GlaxoChinaGate contd. the cartoon

An addiction that is hard to break

http://www.forbes.com/sites/erikakelton/2013/07/29/is-big-pharma-addicted-to-fraud/?

The murky world of academic ghostwriting contd.

Via Macleans.ca
Canada's only national weekly current affairs magazine.


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 it was not unusual for her to approach academics on behalf of drug companies
and withhold information about her relationship with the industry. “I was asked to identify myself as a
writer for the medical education company,” she says, adding that her range of involvement with a
researcher could be anything from editing a manuscript, to writing the entire thing under a researcher’s
byline.

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 ghostauthored 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.”

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.”

Tags: academia, academics, Barbara Sherwin, big pharma, ghostwriting, journals, McGill University,
medical research, pharmaceutical, research
Posted in Science | Edit | 2 Comments
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