With Avandia Now a Zombie, Can an FDA Safety Trial Survive Night of the Living Dead?

(MoneyWatch)  GlaxoSmithKline (GSK)'s Avandia may have survived by the skin of its teeth but as a commercial entity it's as good as dead, according to the FDA panel's vote on the diabetes drug. While the drug may technically stay on the market, it will only stagger onward as a zombie of its former self, covered in unwanted warnings.

The FDA makes a full, final decision at a later date. The next question for GSK is, Can it hold together its massive FDA-ordered trial of the drug, nicknamed "Tide," which was supposed to deliver definitive results about Avandia's risks in 2016? India just pulled its patients, saying it was too risky.

For the record, here's how the FDA vote went on Avandia's marketing:

• A: remove boxed warning: 0
• B: no changes to warnings: 3
• C: additional warnings: 7
• D: additional warnings and use restrictions: 10
• E: Withdraw from market: 12

With that level of doubt, no doctor will choose to prescribe Avandia if there's an alternative treatment available.

The future of Tide -- which FDA also voted to continue -- involves a tricky ethical issue: If you believe Avandia is too risky compared to competing meds you should stop the trial, in which half the patients are getting the more dangerous drug. But if you believe the question is not clear cut you should let the trial continue and wait to see how many people die or survive heart attacks.

The question is tied to the FDA's understanding of the trial, which is not clear cut: The FDA panel heard yesterday that the Tide trial was largely being conducted in the Third World. That's not true. Big chunks of it are being conducted in poor countries or nations with poverty stricken neighborhoods, such as Russia, Chile, the Philippines, Latvia, South Africa, and Pakistan. But there's an even larger number of locations in the U.S. and Germany, etc.

GSK's problem is that each country will likely react differently to the FDA's vote and final decision. So even if the drug stays on the market, GSK's study might be ruined for lack of participation.

Related:

• Glaxo's Dirty Laundry on Troubled Diabetes Drug Avandia: A Rogue's Gallery of Images
• Glaxo CEO Worried in Email Over Heart Attacks From Avandia -- in 1999
• GSK's Alleged Coverup of Bad Avandia Data: A Snapshot of Its Poisonous Corporate Culture