Ghostwriting in Medical Literature

Minority Staff Report 111th Congress United States Senate Committee on Finance Sen. Charles E. Grassley, Ranking Member June 24, 2010

Table of Contents

BACKGROUND ............................................................................................................................ 1 FINDINGS ...................................................................................................................................... 4 A. Despite acknowledgment of medical writers for “editorial assistance,” the role of pharmaceutical companies in medical publications remains veiled or undisclosed ............ 4 B. Some medical schools explicitly prohibit ghostwriting in their policies ............................. 7 C. Detection of ghostwriting by medical schools is limited ..................................................... 9 D. Strengthening journal authorship policies appears to have limited effect on ghostwriting and disclosure of industry financing of medical articles ................................................... 11 E. National Institutes of Health does not have explicit policies on disclosure of industry financing of ghostwritten articles....................................................................................... 14 CONCLUSIONS........................................................................................................................... 14

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BACKGROUND
In 2005, the Senate Committee on Finance (Committee) initiated an inquiry into educational grants for continuing medical education (CME) programs. This inquiry began after reports that drug companies were using the grants to promote off-label uses of their drugs, i.e., uses that had not been approved by the Food and Drug Administration. The findings of that inquiry were released in a Committee staff report in April 2007.1 The Committee’s inquiry revealed that the pharmaceutical industry spent more than a billion