Diabetes drug maker hid test data on risks, files indicate

Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.

But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its website or submit them to federal drug regulators, as is required in most cases by law.

“This was done for the US 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.
The latest documents demonstrate that the company had data hinting at Avandia’s extensive heart problems almost as soon as the drug was introduced in 1999, and sought intensively to keep those risks from becoming public.

Debatable issue

A panel of experts will meet on Tuesday and Wednesday to decide whether Avandia should still be sold and whether it is ethical to test Avandia directly against Actos.
Whether to withdraw Avandia is a question that has split the FDA, with some officials arguing that the drug is useful despite its risks and others insisting that it must be withdrawn.

According to the documents, Dr John Jenkins, director of the agency’s office of new drugs, who has argued internally that Avandia should remain on the market, briefed the company extensively on the agency’s internal debate.

“When drug companies withhold data regarding safety concerns about their medicines, they put patients at risk,” said Senator Max Baucus, Democrat of Montana, chairman of the Senate Finance Committee.  An FDA reviewer who closely examined a landmark Avandia clinical trial called “Record,” found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial’s tally of adverse events, mistakes that further obscured Avandia’s heart risks.

The company’s conduct of the Record trial has received sharp criticism from medical leaders for other reasons as well. To compare Avandia and Actos in 1999, researchers at SmithKline measured Actos’s effects in patients in the same way that they had conducted earlier trials of Avandia so that the results for the two drugs could be compared. When the results of the study suggested that Avandia was more dangerous than Actos, the company decided against further comparisons.