Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
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Alain Braillon (a), David B Menkes (b), Philippe Nicot (c), Susan Bewley (d)
a Senior Consultant, University Hospital, Amiens. France. b Associate Professor of Psychiatry, University of Auckland, Hamilton. New Zealand. c General practice in private office, 75 Avenue Léon
October 14, 2015
Conflict of Interest:
AB and DBM are members of Healthy Skepticism, a non-profit organisation aiming to improve health by reducing harm from misleading health information (www.healthyskepticism.org/). AB and SB are members of HealthWatch-UK, a charity (#1003392) promoting evidence-based science and integrity in healthcare since 1991 (www.healthwatch-uk.org/).
Academia–Industry Relationships: how long a spoon to sup with the devil?
The Annals editors’ argument (1) that physician–industry relationships can be managed by relying on authors’ conflict of interest disclosures is inadequate, in part because they fail to acknowledge the many distorted claims arising from clinical trials and driven by career advancement or commercial interests.(2) Moreover, the editors might have answered their own question “if industry can't be trusted, why engage it in any manner?” if they had taken into account the staggering criminal record of the industry as a whole.(3)The fundamental tension between altruism and self-interest remains. There is, as yet, no reliable database for investigating conflict of interest. The US has made a step forward with the Sunshine Act but important exclusions from its scope are numerous. Small payments (e.g. for pizza) miss the larger problems.(4) The shabby story of Study 329 illuminates the solution. Le Noury et al re-analysed the primary data (5) and produced results contrasting sharply with Keller et al's original claim that "paroxetine is generally well tolerated and effective for major depression in adolescents."(6) Seven years ago, major concerns were raised about Study 329’s ethics and validity.(7) In 2011, the Dean of Brown University’s Medical School, responding to a letter suggesting that the flawed and misleading study be retracted, wrote that the University took such matters “seriously” with a “confidential” internal investigation. Four more years of silence and inaction followed.(www.healthyskepticism.org/global/soapbox/entry/to_brown, braillon.net/alain/media/fus.pdf) Similarly, the journal that published Keller’s paper has failed to provide a rationale for refusing retraction.(8) GlaxoSmithKline, Brown University, the American Academy of Child and Adolescent Psychiatry and its journal must each investigate its role in the Study 329 travesty, share responsibility to redress the damage caused, and take public steps to ensure there is no recurrence.It is clear that there is no spoon long enough to edulcorate industry control of clinical research. The solution is simple: access to primary data after genuine publication. In the field of medical discovery, claims of enduring property rights regarding patient data are unethical and unacceptable.1 The Editors. Walking the tightrope of Academia–Industry relationships. Ann Intern Med 2015;163:477-478.2 Sox HC, Rennie D. Research misconduct, retraction, and cleansing the medical literature: lessons from the Poehlman case. Ann Intern Med 2006;144:609-13.3 Braillon A. Drug industry is now biggest defrauder of US government. BMJ 2012 10;344:d8219.4 Morain SR, Flexner C, Kass NE, Sugarman J. Forecast for the Physician Payment Sunshine Act: partly to mostly cloudy? Ann Intern Med 2014;161:915-6.5 Le Noury J, Nardo JM, Healy D et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ 2015;351:h4320.6 Keller MB, Ryan ND, Strober M, et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry 2001;40:762-72.7 Jureidini J, McHenry L, Mansfield P. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Saf Med 2008;20:73-81.8 Doshi P. No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility. BMJ 2015;351:h4629.
Benjamin Moncada, MD
Universidad Autonoma, Mexico
March 18, 2016
Regarding the paper: “Walking the tightrope of academia-Industry relationships” (AIR) ( 1) it touch a point challenging the dogma of precluding publications from an author that may have ties with the Industry and I think that the considerations made in that paper are very proper In that sense I would like to comment a point that to the best of my knowledge it has not been attended before, that is The disclosure of information about relationship between the Editor of a journal and the industry, that I think it should be implemented as a routine piece of information the same way nowadays is the case for the authors. Going beyond, the same proposal should be exerted for the people selected as reviewers of the material in consideration for publication. This disclosure would be enforced only for paper that in some way have to do with the Industry.I wander whether the editors of major medical journal (yours, NEJM BMJ international committee of medical journals editors (ICMJE), etc) have periodic reunions to treat issues of your work because if that were the case it could be an appropriate forum to treat the aforementioned proposal.About 15 years ago We sent for publication to a prestigious journal in our country a paper titled “The medical student and the pharmaceutical industry” and it was rapidly rejected in less time than average for that particular journal. Neither letters from the reviewers giving explanation for the rejection were sent, which is a common practice in this matter. I realize that the rejection could be correct but suspicious can arouse about whether the relationship that the Editor may have with the industry (and apparently he did) had to do with the rejection. 1.-Ann of intern med.2015;163:477-478. Doi:10.7326/M15-1500
The Editors. Walking the Tightrope of Academia–Industry Relationships. Ann Intern Med. ;163:477–478. doi: 10.7326/M15-1500
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Published: Ann Intern Med. 2015;163(6):477-478.
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