Healthy Skepticism Library item: 10400

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Goldstein S.
Glaxo defends Avandia before Congress hearing
MarketWatch 2007 Jun 6
http://www.marketwatch.com/news/story/glaxo-defends-diabetes-drug-ahead/story.aspx?guid=%7B81B55457%2D4734%2D4AD2%2DBA36%2D349FCF601EDA%7D&siteid=yhoof

Full text:

GlaxoSmithKline released a study defending the safety of its diabetes drug Avandia ahead of a hearing in Congress questioning how the drug won regulatory approval in the first place.

Glaxo, in a study released late on Tuesday, said findings from an interim analysis of a prospective clinical trial add evidence to the overall cardiovascular safety profile of its diabetes drug Avandia. The trial was designed specifically to determine cardiovascular outcomes in more than 4,400 patients with type 2 diabetes.

The study is scheduled to complete in late 2008.

“The interim findings do not show evidence of a significant difference in cardiovascular death and heart attack between Avandia and the control groups, and therefore do not confirm the hypothesis generated by the recently published meta-analysis in the New England Journal of Medicine that raised concerns about these events with Avandia,” said Moncef Slaoui, chairman of research and development.

It did acknowledge more cases of congestive heart failure but said that’s consistent with the well-known association between fluid retention and TZDs, the class of medicine to which Avandia belongs. And it said that despite the increase in congestive heart failure, there wasn’t a difference in cardiovascular hospitalizations and death.

“Patients and physicians should find these data reassuring,” he added.

Shares of GlaxoSmithKline improved 1.5% in London trading.

Navid Malik, an analyst at Collins Stewart, agreed the data could help change opinions about the drug.

“Because this study only looked at cardiovascular safety, it should hold the greatest value in reassuring doctors,” he said in a note to clients. Malik has the stock rated a buy.

But the shares are still down some 12% from before an analysis by a prominent Cleveland Clinic cardiologist concluded the drug increased the risk of heart attacks by 43%.

Since then, new U.S. prescriptions of Avandia have fallen to zero, according to market research data.

GlaxoSmithKline has repeatedly criticized the methodology of the Cleveland Clinic study, and even its author acknowledges that the study was a “meta-analysis” combining findings from previously performed studies.

Glaxo’s Slaoui is due to be one of the witnesses testifying before the U.S. House Committee on Oversight and Government Reform. The Food and Drug Administration commissioner, Andrew von Eschenbach, also will be testifying.

The FDA will hold an advisory committee meeting on Avandia on July 30.

Steve Goldstein is MarketWatch’s London bureau chief.