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Earlier today, the NYT got wind of a 1999 test SmithKline Beecham, now part of GlaxoSmithKline, ran to compare Avandia to Actos.  The results, to put it mildly, were a disaster.

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.

And yet, SmithKline never reported this to the FDA as required by law.  Rather, senior management at SmithKline fell all over itself to keep a lid on it--an effort that continued after it merged with Glaxo Wellcome to form GlaxoSmithKline.

This disclosure couldn't come at a worse time for GSK, as an advisory panel is debating whether Avandia should be yanked from the market.

Just how far GSK, and SmithKline before it, went to hide these results became clear in a Senate Finance Committee report released today.

Rosiglitazone was approved by the U.S. Food and Drug Administration in 1999 to treat type 2 diabetes. But "as far back as 2000, internal e-mails show that GSK executives sought to downplay scientific findings, which raised questions about the safety [of the drug]," the committee wrote, citing an internal memo about a trial comparing rosiglitazone to pioglitazone (Actos) that found rosiglitazone presented a "worse lipid profile" than its competitor.

In another e-mail, sent on July 20, 2001, a GlaxoSmithKline executive, discussing the negative data wrote "we would hope that these do not see the light of day."

The full report, available at the Finance Committee site or at NYT shows that GSK feared it could lose as much as $600 million if the test results came out.  In other words, GSK was more concerned about profit margin than the safety of the nation's diabetics.

The findings probably won't help GSK's image with the advisory panel, which is starting to wonder if the company has any credibility left at all.

"Can we trust the sponsor?" Dr. Ellis F. Unger, a Food and Drug Administration official, asked when referring to GlaxoSmithKline. "I think that’s something the committee is going to need to think about here."

Again and again, committee members hinted at skepticism over GlaxoSmithKline at the meeting, being held over two days in a hotel ballroom in the Washington suburbs. They will vote on Wednesday on whether Avandia should remain on the market.

"I’m just concerned about data quality overall," said Dr. Nancy L. Geller, a panel member who is director of the Office of Biostatistics Research at the National Heart, Lung and Blood Institute.

Told that death estimates can usually be trusted in clinical trials, Dr. Geller quickly retorted: "Not if you report the wrong follow-up date and not if you withdraw someone from a trial just before their death."

According to the NYT, this level of skepticism is almost unheard of from an FDA advisory panel.  It's probably safe to say Avandia's days are numbered.  To my mind, after reading this, GSK ought to be brought up on criminal charges.

Originally posted to Christian Dem in NC on Tue Jul 13, 2010 at 03:31 PM PDT.

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