Big Pharma: More Sordid News

Another reason to question what your doctor and the FDA tell you about the safety and efficacy of any drug has now come to light. The Annals of Internal Medicine has just reported that Merck used the unsavory tactic of a “seeding trial” in its development of Vioxx. (This has come to light as a result of Vioxx litigation, and is not data the public would know if only the FDA, rather that the courts, were looking over Merck’s shoulder.) A seeding trial is carried out by a drug manufacturer just prior to or shortly after FDA approval of a new drug. Ostensibly, such a clinical trial is completed for the obvious medical research benefits, for example post-approval surveillance for safety and efficacy. In reality, there is an unspoken agenda: to get the drug in as many physicians’ hands as possible, enlisting them as investigators while picking up the support for monitoring and paperwork. The physicians receive the prestige of participating in a drug trial as clinical investigators and are financially reimbursed, and the drug manufacturer is familiarizing physicians with the drugs, thereby shortening the path to profitability, or “accelerating uptake” in the parlance. Such trials should be initiated for a legitimate research purpose, not as a pretext for profit.

The guidelines imposed by science, the FDA and institutional review boards are there for a purpose–to be sure that evidence-based science guides critical decisionmaking. When medical journals, the FDA, and the public are deceived with these kinds of tactics, the credibility of the system is corroded. Such deception cannot be permitted to stand without penalty by the FDA, and Merck should be subjected to professional and public scorn.

It is a difficult enough proposition for science to drive decisionmaking in America today. Too often, politics and the mythical thinking justifying the herbal phenomenon win the day. When money corrupts the scientific process, its credibility is undermined and the public increases its distrust of conventional medicine. Simply put: seeding trials are a pernicious practice that should never be permitted.

If you can’t trust the guys in the white coats, who can you trust?


Seeding Trials: Just Say “No”

The ADVANTAGE Seeding Trial: A Review of Internal Documents