One consequence: conflicts of interest, according to Dr. Jerome Kassirer, a former editor of the New England Journal of Medicine and author of the forthcoming book On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health. Kassirer points to a brochure, mailed to physicians last year, touting the benefits of a compound called EPO (erythropoietin) for treating anemia. Drugs containing EPO have been approved only to treat kidney disease and, in certain situations, cancer and AIDS. But after reading the brochure, he says, "only an idiot could walk away not thinking it would be useful to prescribe EPO" for off-label uses. Who funded the brochure? The National Anemia Action Council. And who funds the council? Amgen, the leading maker of EPO.
However the industry sorts out the off-label-use debate, more lawsuits (if not criminal charges) seem likely. New York attorney general Eliot Spitzer's suit against GlaxoSmithKline for failing to widely publish negative studies of off-label uses of its antidepressant Paxil may have opened a new legal line of attack. "You could conceive of people who weren't injured or hurt now filing suit," says Stephens, the former prosecutor. More lawsuits could also translate into higher costs for drug companies and higher prices for drugs. And that's a headache no pill can cure.