Type 2 diabetes patients are at risk when the FDA conducts business as usual

[Warning] The FDA just increased your risk of heart attack and stroke

Don’t look now. But you’ve been readjudicated.

And you probably never felt a thing.

But if you’re not careful…you will.

A shifty shift

In 2010, the FDA put tight curbs on the use of the type 2 diabetes drug Avandia. Essentially they made it a drug of very last resort.

That was a good call. They had plenty of evidence (and it was mounting) that the drug could increase heart attack and stroke risk.

But leave it to the FDA to put this dangerous drug back on the market at full force.

When the agency put the brakes on Avandia, they told GlaxoSmithKline that they could “convene an independent group of scientists to readjudicate” a 2009 study that was just one piece of the evidence against the drug.

Readjudicate? That’s a fancy, bureaucratic way of saying, “Take a do-over” — like kindergarteners on a playground.

And the agency put GSK in charge of it!

At least the fox had to actually get into the henhouse. The FDA basically tore down all four walls.

And then GSK’s hand-picked panel decided that the study did NOT show increased risk of heart attacks.

Poof! Like magic! The evidence was there before. The agency recognized it and acted on it. But then the GSK experts said, “No.” Like the evidence was never there.

So FDA officials shrugged and said, “Okie dokie!” They removed the curbs, and now Avandia can be prescribed normally again.

That’s a nice little system they’ve got there. Runs like clockwork. Except for one thing. The study that was readjudicated is not by any means the only study that exposed Avandia dangers. Other researchers found clear links to heart attack, stroke, and heart failure risk.

But never mind all that. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, says, “Given these new results, our level of concern is considerably reduced.”

Really? Considerably reduced? Well I’d like to test Woodcock’s “level of concern.”

Last summer, I challenged the GSK panel members to take Avandia for one year. Now I challenge Woodcock to do the same.

Then we can readjudicate her level of concern.

Sources:
“FDA requires removal of certain restrictions on the diabetes drug Avandia” FDA News Release, 11/25/13, fda.gov

“FDA lifts constraints on Glaxo diabetes drug Avandia” Bill Berkrot, Ransdell Pierson, Reuters, 11/25/13, reuters.com