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Shadow science: Zyprexa, Eli Lilly and the globalization of pharmaceutical damage control

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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

  1. Eli Lilly & Co. Annual Reports, available at: http://investor.lilly.com/annuals.cfm.

  2. Some studies also associate the drug with hyperlipidemia, also associated with CDV (Wirshing et al, 2002).

  3. 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.

  4. 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.

  5. As Olanzapine is the brand name in Japan, I capitalize it throughout.

  6. For a comparable formulation of this situation and an enlightening case study of it, see Lakoff (2005).

  7. 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.

  8. Lambert et al (2002).

  9. 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.

  10. 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).

  11. 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.

  12. 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.

  13. 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.

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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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