Jean-Hervé Bradol and Marc Le Pape

The word “innovation” initially troubled some people at MSF. When we talked to them about innovation, their minds turned to “invention” and thoughts along the lines of inventing a therapeutic drug or diagnostic test. They seemed to doubt that it was possible to attribute such innovations to MSF. Most people think that humanitarian medical intervention is charity medicine using outdated tools—vaccines, diagnostics, and drugs—developed in rich countries that will soon be replaced by a new generation of medical products. Humanitarian medicine is seen as a means of recycling secondhand products for use in precarious situations, not as a source of innovation. Some innovations, though, can even be relevant to resource-rich countries.

Humanitarian medical intervention does often involve simplified treatment protocols, but that does not necessarily mean rudimentary practices. For example, it might mean diagnosing uncomplicated malaria using a rapid test rather than a microscope. Using only a drop of blood on a small test device, rapid tests can confirm or rule out the diagnosis in a few minutes, without a laboratory, and the result can be read with the naked eye by almost anyone. Incorporating the latest advances in immunology, the rapid test is both more sophisticated and simpler to use than the microscope. The innovation in this case has been to implement the new technology systematically across MSF teams. Previously, the lack of a simple test that could be used in precarious situations (large numbers of patients coupled with a shortage of qualified lab personnel) meant treating malaria without laboratory confirmation—in other words, blindly. Unnecessary or inappropriate treatment was therefore administered in proportions that varied depending on the location and epidemiological profile but were sometimes as high as two-thirds of the cases.

Another example of innovation is the fixed-dose combinations that MSF now uses for treating AIDS and malaria. Taking fewer tablets each day improves patient adherence and is part of a successful treatment strategy. Combining several active ingredients into a single tablet, however, is a complex procedure that cannot be improvised: it takes formal research and development to introduce a product with better therapeutic efficacy. These are just two examples of how MSF’s medical practice among populations in precarious situations is not “substandard” medicine; in fact, it employs the latest technology and products (medical and surgical) that comply with standards recommended in developed countries.

This suggests that MSF, in keeping with our initial premise, has indeed participated in the process of innovation, and continues to do so—but to prove it we must examine the evidence without illusory hindsight. We recognize the risk, particularly since some of this book’s authors have been involved with the organization for many years. Clearly, they cannot observe an organization for which they work as consultants and researchers as if it were any other field of study. Moreover, this examination relies primarily on internal sources, documents, and interviews with MSF participants in the medical programs being analyzed. Drafts of each article were sent for critical review to a group of readers that included other fellow contributors and colleagues from different fields (logisticians, pharmacists, doctors, nurses, sociologists, historians, and political scientists) within the organization.

This approach is in keeping with the self-analysis process by which MSF seeks to identify and build upon important experiences to improve its actions. Since the mid-1980s it has focused, in part, on medical issues (Destexhe, 1987; Brauman, 2000).

Such an approach is expected to improve and advance medical practice by learning from experience. It is also a safeguard against the natural tendency to recall past experiences as a kind of exhilarating, heroic, idealized self-history. Self-examination is not intended to highlight positive actions, but quite the reverse. This is no easy process, and obstacles need to be overcome. Even if risks have been recognized and identified, it is tempting to emphasize the positive results of our interventions. Indeed, glorifying institutional history can distort our perception of humanitarian work, and we must stress here that the improvements in the medical management of the five diseases discussed in this book are the fruit of the collective efforts of many actors and institutions. The contributions of local practitioners, researchers, and health care institutions in affected countries are systematically underestimated. For example, how many people know that it was Niger, the world’s poorest country, which developed the international standard for treating epidemic meningitis—not once, but twice, in 1991 and 2005?

Counterexample

In answer to the skepticism about humanitarian medicine’s capacity for innovation, we describe a number of treatment protocols (cholera, meningitis, human African trypanosomiasis—also known as sleeping sickness—malaria, and AIDS) the development of which seemed to us noteworthy, positive, and linked to MSF’s contribution. These infectious diseases represent a significant part of humanitarian medical activity. New epidemics, increasingly frequent resistance to standard treatments, government perception of infectious diseases as threats to security and economic growth, and commercial and political tensions surrounding access to essential drugs explain, in part, the changes in infectious disease policies in recent years. Though there have been notable advances in other areas of medicine used in humanitarian interventions, they are not dealt with here. For example, psychiatry and clinical psychology have become common practice in the field, and a body of expertise has been developed. To take just two examples from surgery, MSF is now treating fractures by osteosynthesis, or internal fixation, and performing maxillofacial reconstruction. Treatment protocols for women who have been raped have been a major development in gynecology. Pharmacy and laboratory activities have also undergone profound transformation, and we have introduced digital medical imaging in the field. Burkitt’s lymphoma was one of the first cancers to have its own treatment protocol for teams in the field.

The five infectious diseases chosen for this book are relative success stories, but this has not always been the case. As a counter-example, we might mention tuberculosis, for which the tests available at our projects fail to establish a diagnosis in half of all cases. The main diagnostic method—looking for bacilli using direct microscopy after staining—dates back to the late nineteenth century. The vaccine, developed in the early twentieth century, is too limited in efficacy to have a real effect on disease transmission, although it does reduce the frequency of some severe forms. The treatment protocol for common forms is too long and too complicated. Moreover, there have been no new antibiotics for treating the common forms since the 1960s, despite the fact that antibiotic-resistant forms—some of them untreatable—have since appeared. The global spread of AIDS— of which tuberculosis is one of the main opportunistic illnesses— has put the prospect of controlling tuberculosis even farther out of reach.

There was an innovative strategy targeting tuberculosis in the early 1990s. The new approach, called Directly Observed Treatment Short-Course, or DOTS, was based on five main principals: political commitment, microscopy-based diagnosis, continuous drug supply, data collection and analysis, and direct observation of patients taking their medication. The DOTS approach involves a more rational use of existing diagnostic and therapeutic tools, tools that, albeit limited, were at least available. The strategy, which involved humanitarian doctors, was an undeniable advance over earlier practices, but failed to control the disease. It also led to the exclusion of patients not considered important to the overall objective of epidemiological control. This adverse effect underlines the importance of understanding—through careful surveillance prior to embarking on an innovative policy—the new opportunities that a scientific advance is likely to create. It is dangerously idealistic to believe that political will alone, by encouraging caregivers and patients to behave more rationally, can compensate for inadequate science. Not only does the pursuit of unrealistic goals often mean excluding some patients judged non-essential to achieving the (nonetheless impossible) objective—particularly in contexts where there is a paucity of care—but the resources squandered in the pursuit of such illusory goals might have been better distributed.

Case Studies

Malaria

The example of Thailand in the early 1990s (Nosten et al., 2000) involved practical issues (i.e., MSF’s participation in malaria treatment trials in several refugee camps). In this type of situation, in order both to recruit cases and follow them, research teams generally work with treatment teams, as shown by the co-authorship of articles in scientific journals. Some of the humanitarian doctors had reservations about participating in the 8 studies. Their objections were based not so much on formal codes of ethics but on general ideological arguments—“patients can’t understand,” refugees in camps “have no choice,” or with relief organizations providing experimental subjects, patients “aren’t in a position to give their consent freely.” There was also a specific ethical objection to the practice of testing the new protocols successively in the same camps; namely, that the risks of the research were not being distributed equally, but rather borne by a limited number of camps, and concentrated in one population or group. Yet the physician-researchers justified this practice by saying that the refugees derived a direct, immediate benefit from the research, and that access to a new treatment (rather than now-ineffective antimalarials) made them the beneficiaries of what was learned from the studies done on their group—which indeed was true.

Innovation upsets existing relationships between institutions, between practitioners, and between researchers. It produces tensions, shifting alliances, and public opinion campaigns. Each author describes this play of forces and alliances as they reconstruct, in detail, the twists and turns in the innovation process, the arguments from all sides, the actions undertaken, and the political effort expended in forcing the introduction and dissemination of a treatment, a way of organizing care, or a treatment strategy. MSF often plays a specific role in the innovation process, using advocacy to move innovation more quickly from the experimental phase into therapeutic use. Gaining widespread adoption of an innovation also means getting intervention countries to accept a new treatment approach as their national protocol, and working to change public, industrial, and trade policy recommendations. It involves combining medical practice with political action and risking confrontation with the political, economic, and medical powers that be.

With this degree of involvement in the implementation of new treatments, MSF then has to face the consequences. This is where critical self-examination becomes imperative. Once innovations have been proven therapeutically effective, minimalist ethics (Walzer, 1994) and clinical observation consider them a positive thing. But this publicly affirmed belief leads to another, political, one—that innovations can be applied to benefit the whole of society, with positive overall results. So getting new treatments incorporated into national and international health care policies presupposes that the results of applying the protocols on a massive scale will be beneficial. This was MSF’s assumption when, in the early 2000s, it recommended that Artemisinin-based Combination Therapy (ACT) be used to treat malaria in sub-Saharan Africa. MSF fought for the acceptance of ACTs into national protocols. But in countries where they are recommended by the Ministry of Health, ACTs have had only a limited effect on the segment with the highest malaria-related mortality (i.e., children under two years). This doesn’t mean that introducing ACTs to African public sectors was a bad idea—in many countries they were already being marketed in the private sector. But public health policies being what they are in most African countries, the impact of ACTs remains limited. Those who opposed a wider use of ACTs used this to justify abstaining or simply refusing to introduce them. This absurd argument was used, most notably, by pharmaceutical syndicatesSee Jean-Jacques Bertrand, chairman and CEO of Aventis-Pasteur, and chairman of the Syndicat national de l’industrie pharmaceutique (Bertrand, 2000).in the early 2000s. They claimed that unless all of the conditions necessary for success were in place, simply introducing a new drug would be pointless, and destined to fail.

MSF fought the abstention policy, claiming that for practitioners, correctly treating patients and curing them is never pointless. MSF frequently employs this type of public engagement when introducing an innovation; when confronted with doubts, obstacles, even prohibitions, MSF presents access to new treatments of proven efficacy as intrinsically beneficial and as an objective that cannot legitimately be subordinated to other ends (Dodier, 2003, p. 19–23). Their therapeutic efficacy warrants their immediate introduction. This reasoning bears the unmistakable register of minimalist ethics. It uses arguments regarded as widely, if not universally, understandable, because they generally prompt immediate, spontaneous support: “pretty much anybody looking on will see something here that they recognize” (Walzer, 1994, p. 6). This book presents several examples of how, in the face of powerful opposition, MSF publicly leverages medical ethics to promote its treatment choices and their adoption by international public health institutions and health ministries in intervention countries. This type of debate usually takes place far from the political arena, behind the closed doors of ethics committees. Our investigations show the circumstances under which MSF violates this convention, and the results that ensue.

From a public health perspective, however, the appropriateness of accepting a new treatment and putting it into general use can only be judged by considering overall success. Once judged appropriate, how a new treatment is introduced is dictated by a set of norms formalized and legitimized by the World Health Organization (WHO) and health ministries. Faced with these norms, MSF negotiates, argues, seeks, and finds allies within international institutions, health ministries, and pharmaceutical firms; joins research teams; and, at the same time, engages in overt public criticism of the institutions and companies it believes are blocking therapeutic progress and complicating, or even banning, distribution by public health programs.

Sleeping Sickness

The resurgence of sleeping sickness seems to be under control, at least for now. From the early 1980s to the present, control efforts have been based on the methods and medications of colonial military medicine (with modern medical epidemiological techniques used to refine the targeting of priority intervention zones). Success was not a foregone conclusion. Production of traditional drugs was disappearing, and new avenues of treatment went unexplored. There is no doubt that MSF played an important role in terms of the number of patients treated, attempts to preserve the standard intervention tools (pentamidine, melarsoprol, and mobile teams), efforts to standardize the clinical uses of a new screening test (the card agglutination test for trypanosomiasis), and the development of new treatment drugs (eflornithine and nifurtimox). Beyond the satisfaction of having narrowly avoided catastrophe—an endemic resurgence and no drugs for treating it—a close look at activity in recent years leaves some bitterness. Despite the fact that there has been an alternative (eflornithine) to the standard drug (the arsenic derivative melarsoprol) since the early 1980s, the vast majority of patients treated at Stage 2 of the disease (the neurological stage) were receiving the latter—basically a poison—which not only failed to eliminate the parasite in about one-third of cases, but killed 2% to 10% of patients, or even more in certain series. This means that several thousand patients over the past two decades have died from the adverse effects of the treatment. Practitioners refused to accept this situation, as an alternative existed. We have to remember, however, that these research studies created an ethical dilemma. Conducting clinical trials in which some groups of patients continued to receive arsenic in the early 2000s was questionable. Evidence of arsenic toxicity could have been used to override the methodological imperative of comparing a new treatment (eflornithine and nifurtimox) to the standard treatment (melarsoprol).

In this particular case, standard clinical trial methodology raised questions that the review process and national and international ethics committees do not seem to have considered thoroughly. Then there was the 2001 BiTherapy Trial in Uganda, in which five subjects in the two groups receiving melarsoprol died. What additional information did these five deaths—a predictable response to a treatment that is little more than a poison— contribute to science? Did the aim of comparing a new treatment to an old one that had already failed in a third of cases justify such a high human toll? The clinical trial was modified in the wake of these deaths. In any case, the new treatment has the same implementation problems as the previous one. Unlike specialized teams treating large numbers of cases, bush nurses will have difficulty handling even a simplified injectable treatment safely—as the experience in Ibba, southern Sudan, has already shown. This justifies continuing efforts to research an oral treatment that is effective at both stages of the disease.

AIDS

We should note that there has been a change in political perspective in MSF’s arguments. In the late 1980s, the introduction to Santé, médicaments et développement (Destexhe, 1987, p. 12) stated: “Research is a long, expensive process that only pharmaceutical companies can afford, and pharmaceutical industrialization of the Third World is not always the panacea.” In the early 2000s, however, MSF asserted that research should not be left solely in the hands of pharmaceutical companies, using Brazil’s state production of generic antiretrovirals (ARVs) as an example of how to respond to the AIDS pandemic in Africa, where it is taking its most deadly toll. MSF believes that, because of international rules on intellectual property, monopolies held by multinational pharmaceutical companies are among the main obstacles to drug access in low-income countries. And, as noted by Ellen F. M. ’t Hoen,http://www.msfaccess.org/main/access-patents/the-global-politics-of-pharmaceuticalmonopoly-power-by-ellen-t-hoen/.the industrialization of what was known twenty years ago as the Third World is now recognized as a source of progress in the fight against AIDS: “Most of the ARVs currently available at affordable prices come from India” (’t Hoen, 2009, p. 7).

MSF at first criticized what it considered Third-Worldist utopias, in particular the vision of industrialization projects and the celebration of the “barefoot doctor”—a central figure of Maoist China’s health policy which was at the root of public health failures. In the 1990s the organization began to criticize the devastating public health effects of pharmaceutical capitalism. This criticism focused primarily on the considerable advantages—such as patents leading to prolonged trade monopolies—granted to drug manufacturers. MSF commented that as a result, in places where market prospects were poor, entire areas of disease prevention, diagnosis, and treatment were no longer covered by either research for new pharmaceutical products or the distribution of existing ones (Trouiller et al., 2002).

AIDS offered an emblematic example for this criticism at a time when multinational drug companies, governments, and international organizations were in discussions to finalize the intellectual property rules that were adopted in 1994 as the General Agreement on Tariffs and Trade’s Trade-related Aspects of Intellectual Property Rights. The dominant trend at the time was to establish a single worldwide price for a drug and drastically limit the possibility of producing it without a patent. Developing nations such as Brazil, India, Thailand, and Kenya, as well as several NGOs, mobilized at the November 2001 World Trade Organization (WTO) meeting in Doha to adopt a declaration asserting the sovereignty of states who were or would be taking public health measures that might include manufacturing and using drugs without the patent holder’s agreement (compulsory licensing) and importing drugs already produced at a lower price in another country (parallel importation) without permission from either the intellectual property rights owner or the manufacturer.

What set MSF apart in this context was not that it was making the link between the availability of pharmaceutical products in poor countries and intellectual property issues, but that it was drawing the connection as an international association of doctors publicly testifying that their patients were dying as a result of how the wealthiest countries managed pharmaceutical property rights. MSF’s ability to express this opinion simultaneously in multiple forums (gatherings of practitioners and national public health operatives, medical/scientific discussions, WHO and WTO meetings, participation in preparations for the Group of Eight meeting, etc.) was made possible, in the autumn of 1999, by the creation of a specific institutional mechanism— the Campaign for Access to Essential Medicines.

The effect of an approach that couples a demand for flexibility in applying intellectual property regulations with the development of simplified prescribing protocols has been clearly visible: a 99% drop in ARV prices from 1999 to 2007 and an increase in the number of people treated from three hundred thousand in 2002 to three million in 2007 in middle-and low-income countries. However, only a third of patients who need it are now receiving a treatment whose toxicity and limited efficacy have since led to its abandonment by high-income countries. While available data show an increase in the number of people treated, they tell us little about the success or failure of these treatments, which are now prescribed on a massive scale in precarious contexts. Failures are probably more common than suggested by clinical monitoring without laboratory verification (viral load), which is rarely available. Treating more patients or switching drugs to deal with new resistances and reduce toxicity will create new tension around intellectual property issues and increase the strain on program funding.

Meningitis and Cholera

Our critical self-examination should not be limited to studying drug marketing strategies or how we allocate funds internationally for health disasters. We also need to look at the immunization component of MSF’s response to epidemic meningitis. MSF has invested massively in outbreak-response vaccination at the start of meningitis epidemics only to realize later that vaccination came too late to have an effect. Research efforts then focused on defining criteria that would allow more timely decisions on outbreak-response vaccination. Yet however sophisticated the data collection, analysis, and transmission tools, the accuracy of the information and the decisions it leads to ultimately depend on the quality of the epidemiological surveillance. Unfortunately, the latter is rarely more efficient than the country’s public health structure. So the dilemma is that while the vaccine cannot be used prior to the epidemic due to its short duration of efficacy, it’s often not possible to identify a meningitis outbreak quickly enough to use it in time. This would require a public health system that functions well, which is rarely the case. Criticism pointing out the futility of this approach therefore has some merit. Rather than continuing to spend large amounts of money for outbreak-response vaccination yielding meager results, would it not have made more sense to invest in developing a new generation of vaccines that could be used preventively?

A 2007 WHO press releasehttp://www.who.int/mediacentre/news/releases/2007/pr28/en/print.html.reporting recent developments remained vague as to why progress has been so slow in a field where the science and technology needed for a breakthrough has been available since the early 1990s: “MVP [Meningitis Vaccine Project], a partnership between the World Health Organization (WHO) and the Seattle-based nonprofit, PATH, is collaborating with a vaccine producer, Serum Institute of India Limited (SIIL), to produce the new vaccine against serogroup A Neisseria meningitidis (meningococcus).” MVP director Dr. F. Marc LaForce stressed the project’s potential, stating “the vaccine will allow elimination of the meningococcal epidemics that have afflicted the continent for more than one hundred years.”

We should add that while meningitis epidemics may be terrifying to the population, they pose little threat to governments, because in the absence of prevention measures governments do not get blamed when people are affected. This makes it easier for the authorities to acknowledge the epidemics, and attention then focuses on the Ministry of Health’s response capacity. Not only can the government not be held responsible for the scourge, it can ride to the rescue by organizing mass vaccination campaigns. While epidemiological data do not always support outbreak-response vaccination, the political benefits are obvious. The mass vaccination campaign in 2009 in the northern Nigeria states—usually hostile to what they characterize as intrusion by foreign organizations dangerous to the population’s health security—is proof of government interest in immunization against meningitis.

In the case of cholera, MSF’s contribution to the standardization of tools, detection, and treatment procedures in closed settings (refugee camps, prisons, etc.) is undeniable. The major challenge in the fi against cholera is in open settings, either urban or rural, where the burgeoning number of small peripheral treatment centers is inevitably accompanied by extra logistics work and greater laxity in treatment supervision— though the latter is crucial to treatment efficacy, particularly in severe cases. The effi of the strategy in closed settings rests largely on active detection of cases through health worker home visits, a technique that is easier to implement within the limited confines of a refugee camp. Yet the current cholera pandemic is mainly affecting open settings.

EpicentreEpicentre is an MSF satellite organization that specializes in the epidemiology of intervention, research, and training.studied the feasibility and effectiveness of cholera vaccination and participated in the study of a preventive alternative to reactive treatment alone after the start of an epidemic (Legros, Paquet, Perea, 1999). In 1999 the WHO stated that the oral vaccine (B subunit killed whole-cell, or BS-WC, and rBS-WC) is potentially useful in certain high-risk situations, such as slums and refugee camps (WHO, 1999). Yet despite encouraging results, it will be a long while before those living in areas where cholera is endemic and causes recurrent epidemics will receive vaccine protection. Indeed, cholera, because it highlights the lack of public sanitation services, is no favorite with governments, as demonstrated by the deadly 2008 epidemic in Zimbabwe. Governments often forbid the use of the word “cholera” in both internal public health communications and the press, and there is even greater pressure when the country draws a significant portion of its revenues from tourism.

Despite the fact that it is technically possible to control the disease, there appears little political will to do so. In 2007, for example, the number of cases—underreported for political reasons—was estimated by the WHO at something less than two hundred thousand (WHO, 2008), with some 4,000 deaths reported that same year. By contrast, during the 2007–2008 season, fewer than thirty thousand cases5 of epidemic meningitis and 2,500 deaths were reported, and two million vaccine doses were administered. Public policy–wise, there is much more effort put toward meningitis—despite the vaccine’s limitations—than cholera, even though there are more cholera cases and deaths.

The disease studies presented in this work show that humanitarian medicine often contributes to medical innovation by first simplifying, then disseminating, scientific and technological advances among neglected populations where such diseases can be catastrophic. The success of this approach rests on influencing public policy. Indeed, when such efforts do not accompany the development of new intervention techniques, medical innovation ends up having little effect on the fate of the poorest. In this domain, the MSF movement—by virtue of its nature and experience—shows greater skill and motivation in the international arena than in national ones, where the association is sometimes viewed as a foreign interloper unacquainted with the subtleties of the local medical and political establishments.

Political and Scientific Vigilance

What does the association see as its responsibility, once the innovations it has championed become accepted medical practice? This is an ongoing source of controversy, even internal crisis. In fact, there is no universally accepted strategy at MSF for dealing with this responsibility. MSF has, however, taken the initiative in ensuring the supply of effective drugs and lowering their cost; for example, MSF-LogistiqueOn the subject of the MSF satellite organization MSF-Logistique, see the analysis by C. Vidal and J. Pinel in this book.acts as a drug procurement center for all agencies involved in fighting sleeping sickness.

Clearly, for actions such as these to be in any way relevant, a framework is needed for monitoring and analyzing medical policies on a global scale. There must be specific objectives for MSF involvement when public health is at issue, and MSF must have a clear position before entering public debate.

In particular, political and scientific vigilance allow us to trigger public controversy citing medical work performed during epidemic crises. The main counter-argument against this advocates examining the consequences of wider use of new health care practices, declares such examination essential to the proper conduct of interventions, and criticizes MSF for not taking this into account, or for doing so in a simplistic, overly hasty manner. MSF usually responds by arguing that treating patients will necessarily have an overall positive effect. Even though its scientific validity remains controversial, this argument—coming from MSF—carries weight in the public sphere when the association engages in critical debates with international institutions (the WHO, United Nations agencies, etc.), donor institutions, drug companies, health ministries, and various institutions from the medical world (scientific journals, specialist groups, etc.). The case studies show that MSF’s ability to get the validity of innovations recognized has a lot to do with being there at every stage of the legitimization process: clinical and treatment practices, epidemiology, scientific journals, peer information–exchange (and controversy) networks, analysis, and advocacy. Several chapters of this book describe the framework that permits MSF to intervene in this way in the various areas of legitimization.

While the coherence of this system is essential, its responsiveness also requires individual commitment to remain alert; it is only by this commitment that each person can seize upon new medical tools and treatment strategies that can be imported for use in international emergency responses and transformed by humanitarian practitioners.

However, integrating medical innovation into humanitarian practice also means redefining and rewriting treatment protocols, obtaining administrative authorizations, identifying supply sources, managing the logistical and administrative aspects of pharmaceutical imports, training staff in new practices, closely supervising implementation, and continually evaluating results. In other words, it’s a long, demanding process over the course of which initial enthusiasm can turn into exhausting daily uncertainty and, sometimes, disillusionment. When the innovation is a success, its use becomes so routine that hardly anyone remembers how much effort it took to introduce.

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