Carol A. Heimer is a Research Professor at the American Bar Foundation and a Professor of Sociology Emerita at Northwestern University, where she taught courses in law, medicine, and qualitative research methods in sociology. Heimer’s forthcoming book, Governing the Global Clinic: HIV and the Legal Transformation of Medicine (University of Chicago Press), is a comparative study of the “legalization” of American medicine and the broad impact on the role of law in medicine, drawing on ethnographic fieldwork in HIV/AIDS clinics in the United States, Uganda, South Africa, and Thailand.

Q: You’ve been studying law and medicine through a sociological lens throughout your career. What led you to the study of HIV /AIDS clinics?

Broadly, my research focuses on the relationship between laws and rules, on the one hand, and obligations and responsibilities, on the other. It asks how people react to incentive systems and contractual arrangements, including situations in which they may feel that laws and other kinds of rules do not align with their moral compasses. Previously, I did research in infant intensive care units, where it was sometimes difficult to bring rules and moral compasses into alignment both because doctors were often working on the cutting edge of medicine and parents were confronting a situation where the usual norms of parenting didn’t fit well. While I was doing fieldwork in infant intensive care units, I also discovered that the medical professionals could not possibly keep up with all the regulations, guidelines, and policies they were expected to follow. This led me to think about what this infusion of rules and legalistic ways of working meant for the medical world.

I came to believe that a study of HIV treatment and research in clinics located both in the U.S. and other countries would allow me to learn about this infusion of legalistic thinking into the world of healthcare. HIV is often seen as a global disease, with attempts to manage the epidemic collectively. That has led to both money and medical practices coming from the Global North, and particularly from the United States, into clinics all around the world. With that funding comes a plethora of rules and regulations, which may not align with preexisting regulations, the local medical culture, or the reality of practicing medicine on the ground for clinics in the Global South.

Q: How did you select the clinics you studied, and what factors distinguished them from one another?

There are key differences among counties in the gender and age of people infected with HIV and how they became infected. That has substantial effects on the work of HIV prevention, treatment, and research. Further, variability of wealth between countries is a key difference, since it affects resources available to both clinics and patients and is also correlated with the robustness of a country’s pharmaceutical industry.

My research team and I chose two clinics in the United States, a rich country with a vigorous pharmaceutical industry. At the time, American patients were mostly either gay men or IV drug users. In one clinic, patients were mostly insured, while the second clinic’s patients were largely uninsured. This allowed us to see the effect of variations in access to healthcare in the U.S.

In the other three countries—Thailand, South Africa, and Uganda—the epidemic was not confined to any particular group. Thailand has a strong pharmaceutical industry and was able to produce an inexpensive combination drug for treating HIV. South Africa was able to produce some drugs domestically, but Uganda does not have a strong pharmaceutical industry and had to rely on imported drugs.

Another key difference had to do with government willingness to recognize the disease. Uganda quickly acknowledged the disease and began putting programs in place. Thai officials assumed that sex workers were the main spreaders and attempted to prevent the spread of the disease with a “100% condom” policy. South Africa’s early denialism meant that the disease spread rapidly, even during a period when effective treatments were available. Tragically, many babies were born already infected with HIV because the government refused to create a program to prevent mother-to-child transmission.

Q: These clinics have vastly different patients and clinic conditions. Did this affect the type of rules and regulations that each clinic had to work with?

Clinical guidelines for HIV are basically complicated “recipes” to guide diagnosis and treatment, depending on the particular characteristics of the patients. For example, guidelines help clinicians decide what they should do if patients have other diseases in addition to HIV and outline the differences in how to treat children, women, and pregnant women, versus adult men, the group for whom guidelines were first written.

The clinicians in the U.S. clinic that had mostly insured patients were not constrained by the guidelines in the same way as the physicians in other clinics. Although clinics depended on insurance, insurers generally did not insist that they adhere to one specific set of guidelines. This, coupled with the relatively lush funding, meant that clinicians had more leeway to craft care plans that worked best for each individual HIV patient.

This was not the case with any other clinic my research team studied. All of the other clinics faced more severe resource constraints and relied more heavily on external funding, whether from an international organization or their government. That funding generally required clinicians to follow a specific set of clinical guidelines or at least to have very clear local rules about how they were practicing.

In addition, the clinicians in South Africa, Uganda, and Thailand faced considerable skepticism about the quality of their work both as clinicians and as researchers. Many clinic workers felt that outsiders didn’t appreciate the complexity of the local situation and failed to understand all of the adjustments that were required in resource-constrained settings. In some cases, clinic workers needed additional training to learn the international conventions on how to do clinical research. In other cases, clinic workers spent enormous amounts of time writing even more guidelines and standard operating procedures both to guide their work and to make their work more understandable to outsiders.

Q: Are these clinical guidelines enforced by law?

Clinic staff work with a wide array of guidelines, research protocols, regulations, standard operating procedures, and so forth, making for a complex and variable relationship between these rules and formal law. In some instances, physicians and other clinic workers can be held legally accountable for failures to comply with guidelines. More often, though, clinic workers are disciplined by entities that fund treatment or research, by monitors and site visitors, by professional peers, and occasionally by formal investigations. Uncertainty about the legal status of rules is one of the unfortunate by-products of this legalized system. Instead of improving care, the rules sometimes create confusion and even delay the provision of care.

For example, in one South African clinic, the government-funded first-line treatment regimen included the antiretroviral drug d4T. The drug posed a risk of lactic acidosis, a potentially fatal side effect. Program rules required clinicians to seek authorization from the government before suspending the administration of d4T to the patient. Concerned that patients who develop lactic acidosis could die while waiting for permission to modify their treatment, and worried about the consequences of deviating from the strict regulations without permission, the clinicians debated whether to participate in the program, even though they desperately needed the funding and access to drugs. Ultimately, the government interpreted the rule more leniently and the clinic decided to participate.

Another South African case illustrates what can happen when clinical guidelines are adopted as official policy. The South African government program to reduce transmission of HIV from pregnant women to their babies mandated the use of a basic, inexpensive regimen even though a considerably more effective, somewhat more expensive, regimen was available. One doctor in rural South Africa raised money privately to give HIV-infected mothers the better treatment. He got into trouble with provincial government officials for not following the national guidelines. Ultimately provincial authorities dropped the case, but it nevertheless had a chilling effect for clinicians across the country.

Q: Are there any benefits to the “legalization” of medicine in the HIV crisis?

In special circumstances, this legalization of medicine has prodded people to think more broadly about what we owe each other as human beings.

An example of this occurred during the ethics review of a proposed clinical trial in Uganda, jointly supported by the U.S. This particular clinical trial was for an antiretroviral therapy and the Ugandan research subjects were eager to participate. The Ugandan institutional review board (IRB) gave approval for the study, but the American IRB was not satisfied that the project was ethical, noting that if the study was being done in the U.S., the pharmaceutical company would make the treatment available to research participants for longer than the period they had agreed to in Uganda. The American IRB put considerable pressure on the drug company, and it eventually offered a more generous arrangement to the Ugandan research participants. This was clearly a win driven by the legalism of clinical research.

The second example is about the “treatment contracts” that are common especially in poorer countries. At the end of pre-treatment classes, patients are asked to sign contracts promising to faithfully take the HIV drugs for life. But these were one-sided contracts—no one was promising to make the medications available to these patients. To gain access to drugs for their patients, clinicians began creating treatment programs and post-clinical-trial studies to track how the disease progressed over time. Both of these vehicles for garnering funds for treatment show an enlarged sense of what clinics owed their patients, in part created by the legalism of contemporary HIV research and treatment.

Q: What changes would you like to see in the global regulation of these HIV clinics?

Global regulations need to show more respect for variations across countries. Global North countries like the U.S. need to be less heavy-handed about imposing their rules on other places. This is not a new problem and has been discussed extensively by entities like the World Medical Association.

I think the solution to a lot of the dilemmas I saw in my research is to invest much more heavily in raising the standard of healthcare that’s available around the world. Rather than simply focusing on finding drugs that are safe and effective and worrying about narrowly defined rights to parity in research programs, more attention needs to be given to creating broader programs for basic public health. Think about what it would mean if there was less of a gap between treatment received by people in rich and poor countries. Under those conditions, there would be no debate about whether research projects should give control group members in poor countries the same thing that would be given to control group members in rich countries.

What we’ve seen with the COVID-19 pandemic is a good example of this need for strong public health programs. We have failed to recognize that part of the reason diseases continue to spread around the world is because of inequalities in both basic life conditions and healthcare. We also have to move beyond our pattern of responding only to medical emergencies. It’s grimly amusing that a scoring system evaluating the preparedness for pandemics gave the U.S. a high rating, suggesting that the U.S. was well-equipped to deal with health emergencies. Yet when COVID-19 arrived, we did not respond very effectively. That suggests that there were a lot of things that we still don’t take into account when it comes to identifying, studying, and treating epidemics like HIV/AIDS and COVID-19.

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