Adriana Petryna

Clinical Trials Offshored: On Private Sector Science and Public Health

This article addresses the offshoring of clinical trials to middle- and low-income countries, and the complicated ways in which they have become integral to public health and quality of care in these contexts. I focus on the operations of United States-based contract research organizations (CROs), which make up a specialized global industry focusing on the recruitment of human subjects and investigators; they are key players in an outsourced world of clinical development ‘service providers’. To get an on-the-ground understanding of the offshored clinical trial, I worked with regulators, health services administrators, and research clinicians in Eastern Europe and Latin America, two clinical trial market ‘growth regions’. By addressing the strategies of evidence-making that inform clinical trial offshoring, this article identifies the context-specific calculations by which experimental groups are being identified. It also addresses aspects of the clinical trial operational model, in which the failure to predict safety outcomes or a paradigm of expected failure is being exported along with the offshored trial. By highlighting the uncertainties of clinical research, this article points to gaps in systems of human protection as it considers new forms of accountability in private sector science and public health.

Biological Citizenship: The Science and Politics of Chernobyl-Exposed Populations

In the transition out of socialism to market capitalism, bodies, populations, and categories of citizenship have been reordered. The rational-technical management of groups affected by the Chernobyl disaster in Ukraine is a window into this contested process. Chernobyl exemplifies a moment when scientific knowability collapsed and new maps and categories of entitlement emerged. Older models of welfare rely on precise definitions situating citizens and their attributes on a cross-mesh of known categories upon which claims rights are based. Here one observes how ambiguities related to categorizing suffering created a political field in which a state, forms of citizenship, and informal economies were remade.

Judicialisation of the right to health in Brazil.

This article examines Brazils constitutional right to health and their pharmaceutical access. It states that Brazil must raise their funding for essential medicines and pursue strategies to ensure universal availability of medicines that the government has a legal responsibility to provide in order to reduce vulnerability to disease.

Peopling Global Health

The field of Global Health brings together a vastly diverse array of actors working to address pressing health issues worldwide with unprecedented financial and technological resources and informed by various agendas. While Global Health initiatives are booming and displacing earlier framings of the field (such as tropical medicine or international health), critical analyses of the social, political, and economic processes associated with this expanding field — an “open source anarchy” on the ground — are still few and far between. In this essay, we contend that, among the powerful players of Global Health, the supposed beneficiaries of interventions are generally lost from view and appear as having little to say or nothing to contribute. We make the case for a more comprehensive and people-centered approach and demonstrate the crucial role of ethnography as an empirical lantern in Global Health. By shifting the emphasis from diseases to people and environments, and from trickle-down access to equality, we have the opportunity to set a humane agenda that both realistically confronts challenges and expands our vision of the future of global communities.

The Right of Recovery

The responsibility for medicinal access and care has progressively shifted from the biomedical clinic and doctor-patient relations to precarious social institutions and legal and experimental settings. These settings afford proxy public health care, triaging services, and care delivery often on the basis of emergency or strict criteria of eligibility, urgency, or need. In this essay I trace out a conceptual shift in biomedicine and global health from a focus on a right to health (often equated with the right to medicines) to the institutional dynamics that facilitate—or, more usually, obstruct—a right to recovery. The essay addresses this latter right as an unmet therapeutic potential and explores practical and conceptual challenges for what is known as the “sick role” from its original framing as social deviance to be biomedically controlled to a neglected but powerfully informative people-based social science of survival.

Tratamentos jurídicos: os mercados terapêuticos e a judicialização do direito à saúde

This study draw on the struggle of parents of children with mucopolysacchar idosis to access expensive drugs in the name of universal right to health. The work explores how, in Brazil, right-to-health litigation became an alternative pathway to access health care and shows that several public and private stakeholders dispute the judicialization of health. Biotechnology is, therefore, understood to remake human and social worlds as it opens up new spaces of ethical problematization, desire, and political belonging.This study draw on the struggle of parents of children with mucopolysacchar idosis to access expensive drugs in the name of universal right to health. The work explores how, in Brazil, right-to-health litigation became an alternative pathway to access health care and shows that several public and private stakeholders dispute the judicialization of health. Biotechnology is, therefore, understood to remake human and social worlds as it opens up new spaces of ethical problematization, desire, and political belonging.

Chernobyl’s survivors: Paralyzed by fatalism or overlooked by science?:

The author describes the experiences of Ukrainian clean-up workers, resettled families, and parents of exposed children in the decade after the 1986 Chernobyl disaster. The period was marked by a confused state response, lethal radiation doses to clean-up workers, and fragmented research efforts. The unraveling of the Soviet system in 1989 contributed to an atmosphere of chaos and left a legacy in Ukraine of incomplete accounting of the full public health and sociological consequences of the disaster. Being accountable to those people affected, the author writes, is a key challenge of our time, and the present and future consequences of Chernobyl’s health risks are not closed matters. Understanding the scope of the impact will hinge on what kinds of studies, technologies, and funds we are willing to apply, and over what time frame.

Experimentalidade: ciência, capital e poder no mundo dos ensaios clínicos

The outsourcing and offshoring of clinical trials have sparked an unprecedented field of experimental activity. This essay addresses the scientific and regulatory mechanisms by which a global field of experimentality takes form. It charts a clinical trials industry and its move to low- and middle-income countries (particularly in Eastern Europe and Brazil). As the clinical trials enterprise adapts itself to international and national regulatory norms, the acknowledgement of adverse risks to patients and populations is often deferred or engineered out. The essay explores policy gaps with respect to how benefits and liabilities of this enterprise are weighed as well as emergent practices of accountability.

A natureza desafiadora de coletar evidências e analisar a judicialização da saúde no Brasil

We read with great interest the article Studies Published in Indexed Journals on Lawsuits for Medicines in Brazil: A Systematic Review, by Gomes & Amador, published in Cadernos de Saúde Pública 1. We applaud Gomes & Amador’s goal of contributing to the effort of “explain(ing) the judicialization phenomenon, identifying the general profile of lawsuits, drawing inferences on the claims, describing the various issues involved, and proposing alternatives to solve problems” (p. 2). The review examined 17 studies that looked at lawsuits seeking access to medicines in Brazil, including our analysis of 1,080 lawsuits filed against the state of Rio Grande do Sul and published in Between the Court and the Clinic: Lawsuits for Medicines and the Right to Health in Brazil 2. We are writing to correct two errors in the authors’ description of our study. In Table 4 of their article Gomes & Amador (p. 6) state: 1. That the drugs most frequently requested by legal claims in our study were “teriparatide, clopidogrel, insulin glargine, rituximab, and infliximab”. In fact, they were budesonide, acetylsalicylic acid, formoterol, simvastatin, and hydrochlorothiazide; 2. That the medical prescriptions supporting legal claims in our study originated from public health services. In fact, our results showed that 36.8% of the prescriptions came from private practices. CarTaS LetteRS