Avandia Hearing Today

Rep. Henry Waxman's Government Reform Committee will highlight flaws in the Food and Drug Administation's ability and willingness to uncover flaws in best-selling drugs like GlaxoSmithKline's Avandia, a glucose-control agent for diabetics and pre-diabetics. Commissioner Andrew von Eschenbach's comments will undoubtedly be the focus of attention. But I will also be interested in hearing what John Buse, the next head of the American Diabetes Association, has to say. This group, which, like most patient advocacy groups, has substantial ties to the drug industry, has been noticeably silent as the furor over Avandia unfolded.

Glaxo-funded scientists weighed in this morning in the New England Journal of Medicine with an interim report on their ongoing study of the cardiovascular risks associated with the drug, which is known generically as rosiglitazone. In an accompanying editorial, David Nathan of Harvard, who, interestingly enough, has also taken speaking fees from Glaxo, had this to say about the study, which is known as the RECORD trial:

The RECORD trial was directed at determining whether the "promising" impact of thiazolidinediones on insulin sensitivity and cardiovascular risk factors would translate into an improvement in cardiovascular clinical outcomes. In addition, the investigators wanted to "address concerns over cardiac failure; confirm that the better outcomes associated with improved glucose control . . . are applicable to this group of drugs; and allay concerns based on LDL [low-density lipoprotein] cholesterol concentrations." . . . In my opinion, several of these goals seem to reflect a company-oriented posture regarding rosiglitazone, rather than a neutral scientific inquiry.

Another argument for moving to a system where all trials, whether industry or government funded, are run through an agency that could put the proposed protocols out for scientific review prior to beginning the trial (see my post here). The answers you get depend on the questions you ask.