NEJM editors side against Wyeth

Every editor-in-chief of the New England Journal of Medicine has signed up to a brief aimed at blocking the appeal by US drug major Wyeth to the Supreme Court of the United States (SCOTUS), according to Marcia Angell, the NEJM's former editor. The case, Levine versus Wyeth, which is likely to set a precedent on whether or not the Food and Drug Administration's regulations pre-empt state tort law, is due to be heard by the USA's highest court from November 3 (Marketletter August 18).

The law suit was brought initially on behalf of a Vermont resident, Diana Levine, who suffered an adverse event after being injected with a nausea drug, Phenergan (promethazine for injection), in 2000. As a result of this, the patient suffered gangrene and had part of her arm amputated. Wyeth has appealed against a $6.8 million award in favor of the plaintiff, arguing that by complying with the FDA's labeling regulations which warned against injecting Phenergan into an artery, the firm cannot be held responsible.

Speaking to Bloomberg News, Marcia Angell, said: "we all agree that pre-emption is a terrible idea, especially given the fact that the FDA no longer adequately performs its function of assuring that new drugs are reasonably safe and effective." Two former FDA Commissioners, Donald Kennedy and David Kessler, have opposed federal regulatory pre-emption.