A prominent Australian specialist has been named in a New York Times article alleging that the pharmaceutical company Wyeth paid ghostwriters to produce medical journal articles favorable to its hormone replacement therapy product.
Wyeth is alleged to have paid for a consultancy to assist Associate Professor John Eden, a specialist at the Royal Hospital for Women in Sydney and the University of NSW, in drafting a 2003 article on HRT for the American Journal of Obstetrics and Gynaecology.
The article, which appeared after massive falls in HRT sales following widespread adverse publicity about its risks, said:
Although recent results from the continuous combined therapy arm of the Women’s Health Initiative trial showed a small increase in the risk of invasive breast cancer in women on therapy for 5 years or more, a clear consensus regarding the relationship between HRT and breast cancer risk cannot yet be drawn from existing data. Studies have consistently documented that HRT use is associated with improved mortality and survival rates for women with breast cancer.
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Dr Eden, who was clearly distressed by the NYT allegations, told Crikey he stood by the content of his journal article, and was investigating the process that led to its publication.
“The only thing I can say for sure at the moment, on the record, is that I re-read the article on the weekend, the one they’re talking about, I’ve got over 100 publications, I don’t remember every single article I’ve written,” he said.
“I’m very happy with it. I completely stand by what’s in that article. That article is an accurate representation of my view.”
The NYT report said Wyeth executives suggested that Dr Eden write such a paper in 2000, and had the outline and draft manuscript written for him. The journal article does not mention Wyeth or its medical writing consultancy DesignWrite.
It does acknowledge that Dr Eden received editorial assistance from Karen D. Mittleman and Stephen M. Parker, but whether they are connected to Wyeth is not mentioned.
The case has come to light as part of investigations by Senator Charles E. Grassley, a member of the Senate Finance Committee, into drug industry influence on doctors. His office has released dozens of pages of internal corporate documents gathered from lawsuits showing the central, previously undisclosed role of Wyeth and DesignWrite in creating articles promoting HRT as far back as 1997.
The documents reportedly show company executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles — all without disclosing the companies’ roles to journal editors or readers.
The documents include a “publication plan tracking report” by Wyeth showing 10 articles in which manuscripts were completed by the company before they were sent to the putative author for review. Any revisions were subject to final approval from the company, according to the tracking report.
Dr Ruth Armstrong, the deputy editor of The Medical Journal of Australia, said that authors who signed off on ghostwritten articles probably did so because they agreed with the content.
“In doing this they underestimate the subtle persuasive power of language (held by the writer) and the very real influence that acknowledged experts have on their clinical peers,” she said.
“For this reason authors submitting articles to medical journals should be honest about their contribution and the contribution of others, so that readers can judge the influences that have shaped the paper.”
Dr Armstrong notes that the International Committee of Medical Journal Editors requires authors to acknowledge writing assistance and to declare conflicts of interest and funding sources.
However, I’ve recently seen one Australian consultancy advertising for a medical writer to assist with writing “publications for peer-reviewed medical journals” — which suggests the practice of ghostwriting continues, despite the efforts of journal editors.