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Commentary

Published online by Cambridge University Press:  22 August 2007

Leon Flicker  and
Osvaldo P. Almeida
Leon Flicker
Affiliation:
Professor of Geriatric Medicine University of Western Australia, Perth, Australia Email: leonflic@cyllene.uwa.edu.au
Osvaldo P. Almeida
Affiliation:
Professor of Psychiatry of Old Age University of Western Australia, Perth, Australia Email: almeidao@meddent.uwa.edu.au

Extract

In 1919 the Dodge brothers successfully sued Henry Ford for his intended largesse, i.e. decreasing dividend payments by using his company to pursue broader social goals “to employ still more men, to spread the benefits of this industrial system to the greatest possible number, to help them build up their lives and their homes,” one of the mechanisms of which included increasing their wages. The Michigan Supreme Court stated that a corporation exists to benefit its stockholders, and may not use profits for “other purposes” (Hood, 1998). This landmark case demonstrated that the prime purpose of any corporation is to maximize its profits for shareholders. Therefore, it is probably naïve of doctors, researchers and the general public to expect the pharmaceutical industry to be driven by other principles, regardless of how noble they might seem. As a result, the driving force that supports the interests of the pharmaceutical industry may not be always aligned with the interests of doctors, patients and the communities to which they belong. How are we to judge that this conflict has evolved in such a way as to produce “excessive” influence of the pharmaceutical industry over other interested parties?

Information

Type
For Debate
Information
International Psychogeriatrics , Volume 19 , Issue 6 , December 2007 , pp. 1014 - 1020
Copyright
Copyright © International Psychogeriatric Association 2007

In 1919 the Dodge brothers successfully sued Henry Ford for his intended largesse, i.e. decreasing dividend payments by using his company to pursue broader social goals “to employ still more men, to spread the benefits of this industrial system to the greatest possible number, to help them build up their lives and their homes,” one of the mechanisms of which included increasing their wages. The Michigan Supreme Court stated that a corporation exists to benefit its stockholders, and may not use profits for “other purposes” (Hood, Reference Hood1998). This landmark case demonstrated that the prime purpose of any corporation is to maximize its profits for shareholders. Therefore, it is probably naïve of doctors, researchers and the general public to expect the pharmaceutical industry to be driven by other principles, regardless of how noble they might seem. As a result, the driving force that supports the interests of the pharmaceutical industry may not be always aligned with the interests of doctors, patients and the communities to which they belong. How are we to judge that this conflict has evolved in such a way as to produce “excessive” influence of the pharmaceutical industry over other interested parties?

Prescribing

Shah and Finucane have highlighted how industry has assisted in the creation of new diseases, sometimes well beyond community expectations. Medicalizing otherwise normal individuals and diverting health funding to relatively trivial conditions are potential harms associated with this practice. The evidence for so-called “off label” prescribing is stronger, and this practice is inappropriate in that doctors are asked to prescribe medications for indications of which there is little evidence of benefit. However, payment of money for trade shows is not evidence of excessive influence as Bhattacharyya and Burns have pointed out. In fact, one could argue that this transparent presentation of data favoring the industry's medication is entirely appropriate. Of more concern are covert payments to opinion leaders, which can only be justified to shareholders by the influence on the prescribing habits, not only by these individuals, but their colleagues. Respected colleges and medical associations have argued for greater transparency of these relationships so that other doctors can weigh up the arguments of these opinion leaders against any putative financial gain. Despite the support of colleges, medical associations and all our contributors to this debate, it is a significant problem that such transparency has not yet been achieved, nor have the respective colleges indicated how compliance with these guidelines will be monitored or what would be the consequences of non-compliance to the practitioner, the industry and the colleges themselves.

All bodies have argued against excessive gifts and travel grants to non-speaking participants at international conferences. As Shah and Finucane have indicated, in comparative studies of costs and efficacy, direct-to-the-patient advertising is a practice which should be avoided. One of the major problems is that all these promotional activities, funded by industry, inevitably occupy the time of prescribers and has significant opportunity costs. It decreases the time available for academic detailing regarding the risks associated with drugs, which in Australia account for between 2% and 4% of all hospital admissions and up to 30% of the admissions for patients over the age of 75 years (Runciman et al., Reference Runciman, Roughead, Semple and Adams2003). Also opportunity costs exist in favoring drug interventions where there may be more efficacious lifestyle interventions such as smoking cessation, increasing physical activity and sleep hygiene.

Research

An “excessive” influence on research is difficult to define. As Bhattacharyya and Burns have described, the support for research into new drugs and greater applications for existing medications is praiseworthy in itself. Decreased availability of public funding for such research has made the pharmaceutical industry not only a major funder of translational research, but also of basic research. Another point that they emphasize is that a clinician's role in such research must be guided by the ethics of medical practice. Clinicians should only enter patients in trials if a situation of equipoise exists. It is important that clinicians should not be lured by excessive trial payments to participate in studies of “me-too” drugs, at the expense of patients who may be prescribed already proven and effective treatments, a practice that is common and which was well described by Shah and Finucane. Finally, it is important to have structures in place to ensure that the influence of the pharmaceutical industry is not used to bias results. The recent inexplicable failure to report deaths in a large study of rofecoxib may point to bias by the pharmaceutical industry to suppress negative findings (Topol, Reference Topol2004). This has highlighted deficiencies in the regulatory framework in which the pharmaceutical industry operates.

Publication

As Bhattacharyya and Burns have pointed out, much of the data generated by the pharmaceutical industry is of high quality and needs to be published. However, there is also evidence that the industry has worked to suppress or minimize negative findings or deleterious consequences of drugs. This publication bias, eloquently described by Shah and Finucane, is particularly bothersome to those organizations compiling systematic reviews of treatment because publication bias will produce major distortion to the findings of any pooling of data (or meta-analysis). These concerns have resulted in the creation of trial registries, and the adoption of the position by many journals, including International Psychogeriatrics, that trials will not be published unless they have been prospectively registered.

Conclusions

It is apparent from these two contributions that there is actually considerable agreement and overlap between these so-called opposing views. The pharmaceutical industry has a legitimate right to seek to maximize its profits. It is the regulatory framework within which it operates that needs to be carefully managed so that the industry's interests can be balanced against the interests of patients and the communities within which they live. The behavior of doctors and researchers in their dealings with industry requires greater transparency and scrutiny to help achieve this balance. And remember the old adage: there is no such a thing as a free meal, or free congresses, free trips, free books, free printouts, free pens, free samples . . .

Conflict of interest declaration

David Ames has received research support, consultancy fees, speaker's honoraria and/or support to attend conferences from a number of pharmaceutical companies including Astra-Zeneca, Bristol Myers Squibb, De Bio, Eisai, Eli Lilly, Lundbeck, GlaxoSmithKline, Janssen-Cilag, Novartis, Organon, Parke-Davis, Pharmitalia, Pfizer, Protodigm, Rôche, Sandoz, Sanofi-Aventis, Servier, Voyager and Wyeth.

Amit A. Shah and Thomas E. Finucane have no conflicts of interest to declare.

Sarmishtha Bhattacharyya has no conflict of interest to declare other than attending occasional conferences which have been sponsored by drug companies.

Alistair Burns receives honoraria and research grants from companies involved in the manufacture and marketing of drugs for dementia and also expenses for attending meetings. He holds no company stock in any pharmaceutical organization.

Leon Flicker and Osvaldo Almeida have received $0 for consultancies, including Medical Advisory Panels, $0 for travel grants, and $0 for non-competitive research funding from the pharmaceutical industry over the past five years.

Acknowledgment

Amit A. Shah was supported under a Donald W. Reynolds Foundation geriatrics clinician-educator grant during the time this work was written.

References

ABPI 2006. Code of Practice for the Pharmaceutical Industry, Association of the British Pharmaceutical Industry. Available online at http://www.abpi.org.uk/links/assoc/PMCPA/pmpca_code2006.pdf; last accessed 7 July 2007.Google Scholar
American Medical Association 2006. Code of Ethics. Available at http://www.ama-assn.org/ama/pub/category/2498.htmlGoogle Scholar
Ames, D. 2006. Registration of clinical trials submitted for publication in International Psychogeriatrics. International Psychogeriatrics, 18, 191–193.CrossRefGoogle Scholar
Ames, D., Ballard, C., Cream, J., Shah, A., Suh, G-H. and McKeith, I. 2005. Should novel antipsychotics ever be used to treat the behavioral and psychological symptoms of dementia? International Psychogeriatrics, 17, 3–29.CrossRefGoogle Scholar
Ames, D., Petersen, R., Knopman, D., Visser, P. J., Brodaty, H. and Gauthier, S. 2006. For debate: is mild cognitive impairment (MCI) a clinically useful concept? International Psychogeriatrics, 18, 393–414.CrossRefGoogle Scholar
Angell, M. 2000. Is academic medicine for sale? New England Journal of Medicine, 20, 1516–1518.CrossRefGoogle Scholar
Angell, M. 2004. Excess in the pharmaceutical industry. CMAJ, 171, 1451–1453.CrossRefGoogle ScholarPubMed
Anonymous Medical Letter 2002. Escitalopram (lexapro) for depression. The Medical Letter on Drugs and Therapeutics, 1140, 83–84.Google Scholar
ART 2006. Pharmaceutical Research. Alzheimer's Research Trust. Available online at http://www.alzheimers-research.org.uk/research/strategy/pharma/ accessed 5 December 2006.Google Scholar
Barry, E. 2002. Psychiatrists become drug firms’ targets. Boston Globe, 28 May 2002 p. C5.Google Scholar
Berenson, A. 2006. Drug files show maker promoted unapproved use. New York Times. 12/19/2006 http://www.nytimes.com/2006/12/18/business/18drug.htm, accessed 26 December, 2006.Google Scholar
Birks, J. and Harvey, R. J. 2006. Donepezil for dementia due to Alzheimer's disease. Cochrane Database of Systematic Reviews (Online), Issue 1. Art No.: DOI: 10.1002/1465 1858. CD001190.pub.2.CrossRefGoogle Scholar
Breitstein, J. 2004. The making of a new disease. Pharmaceutical Executive, 1 January 2004. http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=80917, accessed 15 January, 2007.Google Scholar
Collier, J. 2006. The price of independence. BMJ, 332, 1447–1449.CrossRefGoogle Scholar
Cosgrove, L., Krimsky, S., Vijayaraghavan, M. and Schneider, L. 2006. Financial ties between DSM-IV panel members and the pharmaceutical industry. Psychotherapy and Psychosomatics, 3, 154–160.CrossRefGoogle Scholar
De Angelis, C. et al. 2004. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. The New England Journal of Medicine, 12, 1250–1251.CrossRefGoogle Scholar
Dornan, P. J. et al. 1999. Reports of randomised controlled trials in acute stroke, 1955–1995: what proportions were commercially sponsored? Stroke, 30, 1995–1998.CrossRefGoogle Scholar
FDA 2006. NDAs Approved in Calendar Years 1990–2004 by Therapeutic Potentials and Chemical Types. http://www.fda.gov/cder/rdmt/pstable.htm, accessed 26 December, 2006.Google Scholar
FDA Office of Public Affairs 2004. Drug maker to pay $430 million in fines, civil damages. FDA Consumer Magazine [online], vol. 38, no. 2004, last accessed 25 January 2006.Google Scholar
Forest Laboratories Inc. 2007. Press release. Available online at http://www.frx.com/news/PressRelease.aspx?ID=847042, last accessed 15 January 2007.Google Scholar
Fugh-Berman, A. 2005. The corporate coauthor. Journal of General Internal Medicine, 6, 546–548.CrossRefGoogle Scholar
Ganguli, M., Dombrovski, A., Mulsant, B., Wilkinson, P., Tharyan, P. and Flint, A. 2007. For debate: the evidence for electroconvulsive therapy (ECT) in the treatment of severe depression in late-life. International Psychogeriatrics, 19, 9–35.CrossRefGoogle Scholar
Geldmacher, D. S., Provenzano, G., McRae, T., Mastey, V. and Ieni, J. R. 2003. Donepezil is associated with delayed nursing home placement in patients with Alzheimer's disease, Journal of the American Geriatrics Society, 7, 937–944.CrossRefGoogle Scholar
Hansen, R. A., Gartlehner, G., Lohr, K. N., Gaynes, B. N. and Carey, T. S. 2005. Efficacy and safety of second-generation antidepressants in the treatment of major depressive disorder. Annals of Internal Medicine, 6, 415–426.CrossRefGoogle Scholar
Harris, G. 2007. Studies lead to withdrawal of drug for bowel ailment. New York Times, 31 March 2007 p. A12.Google Scholar
Healy, D. and Cattell, D. 2003. Interface between authorship, industry and science in the domain of therapeutics. British Journal of Psychiatry, 183, 22–27.CrossRefGoogle ScholarPubMed
Hodges, B. 1995. Interactions with the pharmaceutical industry: experiences and attitudes of psychiatry residents, interns and clerks. CMAJ, 153, 553–559.Google ScholarPubMed
Hogan, D. B., Goldlist, B., Naglie, G. and Patterson, C. 2004. Comparison studies of cholinesterase inhibitors for Alzheimer's disease. Lancet Neurology, 10, 622–626.CrossRefGoogle Scholar
Hood, J. 1998. Do corporations have social responsibilities? The Freeman, 48, 680–684.Google Scholar
Hussein, A. and Smith, R. 2001. Declaring financial competing interests: survey of five general medical journals. BMJ, 323, 263–264.CrossRefGoogle Scholar
IMS Health 2006. U.S. Data Indices – Top-line Industry Data, 2005. http://www.imshealth.com/ims/portal/front/indexC/0,2773,6599_77478579_0,00.html; last accessed 26 December 2006.Google Scholar
Kaduszkiewicz, H., Zimmermann, T., Beck-Bornholdt, H. P. and Van Den Bussche, H. 2005. Cholinesterase inhibitors for patients with Alzheimer's disease: systematic review of randomised clinical trials, BMJ, 7512, 321–327.CrossRefGoogle Scholar
Katona, C. and Cameron, V. 2003. Good psychiatric practice: interim guidance on the relationship between psychiatrists and commercial sponsors and the sponsorship of college activities (CR117). Psychiatric Bulletin, 27, 473–477.CrossRefGoogle Scholar
Kondro, W. and Sibbald, B. 2004. Drug company experts advised staff to withhold data about SSRI use in children. CMAJ, 170, 783.CrossRefGoogle ScholarPubMed
Kravitz, R.L. et al. 2005. Influence of patients’ requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA, 16, 1995–2002.CrossRefGoogle Scholar
Lexchin, J. et al. 2003. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ, 326, 1167–1170.CrossRefGoogle ScholarPubMed
Lowin, A., Knapp, M. and McCrone, P. 2001. Alzheimer's disease in the UK: comparative evidence on cost of illness and volume of health services research funding. International Journal of Geriatric Psychiatry, 16, 1143–1148.CrossRefGoogle ScholarPubMed
Lurie, P., Tran, T., Wolfe, S. M. and Goodman, R. 2005. Violations of exhibiting and FDA rules at an American Psychiatric Association annual meeting. Journal of Public Health Policy, 4, 389–399.CrossRefGoogle Scholar
McHenry, L. 2005. On the origin of great ideas: science in the age of big pharma. Hastings Center Report, 6, 17–19.Google Scholar
Melander, H., Ahlqvist-Rastad, J., Meijer, G. and Beermann, B. 2003. Evidence b(i)ased medicine – selective reporting from studies sponsored by the pharmaceutical industry: review of studies in new drug applications. BMJ, 7400, 1171–1173.CrossRefGoogle Scholar
Mintzes, B. et al. 2003. How does direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary care environments with and without legal DTCA. CMAJ, 5, 405–412.Google Scholar
Moncrieff, J. et al. 2005. Psychiatry and the pharmaceutical industry: who pays the piper? Psychiatric Bulletin, 29, 84–85.CrossRefGoogle Scholar
Moynihan, R. 2002. Drug firms hype disease as sales ploy, industry chief claims. BMJ, 7342, 867.CrossRefGoogle Scholar
Moynihan, R. 2003. Who pays for the pizza? Redefining the relationships between doctors and drug companies. BMJ, 326, 1189–1196.CrossRefGoogle ScholarPubMed
Moynihan, R., Heath, I. and Henry, D. 2002. Selling sickness: the pharmaceutical industry and disease mongering. BMJ, 7342, 886–891.CrossRefGoogle Scholar
msnbc 2006. NIH scientist must forfeit $300,000 fee. http://msnbc.msn.com/id/1632779722/12/06 accessed 16 April 2007.Google Scholar
NICE 2006. Dementia: Supporting People with Dementia and their Carers in Health and Social Care. Clinical Guidelines. National Institute for Health and Clinical Excellence, available online at http://www.nice.org.uk/guidance/cg42; last accessed 5 December 2006.Google Scholar
O'Brien, J., Wahlund, L.O., Scheltens, P. and Förstl, H. 2007. For debate: should neuroimaging be a routine investigation in all cases of suspected dementia? International Psychogeriatrics, 19, 525–538CrossRefGoogle ScholarPubMed
Perlis, R. H., Perlis, C. S., Wu, Y., Hwang, C., Joseph, M. and Nierenberg, A. A. 2005. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. American Journal of Psychiatry, 10, 1957–1960.CrossRefGoogle Scholar
PhRMA 2006. Code on Interactions with Healthcare Professionals. Available at http://www.phrma.org/code_on_interactions_with_healthcare_professionals/.Google Scholar
Public Citizen 2002. America's Other Drug Problem: A Briefing Book on the Prescription Drug Debate. Available online at www.citizen.org/rxfacts.Google Scholar
Radley, D. C., Finkelstein, S. N. and Stafford, R. S. 2006. Off-label prescribing among office-based physicians. Archives of Internal Medicine, 9, 1021–1026.CrossRefGoogle Scholar
Runciman, W. B., Roughead, E. E., SempleS. J., S. J., and Adams, R. J. 2003. Adverse drug events and medication errors in Australia. International Journal for Quality in Health Care, 15, i49–i59.CrossRefGoogle ScholarPubMed
Schneider, L. S. et al. 2006. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. New England Journal of Medicine, 15, 1525–1538.CrossRefGoogle Scholar
Shooter, M. 2005. Editorial. Dancing with the devil? A personal view of psychiatry's relationships with the pharmaceutical industry. Psychiatric Bulletin, 29, 81–83.CrossRefGoogle Scholar
Steinman, M. A., Bero, L. A., Chren, M. M. and Landefeld, C. S. 2006. Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Annals of Internal Medicine, 4, 284–293.CrossRefGoogle Scholar
Topol, E. J. 2004. Failing the public health – Rofecoxib, Merck, and the FDA. New England Journal of Medicine, 351, 1707–1709.CrossRefGoogle ScholarPubMed
Trombetta, B. 2006. Industry audit 2005. Pharmaceutical Executive. Available online at http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=369272; last accessed 26 December 2006.Google Scholar
U.K. Department of Health 2001. Treatment Choice in Psychological Therapies and Counselling. Evidence-based Clinical Practice Guidelines. London: Her Majesty's Printing Office.Google Scholar
U.K. Government Actuary Department. 2003-based National Population Projections. Available online at www.gad.gov.uk.Google Scholar
Whittington, C. J., Kendall, T., Fonagy, P., Cottrell, D., Cotgrove, A. and Boddington, E. 2004. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet, 9418, 1341–1345.CrossRefGoogle Scholar
Wolinsky, H. 2005. Disease mongering and drug marketing. Does the pharmaceutical industry manufacture diseases as well as drugs? EMBO Reports, 6, 612–614.CrossRefGoogle ScholarPubMed