I was relieved to see on a CBC News report that somebody’s finally calling a spade a spade when it comes to medical school academics who pretend to be the actual authors of research papers about prescription drugs. Two Canadian law professors interviewed for the piece actually used the word “fraud”. They then called for legal sanctions against any academics who lend their names to medical journal articles that are actually ghostwritten by pharmaceutical industry writers. Here’s what their report had to say on this:
“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.
“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 a policy paper in Public Library of Science‘s journal PloS Medicine*.
“In the article, Lemmens and his colleague Professor Simon Stern argue:
“We argue that a guest author’s claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO).
“The same fraud could support claims of ‘fraud on the court’ against a pharmaceutical company that has used ghostwritten articles in litigation. This claim also appropriately reflects the negative impact of ghostwriting on the legal system.”
“They also argue that legal remedies are needed for medical ghostwriting since medical journals, academic institutions and professional disciplinary bodies have not 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. Lemmens added:
“Our theory does not depend on the accuracy of the data. 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).”
“Meanwhile, an investigation reported by CBC Marketplace helped to explain the job of the medical ghostwriter:
“People with scientific backgrounds – often with PhDs – are paid to stay in the shadows and crank out favourable reports for drug companies. Then, drug companies get doctors to put their names on the studies for public — for money, prestige, or perks.”
“Marketplace tracked down industry-paid medical ghostwriters in Vancouver, Montreal and Ottawa. Here’s how one, referred to just as “Blair Snitch”, explained his role as a ghostwriter:
“I’m given an outline about what to talk about, what studies to cite. They want us to be talking about the stuff that makes the drug look good.There’s no discussion of certain adverse events. That’s just not brought up. You’re being told what to do. And if you don’t do it, you’ve lost the job.”
“Snitch says he is paid to write up positive reports. Bad side effects that could affect patient safety are sometimes completely ignored. He makes over $100,000 a year as a medical ghostwriter. A single article that makes its way into a prestigious medical journal – like The Lancet or New England Journal of Medicine – will earn him up to $20,000.”
© 2011 CBC News
* Stern S, Lemmens T, 2011 “Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles”. PLoS Med 8(8): e1001070. doi:10.1371/journal.pmed.1001070
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