Glaxo's Dirty Laundry on Troubled Diabetes Drug Avandia: A Rogue's Gallery of Images

Last Updated Jul 13, 2010 6:13 PM EDT

No wonder GlaxoSmithKline (GSK) agreed to settle about 10,000 lawsuits filed over the diabetes drug Avandia. A look at the company's internal documents and other records show that if GSK's dirty laundry had been aired before a jury it would have been very difficult to explain.

Some of those documents -- emails, internal memos, studies and databases -- were attached to this letter from the Senate Finance Committee to the FDA. What follows is a photo gallery of some of the juicier material.

The FDA was not aware -- and GSK had not informed it -- that the Canadian prescription label on Avandia had a warning for heart disease because reports showed a threefold increase in that condition for Avandia patients. This came out in deposition testimony from Dr. Rosemary Johann-Liang, a former FDA medical reviewer who left the agency after she clashed with her bosses over whether Avandia should carry stricter warnings for heart problems. She was asked whether GSK had ever informed her that in Canada the drug carried a much stricter warning:

Avandia was part of GSK's ghostwriting program, in which company marketers wrote academic papers and slapped doctors names on as "authors." This image is a letter instructing sales reps to recruit doctors for CASSPER, GSK's nickname for the program:

This email shows two GSK executives describing an Avandia article as "ghost written" -- and not very well, either -- and that it has been written for the so-called "author" who has yet to see the draft:

The FDA isn't innocent in all this. It delayed imposing a serious "black box warning" for congestive heart failure on Avandia for nearly two years. These images are from Johann-Liang's testimony about her interactions with three of her FDA colleagues, OND director Bob Meyers, OND head John Jenkins, and director of the Division of Drug Risk Evaluation Dr. Mark Avigan. She had been asked to study fluid retention and macular edema (eye problems) in Avandia users, but ended up recommending that the drug carry a serious "black box" warning for congestive heart failure instead, in February 2006:

Instead of moving to impose a black box warning for heart failure, Avigan was upset that Johann-Liang didn't stick to the macular edema brief, so he creates a bureaucratic bottleneck for future Avandia reports:

The FDA eventually followed Johann-Liang's recommendation and imposed the black box warning for congestive heart failure in late 2007 -- nearly two years after she had suggested it:

Meanwhile, GSK execs tried to make sure that "data should not see the light of day" if it was bad for Avandia. These three images show GSK executives making sure that data that would have showed higher risks for Avandia was to be neither released nor studied:

Image via Flickr user cdrummbks, CC 2.0 Related: Hat tip to Pharmalot.

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