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GSK's Alleged Coverup of Bad Avandia Data: A Snapshot of Its Poisonous Corporate Culture

With fresh allegations that GlaxoSmithKline (GSK) withheld data on the dangers of its diabetes drug Avandia, it's time to ask (again) whether the company is poisoning itself with its own corporate culture. GSK has a history of adopting the most combative, scorched-earth positions possible in defense of its brands. That strategy may now be blowing up in the company's face, as the revelation comes on the same day that the FDA meets to consider the future of the drug.

The New York Times reports that in 1999 GSK began studying Avandia against Takeda's competing drug, Actos, and found that the Avandia patients faced greater risks for heart trouble. The company decided to cover up the results, the NYT reports:

"This was done for the U.S. business, way under the radar," Dr. Martin I. Freed, a SmithKline executive, wrote in an e-mail message dated March 29, 2001, about the study results that was obtained by The Times. "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK," the corporate successor to SmithKline.
... When Rhona A. Berry, a company official, asked about publishing two of the trials, Dr. Freed responded in an e-mail message dated July 20, 2001, that referred to Avandia by the abbreviation of its generic name, rosiglitazone: "Rhona -- Not a chance. These put Avandia in quite a negative light when folks look at the response of the RSG monotherapy arm," the message said. "It is a difficult story to tell and we would hope that these do not see the light of day."
Memo to managers: If you ever find yourself typing an email that asks colleagues to make sure something does "not see the light of day," you're probably doing something wrong. The emails come after Bloomberg reported that Rosemary Johann-Liang, a former manager in the FDA's drug-safety unit, told a deposition that a 2001 GSK study found Avandia posed a greater heart-attack risk than rival medicines:
Glaxo also didn't turn over an e-mail from researchers who concluded Avandia "strengthens the signals" of heart ailments, she testified in a pre-trial deposition last month ...
It all casts GSK in a very poor light. But then, GSK has worked diligently to make itself look as shadowy as possible. The company's own history makes the case against it: For the record, GSK spokeswoman Mary Anne Rhyne says the studies from 1991-2000 "did not contribute any significant new information" about Avandia and that "there was no signal of an increased risk for heart attacks associated with Avandia." Rhyne said. "GSK identified this internal review and described its results in a Periodic Safety Update Report that was submitted to the FDA."

Coming up: The FDA will almost certainly withdraw Avandia or hobble it with so many warnings that its commercial life will be ended. Litigation from patients who took the drug and had heart attacks will move forward. About 8,000 of some 11,000 suits are consolidated under seal in federal court in Philadelphia.

GSK agreed in May to pay about $60 million, to resolve 700 Avandia suits, per Bloomberg. The company's potential liability may go as high as $1.1 billion, according to Gbola Amusa, a UBS AG analyst in London.


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