Just say no

doi:10.1136/bmj.b4527

Published 2 November 2009, doi:10.1136/bmj.b4527
Cite this as: BMJ 2009;339:b4527

Letters

Seeding trials

Just say no

The first 150 words of the full text of this article appear below.

The postmarketing observational studies referred to by AnnetteTufts in her news story are sham studies that are generallyreferred to as "seeding trials."¹ ² The actual research takingplace is the evaluation of the return on investment (ROI) frompaying physician "investigators" to participate in the shamstudy. The ROI is measured by tracking the increased use ofthe drug by participating doctors, who are the real subjectsof these studies.³

No patient would ever agree to participate in a trial designedto determine how the use of physicians as investigators canincrease drug sales. No institutional review board would everapprove such a trial. Unfortunately, the side effects from thesesham trials are real.⁴

Drug companies are systematically misleading patients and doctorsin these seeding trials. The Nuremberg Code (and all other medicalresearch codes) requires that research subjects should be informedof the purpose of the research. This . . . [Full text of this article]

David Egilman, clinical associate professor

¹ Brown University, Department of Community Health, 8 North Main Street, Attleboro, MA 02703, USA

david@neveragainconsulting.com

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