Abstract
In 2002, following reports of adverse side effects experienced by Japanese patients taking the antipsychotic medication, Zyprexa, Japan's Ministry of Health, Labor and Welfare required Eli Lilly & Co. to place a new warning label on its drug and to send out a ‘doctors letter’. The company feared that this would threaten its sales of Zyprexa not just in Japan, but globally. US court documents from suits against Lilly in 2006 show how Lilly focused their scientific and sales attention not on the reported side effects of their drug, but on how prescribing physicians perceived the side effect profile of the drug. The company actively pursued a strategy of creating a shadow science to drown out noncompany-sponsored (and competitors’) research reports on the side effects of the drug. I draw on ethnographic research in Japan to describe how Lilly dealt with the threat to the brand equity of Zyprexa there, and how they sought to keep their global marketing program for the drug on course. I conclude with a discussion of the encounter between the global marketing aspiration of the firm and the contingencies associated with the Japanese environment in particular.
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Notes
Eli Lilly & Co. Annual Reports, available at: http://investor.lilly.com/annuals.cfm.
Some studies also associate the drug with hyperlipidemia, also associated with CDV (Wirshing et al, 2002).
This is likely the case for several reasons: (a) it is believed that the causal relationship of taking the drug to these diseases can be shown only statistically; (b) because all antipsychotic drugs have severe side effects (the same or different to Zyprexa, differing only by degree); and (c) because the company's argument, backed by studies it has commissioned, is that people with mental illness have a tendency to have high blood sugar and other metabolic disorder markers before they begin taking the drug. These claims have been staunchly disputed (Le Noury et al, 2008) but they have not, as yet, been unseated.
The documents are available for downloading here: http://www.furiousseasons.com/zyprexadocs.html. I have not labelled specific files in this paper, as I have drawn from a collated version and the Furious Seasons document breakdown is not systematic by theme or date. Key word searches on Google for exhibits cited in my paper will bring up the originals.
As Olanzapine is the brand name in Japan, I capitalize it throughout.
For a comparable formulation of this situation and an enlightening case study of it, see Lakoff (2005).
It might be possible to show from the Zyprexa documents that company-sponsored research could build on prior company-sponsored research, creating a legitimating echo effect for their claims.
I do not have data on the number of sales reps to physicians in Japan (in the United Kingdom it is one rep for every three MDs; in the United States one for every six); however, Japanese doctors refer to the reps as otoko geisha, or male geisha.
The confusion of rationality and morality appears to me a regular feature of US–Japan trade. In regard to the national trade disputes of the 1990s, ‘The polarity between fair trade and unfair trade – the explicitly moral terminology originating from the US side – was met by an equally polarized rejoinder from the Japanese. When the Americans claimed to be rational, the Japanese were “hyperrational”, and where the Americans were logical, the Japanese claimed to be “supra-logical”. This Japanese repartee to an accusation of unfairness with a baffling indictment that Americans are too logical does not imply that the two nations misinterpreted one another. Rather, the transposition of discourse from the moral to the rational domain was entirely natural to the terms of the debate. The US side of the negotiation habitually interspersed notions of the virtues of economic efficiency and rationality with Virtue in general. The Japanese were simply responding in kind’ (Applbaum, 1998, p. 8).
However, as of March 2009, Olanzapine has been approved in Japan only for schizophrenia, and for many years was not considered useful there as a first-line treatment.
http://www.naturalnews.com/024089.html, accessed 19 May 2009. See also, for example, http://www.pharmalot.com/2008/03/zyprexa-label-in-japan-was-tougher-than-in-us/, accessed 19 May 2009 and http://www.zyprexasideeffectslawyer.com/html/reports.html, accessed 19 May 2009.
Contingencies associated with cultures of international trade can also have decisive effects. Andrew Lakoff reports that many Argentinian psychiatrists regard psychopharmaceuticals as an imperialist invasion (Lakoff, 2005). The grounds for cultural resistance to US influence as expressed through commerce are also in evidence in Japan (Applbaum, 1998), a sentiment liable to be deployed expediently by domestic pharmaceutical competitors.
References
Abraham, J. and Davis, C. (2009) Drug evaluation and the permissive principle: Continuities and contradictions between standards and practices in antidepressant regulation. Social Studies of Science 39: 569–598.
Abraham, J. and Lewis, G. (2002) Citizenship, medical expertise and the capitalist regulatory state in Europe. Sociology 36: 67–88.
Abraham, J. and Reed, T. (2001) Trading risks for markets: The international harmonisation of pharmaceuticals regulation. Health, Risk & Society 3: 113–128.
Appadurai, A. (1986) Introduction: Commodities and the politics of value. In: A. Appadurai (ed.) The Social Life of Things: Commodities in Cultural Perspective. Cambridge: Cambridge University Press.
Applbaum, K. (1998) Rationality, morality and free trade: US-Japan trade relations in anthropological perspective. Dialectical Anthropology 28: 1–30.
Applbaum, K. (2004) The Marketing Era: From Professional Practice to Global Provisioning. New York: Routledge.
Applbaum, K. (2006) Educating for global mental health: American pharmaceutical companies and the adoption of SSRIs in Japan. In: A. Petryna, A. Lakoff and A. Kleinman (eds.) Pharmaceuticals and Globalization: Ethics, Markets, Practices. Durham, NC: Duke University Press, pp. 85–110.
Applbaum, K. (2009) Getting to yes: Corporate power and the creation of a psychopharmaceutical blockbuster. Culture, Medicine and Psychiatry 33: 185–215.
Applbaum, K. (2010) Marketing global healthcare: The practices of big pharma. In: L. Pantich and C. Leys (eds.) The Socialist Register – 2010 Morbid Symptoms: Health Under Capitalism, New York: Monthly Review Press, pp. 95–115.
Awad, G. (2004) Antipsychotic medications: Compliance and attitudes towards treatment. Current Opinion in Psychiatry 17: 75–80.
Berenson, A. (2006) Eli Lilly said to play down risk of top pill. The New York Times, 17 December.
Bourdieu, P. (1977) Outline of a Theory of Practice, Translated by R. Nice. Cambridge: Cambridge University Press.
Charlton, B.G. (2005) If ‘atypical’ neuroleptics did not exist, it wouldn’t be necessary to invent them: Perverse incentives in drug development, research, marketing and clinical practice. Medical Hypotheses 6: 1005–1009.
Ecks, S. (2008) Global pharmaceutical markets and corporate citizenship: The case of Novartis’ anti-cancer drug Glivec. BioSocieties 3: 165–181.
Hacking, I. (1998) Mad Travelers: Reflections on the Reality of Transient Mental Illness. Charlottesville, VA: University Press of Virginia.
Hacking, I. (1999) The Social Construction of What? Cambridge, MA: Harvard University Press.
Healy, D. (2002) The Creation of Psychopharmacology. Cambridge: Harvard University Press.
Healy, D. (2009) Trussed in evidence? Ambiguities at the interface between clinical evidence and clinical practice. Transcultural Psychiatry 46: 16–37.
Hiroto, I. and Sederer, L.I. (1999) Mental health services reform in Japan. Harvard Review of Psychiatry 7 (4): 208–215.
Hodgson, J.D., Sano, Y. and Graham, J.L. (2007) Doing Business with the New Japan. Lanham, MD: Rowman and Littlefield.
Kirmayer, L. (2001) Cultural variations in the clinical presentation of depression and anxiety: Implications for diagnosis and treatment. Journal Clinical Psychiatry 62 (suppl 13): 22–28.
Kirmayer, L. (2006) Beyond the ‘new cross-cultural psychiatry’: Cultural biology, discursive psychology, and the ironies of globalization. Transcultural Psychiatry 43: 126–144.
Kirsch, I. and Saperstein, G. (1998) Listening to Prozac but hearing placebo: A meta-analysis of antidepressant medication. Prevention and Treatment, 1, article 0002a. http://journals.apa.org/prevention/volume1/pre0010002a.html, accessed from 1 June 2009.
Koller, E.A. and Doraiswamy, P.M. (2002) Olanzapine-associated diabetes mellitus. Pharmacotherapy 22: 841–852.
Lakoff, A. (2005) Pharmaceutical Reason: Knowledge and Value in Global Psychiatry. Cambridge: Cambridge University Press.
Lambert, B.L., Chou, C.H., Chang, K.-Y., Iwamoto, T. and Tafesse, E. (2002) Assessing the risk of antipsychotic-induced Type II diabetes among schizophrenics: A matched case-control study. Poster presented at the 15th European Neuropsychopharmacology Conference; October, Barcelona, Spain.
Lane, C. (2007) Shyness: How Normal Behavior Became a Sickness. New Haven, CT: Yale University Press.
Lee, B. and LiPuma, E. (2002) Cultures of circulation: The imaginations of modernity. Public Culture 14: 191–213.
Le Noury, J. et al (2008) The incidence and prevalence of diabetes in patients with serious mental illness in North West Wales: Two cohorts, 1875–1924 &1994–2006 compared. BMC Psychiatry 8: 67.
Lieberman, J.A. et al (2005) Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. New England Journal of Medicine 353: 1209–1223.
Levitt, T. (1983) The Marketing Imagination. New York: Free Press.
Mann, M. (2009) Eli Lilly pleads guilty to off-label marketing of Zyprexa. ABA Health Resource 5 (7), http://www.abanet.org/health/esource/Volume5/07/Mann.html.
Matheson, A. (2008) Corporate science and the husbandry of scientific and medical knowledge by the pharmaceutical industry. BioSocieties 3: 355–382.
Moynihan, R. and Cassells, A. (2005) Selling Sickness. New York: Nation Books.
Oldani, M. (2004) Thick prescriptions: Towards an interpretation of pharmaceutical sales practices. Medical Anthropological Quarterly 18: 325–356.
Oldani, M. (2009) Beyond the naïve ‘no-see’: Ethical prescribing and the drive for pharmaceutical transparency. Physical Medicine & Rehabilitation 1: 82–86.
Petryna, A., Lakoff, A. and Kleinman, A. (eds.) (2006) Global Pharmaceuticals: Ethics, Markets, Practices. Durham, NC: Duke University Press.
Rosenheck, R.A. (2005) The growth of psychopharmacology in the 1990s: Evidence-based practice or irrational exuberance. International Journal of Law and Psychiatry 28: 467–483.
Rosenheck, R.A. and Sernyak, M.J. (2009) Developing a policy for second generation antipsychotic drugs. Health Affairs, doi: 10.1377/hlthaff.28.5.w782.
Sahlins, M. (2004) Apologies to Thucydides: Understanding History as Culture and Vice Versa. Chicago, IL: University of Chicago Press.
Sismondo, S. (2007) Ghost management: How much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med 4 (9): e286, doi:10.1371/journal.pmed.0040286.
Spielmans, G. (2009) The promotion of olanzapine in primary care: An examination of internal industry documents. Social Science and Medicine 69 (1): 14–20.
Timmermans, K. (2004) Harmonization, regulation and trade: Interactions in the pharmaceutical field. International Journal of Health Services 34: 651–661.
Turner, B.S. (2001) Risks, rights and regulation: An overview. Health, Risk & Society 3: 9–18.
Tyrer, P. and Kendall, T. (2009) The spurious advance of antipsychotic drug therapy. Lancet 373, doi:10.1016/S0140-6736(08)61765-1.
Wirshing, D.A., Boyd, J.A., Meng, L.R., Ballon, J.S., Marder, S.R. and Wirshing, W.C. (2002) The effects of novel antipsychotics on glucose and lipid levels. Journal of Clinical Psychiatry 63: 856–865.
Acknowledgements
I thank Robert Rosenheck for his corrections and comments on the first draft of this article. Thanks are also due to Ingrid Jordt, Lawrence Cohen, Paul Brodwin, Martha Poon and BioSocieties’ conscientious reviewers for their input.
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Applbaum, K. Shadow science: Zyprexa, Eli Lilly and the globalization of pharmaceutical damage control. BioSocieties 5, 236–255 (2010). https://doi.org/10.1057/biosoc.2010.5
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DOI: https://doi.org/10.1057/biosoc.2010.5