March 24 2010

Ensuring Integrity in Industry-Sponsored ResearchPrimum Non Nocere, Revisited

Author Affiliations

Author Affiliations: Dr DeAngelis (cathy.deangelis@jama-archives.org) is Editor in Chief and Dr Fontanarosa is Executive Deputy Editor, JAMA.

JAMA. 2010;303(12):1196-1198. doi:10.1001/jama.2010.337

The most fundamental principle of medicine, primum non nocere, holds for every physician, whether functioning as a clinician providing direct patient care; as a researcher, reviewer, or editor involved in medical publishing; or as an administrator overseeing an academic institution, health care organization, or pharmaceutical company research program. In all situations affecting patients, physicians must do no harm.

The Commentary in this issue of JAMA by Nissen1 describes a disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial of rosiglitazone and reveals a situation in which concerns about preserving market share apparently trumped concerns about the potential for causing patient harm.2 Analyzing this situation and others involving misleading reporting and possible misrepresentation of industry-sponsored research37 has become only too common, and it appears that physicians functioning at several levels failed to put the well-being of patients first.

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