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Ghost writing the norm for over a decade

Nature News

Questions over ghostwriting in drug industry

Analysis claims papers drafted by medical writers downplayed risks of hormone replacement therapy.

 

http://www.nature.com/news/2010/100907/full/news.2010.453.html#comment-id-13486

Published online 7 September 2010 | Nature | doi:10.1038/news.2010.453

Nature News

Questions over ghostwriting in drug industry

Analysis claims papers drafted by medical writers downplayed risks of hormone replacement therapy.

 

Journal 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.

The 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.

"People 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.

Millions 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.

But 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.

Literary haunts

Fugh-Berman's 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.

Between 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.

"The 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."

More 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.

At 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 Fugh-Berman.

Ghostwritten articles also questioned other therapies and the effectiveness of generic hormone treatments, she says.

Author contributions

In 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."

The 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.

"This 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."

But 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.

"How 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 therapy.

Sales of U.S. market leader Wyeth's Prempro have fallen by about 50 percent since 2001 to around $1 billion a year.

 

 

  • References
    1. Fugh-Berman, A. J. PLoS Medicine 7, e1000335 (2010). | Article
    2. Writing Group for the Women's Health Initiative Investigators. J. Am. Med. Assoc. 288, 321-333 (2002). | Article

 

> Millions of women took a mix of the hormones oestrogen
> and progesterone called Prempro.

Is Nature ignorant of the vital fact that Prempro contains no progesterone, but instead the artificial progestogen Provera? The other component is Premarin, which is a very uncertain, patent mixture of substances from the urine of pregnant mares. Whilst that in no way invalidates the main point of the report, or the research, indeed the it makes the need for clear statements and open scientific evidence absolutely clear, it completely invalidates all the material in the report generalising about HRT, because Prepro is totally unrepresentative of any other product used for HRT purposes.

Provera has crucially different effects to the natural hormone progesterone. And Premarim has different effects to the natural hormone estradiol. The literature has detailed those, and explained them, over many years. Much of it was known before the NIH chose to use Prempro in its intended landmark study.

Using a study of the effects of Prempro to attack the entire use of HRT has, through needless fear, caused millions of women to forgo considerable benefits of HRT using better products.

This point has been repeatedly made by endocrinologists. Why does Nature not know it?

 

 

 

 

FiercePharma    http://us.mc817.mail.yahoo.com/mc/welcome?.partner=sbc&.gx=1&.tm=1284063065&.rand=akaq9911d0fld#5

Study Details Wyeth Ghost-writing on Prempro

Unsealed court documents haven't been kind to Big Pharma. They've raised questions about AstraZeneca's marketing techniques on Seroquel and Amgen's Enbrel sales efforts; they've fueled critics of Abbott Laboratories' AIDS-drug pricing; they've provided evidence for journal articles on Merck's Vioxx marketing. And they've provided ammo for foes of ghostwriting.

It's this last bit that's hit the news again today: Some documents from Wyeth's ongoing litigation over hormone replacement therapy are the basis of a sharply critical new study in PLoS Medicine. This isn't the first time we've heard about Wyeth-commissioned journal articles about Prempro. But this study offers details about the interactions between the drugmaker, DesignWrite, and the academics named as authors of the papers. 

According to the study--co-authored by prominent ghostwriting critic Adriane Fugh-Berman--Wyeth paid a ghostwriting firm to write journal articles that highlighted HRT's benefits and downplayed its risks. The professional writers from DesignWrite sometimes got only minimal help from the bylined academics, the study says.

The ghostwritten articles were published years ago, between 1997 and 2003. Pfizer (which bought Wyeth last year) says it has cracked down on ghostwriting, with new policies that require academic authors to be involved in papers from start to finish. Contributions of other authors are required to be disclosed as well. Whether that's enough to stave off bias--and prevent future court-document criticism--remains to be seen.