An article published yesterday in PLoS Medicine, and first presented at an event hosted by the CILP, by Professors Simon Stern and Trudo Lemmens has been receiving considerable media attention. Titled “Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles“, Stern and Lemmens argue that “guest authorship is a disturbing violation of academic integrity standards, which form the basis of scientific reliability.” They continue, “The false respectability afforded to claims of safety and effectiveness through the use of academic investigators risks undermining the integrity of biomedical research and patient care.”
The practice of ghostwriting is part of a marketing strategy that can distort the evidence on a drug, Lemmens said. It is a practice that worked in the shadows until the use of some popular drugs, like the discontinued painkiller Vioxx, became problematic. Class action lawsuits revealed that industry authors often wrote medical articles, downplaying a drugs risks while focusing on its virtues, then recruited academic experts as “guest” authors to lend their credibility. This was done even if the academic had not participated in designing the study, gathering the data, analysing the results or writing up of the findings, which are basic requirements of authorship.
In their paper, Stern and Lemmens argue that since medical journals, academic institutions, and professional disciplinary bodies have not succeeded in enforcing effective sanctions, a more successful deterrence should be through the imposition of legal liability on these guest authors, “and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO).”
Besides the serious problem of doctors and other health professionals relying on these ghost-authored articles to choose and recommend medication, ghostwritten publications are also used in court to support a manufacturer’s arguments about a drug’s safety and effectiveness. The academic expert also lends their credibility in support of pharmaceutical and medical device companies when/if they have to appear to court.
Stern and Lemmens then also argue that “The same fraud could support claims of ‘fraud on the court’ against a pharmaceutical company that has used ghostwritten articles in litigation.” Such a claim could prevent the pharmaceutical sponsor of the articles from presenting them as evidence in court, and could also lead to sanctions against the lawyers who sought to treat the articles as legally valid evidence.
Concerns about ghostwriting have troubled the medical profession and editors of medical journals for years. Industry-sponsored articles, with only minor contributions from academic “guest authors,” have been published in leading medical journals, including articles on Hormone Replacement Therapies, Vioxx, Neurontin, Fen-Phen, and various anti-depressants. These articles are often cited by the pharmaceutical sponsors to promote off-label use of their products.
As well, the issue of whether the information or data in the ghost authored article is accurate is irrelevant the authors argue. “False representation of authorship is in our view fraud, regardless of the accuracy of the reporting,” Lemmens said in an email to the CBC.
To the academics who participate in this guest authorship-ghostwriting, Lemmens says: “It’s a prostitution of their academic standing. And it undermines the integrity of the entire academic publication system.”