The FDA’s own little “Avandiagate,” complete with Nixonian “dirty tricks,” emerged in May’s mass media coverage of the editorial decision at the New England Journal of Medicine to rush online publication of preliminary safety data on this GlaxoSmithKline diabetes top-seller.
As former FDA deputy commissioner Scott Gottlieb, now at the American Enterprise Institute, was calling the NEJM‘s decision politically biased in a Wall Street Journal op-ed piece, one of Gottlieb’s political recruits to the agency, Douglas Arbesfeld, took his own action. He sent e-mails to selected reporters headed “What are St. Steven’s feet made of? Clay, perhaps?” attaching a WSJ online edition blog 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.”
Nissen has heatedly denied the charge, calling it “extremely offensive.”
While there are legitimate questions about the NEJM decision, the idea of an FDA employee publicly taking sides on a matter that his agency had under review at the time is disturbing. Arbesfeld’s astonishing tactic earned him an official reprimand in his FDA personnel file and public repudiation by commissioner Andrew von Eschenbach at a June 6 Capitol Hill hearing.
Although the commissioner assured the hearing that the agency has no campaign against Nissen, the agency’s attempt to isolate the incident to one individual is worrying. The agency should officially remind its other consultants and employees of their common duty to be neutral in scientific controversies until they’re objectively settled.
FDA staff turnovers are so high that ethical retraining should be continual. But after a decade of budget cuts, maybe there aren’t sufficient resources for this.
Dickinson is editor of Dickinson’s FDA Webview (fdaweb.com)
From the July 01, 2007 Issue of MM+M - Medical Marketing and Media
