Not even three months in, and we already have a leading contender for the decade's biggest drug scandal.

The diabetes drug Avandia (rosiglitazone) is being blamed for tens of thousands of heart attacks... its maker, GlaxoSmithKline, is accused of trying to fudge the record to protect its sales... and the FDA just stood by and let it all happen.

Or, as I like to say, just another day in Big Pharma's world.

The damning report--which blames Avandia for 83,000 heart attacks between 1999 and 2007--sounds like something I might have written. But it actually came from the U.S. Senate, where the Finance Committee recently capped a two-year investigation into this dangerous diabetes drug.

And as if proving the very point of this report, the FDA still can't get it right.

At least two FDA reviewers have said publicly that Avandia needs to be yanked off the shelves. At the same time, the FDA itself issued a statement saying patients should keep right on taking their Avandia.

Which FDA do you believe?

This agency is part of a system that's stacked against the patient. Avandia's risks aren't new--we've known for years this med is bad news... yet it's still out there, like a horror movie monster lurking in the woods.

Just take a look at a headline I found in Time magazine: "Is Avandia the next Vioxx?" The story quoted an editorial in the New England Journal of Medicine that stated, "the rationale for prescribing rosiglitazone at this time is unclear."

Sounds like it's finally the end of the line for this med, right? Wrong--both the Time article and Journal editorial were written back in 2007.

Yep... just like that horror movie monster, Avandia only looked dead.

The Senate report says GlaxoSmithKline downplayed all the problems with this med and even tried to intimidate independent physicians so they'd toe the line. If that accusation is true, it could explain one of the most bizarre sets of decisions in FDA history.

In 2007, an independent panel convened by the FDA looked at the mounting evidence against Avandia and voted 20-3 that the med was causing heart attacks. Then, an independent panel convened by the FDA voted 22-1 to keep this drug on the market.

What happened? Did the second panel miss the memo from the first one?

Nope... because it was the same panel!

The FDA accepted the advice, kept the drug on the market, and thousands of people got their tickets punched for the ER.

Today, after compiling years of data highlighting the dangers of this med, the FDA says it's still not ready to act. The agency says it's still reviewing data it received more than six months ago, and that they'll have a meeting on this... in July.

Nothing like a little urgency, right?

Printer-friendly version