IN NOVEMBER, the Supreme Court will hear a case that could make it much more difficult for public officials to expose drug industry practices that put profits ahead of patients. The court could conceivably strip state courts of the right to hear cases challenging the safety and effectiveness of drugs that have been approved by the US Food and Drug Administration. Such state lawsuits have been instrumental in forcing the industry to open its books and reveal embarrassing information.
Recently, for instance, researchers relied on trial documents to shed light on a dubious marketing practice employed by some drug companies: running studies purportedly meant to examine drug safety that in reality are designed to encourage the widespread adoption of a new drug. Such studies are called "seeding trials," and while they are thought to be relatively common, the Aug. 18 report in the Annals of Internal Medicine was the first to investigate these stealth marketing tactics in-depth and raise questions about the ethics of deceiving doctors and patients about the true purpose of these studies.
The report's researchers were able to expose the machinations behind a particular seeding trial - a 1999 study of the painkiller Vioxx by Merck - only because they got their hands on internal Merck documents subpoenaed by plaintiff attorneys. They had sued the firm after Vioxx was withdrawn from the market amid growing evidence that it increased the risk of heart attacks and strokes. This is not the first time that litigation has provided the public with a glimpse of the lengths to which some drug companies will go to create blockbuster drugs. In 2004, the New York State attorney general's office relied on GlaxoSmithKline's own internal documents to sue the drug company for deceiving physicians and consumers about the safety and effectiveness of its best-selling antidepressant, Paxil. Similar to the Merck case, GlaxoSmithKline's internal documents revealed a rich vein of duplicity among company officials intent on suppressing negative findings about Paxil in treating depression among children and adolescents.
