 2001. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK” [emphasis mine].

According to one especially damning email, executives estimated that if the study ever leaked, it could cost the company more than $600 million from 2002 to 2004.

Oops. Looks like the cat’s out of the bag, fellas.

Back then, it wasn’t illegal for a company to keep a negative study under wraps (unethical, yes, but not illegal). But another GSK cover-up led to a legislative change in 2007 that now requires companies to be up front about all of the research——good and bad.

That decision came on the heels of the discovery that GSK hid data on its antidepressant, Paxil. This time, though, the drug wasn’t causing an increase in heart attacks. It was causing an increase in suicidal thoughts and behaviors… in children.

Will this company stop at nothing to make a buck? I wouldn’t be surprised if the executives’ own grandkids were hopped up on these drugs.

Hiding entire studies is bad enough. But it turns out that you can’t even trust the accuracy of the ones that the company has released.

For the RECORD…

The most recent Avandia study——funded by none other than Glaxo itself——was supposed to prove once and for all that Avandia was perfectly safe. And at first glance, it did. Because according to RECORD, Avandia did not cause an increased risk in heart problems.

But not everyone is convinced. FDA researcher Dr. David Graham said, “You can’t trust it, and if we do trust it, we’re engaging in the willing suspension of disbelief.”

I hate to break it to you, David, but the medical community at large has been “engaging in the willing suspension of disbelief” for as far back as I can remember.

But David isn’t alone in his criticism. When the FDA reviewed the study, they uncovered at least a dozen unreported heart problems in the tally of the drug’s adverse events. According to a memo posted on the FDA’s website, the trial was “inadequately designed and conducted to provide any reassurance about CV (cardiovascular safety) of resiglitazone [Avandia].”

And yet, despite the evidence, the FDA advisory panel still sided with the drug company. I can’t help but shake my head. The FDA will make its final decision in the next few months. They’re not required to take the panel’s advice, but they nearly always do.

Here’s what to do:

This is a lot of fuss and muss over a drug that most people don’t need in the first place. If there’s any disease that you should feel like you have control over, it’s type 2 diabetes. You should know by now that diabetes is completely, 100 percent diet and lifestyle related.

Bottom line: All the drugs in the world won’t save you if you keep on downing doughnuts and cheese puffs. Stick to my high-fat, low-carb diet, and you’ll be just fine. Continue on with the USDA’s sad idea of a food pyramid, however, and you’ll end up like the millions of people with diabetes——trying to choose between a drug that increases the risk of heart problems and early death, and a drug that increases the risk of heart problems and early death slightly less than the first option.

The choice is yours.

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