James Orbinski traveled a long and painful road on his way to the Oslo City Hall podium on December 10, 1999. The Canadian doctor received his medical degree at McMaster University in Hamilton, Ontario, in 1990, and less than three years later found himself in Somalia with Médecins Sans Frontières during the famine, civil war and botched US intervention. When he returned home, he knew things had changed in him forever. As he gave advice to a patient in his small-town practice, a mother having difficulty breastfeeding, she mentioned that his mind seemed to be elsewhere. Orbinski admitted she was right, and when she left his office he sat silently for 20 minutes and realized he couldn’t do this kind of medicine anymore. He closed his office and went back into the field with MSF, first to Afghanistan and later to Rwanda, arriving a month after the genocide began. During one of those terrible days in 1994, Orbinski tried to negotiate with a Hutu commander whose killing squad had surrounded a building filled with Tutsi children. “There was a long pause,” he later told a journalist. “He looked at me and said, ‘These are insects and they will be crushed like insects.’” When the doctor returned the next day, a blue tarp covered the bodies of the children who had been hacked to death.
Orbinski suffered from post-traumatic stress disorder for a year and a half after the genocide — he would see that tarp in his mind over and over, the memory triggered by passing blue cars as he drove along the highway. But whatever ghosts still haunted him in 1996, he was back in Africa, working among the Rwandan refugees who had fled to Zaire.
In 1998, he became the international president of MSF, the first non-European to hold the position. Orbinski is a medical researcher, with a specialty in pediatric HIV, but, like Rony Brauman and other charismatic former leaders of MSF, he’s also a philosopher with a keen understanding of politics (and a master’s degree in international relations). During his three-year tenure as international president, he met with some of the organization’s other big thinkers — including Brauman, Austen Davis, and Jean-Marie Kindermans — to try to draft a mission statement that would illuminate the MSF charter in a way that all the national sections could agree on. At one point, they had at least a dozen sections on side, but no document had been approved. Just then, on October 15, 1999, the news arrived that Médecins Sans Frontières had been awarded the Nobel Peace Prize “in recognition of the organization’s pioneering humanitarian work on several continents.” MSF decided to use this opportunity to lay out its mission in a much more public forum — the Nobel acceptance lecture, delivered by Orbinski in Norway that December.
In a provocative opening, Orbinski set aside diplomatic niceties and immediately called for the Russian government “to stop the bombing of defenseless civilians in Chechnya.” He outlined the humanitarian impulses that have guided the organization over three decades. Then he went on to announce what would become MSF’s next crusade. “More than ninety percent of all death and suffering from infectious diseases occurs in the developing world,” Orbinski said, and tropical illnesses are killing people because “life-saving essential medicines are either too expensive, or not available because they are not seen as financially viable, or because there is virtually no new research and development” into new treatments. “This market failure,” he declared, “is our next challenge.”
And so it was. Along with the Nobel gold medal and diploma, MSF picked up a check for 7.9 million Swedish crowns, equivalent to just over a million US dollars. It wasn’t the largest donation MSF has ever received, but it packed more symbolic punch than any other. MSF decided to use the money to kick-start the Campaign for Access to Essential Medicines.
The term “essential medicines” isn’t just rhetoric. It refers to a list drawn up by the World Health Organization and includes more than three hundred drugs — for everything from HIV to gout — that are considered the minimum needed to set up a basic health-care system. The Access campaign, however, focuses on the developing world’s deadliest diseases, each of which has a unique set of barriers to treatment. There’s leishmaniasis, a parasitical disease in Asia and Africa, currently treated with a 60-year-old drug that is unaffordable for most patients. Sleeping sickness, or human African trypanosomiasis, is carried by the tsetse fly in sub-Saharan Africa and is also treated with a decades-old drug that faces growing resistance — it’s so toxic that it burns when injected, and it fatally poisons up to a tenth of those who receive it. Tuberculosis kills two million people a year and is increasingly drug resistant because most patients do not follow the entire nine-month treatment regimen. As for meningitis, an effective vaccine is available, but too few doses are being manufactured and too little money is pledged to administer them.
Pharmaceutical companies devote little or no research to new treatments for these and other tropical diseases because the promise of profit is negligible compared with drugs for erectile dysfunction, hair loss, obesity and wrinkles. To change this trend, MSF helped found the Drugs for Neglected Diseases Initiative, which coordinates new research and development into ailments that have been ignored by the profit-driven drug industry. This initiative has been the most internally controversial part of the Access campaign, with some arguing that MSF should not be involved in long-term lobbying or R&D. In 2002, after an otherwise unanimous vote in the International Council, MSF-Holland refused to help fund DNDi, as it is called. The dispute dragged on for more than a year before the Dutch reluctantly gave in. In the opinion of many, it reignited the strife between sections that MSF had worked so hard to overcome.
In other ways, however, the campaign’s grand scope has brought together MSFers of many backgrounds — not only the doctors and nurses in the field, but also a determined team of lawyers, pharmacists and lobbyists. Nowhere is this more true than in the fight to deliver treatment for malaria, the infectious disease that has probably killed more human beings than any other in history, and AIDS, the scourge that’s poised to take over that dubious honor.
Unlike leishmaniasis and sleeping sickness, malaria is well known to everyone in the West, though today it’s largely thought of as a historical curiosity like smallpox or the Black Death. Yet it was endemic in many developed countries only a few decades ago — Holland did not eradicate it until after the Second World War. Today, while industrialized countries pour money into public-health bugaboos like swine flu and West Nile virus, malaria quietly kills about a million people every year, mostly children, and 90 percent of them in Africa. To give some perspective: the H1N1 virus was blamed for just over 10,000 deaths in 2009, about one percent of those killed by malaria. For those who need to put monetary figures on this body count, the World Health Organization estimates the annual economic cost of malaria in Africa is $12 billion.
At the root of this devastation are a single-celled organism with an insatiable lust for hemoglobin and a tiny insect with a taste for human blood. Although malaria has been known for centuries, its cause was a mystery until 1880, when French doctor Charles-Louis-Alphonse Laveran used a primitive microscope to examine a malarial blood sample and became the first person to observe the Plasmodium parasite that causes the disease. Seventeen years later, British physician Ronald Ross, working in India, proved that this parasite is transmitted to humans by mosquitoes, a discovery that earned him a Nobel Prize in 1902. About 30 species of mosquito — all in the genus Anopheles — are significant carriers, and when females bite humans they deposit Plasmodium sporozoites into the bloodstream. These spores convene in the liver, where they marshal themselves for two to four weeks before launching an all-out assault on the red blood cells. Once inside the red cells, the parasites feed voraciously on hemoglobin, the substance that carries oxygen around the body. They reproduce quickly and eventually burst through the cell membrane, releasing their offspring to infect other red blood cells.
Four species of Plasmodium cause malaria in humans, although one —P. falciparum — is far more deadly than the others. In addition to fever, symptoms of the disease include chills, muscle aches, headaches, abdominal pain, vomiting, diarrhea and general malaise, though they vary from mild discomfort to sheer misery. Severe malaria can cause jaundice, kidney failure or abnormal bleeding, and the falciparum parasite can enter the brain’s bloodstream — a condition called cerebral malaria — leading to delirium, convulsions, coma and potentially death. In children, falciparum malaria can also kill by causing severe anemia. Adults in endemic areas who have survived repeated infections eventually build up some immunity and usually endure subsequent bouts with only minor symptoms. (Travelers, including MSF expats, who visit endemic areas have none of this immunity and can become severely ill if they fail to take precautions, such as sleeping under a bed net, using insect repellent and taking malaria prophylaxis.) The exception is pregnant women, who lose their immunity and can become dangerously anemic if they contract malaria. Moreover, the parasites converge on the placenta — so much so that they may barely register elsewhere in the body — and retard the growth of the fetus. When these babies are born, they are often too small to survive.
Even in areas where malaria is endemic, it can be extremely difficult to diagnose in underequipped health centers. Ideally, a lab technician should examine the blood for parasites under a microscope; where this is impossible, MSF uses a rapid blood test — similar in principle to a home pregnancy test — that takes only 15 minutes. Done rigorously, both methods are around 90 percent accurate, but lack of training and time lessen that reliability. For doctors who rely only on observing symptoms, malaria is notoriously hard to identify, since many unrelated conditions cause fever, chills and aches. While the diagnosis in young children is often accurate, MSF doctors have worked in areas where 80 percent of adults and kids over five who are thought to have malaria are actually suffering from something else. This misdiagnosis not only leads to wasted medicines and more potential for the drugs to encounter resistance, but also means those patients are enduring some other illness — such as hepatitis, meningitis, pneumonia or typhoid — that’s going untreated. Some end up back in the hospital days or weeks later, while others die at home.
Malaria occupies an important place in pharmacological history. As far back as the 1630s — when doctors still thought illness was caused by an imbalance of blood, bile and phlegm — Jesuit missionaries in Peru discovered that the bark of the cinchona tree, when ground into powder, could be used to cure malarial fever. It was the first time that a chemical compound — later identified as quinine — was successfully used to treat an infectious disease. Almost four centuries later, quinine is still an effective treatment in Africa, but it can have truly unpleasant side effects, including nausea and tinnitus (ringing in the ears), and it is toxic in large doses. Taken orally, quinine is unpalatably bitter, and if delivered intravenously it requires three daily injections. Either way, treatment takes a full week, which can strain the resources of a crowded health center.
In the first half of the 20th century, two new discoveries promised to wipe out malaria for good: chloroquine, a drug first developed in 1934, and the insecticide DDT, introduced in the 1940s. A massive international effort to spray mosquito breeding grounds in the 1950s and 1960s helped eradicate the disease from parts of Europe and Asia, and even in Africa malaria rates declined into the 1980s. By then, however, the falciparum parasite had developed a resistance to chloroquine in many areas. In the 1990s, doctors were encouraged by sulfadoxine-pyrimethamine (SP), but again the adaptable parasite quickly developed a resistance to this treatment, too. MSF now considers chloroquine and SP “virtually useless” in much of sub-Saharan Africa. One or the other, however, is still the first-line treatment in most of these countries.
In October 2002, MSF announced its intention to replace these drugs in all its malaria projects with two-drug cocktails called artemisinin-based combination therapies, or ACTs. Artemisinin, like quinine, is extracted from a plant whose medicinal qualities have been tapped for centuries — an aromatic herb, Artemisia annua, known in its native China as qinghaosu and in the West as sweet Annie, or sweet wormwood. The herb yields a substance that is not only swift and effective in treating malaria — it kills parasites 10 times faster than quinine — but has virtually no side effects. Used alone, artemisinin-based drugs such as artesunate and artemether relieve symptoms in a day or two, though it takes about a week to clear the body of parasites. However, when they are combined with another antimalarial drug — such as amodiaquine, lumefantrine, mefloquine or even SP if there is no resistance — treatment can be shortened to three days, a regimen people are much more likely to complete. More important, the one-two punch of ACTs radically reduces the likelihood that P. falciparum will fight back. The parasite already needs to undergo several mutations to defeat a single drug, so the chances of developing a resistance to two drugs simultaneously are remote. In the decade or so that MSF has used artemisinin combinations — admittedly on a small scale, mainly in Southeast Asia, and in a few feeding centers and refugee camps in Africa — they have shown no sign of losing their potency.
MSF failed to meet its target date of bringing ACTs into widespread use in Africa by the end of 2003, though the organization estimates that it treated 100,000 patients with the therapy that year. It has faced a number of challenges, beginning with what MSF sees as the reluctance of public-health decision makers to get behind the new drug. The general trend in malaria control is toward prevention — spraying during epidemics and distributing insecticide-treated bed nets — rather than treatment. The Global Fund to Fight AIDS, Tuberculosis and Malaria pledged $30 million over five years to purchase artemisinin-based drugs, and Roll Back Malaria — a WHO-founded joint venture — called them “the way forward for treating malaria.” But all these initiatives moved far too slowly for MSF. In November 2003, the organization assembled an international team of malaria experts and drafted a letter to Roll Back Malaria, arguing that its new four-year plan was “a backward step in malarial control” that would “reverse more than five years of consultation and expert opinion.” As for other NGOs that are still using the older drugs, UK physician Christa Hook, one of the architects of MSF’s malaria strategy, puts their resistance down to financial dependence on Western governments, and an inclination “not to pioneer.”
“The other main problem,” says Hook, “is that in some countries there’s a very strong bureaucracy, a very strong ministry of health that is not allowing us to use ACTs. Within such countries, we sometimes have totally independent facilities — for example, we might run a mobile clinic, or a therapeutic feeding center, which is not ministry of health at all — where we can introduce ACTs, despite the country not changing its policy. We’ve used it in refugee camps because, again, they’re separate — they’re run entirely by NGOs, or UNHCR.”
MSF has grown accustomed to ruffling the feathers of UN agencies and other aid organizations, but its zeal for artemisinin has even rankled health ministries in some of the countries where it works. In Ethiopia, where a malaria epidemic threatened 15 million people in 2003, MSF lobbied hard for the immediate introduction of artemisinin combinations, only to find opposition from UNICEF, the local WHO official and the Ethiopian authorities. The health ministry argued that it was inappropriate and unethical to introduce a treatment in the middle of an epidemic and preferred to wait for the results of its own studies before introducing ACTs. On December 23, health minister Kebede Tadesse attacked MSF in a bombastic press release:
[MSF’s] track record is exemplary and we are very grateful to the many devoted volunteers for their unreserved contributions … However, for reasons not well known to us, and based on their totally unscientific and unverifiable observations of the present malaria situation in a few localities, [they] have embarked on a concerted campaign of misinformation and peddling of new and uncalled for drugs and treatment regimes. We have tried to reason out with them repeatedly, but they have become unamenable to ration [sic] and are progressively resorting to dictatorial mechanisms to have their views and ways of doing things accepted. We would like to point out that any health authority of a sovereign and democratic country, however poor and short of essential resources it may be, is duty-bound to strictly follow the rules and regulations set by its government … It is unbecoming of MSF to try to disrupt such norms and good standards of ethical practice, so as to fit with their newly acquired whims and erroneous expectations …
It is obvious that they are unfairly taking advantage of their access to reputable journalists and media and the unlimited time and resources at their disposal, which we are unfortunately less endowed with. We would like to take this opportunity to publicly appeal to MSF leadership, once again, to come to their senses, and restrain from unnecessarily diverting us from our primary and urgent task of attending to the sick and alleviating their sufferings. It pains us to see a once exemplary organization being led by charlatans masquerading as the sole agents of medical and scientific knowledge and wasting valuable time in activities far beyond their commendable humanitarian mandate, which by the way, is still in high demand.
Hardly anyone now questions the effectiveness of ACTs, and Hook rejects the argument that they are untested — some combinations have been used since the 1980s and their safety has been well documented. The one exception is in treating women in the first trimester of pregnancy; for them, only quinine is safe and effective. What, then, is behind the objections to the new treatment? The main issue is price: a full course of ACTs is many times more expensive than a regimen of chloroquine or SP, and the price for artemisinin is extremely volatile — it tripled between 2004 and 2007. The current supply of the drugs is also limited — there is certainly not enough to treat 300 million new cases a year — and they have a relatively brief shelf life.
Aside from economic factors, even health ministries that acknowledged the benefits of ACTs moved cautiously to determine the best drug pairing and to gain experience in administering the new treatments. Ideally, the two medications are put together in a “fixed dose combination,” a single pill to be taken once a day. The next best option is combining two individual pills in a blister pack, which makes it clear to the patient that they need to be taken together. Artemisinin-based drugs can also be given by daily intravenous or intramuscular injections.
Finally, a few governments have worried that if they treat some patients with ACTs now, they’ll set a precedent they won’t be able to sustain. “It’s a fair concern,” says Hook, but she wonders why UNICEF won’t pledge itself to that goal. “Nobody expects countries to pay for all their vaccines — UNICEF pays for the lot. So why do they make a difference between vaccine-preventable disease and diseases which kill a damn sight more children, like malaria?” Hook was encouraged that UNICEF joined MSF in co-sponsoring a symposium on ACTs in April 2004. “Hopefully, we are entering a new phase of cooperation, with clarity about the need to change to effective drugs. It will certainly make a big difference if UNICEF speaks out.”
For Christa Hook, the debate comes down to a fundamental humanitarian idea. “If you treat and cure one person with malaria, then you’ve done good. And if you introduce the treatment into a refugee camp, or a crisis where malaria is even worse than it normally would be, I can’t see people saying, ‘We can’t do it next year, so we won’t do it this year.’ That’s nonsense. I think it’s totally wrong to say to someone, ‘I’m sorry, I’ve got the means to save you, but I don’t want to think that next year maybe I couldn’t.’ We try to make sure that treatment will be available next year, but we can’t guarantee it. And it’s not MSF’s job to guarantee it, it’s the country’s job. Sometimes we get field people from very developmental backgrounds who don’t want to do anything unless they can see what’s going to happen in ten years’ time. Ten years’ time can take care of itself — there might be a vaccine by then. Let’s save the people who are dying this year.”
In April 2009, the Global Fund, Roll Back Malaria, several European governments and other partners launched the Affordable Medicines Facility for malaria program (AMFm) to try to reduce the cost of artemisinin-based drugs. Their goal is to bring down the wholesale price of ACTs from $4 per dose to $1, and then to subsidize 95 cents of that amount with donor funds. That should drive the retail cost of ACTs so low that they will be able to force older treatments like chloroquine and SP out of the market for good.
There’s a story that’s made the rounds in MSF about a patient in Kenya, a teacher suffering from AIDS-related meningitis. His drug regimen, which offered no hope of a cure, cost about $20 a day, and after exhausting his savings in a few weeks, the man began to sell his furniture and possessions. When that money ran out too, he planned to sell his house. An MSF physician eventually talked him out of that decision, which would have left the man’s family with nothing, and instead helped the teacher plan for his inevitable death. The doctor wondered why, instead of being able to prolong his patient’s life with affordable medicines, he was reduced to making funeral arrangements. That feeling of helplessness goes some way in explaining why AIDS has become the highest-profile disease in MSF’s Access campaign.
Malaria and AIDS differ not only in their pathology and the way they’re transmitted but in hugely important cultural ways. With proper treatment, malaria can be quickly and completely cured; people infected with HIV, in contrast, need daily medication for the rest of their lives. Malaria carries no stigma and presents far fewer societal hurdles for doctors delivering treatment. Perhaps most important, at least when it comes to fighting for access to medicines, HIV infects about two million people in North America and Europe. That means there is a vocal, well-funded, and well-organized group of activists in the West who are willing to be advocates for HIV-infected people in the developing world. And that pressure seems to be having an impact.
In 2003, the United Nations estimated that more than 40 million people in poor countries were living with the virus and, of the six million patients who required immediate antiretroviral (ARV) treatment, only about eight percent were getting it. Aid agencies have been almost paralyzed by these overwhelming needs, and many within MSF feel the organization was too slow to get involved in HIV treatment. The Belgian office established a free and anonymous AIDS clinic in Brussels in 1988, when much of the world was still in denial about the global scope of disease, but by 2001 the organization as a whole was treating just 600 AIDS patients in eight projects worldwide. Before 2003, the Belgians were active only in South Africa and Thailand. MSF-France treated its first patient with ARV triple therapy (a combination of three drugs that prevent the virus from replicating) in late 2000 in Thailand, while MSF-Holland showed “no real commitment to HIV until November 2002,” admits Richard Bedell, who cites a number of reasons for these delays. To begin with, HIV programs, like those targeting malaria, were focused on prevention until 1996, when triple therapy emerged to make treatment possible. The drugs can now cut mortality rates by more than 80 percent. Although medical humanitarian organizations recognize that disease prevention is important, they don’t always see a role there for themselves; certainly it has never been at the core of MSF’s work. “But it just became more and more obvious that we couldn’t turn away from this,” Bedell says. “It was too important, too compelling. There’s a powerful humanitarian argument for AIDS treatment. We don’t know that it will change the epidemiology, but by demonstrating that people with HIV are worthy of being cared for, you humanize the whole disease, you change the attitude toward it.” Once the commitment was there, MSF’s programs grew rapidly, with the goal of bringing ARV therapy to 25,000 patients in 25 countries by the end of 2004.
MSF decision makers continue to feel overwhelmed by the scope of the AIDS crisis and wonder how a single aid group can really have an impact. “This a huge problem that requires society-altering changes,” says Bedell. “We’re not the WHO, we can’t do all of that. Meanwhile, the whole range of other humanitarian needs hasn’t disappeared, of course.” Moreover, before an organization can begin treating people for HIV, many other systems have to be in place, including the means for testing and counseling people confidentially, and an effective program for treating tuberculosis, the leading cause of death in HIV-infected people. Of the 6,000 patients receiving ARVs in MSF-France projects in 2004, up to two-thirds had TB. Most important of all, you need affordable drugs, and before 2002 there simply were none. The price of triple therapy was at least $10,000 per person every year. “We would have a hard time justifying the use of ten thousand dollars a year on a very small number of patients,” Bedell says, “unless we thought it was part of a strategy to move toward something cheaper.”
It was part of a strategy — one that goes way beyond MSF, of course, and includes Oxfam, Health Action International and innumerable other activists. Together, they succeeded in driving down the price of ARVs in 2002, and less than two years later generic versions could be bought in some countries for as little as $200 annually per patient. The work has been grueling — it’s taken humanitarians into the byzantine world of patent law and international trade summits — and it’s far from over. But even MSF admits the drop in prices happened more quickly than even their most optimistic forecasts.
At the center of the issue are the patents that countries grant to pharmaceutical companies, giving them a monopoly and the right to charge prices that exponentially exceed their production costs. Between 1986 and 1994 — a period that saw AIDS grow into a global pandemic — the World Trade Organization drew up the Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS. National governments still have widely different laws covering copyright, patents and other intellectual property, but TRIPS sets minimum guidelines that all member countries eventually have to follow, such as making sure that patented products, including medicines, are protected from competition for at least 20 years.
However, TRIPS allows governments, at least ostensibly, to make certain exceptions. For example, governments may issue “compulsory licenses” that permit local manufacturers to produce and sell cheaper generic versions of a patented drug during a public health crisis. A similar provision allows “parallel importing,” or the right to purchase generic drugs from another country without the permission of the patent holder. These generic drugs, often manufactured in India or China, can be bought for a fraction of the cost that patent holders charge because their manufacturers don’t have a monopoly and don’t have to recoup money invested in research or clinical trials. The drugs are of comparable quality, and they must be approved by the same national authorities that approve the patented variety. They offer another benefit as well. In triple therapy for HIV, for example, the three drugs may be patented by three different companies with no interest in combining them. A generic firm, however, can put them into a single pill and make it much easier for patients to stay on their regimen. The Indian generic manufacturer Cipla offers a popular fixed-dose combination called Triomune.
The flexibility in the TRIPS agreement was supposed to balance two legitimate interests: the right of a company to benefit from its investment in R&D, and the right of people to purchase life-saving medicines at an affordable price. The problem is that rich countries have a greater stake in the former, while poorer nations gain from the latter, setting the stage for an unfair fight. And the TRIPS provisions are vague, leaving African countries to wonder how liberally they can interpret them without facing reprisals from wealthy countries with powerful pharmaceutical lobbies. It didn’t take long to find out. When South Africa passed a law in 1997 that allowed the import of generic drugs to treat AIDS, it was immediately challenged by 39 drug companies. After four years of intense pressure from AIDS patients and international organizations — including MSF, whose “Drop the Case” petition garnered 293,000 signatures — the companies backed down in the face of overwhelmingly bad PR. In the meantime, hundreds of thousands of South Africans succumbed to AIDS.
In the wake of that dispute, African nations asked that the trade agreement be clarified at the World Trade Organization’s (WTO) ministerial conference in Doha, Qatar, in November 2001. In the months leading up to that summit, antiretrovirals for developing countries were the focus of the battle for access to affordable generic medicines. Then something happened to bring the issue home for North Americans.
In October, just weeks after the terrorist attacks on New York and Washington, five people died in the United States after opening letters laced with anthrax spores. In response, millions of North Americans clamored for ciprofloxacin, an antibiotic that can be used for anthrax prophylaxis. In both the United States and Canada, this drug was patented by Bayer Corporation and sold under the name Cipro, to the tune of over a billion dollars a year. With the increased demand during the anthrax scare, Bayer charged pharmacies a wholesale price of $4.67 per 500-milligram tablet; a one-month supply, then, would cost the average American over $700. Meanwhile, in India, where ciprofloxacin is not patented, Bayer was selling it in a competitive market for about $17 a month — and still making a profit.
When the US Department of Health and Human Services asked Bayer to provide 100 million doses for its emergency stockpiles, the company offered them at $1.83 apiece — a considerable discount, but still far more than the government was willing to pay. Health and Human Services reportedly discussed invoking the TRIPS provisions and a little-used US law to get around Bayer’s patent, since generic manufacturers were offering them ciprofloxacin for as little as 40 cents a pill. Health Canada, which also has strict limits on compulsory licensing, actually placed an order with a generic manufacturer, though it later canceled the deal after Bayer threatened to sue. In the end, neither government violated the patent, and it’s not even clear that the United States seriously considered doing so, knowing that its double standard would be exploited in the upcoming Doha conference. In any case, Bayer was compelled to reduce its price radically to 95 cents a dose, and both countries got a taste of what it was like to have a potentially life-saving drug controlled by a profit-driven company with a monopoly.
When the WTO delegates met in Doha in November, they hammered out an agreement that clearly put public health interests above profit. The agreement explicitly recognized the suffering caused by AIDS, tuberculosis and malaria and it stressed that TRIPS “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.” The poorest countries were told they did not have to grant pharmaceutical patents until 2016. The Doha agreement also confirmed their right to manufacture or import generic versions of essential drugs, and not only during emergencies; however, the delegates could not agree about whether generic manufacturers should be able to export drugs to countries unable to make their own, since TRIPS states that compulsory licensing is intended “primarily for the supply of the domestic market.” The upshot for poor countries was that their right to import cheaper drugs was effectively rendered meaningless, since other nations wouldn’t be allowed to fill their orders.
The WTO members agreed to resolve the sticking point by the end of 2002. After intense negotiation they missed that deadline, but they finally reached a decision on August 30, 2003. Again, public health prevailed. The agreement allowed generic manufacturers to export drugs to countries that lack the ability to produce them, provided they meet several conditions: they must openly declare these exports to the WTO, for example; and they are asked to use special packaging, coloring or shapes designed to prevent the drugs from being diverted and sold illegally in other countries. Western nations fought for even stricter controls, including limits on which diseases constituted a public health problem, but were unable to obtain them. “The final piece of the jigsaw has fallen into place,” the head of the WTO boasted after the agreement, “allowing poorer countries to make full use of the flexibilities in the WTO’s intellectual property rules in order to deal with the diseases that ravage their people. It proves once and for all that the organization can handle humanitarian as well as trade concerns.” MSF acknowledged the progress, but remained skeptical about whether these agreements will have any teeth: “Trade rules and declarations are one thing on paper,” it declared in a press release, “but they will only mean something to sick people when countries begin to put them into practice.”
MSF continues to argue that many governments are afraid to take advantage of compulsory licenses, fearing retaliation from developed countries where the pharmaceutical industry has a powerful lobby, especially the United States. It took until early 2007 for Thailand to successfully import generic versions of two HIV drugs, which they obtained from India for as little as one-sixth the price demanded by the patent holder. Thai officials say they were under enormous pressure from American diplomats, and they feared Thailan would end up on the US’s trade blacklist; however, by 2009, the fears of an economic backlash seemed to be unfounded, AIDS patients were still receiving free treatment, and MSF was calling Thailand’s experience a success story.
But there have been just as many setbacks. In the spring of 2004, Canada became the first industrialized nation to pass a law that ostensibly allows generic manufacturers to export affordable drugs to poorer countries. The legislation was heralded as a leap forward by many observers, but not by MSF officials, who said the bill had too many limiting clauses, such as a list of eligible drugs that didn’t include fixed-dose combinations for treating HIV. More than five years later, only one country, Rwanda, had received triple-combination AIDS drugs under Canada’s Access to Medicines Regime. In the fall of 2009, Apotex, the generic manufacturer who developed the drug for Rwanda after consulting with MSF, said the ordeal was so difficult that they “would think very long and hard about whether we could put this kind of investment and effort forward to repeat the process.”
MSF and its allies showed that the price of antiretrovirals could decrease by a factor of at least 30 without bankrupting pharmaceutical companies. Activists have pushed AIDS to the top of the public health agenda, and they have had the right to affordable treatment set out in international trade agreements. But with every step forward, there’s always someone tugging a little harder on the leash, and doctors are still planning funerals for their patients. MSF is well aware that it can achieve only so much. “It’s so much bigger than us,” says Richard Bedell, “but we can’t be paralyzed by the absence of a perfect solution.”
Malaria and AIDS were obvious places to begin the Access to Essential Medicines campaign, since effective drugs for both diseases were available at the time, even though they were not getting to those who needed them most. When the Access campaign began in 1999, however, malnutrition was not in the same category. Food aid alleviated hunger, but there was no “essential medicine” with the potential to treat malnutrition on a large scale.
According to the World Health Organization, malnutrition affects about 178 million children around the world, and as many as five million die every year. Those numbers are staggeringly large, which is why conquering malnutrition has long seemed like a pipe dream. It is a problem so big, with such deep underlying causes, that even the most idealistic humanitarian might have been forgiven for thinking that only a tiny percentage of these children could be saved. But that has changed since the turn of the millennium. No one is talking about ending world hunger, but saving millions of children from malnutrition — an important distinction — seems possible for the first time in history. “In the first decade of the twenty-first century,” says Susan Shepherd, an American pediatrician who coordinates MSF’s Nutrition Working Group in New York, “there is no doubt that we have treated far more children for acute malnutrition than were treated in the entire twentieth century.”
MSF’s Starved for Attention campaign, launched in 2007, grew out of the organization’s experiences in Niger, where thousands of children starved to death during the terrible food crisis that peaked in 2005. That year, Niger was ranked as the poorest nation on the planet by the UN’s Human Development Index, and the country was the center of an enormous international aid effort: NGOs treated about a quarter of a million malnourished children. By September, because of a combination of drought and high food prices, the World Food Programme estimated that 1.2 million people in Niger were still experiencing “severe food insecurity.”
Although the situation in Niger captured the world’s attention in 2005, malnutrition in this west African country is rampant even in years with good harvests. According to UNICEF, 40 percent of Niger’s children are chronically undernourished. The hunger follows a seasonal pattern that is typical in the region: when MSF began its first nutrition programs in the Maradi region, where malnutrition is particularly acute, they noticed that the feeding centers were especially crowded between June and September, the so-called “hunger gap” that occurs just before the annual harvest.
During 2005, MSF treated more than 63,000 severely malnourished children in Niger, with 38,000 of those in Maradi alone. It was, by a wide margin, the largest nutritional intervention MSF had ever done. But it wasn’t just the sheer size of the Niger projects that set them apart, it was the way the tiny patients were treated. In years past, severely malnourished children typically spent several weeks in a therapeutic feeding center — a specialized nutrition hospital. This ordeal is a burden on the children’s family, who are forced to be away from their work in the fields and their household duties, including looking after other children. It also means that the medical teams could only handle the most serious cases. “It’s not safe to build nutrition hospitals that have more than two hundred beds,” Susan Shepherd explains. “You just create more trouble: you transmit more infections and you hurt more than you help.” So MSF experimented with a new strategy. If an examination found anorexia, severe swelling or other serious illness, the child was admitted to the hospital. But if the malnutrition was uncomplicated, the child was sent home with a week’s supply of Plumpy’nut, one of a relatively new breed of products called ready-to-use therapeutic foods (RUTFs). The MSF staff explained to the mother or caregiver that the child should eat two 92-gram packets of Plumpy’nut each day and return to the feeding center in a week for a checkup.
The success of this outpatient strategy was remarkable: the overall cure rate for MSF’s 2005 programs in Niger was over 91 percent, compared with 83 percent the year before, and the mortality rate was nearly halved, from 6 percent to 3.2. What’s more, these excellent results came at a time when the demands on MSF’s resources were stretched to the limit by the number of children showing up at the feeding centers. It seemed that giving families the means to feed their children at home prevented many uncomplicated cases of malnutrition from becoming life-threatening. Buoyed by its early success, MSF treated more than 150,000 acutely malnourished children in 22 countries during 2006, with similar results. That number swelled to 300,000 children in 2008. Suddenly a problem that seemed overwhelming, even hopeless, had a potential solution.
There are a couple of reasons why the treatment of malnutrition has taken a quantum leap since 2005. The first is a growing understanding that children under three years old have different nutritional needs from adults. “In addition to breastmilk, children need extra proteins, vitamins and minerals in their diet, and these nutrients must be of good quality so their bodies can easily assimilate them,” says Shepherd. “The vast majority of malnutrition develops in the first two to three years of life, when children are going through a rapid growth phase. It affects not only their skeleton and their muscles, but everything in their bodies, including the brain.” Corn, rice, wheat, millet and cassava — staples in Africa and South Asia — can’t provide growing children with all these essential nutrients, Shepherd explains, nor can the fortified blends that are a main component of international food aid. “For the last twenty years we had been treating the worst of the worst in nutrition hospitals with therapeutic milk, while everyone else was getting a corn-soya blend, and nobody questioned the nutritional value of that. We now realize that corn-soya blend is just not an appropriate food for young, growing kids.”
When essential proteins, vitamins and minerals are lacking in a child’s diet, the immune system can quickly break down. That puts malnourished children on the road toward any number of life-threatening diseases. “In North America and Europe, kids get bouts of respiratory illness, cold viruses and diarrhea, but usually this doesn’t develop into a severe infection,” Shepherd says. “Unfortunately, for kids in sub-Saharan Africa or in South Asia who are malnourished, their immune system is compromised, and a common cold virus can turn into pneumonia. They may get better for a time, but a lot of vitamin and mineral deficiencies suppress the appetite. So these kids don’t regain their weight loss, and then they are more vulnerable to the next infection that comes around. You get this vicious circle of deficient diet, infection, weight loss, failure to regain weight, on and on.”
Irish physician Michael Golden pioneered specialized foods for treating malnourished children in the 1970s. Working with a small number of patients in Jamaica, he helped create the first therapeutic milk, made from milk powder and oil, and fortified with all of the essential micronutrients that growing children need. Golden eventually drew up guidelines for the World Health Organization that explained how to safely treat children with these milk formulas, which came to be called F75 and F100, according to the number of calories in each dose. The aid group Action Contre la Faim (Action Against Hunger) was the first to bring therapeutic milk into widespread use in its programs in 1994. It was a life-saving innovation, but it has some serious limitations: the milk powder must be carefully mixed with clean water under sterile conditions in a hospital, and it is only safe to drink for two hours after mixing. That makes it unsuitable as a take-home treatment.
The inspiration for a new product that would solve those problems came one day in 1997. French pediatric nutritionist André Briend was working in Malawi when he noticed that the mix of lipids, sugar and protein in the WHO’s recommended diet for treating malnourished children was similar to that of Nutella, the popular chocolate and hazelnut spread. Briend borrowed a blender from a nearby restaurant and began experimenting, eventually creating a spread from milk powder, peanuts, peanut oil and sugar, fortified with the same vitamins and minerals as F100, but which does not need to be mixed with water. The French food manufacturer Nutriset patented the product as Plumpy’nut and packaged it in individual foil wrappers that preserve it for long periods and make it easy to distribute to families.
Revolutionary as Plumpy’nut and other ready-to-use therapeutic foods were, they would not have been as effective without equally innovative ways of identifying severely malnourished children, which is not as simple as it may sound. Aid organizations have traditionally used weight-for-height guidelines to diagnose malnutrition in the field, because more thorough clinical examinations just aren’t practical. But even comparing a child’s weight and height requires two careful measurements, precisely calibrated scales, and tables of numbers that can be confusing for community health workers to use. More recently, MSF has used a simple tool nicknamed the “Bracelet of Life,” a color-coded band used to quickly measure the child’s mid-upper arm circumference (MUAC). If the sliding gauge lands in the green area (more than 135 millimeters), the child is adequately nourished, while orange indicates moderate malnutrition and red indicates a severe case.
When the MUAC bracelet was introduced, a measurement of 110 millimeters was the cutoff for severe malnutrition. However, newer guidelines set by the World Health Organization are more stringent, and many children once considered only moderately malnourished are now classified as severe. At one nutrition program in Burkina Faso, MSF set the cutoff for severe malnutrition at a MUAC measurement of 120 millimeters, and that seemingly small change has turned out to make a dramatic difference in the way children are treated: by identifying severely malnourished kids earlier, MSF can start them on RUTFs at home before they become so ill that they need hospitalization. “Children identified as severely malnourished graduate from the program after they have received the therapeutic food for a minimum of four weeks and their arm circumference is at least a hundred and twenty-five millimeters,” says Shepherd. “In our programs in Burkina Faso, we’ve found that eighty to eighty-five percent of the children never have to come to the hospital. They can be managed completely at outpatient clinics and at home by their mothers. We’re hoping that this is a model that we can try in other areas as well.”
Unfortunately, the widespread use of ready-to-use therapeutic foods has been slowed by the same kinds of issues that prevented antiretrovirals from getting to HIV patients for so long. MSF points out that although donor countries spend billions on food aid every year, less than two percent is actually targeted to malnutrition. One of the reasons that RUTFs are not more widely produced is that Nutriset holds a patent on the Plumpy’nut recipe. Late in 2009, MSF penned an open letter that criticized the company for threatening one of its competitors with a lawsuit over intellectual property. “It appears,” MSF wrote to Nutriset, “that you have decided to adopt a policy of aggressive protection of your patents that could be considered an abuse in relation to humanitarian products.” As with the legal wrangling over affordable AIDS treatment, the issues surrounding access to RUTFs will likely take years to resolve. In the meantime, 178 million children await the outcome.