We know the FDA is slow and ineffective, but this is ridiculous (and dangerous!)

Useless is as useless does

If your house burned down and after it was reduced to a pile of charred timbers your neighbor was standing outside, drinking a beer, just watching the whole thing, what would you call that neighbor?

Okay — hold that thought.

Now let’s take a look at three dates:

* September 2010 — The FDA decides to restrict the use of Avandia, GlaxoSmithKline’s very dangerous type 2 diabetes drug

* May 2011 — The FDA officially informs the public about the new restrictions that will require patients to enroll in a special program in order to receive Avandia

* November 2011 — The date the new restrictions will take effect…MORE THAN ONE YEAR AFTER THE DECISION TO RESTRICT AVANDIA!

Insane? That’s not even the worst of it.

Four years ago, an FDA advisory committee concluded that Avandia might increase the risk of heart attack. The committee’s recommendation: Keep Avandia on the market.

It’s one step (or less!) shy of accomplice. (Not to mention as useless as a neighbor who watches your house burn down and doesn’t think to call 911.)

But as bad as the FDA has been throughout the Avandia fiasco, it’s the executives for GSK who were caught holding a smoking gun. And the time has come for some sweet comeuppance.

The domino theory

If you’re new to the Avandia horror show, here’s a quick recap…

Last year I told you about an FDA report with a 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.

That’s horrendous, but here’s what’s worse: At the beginning of the decade (2001), one GSK executive made this comment in an e-mail about a study that that linked Avandia to serious heart problems: “These data should not see the light of day to anyone outside of GSK.”

Oops! Not only did the data see the light of day, but the e-mail did too, obviously. And when the dangers of Avandia and the cover-up of those dangers finally came to light, what happened to those executives?

Absolutely nothing.

Even in a blatant case like this it’s virtually impossible to bring criminal charges against drug company execs who sell a dangerous product they know could inflict harm on many users.

So we’re not going to get the satisfaction of seeing executives in handcuffs getting frog-marched out of GSK headquarters into a police van.

We’ll have to settle for the next-best thing…

A few days ago, South Carolina became the third state to file a lawsuit against GSK for false and illegal marketing.

According to the suit, GSK defrauded South Carolina and, “bilked the state out of millions of dollars by making false representations that Avandia was better at lowering blood sugar than existing medications.”

The state hopes to join Louisiana and Utah in recouping millions of dollars in damages and penalties.

In response to the suit, here’s the official GSK statement: “GlaxoSmithKline stands behind the safety and efficacy of Avandia when used appropriately and according to its label.”

I don’t know about you, but my response to that statement is that I’d like all the GSK execs to start taking Avandia “according to its label” and see if they still feel the same way.

Sources:
“Drug Information Update- Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl” Food & Drug Administration, 5/18/11, fda.gov
“SC Attorney General’s Office Sues Maker of Avandia” Spartanburg Herald-Journal, 6/1/11, pharmalive.com