On the Proposed Changes to the Credibility Gap in Industry-Supported Biomedical Research: A Critical Evaluation

Article excerpt

A task force of pharmaceutical industry employees and medical journal editors propose 10 recommendations to address the problem of erosion of confidence in the reporting of the results of industry-sponsored clinical trials. These recommendations would not restore credibility to industry-sponsored biomedical research. A radical solution is required that severs the relationship between the industry and the journals and restores the integrity of the medical literature.

Keywords: conflict of interest; credibility gap; ghostwriting; key opinion leaders; medical journals; pharmaceutical industry

Those who cannot remember the past are condemned to repeat it.

-George Santayana

In a recent commentary in the Mayo Clinic Proceedings, a group comprising pharmaceutical industry employees and medical journal editors propose 10 recommendations for restoring confidence in industry-sponsored studies published in medical journals (Mansi et al., 2012). The paper is welcome because its 10 recommendations, if followed, would eliminate some of the worst practices that have fatally undermined the biomedical literature over recent decades. It is also welcome as an admission for that past practice, authored as it is by some of the very individuals whose companies created, maintained, and implemented ghostwriting strategies. But describing the problem as a "credibility gap" seriously underestimates a state of affairs that has had lethal consequences.

Medical journals should be our most trusted repositories of knowledge; there are serious repercussions for prescribing physicians and for patient health if they fail that trust. But at present, they are often used by industry as instruments for drug promotion disguised as science. The guilty parties include not only the pharmaceutical and medical device industries and their for-profit agents who ghostwrite the manuscripts. It also includes investigators who get research publications and all of the other opportunities that collaboration with industry offers to "key opinion leaders," such as well-paid teaching and consulting opportunities. Particularly for early career academics, this "leg up" gives them better chances to win competitive funding from agencies such as the National Institute of Mental Health (NIMH), further advancing their careers (Jureidini, 2012). And medical journals themselves reap enormous profits from journal reprints, supplements, and advertisements (Handel et al., 2012; Lexchin & Light, 2006). Now that industry is on the record for having created the credibility gap, it is in their interest to restore confidence because otherwise any industry-sponsored study will be rightly viewed with skepticism. What is needed, however, is radical rather than incremental change-change that serves medicine rather than the interests of industry, journal publishers, and key opinion leaders.

CONSPIRACY TO CONCEAL THE FUNDAMENTAL PROBLEM

Since the controversy was first exposed in the late 1990s, industry representatives denied repeatedly that they ghostwrote the literature and manipulated the scientific data to favor their products. For example, in a report to the United Kingdom House of Commons Health Committee, witnesses from both GlaxoSmithKline and AstraZeneca testified that their respective companies did not engage in ghostwriting practices with one industry spokesperson claiming that "the issue of ghost-writing, as alleged, is not something I recognise at all" (House of Commons Health Committee, 2005, p. 56). When those few documents from litigation in the United States that were declassified entered the public domain and came to the attention of the United States Congress, it became more and more difficult to maintain a plausible deniability (Grassley, 2010). But even today, there is ongoing litigation in which industry executives argue that they never did engage in ghostwriting and there is nothing immoral or illegal about their "author assistance" programs. …

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