Marc Le Pape and Isabelle Defourny

MSF is no stranger to controversy. Indeed, the organization does not view controversy as negative, but rather as an engine for change. Here we present two recent examples of innovative medical practice where MSF was involved in controversies and used them to its advantage. The controversy originated within the MSF movement; the organization then found itself in disagreement with national authorities in the countries where it operated, international institutions such as the World Health Organization (WHO), the World Bank, the United Nations Children’s Fund (UNICEF), pharmaceutical companies, governmental agencies and/or donor organizations—particularly the United States Agency for International Development (USAID)—and renowned specialists in medicine, epidemiology, and the economy. The two examples we have chosen concern the treatment of malaria in Burundi and of malnutrition in Niger.

Conflicting opinions created powerful constraints on validating improved treatment protocols and therapeutic strategies. Different and rival validation processes were suggested. We will describe the different stages of the controversy and the people involved (Lemieux, 2007). Likewise, we will illustrate the connections between experimental demonstration, humanitarian medical practice, and the different forms of public and political involvement.

 

Malaria in Burundi: The Introduction of Artemisinin-Based TreatmentsSee the chapter written by S. Balkan and J.-F. Corty. It describes the development and initial use of these treatments in Southeast Asia. We use the term Artemisinin-based Combination Therapy (ACT) to designate therapeutic drug associations based on artemisinin derivatives.

The Beginning of the Controversy (2000–2001):

Therapeutic Requirements

On December 12, 2000, MSF published a press release in Paris, Brussels, and Geneva entitled “Malaria epidemic in Burundi: MSF teams are dealing with an unprecedented influx of patients. MSF demands support from the WHO for more effective treatments.” This warning was based on data from sixteen health centers at which MSF was working, as well as on a retrospective mortality survey conducted between October 13 and December 9, 2000, which found “worrying levels of mortality.” The press release described MSF’s curative and preventive initiatives “from the beginning of the epidemic,” and indicated factors “favoring” the sudden increase in the number of cases and the high mortality rate. Three factors were identified: the development of swamp farming; the abandonment of anti-vector policies; and the “probable high resistance to chloroquine.” The press release ended with an appeal to the WHO and the Roll Back Malaria (RBM) network—a WHO initiative created in 1998 associating UNICEF, the United Nations Development Programme (UNDP), the World Bank, and other private and public partners to fight malaria (Packard, 2007, p. 217–227)—to “support the use of artemisinin-based treatments.”

The press release was the first public expression of dissent. There was no divergence of opinion regarding the incidence of malaria, however: to underline the “dramatic” increase in the number of cases, the WHO, in its recommendations, had referred to an MSF survey of three health centers (Kassankogno, Allan, Delacollette, 2000).The malaria epidemic was unusual for several reasons. It occurred in the Burundian high plateaus, a zone where malaria is not usually present, and a very large number of people were affected. Epicentre performed retrospective mortality studies in three provinces that estimated 1.5 million cases and sixteen thousand deaths in these provinces alone for the epidemic of 2000–2001 (Guthmann et al., 2007). Figures of thirty thousand deaths and 3 million cases appear realistic for the seven affected provinces. Burundi has a population of 7.5 million.

The controversy began in November 2000, but was not made public at the time. The desk officer responsible for programs in Burundi stated at the MSF board meeting of November 17: “Sadly it is currently impossible for us to use artemisinin derivatives because the government has asked us ‘not to introduce any new drugs.’ All efforts to secure support from the WHO have proven fruitless because the organization will not recommend the use of medicines that are not registered in the country. This is a sad example of the ongoing struggle to use the best available treatments.”

MSF sparked controversy amongst its peers on the following issues:

• Criticism of policy. In general, the WHO should not base its advice on local government policy as this hinders diagnostic and therapeutic progress.

• The choice of treatment. At the beginning of November 2000, MSF recommended the use of artemisinin derivatives combined with sulfadoxine-pyrimethamine (Fansidar) for the treatment of uncomplicated malaria in Burundi. For complicated malaria cases, MSF recommended artemether (Paluther) combined with sulfadoxine-pyrimethamine.

These choices were justified by the therapeutic efficacy of the treatments, a lower rate of transmission, and the reduction in the development of resistance. Furthermore, artemether was on the WHO’s list of essential drugs, which should have facilitated its introduction.

The fear of high resistance to sulfadoxine-pyrimethamine developing if used as monotherapy in response to the epidemic. On November 16, the WHO began to recommend the use of sulfadoxine-pyrimethamine (replacing chloroquine) as first-line treatment for uncomplicated cases.

The need to conduct chloroquine and sulfadoxine-pyrimethamine resistance studies in Burundi, as prescribed by WHO protocols.

The RBM coordinator initially replied to these fears, criticisms, and proposals by email over the RBM network on December 13, then again the following day in a public document in which the WHO justified its recommendation for the treatment of uncomplicated malaria (i.e., replacing chloroquine with sulfadoxine-pyrimethamine). Sulfadoxine-pyrimethamine was to be prescribed as monotherapy, without combinations with other anti-malarials.WHO, Burundi—Malaria epidemic, Treatment choices, December 14, 2000.Three justifications were made:

Therapeutic efficacy. Studies conducted in Rwanda and Tanzania were cited as proof.

Operational constraints. Burundian medical staff were already familiar with this treatment, and it was available in large quantities in Burundi and elsewhere in the region.

Observance of treatment, facilitated by the extremely simple single-dose regimen.

The authors of the WHO report explained why they did not recommend a combination of sulfadoxine-pyrimethamine and artesunate as first-line treatment, despite recognizing its efficacy. They referred to the lack of available data in Africa, the problem of adherence to treatment, and the fact that artesunate had not been registered by Burundian health authorities. But one development was announced in the document: the Ministry of Health had adopted artemether for the treatment of severe malaria. Earlier, in an internal document, the WHO had already recommended artemether as second-line treatment, but only “if it is registered in the country” (Kassankogno, Allan, Delacollette, 2000).

In his communication of December 13, the RBM coordinator added that even if the therapeutic efficacy could justify the use of an artesunate–sulfadoxine-pyrimethamine combination, a series of factors specific to the situation in Burundi led to problems with its use, including: difficult access to patients, the lack of qualified medical staff, and the absence of stocks of the drug in the region. The MSF desk officer conducting the discussions in Paris was quick to address the issues over the network Website, focusing on the effectiveness of sulfadoxine-pyrimethamine. According to resistance surveys conducted in two Rwandan health centers in 1999 and 2000 by the WHO, the drug was effective in only 64% of cases at the first site and just 53% at the second site. The officer added that this data, as yet unpublished, had been communicated to MSF by the WHO. He was therefore less optimistic than the WHO about sulfadoxine-pyrimethamine monotherapy. Its use on a massive scale would accelerate the development of resistance. He reaffirmed the arguments in favor of artemisinin-based treatments, arguments already presented to the RBM network and publicly stated by MSF on December 12.

The MSF author went on to stress several points in his response:

Burundian patients were already used to taking treatment over several days—conventional chloroquine treatment lasts three days—so there was no reason to believe that observance would be more problematic with the MSF-recommended regimen.

Artesunate had already been introduced into Burundi. It was available in pharmacies in Bujumbura, and was also registered as a medication reimbursed by the civil servants’ health insurance. Treatment protocols, however, were often inadequate. Its inclusion in the national malaria protocol, at least during the epidemic period, would reduce the risks of uncontrolled prescription.

The logistical and professional constraints were real, but MSF field experience in three provinces showed that the epidemic zones could be reached using mobile clinics. As to the lack of specialized staff, the MSF author took a practitioner’s stance: why would the medical staff, already familiar with three-day chloroquine–sulfadoxine-pyrimethamine treatments, not be able to adapt to the three-day artesunate–sulfadoxine-pyrimethamine treatment?

Supply of the new drug was a significant problem, but MSF declared it was prepared to supply artemisinin derivatives if they were accepted by the Ministry of Health. The objective was to introduce artemisinin-based combinations “at low cost.” It should be noted here that the MSF author broached the economic side of the problem, but without explaining how to obtain low-cost combinations, or comparing the costs of the different treatments proposed.

Medical necessity (the term ethics was not used): although it was perhaps not possible to introduce artesunate everywhere in Burundi, it should at least be introduced where possible. Not all patients would be accessible, but some at least would receive the correct treatment.

The “treatment choices” document published by the WHO on December 14, 2000, did not put an end to the controversy. At the MSF France board meeting on December 22, the Burundi epidemic was back on the agenda. The medical and logistics experts involved at headquarters noted that the debate (“essentially via email and the WHO RBM debating site”) “had the effect of modifying WHO recommendations that now include the treatments we advocate (using artesunate), but stop short of recommending them for first-line treatment.”

MSF therefore continued to criticize the first-line treatment recommendations, notably in a letter published in The Lancet in March 2001 (Gastellu-Etchegorry, Matthys, Galinski, White, Nosten, 2001). This letter was signed by two MSF medical directors and three medical researchers specialized in malaria. The authors described using combinations including artemisinin derivatives as an “ethical obligation,” as they were the most effective treatments available. They added that this ethical obligation applied not only to doctors, but also to NGOs and international agencies. The authors therefore asked that the WHO and donor agencies recommend the “immediate” use of these treatments.

In April 2001 the WHO adopted a new protocol recommending the use of combination therapies, preferably ACTs, for fi and second-line treatments in countries with proven resistance to standard monotherapies (WHO, 2001). These were general recommendations, and it was up to individual states to integrate them into their national protocols. The decision was taken in Burundi in July 2002, and implemented some months later in 2003.

Conflict with the Burundian Ministry of Health (2001–2002): An Ethical Obligation

The French section of MSF began using ACTs in 2001, even though the Burundian Ministry of Health did not recommend them for the treatment of uncomplicated malaria. Local health authorities were informed, and tolerated this practice until October 2001, when MSF-France decided publicly to denounce the treatment protocol for uncomplicated malaria, unfavorably comparing the poor results of the national protocol with artemisinin-based treatment data obtained from one of their programs in Kayanza Province. The Health Ministry replied by demanding the withdrawal of ACTs from all health centers where MSF was active, then, shortly afterwards, on November 8, decided to suspend all MSF activities in Kayanza Province for two months. In mid-December, the Burundian authorities expelled MSF-France’s head of mission from the country.

The general director of MSF-France wrote to Burundi’s health authorities and the WHO to justify localized introduction of the new treatment. The letter, dated November 9, was also sent to high-ranking members of the RBM network. It listed all the organization’s arguments, emphasizing the therapeutic efficacy of the new treatment. Medical officials in Burundi nevertheless continued to implement a protocol (sulfadoxine-pyrimethamine monotherapy) that MSF practitioners in the field had noticed was no longer working. MSF believed the national protocol could no longer be respected, and decided to start using an artemisinin-based combination “immediately” without waiting for the results of assessments by the Ministry of Health and the WHO. This is also why “volunteers were sent to the field with supplies of artesunate and amodiaquine.” The letter brought ethical obligations to the forefront, stressing that a doctor is obliged to administer effective treatment, and affirming that MSF respected this obligation in Burundi, as it did elsewhere in the world. Our analysis here does not seek to determine whether this level of rigor was, in 2001, universally practicable and practiced by MSF, but we note that theory and practice were coherent in Kayanza Province. For Burundi, this was a challenge to national sovereignty. It is thus understandable that the controversy escalated into a crisis, as each camp claimed to act on fundamental principles, which only served to intensify the disagreement. In the end, only a meeting between the Burundian president and the presidents of the MSF international movement and MSF-France resolved the crisis. At the end of the talks, the Burundian president asked MSF to continue working in Burundi.

In March 2002, several MSF senior staff members met with the WHO director general, who agreed to support the transition to artemisinin derivative–based treatments, but reminded them that the WHO was a decentralized organization, and that the African branch did not agree with the policy. She stressed that the United States also expressed strong opposition to the use of ACTs .

The escalation from disagreement to crisis had repercussions within the MSF movement. From November 2001, MSF-France asked the three other sections working in Burundi, “Why are we the only MSF section in this mess? How are you treating uncomplicated malaria?” The controversy within the movement intensified and spread on January 16, 2002, when a letter entitled “Are we alone?” was sent—in French and English— by the Parisian desk officer for Burundi “to all MSF sections, their presidents, general directors, operations directors, desk officers and program managers.” The letter not only suggested an appropriate strategy for Burundi, but also for generalizing the new treatment and bringing the whole MSF movement into the process. The issue was to address “the question of malaria treatment in general in Africa” and to start a public campaign to obtain approval and use of effective treatments for “all populations” in countries affected by chloroquine and sulfadoxine-pyrimethamine resistance. According to the author, this position should be publicly adopted by all MSF sections, adding: “Who is prepared to stand up, speak out and act?”

The letter sparked strong emotions within the MSF movement, and created a confrontation essentially on the following question: what is the best strategy to trigger change in the national protocol  in Burundi? The author sent the letter to all senior MSF decision-makers; this tactic was denounced as bypassing the usual decision-making procedures in order to get the French section’s strategy approved. Some opponents stressed that the Parisian position was in line with general agreement throughout the movement on the necessity to change such protocols. They explained that the French section was in no way fighting the battle on its own, but that it had isolated itself in Burundi through the strategy of confrontation it alone had adopted; it was simply being brought back to order and to reality. Others denounced MSF-France’s self-glorification: the section gave the impression that they alone were fighting for the right protocol. The criticisms were based on the belief that there was a more effective strategy than confrontation: a strategy involving “silent diplomacy,” working to convince, and intervening at all levels with all involved parties. This alternative approach was seen as the best way to help change the protocol.

When the Burundian government agreed to a change of protocol, the process of dealing with disagreements between the different sections finally returned to its normal course, through institutional regulation.

Economic Constraints

MSF’s first public interventions only rarely mentioned the cost of ACTs. Nothing was mentioned in the press release dated December 12, 2000, and only a passing reference was made in the article published in The Lancet in March 2001: “We appreciate the considerable operational and economic obstacles involved in changing national malaria policies, but there is an ethical obligation …” (Gastellu-Etchegorry, Matthys, Galinski, White, Nosten, 2001).

But MSF did not neglect the problem of the cost of ACTs. Initially, the issue was not a matter of public debate, but it was discussed within the organization and in exchanges with the WHO and the Burundian authorities. MSF-France’s medical and logistical director declared at a board meeting in December 2000 that “we hope to bring the price down to one dollar,” without explaining how he might go about it. In an October 2001 letter to Burundian parliamentarians, the general director of MSF-France admitted that cost “is a major difficulty” and added that MSF was committed to “finding solutions,” comparing the situation with that of the treatment of AIDS patients. At the beginning of 2002, once the necessity to change to ACTs in general in Africa had been recognized—particularly for countries with high levels of resistance to sulfadoxine-pyrimethamine and chloroquine (Guthmann et al., 2008)—MSF began to focus on overcoming the financial obstacles. This became evident during the annual meeting of the East African Network for Anti-malaria Treatment. On February 13, 2002, in Nairobi, MSF published a report entitled “Changing national malaria treatment protocols in Africa. What is the cost and who will pay?” The report presented a cost assessment for changing the protocols in five African countries (including Burundi). Its author declared that the change would be too costly to be borne by the governments involved and would require international funding. This sparked another lengthy controversy involving NGOs, donor agencies (particularly USAID), and international institutions. The focus was on the search for solutions to guarantee both a drop in the cost of ACTs, and their supply.

In September 2008, the director of the Global Fund to Fight AIDS, Tuberculosis and Malaria declared that an economic mechanism had been established that should, from 2009 onwards, allow the sale of ACTs in pharmacies at an equivalent cost to chloroquine in countries with endemic malaria. The mechanism requires the Global Fund to invest $150 million to $300 million yearly.“Michel Kazatchkine: “When the world gets together, we get results,” La Croix, September 9, 2008.

 

Severe Acute Malnutrition:For criteria defining severe acute malnutrition see WHO, UNICEF, WHO child growth standards and the identification of severe acute malnutrition in infants and children, Geneva, 2009.From Treatment to Prevention

Between April and June 2005, MSF published three press releases in Paris on the gravity of the “nutritional crisis in Niger” and described its response to the problem. None of the three press releases mentioned the word “famine.”

On April 26, 2005, MSF reported an “abnormally high” number of children suffering from severe acute malnutrition admitted to their inpatient and outpatient facilities in Niger. The association called for urgent “general food distributions,” without indicating who should be responsible (other “aid actors” were mentioned, but without giving details).

A second press release, on June 9, 2005, highlighted the fact that twice as many children under five had been admitted to MSF nutritional programs as in 2004. The report was based on a nutritional survey performed by MSF and Epicentre at the end of April 2005. Unlike the preceding press release in April, the June 9 press release clearly stated a demand for a new general policy and that “exceptional measures must be undertaken urgently.” MSF called for food distributions so that “the most vulnerable populations can gain direct, free access to food.” MSF also introduced provocative elements in its public communication, criticizing the inadequacy of Nigerien government operations (“sales of moderately priced cereals”). It called for the “mobilization of donors and of international organizations such as the [United Nations World Food Programme (WFP)] and UNICEF,” as the only way to provide free food distributions. The call for help was accusatory: stating that these institutions needed to mobilize was to say that, until then, they had been failing their mandates.

A third press release was published on June 28. The urgent need to act was reiterated, but more forcefully: “there will be thousands of avoidable deaths this summer.” MSF continued to denounce “the reluctance of donor agencies and the government to provide free food distributions,” as they “obstruct appropriate relief efforts.” However, the press release also had a singularly practical approach compared with previous ones. MSF’s president took a practitioner’s stance when he stated, “easy-to-use nutritional products adapted for children now exist, that save lives in a few weeks of treatment.” Neither of the two previous press releases mentioned this therapeutic argument, clear even to those that know nothing about the treatment of malnutrition and the debates on free food distributions.

Many controversies have arisen on the treatment of infanto-juvenile malnutrition in Niger and some are still ongoing (Olivier de Sardan, 2008). In 2005, the controversy intensified, transcending the medical domain to become a political crisis. We will not give an account of all the twists and turns, nor the diversity of positions taken. The collective work edited by Xavier Crombé and Jean-Hervé Jézéquel (2009) provides a description of the different levels of controversies and public commitments that characterized the crisis. The most visible debates could be qualified as political, economic, sociological, epidemiological, and medical.

Here we describe two controversial aspects of MSF’s action: first, free food distribution; and second, the introduction of new nutritional products associated with the change in therapeutic strategies.

The Therapeutic Innovation Predates 2005

At the end of July 2001, MSF started a nutritional program, including two inpatient centers for severe acute malnutrition. At the same time, a new approach was adopted: after a limited period of hospitalization in a typical nutritional facility, the treatment was then continued at home with weekly medical checkups. According to an MSF assessment, the outpatient treatment was possible with the use of “ready-to-use specialized food” (Priem, 2002). The report specified that “the MSF team was initially a little reluctant to set up this outpatient phase of treatment, essentially because of fear of relapses” (Priem, 2002, p. 11, 20–21). “The teams were worried about not being able to monitor the development of medical complications, as it was difficult for mothers to travel to MSF’s facilities. Malnourished children have lower levels of immune defenses.”Quote from an MSF doctor.Despite these fears, the new strategy was progressively implemented. In November 2001, in Dakoro, in the Maradi Province, 80% of children initially hospitalized were then transferred to the outpatient phase of treatment (i.e., nutritional rehabilitation at home). Assessment revealed a weakness in the program (a high dropout rate), but nonetheless concluded that home-based nutritional rehabilitation was “satisfactory.” The evaluation was based on traditional indicators such as daily mean weight gain, mean duration of treatment, the percentage of readmissions to hospital from home, and the “modes of exit” from the program—cured, defaulted, or deceased.

Steve Collins, a doctor working with Concern, an Irish NGO, had been using ready-to-use foods since 2000, and had demonstrated the effectiveness of home-based care (Collins, 2002). MSF was not then in favor of the strategy, as such limited medical help was deemed too risky for severely malnourished children.

Driven by senior staff convinced of the work by Steve Collins, in July 2003 MSF decided to initiate treatment at home except in complicated cases requiring hospitalization (Tectonidis, 2004). This decision aroused misgivings among MSF medical practitioners. Indeed, many of those working in the field were worried that the positive effect of the home-based treatment might be of shorter duration than that obtained in conventional, inpatient therapeutic feeding centers. Another worry was that mothers would not keep the ready-to-use therapeutic food solely for their malnourished children but share it with all their children (Priem, 2002, p. 20, 22). Defenders of the program responded with field data on the “extensive outpatient phase treatment of malnutrition” (Tectonidis, 2005b), which showed low rates of readmission to hospital, lower relapse rates, and comparable daily mean weight gains overall for the programs. The arguments heard during the outpatient strategy controversy were varied. Defenders of the policy evoked arguments and data from clinical experiences, while its detractors stressed the weaknesses witnessed during the first years of the programs (July 2001 to July 2003) and asked cultural and sociological questions about mothers’ behavior: “How can we be sure that they respect treatment regimes once at home?”

MSF Put to the Test by the 2005 Crisis

In February 2005 MSF noticed that admissions to nutritional programs had risen compared with February 2004. This trend was confirmed over the following months. The continuing increase in admissions led to the three press releases mentioned earlier. Senior MSF staff in charge of operations in Niger were initially hesitant to describe the situation as a crisis requiring specific emergency responses, however. Perhaps the rise in the number of admissions was mainly because Nigerien mothers, confronted with chronic poverty-provoking cycles of acute malnutrition, recognized the efficacy of the outpatient programs. Was it MSF’s responsibility to respond to an endemic problem linked to poverty? These doubts and questions were raised by some of those in charge.

While disagreement continued within the organization on how to identify signs of danger and the limits of humanitarian responsibility, new indicators and arguments were used publicly to illustrate the gravity of the situation. The results of several nutritional surveys conducted by various institutions, including MSF,Nutritional and Retroactive Mortality survey, Keita, Dakoro, and Mayayi districts, April 2005 (Epicentre); Food Security survey in the Tahoua district, May 2005 (MSF-France); survey by Helen Keller International and the WFP in the Maradi and Zinder regions in January 2005, revealing “alarming levels of malnutrition” and recognizing that “the situation in these two regions of Niger, and probably other regions, is comparable to those of populations living in war zones or other crises” (WPF, HKI, 2005).were particularly pertinent. Furthermore—and this was the decisive argument within MSF—the need for medical care and the number of admissions to nutritional facilities were continuing to rise. This was universally agreed upon, but disagreement persisted as to the extent of the humanitarian response. From April to June 2005, press releases stated the gravity of the situation and the urgent need to intervene using both types of indicators: epidemiological survey results, and medical observation and data from MSF nutritional centers.

MSF’s main demand on June 9, 2005, was for “free food distributions to populations worst affected by malnutrition,” leading to the call for “mobilization of donor agencies and of international organizations, such as the WFP and UNICEF.” One of the justifications was the observation that the Nigerien government’s plan of action—essentially based on selling cereals at moderate prices—was not improving the situation in the most affected rural areas. From March to July, MSF gradually acquired the capacity to target priority zones by cross-referencing data from treatment facilities, nutritional surveys, and socio-economic indicators (Jézéquel, 2005). The organization was thus able to target priority zones hardest hit by acute infanto-juvenile malnutrition.

In the MSF press releases of June 9, June 28, and August 22, the vast numbers of children arriving at feeding centers were cited as proof of the inefficacy of the government response. MSF produced descriptive statements to demonstrate the gravity of the “acute malnutrition epidemic.” The medical diagnosis— “these are children who will die, and we can save them”—struck a sensitive chord. There were others who shared MSF’s point of view. In July 2005 the WFP, breaking with official strategy, began free food distributions. Public controversy flared again, however, sparked by another MSF press release published on August 22, the day before the UN Secretary General was due to arrive in Niger. The press release said the food distributions were insufficient and ill-adapted in terms of geographical targeting. It went on to reproach agencies for not supplying “specialized foods” for very young children who were “dying from hunger” and were the “principal victims of malnutrition.” The issue of saving children by providing specialized food was raised repeatedly in public from the end of June (i.e., the beginning of the hunger gap, when the deterioration of the situation had become foreseeable).

This insistence on targeted free food distributions and appropriate solutions for very young children (“from six to fifty-nine months of age”) used field experience as a counterargument against the strategies adopted by the Nigerien government and other key institutional actors. MSF’s expertise and experience did not explicitly challenge the free market, but described its effects, or rather lack of effects, on the population. In the same vein, MSF requested that all health care for children be free of charge for the duration of the hunger gap.

What were the alternative doctrines and policies to those recommended by MSF and other humanitarian organizations (particularly Action Against Hunger)? On the one hand, there was what could be described as an analytical contention, and, on the other, a more polemical contention during peak moments of controversy.

USAID was quick to offer opposing analytical arguments (USAID, 2005). First, the agency recognized the existence of a “grave nutritional crisis” in certain areas of Niger: a “predictable and inevitable” result of chronic poverty. The authors of the document contested the number of people at risk according to “certain press reports,” then affi that 2.4 million to 3.6 million people were exposed to food shortages, and that “some will die from lack of food, poor quality water, or other problems not linked to food.” This fatalistic judgment did not explicitly target MSF, but challenged the effectiveness of the association’s food aid policy, which was not seen to take into account the multi-factorial character of child mortality. The type of aid that MSF provided meant that it responded locally to the emergency, but did not address the factors aggravating malnutrition. The authors believed it was necessary to study these other factors and the food situation in the most affected zones of Niger where MSF was working (alongside many other agencies from July 2005 onwards). In the end, the analysis did not disagree with MSF’s activities, as it recommended immediate emergency aid including free food distributions and “food supplements for children less than fi years old.” But the causes of the crisis were not, and could not, be tackled this way, and there was a lot of skepticism regarding the medical solutions offered by MSF.

One controversy sparked by MSF’s interventions began with two BBC reports of September 13 and 15, 2005, about MSF’s accusation that the WFP was not delivering aid to those most in need.BBC News, September 13, 2005, and BBC TV, 15 September 15, 2005: Hilary Andersson, “Niger food is ‘misdirected.’” The WFP responded (without mentioning the BBC) in a press release published in Niamey on September 15: “More food to the most needy—WFP moves into next phase of Niger operation.”

On September 15, the WFP’s director sent a letter to the president of MSF-France protesting the condemnation of his organization. This was in contrast to the cooperation between the WFP and all MSF sections in the field. He believed that private discussions were preferable to public confrontation, as the latter was counterproductive. In other words, progress is not made by denouncing one’s partners in the press, but by speaking with them directly; and MSF was not helping malnourished children with its press release, but just gaining publicity. The WFP’s director suggested setting up a forum with MSF to discuss operational problems and to come to a “common understanding” of working with the media. In his opinion, there was no split between MSF and the WFP; they should still work together. The president of MSF France responded that public controversy had achieved better results than meetings with aid organizations. The public debate had convinced relief organizations and the Nigerien authorities of the necessity of distributing food, and of giving priority to zones with the highest levels of acute malnutrition, which had not been the case up to mid-July.

In the end, the aid objectives announced by the WFP in its press release September 15, 2005, matched the emergency priorities defined by MSF.

 

Nutritional Strategies and “Ready-to-Use Therapeutic Foods” (RUTFs)

Ready-to-Use Foods and Prevention

During 2005 the MSF sections in Niger treated sixty thousand children suffering from severe acute malnutrition, adopting the method initiated by Steve Collins in 2000. MSF’s innovation was not the method but its application on such a large scale and with such high cure rates (over 80%). This was unprecedented; it was the first time that it had been proven possible to treat such a large number of children with severe acute malnutrition. Over the summer of 2005 the Ministry of Health embraced this strategy in their revised national treatment protocol for severe acute malnutrition.

In 2006 MSF staff in Paris responsible for operations in Niger decided to no longer limit RUTFs to the treatment of severe acute malnutrition, but to use them from the earlier stage of moderate malnutrition. The extended use of RUTFs was initially trialed in two of the hardest-hit districts of the Maradi province in 2006. At the end of the year, all involved agreed on the operation’s medical efficacy, but also on its very high cost. The cost was partly due to the price of Plumpy’nut, but more significantly to screenings carried out to identify patients suffering from acute malnutrition. Consequently, the decision was taken to simplify care and to stop selecting children based on whether they were suffering from acute malnutrition or not. During the hunger gap period (May to October), in one district, all children in the age group most in danger (six months to three years of age) would receive a daily nutritional supplement in the form of a new ready-to-use product, Plumpy’doz,Plumpy’doz is a dense, ready-to-use food. Made of milk powder, oil, sugar, and micro nutrients, it is rich in vitamins and minerals. Unlike Plumpy’nut, it is complementary to a child’s normal diet. It contains all the vitamins and minerals required for growth, but only some of the proteins and calories.while children with severe acute malnutrition would receive specific treatment in a therapeutic program (twenty-two thousand cases in 2007).

During the evaluation of this strategy at the end of 2007, program managers observed that the number of admissions compared with those of preceding years (2002–2005) had dropped from June onwards and stayed relatively low until October. The strategy of general distribution to all children up to three years of age adopted in 2007 had the same effect in terms of the reduction of the number of cases of severe acute malnutrition as the method of selection used in 2006. This information justified the early intervention strategy (i.e., the distribution of Plumpy’doz to all children from six months to three years of age during the six-month period of the year when hunger gaps are recurrent). In terms of budget, detailed analysis of spending in the district of Guidam Roumji showed that 77% of the budget was spent on specialized food for children in 2007, comparing favorably with just 35% in 2006, when large-scale selection operations where required. MSF does not generally recommend early distributions of ready-to-use foods to whole age groups for several months a year in all situations of chronic malnutrition, but recommends it in cases of high levels of acute malnutrition and associated mortality.

The above summary of MSF operations in Niger was based on information given to us by their initiators. A reminder of some of the controversies linked to the increased use of ready-to-use foods should also be provided.

In 2007, when the Niger program managers proposed early intervention with the main argument of simplifying treatment, there were strong objections within the association. Some challenged whether such an extension of the program should be MSF’s responsibility; they believed that such chronic problems are the domain of development policies and not of emergency organizations such as MSF. They believed that MSF should limit itself to treating epidemics of severe acute malnutrition using the validated outpatient treatment strategies, and avoid extending treatment to prevention in moderately malnourished children or all children in poorer countries. Similar criticisms were expressed by other organizations, accusing MSF of proposing only a medical solution to the problem of undernourishment, whereas it includes much wider factors. Current emergency medical methods for severe cases cannot be generalized in the long term—to reduce under-nourishment, other factors and constraints must be taken into account: economics, agriculture, sociology, etc. MSF responded that child mortality was catastrophically high in zones with high incidences of undernourishment, and that a medical means of reducing mortality rates existed. The results obtained in Niger showed that it was possible to reduce severe acute malnutrition in high-risk zones by distributing preventive ready-to-eat foods to all children from six to thirty-six months of age. Why then wait for the children to become severely sick and come for a consultation before proposing treatment?

An article published in Science (Enserink, 2008, p. 36) suggested—wrongly according to some (Bradol, 2008)—that MSF advocated a strategy of universal prevention by the distribution of fortified milk paste to millions of under-nourished children in sub-Saharan Africa and South Asia. In 2005, 19.3 million children were estimated to be suffering from severe acute malnutrition worldwide, and another 178 million suffering from stunted growth (Black, 2008, p. 245). Within MSF, it was generally accepted that priority must be given to populations where malnutrition causes high mortality rates or where it is most prevalent. Nonetheless, other than severe epidemic flare-ups, not everyone agreed on intervention thresholds, whether at a population level or for individual patients. As with many controversies within MSF, disagreements on practical intervention strategies were linked to the recurring issue of MSF’s role and its medical and humanitarian responsibilities.

The Cost of Ready-to-Use Foods

MSF identified the cost of ready-to-use foods as a problem early in 2002, and support for local production in Niger was considered to help reduce costs. At this point, Plumpy’nut-type milk pastes were limited to the treatment of severe acute malnutrition. The question of cost only really came to the fore after 2006, when MSF advocated wider-scale use of these products.

There was little scientific opposition at the time to the use of ready-to-use milk-based foods for the treatment of moderate acute malnutrition or as preventive dietary supplements in regions where malnutrition was a serious health problem causing high mortality in young children. Because of the cost, however, this kind of strategy was not regarded as realistic, and as such the recommended use of these products was limited to severe cases. It was also stressed that this nutritional strategy would create further economic dependence because of its cost and need for international funding (UNDP, Integrated Regional Information Networks, September 6, 2006).

MSF publicly recognized the economic factor as a problem. It was true that wider-scale use of RUTFs would not be feasible without reducing production costs and increasing funds for nutritional programs.According to a study published in The Lancet (Morris et al., 2008), international funding for malnutrition did not exceed $250–300 million a year for 2000 to 2005. According to the authors, if that sum were distributed in its entirety to the twenty countries with the highest levels of malnutrition, this would only represent two dollars per malnourished child.MSF nevertheless maintained that treatment could not be restricted to severely malnourished children when intervening in regions with high incidences of malnutrition, even in the short term. In countries such as Niger, recommending restricted treatment would lead to queues of starving children, huge therapeutic feeding centers, and inevitable media attention. It was understandable that such a poor image of countries in difficulty was not acceptable to their governments.

 

The Constructive Role of Controversies

This analysis of controversies and public disagreements reveals the conflictual nature of the process of innovation. Cases of malaria and under-nutrition are in no way exceptional, and senior MSF staff members are used to dealing with controversies. It is part of the usual procedure, inseparable from medical care whenever alternative medical practices need to be adopted as the standard. In this document, we have described how MSF deals with such controversies, and what results it has achieved.

MSF treatment protocols regarding ACTs became recognized international recommendations after a period of disagreement. In the treatment of severe acute malnutrition, MSF demonstrated the large-scale feasibility and effectiveness of a strategy set up by several institutions (Institut de Recherche pour le Développement, the WHO, universities, Nutriset) and NGOs (Action against Hunger, Concern).In June 2007 several UN organisations, including the WHO, announced that they recommended home-based care and the distribution of RUTFs as treatment protocols for uncomplicated severe acute malnutrition (WHO, WFP, UNICEF, 2007).

After the 2005 crisis, Nigerien authorities, donor agencies, and international aid agencies adopted several new measures including treatment of severe acute malnutrition at home with new generation foods, treatment of moderate malnutrition with standard cereals, and free medical treatment for children and pregnant women. Unfortunately, apart from centers supported by international organizations, free care for children and pregnant women was not feasible due to lack of funds.

The number of children treated for malnutrition in Niger increased from a few thousand before 2005 to more than three hundred thousand in 2006. But the move towards a medical intervention aimed at reducing the incidence of severe acute malnutrition through early distribution of nutritious foods still attracts criticisms and questions. Local results have not been sufficient to justify implementing these strategies or to end disagreements about the need for epidemiological proof of effectiveness. This is why MSF is launching a debate on the economic and political dogmas used to restrict nutritional programs.

 

Bibliography

Black, R., L. Allen, Z. Bhutta, L. Caulfield, M. De Onis, M. Ezzati, C. Mathers, J. Rivera; Maternal and Child Undernutrition Study Group. 2008. “Maternal and child undernutrition: global and regional exposures and health consequences.” The Lancet 371 (9608): 243–260.

Bradol, J.-H. 2007. “Niger 2005: l’année du biscuit.” In Niger 2005. Une catastrophe si naturelle, X. Crombé, J.-H. Jézéquel, editors. 273–294. Paris, Karthala: MSF.

–––. 2008. “Responses to a seasonal high incidence of severe acute malnutrition, operational lessons and policy changes.” Symposium at “Starved for Attention. The Neglected Crisis of Childhood Malnutrition,” Columbia University, New York, September 11–12.

Collins, S. 2002. “Outpatient care for severely malnourished children in emergency relief programmes: a retrospective cohort study.” The Lancet 360 (9348): 1824–1830.

Crombé, X., J.-H. Jézéquel, editors. 2007. Niger 2005. Une catastrophe si naturelle. Paris, Karthala: MSF.

Enserink, M. 2008. “The Peanut Butter Debate.” Science 322: 36–38.

Gastellu-Etchegorry, M., F. Matthys, M. Galinski, N. J. White, F. Nosten. 2001. “Malaria epidemic in Burundi.” The Lancet 357 (9261): 1046–1047.

Guthmann, J.-P., M. Bonnet, L. Ahoua, F. Dantoine, S. Balkan. 2007. “Death Rates from Malaria Epidemics, Burundi and Ethiopia.” Emerging Infectious Diseases 13 (1): 140–143.

Guthmann, J.-P., F. Checchi, I. Van den Broek, S. Balkan, M. Van Herp, E. Comte, O. Bernal, J-M Kindermans, S. Venis, D. Legros, P. Guerin. 2008. “Assessing Antimalarial Efficacy in a Time of Change to Artemisinin-Based Combination Therapies: The Role of Médecins Sans Frontières.” PloS Medicine 5 (8): 1191–1199.

Jézéquel, J.-H. 2005. “Ici, l’enfant n’a pas de valeur”. Sécurité alimentaire, malnutrition et développement au Niger. Paris: Médecins Sans Frontières.

Kassankogno, Y., R. Allan, C. Delacollette. 2000. Management of malaria in epidemic affected areas of Burundi. Geneva: World Health Organization.

Lemieux, C. 2007. “A quoi sert l’analyse des controverses?” Mil neuf cent, revue d’histoire intellectuelle 25: 191–212.

Morris, S., B. Cogill, R. Uauy. 2008. “Effective international action against undernutrition: why has it proven so difficult and what can be done to accelerate progress?” The Lancet 371 (9612): 608–621.

Nosten, F., M. Van Vugt, C. Luxemburger, K.L. Thway, A. Brockman, R. McGready. F. Ter Kuile, S. Looareesuwan, N.J. White. “Effects of artesunate-mefloquine combination on incidence of Plasmodium falciparum malaria and mefloquine resistance in western Thailand: a prospective study.” The Lancet 356 (9226): 297–302.

Olivier de Sardan, J.-P. 2008. “Introduction thématique. La crise alimentaire de 2004–2005 au Niger en contexte.” Afrique contemporaine 225: 17–37.

Packard, R. M. 2007. The Making of a Tropical Disease. A Short History of Malaria. Baltimore, The Johns Hopkins University Press.

Priem, V. 2002. Évaluation de l’intervention médico-nutritionnelle de Médecins Sans Frontières sur le département de Maradi. Missions Dakoro et Maradi. Août 2001-janvier 2002. Niger. Paris: Médecins Sans Frontières.

Tectonidis, M. 2004. MSF au Niger. Projet nutritionnel de Maradi. Visite du 8 au 19 mars 2004, MSF archives, Paris.

–––. 2005a. Historique et analyse du programme de nutrition de Maradi.

MSF archives, Paris.

–––. 2005b. Prise en charge ambulatoire de la malnutrition aiguë. MSF archives, Paris.

–––. 2006. “Crisis in Niger—Outpatient Care for Severe Acute Malnutrition.” New England Journal of Medicine 354: 224–227.

United States Agency for International Development (USAID). 2005. Niger: An Evidence Base For Understanding The Current Crisis (28 July 2005). Washington: United States Agency for International Development.

World Health Organization (WHO). 2001. Antimalarial Drug Combination Therapy: Report of a WHO Informal Consultation. Geneva: World Health Organization.

–––. 2007. Community-based management of severe acute malnutrition. A Joint Statement by the World Health Organization, the World Food Programme, the United Nations System Standing Committee on Nutrition and the United Nations Children’s Fund. Geneva, Rome, New York: World Health Organization, Standing Committee on Nutrition, World Food Programme, United Nations Children’s Fund.

World Food Programme (WFP), Helen Keller International (HKI). 2005. Évaluation de base de l’état nutritionnel des enfants de 6 à 59 mois dans les régions rurales de Maradi et de Zinder. Rapport de deux enquêtes. Niamey: World Food Programme, Helen Keller International.

World Food Programme. 2006. Annual Report 2005. Rome: World Food Programme.