Abstract
Governing the Global Clinic: HIV and the Legal Transformation of Medicine examines how laws, regulations, and other rules shape HIV treatment and research. Heimer describes the rise of legalization, that is, the propensity to turn to rules to solve problems, and its impact on the global HIV field. She asks what happens when rules designed largely for wealthy countries are applied in settings with very different health systems and conditions for medical care and clinical research. Drawing on ethnography conducted between 2003 and 2007 in five HIV clinics—two in the United States and one each in Thailand, South Africa, and Uganda—Heimer shows the on-the-ground impact of legalization.
In the HIV field, rules proliferate. There are “hard” laws, such as mandatory reporting and malpractice liability, and various “soft” laws such as clinical guidelines, testing protocols, and reporting requirements from funders and states. Heimer challenges readers to reconsider the impulse to turn to rules to solve problems. Rules may create order, but they also generate unintended consequences and can limit meaningful forms of clinical and research practice. Staff members’ efforts to meet the many requirements they are held accountable for may result in performative compliance, tensions between mandates and their sense of what is best for patients, a focus on immediate organizational needs at the expense of longer-term goals, and a diversion of time and resources from other essential work. Emphasizing rule compliance can also reinforce global inequalities, as under-resourced clinics in the global South struggle to meet standardized expectations and are often granted less credibility in the scientific community.
A notable strength of this book is the breadth of theoretical and empirical terrain it covers. The book builds on scholarship on the global reach of law by focusing on meso- and micro-level analyses of how hard and soft law operate in health care. Throughout the chapters, Heimer engages with work on legalization, standardization, ignorance, ethics, and clinical practice, while also providing a rich historical account of the global HIV field. She illustrates the array of rules that shape clinical and research work, showing how clinical guidelines, research ethics regulations, IRBs, and global and national policies influence practice.
Heimer’s argument about the uneven impact of rules is demonstrated across the clinics she studies. For instance, Chapter Four shows that outside the United States, clinical guidelines often fail to fit local patient populations, either because they were written for different demographic groups or because they assume social conditions that do not exist locally. Antiretroviral therapy (ART) guidelines developed for western patient populations posed fewer challenges for well-resourced U.S. clinics but proved more problematic elsewhere—for example, in Thailand, where standard doses were often inappropriate because Thai patients are, on average, smaller than those in western countries. In Chapter Five, we see how an intense focus on rule-following does not always support research; in some cases, it actively hinders it. This was especially evident in clinics outside the United States, where researchers often devote significant time to performing compliance, partly because their clinic’s legitimacy depended on being seen as compliant.
Another strength is Heimer’s portrayal of the tensions clinical staff face and the ways they try to manage them as best they can. There were devastating moments throughout the book. For example, in a South African clinic, staff worried that they would need permission before switching medications for patients whose regimens were failing; because obtaining permission can take time, they feared that some patients might die before the change was authorized (Chapter 4). Patients could be exposed to thousands of dollars in unexpected costs—costs that were deemed acceptable as long as the IRB consent form had been signed (Chapter 7). Mothers living with HIV, intensely instructed in how to prevent transmission, may wean infants too early, putting them at risk of other illnesses and even death (Chapter 7). Yet staff were also resourceful. For instance, some clinics designed observational studies as a means of securing drug supplies for their patients, keeping them in the clinic and thus eligible for future projects. Otherwise, leaving a study could mean losing access to lifesaving medication or relying on regimens that might be ineffective or cause harmful side effects (Chapter 7).
Perhaps an inevitable trade-off in a book of this scope is a loss of some ethnographic depth. Ethnographic observation is the foundation of the project, and, as Heimer notes, questions about how rules matter “can be answered only with detailed ethnographic observation” (p. 24). But in presenting this material to readers, the activities of the clinics were sometimes summarized. Although the book includes examples and quotes, richer, more textured descriptions of the clinics, their staff, and their everyday practices and lives would bring these settings more vividly to life and offer a fuller sense of staff members’ perspectives. Readers familiar with the global HIV field may be able to picture these environments, but those outside the field might benefit from additional ethnographic detail to understand what these clinics are like.
The book also left me thinking about the analytical difference between rules and the accumulation of rules. Chapter Three offers a fascinating analysis of the “mushroom cloud” of rules, as one of Heimer’s interlocutors described it. Clinical guidelines, fiscal requirements for publicly funded programs, insurance regulations, directives from compliance bureaucracies such as the FDA, university IRBs, and Good Clinical Practice standards, along with public pressures, all descend on clinic staff. Clinics face a rapid proliferation of rules as well as the reality that these rules are not always coherent with one another. However, as the subsequent chapters each focus on specific types of rules, like clinical guidelines or research protocols, the “mushroom cloud” starts to feel somewhat diffuse. While it is valuable to examine the particularities of various rules, dividing the analysis in this way can dilute the force of the argument about rule accumulation. Yet it is precisely the interaction—and at times the incoherence—among these various rules, and the ways they shape action, that feels most distinctive about the book. Empirically, it was clear that staff members were frustrated by the array of rules they needed to follow. But, while the book already covers substantial theoretical ground, I felt there was room for Heimer to push the scholarship further. What kinds of dilemmas does this “mushroom cloud” of rules create that differ from those we already associate with evidence-based medicine or with clinical research considered on its own? Is the difference a matter of scale—that is, more rules to follow—or is there something analytically distinct about the “mushroom cloud”?
All in all, Heimer’s book is an important contribution to global health research. Her critique of legalization extends beyond HIV clinics to any arena where rules are continually added but seldom removed. While the book is powerful as a whole, it will also be of particular interest to readers focused on evidence-based medicine, clinical research protocols, and other domains where rules accumulate and shape everyday practice.