Sowing the Seeds of Unethical Research: The Story of the STEPS Trial

According to a review of documents revealed in litigation, a large phase IV clinical trial of gabapentin was merely a ploy to sell more of the drug.

“Seeding trials” — industry-funded, phase IV clinical trials that typically use trifling hypotheses about already-approved drugs or devices — aim to sell more of a product, not to advance science. Those who agree to participate, as investigators or subjects, are often unaware of the marketing intent. Institutional review boards (IRBs) rarely identify the false intent or provide critical feedback. Quality control is often lax. So it was with STEPS (Study of Neurontin: Titrate to Effect, Profile of Safety), conducted in the 1990s.

These authors, who had consulted to plaintiffs in a suit involving gabapentin (Neurontin), have now analyzed documents on marketing, sales practices, and product liability litigation. STEPS recruited 772 physician-in…

Reviewing Author

Robert Holloway, MD, MPH