JEMH Vol4 No1 Sept Supp

JEMH INTRODUCTION INTRODUCTION he Journal of Ethics in Mental Health would like to warmly thank Dr. Richard Warner for Tinviting authors to contribute to this special supplement on the relationship between psychiatry and the pharmaceutical industry. We are also very grateful to Dr. Warner for contributing his guest editorial. Dr. Warner is Professor of Psychiatry and Adjunct Professor of Anthropology at the University of Colorado and an internationally recognized authority in a number of areas, including recovery from schizophrenia and social inclusion. He is well known for his comprehensive views of treatment and recovery and the range of issues that aff ect it, including the role of medications. Ron Ballantyne MSW MBA Editor-in-Chief e-mail: [email protected] JEMH · April 2009 · 4(Sept. Suppl.) | 1 © 2009 Journal of Ethics in Mental Health (ISSN: 1916-2405) GUEST EDITORIAL Ethical Problems in the Relationship of Psychiatry to the Pharmaceutical Industry Richard Warner, M.B., D.P.M. Director, Colorado Recovery Clinical Professor, University of Colorado, USA sychiatry and the pharmaceutical industry have in the “off -label” promotion of medication use, industry been embarrassed by U.S. senate hearings and a control of research priorities, bias in reporting research Pseries of articles in the New York Times revealing results, the “ghostwriting” of research articles and the that a number of prominent psychiatrists have failed to involvement of industry in the ongoing education of report signifi cant fi nancial confl icts of interest. Harvard physicians. (See McHenry and Jureidini in this issue.) research psychiatrists, whose work has encouraged the use of antipsychotic medication in children, failed to Th e off -label promotion of pharmaceuticals by key report to the university most of their consulting income psychiatric opinion leaders has been considered by some from pharmaceutical companies, skirting a requirement observers, including Moncreiff in this issue, to spill over that involvement in human subjects’ research be free into “disease-mongering,” as it seeks to fi nd new uses of signifi cant personal industry remuneration. Another for approved drugs. An example would be the 40-fold research psychiatrist at Emory University did not declare increase in the diagnosis of bipolar disorder in the U.S. $1.2 million of $2.8 million in industry earnings to his between 1994 and 2003 based on the work of the Harvard university. An infl uential psychiatrist who hosted a psychiatrists targeted by the senate hearings. Th e work of popular National Public Radio program failed to report these researchers in identifying bipolar disorder in children $1.3 million in drug company earnings: when the network has stimulated a greatly expanded use of antipsychotic learned of this confl ict, they removed the program from medications in this age group. More than a quarter of the its satellite service (Harris, 2008a). prescriptions for Johnson and Johnson’s antipsychotic, Risperdal, is now for children and adolescents, although Th e close ties between academic psychiatry and industry only a small fraction of those with a psychotic illness that spawned the concerns raised by the U.S. senate would be expected in this population. Th e close links hearings have become more prominent since the passage between the drug company and the research team is of the Bayh-Dole Act in 1980. Th e intent of that act was illustrated by the three research goals of the Harvard to speed the commercialization of government-funded center for the study of pediatric psychopathology in research discoveries and create new markets and industries. their 2002 annual report – “improve psychiatric care An unintended consequence has been decreased public for children, have high standards and ‘move forward trust in biomedical research. Th e confl icts between the commercial goals of J.&J.’”(Harris, 2008b). A similar serving patients and marketing products have led to the concern about “disease-mongering” has been raised by formulation by the American Association of Medical the broad international interest in the “prevention” of Colleges of new standards to restrict the participation of psychosis through the use of medications and other investigators with fi nancial confl icts of interest in human interventions before the condition is fully apparent. subjects’ research. Some observers fear that expanded Th is interest persists despite the observation that the academic-industry partnerships have led to a credibility best screening instruments for the prediction of psychosis crisis for medicine fostered by such practices as increases have a 98% false-positive rate in the general population JEMH · April 2009 · 4(Sept. Suppl.) | 1 © 2009 Journal of Ethics in Mental Health (ISSN: 1916-2405) GUEST EDITORIAL and a 66% false-positive rate in highly selected groups appointments with doctors, we may assume that the in- of disturbed young people in two intervention studies dustry believes that their investment in detailing is pro- funded by the makers of the antipsychotic medications ductive. Th e industry hires one representative for every Risperdal and Zyprexa. Th e use of medications in these six physicians in the U.S. (See Pollack et al. in this issue.) prevention trials was associated with a signifi cant risk of Teaching hospital physicians meet with representatives side eff ects (Warner, 2005). once or twice a month on average and, prior to the im- position of recent restrictions, accepted industry funded Concern about industry infl uence in creating bias in the meals at least once a month (Lurie et al., 1990). Industry reporting of research results, emphasized by Fava in this also contracts with companies that provide continuing issue, has been heightened by a survey which reveals medical education (CME) to physicians. To what extent is that a majority of medical school research departments the practice of physicians compromised by these eff orts? do not prohibit the common practices of ghostwriting Industry sponsored CME presentations have been shown articles or of industry sponsors inserting their own to preferentially highlight the sponsor’s drugs (Wazana, statistical analyses. Two-thirds of these departments 2000). Meeting with drug representatives, accepting free would allow sponsors to prohibit researchers from sharing meals and attending company-sponsored CME events their data upon conclusion of the study (Mello et al., have been shown to be associated with increased prescrib- 2005). Financial confl ict of interest has been shown to ing of the sponsor’s drugs and non-rational prescribing be frequent, and declaration of this confl ict close to zero, practices (Lurie et al., 1990; Chren & Landefeld, 1994; among lead authors in medical articles (Krimsky et al., Wazana, 2000). Sometimes this marketing is clearly not 1998), Diagnostic and Statistical Manual panel members in the patient’s interest. When the anticonvulsant gabap- (Cosgrove et al., 2006) and authors of clinical practice entin was released, the off -label promotion of the drug as guidelines (Choudhry et al., 2002). Selective reporting of a mood-stabilizer for people with bipolar disorder, based research results distorts the data available to practitioners. on low-quality review articles distributed by industry When published studies of SSRIs were compared to study representatives, led to a surge in its use. Th e subsequent data submitted to the Swedish drug approval authority, randomized controlled trials, however, found it to be it was found that studies showing positive eff ects were ineff ective for this purpose (Williams et al., 2009). Physi- more likely to be published multiple times and that many cians are at risk of branding themselves as collaborators articles ignored less favorable data. Th ese biases varied with the pharmaceutical industry. Although, in a study of from product to product, making it impossible to form an resident physicians in Virginia, only a small percentage accurate impression of the eff ectiveness of any one SSRI were willing to wear a pharmaceutical company logo on (Melander et al., 2003). A review of all the clinical trials the breast pocket of their white coat, virtually all were in four major psychiatric journals between 2001 and 2003 carrying industry-branded equipment, including 95% found that nearly half of the authors reported fi nancial who were sporting a drug company logo on their stetho- confl ict of interest, and that these clinical trials were fi ve scopes – all gift s from company representatives (Sigworth times more likely to report a positive result for the test et al., 2001). Th e physicians’ behavior met AMA stan- product (Perlis et al., 2006). Pharmaceutical companies dards, that industry gift s should be of negligible value, hire medical communications companies to write journal but is that standard adequate? Does carrying company articles favorable to their product and pay a well-known branded equipment constitute product endorsement or, academic to publish it under his or her name. At least more broadly, an endorsement for the use of medications 10% of medical articles are ghostwritten in this fashion, in general, to the exclusion of other approaches? including 50% of industry-sponsored drug trials (Moff att & Elliott, 2007). A relationship which has been profi table to both pharmaceutical companies and physicians has become an More than three-quarters of industry spending on mar- embarrassment. New regulations are being promulgated keting is for free samples and detailing physicians. Since to restrict gift -taking, funding for educational travel and samples assist pharmaceutical representatives in getting confl icts of interest in research. Will they be enough to JEMH · April 2009 · 4(Sept. Suppl.) | 2 © 2009 Journal of Ethics in Mental Health (ISSN: 1916-2405) GUEST EDITORIAL restore public confi dence in the bias-free practice of Mello, M.M., Clarridge, B.R., Studdert, D.M. (2005) Academic medi- psychiatry? Equally important, where will psychiatrists cal centers’ standards for clinical-trial agreements with industry. learn of advances in psychiatry – from meetings with New England Journal of Medicine, 352: 2160-2162.

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