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Pharmaceutical Ghostwriting Trend Mars Credibility of Research and Negatively Impacts Patient Safety

Posted on: Thursday, 17 April 2008, 15:00 CDT

A new article in the Journal of the American Medical Association (JAMA) showing how Merck used ghostwriters to hide of the perils of Vioxx (http://jama.ama-assn.org/cgi/content/full/299/15/1800) is only one example of how ghostwritten academic articles can impact patient safety, according to a Policy Brief released today by The Prescription Project. Ghostwriting was also integral in generating positive reports on Neurontin, Zoloft, Paxil, and Fen Phen, all drugs which were later found to have undisclosed or underreported side effects.

The Prescription Project's Ghosts in the Machine, Addressing the Conflict between Medicine and Industry-Sponsored Ghostwriting provides a clear analysis of how ghostwriting works, its prevalence, case studies where ghostwriting helped manipulate data in favor of the medication being studied, and clear recommendations on how to restore credibility to academic writing. For the full brief, www.prescriptionproject.org/newscenter/reports_publications.

"Ghostwritten articles in medical journals give the appearance of objectivity," said Allan Coukell, Policy Director of the Prescription Project. "In fact, doctors may be making their prescribing decisions based on articles that conceal the extent of industry influence over the content."

Ghosts in the Machine details the ways in which ghostwriting harms patients, including: influencing physician prescribing habits using inaccurate or incomplete data, suppressing negative data from less successful clinical trials, manipulating results by selective reporting of data, creating a demand for off-label uses for drugs and identifying "new" diseases (designed to support sales of a specific prescription) and their miracle therapies.

To restore trust in the medical profession, The Prescription Project recommends a wide array of steps designed to eliminate ghostwriting, including:

Standards for all journal authors that include unrestricted access to all data, full participation in the writing and editing of any article that bears their name, and disclosure of any financial relationship.

Recognition of the role of medical communications companies in any published article.

Consistent guidelines for authorship and disclosure of conflicts adopted by all medical journals, professional medical associations and academic medical centers

A full investigation into the incidence and impact of ghostwriting by state and federal lawmakers, attorneys-general and agencies with oversight authority.

"Medical journals are designed to be an unbiased source of factual information," said Coukell. "By adhering to both JAMA's new recommendations and the more comprehensive approach outlined by the Prescription Project, doctors can be sure they are not putting their patients at risk when they make decisions based on journal articles."

About The Prescription Project

The Prescription Project is led by Community Catalyst in partnership with the Institute on Medicine as a Profession. Created with The Pew Charitable Trusts, the Project promotes evidence-based prescribing and works to eliminate conflicts of interest in medicine caused by pharmaceutical marketing to physicians by working with academic medical centers, professional medical societies, public and private payers, and state and federal policymakers. For more information, please visit www.prescriptionproject.org.

Source: Business Wire

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