guardian.co.uk, Ian Sample, science correspondent,Tuesday 2 August 2011
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Ghostwritten articles about Vioxx, which was later withdrawn amid
safety concerns, had minimal input from guest authors. Photograph: Spencer Platt/Getty |
Doctors and scientists who put their names to medical articles they have not written should be charged with professional misconduct and fraud, according to legal experts.
The
proposals aim to stamp out the shady business of "guest authorship",
where research papers written by pharmaceutical companies or industry-sponsored
medical writers are passed off as the work of influential, independent
academics.
In the
worst cases, doctors receive payments or other incentives to endorse articles
without being familiar with the studies or data the reports describe. Often,
the articles are biased and do not carry the names of the real authors.
The medical
profession has long been troubled by guest authorship and ghostwriting, but the
issue has become harder to ignore in recent years as the extent to which drugs
companies use the tactic as a marketing tool has become clear.
Articles
drafted by industry with minimal involvement from guest authors have been
published in leading journals on hormone replacement therapy (HRT), Vioxx (an
anti-inflammatory drug that was withdrawn amid safety fears), Neurontin (used
in pain relief), antidepressants, and the combination diet drug, Fen-phen (also
withdrawn for safety reasons).
While the
practice is not currently considered to be illegal, it is widely regarded as
unethical and potentially harmful to patients because it skews the information
that appears in medical journals.
Writing in the journal, PloS Medicine, Simon Stern and Trudo Leemens, who are law
professors at the University of Toronto, warn that measures brought in by
publishers and professional bodies to curb guest authorship and ghostwriting
have so far failed to tackle the problem. They call for more severe sanctions
against those involved, even when the articles are scientifically accurate.
"It's
a prostitution of their academic standing. And it undermines the integrity of
the entire academic publication system," Leemens said.
"A
guest author's claim for credit of an article written by someone else
constitues legal fraud, and may give rise to claims that could be pursued in a
class action," the authors write. The same offence could also support
claims of "fraud on court" when drugs companies rely on ghostwritten
articles in court cases. Stern and Leemens argue that pharmaceutical companies
and the medical writers they sponsor may also incur liability for soliciting
and facilitating fraud.
In 2009, a
trove of documents relating to ghostwriting and guest authorship were released
following a request in court by PloS Medicine and the New York Times. The
papers revealed that Wyeth, a pharmaceutical company, had used ghostwriters to
prepare 26 medical articles that emphasised the benefits and downplayed the
risks of taking HRT for conditions such as heart disease and dementia.
Government funded studies on the therapy were later stopped after the treatment
was shown to raise the risk of breast cancer, heart disease and stroke.
Adriane Fugh-Berman, a doctor at Georgetown University Medical Centre in Washington DC,
who was an expert witness for the women who brought the civil action against
Wyeth, said the Canadian lawyers had put forward a "provocative proposal
for a serious problem".
"Ghostwriting
distorts the scientific literature on drugs and other therapies, and changes
prescribing decisions in a way that may be harmful to patients. It is thus a
threat to public health. Academic institutions give lip service to being
against ghostwriting but no academic has been sanctioned. Fear of legal action
really might deter the practice, which is euphemistically termed 'editorial
assistance'," she told the Guardian.
Some
journals, including PloS Medicine, have called for bans on guest authors and
warn that unacknowledged ghostwriting will be retracted if discovered after
publication, with the academics being reported to their institutions.
Fiona
Godlee, editor of the British Medical Journal, said the practice continues to
be a problem in the medical literature.
"Guest
authorship and ghostwriting is absolutely unacceptable and we have been saying
this for a long time. It is misleading, a form of fraud, and it would be good
to see much stiffer penalites and legal liabilities for people who involve
themselves in this," she said.
"The
benefits of being a guest author are still substantial. You get a piece of work
under your name that you didn't have to bother writing, the company involved
will push to get it published in a high-profile journal, and visibility,
promotion and all sorts of things come your way, not to mention international
travel and speaking at conferences."
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