A Food and Drug Administration (FDA) panel meets this week to debate the fate of GlaxoSmithKline's blockbuster diabetes drug Avandia, which some researchers say is a heart attack risk.
In an article published today, The New York Times says it has obtained documents that show SmithKlineBeecham -- the firm's name in 1999 -- buried a disastrous study that suggested Avandia posed greater heart risks than a competing drug.
As evidence of a smoking gun, the Times points to this 2001 email from Dr. Martin I. Freed, a GSK executive:
"This was done for the U.S. business, way under the radar. Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK," the email states.
It wasn't until 2007, eight years after the study cited by the Times, that health researchers began to pose questions about Avandia's risks. That year a study by a Cleveland Clinic cardiologist, using data obtained from GSK, raised the first red flag.
Information withheld
The Times report says the documents it has uncovered demonstrate the company was sitting on incriminating data that surfaced soon after Avandia's introduction. In one document cited by the newspaper, GSK tried to add up the lost sales that would result if Avandia's heart safety risk became established. The document put the cost at $600 million over a two-year period.
The Times quotes a GSK spokeswoman as saying the company did not publicize the results of the 1999 study because they "did not contribute any significant new information."
Patients taking Avandia have, over the years, reported adverse effects of the drug to ConsumerAffairs.com.
"I was put on Avandia for type 2 diabetes at least two years ago," Patsy, of East Peoria, Ill., reported in 2008. "I started having dizziness and blackout spells not long after. My doctor said he didn't know what caused them. Three or four times I went to the ER where they got it resolved in from one to three days. The last time, in July of 2007, it did not resolve and still hasn't. I was told at that time I had congestive heart failure also and am being treated for that now."
Wrong conclusion
Last week a medical reviewer for FDA said GSK's analysis of a study it used to justify Avandia's safety was completely misinterpreted. Dr. Thomas Marciniak, in a posting on the FDA web site, said the study actually shows the opposite of the company's position -- Avandia may cause heart attacks.
Marciniak's review was part of an FDA effort to brief an expert panel today and tomorrow to determine whether questions about Avandia are serious enough to require its removal from the marketplace. GSK's analysis was part of its case that the drug should not be removed.
But in looking at the data, Marciniak wrote that the information in the study was so misinterpreted that it's hard not to conclude it was done on purpose.
"One does not have to be a mathematician or to perform calculations to come to the conclusion that a combined look at all the trials of Avandia would demonstrate that it causes heart attacks," Marciniak wrote.
