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An Open Secret

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One of the most widely known instances of scientific ghostwriting involves Wyeth, the medical-writing company DesignWrite, and the hormone replacement drugs Premarin and Prempro. According to documents that PLoS and the New York Times sued to make available to the public, and which are now housed on a website at the University of California, San Francisco, DesignWrite and Wyeth developed research and review articles that portrayed hormone replacement therapies in a positive light. Outside academic authors were then brought into the process after the first drafts were developed, the papers say. Then, this came to a halt when the Women's Health Initiative stopped its hormone replacement therapy study in 2002 due to an increased risk of breast cancer and an overall lack of benefit. Wyeth has said that the articles are scientifically accurate.

It wasn't a one-time thing — the records from Wyeth indicate at least 26 ghostwritten articles — and it's not limited to Wyeth: GlaxoSmithKline had a program in place to promote Paxil, as did Merck for Vioxx. Furthermore, the editors of the Journal of the American Medical Association presented an analysis of six general medical journals at the Peer Review Congress in September that found that ghostwriting is indeed widespread. According to an updated version of that abstract, they surveyed the corresponding authors of 900 research, review, and opinion articles from 2008. Of the authors contacted, 630 responded. The surveyors report that 7.8 percent of the articles had ghost authors and 25.5 percent included honorary authors, as compared to 19 and 11 percent, respectively, in a 1996 survey. "The prevalence of honorary and ghost authors has not changed significantly since 1996, thus is still a concern," they conclude.

Having someone help prepare a manuscript is helpful; the problem arises when the science is influenced. Meta-analyses and literature reviews have shown that a clinical trial with an industry sponsor, or performed by an investigator with financial ties to a drug company, are more likely to find the drug to be effective. Also, industry-funded research is more likely to report favorably on a drug, even if that conclusion isn't supported by the data.

US Senator Charles Grassley (R-Iowa) has made it his mission to ferret out instances of financial influences on medicine. Over the summer, he sent letters to medical journals inquiring about ghostwriting practices. In those letters, Grassley wrote that "concerns have been raised … that some medical literature may be little more than subtle advertisements rather than independent research." He also wrote to then-acting director of NIH, Raynard Kington, to ask about the policy regarding NIH-funded investigators listed as an author of a ghostwritten-article. On C-SPAN's "Newsmakers," the new NIH Director Francis Collins said that he was concerned about conflict of interest and that grantees and institutions "need to be more forthcoming about disclosure."

To combat ghostwriting, a 2007 PLoS Medicine paper suggested that journals should list each author's contribution to the project. "This practice could increase the likelihood that publications accurately, fairly, and comprehensively reflect the collected data," the researchers write. And journals and other bodies have begun to do just that. The International Committee of Medical Journal Editors encourages its members to have a contributorship policy as well as one to identify which author or authors are responsible for the integrity of the work. PhRMA, a pharmaceutical trade organization, has changed its authorship standards to be in line with the ICMJE standards.

But how well these disclosure policies will work in combating ghostwriting is uncertain. That JAMA-led study noted that they saw no significant differences in rates of ghostwriting between journals with and without author disclosure policies.

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