As I see itLook for more Avandias. Regardless of the anti-diabetes drug's medical merits, the recent furor surely opens an era of politico-medical soap operas that will ensnare other drugs.
The ingredients threaten any marketer of a blockbuster drug. First, you need a politically aware scientist with a credible track record. Second, add some disquiet over the competence of the FDA. Third, throw in a measure of statistics on unforeseen adverse events. Broil under a media spotlight, and watch as another marketer plummets.
Since all new drugs are apt to harbor unforeseen adverse effects, all may be for this kind of unwanted publicity. In Avandia's case, the esteemed Cleveland Clinic cardiologist Steven Nissen was exposed as having collaborated with House Democrats and the New England Journal of Medicine to embarrass the FDA and put GlaxoSmithKline's stock prices into a tailspin over heart attack risks Nissen had uncovered in an unprescriptive meta-analysis.
Adding fuel to the fire was FDA's own untidy house. Its deputy director for drug risk evaluation, Rosemary Johann-Liang, publicly quit after being privately reprimanded by her boss for approving a stronger warning label for Avandia and Actos. Another FDAer, spokesman Doug Arbesfeld, was caught taking Avandia's side in an e-mail to reporters headed “What are St. Steven's feet made of? Clay, perhaps?” in which he seemed to endorse a Wall Street Journal online blogger's comment: “Wake up, pharmaceutical companies…if you don't hire the Cleveland Clinic for your big trials then you face the firing squad from Nissen and Company.” Arbesfeld was rebuked by commissioner Andrew von Eschenbach for this, but experience teaches that you can expect few others, in the FDA or beyond, to learn from the episode.
Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)