2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003

Avandia Vote a Rebuke to Media Alarmism
Trevor Butterworth, July 30, 2007
Critics of diabetes drug hyped by media find their data dismissed.

A Food and Drug Administration advisory panel recommended in a 22 to 1 to one vote that the diabetes drug Avandia remain on the market, with additional warnings about cardiac risk, but not the most extreme drug warning – a black box – in the FDA arsenal.

The recommendation, which is non-binding but almost certain to be followed, resulted from a hearing where critics of Avandia saw their arguments and data dismissed as incomplete and incorrect. "The quality of the analysis far exceeds the quality of the data," said Nancy Geller, chief of biostatistics research at the National Institutes of Health.

The result is a huge embarrassment for the media, especially the New York Times, which gave enormous and largely uncritical coverage to the most prominent of the critics, cardiologist Steve Nissen, on both its news and op-ed pages.

The Times characterized Nissen’s critics as “Republicans,” when numerous other medical experts had written stinging analyses of the flaws in the meta-analysis he published in the New England Journal of Medicine claiming that Avandia increased the risk of heart attack by 43 percent. (For more on the statistical flaws missed by the press see here, here, and here).

That study was dismissed by the panel. In addition, the briefing paper data that the Times cited as concluding a risk for Avandia was determined to not demonstrate statistical significance.

Another critic, FDA advisor David Graham started the day by calling for Avandia to be banned. "Any drug that increases the risk of coronary heart disease im diabetics is unacceptable," Graham told the panel. CNN/Money reported that Graham said that Avandia was ‘inferior’ to the competing drug Actos, which decreases cardiovascular risk.

But Graham was rebuked by other panel members for making such a comparison with data that didn’t support such an analysis. Graham was also criticized for ignoring microvascular risks to diabetics, such as amputation and blindness, which occurs when blood sugar levels are not controlled. (In most of the breaking news reports on the hearing, Graham’s criticisms of Avandia were all reported, but the criticisms of Graham  by other panel members were not).

The panel also recommended that the drug’s manufacturer, Glaxo Smith Kline conduct more extensive tracking of the use of the drug so that accurate risk assessments could be made.

View the Technorati Link Cosmos for this entry