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Ghostbusters: Authors of a new study propose a strict ban on medical ghostwriting

A scientist who takes credit as an author on an article secretly written by a pharmaceutical company should face punishment like any other plagiarist



ISTOCKPHOTO/MIKDAM

When students pawn someone else's work off as their own, they get expelled. But when some professors do the same thing, they get a "pat on the back," and maybe even a few extra bucks. Scientists credited for research articles that were secretly penned by ghostwriters from pharmaceutical companies often are not reprimanded for their misrepresentations; rather, their ranks and career trajectories often improve.

Although this practice of undisclosed authors (with undisclosed commercial interests) writing articles under the pretense of unbiased scientific inquiry raises serious concerns about academic integrity, few institutions have policies to discourage it. The authors of a new study published in PLoS One hope to make medical ghostwriting a faux pas on par with plagiarism and data falsification.

After the results from their survey on ghostwriting prohibition policies revealed that 37 of the top 50 academic medical centers in the U.S. have none, Jeffrey Lacasse of Arizona State University's School of Social Work and Jonathan Leo of Lincoln Memorial University in Harrogate, Tenn., took the opportunity to propose an unambiguous policy on the matter in their article. "I think some people think they don't need a policy addressing ghostwriting because it would fall under plagiarism," Leo explains. "Maybe an administrator would say the plagiarism policy covers ghostwriting, but I think the profs would adamantly disagree."

Once medical publishing's "dirty little secret," ghostwriting is no longer under wraps, thanks in part to a 2009 federal court decision to release 1,500 documents describing the strategic placement of marketing messages into peer-reviewed medical literature. In their article Lacasse and Leo say these cleverly crafted advertisements from pharmaceutical companies shape the literature in subtle but important ways, and can even affect how clinicians perceive and prescribe treatments.

"Your typical family practice physician is bombarded with glossy reprints," Lacasse explains. "The more prestigious the university and the researcher's name on it, the more weight that's going to carry with the doctor."

Policies prohibiting ghostwriting in U.S.-based academic medical centers were recommended in a 2009 report on conflict of interest in medical research, education and practice published by the National Academies' Institute of Medicine in Washington, D.C. In the report a quote from the dramatist Goethe reads: "Knowing is not enough; we must apply. Willing is not enough; we must do." But more than half of the centers investigated by Lacasse and Leo had no formal policies on ghostwriting or authorship whatsoever.

The top 10 academic medical centers have policies—five flat-out banning ghostwriting: Johns Hopkins University; Washington University in Saint Louis; Stanford University; the University of Washington in Seattle; and Columbia University. Five have "more ambiguous rules": Harvard Medical School (although the authors acknowledge that Harvard's authorship policy is so stringent that it makes ghostwriting nearly impossible); the University of Pennsylvania; the University of California, San Francisco; Duke University; and Yale University.

Despite a longstanding policy on authorship that indirectly prohibited ghostwriting, on July 1, 2009, Johns Hopkins University School of Medicine in Baltimore (ranked second among U.S. medical schools by a U.S. News survey) explicitly banned the act as part of a larger policy on interaction with industry.

"The policy was developed for many reasons," explains Julie Gottlieb, associate dean of policy coordination. "But our main concern was the role of industry in academic medicine—its effects on research and the education and clinical care we provide. Ghostwriting is an issue that has cut across these missions to some extent, largely in the area of research. I think the overwhelming feeling is that it's not in accord with standards of professional practice—in research, education or clinical care—to put your name to something that you had no role in writing."

An allegation of ghostwriting at Johns Hopkins spurs an intense review process, which can lead to serious consequences depending on the findings. Provisions for addressing ghostwriting ban violations are outlined in their policy.

Harvard Medical School has long prohibited faculty members from engaging in ghostwriting through authorship policies, which state that everyone who is listed as an author should have made a substantial, direct, intellectual contribution to the work, and that honorary or guest authorship is not acceptable—is even deplorable. Yet ghostwriting is not explicitly banned.



For the majority of academic medical centers that lack a policy (New York University, Brown University and Baylor College of Medicine, to name a few) Lacasse and Leo outlined basic steps toward developing, implementing and enforcing one in their article. "The main goal of the proposal was to reduce the prevalence of ghostwriting," Lacasse explains. "Why would it stop if there weren't some repercussions?"

Lacasse and Leo suggest that a strict ban be enacted by the deans of academic medical centers following a period of amnesty spanning the remaining months of the 2009–10 academic year, after which any scientist who violates the ban should be deemed guilty of academic misconduct. Lacasse and Leo even recommend that scientists who have participated in ghostwriting in the past should confess, and that their ghostwritten papers be reevaluated and even retracted if appropriate. It is unclear what incentives would exist for scientists to come clean. "We're arguing for a change in culture where it's a very negative thing to have been involved in ghostwriting," Lacasse says.

And whereas their proposal for the ban starts with the deans, Lacasse and Leo say they would love to see a task force within the National Institutes of Health (NIH), the world's largest biomedical research funder, according to a 2008 article published in BMC Genomics. "Many people who've participated in ghostwriting are recipients of NIH grants," Leo says.

While NIH policy does not use the term "ghostwriting," federal regulations on research misconduct such as plagiarism and fabrication could be applicable to ghostwriting, according to an NIH spokesperson.

In a recent interview on C–SPAN's "Newsmakers" program, NIH Director Francis Collins announced that the agency would issue a "proposed rule" early this year that will require pharmaceutical companies to publicly disclose financial relationships with NIH-funded scientists. "I was shocked by that revelation—that people would allow their names to be used on articles they did not write, that were written for them, particularly by companies that have something to gain by the way the data is presented…. If we want to have the integrity of science preserved, that's not the way to do it," Collins said in the December 21 interview.

NIH is currently drafting a Notice of Proposed Rulemaking, which could introduce revisions and enhancements to the current regulations, according to a spokesperson. The notice will be posted for public comment as NIH develops the final rule, which is anticipated in summer or fall of 2010.

Lacasse and Leo plan to follow up on their proposal at the beginning of the 2010 academic year, and hope to see evidence of a culture change. Lacasse says most nonmedical academics are astonished that ghostwriting occurs. "Try explaining to a history prof that on the other side of campus a prof is getting credit for work he didn't do!"

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