Big pharma abusing poor girls in the developing world? Governments beholden to the global pharmaceutical market? These sorts of conjectures are commonplace in contemporary discourse in global health and political economy, and this book illustrates and explores another example. In Pharmocracy: Value, Politics and Knowledge in Global Biomedicine, Kaushik Sunder Rajan tackles a perpetual challenge in the politics of biomedicine – the dominance of big pharma over the everyday experience of health within some of the world’s poorest populations – by showing how the international harmonisation of clinical trials and intellectual property (IP) regimes must be understood in terms of expansive corporate hegemony.
The term ‘pharmocracy’ was coined by Bill Falloon in his synopsis of the relationships between the US Food and Drug Administration (FDA), US Congress and the pharmaceutical lobbying groups, with the health of the everyday US citizen at the mercy of the interactions between the major pharmaceutical and regulatory players whose primary aim is profit-making. Similarly, Rajan explores the impact of biomedical industry and regulatory bodies in a different democratic setting – that of India. India is a particularly interesting case study as it has been often heralded as the future of the biomedical through its thriving generic drug industry (which is the source of affordable medicine in much of the Global South, including Medécins Sans Frontières’ procurement of 75 per cent of its antiretroviral drugs from the country), developing Research and Development (R&D) sector and growing political and economic global capital.
His argument follows that the pharmocracy witnessed in India is the global hegemonic power of the multinational Euro-American pharmaceutical industry. Through analysis of the national regulatory frameworks which have developed in India since 2005, it is argued that these national policy changes have been implemented to facilitate ‘first world’ corporate interests, which have major consequences for Indian public health. As he states, the aim of the book therefore is to think about ‘the impact of political economic structures of global biomedicine on both health and democracy, which further involves considering democracy in terms of forms of responsibility and the structures of accountability they engender’ (233).
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The book uses two case studies to emphasise the argument – that of the Gardasil HPV vaccine scandal in Andhra Pradesh and Gujarat, where seven girls died in the wake of being vaccinated, and the 2006 patent denial of Novartis’s anti-cancer drug Gleevec, where IP rights as a means for greater pharmaceutical production were challenged by ‘genocidal’ considerations about access for those who need the drug and are not able to afford the high price tag, the latter of which ended in the Indian Supreme Court.
Chapter Two provides a detailed analysis of the vaccination controversy and what this tells us about the challenges facing medical practice, interpretation and accountability in contemporary India. Rajan’s enquiry into this scandal seeks to answer two empirical, and broadly epistemic, questions: was the study conducted ethically, and did the girls die as a consequence of the vaccination?
The chapter considers the regulatory change in India in the last two decades that has allowed for the harmonisation of clinical trials, driven by Indian Clinical Research Organisations. This has been welcomed by the Western pharmaceutical market as lower labour and infrastructure costs, alongside a large population of treatment-naïve patients, have meant that clinical trials have begun to be outsourced to India (as well as other parts of the globe). Moreover, it has been championed domestically as early estimates suggested that it might become a one billion dollar industry by 2010.
Yet, the outsourcing of clinical trials raises obvious ethical questions about the value of health and life amongst different populations – a concern which Rajan deals with in depth and eruditely. He shows how informed consent – a challenge for all clinical research – was inherently flawed in this instance by highlighting that the concept of consent was not properly explained to the girls, that their mothers did not understand that it was not an approved governmental vaccination programme and that, in one instance, a hostel director gave consent for all the girls under her charge. That the trials took place amongst a vulnerable tribal group is also a question of concern for Rajan, as well as the fact that the vaccination cards were all written in English. This leads to his rhetorical consideration as to whether this group were used for the vaccination rollout due to their illiteracy and lack of political capital.
In answering the second question – whether the vaccination was responsible for the girls’ deaths – the government committee concluded that there was not sufficient evidence to make this causal link. However, as Rajan argues, this case highlights the misreporting of deaths and the variety of approaches to medical governance in India.
Moving on from these questions, the chapter also examines the governance and regulations around clinical trials. Rajan is clear to point out that the HPV case was a postlicensure observational study to assess the feasibility of implementing the HPV vaccine as part of the Indian routine vaccination programme, rather than a clinical trial. Yet, the Gardasil events ignited public interest and civil society groups, who pressured parliament into discussions about the regulatory framework through which public-private vaccination activity takes place (the study was conducted jointly between the Indian Council for Medical Research and a global non-profit Program for Appropriate Technology in Health (PATH)). Regulatory changes were made as a consequence of the HPV vaccine scandal.
Importantly, an update was also included which required financial support to be given to the clinical subject and their families in the instance of ill health or death; this was to come from the trial sponsors. Unsurprisingly, this regulatory change was not welcomed by the Western pharmaceutical market or the Indian clinical research institutes, both of which lobbied the government with the result that these regulatory updates were reversed within a month. Rajan suggests that this is evidence of ‘third world’ national regulations being implemented to further first-world corporate interests and the corporate hegemonic role in biomedicine.
Thorough extensive ethnographic interviewing of a range of individuals from patients to parents, from the producer of generic drugs in India to civil society advocates in both the Gleevec and Gardasil cases, Pharmocracy provides a rich account of some of the more complex emotive concerns surrounding these moral, legal and financial questions of knowledge, value and politics. These are substantiated with in-depth triangulation of policy and legal documentation and philosophical thought. It is expertly researched and presented by a world-leading academic in the field who has devoted considerable research to the moral and philosophical concerns of the biomedical.
Yet there are some biases evident in this book. For example, the focus centres on the Western pharmaceutical industry being the source of ill, but there is no consideration of the several multinational Indian pharmaceutical companies operating today in similar domains. I wonder how Rajan would conceptualise these in terms of value, knowledge, politics and hegemony? Secondly, the author makes generalisations about the Global South in contrast to Western pharmaceuticals, yet only provides examples from India. I would question the assumptions that he makes about ‘the global’ without global case studies. Finally, Rajan’s analysis of health is reduced to the western biomedical, rather than considerations of traditional healing or other forms of knowledge in health upon which a differing postcolonial perspective may reflect.
However, Pharmocracy leaves me with more questions than answers – which is a good thing. It opens up further reflection on what we know about pharmaceutical production and consumption, and what governance structures exist that affect the drugs that the globe will rely on one day.
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