Published online 7 September
2010 | Nature | doi:10.1038/news.2010.453
Questions over ghostwriting in drug industry
Analysis claims papers drafted by
medical writers downplayed risks of hormone replacement therapy.
articles on hormone replacement therapy (HRT) ghostwritten by medical writers employed by the pharmaceutical industry serially
understated the treatment's risks and promoted unapproved uses, according to an analysis of industry documents.
analysis, published today in the journal PLoS Medicine1,
is based on some 1,500 e-mails, contracts and other documents made public in July 2009, after The New York Times and PLoS
Medicine successfully argued that their release would be in the public interest. Many thousands more papers remain sealed
as part of ongoing lawsuits brought by more than 14,000 women against the drug maker Wyeth, which was bought last year by
the pharmaceutical giant Pfizer, based in New York.
needed to know about what was going on behind closed doors in terms of these articles," says Adriane Fugh-Berman, a researcher
at Georgetown University Medical Center in Washington DC, who conducted the analysis. She is a paid expert witness for plaintiffs
against Wyeth and Pfizer.
of women took a mix of the hormones oestrogen and progesterone called Prempro. HRT was intended to ease the symptoms of menopause,
but many studies suggested that it also helped to protect against heart disease, osteoporosis and other conditions.
a landmark 2002 study2
of tens of thousands of women enrolled in the Women's Health Initiative clinical trial found that HRT did not prevent heart
disease, and increased the risk of breast cancer and stroke. Breast cancer rates in the United States have since fallen as
many women abandoned HRT, although it is still prescribed to combat severe symptoms of menopause such as hot flushes.
study focuses on Wyeth's previously disclosed use of ghostwriters on papers discussing Prempro. The documents detail arrangements
made between Wyeth, DesignWrite — the company it employed to pen articles on HRT, based in Princeton, New Jersey —
and the academic authors named on papers.
1997 and 2003, DesignWrite oversaw the publication of dozens of peer-reviewed articles, conference abstracts and posters on
HRT, receiving up to US$25,000 per project. The documents suggest a deep involvement in writing, editing and overseeing the
publication of the papers, with sometimes only minimal involvement from the named authors.
beauty of this process is that we become your postdocs," reads one 2001 e-mail from a DesignWrite employee to an academic
author. "We provide you with an outline that you review and suggest changes to. We then develop a draft from the final outline.
You have complete editorial control of the paper but we provide you with the materials to review/critique."
troubling, says Fugh-Berman, is that the ghostwritten articles downplayed the risk that HRT might promote breast cancer by
disputing epidemiological data showing such a link.
the same time the papers supported unvetted 'off-label' uses for HRT that were not approved by drug regulators, including
healthier skin, protection against Alzheimer's and Parkinson's diseases, and a generally higher quality of life. Drug companies
are not allowed to make such claims in their advertising. "They have to be channelled through the mouths of academics," says
articles also questioned other therapies and the effectiveness of generic hormone treatments, she says.
a statement provided by spokesman Christopher Loder, Pfizer disputes Fugh-Berman's conclusions. "This article completely —
and conveniently — ignores the fact that the published manuscripts were subjected to rigorous peer review by outside
experts on behalf of the medical journals that published them."
company also notes that it has clamped down on ghostwriting by requiring that academic authors are involved in papers throughout
their writing, and that the contributions of authors who did not write the paper are explained.
behaviour has happened, but arguably not often, and probably not recently," says Thomas Stossel, director of the Translational
Medicine Division at the Brigham and Women's Hospital in Boston, Massachusetts. Fugh-Berman's analysis conflates legitimate
services offered by professional medical writers and ghostwriting, he says. "The fact is that such writers provide assistance
to academics as well as commercial entities, just as speechwriters abet politicians."
Leemon McHenry, a medical ethicist at California State University in Northridge who has investigated the use of ghostwriters
on articles about other drugs, thinks that the practice stretches beyond these high-profile cases.
many other drugs have been promoted in the same way, but you never find out about them because nobody's suffered heart attacks?"
he says. "Nobody finds out about this at all until there's been some major damage and the lawsuits get filed."
Use of HRT plummeted in 2002 after the publication of the Women's Health
Initiative study, which found an increased risk of ovarian cancer, breast cancer, strokes and other health problems from hormone
Sales of U.S. market leader Wyeth's Prempro have fallen by about 50 percent
since 2001 to around $1 billion a year.
A. J. PLoS Medicine 7, e1000335 (2010). | Article
Group for the Women's Health Initiative Investigators. J. Am. Med. Assoc. 288, 321-333 (2002). | Article