Scientific Research or Corporate Marketing?
Laurie BriggsJuly 01, 2010 4:32 PM
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On June 24, 2010, a Congressional staff report on ghostwriting in medical literature was issued by the U.S. Senate Finance Committee’s ranking minority member, Senator Charles E. Grassley. A ghost writer is a professional writer who is paid to write an article, story, or report, etc., which is officially credited to different person. Though celebrities, executives, and politicians may have ghostwriters for speeches; using ghostwriters when publishing medical research and reports presents dangers to appropriate medical treatment and to the professional credibility of medical experts.
After reports surfaced that drug companies were using educational grants from the Senate Finance Committee (hereinafter “Committee”) to finance and promote off-label uses of their drugs [uses not approved by the Food and Drug Administration (hereinafter “FDA”)], the Committee inquired about financial relationships between pharmaceutical & device companies and articles published in medical journals. During the inquiry, the Committee reviewed the policies and reporting practices of over a dozen medical schools that frequently submit medical research articles for publication in national medical journals. The Committee’s inquiry resulted in distinct cases where there existed inconsistencies between the amount in payments physicians and scientists (authors of medical articles) received from drug companies and the amount reported by the institutions. These conclusions led to the adoption of the Patient Protection and Affordable Care Act, a bill incorporated into the Health Care Reform legislation, which mandates that pharmaceutical and device manufacturers report to officials, their annual payments made to physicians.
After that initial inquiry the Committee focused on a 2008 study, published by the Journal of the American Medical Association (JAMA), which concluded that a pharmaceutical company (“Merck & Co.) manipulated scientific literature through ghost writers to market the pain killer Vioxx (which was later pulled from the market in 2004). This initiated an official government inquiry into “an industry practice to get articles published in major medical journals touting the benefits of a company’s product without public disclosure that the company initiated and paid for the development of the articles.” The practice of ghostwriting involves: 1) a pharmaceutical company, “A”, hiring a medical writer (ghost writer) with little or no medical expertise to develop and write a research manuscript about a particular drug; 2) then, edits would be made by the hiring pharmaceutical company “A” (even when the subject of the research is A’s drug); 3) the manuscript would be officially authored by a prominent academic physician or scientist in exchange for monetary contribution to an institution or the physician/scientist themselves; and 4) the “research” article would be published in a medical journal. Medical writers (or ghost writers), may be acknowledged in the final publication for their “editorial assistance” though published articles rarely disclose information regarding the medical ghost writing process.
Acknowledgement of “editorial assistance” do provide the reader with clues that an article may have been ghostwritten, however, it does not give the reader (particularly physicians) information about the role a pharmaceutical or device company may have played in drafting, reviewing or paying for an article. Thus, the final publication has a dangerous potential for enabling a pharmaceutical company to use medical or scientific literature to further the pharmaceutical company’s commercial interests in increasing revenue for a particular drug (i.e. Vioxx).
The danger is that an article published in a medical journal may be relied upon by a treating physician or medical provider as independent, scientific research rather than a potentially slanted marketing piece. The lack of transparency regarding a pharmaceutical company’s role in the development of medical literature is alarming and suggests that without careful regulation, medical articles will increasingly become a pharmaceutical companies’ choice for marketing to physicians, rather than informing them.