Ghostwriting in medical literature

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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 bymedical 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 ofghostwritten 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 medicaleducation (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 billiondollars a year to fund CME programs. Since releasing that report, Ranking Member Charles Grassley expanded his inquiries into the financial relationships between drug and device companies and academic physicians and scientists. These financial relationships include payments to physicians and scientists for consulting services, speaking engagements, and research activities. Senator Grassley also examinedthe policies and reporting practices at over a dozen medical schools in the United States and found that the medical schools have not adequately monitored the outside income of their researchers and faculty. The National Institutes of Health (NIH) relies on an institution to report and manage its faculty members’ conflicts of interest in order to maintain the integrity of federal funding forbiomedical research. However, Senator Grassley found cases where there were vast disparities between the amounts of payments leading physicians and scientists received from drug companies and the amounts they reported to their institutions. Senator Grassley’s inquiries led to the introduction of the bipartisan Physician Payments Sunshine Act, which he co-authored with Senator Herb Kohl. This bill wasincorporated into the recently passed health care reform legislation, the Patient Protection and Affordable Care Act,2 which was signed into law by President Obama on March 23, 2010. Beginning in March 2013, drug, device, and biologics manufacturers will be required to report annually payments they made to physicians nationwide. About two years ago, Senator Grassley inquired about an industrypractice to get articles published in major medical journals touting the benefits of a company’s product without public disclosure that the company initiated and paid for the development of the articles. Specifically, Senator Grassley wrote to Merck & Co., Inc. (Merck) and Scientific Therapeutics Information (STI), a medical publishing company, following the publication of a study in the Journal of...
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