The murky world of academic ghostwriting

Lawsuits are shedding light on the dubious relationship between medical researchers and pharmaceutical companies

Photograph by Flickr user striatic

When Barbara Sherwin, a McGill University psychology professor, became embroiled in a ghostwriting case in 2009, many wondered how an esteemed academic—one who dedicated her life to researching the relationship between hormones and cognition—could be accused of attaching her name to an article she didn’t write.

Her alleged transgression came to light in a class-action suit involving 8,400 women against the drug company Wyeth (now part of Pfizer). Lawyers representing the women, who claim they were harmed by their hormone replacement therapy (HRT) drugs, discovered that scientific research papers extolling the virtues of the treatment while downplaying potential harm appeared to have been written, not by the academics who signed their name to the papers, but by writers hired by the pharmaceutical company.

According to court documents filed by the plaintiffs, Wyeth paid the Princeton, New Jersey-based medical communications company DesignWrite to produce articles on HRT for publication in academic journals between 1997 and 2003. DesignWrite would write the papers, then approach leading academics to claim authorship for them.

Sherwin’s name appeared in the court documents in the form of DesignWrite correspondence and internal meeting notes. She has, until now, remained silent about her side of the story. But the topic has stayed in the news, as similar cases continue to reveal apparent conflicts of interest between academia and pharmaceutical companies.

Sherwin’s relationship with the pharmaceutical company started innocently enough. In the early 1990s, she was invited to give a presentation about her work on androgens and psychological functioning in women. There, she met a woman named Karen Mittleman during the lunch break. Mittleman introduced herself as a PhD and a former academic who worked in medical communications. The pair hit it off, and kept in touch. “I liked her, and considered her a casual friend,” Sherwin told Maclean’s over the phone from her office at McGill.

Several years later, in 1998, Mittleman called Sherwin to ask if she wanted to write a paper for the Journal of the American Geriatrics Society at the invitation of the journal’s editor. The subject was pharmacological treatment options for age-associated memory loss. Sherwin, an expert on hormones and how they influence memory and mood in people, had just completed a grant proposal on the subject, and said she’d be happy to write the article.

“[Mittleman] told me she would provide support by typing the manuscript and formatting it in the style of that particular journal,” explains Sherwin. The work itself would be based on Sherwin’s notes. In return, Mittleman, a senior writer at DesignWrite, promised to send Sherwin typed drafts for editing, and hard copies of references the professor requested. “I was completely under the impression that [Mittleman] was working for the journal, that it was the journal who hired her.”

What Mittleman never revealed was that her employer, DesignWrite, had a business relationship with Wyeth and other pharmaceutical companies. The ensuing article, which was peer-reviewed and listed Sherwin as its sole author, appeared in the April 2000 edition of the Journal of the American Geriatrics Society. Sherwin says the work was her own, and that Mittleman had no input on the content beyond typing and formatting Sherwin’s notes. She also says she had no reason to believe there was any problem with the paper—until 2009, when Sherwin became the only Canadian researcher embroiled in the ongoing scandal in the US involving the class-action suit against Wyeth.

A 2009 study found that 7.8 per cent of articles published the previous year in six leading medical journals had at least one ghostwriter. Paul Hebert, editor-in-chief of the Canadian Medical Association Journal, estimates he rejects between five and 10 manuscripts per year because they were ghostwritten in collaboration with pharmaceutical companies. Blockbuster drugs such as the painkiller Vioxx (pulled from the market in 2004 after it was linked to heart problems), and the antidepressants Paxil and Zoloft, continue to come under scrutiny for citing ghostwritten articles that promote their use. Similarly, in 2004, it was found that the manufacturer of Neurontin used a ghostwriting campaign to market off-label uses.

Sherwin says, “If you’re approached by someone who is the head of marketing for Wyeth, then you know. I got a phone call from Karen saying the journal invited this paper, do you want to write it? This was a person I had known for several years.”

Sherwin says she was ultimately cleared by McGill after an eight-month investigation she describes as “emotionally devastating.” (The university has never formally released the results of its investigation.) The Quebec Order of Psychologists also investigated the allegations against Sherwin, and told Maclean’s “no disciplinary actions were taken.”

Richard Janda, a McGill law professor who became Sherwin’s advisor during the ordeal, says the university concluded no one but Sherwin had any input on the article. McGill also found that Sherwin had no way of knowing Wyeth was involved in the publication, and that the paper did not favour Wyeth’s drugs. (It had one section on estrogen and looked at seven other classes of non-hormonal drugs that might benefit mild cognitive impairment. Sherwin and Janda estimate that just over one per cent of the 163 references in the paper cite studies involving Wyeth products.)

Sherwin was, however, reprimanded for not acknowledging the “editorial assistance” she received. She says she offered to credit Mittleman, who declined, saying, “You did all the work.” Maclean’s tried to contact Mittleman, but she did not respond. In her 2006 court deposition, she claimed that a DesignWrite medical writer wrote the Journal of the American Geriatrics Society paper, but that Sherwin appeared as the author.

When the news of Sherwin’s involvement with DesignWrite broke, the McGill professor released a statement (which she now says was penned by the univsersity’s public relations department) defending her work while admitting, “I made an error in agreeing to have my name attached to that article without having it made clear that others contributed to it. It is an error I regret and which had never occurred before or since.”

Newspaper articles at the time questioned the statement, noting that court documents appeared to reveal that Sherwin had worked with DesignWrite again on another article that appeared in the journal Endocrine Reviews in 2003.“I never published anything in conjunction with DesignWrite after [2000],” Sherwin told Maclean’s via email. “I had told Karen (as a friend) that I had been invited to write a review for another journal in 2000. She volunteered help, which I forcefully declined. She nonetheless sent some unsolicited text to me, which I destroyed upon receipt and never spoke to her again.”

Sherwin also added that the allegation of DesignWrite’s involvement in a second paper was dismissed by McGill. “DesignWrite had clearly tried (and failed) to appropriate my second review,” she wrote to Maclean’s. Sherwin believes the hope was that the first article would lead to more collaboration, and incrementally, more influence on her work.

In a written statement to Maclean’s, DesignWrite defended its collaboration with academics, saying it had never promoted bad science and that it was simply trying to help advance worthwhile research. “It is perfectly normal, acceptable, and ethical for physicians to have substantial assistance in drafting articles,” the statement reads. “The exact amount of that assistance can vary, but as long as the physician author has control over the final product and final approval over the article, the exact amount of assistance provided is not an issue.”

At a University of Toronto conference on ghostwriting held earlier this week, a former ghostwriter, Linda Logdberg, says her range of involvement with a researcher could be anything from editing a manuscript, to writing the entire thing under a researcher’s byline. “In every situation I remember,” she added, “the academic researcher knew a lot more than I did about the politics of what he or she was doing.”*

Though the Wyeth ghostwriting cases go back a decade, those who study the problem say it persists. Trudo Lemmens, the University of Toronto law professor who hosted the conference, says biomedical ghostwriting is a public health issue in need of serious attention. “We know that erroneous or wrong use of pharmaceuticals is a leading cause of hospitalization in both the U.S. and Canada, so if ghost-authored publications contribute to that, particularly if they do not accurately represent the evidence, and over-emphasize positive studies, physicians who give their names [to these articles] are indirectly responsible for the prescriptions that are handed out.”

Along with fellow law professor Simon Stern, Lemmens is looking at the legal tools that can be used to fight the practice of ghostwriting and hold academics legally and professionally accountable. Ghostwriting is difficult to detect outside of legal discovery during class-action suits against drug companies, he says, and universities are often slow to reprimand their own researchers, who bring prestige and large research grants to their institutions.

In the world of journals, PLoS Medicine has been leading the effort to curb ghostwriting. It found that only 13 of the top 50 medical schools in the U.S. have a policy that prohibits ghostwriting, which Jocalyn Clark, senior editor of the journal, says is similar to the picture here in Canada.

Clark explains that that policies in place at PLoS Medicine now require that all authors must declare their competing interests and all the sources of funding for their work. “Many of the leading medical journals now have competing interest policies,” she says, “but the large bulk of medical and science journals in the world do not have that standard.”

For now, Sherwin’s story reveals just how complex, sophisticated, and murky the relationship between industry and the academy can be. “There’s a certain amount of deviousness that went on here,” she says. “DesignWrite had a publication plan, they were working with pharma. I spent my life staying away from pharmaceutical companies. If [Mittleman] had said there would be an honourarium, if she had mentioned Wyeth’s name, I could have known.”

*****

*An earlier version of this article incorrectly stated Lodberg would conceal her relationship with the pharmaceutical industry from the academics with whom she worked.




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The murky world of academic ghostwriting

  1. Excellent article. Neurontin is an interesting "test subject" for these ghostwriting/off-label promotion issues, because it's been used in matters of first impression in United States courts. In preparing for a trial, research performed by Kay Dickersin of Johns Hopkins found that the data presented in publications (ghostwritten medical articles) bore little resemblance to original clinicial trial research reports. The resulting article in the New England Journal of Medicine: http://www.nejm.org/doi/full/10.1056/NEJMsa090612
    More about the most recent major Neurontin trial, in which Kaiser won $147M (US) from Pfizer, and in which evidence of "publication bias" of clinical trial results was accepted by the judge: http://www.greenellp.com/press-releases/case-trie

  2. There's deception everywhere here, INCLUDING the willingness of the "author" to succumb to vanity by accepting the concealment of a (co-)author's identity. If that failed to ring any alarm bells, that still reflects poorly on the known author(s).

    • Nice dodge. Try to blame the victim? The liar is excused because the lied to individual was fooled? Is that what you are saying?

      • The credited author knowingly concealed the truth about the real author, or at the least a co-author who should have been credited. This is not the conduct of an ethical academic. She is at least in part a "victim" of her own lamentable conduct.

        Your liar is in no way excused; a helpful hint for you needs to be repeated, apparently: "There's deception everywhere here."

        My point is there is more than one liar in this story.

  3. Big Pharma has large lobbying groups to ensure that they achieve the goal of profit. The liberation treatment being used in multiple sclerosis is offering relief of symptoms and improving quality of life, yet Big Pharma is sponsoring studies with researchers that are already biased against the new theory of the possible cause and/or effect of chronic cerebral spinal venous insufficiency (CCSVI) in MS. Both Big Pharma and MS specialized neurologists have a lot to lose if a simple angioplasty can alleviate the symptoms and prevent progression of multiple sclerosis.

    Mr. Colin Rose will no doubt have a rebuttal with placebo effect, but thousands of patients with positive responses cannot be explained by this alone.

    • Mr. Colin Rose will no doubt have a rebuttal with placebo effect, but thousands of patients with positive responses cannot be explained by this alone.

  4. In my view, what this whole issue hinges on is the clear deception by Wyeth and Mittleman. How can we have trust in pharmaceutical company's when they play such unethical actions? Of course, pharmaceutical companies have a right to publish material but there must be full disclosure. In this case, it was an outright case of deception.

  5. she says. “DesignWrite had a publication plan, they were working with pharma. I spent my life staying away from pharmaceutical companies. If [Mittleman] had said there would be an honourarium, if she had mentioned Wyeth's name, I could have known.

  6. Apart from that, my observations of the debates, which included a thorough scanning through all the posted youTube editions, showed Harper's determination to gun (prison slang for staring-down) his questioner, and then play to the camera in answering. This calculated risk played well to the public. Except (and someone else noticed) when the video director (mischievously) switched to a side camera, leaving Dear Leader imbecilely preaching into a dead tube

  7. Lemmens is looking at the legal tools that can be used to fight the practice of ghostwriting and hold academics legally and professionally accountable. Ghostwriting is difficult to detect outside of legal discovery during class-action suits against drug companies, he says, and universities are often slow to reprimand their own researchers, who bring prestige and large research grants to their institutions.

  8. Clark explains that that policies in place at PLoS Medicine now require that all authors must declare their competing interests and all the sources of funding for their work. “Many of the leading medical journals now have competing interest policies,” she says, “but the large bulk of medical and science journals in the world do not have that standard.”

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