Does the A Stand for Avandia?

July 31st, 2007

I suppose I shouldn’t be shocked or surprised anymore by what anyone at the FDA(vandia) does. I know they’re funded by Big Pharma. I know that many of their decisions seem to make no sense at all from a saving-American-lives standpoint. But I guess I always hold out hope that they’ll do the right thing…and I’m still bitterly disappointed when they don’t even bother pretending to have our best interests in mind.

The big non-shock today came in the form of an overwhelming committee vote to keep Avandia on the market – a 22 to 1 vote (at least there’s one sensible soul over there). That came after a 20 to 3 vote that Avandia raises the risk of heart attack. (Are you following the logic?) The only way this vote makes sense to me is if everyone on the committee owns shares of GlaxoSmithKline (Avandia’s manufacturer) – but, of course, I don’t know that to be true.

But let’s backtrack a minute, and look at some of the evidence the committee had in front of them while deciding Avandia’s fate.

· An FDA drug safety officer, Dr. David Graham, estimates that Avandia has caused up to 205,000 cardiovascular events (including heart attacks, strokes, and deaths) from 1999 to 2006. He wants the drug taken off the market.
· FDA bigwig Dr. Robert Meyer (who, by the way, heads up the office that originally approved Avandia) completely disagrees with Graham, falling back on the “other diabetes drugs also have risks” defense.
· A recent study published in the New England Journal of Medicine concluded that Avandia takers faced a 43% higher heart attack risk than patients taking different or no diabetes medication.
· About two years ago, GSK itself brought the risks to the FDA’s attention, but infighting at the agency kept anyone from acting on the information.
· GSK representatives testified at the committee meeting, mainly arguing that the “drug is safe.”
· Global sales of Avandia in 2006 were about $3.4 billion, which is quite unlikely to happen this year. (Not really sure if the committee guys care about this, but it would be hard for them to not know it.)

Now, the FDA doesn’t have to follow the advice of the committee…but it almost always does. Let’s think. Will they uphold a nearly unanimous committee vote in favor of leaving an FDA-approved drug alone, or incur the wrath of Big Pharma and pull one of their biggest moneymakers off the market? Stay tuned…

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