Time for FDA officials to wake up and do what they’re supposed to do!

Too Little Too Late

Okay, I get it–the FDA is a bureauracy so it moves as slow as mud. But here’s a message from Earth to the FDA: PEOPLE ARE DYING OUT HERE!

I’m talking about Avandia, of course–the type 2 diabetes drug that makes jumping over canyons on a motorcycle seem like a safe career choice.

I’m sure you heard that the FDA’s panel of experts “came down hard” on GlaxoSmithKline, the company that makes Avandia. Their recommendation: Take this dangerous drug off the market or severely restrict its sale.

That’s coming down hard? No. This is coming down hard: Don’t wait for the official decision from the higher-ups at the FDA, suspend sales TODAY.

Think of 9/11. When jets started crashing, did the FAA convene a panel to make a recommendation? No. They didn’t allow a single commercial jet off the ground until they were confident the immediate risk had passed.

Or look at the way the FDA handled a few cases of sickness due to E. coli contamination of spinach. They located the probable sources and shut them down. They didn’t allow those sources to put spinach on the market while agency officials carefully weighed their options.

Meanwhile, what’s the FDA response to Avandia? After YEARS of obvious heart risks, some officials still have to be dragged to a decision kicking and screaming as if they were sending their own mothers to the electric chair.

Drop that gun!

Recently I told you about an FDA report that produced this shocking estimate: Over the past decade, 48,000 people experienced stroke, heart failure, or death because they used Avandia instead of Actos, another type 2 diabetes drug.

48,000! That’s intolerable! I mean, what does it take to get a drug taken off the market? Do pills have to explode in your mouth? Does a drug company executive have to be caught holding a smoking gun?

Well, here’s the gun…

In a 2001 e-mail sent within the company, one executive made this comment about a study that linked Avandia to serious heart problems: “These data should not see the light of day to anyone outside of GSK.”

The New York Times reports that this e-mail was just business as usual. Apparently some GSK executives knew about Avandia heart risks and suppressed the data for more than a DECADE!

So why in the world should the FDA play nice with GSK? At the very LEAST, the agency should, you know, ACT like it’s their job to protect the public, and advise everyone who’s taking Avandia to see their doctor immediately to discuss getting off this drug NOW!

To Your Good Health,

Jenny Thompson

Sources:
“F.D.A. Panel Votes to Restrict Avandia” Gardiner Harris, New York Times, 7/14/10, prescriptions.blogs.nytimes.com
“Diabetes Drug Maker Hid Test Data, Files Indicate” Gardiner Harris, New York Times, 7/12/10, nytimes.com