Seeding Trials: Just Say “No”

The public has lacked convincing documentary evidence of a long-suspected drug company practice: promoting a new drug by sponsoring a randomized trial in which participating physicians use the drug as they follow the trial protocol. This practice—a seeding trial—is marketing in the guise of science. The apparent purpose is to test a hypothesis. The true purpose is to get physicians in the habit of prescribing a new drug.

Why would a drug company go to the expense and bother of conducting a trial involving hundreds of practitioners—each recruiting a few patients—when a study based at a few large medical centers could accomplish the same scientific purposes much more efficiently? The main point of the seeding trial is not to get high-quality scientific information: It is to change the prescribing habits of large numbers of physicians. A secondary purpose is to transform physicians into advocates for the sponsor's drug. The company flatters a physician by selecting him because he is “an opinion leader” and incorporates him in the research team with the title of “investigator.” Then, it pays him good money: a consulting fee to advise the company on the drug's use and another fee for each patient he enrolls. The physician becomes invested in the drug's future and praises its good features to patients and colleagues. Unwittingly, the physician joins the sponsor's marketing team. Why do companies pursue this expensive tactic? Because it works (1, 2).

It works, but it may endanger the unwary physician. The tide is turning against the physician who accepts emoluments from drug companies. Academic institutions and professional organizations are issuing ethical guidelines that proscribe transactions in which drug companies pay physicians an amount that is disproportionate to the services that the physician provides (3, 4). The office of the U.S. Inspector General has …