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Ghostwritten medical articles called fraud

It's fraudulent for academics to give their names to medical articles ghostwritten by pharmaceutical industry writers, say two Canadian law professors who call for potential legal sanctions.

Studies suggest that industry-driven drug trials and industry-sponsored publications are more likely to downplay a drug's harms and exaggerate a drug's virtues, said Trudo Lemmens, a law professor at the University of Toronto. The integrity of medical research is also harmed by ghostwritten articles, he said.

'False representation of authorship is in our view fraud.'— Trudo Lemmens
Ghostwriting is part of marketing that can distort the evidence on a drug, Lemmens said. Industry authors are concealed to insert marketing messages and academic experts are recruited as "guest" authors to lend credibility despite not fulfilling criteria for authorship, such as participating in the design of the study, gathering data, analyzing the results and writing up of the findings.

Class actions involving drugs such as Vioxx, hormone replacement therapy and antidepressants suggest guest authors often fail to meet criteria for authorship, according to the policy paper in Tuesday's issue of Public Library of Science's journal PloS Medicine.

In the article, Lemmens and his colleague Prof. Simon Stern argue that legal remedies are needed for medical ghostwriting since medical journals, academic institutions and professional disciplinary bodies haven't succeeded in enforcing sanctions against the practice.

The institutions have divided loyalties, the authors say, which may explain why they've been slow to act. For example, universities wish to protect academic integrity while also protecting their employees from unjust accusation.

A legal response could act as a powerful deterrent, Stern said.

"Our theory does not depend on the accuracy of the data," Lemmens said in an email. "False representation of authorship is in our view fraud, regardless of the accuracy of the reporting."

Doctors and patients perceive published studies to be independent assessments made by academic experts, the authors noted.

Ghostwritten publications are used in court to support a manufacturer's arguments about a drug's safety and effectiveness, and academic experts who appear as witnesses for pharmaceutical and medical device companies also boost their credibility with the publications on their CV, Lemmens said.

Lemmens and Stern suggest that imposing legal liability on guest authors in the U.S. "may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO)."

The policy paper and a related conference held at the University of Toronto in May were supported by a grant from the Social Sciences and Humanities Research Council on the Promotion of Integrity in Biomedical Research.


http://www.cbc.ca/news/health/story/2011/08/02/ghostwriting-medical-legal-fraud.html