Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial

Abstract

Pharmaceutical companies use a variety of techniques to promote their products, including “seeding trials.” Seeding trials are clinical trials, deceptively portrayed as patient studies, which are used to promote drugs recently approved or under review by the US Food and Drug Administration (FDA) by encouraging prescribers to use these medications under the guise of participating as an investigator in a clinical trial.¹ In fact, marketing departments, rather than clinical research departments, are known to design and conduct these trials.² Although seeding trials are not illegal, they are unethical. Their primary goal is to expose physicians to a new drug and have them interact with the pharmaceutical company sponsor and its sales representatives, in order to influence prescribing decisions, independent of any findings from the actual study. In addition, physician “investigators” are the actual trial subjects, and this information is neither disclosed to them nor the human participants. There are no current estimates of how frequently seeding trials are conducted, and most evidence of their planning and conduct has come from documents produced in tort litigation against pharmaceutical companies.³