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Making medicines essential: The emergent centrality of pharmaceuticals in global health

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Abstract

Expanding access to pharmaceuticals has become one of the most visible aspects of twenty-first century global health practices, as evidenced by the moral urgency of antiretroviral rollout and the pressing call for new drugs for neglected diseases. However, the role of prescription drugs in public health was far less obvious to the framers of international health organizations only a half-century ago. This article examines the evolving role of pharmaceuticals in global health practices by charting the emergence of the category of ‘essential medicines’: initially a list of 186 drugs first defined by the World Health Organization (WHO) in 1977 to be ‘basic, indispensable, and necessary for the health of the population’, and subsequently expanded by actors beyond the WHO including NGOs, pharmaceutical companies and the broader financial community. This apparently simple act of list-making worked to transport a set of commodities from the private, commercial sphere into a public health commons, and sparked a series of methodological, logistical and political controversies over the winnowing of ‘essential’ from ‘inessential’ that collapsed evidentiary, regulatory, participatory and market terms into a single process. To ask ‘what practices render a medicine essential?’ is therefore to address the shifting ecology of knowledge governing global health today.

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Notes

  1. On the emerging ethnography of antiretroviral rollout, see Fassin (2007), Biehl (2009), Nguyen (2010) and Mahajan (2010). On neglected diseases see Light (2010). On pharmaceuticals for chronic disease see Yach et al (2004).

  2. Though I use the terms essential medicines and essential drugs almost interchangeably, they serve to divide historical periods: essential medicines is a twenty-first-century term whereas essential drugs was largely a twentieth-century term.

  3. On the politics of international health agencies in the Cold War, see Douglas (1987), Mingst (1990), Siddiqi (1995), Brown, Cueto and Fee (2006).

  4. Though Kanji et al (1992) provide a broad synthetic account and Chowdhury (1995) a detailed case-study of essential drugs in Bangladesh, most histories of essential drugs to date have been actors narratives, for example, Quick et al (2002), Quick (2003), Helling-Borda (2003), Laing et al (2003), with the exception of Robertson and Hill (2007).

  5. For critique of these claims, see Cohen (1983), Arnold (1988), Worboys (2000).

  6. ‘At present there is something like a vicious circle. Because there is no immediate shortage of them, drugs which are not essential continue to be used, and as they are used further supplies are imported to keep up the stock’. Quotations are from ‘Non-essential drugs: Hints to prescribers’ (1940, p. 603); see also ‘Economy in essential drugs: more hints to prescribers’ (1940).

  7. For example, Evatt (1881, p. 603): ‘I take it that a formulary of prescriptions for our army hospitals is absolutely essential. It need not be too elaborate, but should contain a very full list of pills and powders. These two modes of administering drugs will be always important in the field; and by having such formularies one could telegraph for the drug wanted, and get it by field-post, and not by the slower transport train’. See also the reply by Woodward (1881, p. 799): ‘I think I may safely estimate that a pair of ordinary sized saddle-bags would contain a fully equipped dispensary, sufficient to meet the medical requirements of a thousand men for a three-months’ campaign – even including anesthetics, to be carried in metallic flasks, fitted with close-fitting screwed tops, instead of the glass bottles at present in use’.

  8. An online index of contents of medics’ kits in WWI and WWII can be found at David Steinert's WWII Combat Medic (http://home.att.net/∼steinert/).

  9. Such an approach was grounded in wartime declarations of therapeutic essentiality and in interwar professional practices of medical and pharmaceutical education. The Council on Drugs of the American Medical Association (AMA) had by that point published several editions of a textbook of Useful Drugs: A Selected List of Essential Drugs intended to encourage to rationalize medical pedagogy. By the mid-twentieth century, however, the AMA Council on Drugs had proven unable to function as arbiter of therapeutic necessity – largely due to institutional convergence between the AMA and the Pharmaceutical Manufacturers Association – and instead published compendia that merely reflected the totality of Food and Drug Administration (FDA)-approved therapeutic agents without comment on their relative relevance to public health or clinical practice. The history of the Pharmacopoeia Internationalis illustrates a similar trajectory of moving away from the project of discriminating essential from inessential drugs.

  10. On the postwar ‘drug explosion’ in the global North and the ensuing difficulties of distinguishing therapeutic innovation from innovative repackaging, see Bud (2007), Greene (2007), Lesch (2007), Rasmussen (2007), Watkins (2007), Strasser (2008), Greene and Podolsky (2009) and Herzberg (2009).

  11. For example, Mintz (1965), Silverman (1974).

  12. By the early 1970s, Pakistan, Mozambique and Sri Lanka had each attempted to establish restricted formularies of generic drugs with tight controls on pharmaceutical imports. Each nation was subsequently subjected to highly unfavorable positions within international trade and either swiftly abandoned these efforts, like Pakistan, or gave up such strategies after the outbreak of war (as in Mozambique) or a series of government collapses and, ultimately, civil war (as in Sri Lanka) (see Muller, 1982; Medawar, 1984; Kanji et al, 1992).

  13. See UNCTAD (1982), also described in Kanji et al (1992).

  14. As mentioned earlier, the primary health-care concept was already strongly supported by Mahler, who was influenced by works such as John Bryant's Health and the Developing World (1969) and Kenneth Newell's Health by the People (1975).

  15. Azarnoff's draft (which would later circulate as a document intended to help nations develop their own essential medicine lists) listed 10 thematic criteria for circulation – (i) use of generic names only, (ii) proven efficacy and safety in Randomized Controlled Trials, (iii) inexpensive, (iv) stable substance, (v) minimal degree of medical expertise (diagnostic and therapeutic) necessary to use drug properly, (vi) minimal degree of specialized technology needed to use drugs properly, (vii) local disease states that complicate utilization of drug (for example, malnutrition), (viii) local prevalence of specific diseases (for example, resistant strains), (ix) pharmacokinetic parameters, and (x) local manufacturing capabilities (Azarnoff and Nakajima (1977, p. 2), see also Helling-Borda (2003)).

  16. To deflect anticipated critique from industry the WHO had included five IFPMA members, including the IFPMA president, in the consultations in 1976 and 1977 that led to the formation of the first essential drugs list (see Egli, 1977).

  17. ‘The pharmaceutical industry is not aware of any developed nation where regulatory authorities can provide assurance of the bioequivalence or interchangeability of the drug supply within their jurisdiction; and the state of regulatory effectiveness in most developing countries is substantially less advanced. Because of this reality, governments, the medical profession, and the patient must rely upon the reputations of companies with consistent histories of producing high quality products as the best assurance of safety and therapeutic effectiveness … To discourage [the use of brand names] as the WHO Report does would have grave repercussions for the quality of pharmaceutical supplies and health care, whether in developed or developing nations’ Egli and Mahler (1978, p. 2). On the problem of equivalence in generic drugs, see Hayden (2007), Greene (forthcoming), Tobbell (forthcoming) and Carpenter and Tobbell (forthcoming).

  18. Crout had suggested that the name of the list be changed from ‘essential drugs’ to ‘basic drugs’, noting that ‘the idea that most drugs are non-essential is obviously bothersome to the industry, whereas they can accept the idea that most are non-basic’ (J. Richard Crout to V. Fattorusso, 9 February 1978, E 19 81 1, folder 1. WHO Archives, Geneva).

  19. At the 1978 World Health Assembly, the WHO's pharmaceuticals group presented a technical report calling for an ‘action program’ where the WHO would work directly with national governments to strengthen their capacity to select and supply essential drugs to their full populations, and announced that the WHO had ‘initiated a dialogue with interested research-based pharmaceutical industries and there are good prospects for future collaboration’, whereas Max Tiefenbacher claimed that ‘the industry has a vital role to play in the WHO action program. We stand ready to continue the dialogue – with new visions and initiatives’ (Hey, 1978). The IFPMA's annual report for 1978 mentioned ‘lists of essential drugs, a concept which IFPMA has rejected in its statement to the Director General as being against the interests of the WHO's prior stated objectives. Nevertheless, IFPMA has responded positively with the WHO's request to improve the dialogue with the pharmaceutical industry and is sympathetic [to the principles of Primary Health Care laid out at Alma Ata]’ (IFPMA, 1978). For a contemporary analysis of the shift from list-making to implementation, see Reich (1987).

  20. The foundational International NGO Seminar on Pharmaceuticals in Geneva took place immediately following the 1981 World Health Assembly in Geneva, and included over 50 organizations from 26 countries (see Fazal, 2006).

  21. WHO (1987), see also Laing et al (2003).

  22. For example, Brooks (1985), PMA (1985). See also Mingst (1990), Siddiqi (1995). As Siddiqi cites (p. 8), this claim of politicization had earlier been made by US Ambassador William Scranton that ‘the absence of balance, the lack of perspective and the introduction by the WHO of political issues irrelevant to the responsibilities of the WHO do no credit to the United Nations. Indeed, this is precisely the sort of politicized action which decreases respect for the United Nations system’.

  23. After much debate on the subject, the mid-to-late 1980s also saw a concerted move away in WHO policy from an emphasis on broad ‘horizontal’ programs (such as the Alma Ata-PHC concept and the essential drugs movement) and toward more operational programs such as ‘selective primary health care’; Kenneth Newell described these linked phenomena as a ‘counter revolution’ against the spirit of Alma Ata (Newell, 1988).

  24. For example, Stolk et al (2006), Lancet (2006), De Lima (2007), Robertson and Hill (2007).

  25. Chirac (2003, p. 12) (see also Chirac and Laing, 2001).

  26. For recent ethnography positioning MSF as a case study in the novel articulation of global humanitarianism, see the recent publications of Redfield (2006, 2008a, 2008b, 2008c) which builds on the earlier work of Fox (1995).

  27. ‘Sans-frontierisme’ has extended beyond MSF/Doctors Without Borders to include professional associations of nurses, teachers, pharmacists, plumbers, astronomers and other groups who claim to operate beyond – rather than within – the borders of the nation-state.

  28. On the delay of the WHO EDL reforms – and the role of US resistance in particular – see Steiger (2001).

  29. Noting the diversity of offerings in pharmacophilanthropic programs, Sturchio (2006) describes that Abbott had launched ‘Abbott Access’ in 2001, and offered Kaletra and Norvir as well as a rapid HIV test branded ‘Determine® HIV’; Boerhinger Ingelheim had made the Virammune® Donation Programme available free of charge for the prevention of mother to child transmission of HIV (PMTCT), though much of the other programs were dependent on ‘sustainable preferential pricing’; and Bristol-Myers Squibb, GSK and Boehringer Ingelheim have granted licenses to generic manufacturers in South Africa. Merck's own contribution, titled the ‘African Comprehensive HIV/AIDS Partnership’, established in partnership with the Bill & Melinda Gates Foundation, involved a direct donation program to the Botswana national ARV therapy program. Hoffmann-La Roche, moreover, had shifted its patent policy to (a) not file any patents for any Roche medicines in low-income nations and sub-Saharan Africa, and (b) promise not to take action in these countries against the sale or manufacture of generic HIV medicines.

  30. Even in 1978, as the IFPMA was actively denying the possibility of a list of essential drugs, a few pharmaceutical firms had approached the WHO unilaterally to lobby for admission to the essential drugs list, leading the WHO to censure companies on more than one occasion for the use of the essential drugs logo for promotional purposes. Eaton Laboratories lobbied the WHO for ‘inclusion of nitrofurantoin macrocrystals as a primary drug in the management of urinary tract infections in the WHO Essential Drug List’. American Cyanamid sent a similar list of four of their own products (leucovorin, minocycline, chlortetracycline and traimcinolone) that they suggested to be added to the list. Each of the companies met with some success – both nitrofurantoin and chlortetracycline were included in the 1979 revision of the essential drugs list (see Keenan, 1978); Affleck, 1978);WHO, 1979a, 1979b).

  31. http://www.atmindex.org/, accessed 10 April 2010.

  32. Pfizer responded to their low ranking on the 2008 ATM Index, ‘We recognize that we have yet to meet our full potential, as reflected in pharmaceutical company rankings such as the Access to Medicines Index ranking, and value the feedback and insights provided by the many stakeholders we engage and partner with on access to medicine issues’, http://www.pfizer.com/responsibility/cr_report/access.jsp; Merck has posted a similar report: http://www.merck.com/corporate-responsibility/summary-data-resources/kpis-gri-atmi-mdgs/atmi-2008-index.html, accessed 10 April 2010.

  33. As cited on the ATMF website: http://www.atmindex.org/index/what_leaders_are_saying, accessed 10 April 2010.

  34. As proclaimed on the Abbott website: http://www.abbott.com/global/url/content/en_US/10:10/general_content/General_Content_00004.htm, accessed 10 April 2010.

  35. http://www.walmart.com/cp/4-Prescriptions-Program/546834, accessed 10 April 2010.

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Acknowledgements

The author gratefully acknowledges the time and historical insight provided by several former and current actors within the Essential Medicines Programme of the WHO, especially Margaretha Helling-Borda, Hans Hogerzeil, Richard Laing and Jonathan Quick. The archival work supporting this project would not have been possible without the generous assistance of Marie Villemin at the archives of the WHO, and the manuscript benefitted from discussions with Paul Cruickshank, Dennis Ross-Degnan, David Jones, Stephen Pemberton and Anita Wagner. Earlier versions of this article were presented at a Global Health Histories Seminar at the WHO in December 2009, the November 2010 meetings of the American Anthropological Association and a December 2010 conference on Drugs, Standards and the Practices of Globalization supported by the European Science Foundation, the Centre de Recherches Médecine, Sciences, Santé et Société and the Ecole des Hautes Etudes en Sciences Sociales.

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Greene, J. Making medicines essential: The emergent centrality of pharmaceuticals in global health. BioSocieties 6, 10–33 (2011). https://doi.org/10.1057/biosoc.2010.39

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