Provided by Ralph Nader and the Center for Study of Responsive Law.

P.O. Box 19312
Washington, DC 20036

President William Jefferson Clinton
The White House
1600 Pennsylvania Avenue NW
Washington, DC 20500

February 3, 1998

Dear President Clinton:

During your recent State of the Union address, you called for a substantial increase in Federal spending for basic biomedical research in the forthcoming budget. As you are aware, enhancing biomedical research funding and the budget of the National Institutes of Health has bipartisan support in Congress.

While the United States prepares to invest more heavily in research and technologies for public health, I am writing to ask that the needs of the world's poor, who suffer greatly from infectious diseases, be given special attention in the funding process. As Vice-President Gore, speaking before the National Council for International Health in 1996, recognized, emerging infectious diseases are among "the most significant health and security challenges facing the global community". Yet, despite the importance of this challenge to America, our commitment, both before and after Mr. Gore's onetime priority call, to researching the vicious, re-emergent scourges of the developing world remains embarrassingly low.

In this letter, I focus on the example of malaria: a disease which is an everyday fact of life in the developing world, but for which there is very little research funding. Although last year was the centenary of the discovery of the cause of malaria (it is caused by a parasite transmitted by the bite of an infected mosquito), the disease remains an epidemic of undiminished force at the end of the millennium. In the words of the World Health Organization:

Malaria is endemic in 91 countries, with about 40% of the world's population at risk. Each year there are 300-500 million clinical cases of malaria, 90% of them in Africa, and between 1.5 million and 2.7 million deaths. Among all infectious diseases, malaria continues to be one of the biggest contributors to disease burdens in terms of deaths and suffering. By undermining the health and capacity to work of hundreds of millions of people, it is closely linked to poverty and contributes significantly to stunting social and economic development...[And] in many parts of the world, malaria is becoming an even greater problem than before.1

Numbers like these are so alien to American experience that they are hard to comprehend. To envision the number of children killed by malaria annually, imagine seven jumbo jets, full of children, crashing every day. To get a sense of malaria's ubiquity in the tropical world, consider that if Americans, rather than Africans, were malaria's victims, every American would be hospitalized on average once a year. Many would be hospitalized twice.

As if this were not enough, malaria kills the weak and rends the fabric of families. Children under five years old are much more likely to die of malaria than adults: about a million African children are killed by the disease each year2 -- or one child in twenty.3 Women, too, are especially vulnerable. By the simple act of pregnancy, a woman increases her risk of of serious or lethal malaria by four-fold.4 If she is lucky enough to survive, malaria will frequently cause reduced birthweight in her infant. The parasite can even infect her fetus, condemning her newborn to begin life with malaria.5

Yet no matter how compelling these humanitarian arguments may be, scientists have been given little opportunity to bring malaria under control. There is as yet no proven vaccine against malaria; and only a handful of drugs, most of which have been overused and are now ineffective. In Southeast Asia, scientists have even discovered strains of "multidrug-resistant malaria with no safe, effective alternative for treatment -- i.e. malaria virtually without a cure -- which they expect will spread to other continents within a decade.6 Such developments should worry us, because our global pharmacopeia is already sparse, and existing drugs are losing efficacy by the day. As scientists bemoaned in the Journal of the American Medical Association last year, "few new drugs will be available in the future because of reduced funding for antimalarial drug research and development."7

Indeed, malaria scientists are correct to complain about a scarcity of research funding. In FY1993, the world spent about $84 million on malaria research.8 The Federal Government contributed about half that amount, or $42 million. By contrast, the Government presently spends about $2.3 billion on cancer research, and $1.5 billion on HIV/AIDS research. To put it another way, in an era when the United States spent as much as $36,000 on research for each fatal case of AIDS within its borders, it spent only about $21 on research for each fatal case of malaria abroad.9

The AIDS problem deserves the funding it receives, but it must not be forgotten that malaria is no less of a scourge, and as the overall federal biomedical research budget grows, malaria surely deserves better than neglect. Indeed, malaria kills almost as many people, per annum, as have died of AIDS in the last 15 years. 10

Malaria's neglect has roots in the policies of past Administrations, and has continued into your own term of office. For example, in 1994 USAID's malaria vaccine development program was cut by more than half. It is because of brutal cuts such as this that one science reporter today calls America's malaria effort "a pittance"12

What is to be done? Government must take the lead. The pharmaceutical industry is economically unwilling or unable to recoup an investment in malaria research, for the simple reason that the prospective market for antimalaria products is not sufficiently affluent.13 The Institute of Medicine of the National Academy of Sciences notes that "not a single major Western pharmaceutical company is now developing new drugs for malaria"14, and the number of companies working on malaria vaccine technologies can be counted on a single hand. But as with other areas of technology where Federal funding led the way, to the benefit of America as a whole, malaria research too promotes our national self interest. There are at least four reasons for this.

First, although malaria is no longer endemic to the United States (it was very common in the early part of this century), the disease still afflicts Americans. Every business traveler, soldier or vacationer returning home from a malarious area is at risk of the disease, no matter how brief their sojourn abroad. About 1500 American travellers each year are hospitalized in the US with this sort of "imported" malaria.15 And as international travel grows, especially business travel to newly-industrializing countries, some of which harbour multidrug-resistance, the incidence of malaria among Americans is certain to rise.

These dangers are illustrated by the experience of American troops abroad. In Vietnam, malaria was the most frequent cause of hospitalization after combat wounds, affecting nearly 10% of soldiers at a given time.16 Troops deployed to Somalia for Operation Restore Hope were no more fortunate. Despite military training and discipline in the use of antimalarial drugs, soldiers got 48 cases of malaria while in Somalia.17 On returning home, the soldiers got another 112 "imported" cases, all requiring hospital treatment.18 Many of the soldiers' cases were drug-resistant, and up to 43% of soldiers who were treated suffered one or several relapses later.19 In all, malaria was the number one cause of hospitalization for troops who saw service in Somalia.20

The lesson for civilian travelers could not be clearer: traveling in a malarious area, no matter how prudent one may be, is dangerous. No antimalarial drug is perfect; no exposure is without risk; and no person is immune. Suffice it to say that scientists have even recorded cases of malaria among travelers who were simply on board an aircraft that made a brief refuelling stop in West Africa.21

Second, the global burden of malaria has serious economic implications for developing countries, and by extension, implications for American foreign policy. Malaria is a perennial plague, and works like a "disease tax" in Africa: limiting inward capital investment, squelching development, damping trade in goods and services, and generally depressing the standard of living.

Third, research in malaria has the potential to enhance American activity in core, commercially valuable technologies. As I mentioned, nobody has succeeded in vaccinating humans effectively against malaria, or for that matter, any other parasitic disease. But it is precisely because malaria vaccine development is so technically challenging that the knowlege gleaned in research is so valuable. As the Institute of Medicine of the National Academy of Sciences observed:

The inherent complexity of the malaria parasite and the resulting immune response make it a natural target for cutting-edge fundamental and applied research. As a result, malaria vaccine research has historically been a leader in the development of new technologies with broad applicability to human health. For example, the world's first recombinant vaccine produced in bacteria and the first synthetic peptide vaccine to be tested in humans were malaria vaccines. The most complex vaccine yet devised...is a malaria vaccine now undergoing testing in humans...In addition, some of the most advanced adjuvant work has been driven by malaria vaccine research, and these agents are likely to be important components of vaccines against HIV/AIDS, herpes, cancer, and other diseases.22

Just as public support for space science in the 1960s, or particle physics today, are seen as valuable to the cultivation of American scientific advances, malaria vaccine research presents an unequalled opportunity to give rise to technologies that would help us combat other diseases endemic to America. These could be parasitic diseases, such as cryptosporidiosis, which caused 400,000 illnesses in Milwaukee in 199423; or they could be terrible scourges such as AIDS. Needless to say, the commercial significance of these technologies for American industry is certain to be enduring.

Lastly, malaria research can help promote America's stature in the developing world, which is wise foreign policy, while at the same time promoting Americans' traditional values of helping the weakest help themselves. Last year, at the instigation of Dr. Harold Varmus, Director of the National Institutes of Health, the malaria research community met in Dakar to create the Multilateral Initiative on Malaria (MIM). The objective of the MIM is to create networks of American, European and African laboratories to work in collaboration on malaria research.24 For a modest investment in the MIM, the United States can build scientific capacity in Africa, promote contacts between American researchers and their European colleagues, and work toward conquering a devastating disease -- all of which makes for excellent scientific diplomacy.

I cannot stress enough, Mr. President, that biomedical research on malaria is not about traditional, third-world aid: it is about basic science, done largely in American laboratories, that has the potential to help the least fortunate countries of the world throw off the yoke of disease that stifles their life expectancy and material progress. There is no "cycle of dependency" in funding malaria research. There is only Americans' goodwill to stop the pointless death of children; to support the health of women; and to foster economic security for all people of the globe.

Malaria deserves serious attention from your Administration. I would recommend that the White House become involved by convening the best experts the field has to offer, to design and steer a renewed American research effort, backed by a funding committment equal to the scientific challenge. An early, initiatory gathering of these knowledgeable persons with you at the White House would demonstrate the priority given this scourge by your Presidency.

Sincerely,

Ralph Nader

For additional information, please call:

Dr. Amir Attaran
Malaria Project Director
Center for Study of Responsive Law
(202) 387-8030
aattaran@essential.org




Footnote 1: World Health Organization, The World Health Report 1996 (WHO, Geneva, 1996), p. 47 [hereinafter World Health Report].

Footnote 2: For percentage, see World Bank, World Development Report 1993: Investing in Health(Oxford University Press, Oxford, 1993), at 208-9 [hereinafter World Development Report].

Footnote 3: J. Anderson et al , Malaria Research: An Audit of International Activity (The Wellcome Trust, London, 1996), at 12 [hereinafter Wellcome Malaria Report].

Footnote 4: N. Diagne et al, (1997) "Incidence of clinical malaria in pregnant women exposed to intense perennial transmission", Transactions of the Royal Society of Tropical Medicine and Hygiene 91(2):166-70.

Footnote 5: P. Fischer (1997) "Congenital malaria: an African survey", Clinical Pediatrics 36(7):411-13; H. Silver, "Malarial infection during pregnancy", Infect Dis Clin North Am 11(1):99-107.

Footnote 6: D. Wirth and J. Cattani (1997) "Winning the war against malaria", MIT Technology Review, August/September 1997.

Footnote 7: H. Lobel and P. Kozarsky (1997) "Update on prevention of malaria for travelers", Journal of the American Medical Association278(21):1767-1771.

Footnote 8: The numbers are even less (about $67 million) if one excludes non-State funded research, e.g. foundation grants and other charitable funding. See M. MacLean et al. (1997) "Making malaria research bite", Nature Medicine 3(1):14; and Wellcome Malaria Report, supra, at 17.

Footnote 9: AIDS figure from Rep. Robert Livingston, Chairman, House Appropriations Committee, cited in M. Pines, "Can AIDS be Tamed?", in A Report from the Howard Hughes Medical Institute: The Race Against Lethal Microbes (Howard Hughes Medical Institute, Chevy Chase, Maryland, 1996), p. 49-50; Malaria figure calculated by taking US funding contribution ($42 m) from Wellcome Malaria Report, supra, and dividing by WHO's estimate of about 2 million malaria deaths annually, from World Health Report, supra.

Footnote 10: The Malaria Foundation Factpack (October 1997), http://www.malaria.org/factpack.htm.

Footnote 1: Wellcome Malaria Report, supra, at 16-7.

Footnote 12: Daniel S. Greenberg, "A Pittance to Fight Malaria", Washington Post, January 4, 1998.

Footnote 13: Institute of Medicine, National Academy of Sciences, America's Vital Interest in Global Health (National Academy Press, Washington, 1997), p. 36-7.

Footnote 14: Ibid.

Footnote 15: Centers for Disease Control, MMWR (Jun 13, 1997) 46(23):536-539.

Footnote 16: S. Neel (1973) "Vietnam Studies: Medical Support, 1965-1970" Washington, D.C.: US Department of the Army.

Footnote 17: Wallace MR et al. (1996) "Malaria among United States troops in Somalia", Am J Med 100(1):49-55.

Footnote 18: Newton, supra.

Footnote 19: Smoak BL et al. (1997) "Plasmodium vivax infections in U.S. Army troops: failure of primaquine to prevent relapse in studies from Somalia", American Journal of Tropical Medicine and Hygiene 56(2): 231-234.

Footnote 20: Dr. R. De Fraites, Preventative Medicine Staff Officer, Office of the Army Surgeon General, January 1998 (personal communication to Dr. A. Attaran of my office).

Footnote 21: M. Isaacson (1989) "Airport malaria: a review", Bulletin of the World Health Organization 87:737-43; H. Lobel et al "Long-term malaria prophylaxis with weekly mefloquine", Lancet 341:848-51. Both cited in Institute of Medicine, National Academy of Sciences, Vaccines Against Malaria: Hope in a Gathering Storm, (National Academy Press, Washington, 1996), p. 7.

Footnote 22: Institute of Medicine, National Academy of Sciences, Vaccines Against Malaria: Hope in a Gathering Storm, (National Academy Press, Washington, 1996), p. 13-4.

Footnote 23: M. Kramer et al (1996) "Surveillance for waterborne disease outbreaks - United States 1993-1994" MMWR CDC Surveillance SummaryŻ45(1):1-33.

Footnote 24: B. Mons et al "Partnership between South and North crystallizes around malaria", Science 279:498-99.