Sweet comeuppance–a drug company executive gets a public scolding

While we’re waiting for the FDA to wake up and do the right thing, we can take at least a little comfort from my favorite moment of the Avandia panel discussions.

Sometime during the second day, a GlaxoSmithKline VP was given a chance to support the results of an Avandia trial called Record. He stated that the trial had been well designed, and GSK conduct in reporting the trial was “appropriate.”

Thing is, just two days earlier, the New York Times reported that Record had been roundly criticized by the FDA, and “at least a dozen” serious heart problems that occurred among Avandia users in the trial were not included in the reporting of adverse events.

So if this were a movie, an FDA official would have jumped to his feet and shouted at the GSK exec: “Appropriate!? Given the choice between protecting patients and making billions in profits, GSK chose profits! And everyone who participated in that deception is a criminal!”

But Hollywood didn’t script this one, so here’s what an FDA official actually said: “It’s not a supposition that GlaxoSmithKline intervened with the adjudication–it’s documented.”

For those of you who haven’t graduated law school or prepared for a career in “vague” that’s just a fancy “this is what you pay my salary for” way of saying, “We’re not just guessing that you altered the results. The facts are right here in black and white!”

But he didn’t stop there.

Noting that ailing patients were dropped from the study, he added an edge of sarcasm: “This is a great way to improve your mortality statistics, which everybody tells me can’t be biased.”

Well, it’s a bit dry, but for a government bureaucrat, that just about qualifies as an in-your-face scolding!

To Your Good Health,

Jenny Thompson