Thursday, September 8, 2011

Compromising the medical literature

To ensure that its clinical review articles reflect current medical literature, the American Family Physician journal (of which I am an editor) requires prospective authors to consult several evidence-based resources that synthesize the best available evidence from clinical trials and other high-quality studies. The goal of this process is to produce unbiased recommendations for primary care physicians. But what if the authors of clinical reviews are actually professional scientific writers paid by pharmaceutical companies, rather than the physicians whose names are listed as authors?

In fact, drug-company funded "ghostwriters" have been publishing articles in the medical literature for years. A study by the editors of JAMA found that from 2 to 11 percent of articles published in 2008 in six major journals (including the New England Journal of Medicine) were actually written by people who were not named as authors. While the study could not establish that these ghostwriters had been directly financed by industry, the practice of writing up a scientific study and then recruiting a lead author (usually an academic physician under pressure to "publish or perish") has been well-documented in the case of previous "blockbuster" drugs that were taken by millions of patients for common conditions but later turned out to have dangerous or fatal side effects, including Wyeth's Prempro and Merck's Vioxx.

Ghostwriting is not the only way that the pharmaceutical industry is able to influence the interpretation of evidence in its favor. A Letter to the Editor in the Sept. 1 issue of AFP points out that a 2005 Cochrane Review on medications for diabetic neuropathic pain (cited in a 2010 review article on this topic) unintentionally exaggerated the effectiveness of gabapentin in treating this condition due to the manufacturer's selective publication of favorable trials and suppression of unfavorable ones. In an accompanying editorial, Drs. Adriane Fugh-Berman and Jay Siwek review these and other "stealth marketing" tactics that can potentially compromise the medical literature, along with ways that readers can help correct these biases:

Distorted information, once ensconced in the medical literature, is propagated by industry and by well-intentioned authors who unwittingly cite these studies. The medical literature is a permanent record that scientists and physicians rely on for decisions that ultimately affect patient care. Although the scientific process is never linear, the self-correcting process by which evidence is continually refined can be corrupted by the infiltration of medical journals with research studies and review articles distorted by a hidden marketing agenda.

Although there is no foolproof way for readers to detect undue industry influence, readers should be alert for marketing messages that disparage older, generically available drugs or that position newer branded (or upcoming) drugs as more effective, more convenient, safer, or filling an unmet need. The last sentence of the abstract is typically where the marketing spin is inserted. Readers should alert medical journals to suspicious articles by writing letters to the editor.

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The above post was originally published on the AFP Community Blog.

1 comment:

  1. Two articles in the August issue of PLoS Medicine provide additional perspective on the phenomenon of medical ghostwriting: a personal account from a former ghostwriter (http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001071) and a piece advocating reforms in the way that authorship is assigned in medical journals (http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001072).

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