Misoprostol: The Social Life of a Life-saving Drug in Global Maternal Health

Introduction

This paper is about a drug called misoprostol and its controversial clinical and social life. Although originally developed as a prevention for gastric ulcers, misoprostol is a uterotonic —it causes the cervix to ripen and the uterus to contract—and in the 1980s, it developed an off-label reputation as an abortifacient. Misoprostol has other off-label uses in reproductive medicine—for induction of labor and for the treatment of postpartum hemorrhage (PPH), for example—but it is the drug’s association with off-label, clandestine abortion that has most profoundly shaped its social life as a marginal character, a pharmaceutical outlaw, in the realm of reproductive medicine and global maternal health over the past 30 years. The concern with misoprostol’s abortifacient properties, however, is only part of the story; the social life of the drug has also been shaped by the question of what I call authoritative practice, that is, the question of who is allowed to deliver medicine. Both issues are about the specters of misuse of misoprostol: off-label, illegal, immoral, or by unlicensed providers. These specters of misuse have shaped the life of misoprostol in terms of scientific experimentation, product approval and regulation, circulation, and clinical practice.

I begin the story of misoprostol as it appears in reproductive medicine in North America and Europe and follow the drug in and out of the shadows of illicit use to the realm of global maternal health where its potential to reduce maternal mortality in low resource settings is being tested and debated. I take a “social lives of medicine” approach in which it is understood that “[t]here is no pure (pharmaceutical) object that precedes its socialization and interpretation” (Hardon and Sanabria 2017, 118; see also Cohen et al. 2001; van der Geest and Whyte 1989; Whyte, van der Geest, and Hardon 2002). Medicines are made meaningful and “socially efficacious” in laboratories, regulatory regimes, and clinical settings as well as out in the world at large. The meanings and uses ascribed to them are mutable as social norms and political agendas change toward particular illnesses and bodily states—as in the case of lay experts and patient groups advocating for changes to testing and access (Epstein 1995). Medicines are also frequently remade and rescripted in the hands and bodies of users in a process called domestication (Childerhose and MacDonald 2013).

In this paper, I focus my ethnographic attention on the social lives of misoprostol in the realm of global health where two women’s health nongovernmental organizations (NGOs) have been working to legitimize the drug for reproductive indications through clinical testing and advocacy. Their efforts have centered on misoprostol for the prevention and treatment of PPH—the leading cause of maternal death worldwide (Say et al. 2014)—and for safe medical abortion, unsafe abortion being another major cause of maternal mortality (Haddad and Nour 2009). The second ethnographic section of this paper unfolds in Senegal where one of these NGOs has completed clinical trials on misoprostol and is working with the national government to introduce it into the formal health-care system. The final moment in the social life of misoprostol that I attend to in this paper takes place on the scientific program of the International Confederation of Midwives Congress in Toronto in summer 2017 on a panel about innovations in reproductive health technologies designed for low resource settings.

There are two main contributions of this paper. First, I argue that these two women’s health NGOs have reshaped the social life of misoprostol by engaging in a form of pharmaceutical activism—a term that social science scholars have used to describe challenges to the status quo arrangements of the testing, regulation, circulation, and use of pharmaceuticals (Beihl 2004, 2007; Epstein 1995). My research participants, however, were uncomfortable framing their work as activism and so I sought a more particular way of understanding their work. The notion of protocol feminism (Murphy 2012), with its ties to the early days of the women’s health movement in which the domestic sphere was staged as a generative space for experimentation and solidarity, more fittingly describes the ways that misoprostol is being reassembled as accessible, routinizable, and do-able for women’s reproductive health. As informally developed protocols for self-induced abortion began to travel (more on this below) and the drug was caught up in political and regulatory debates, these NGOs sought to formalize knowledge and standardize protocols though scientific research in order to increase access to and confidence in this potentially life-saving drug. Though other actors including other agencies and commercial interests played a role in the movement of misoprostol from outlaw status to the near mainstream, I have focussed here on the significant contributions of these two NGOs in order to highlight their unique contributions.

The second argument is that the social life of misoprostol has been shaped by the specter of unauthorized medical practice as much as by its association with abortion. To elaborate, I introduce the concept of authoritative practice. Inspired by anthropologist Brigitte Jordan’s (1984) idea of “authoritative knowledge,” which means the knowledge that gets to count, the knowledge upon which decisions can be made (Davis-Floyd and Sargent 1996), the idea of authoritative practice is about the health provider who gets to count, who is authorized socially and by regulatory bodies to make clinical decisions, and who is entrusted with the knowledge and use of biomedical devices and drugs. The location of treatment and care is also an arbiter of authoritative practices, as we shall see in this story. I will also draw on the notion of “networks of expertise,” which questions to whom expertise—fundamental to authoritative knowledge and practice—belongs (Eyal 2013).

A Brief Note on Research Methods

This research on misoprostol grew out of a larger research project tracing the logic and practices of the global campaigns to reduce maternal mortality since the 1980s. For more than a decade I’ve been conducting ethnographic fieldwork and interviews within the global maternal health advocacy community comprising governmental organizations, NGOs, United Nations (UN) agencies, and private foundations, as well as celebrity activists and spokespersons, world leaders, scientists and researchers, and pharmaceutical industry representatives. Following the social life of misoprostol involved covering much ethnographic ground, I have conducted more than thirty semi-structured, open-ended interviews; of these, eight were focused specifically on the topic of misoprostol, and in many others, it was one issue among many that were discussed. I also networked and gathered data online, joined webinar events as a participant observer, and followed twitter feeds, blogs, and listservs of global maternal health advocacy groups. This period of multi-sited fieldwork at global conferences and NGO sites extends from the mid-2000s until the present. Since 2016, I have also made a series of extended trips to Senegal living and conducting research in Dakar and rural regions of the country from January to June 2016, May to June 2017, and May 2018.

Misoprostol: A History of Controversy

Misoprostol was originally developed for the prevention of gastric ulcers by the Swiss pharmaceutical company Searle (now Pfizer) and marketed under the brand name Cytotec. In the 1980s, Cytotec developed an off-label reputation as a uterotonic, a drug that stimulates the cervix to ripen and the uterus to contract. Thus, it has clinical uses in reproductive medicine for the induction of labor, prevention and treatment of PPH, medical abortion, and postabortion care. In the 1990s, Searle’s patent for Cytotec expired and was not renewed—most likely because of the off-label, black market association with abortion (Chong, Su, and Arulkumaran 2004; Weeks, Fiala, and Safan 2005). ¹ Yet Cytotec remained available and was in common enough off-label usage among physicians in the United States that in 1999 the American College of Obstetricians and Gynecologists (1999a, 1999b) released an opinion and a practice bulletin endorsing the drug and educating its members about its uses for induction of labor. In response, Searle issued a letter strongly advising against the use of Cytotec by pregnant women due to its abortive properties and reminding physicians that the company had not conducted testing with respect to its reproductive indications (Cullen 2000). ² Consequently, its use began to be restricted in many hospitals and pharmacies.

Cytotec continued to be marketed for its original purpose and several generic brands of misoprostol subsequently emerged ³ —though without retesting and relabeling for uses in reproductive medicine. In many jurisdictions where safe and/or legal abortion is unavailable or inaccessible, misoprostol now exists in a sort of gray market where the drug is legal and available for its original indication and may be used off-label in hospital by obstetricians (though not for medical abortion). Where the sale of misoprostol has been severely restricted or suspended by health authorities over concerns about “misuse”—in Brazil, Chile, and Mexico, for example—it can be acquired on the black market for highly inflated prices (de Zordo 2016; Drabo 2019). ⁴ Even in jurisdictions where abortion is legal and relatively accessible, the drug is still dogged by controversy. In Canada, for example, misoprostol when taken in sequence with mifepristone (known as “the abortion pill” RU486) is marketed under the brand name mifegymiso, is legally available by prescription for treatment of incomplete miscarriage, and yet some physicians have refused to prescribe it and some pharmacists have refused to dispense it (Vogel 2017). This history of controversy has hobbled misoprostol’s move into the realm of global health where it holds the potential to reduce maternal mortality in remote and low resource settings. This is the story to which I now turn.

Misoprostol in Global Maternal Health

Maternal mortality is defined as the death of a woman from pregnancy related causes and up to forty-two days postpartum. A key indicator used in global health, the maternal mortality ratio (MMR) is calculated by the number of deaths per 100,000 live births. In Europe and North America, the MMR ranges between three and ten, while in sub-Saharan Africa, it is often in the hundreds, and in a few nations or regions within nations, it may be in the thousands. In the 1980s, an estimated 500,000 women around the world died each year in pregnancy, childbirth, and the postpartum period, the vast majority of them in the developing world. With little awareness, funding, or political will to address the problem, maternal mortality was dubbed “the neglected tragedy” (Rosenfield and Maine 1985). The Safe Motherhood Initiative (SMI), launched in 1987 by the World Health Organization (WHO), the World Bank, and the United Nations Population Fund, was the first global effort to tackle the problem. The Initiative challenged all nations of the world to reduce maternal deaths by half by the year 2000 and developed policy and practical guidelines to help them meet this goal. In the first decade of the SMI, thousands of projects were implemented around the world, and research conducted during this time began to generate a better understanding of factors contributing to maternal mortality in low resource settings. Researchers identified a set of “direct” obstetrical causes of maternal death including hemorrhage, sepsis, obstructed labor, unsafe abortion, and convulsive disorders of pregnancy, and a set of “indirect causes” including poverty, remote locations, gender discrimination, “harmful cultural beliefs and practices,” lack of transport, poor health, and nutritional status (De Brouwere and Van Lerberghe 2001). One of the key models for understanding maternal death was also developed around this time, the model of the three delays: delay in the decision to seek care, delay in accessing care, and delay in the provision of care (Thaddeus and Maine 1994).

A significant detail about the SMI for understanding the social lives of misoprostol is that it was forged at a particular moment in the history of global health policy when traditional birth attendants (TBAs) were promoted as part of the solution to reducing maternal death. The formal incorporation of TBAs into global maternal health policy, however, was short-lived, and within a decade, they were sidelined in a policy shift toward the prioritization of skilled attendants—nurses, midwives, and physicians. This policy shift and the debates that emerged around it reveal a deep ambivalence toward TBAs at the highest levels of policy and research. Indeed, what I call the TBA question has been one of the core policy debates in global maternal health (MacDonald forthcoming; see also Storeng 2010; Lane and Garrod 2016). It comes to figure significantly in the life story of misoprostol when decades later the proposal is made that misoprostol be administered by community-level health workers. I will elaborate this debate when I present the ethnographic data in the sections below, but I flag it here as a salient piece of the policy context; like the specter of misuse for abortion, the specter of misuse by unauthorized providers shapes the current misoprostol debate.

Anthropologist Peter Redfield (2013) has described humanitarian action as a moral response to the retreat of politics. I argue here that misoprostol has been lingering in an abandoned space created by the retreat of the pharmaceutical industry, science as usual, and the hegemony of biomedicine over authoritative knowledge and practice. Although misoprostol was turning out to be a safe, affordable, portable, effective drug with the potential to prevent and treat life-threatening events, its history of off-label use for abortion (literally unscripted), and its proposed administration by TBA-like community health workers considered too untrustworthy or untrained to use it correctly, was hobbling its uptake. Into this abandoned (and potentially deadly) space stepped two unique reproductive health NGOs in the global north: Options for Reproductive Health (ORH) and Global Gender Technologies (Gender Tech; both are pseudonyms). In the remainder of this paper, I describe the work of these two NGOs with misoprostol and then move on to describe the work of ORH on misoprostol in Senegal.

Making the Case with Science

ORH is a research NGO whose mission is to develop new biomedical products for maternal health in low resource settings and for underserved groups around the world. They believe that reproductive health technologies and high-quality reproductive health services should be available at low cost to women everywhere in the world in the name of dignity and autonomy. What they do is a good example of what historian Michelle Murphy (2012) calls “doing feminist techno-science differently”—a phrase that she initially developed to describe the activities of feminist self-help movements in the 1970s in North America. Doing technoscience differently means that rather than rejecting science and biomedicine for the ways they have not served and often harmed women, feminist technoscience and biomedicine happen either outside the system, away from mainstream politics, corporate interests, and sexist scientific thinking, or inside the system but in a different way. In the case of misoprostol, ORH and Gender Tech are operating within the system of normative scientific practice, but posing scientific questions that few seemed to want to ask, and they are using evidence to formally rewrite the “technology script” of a drug that few seemed to want to touch (Akrich 1992).

ORH got its start with private funding during the era of “the global gag rule,” the notorious US government policy that prohibits any organization, domestic or foreign, receiving US government funds to support activities that provide information, referrals, or clinical services for legal abortion or postabortion care—even in jurisdictions where it is legal. Officially called the Mexico City Policy, the global gag rule has been in and out of favor with American Presidents since the 1980s when it was first signed by Ronald Reagan. George Bush, Sr., continued it. Bill Clinton rescinded it. George Bush, Jr., reinstated it. Barack Obama rescinded it. On January 23, 2017, Donald Trump made reinstating the global gag rule one of the first executive orders of his presidency.

ORH develops and tests an array of products, bringing them from concept to implementation. In addition to their work on misoprostol, for example, they are working on a simple urine blot test for preeclampsia, (a convulsive disorder of pregnancy), a spring infusion pump for administering intravenous (IV) fluids when there is no electricity, and a device to administer the correct dosage of magnesium sulphate for the treatment of preeclampsia. ORH does technical writing and translation to accompany their products in different linguistic and cultural settings. They disseminate their work in medical journals, at technical meetings, in the media, and online.

ORH has been working for many years on the clinical testing of misoprostol, partnering with local physicians and researchers in low resource countries, producing knowledge about proper dosage, administration, and efficacy for a limited range of indications in reproductive medicine, mostly targeting PPH. Their work goes beyond clinical testing, which in many ways is only the first step of their larger mission. They typically conduct advocacy with Ministries of Health in the countries in which they work. They then bring their evidence to global-level policy bodies. They consider one of their major accomplishments to be getting misoprostol included on the WHO Essential Medicines List (EML), first for the treatment of incomplete abortion or miscarriage (with mifepristone) in 2010, then for the prevention of PPH in 2012, and then for the treatment of PPH in 2015. The EML is a powerful tool of legitimacy and information for both nations and organizations operating internationally because it is the WHO expert recommendation about safe, effective, and affordable medicines that every nation should have on hand. ⁵ The Executive Director of ORH described to me the process.

We figured out we could do it. We used to think only pharmaceutical companies could do it, but we found the application form buried on the WHO website and so we applied [to have misoprostol listed as an essential medicine]…. The push back from WHO is always “we need more data”—that’s their mantra. So we were like, OK we will get more data! So that’s what we are doing.

Gender Tech began with a similar vision and mandate: to bring low-cost technologies, including drugs, devices, and new interventions, to developing countries with a high burden of disease. It is a university-affiliated organization that conducts clinical trials, disseminates findings in scientific journals and at conferences, and works with foreign governments to train staff and offer technical assistance for the applications they develop. They also focus on the national-level registration of drugs and devices—a process required before any pharmaceutical product can be legally imported and marketed. Gender Tech began to focus on misoprostol, due to the controversy around it, not in spite of it. As the Medical Director explained to me, there were two aspects of the status quo marginalization of misoprostol to which she objected. One, she viewed the failure to pursue scientifically the full potential of the drug in global maternal health as discrimination against women in low resource countries, especially those who delivered at home.

We realized there was absolutely nothing [to prevent or treat PPH] for women who delivered at home. The health systems interventions proposed by WHO did not address women who delivered at home. We wanted to address the inequity for those women.

Her second objection and professional call to arms for research on misoprostol was that the drug had been made guilty by association; the drug’s patent had expired with no attempt to retest for reproductive indications, it was being avoided by providers afraid of litigation and accusations of misuse, and was considered too hot to handle in countries with legal restrictions on access to abortion or that received United States Agency for International Development (USAID) funds restricted by the Mexico City Policy. The Medical Director of Gender Tech found medically unethical the marginalization of a safe, effective drug for life-threatening PPH because of its association with abortion. She told me a story about an event organized by her NGO, in one of the countries in which they conduct research, to share the results of their latest clinical trial on the use of misoprostol for “incomplete abortion,” which includes spontaneous miscarriage. They invited local physicians, nurses, midwives, and some NGO reps to come to the hospital for the event. As the regrets rolled in, the story came out that many invitees had received e-mails from their US funder telling them they could not attend the event because it was perceived to be about abortion—a violation of the “global gag rule.” It must be pointed out that even in countries where abortion is severely restricted by law, postabortion care is not unlawful because it is often impossible to distinguish between spontaneous miscarriage and induced abortion and also because of the ethical duty of physicians and nurses (and the state) to offer medical care to the sick.

Using the language of inequity and ethics and appealing to the value of scientific inquiry and evidence, these two organizations forged scientific research programs that filled the void of clinical evidence and explicitly engaged the social norms and regulatory regimes of evidence and expertise that had thus far shaped the potential for misoprostol to play a role in global maternal health, transforming its outlaw status into one of legitimacy. Seen through the lens of feminist science and technology studies (STS) theory, ORH and Gender Tech created an evidence based clinical protocol with practical value that at the same time bore within it a critique of the politics of reproductive health science and medicine, in other words, a feminist protocol (Murphy 2012, 33). In the next section, I follow misoprostol into the clinical and policy space of Senegal.

Misoprostol in Senegal

Although Senegal has made progress in reducing maternal deaths since 1990 (down from about 520 deaths per 100,000 live births to 315 in 2015), the problem persists, especially in rural areas (Agence Nationale de la Statistique et de la Démographie 2017; Kassebaum et al. 2015; WHO 2015). Poverty and weak transportation and health infrastructure in many regions of the country mean that 50 percent of women give birth at home or at a simple structure called a Case de Santé (health hut) attended by a matrone (a community health worker who has received training in maternity care and liaises with local state trained midwives and nurses). ORH began its work in Senegal in the mid-2000s by first approaching the Ministry of Health and Social Action (MOHSA) to get permission and find local partners to conduct clinical trials on misoprostol. Their request was initially met with skepticism. At that time, the WHO had yet to list misoprostol on the EML, and the evidence base was small. The evidence base for the use of the drug in Senegal specifically was nonexistent. With persistence on the part of an ORH Research Associate, they were eventually given permission to run two small studies. The first compared misoprostol to manual vacuum extraction in postabortion care (standard protocol at the time in Senegal), a relatively invasive procedure done in hospital by skilled professionals with anesthesia. This study took place in hospital where there was already both research capacity and infrastructure. Even though abortion is illegal in Senegal, postabortion care has been in place since the 1990s (Suh 2006, 2015). As a member of the ORH research team explained to me:

We have done that study in several other countries. We weren’t doing it so much for the result of the study…but we did it because it would demonstrate to Senegal that, yes, misoprostol is as effective as the standard of care and can be used. And that happens often. Every country kind of wants their own experience, and their women are different, and their doctors are different, etcetera. So we weren’t surprised to find that misoprostol was very effective.

ORH’s goal with these two studies was to “make the case with evidence” to influential Senegalese scientists, physicians, policy makers, and lawmakers. The study found that misoprostol was clinically safe and effective for these two indications, and further that in the case of the prevention of PPH, matrones were capable of correctly administering the drug, managing the side effects, and referring to higher-level facilities when necessary (Diop et al. 2016). As a result of these studies, the MOHSA in Senegal rewrote its National Norms and Protocols for the prevention and management of PPH—a move that opened the way for misoprostol to be used in the formal health care system including at the community level (MOHSA 2015).

Who Can Deliver Medicine?

Even if misoprostol could be decoupled from its association with clandestine abortion, and even as evidence is mounting that shows it to be safe and effective to prevent and treat PPH, and to manage postabortion care, the prospect of including community-level providers in the administration of the drug has been a significant barrier. Understanding the resistance to incorporating TBAs in twenty-first-century global maternal health requires a bit of history. In the first section of this article, I flagged a pivotal moment in global maternal health policy when support for the training and integration of TBAs in safe motherhood projects was cut in the late 1990s in favor of the goal of having a skilled attendant at every birth. A closer look at the rationale for this policy shift and the debates around it reveals a deep ambivalence among policy makers at the highest level toward the idea of extending authoritative knowledge and practice to community birth attendants.

The TBA was defined in the WHO literature in the 1970s as “a person (usually a woman) who assists the mother at birth, and who initially acquired her skills delivering babies by herself, or by working with other TBAs” (Verderese and Turnbull 1975, 18; WHO 1992). Although UNICEF and various national health ministries had previously been training TBAs, the SMI in 1987 was the first global initiative to make it a key component. Prior to that time, the focus of international health efforts had been on transforming health systems in low resource settings to resemble biomedical institutions of the west (Foster 1999). The SMI approach, in contrast, acknowledged that not all women could or would present to health facilities to give birth and that many nations were limited in their abilities to provide well-staffed, well-stocked facilities. Incorporating TBAs was envisioned as a way of bridging that gap in a practical and low-cost way. It was also in keeping with the Primary Health Care model of international health, which envisioned decentralized health-care services that could reach more people, in part by recognizing the importance of local knowledge and valorizing the participation of local practitioners (WHO 1978a; Tinker and Koblinsky 1993, 15).

A decade later, however—when it appeared that the SMI had made little progress in measurably reducing maternal deaths or generating political will—the TBA component was deemed a failure and sidelined in favor of a renewed push for facility-based births with skilled attendants (SMI [IAG] Group 2002; WHO 2004). A high-level technical consultation in 1997 had come to the conclusion that TBAs had proven ineffective in reducing rates of maternal mortality (in part due to their illiteracy and inability to learn or accept scientific knowledge) and that training them was a waste of time and resources (Starrs 1998, 30). It was acknowledged in that technical report and other commentaries around that time that TBAs could not have hoped to make a dent in the MMR alone, but the analysts and architects of the new policy did not recommend the building of enabling environments to help them function (Bergstrom and Goodburn 2001). Rather, the focus turned to the promotion of skilled attendance at birth: “A skilled birth attendant can be a midwife, a nurse with additional midwifery education, or a physician with appropriate training and experience, but does not include traditional birth attendants” (Starrs 1998, 29; see also the SMI [IAG] Group 2002).

Although the evidence and rationale was a matter of some debate, in the years following this policy shift, a narrative of failure, disappointment, and lessons learnt solidified in global health policy documents. ⁷ For example, in the 2005 World Health Report, in a shaded box entitled “Traditional birth attendants: another disappointment,” the authors state: “The strategy is now increasingly seen as a failure. It will have taken more than 20 years to realize this and the money spent would perhaps in the end have been better used to train professional midwives” (WHO 2005, 70).

Given this history of the TBA question in global maternal health, it is not surprising that the proposal that these community health workers be trained and authorized to administer misoprostol for PPH in low resource settings was met with deep skepticism. While there is no doubt that well-staffed and well-stocked facilities, and access to emergency obstetrical services, are essential components of quality maternity care everywhere, the fact remains that many women around the world continue to give birth in their communities and face major obstacles of geography, time, money and nonprioritization of their care in getting to higher-level facilities. For ORH and Gender Tech, access to care for women who cannot or choose not to give birth in facilities is an ethical imperative that misoprostol can help to realize. Decoupling misoprostol from abortion is the first step in expanding the reach of misoprostol as an essential medicine. Extending some degree of authoritative knowledge and practice to community-level providers and even to women themselves is the next.

I return here to the notion of authoritative practice, building on anthropologist Brigitte Jordan’s (1984) idea of “authoritative knowledge” to refer to the health-care provider who gets to count, who is authorized to make decisions, who can be entrusted with the knowledge and the use of biomedical technologies, including drugs. Jordan first developed this notion based on her ethnographic fieldwork with Mexican parteras (traditional midwives), and so it has special relevance here for discussing the TBA question in global maternal health. She argued that knowledge becomes authoritative either because it is efficacious, that is, it better explains the phenomenon at hand for the purposes at hand or because it is associated already with some form of structural authority or both (Jordan 1984, 152). In Jordan’s model, authoritative knowledge in biomedicine is both given and achieved, but even its given-ness must be produced and maintained through exclusionary norms and practices (Hahn and Kleinman 1983). Authoritative practice is likewise a status that is only partly about the efficacy of the skills and tools it claims. Thus, the challenge for ORH and Gender Tech has been not only about accumulating evidence of misoprostol’s biochemical efficacy in the body but also challenging the authority to determine who can deliver biomedicine.

Gil Eyal’s (2013) “sociology of expertise” approach is a helpful analytical tool here because it approaches expertise not as something that is the exclusive domain of the professions, but rather, drawing on Abbott’s (1988) model of expertise as a set of tasks and tools to get a job done, as an assemblage, an actor network, a dispositif. Eyal’s empirical work demonstrates how knowledge and expertise often travel back and forth across patient, lay, and formal expert lines, but to become legitimate, they ultimately must be transcribed into standardized forms sanctioned by formal experts and their governing bodies. The networks of expertise in which misoprostol circulates are multiple. First is the original clandestine network of women in Latin America within which knowledge of the drug began to circulate. Notably, this network relied on a certain invisibility and secrecy in order to access misoprostol as a commodity and to draw on its biochemical properties while circumventing biomedicine and the law (van der Geest and Whyte 1989). As knowledge about the drug traveled and Gender Tech and ORH began their work, the network crossed back over formal lines of expertise to encompass scientific, regulatory, and policy actors during the testing and approval of misoprostol for reproductive indications. The network changed shape and composition again as Gender Tech and ORH began to disseminate standard protocols for the use of misoprostol for self-induced abortion and PPH in multiple languages on multiple online platforms. Finally, testing the ability of community-level birth attendants to administer misoprostol for PPH again expands this network of expertise, proposing a nonprofessional provider authorized and effective in the delivery of biomedicine. One caveat in all this is that despite the accumulation of evidence, protocols, and policies adopted at the highest levels, women in jurisdictions with restrictive abortion laws have not changed the basic networks by which they gain access to the drug and information on how to use it.

With a final brief story, I track the social life of misoprostol to the Congress of the International Confederation of Midwives in Toronto in summer 2017 at which a scientific panel convened to disseminate research on new portable reproductive health technologies. Among them were misoprostol for PPH and incomplete miscarriage, a uterine tamponade for the treatment of PPH, an absorbent mat for measuring blood loss during labor, and a multilevel pregnancy test to document when a pregnancy is no longer evolving. While there is nothing surprising about the time, effort, and hope invested in new medical technologies to address global health problems—indeed innovation and entrepreneurialism are high on the global health agenda—what is new is the intended locations and providers for many new scientific interventions. A new cadre of researchers and developers are developing medical technologies for homes and community health posts staffed by community health workers. As one panelist argued “We need to start shifting the conversation to not just about moving women closer to health facilities but also moving technologies from higher levels to lower levels.” For women in low resource countries with hard to access and/or understaffed and underresourced facilities, staying home may sometimes be the most rational option. My point in including this final story is to illustrate something of the broader milieu of misoprostol within what has been called the “innovative turn” in global health (Scott-Smith 2016), which reimagines new sites and new combinations of efficacious tools and authoritative providers.

Conclusion

Pharmaceutical activism has been described as a process in which the usual coconspirators of pharmaceutical products and circuits—markets, research, infrastructures, policy bodies, and governments—are disrupted to make room for more equitable and ethical models of health-care delivery. “Here, out of constraint and imagination,” writes anthropologist Joao Beihl, “global market logics and the politics of science and technology are forced into explicitness and become a new and productive field of tension and negotiation” (2004, 117). In this paper, I have presented the work of Gender Tech and ORH within this broad analytical frame of pharmaceutical activism while offering further precision, by way of Michelle Murphy’s notion of protocol feminism and Gil Eyal’s networks of expertise, to think about how knowledge about misoprostol was produced in order to retool and reposition the drug to address two major causes of maternal suffering and death in low resource settings: PPH and unsafe abortion. ⁸

Taking a social lives perspective, in this paper, I have described misoprostol’s multiple lives and overlapping networks of expertise. Latin American women seeking to manage their own reproductive lives domesticated a drug developed for gastric ulcers and rewrote its script for reproductive medicine in their own homes. As this knowledge traveled back into pharmacies, clinics, and hospitals through word of mouth, the drug became entangled with the regulatory regimes and social and legal scripts that govern and organize pharmaceuticals and authorize who can deliver medicine and where. Abortion politics and the question of authoritative practice shadowed both. But then women’s domesticated knowledge and use of misoprostol was drawn back to the clinic, the clinical trial, and the regulatory regimes of pharmacy in moves orchestrated by ORH and Gender Tech as they operationalized their own ethical frames to produce persuasive scientific evidence of its efficacy, safety, and practical advantages. They developed protocols designed to travel, not just through word of mouth but via Internet sites and mobile phones, expanding and diversifying the existing network of expertise already built up around the drug. They also made their case with evidence to policy makers at the highest levels—the WHO, FIGO, and national ministries of health. It is notable that the standardization of misoprostol ensured its improvisational capacity on the ground and its potential to safely and effectively expand into new networks of expertise and engage new users and providers. Thus, this paper contributes to key concerns in science and technology studies as they intersect with critical global health scholarship, medical anthropology, and the anthropology of reproduction, contributing an ethnographic perspective on the clinical social and regulatory lives of a drug.

Although I end my paper here, the social lives of misoprostol continue to unfold. For PPH in clinical spaces misoprostol is now much more mainstreamed, and a growing number of global health experts now agree that community-based distribution of misoprostol for the prevention of PPH is a safe and feasible ethical imperative (Hobday et al. 2018). There is policy momentum as well; both the WHO (2012) and FIGO (2017) continue to update their recommendations and guidelines for the use of misoprostol for the prevention of PPH. The International Confederation of Midwives (ICM) has issued a joint statement with FIGO (ICM 2014). The WHO (2018) also recently promoted medical abortion with misoprostol as a “harm reduction strategy” that can replace risky abortion procedures worldwide. Meanwhile, several studies have documented that self-use of misoprostol obtained directly from pharmacies in jurisdiction where abortion access is socially or legally restricted reduces abortion-related morbidity and mortality because it replaces more harmful methods (Moland et al. 2017, 21; though this has not yet translated into policy recommendations). Although misoprostol as a tool in reproductive health care is no longer such an outlaw, many barriers to access—some formal and some informal, some regulatory and some economic—remain.

Metrics that can capture the impact of these new deployments of misoprostol in terms of reduced rates of maternal mortality will no doubt figure in the growing reach and acceptance of the drug in global maternal health. Those numbers, while critically important, will tell only part of the story (Adams 2016). What other pieces of the storied lives of misoprostol are yet to be told or yet to unfold that will provide further insight and pinpoint sites for further feminist informed study? At this juncture, a number of questions present themselves as salient to explore. For example, as a new generation of activists emerges whose mission is to make evidence-based information on misoprostol for self-induced abortion widely accessible, it will be important to track how they are faring and what are the social and political reverberations of their work in specific locales. For another example, drug traffickers, black market sellers, physicians, pharmacists, generic producers, and Internet pharmacies will continue to play significant roles in the circulation of misoprostol in many jurisdictions; such networks of distribution and profit making have only begun to be mapped and described (Drabo 2019; de Zordo 2016, 30). Finally, the impact of these many lives of misoprostol must continue to be followed into the hands and bodies of women themselves with attention to the varied and particular ways they are used and made meaningful.