G8: Drugs for neglected diseases

The vast majority of people dying of neglected diseases live in poor countries, and the African continent is home to most. Effectively, the health needs of a large part of the world's population are ignored.
Infectious and parasitic diseases in poor countries cause incalculable suffering, killing more than 12 million people a year. MSF volunteers and doctors working in more than 400 projects in over 80 countries witness this first hand. Most of these diseases are preventable or treatable. However, appropriate medicines are increasingly unavailable due to increasing drug resistance, discontinued production or the high cost of drugs, and, not least, the lack of ongoing research and development for new or innovative treatments for neglected diseases. Neglected diseases are seriously disabling or life-threatening diseases for which treatment options are inadequate or do not exist, and for which drug-market potential is insufficient to readily attract a private sector response. They fall into two categories: those such as malaria and tuberculosis (TB), for which some pharmaceutical market exists in wealthy countries, attracting some private R&D efforts; and those such as African sleeping sickness, kala-azar, Chagas disease, and lymphatic filariasis, for which the market has completely failed. The vast majority of people dying of neglected diseases live in poor countries, and the African continent is home to most. Malaria, for example, kills more than one million people every year, 75% which are African children. Infectious diseases also keep poor people - and their countries - poor. By some estimates, malaria has cut sub-Saharan Africa's economic strength in half. The recent announcement that researchers have cracked the genetic code of the malaria parasite should give hope to those at risk. Indeed, new medicines are badly needed, as the current treatments are less and less effective as resistance to old drugs develops. Unfortunately, it is an open question as to whether this knowledge will be translated into rapid development of new drugs to treat malaria. Why? The answer is simple: because the people most affected by malaria will not be able to afford to pay for new medicines. The same is true for sufferers of tuberculosis, a disease that researchers also know a great deal about but for which few new treatments have been developed in over 30 years. The situation is even worse for other neglected diseases such as African sleeping sickness and kala-azar. The last few decades have witnessed the discovery of innovative treatments for everything from cardiovascular diseases and cancer to baldness and impotence. But innovative medicines are typically developed for profitable - or healthy - markets, not for the health needs of the world's majority.
African sleeping sickness is a parasitic disease transmitted by the tsetse fly, which affects 500,000 people every year and threatens a further 60 million in 36 African countries. An estimated 150,000 people died of sleeping sickness in 1996 alone - the most recent year for which best estimates exist. If left untreated, the disease is 100% fatal. Yet the most common treatment contains arsenic, is extremely painful when injected, and kills one in every twenty patients treated. Even for those who do survive the side-effects of treatment, there is still no guarantee of a cure: growing resistance means that the drug fails in 25-30% of cases in some areas. For these people, the failure to create effective, affordable and innovative treatments means certain death. Unless this crisis is addressed, the number consigned to this fate will continue to grow as drug resistance increases. Kalazar is another parasitic disease that kills many thousands of people every year, most of them in Africa and Asia. More is known about the molecular biology, immunology and genetics of sleeping sickness and kala-azar than any other parasitic organism. Yet virtually no new medicines have resulted from this wealth of knowledge. The last few decades have witnessed the discovery of innovative treatments for everything from cardiovascular diseases and cancer to baldness and impotence. But innovative medicines are typically developed for profitable - or healthy - markets, not for the health needs of the world's majority. Effectively, the health needs of a large part of the world's population are ignored. Over the last 25 years, less than 1% of all new medicines developed globally were for tropical diseases and tuberculosis - diseases that account for more than one tenth of the world's illness and death. Purchasing power, not need, is defining drug research priorities. Only 10% of global health research money is devoted to conditions that account for 90% of the global disease burden. Last year, the total global expenditure on health research was estimated at US$60-70 billion. Of this, less than US$70 million was spent on developing new and badly needed treatments for malaria, tuberculosis, African sleeping sickness and kala-azar. Publicly funded researchers generally concentrate on basic medical discoveries. Bringing such promising discoveries to market is almost always done by the work of pharmaceutical companies, which have no incentive to produce medicines for people who cannot pay. A Harvard University survey of eleven top-grossing pharmaceutical companies showed that, in the last five years, none had brought a drug to market sleeping sickness, kala-azar and Chagas disease - three of the most neglected diseases and that their drug development pipelines for these diseases were virtually empty. This reflects a chronic crisis of neglect that began with the withdrawal of colonial interests from the developing world. This crisis in drug research and development for neglected diseases represents a fatal imbalance between developed and developing countries. Addressing it will require a change in the way medicines for neglected diseases are defined. They should be considered public goods, not consumer products.
Public policy failure compounds this market failure. Having left drug development to the most profitable industry in the world, governments are failing their responsibility to meet the health needs that the market fails to address. Patents are granted with the aim of stimulating innovation, but a market monopoly is irrelevant when the market is non-existent. No amount of market tinkering will stimulate drug companies to invest in drug development for kala-azar or African sleeping sickness patients in Sudan or the DRC. These people are too poor to constitute a 'viable market' to attract private sector investment. In recent years, we have witnessed some efforts towards finding solutions for certain neglected diseases. Public-private partnerships, such as the Global Alliance for TB Drug Development and the Medicines for Malaria Venture, have been set up to research and develop new medicines for TB and malaria respectively. These rely on potential Northern markets to stimulate research and development of new treatments: tourists get malaria and TB affects the Western world. While it is too early to assess how successful these partnerships will be, their existence certainly contributes to making the situation less hopeless. Philanthropic actors are also contributing: the Bill and Melinda Gates Foundation alone is responsible for the single biggest boost to the fight against tropical diseases in recent years. But charity, while certainly welcome, is not a long-term, sustainable solution, especially for the most neglected diseases where no viable market exists in the developed or the developing world. Ensuring the development of life-saving medicines should not be based on philanthropic donations or a coincidence of government and industry interests. This crisis in drug research and development for neglected diseases represents a fatal imbalance between developed and developing countries. Addressing it will require a change in the way medicines for neglected diseases are defined. They should be considered public goods, not consumer products. New approaches for drug research and development should not be driven by return on investment, but by need. Here, governments must become directly responsible in searching for solutions. Essential research obligations for neglected diseases for the pharmaceutical industry should be set. A needs-based research agenda for the most neglected diseases must be defined at the international level and adequate public funding allocated to ensure that these needs are properly addressed. Not-for-profit drug research capacity must be supported, especially in those countries affected by neglected diseases, so that the capacity to address them is closest to the need. Capacity building in, and technology transfer to developing countries should be key elements in meeting this public responsibility. Ultimately this is a matter of political responsibility to mobilize necessary expertise and funds. The current spending on bio-terrorism by Western governments shows what resources can be marshalled when diseases are identified as a national threat. On the other hand, current pledges to the UN's Global Fund to fight AIDS, tuberculosis and malaria - a fraction of what is required to fight these diseases which collectively kill seven million people each year - show how slow political commitment can be when diseases are not seen as a national concern. As G-8 leaders gather in Kananaskis, they should give high priority to the issue of generating drug research and development for neglected diseases in Africa and elsewhere in the developing world. National self-interest and profit prospects can no longer be the single motor of medical research and development. Advances in science and medicine can contribute to alleviating the suffering and meeting the critical medical needs of the millions who die of neglected diseases in the developing world. For this to happen, serious political leadership is required. It means acting on what is a public duty to equitably address health issues at a global level for people in both developing and developed countries. James Orbinski, MD, is chair of the Médecins Sans Frontières /Doctors Without Borders Drugs for Neglected Diseases Working Group. Bernard Pécoul, MD, is director of the Médecins Sans Frontières Access to Essential Medicines Campaign.