Critics of the pharmaceutical industry have long complained that drug companies resort to unscrupulous tactics to market their wares, handpicking friendly researchers (to whom they pay handsome consulting fees) for clinical trials, ghost-writing the results, and running studies for the express purpose of encouraging the adoption of new drugs. Such studies are known as “seeding” trials, and a new report in the current issue of the Annals of Internal Medicine reveals in disturbing detail how one company — Merck — paid for, ran and published such a seeding trial without bothering to tell the so-called authors of the study its true purpose: to encourage the use of Vioxx among primary care physicians. Indeed, as the editorial accompanying the report notes, “…deception is the key to a successful seeding trial. Institutional review boards, whose purpose is to protect humans who participate in research, would probably not likely approve an action that places patients in harms’ way in order to influence physicians’ prescribing habits.”
As the Annals report notes, the seeding trial itself had little scientific merit. At the same time the it was launched, Merck was also starting the VIGOR trial to be the “definitive study of gastrointestinal toxicity.” Interestingly enough, both the seeding trial, known as ADVANTAGE, and the VIGOR trial, uncovered the increased cardiac risk for Vioxx compared to naproxen, although as the world now knows, that risk was underestimated when the VIGOR study was first published in the New England Journal of Medicine in 2000.
The true purpose of the ADVANTAGE trial only became apparent because the extensive litigation around Vioxx unearthed internal Merck documents that showed the extent to which its marketing department had planned and run the whole shebang. As this and other cases illustrate, it is very difficult to get an inside view of drug company tactics short of a subpoena or official law enforcement request. Indeed, it took both to pry out of GlaxoSmithKline internal documents that showed the extent to which the pharmaceutical giant had tried to suppress negative results about the safety and effectiveness of its blockbuster antidepressant, Paxil.
As I reveal in Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial, GlaxoSmithKline only gave up these damaging corporate documents after an official request from the New York Attorney General’s office and a subpoena from lawyers representing the families of teenagers who killed themselves on Paxil or tried to. The resulting New York AG lawsuit essentially forced GlaxoSmithKline to post the results of all its clinical trials, negative as well as positive, on a publicly available website and led to other reforms as well. Yet such valuable “windows” into the drug industry could be closed if the US Supreme Court allows federal agencies to “pre-empt” state lawsuits against the drug industry. That is something none of us should wish for.