Monday, September 5, 2011

Compromising the medical literature

To ensure that our clinical review articles reflect current medical literature, American Family Physician 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 points out that a 2005 Cochrane Review on medications for diabetic neuropathic pain (cited in a 2010 AFP 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.

2 comments:

  1. A timely warning and sad truth about the "polution" in our medical literature. Family Physicians are well positioned to champion the use of "cleaner" publications that we apply to our patient care. Easier said than done, but the AFP article is a reminder and guide to more judicious reading of the literature. Thanks, Dr Lin.

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  2. Agreed, this is very timely and is greatly needed in the health access workforce area.

    HRSA reports claim 155,000 primary care IM by 2020 when there can only be half of this level by 2020 with less than 50,000 by 2030. This is the result of only 1400 per year entering primary care IM for a decade with no change likely along with known losses such as 20,000 for hospitalist workforce. To get to 155,000 from 2010 to 2020 all 7000 annual IM grads would need to enter and remain in primary care for all class years. Association reports have the same problems and are a basis for generic expansions or IM expansions - that fail to work efficiently or effectively for health access improvement.

    Nurse practitioner reports and articles have numerous problems such as categorizations by training program type rather than a real workforce measure such as type of employment or position. Only those who train in family practice and remain in family practice are the true direct care clinician NP health access solution - a small portion of total NP graduates. Also 270,000 primary care nurses, the largest primary care workforce, are ignored along with their most complex duties getting more complex.

    Health access articles and reports are full of assumption and hyperbole along with the usual promises that cannot be kept - such as innovation focus without having the workforce that can be innovative or models that promise health access but cannot deliver.

    Lack of specificity and rigor hurts those who remain in health access over entire careers at by far the highest levels - specifically family medicine residency graduates and those who train them.

    www.basichealthaccess.blogspot.com - currently Does Primary Care Experience Matter?

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