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

P.O. Box 19312
Washington, DC 20036
Tel. (202) 387-8030

May 4, 1998

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

Dear President Clinton:

Thank you for your letter of March 22 on infectious diseases, which arrived only a couple of days after your address of March 24 in Mukono, Uganda, in which you spoke of the tragic malaria problem in Africa and announced a further $1 million for the West African Malaria Center in Mali.

While this is a welcome, first step toward a reinvigorated American malaria effort, I must concur with your sentiment that "this should be only the beginning of our efforts to attack this problem" of infectious diseases of the developing world.

I am encouraged by your statement in Uganda that, as a nation, "we want to do more. "The timing of this is fortuitous: America's global partners also want to do more at the moment. I am, accordingly, writing on this occasion to suggest how your Administration may, through unilateral and multilateral action, renew America"s commitment to controlling the scourge of malaria.

1. "A disaster of immense proportions"

The malaria epidemic is worse than ever, particularly in Sub-Saharan Africa. Since the failure of malaria eradication efforts in the 1960s, the disease has regained the upper hand. Sri Lanka, which had only eighteen malaria cases in 1963, today has over one million annually1. In Senegal, the final stop of your African tour, French scientists reported a seven-fold increase in malaria deaths over the last five years2. Every year, almost half a billion people are diagnosed with malaria and 2.7 million human beings lose their lives to the disease3. As you noted in Uganda, malaria takes a far greater toll of African lives than does AIDS. About as many Africans will die of malaria in 1998 alone, as have died of AIDS in the last fifteen years4.

In Uganda, you were correct to warn that Americans cannot ignore the malaria problem - that "with increasing globalization we are all at risk." Every year, about 1500 Americans returning home from foreign travels are hospitalized with malaria, after spending as little as one day abroad5. For those who reside overseas, such as American military forces or Peace Corps workers, the risks are even more severe. Malaria was the leading cause of hospitalization among troops who served in Somalia6, and caused over 1600 cases of serious illness among Peace Corps workers in West Africa in the late 1980s alone7. Even persons who do not travel may contract malaria from contaminated blood transfusions: two Americans died last year in just this way8.

What is worse, resistance to anti-malarial drugs, and the absence of an effective malaria vaccine, are threatening to make the disease incurable for the first time since the 17th century. Researchers in South East Asia recently discovered strains of malaria that cannot be treated by any drug now on the market9. The introduction of these strains to Africa within a decade, where 90% of malaria cases occur, would be "a disaster of immense proportions," in the words of researchers at Harvard University and the WHO published recently in the Journal of the American Medical Association10. Yet despite this looming crisis, the National Academy of Sciences reported in 1996 that "not a single major Western pharmaceutical company is now developing new drugs for the disease."11

Although the United States contributes half of the world's malaria research budget, the overall numbers are far too low. A research audit by the Wellcome Trust in 1996 found the malaria research budgets of all nations, charities, drug companies, and the WHO total under $90 million annually - about as much as the budget of a single, modestly-sized hospital in the United States.

To redress the neglect of malaria, your Administration needs a two-track approach. As a matter of domestic policy, America must fortify its research commitment through inter-agency cooperation and a real increase in appropriations. As a matter of foreign policy, America must put malaria research and control squarely onto the diplomatic agenda, where it already has the support of our international partners. The following are my specific recommendations.

1. Inter-Agency Coordination is Essential to Efforts on Malaria & Infectious Disease Generally

At present, America's malaria effort is divided, not always rationally, between four agencies: the Centers for Disease Control, Department of Defense, National Institutes of Health, and the US Agency for International Development. This division has been criticized before. Two separate National Academy of Sciences, Institute of Medicine panels (in 1991 and 1996) called the division of effort "disarticulated", and warned that, "there is inadequate joint planning and coordination among U.S.-based agencies that support malaria research and control activities"12.

Your Administration should take two steps to bring the malaria agenda under one strategic umbrella. First, the recommendation of the NAS-IOM panels, for "the establishment of a national advisory body on malaria", should be acted on at once. Such a body would coordinate, monitor and report on the progress of malaria research and control13. In these ways, it would emulate other inter-agency bodies that were pivotal in fighting diseases: the Polio Vaccine Committee and the National Task Force on AIDS Drug Development are two examples14. Seven years after the first NAS-IOM recommendation, it is high time the American government formally coordinate its malaria research and control effort.

Second, you should convene the heads of several Executive Branch agencies to develop an Administration-wide agenda for infectious diseases generally. In my discussions with members of your Administration, all have agreed there should be an assembly of this type, namely: Secretary Donna Shalala; Surgeon General David Satcher; Ambassador J. Brian Atwood, USAID Administrator; Dr. Harold Varmus, NIH Director; Mark Gearan, Peace Corps Director; Dr. Helene Gayle, Director of CDC's Center for HIV, STD, and TB Prevention; Ambassador Richard Morningstar, State Department Coordinator of Assistance to the Newly Independent States; and Josh Gotbaum, Executive Assistant Director of OMB. This meeting could reaffirm your June 1996 Presidential Decision Directive on infectious diseases, and set the stage for a major Presidential address on the challenges of infectious diseases - from malaria to AIDS to TB - at a later date.

2. America Must Support Multilateral Activities Against Malaria

Since 1997, the global community has become much more aware of malaria, and a number of multilateral and diplomatic initiatives have been or will soon be taken against the disease. Diplomatic action and multilateralism are part of your June 1996 Presidential Decision Directive, which called for a the U.S. to collaborate with other nations and international bodies on emerging infectious diseases. In that spirit, your Administration should pay especially close attention to the following three developments.

2(i). The Multilateral Initiative on Malaria

Your Administration must work aggressively to build the Multilateral Initiative on Malaria (MIM) - a scientific and diplomatic collaboration between the U.S., eleven European countries, twenty-one African countries, four Asian countries, the Burroughs Wellcome Fund, the Malaria Foundation, the Organization of African Unity, the Wellcome Trust, the World Bank, and the World Health Organization - to coordinate new research essential to controlling the rising global incidence of the disease. The leadership of NIH Director Dr. Harold Varmus was instrumental in convening the first MIM conference in Dakar, Senegal in January 1997. The MIM continues to merit American support now that it has become a pre-eminent international research collaboration - one that involves, for the first time, African scientists on an equal footing with American scientists.

At Dakar, the MIM partners identified areas in which they agree that research is acutely needed. The CDC, DoD, NIH and USAID all have research plans aimed at these areas, but most are inactive for want of funding. For example, the DoD is sitting on about fifteen drug and vaccine candidates suitable for testing, and NIH has a vaccine plan that would test another thirty vaccine candidates within a decade15. The limitations are not technical, so much as financial. Your Administration ought to seek special appropriations, in this Congress, so that these and other research plans may proceed. Also, OMB must be instructed to consult with the above agencies, to ensure that their malaria research plans are accommodated in the forthcoming budget.

In deciding to make available more funding for malaria research, history lends a helpful perspective. The last time the United States seriously grappled with malaria was in the years from 1958-63. Back then, Congress gave its bipartisan support to a global malaria eradication program which cost the equivalent of billions of today's dollars16. President Eisenhower called for the "unconditional surrender" of the disease; and Senator John F. Kennedy predicted that children would be born into a world naive of this scourge. Unfortunately, in the end malaria eradication failed, but this is hardly surprising: the eradication plan was proposed just one year after scientists deciphered the structure of a mysterious thing called "DNA". Four decades later, our expertise in vaccinology, pharmacology and genetics is beyond the imaginations of the architects of that program, and the technical barriers are no longer so daunting. There is no doubt that today we can, for a fraction of the cost of that program, develop effective drugs or vaccines17.

2(ii). WHO's Roll Back Malaria Plan

You will have heard the news that Dr. Gro Harlem Brundtland will be confirmed later this month as director of the World Health Organization. Under her leadership, the WHO is imminently to launch the "Roll Back Malaria" campaign, which is aimed at halving the number of malaria deaths by the year 2010, and halving them again by 2015. This will require a large-scale, sustained malaria control program, primarily in Africa. It will also require more research, much of it under the auspices of the WHO's Tropical Disease Research (TDR) program.

United States scientific and aid agencies both contribute to and receive funds from TDR. In recent years, U.S. projects have in fact received more money from TDR than they have contributed18. Your Administration ought to watch Dr. Brundtland's Roll Back Malaria plan with the greatest of interest, and strengthen the involvement of American scientists and development specialists in TDR research as a means of supporting this very noble plan.

2(iii). Malaria and the Agenda of the Group of Eight (G-8) Summit

In preparation for the upcoming G-8 summit of leaders this month, Japan and Britain are calling for concerted action on malaria research and control, and this will be raised in the G-8 session and discussions on "global economic issues". The rationale for treating malaria under this rubric is inescapable: as the G-8 economies grow increasingly connected to developing country markets, the health of people in those countries becomes a matter of global economic and political security. You alluded to this linkage when, in Uganda, you commented that, "By weakening as well as killing people, malaria contributes to poverty and undermines economic growth."

Your Administration should ensure the U.S. goes into the G-8 summit with a position on malaria no weaker than that of our partners. At last year's G-8 summit, Prime Minister Hashimoto urged more international cooperation on parasitic diseases: the Japanese are returning this year with a firmer proposal19. Similarly, the Blair government shall also announce a large disbursement - on the order of 60 million ($100 million) - for malaria control and research around the dates of the summit, and this will be very heavily promoted to the press. If the U.S. is to not lose its position as the world's preeminent supporter of malaria research - a fact you cited with pride in Africa - it too must be prepared to grant an increase to American funding. That increase should not be an exercise in tokenism, but a major augmentation consonant with the devastating, global proportions of malaria. With the summit less than two weeks away, your Administration must make a decision on doing this shortly.

* * *

Your growing recognition of the global malaria crisis is a first step toward committing the seriously increased budgetary resources that are needed to banish this scourge. I look forward to being of assistance as your Administration turns to further action on this problem.

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


Footnotes

Footnote 1: Laurie Garrett, The Coming Plague: Newly Emerging Diseases in a World Out of Balance (Penguin, New York, 1995), p. 51 [hereinafter The Coming Plague]

Footnote 2: D. Butler (1997) "Time to put malaria control on the global agenda", Nature 386:535-6.

Footnote 3: World Health Organization, The World Health Report 1996 (WHO, Geneva, 1996), p. 47 [hereinafter World Health Report].

Footnote 4: The Malaria Foundation Factpack (October 1997), http://www.malaria.org/factpack.htm

Footnote 5: Centers for Disease Control, MMWR (Jun 13, 1997) 46(23): 536-539.

Footnote 6: 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 7: Institute of Medicine, National Academy of Sciences, Vaccines Against Malaria: Hope in a Gathering Storm, (National Academy Press, Washington, 1996), p. 7 [hereinafter NAS-IOM Malaria Report #2].

Footnote 8: Dr. D. Wirth, Director of Harvard Malaria Project, Briefing to Congressional Biomedical Research Caucus, April 29, 1998.

Footnote 9: Ibid.

Footnote 10: P. Olliaro, J. Cattani and D. Wirth (1997) "Malaria, the Submerged Disease", Journal of the American Medical Association 275(3):230-233.

Footnote 11: Institute of Medicine, National Academy of Sciences, America's Vital Interest in Global Health (National Academy Press, Washington, 1997), p. 36-7.

Footnote 12: NAS-IOM Malaria Report #2, supra, p. 16; Institute of Medicine, National Academy of Sciences, Malaria: Obstacles and Opportunities (National Academy Press, Washington, 1991), p. 11-12 [hereinafter NAS-IOM Malaria Report #1].

Footnote 13: NAS-IOM Malaria Report #1, supra, p. 12.

Footnote 14: NAS-IOM Malaria Report #2, supra, p. 21.

Footnote 15: NIAID Research Plan for Malaria Vaccine Development (1997), NIAID, NIH. Also Military Infectious Diseases Research Program, Department of Defense (as at April 1998)

Footnote 16: The Coming Plague, supra, p. 49.

Footnote 17: For instance, NIAID suggests that vaccine development would cost about $350 m, spread over 10 years.

Footnote 18: Personal Communication, Nelle Temple-Brown, WHO External Relations Officer, Washington (Jan. 13, 1998).

Footnote 19: Summary of "A Report on Global Parasite Control", Draft of 9 March, 1998; Government of Japan.

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