A growing dichotomy: The gap between therapeutic haves and have-nots
Experts confront tough resource allocation questions
In its relatively short but intense history, the world AIDS epidemic is facing the best of times and the worst of times, a rapidly changing period of great hopes and bitter ironies precipitated by a flurry of treatment breakthroughs.
As powerful new drug combinations have slowed AIDS incidence in this country for the first time in 15 years, an estimated 16,000 people become infected each day in countries where most AIDS patients may never be able to afford these expensive therapies. The gap between what is available and what is affordable widens and divides.
"This is one the greatest challenges the community of nations faces how to stop the world from being divided into the therapeutic haves and therapeutic have-nots," said U.S. Rep. Henry Waxman (D-CA), at the First International Conference on Health-care Resource Alloca-tion for HIV/ AIDS in Washington, DC.
How to respond to that challenge was the question posed to an international gathering of scientists, ethicists, public health leaders, and drug manufacturers who convened for the conference. Two days of discussion brought forth several controversial proposals that would immediately help bridge the gap in this country and lay the groundwork globally for wider access to life-saving AIDS treatments. These proposals included revamping the AIDS Drug Assistance Program (ADAP) to require that states match federal funds and provide adequate drug formularies (see article on p. 3), accelerating the national vaccine effort so a vaccine is tested in humans by the year 2000, (see article on p. 4), and expanding Medicaid coverage to include asymptomatic HIV infection (see article on p. 6).
Sponsored by the International Association of Physicians in AIDS Care (IAPAC) in Chicago, the conference took its cue from its honorary chairman, Nobel laureate Rev. Desmond Tutu, who commended IAPAC for having "the courage to convene a conference to re-establish the sanctity of human life as the basis for improving global access to life-saving and life-extending drugs." President Clinton, in a greeting letter to the conference, also expressed the obligation to find solutions to the global crisis. "With 3 million new infections every year, we must recognize that most of these people will not have access to the new progressive drug therapies. . . . A concentrated effort towards developing a vaccine is paramount."
Indeed, the new combination therapies are threatening to deepen the divisions among people with HIV around the world, said Hoosen Coovadia, MD, head of the pediatrics and child health department at the University of Natal in South Africa and chairman of the International Conference on AIDS in 2000. "I think the language of HIV will shift if we continue in this direction to a preoccupation with drug management rather than an emphasis on prevention and vaccination," he told conference attendees. "I challenge the world community to change the language of this disease, so that the problems of the majority of [people affected by] this dreadful disease, who happen to be living in developing countries, assume a primacy that they don’t have at present."
William Linder, JD, executive secretary of the 12th International Conference on AIDS, which will be held in June in Geneva, cast the crisis in terms of a North-South division. While 90% of the technological resources are in the developed countries, 90% of the AIDS cases are in the developing countries, he noted. For the first time, the International Conference on AIDS will address that imbalance by having participants from both regions set priorities for the scientific and the social issues presented in Geneva this summer.
"Money is the North; AIDS sufferers are in the South," he said. "We really have an ethical and moral problem that has to be addressed if we are going to address the crisis that confronts us. Even if drugs were discounted 70% to 80%, the annual income of [people in] African countries is between $150 and $750 a year. It is fantasy, absolute fantasy that they will ever afford them, so we have to find another way to address this issue."
Creating new ways to distribute drugs
One of those ways was recently announced by UNAIDS, the joint United Nations program on HIV/AIDS, which is launching the pilot phase of its "UNAIDS HIV Drug Access Initiative," a collaborative effort between public and private sectors to identify strategies for increasing HIV drug access for poor countries. Several drug companies have agreed to subsidize their drugs while non-profit companies will help distribute them to four initial countries.
The debate over global health resources comes at a time when the AIDS pandemic is galloping unchecked throughout the globe. On Dec. 1, World AIDS Day, UNAIDS was expected to announce that estimates of the worldwide AIDS cases may be underestimated and that as many as half of adults in some cities in Zambia, Malawi, and Botswana are infected with the virus. While AIDS cases dropped for the first time in the United States and Europe this year, the epidemic is only beginning in China and the republics of the former Soviet Union, and will continue to increase most rapidly in India, where an estimated 4 million people are already infected, Linder pointed out.
The gap between developed and undeveloped nations is not only one of money but also of understanding. What works in the United States, which values individual rights, may not work in developing countries where community needs supersede individual ones, Coovadia noted, adding that misunderstandings and ethnocentrism can cause greater divisions.
Such conflicting views have been underscored by the recent uproar over the ethics of designing placebo-controlled trials for reducing perinatal transmission in Africa and Thailand. Both countries decided to evaluate modified doses of zidovudine in pregnant women and their infants in hopes that a lower-drug regimen would be economically feasible in developing countries. The New England Journal of Medicine recently compared the trials to the notorious Tuskegee studies on syphilis, noting that it is unethical to offer women placebos when it is already known that the treatment works. Study investigators have pointed out that, unlike the Tuskegee study, the women were offered informed consent, and that a placebo-controlled trial is the only valid way to determine what regimen is effective.
"We have arguments [for the study] based not simply on what one can afford but on social arguments and logistical arguments," Coovadia explained. "What this [controversy] did is it took away from us our sovereignty of national opinion and the sovereignty of our ethics committee. . . . You can decide for yourself but you cannot decide for us. You must respect our autonomy."
Unlike the benchmark ACTG 076 study, which first showed that zidovudine could reduce perinatal transmission in the United States, the perinatal study in the west African country of Cote d’Ivoire faced unique obstacles. As an example, Coovadia noted that nearly half the women in the study did not return for their HIV test results and half of those who did receive their test results did not inform their partners.
Developing countries face other problems in the context of maternal-infant transmission that are easily solved in developing ones. Even if African women are given AZT and HIV transmission is prevented at birth, many women face economic and cultural pressures to breast-feed. At a recent conference in Durban on breast-feeding, for example, a woman from Malawi stood up and told Coovadia, "You scientists can do what you want about the advisability of breast-feeding but in Malawi it is no choice. A woman either breast-feeds or her baby dies because she simply cannot afford formula."
With less than one percent of government expenditures about 30 cents per person in many African countries going to AIDS programs, the epidemic is overwhelming health infrastructures. And yet there has been progress. National AIDS programs have been set up in all sub-Saharan countries in a move to give AIDS programs more visibility and clout. In Zimbabwe, female condoms are being distributed with widespread success. Tanzania is aggressively treating sexually transmitted diseases as a way of reducing the risk of HIV. And South Africa has made a major commitment to fighting HIV by increasing its funding.
Drugs for all in Brazil
A startling contrast to other developing countries is Brazil, where a law was passed last year making HIV treatment the right for every citizen, said Celso Ferreira Ramos-Filho, MD, associate professor of medicine at the Federal University of Rio de Janeiro in Brazil. And yet with the advent of combination therapy, the cost of providing standard treatment is estimated to jump from $150 million to $800 million next year.
"I don’t think the government will be able to pay for that," he said, adding that the minister of health had stipulated in his proposed budget funding for only those who have been receiving treatment.
The specter of discontinued treatment because of lack of funding forced one conference member to ask whether it was better not to provide these drugs rather than to provide them without a long-term commitment and contribute to the rise in resistant strains.
At the same time, Brazilian politicians are faced with the same pressures in the United States not to give HIV/AIDS special treatment, Ramos-Filho said, noting that more deadly diseases threaten the country, such as malaria, with more than 600,000 cases last year.
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