Here's something the FDA would rather you didn't know

Skull & Bones

At what point do you start labeling something as a poison?

How about if it increases stroke risk by 27 percent?

Or increases heart failure risk by 25 percent?

Or increases risk of either heart attack or stroke by 14 percent?

Or increases risk of death by 13 percent?

What if you could predict that one out of every 60 people who took this so-called “medicine” would be harmed in one of these ways?

And what if that meant that over a decade, more than 100,000 people have probably experienced one of these “excess events” after taking the medicine?

At what point do you put skull and crossbones on the label so people will know to keep this dangerous junk on a high shelf in the basement where no one can accidentally ingest it?

Nothing exceeds like excess

The stats above all come from an FDA report about a drug that helps control blood sugar. And the dreadful irony here is that diabetics take this medicine hoping to avoid the common dangers of their disease, such as increased risk of heart attack, heart failure, and stroke.

The drug is Avandia. And as I’ve mentioned before, Avandia’s link to heart problems is so well known that if this were a different era, we’d be lighting torches and hoisting pitchforks as we stormed the gates of the factory where this very dangerous stuff is made.

But we don’t go in much for violent mob rule these days. We don’t have to because here in the 21st century we have professionals on duty at the FDA who help the public avoid drugs like Avandia.

I’m kidding, of course! Look up “drug company enabler” in the dictionary and you’ll find a photo of FDA headquarters.

But then we have Dr. David Graham.

He’s one of the very few guys at the FDA who genuinely keeps a sharp watch on dangerous drugs. Dr. Graham was the one person at the agency who shook the world awake to the dangers of Vioxx and a number of other dangerous drugs. And it’s Dr. Graham who is leading the charge to inform the public about the “excess events” linked to Avandia.

But I don’t think you’ll be surprised to learn that he believes FDA officials are trying to suppress his very damaging Avandia report. Apparently, the Journal of the American Medical Association is standing by, ready to publish Graham’s findings. But some higher ups at the agency are dragging their heels, delaying the green light to publish.

This matters because once the report is validated by JAMA, it has a good chance of making the evening news.

But you and I know better than to wait for the FDA and JAMA to get their acts together. You can act right now by forwarding this e-mail to anyone you know who may have diabetes.

Someday the evening news might catch up, and someday GlaxoSmithKline (the maker of Avandia) might take their very risky drug off the market.

Till then, it’s just us and the power of the forward button.

To Your Good Health,

Jenny Thompson

“The FDA Denies Suppressing an Avandia Study” Ed Silverman, Pharmalot, 6/10/10,

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