On the Proposed Changes to the Credibility Gap in Industry-Supported Biomedical Research: A Critical Evaluation
McHenry, Leemon, Jureidini, Jon, Ethical Human Psychology and Psychiatry
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.
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. The motions to the courts in which these arguments are advanced are seldom revealed to the public.
The current recommendations would help to bring industry and journals into conformity with the International Committee of Medical Journal Editors (ICMJE) guidelines. Few would doubt, for example, the importance of recommendations that would eliminate selective reporting of data, disclose accurately the contributions of medical writers, statisticians, trial investigators, honestly report adverse event data, end ghostwriting and guest authorship, and, perhaps most importantly, give research priority to serious public health concerns rather than disease mongering. The recommendations proposed in the Mansi et al. (2012) report are necessary, but they are not sufficient to address the full extent of the problem.
First, for more than 10 years, the industry already has had in place internal operating policies and published guidelines that expressly prohibited ghostwriting, misrepresentation of data, and off-label promotion by sales representatives, but these have had little effect on the actual practices of pharmaceutical marketing in the period that generated the greatest volume of ghostwritten publications (Wager, Field, & Grossman, 2003). Consider, for example, ghostwriting scandals that have been exposed from GlaxoSmithKline's paroxetine (Paxil) or Pfizer's sertraline (Zoloft; Healy & Cattell, 2003; McHenry & Jureidini, 2008). There is no assurance that industry will follow the present recommendations any more rigorously. The comparison of companies' ethical integrity statements and the documents released from litigation demonstrate a serious disconnect between statements of high-minded idealism and actual behavior in the context of the reality of competition between drug companies (see Drug Industry Document Archive [DIDA]). Second, ghostwriters working covertly within the industry have come forward to expose how they work effectively within ICMJE guidelines and still manage to conceal their input and the origin of the manuscript (Matheson, 2011). Bringing industry into conformity with ICMJE policy does not obviate a flawed process because of the inherent problems of defining "authorship," "substantial contribution," and the like. Third, there remains the problem of the thousands of ghost-managed and/or ghostwritten articles, reviews, and letters to the editor that seriously misrepresent the science and remain unretracted in the medical literature. GlaxoSmithKline's infamous study 329 of off-label paroxetine use in children and adolescents remains a paradigm case (Newman, 2010). Even when confronted with undeniable evidence of fraud, journals refuse to retract industry studies (Jureidini & McHenry, 2010). If the industry were serious about restoring credibility, correcting the present and past scientific record would be the best place to demonstrate a commitment.
TWO DIVERGENT AIMS
The academy and industry have fundamentally different primary aims. In the case of academic medicine, the aim should be to discover truth via collaborative research, to produce well-designed clinical research, and report honestly and objectively the results of such research in the interest of improving our understanding of disease and treatments. Industry may subscribe to the aspirations of academic medicine, but experience demonstrates that their financial objectives-to make profits for their shareholders, to create blockbuster status for drugs, and increase their market share against competitors-will always be their primary aims.
Industry fails to understand that critical evaluation is an essential part of the scientific process and the pursuit of truth; instead, industry views criticism as "product disloyalty" and attempts to "neutralize" critics by intimidation tactics, legal threats, and ghostwrite replies by engaging the services of public relations firms and medical communication companies (Schafer, 2004). Instead of embracing the values of academic freedom, the industry must operate in a competitive environment that places great emphasis on secrecy. For example, when confronted with challenges from plaintiff's attorneys to declassify thousands of documents produced in litigation involving fraudulent industry-sponsored studies, the companies routinely use the trade secrets law to withhold such information from entering the public domain. What might be a legitimate practice of protecting a patented formula is often abused to conceal the full extent of the pollution of the medical literature. Guidelines about industry "best practice" (Cutting Edge Information, 2011; Sismondo, 2009) show that all pharmaceutical companies function in a similar manner regarding their publication strategy and use of key opinion leaders as product advocates. So it is implausible that competitors would learn genuine secrets from the release of these documents.
The basic problem is that many medical journals and senior academics have an unhealthy dependence on industry funding, and editorial decisions are frequently based on commercially valuable content (Horton, 2004, p. 7). To restore faith, academic journals must sever financial ties to the industry. PLoS Medicine is one example of a medical journal that has done so and has devoted itself to the "fundamental business of disseminating science rather than making societies or publishers rich" (Smith, 2006, p. 115).
THE ENTERPRISE IS BASED ON A FALSE PREMISE AND RADICAL SOLUTIONS ARE NEEDED
The approach taken by Mansi et al. (2012) is predicated on an assumption that the "industry- investigator-editor enterprise" is desirable and worth preserving. It probably is, but only for the protagonists. The very concept, in our view, betrays a disturbing sense of entitlement. As we have noted, industry gets papers published that marketing staffcan then use to promote their wares, investigators get research publications and career advancement, and editors get income from reprint sales that is an essential component of most medical publishers' business model.
But the industry-investigator-editor enterprise is not desirable for patients and taxpayers. Patients end up being treated with newer drugs with unknown adverse effects when older, better understood drugs or nondrug solutions would be safer. Consumers ultimately pay for the extra cost through insurance premiums or taxes, not to mention their health. Opportunity costs mean that more productive health spending is compromised. So the industry-investigator- editor enterprise should not exist. The only legitimate mutual interest shared by the parties is the free dissemination of data and knowledge. This will be best achieved by doing away with the publication of pharmaceutical research in its current form.
In the age of the Internet, there is no longer any legitimate scientific or academic purpose to publishing industry-sponsored studies in medical journals. Journals should therefore decline to publish any paper reporting data from a company-sponsored trial. Companies can simply post their protocols online, and then, when the results of their studies become available, publish the data in full on their Websites. Third parties, perhaps commissioned by journals, can then offer rigorous, critical evaluation of the methodology and trial results. In this manner, the medical journals can escape their conflicts of interest with industry. No longer will there be a need for key opinion leaders to lend their names and academic affiliations to ghostwritten papers. No longer will there be rewards for medical communication companies to plant marketing messages and spin data from the final summary reports in the journals. No longer will anyone take seriously an academic's curriculum vitae that list more than 900 publications.
This is a radical solution, one that makes a more serious attempt to restore the scientific and ethical integrity of the literature, if ever there was a golden age for medical journals (see Smith, 2005). Medical journals that continue to maintain their dependence on industry will no longer be able to claim academic and scientific status. Articles published in these journals will not be counted among an academic's credentials for tenure and promotion. Those journals that are already seen in the minds of many current prescribers as "industry throwaways"-The Journal of Clinical Psychiatry, Clinical Therapeutics, The Journal of the American Academy of Child and Adolescent Psychiatry, and the like-may not survive.
The idea of an independent basis for judging therapeutic claims of pharmaceuticals is nothing new. It was the focus of the Journal of the American Medical Association (JAMA) Editor, George H. Simmons' famous complaint in 1907 about "debauching our medical journals" (p. 1645) and his reform campaign designed to keep in check a commercialism that threatened to undermine the scientific basis of medicine (Marks, 1997, p. 24). But it is an idea that has been overpowered by government lobbying by industry advocates and business friendly legislation for well more than a hundred years. What is new is that the goal is much more achievable with the global communication of the World Wide Web.
The 10 recommendations for closing the credibility gap proposed by pharmaceutical industry employees and medical journal editors cannot solve the fundamental underlying problem. Medical journals must sever their financial ties to the pharmaceutical industry because academic medicine and industry have two fundamentally divergent aims. That this would result in a massive shake up of the medical publishing industry could only benefit the cause of academic medicine.
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Leemon McHenry, PhD
California State University, Northridge
Jon Jureidini, PhD, MB, BS
University of Adelaide, Australia
Leemon McHenry is a research consultant for the law firm of Baum, Hedlund, Aristei, and Goldman in Los Angeles, California. He and Jon Jureidini are members of Healthy Skepticism.
Acknowledgments. The authors wish to thank Ronald Goldman, Esq, for legal review and Jeffrey Lacasse and two anonymous reviewers for critical evaluation.
Correspondence regarding this article should be directed to Leemon McHenry, PhD, Department of Philosophy, California State University, Northridge, 18111 NordhoffStreet, Northridge, CA 91330. E-mail: firstname.lastname@example.org…
Questia, a part of Gale, Cengage Learning. www.questia.com
Publication information: Article title: On the Proposed Changes to the Credibility Gap in Industry-Supported Biomedical Research: A Critical Evaluation. Contributors: McHenry, Leemon - Author, Jureidini, Jon - Author. Journal title: Ethical Human Psychology and Psychiatry. Volume: 14. Issue: 3 Publication date: October 1, 2012. Page number: 156+. © Springer Publishing Company 2008. Provided by ProQuest LLC. All Rights Reserved.
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