One Step Ahead of Us
XIV International AIDS Conference
July 7-12, 2002; Barcelona
Data presented at the XIV International AIDS Conference called to mind similarities between the disease's effect on the individual and the pandemic's effect on global society. African human rights activist Graça Machel pointed out this similarity in her plenary address to conference participants, assembled this year in Barcelona.
"HIV/AIDS has proven itself to be an incredibly aggressive and comprehensive virus," Machel said. "By undermining the immune system, the virus effectively attacks the whole body. Then there is the social stigma attached to HIV/AIDS, the economic fallout from subsequent illness, and the lack of access to treatment and care that might minimize the effects of the virus. It attacks the human, the individual. And it attacks physically, emotionally, spiritually, in a very aggressive manner. And these individual effects and impacts are multiplied in our communities, our countries and our regions."
As many participants at Barcelona commented, it seems that both a medical solution to HIV disease and a coordinated public policy program that could stem the global tide of infection and death are always just out of reach.
With respect to medical developments, researchers confirmed for conference-goers that an HIV vaccine and cure continue to remain elusive. Findings presented by Robert Siciliano (Johns Hopkins School of Medicine, Baltimore) suggest that current medications, while very effective at prolonging life, could never be developed into a cure. Siciliano noted, in this regard, that, "the latent reservoir for HIV in resting memory CD4 cells guarantees lifetime persistence of the virus and makes the disease intrinsically incurable with antiretroviral therapy alone."
Siciliano attempted to present a positive side to this grim news, however. "First, [this] fact is as powerful an argument for preventive efforts as we will ever find," he said. "And I believe that [highly active antiretroviral therapy (HAART)] can completely arrest virus evolution. In principle, this makes it possible to offer everyone with HIV infection the chance for a normal life."
Even the good news from medical researchers, however, turned bittersweet in light of information provided by epidemiologists on the spread of the disease and the very low numbers of HIV-infected people actually receiving the effective treatment antiretroviral drugs have made possible. First, the rate of infection exceeded predictions; more people than expected are infected in 2002. Second, in the developing world, where 95 percent of people living with HIV/AIDS live, fewer than 10 percent have access at all to antiretroviral drugs.
"It is now clear that the AIDS epidemic is still in its early stages," said Peter Piot, Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS), in the speech he made to open the conference. "And let's be equally clear: our fight back is at an even earlier stage." These were strong words and a challenge indeed to redouble our efforts.
But Piot lamented that no effort, even when largely successful, seemed to be quite enough. There are now many more mother-to-child transmission (MTCT) programs operating than there were two years ago, he reported. Nonetheless, the number of HIV-infected women who transmit the disease to their children remains quite high. "Why are three-quarters of a million babies born with HIV a year, when it is eminently preventable? Why have we failed to stop the dramatic expansion of HIV?"
In fact, there is no global consensus that healthcare is a human right. Most of the featured speakers in this relatively liberal European setting, however, spoke as if there were such a universal understanding (See "Spain as Host" sidebar). José María Mediluce, Chairman of the Green European Solidarity Foundation, stated in his opening ceremony speech that, "The fight against AIDS is a fight for human rights. And, among others, the rights to healthcare, sanitation, clean water, and generic medicines are basic to the rights of people affected by AIDS and all are part of the same reality."
Bill Clinton and Nelson Mandela, former presidents of the United States and the Republic of South Africa, respectively, each devoted considerable time in their addresses during the closing ceremonies of the conference to the issue of discrimination against people living with HIV/AIDS. "Many people who have AIDS are not killed by the disease itself. They are killed by the stigma suffered by everyone who has HIV/AIDS," said Mandela. He offered a moving story of his personal battle against the discrimination associated with HIV, describing how, while President, he traveled through the country inviting children with HIV/AIDS and physical disabilities to dine with him. "The fact that the President of the country is sitting at the table with children with HIV/AIDS and those who are disabled, makes the parents less ashamed of their children," he said. He called on other world leaders to lead by such actions.
Clinton, in turn, cited a Human Rights Watch report that documented police brutality against AIDS activists in India, and said, "The government must stop this. And not just in India, but everywhere." He pointed to former U.S. Senator Jesse Helms -- who recently stated that instead of opposing AIDS funding during his tenure, he wished he had advocated for it -- as a hopeful example that "anyone can have a change of heart."
Much of the contention surrounding patent rights for antiretroviral medications, however, remained unvoiced at the conference. Many speakers made impassioned arguments for easing of patent restrictions, but those agreeing with the pharmaceutical industry and with concerns over inadequate infrastructure and risks of drug resistance, seemed more hesitant to make their opinions heard in conference plenaries or oral sessions, fearing the ire of activists and patient groups.
Among drug access advocates, many at the Barcelona conference held up Brazil and Thailand, with their local manufacturing programs for pharmaceuticals, as models of appropriate reform. Paolo Teixeira, Director of the Brazilian STD/AIDS Program, described his country's strategy of providing antiretroviral treatment in conjunction with a nationwide prevention program as more or less an obvious action. "There is no 'Brazilian Model,'" he told a plenary audience. "What we have been doing is to put into practice principles that have long been recognized by the international community. At their very core is the Universal Declaration of Human Rights, adopted more than 54 years ago." Brazil has documented significant reductions in HIV/AIDS incidence, including new cases, as well as a reduction in the number of deaths from AIDS.
"In Brazil," Teixeira added, "the average cost for patient per year in antiretroviral therapy decreased by half in the last years. This reduction occurred because of a combination of two concomitant factors. First, investments made by the Ministry of Health to set up domestic national laboratories. Currently, the Brazilian Ministry of Health distributes 15 antiretroviral drugs, of which eight are locally produced. Second: the effective negotiation, based on tiered or differentiated prices, with drug companies. ... National production under compulsory licensing has been a strong argument to push these companies to the negotiation table."
Teixeira concluded his remarks by reiterating Brazil's offer of technical assistance to other countries wishing to institute local production. However, he expressed Brazil's wish not to become an exporter of generic medications, saying that would "fundamentally alter the mission which the Brazilian public laboratories serve," namely, that of utilizing local manufacturing to regulate domestic prices.
At an oral session on strategies for lowering treatment prices, which drew an attentive and vocal audience, K. Kraisintu presented the results of Thailand's manufacturing of generic medications. Thailand's Governmental Pharmaceutical Organization (GPO) produces more than 300 items, she said, including antiretroviral medications and drugs to treat opportunistic infections [MoOrG1038]. The Thai GPO introduced a lamivudine (3TC)/nevirapine (NVP)/stavudine (d4T) co-formulated drug in April 2002. "The reasons for doing this," she said, "are that we wanted to simplify treatment, we wanted to increase compliance, we wanted to reduce the resistance, and, most of all, we wanted to reduce the cost of treatment." Participant discussion included a comment that drugs are not the only patents driving treatment costs up. Kraisintu agreed that CD4 monitoring was a cost issue for her country, but that they planned to internally manufacture that technology as well: "Wait and see. I will make it lower!"
Presenters at the treatment pricing strategies session focused on local pharmaceutical production of essential anti-HIV medications in low-income countries, patent restrictions, and standardized price negotiations. AIDS drug activist Jamie Love advocated the creation of a "non-voluntary patent pool for interventions that address essential public health needs." Love would include on this list the most effective known antiretroviral treatments for HIV. During the same session, the issue of inflation of drug prices at the local retail level was raised by an audience member, who cited the doubling and tripling of prices at local pharmacies in southern Africa to demonstrate that prices charged by drug manufacturers were not the only factors driving up cost. Love agreed, saying that in Central America, as well, patents "are not really the issue," but that distribution systems increase drug costs in those countries.
At another session on the cost of drug access expansion, a South African study presented by Andrew Boulle on cost-effectiveness of antiretroviral treatment [TuOrG1248] was greeted with praise from a large audience, primarily composed of activists and economists. Boulle made two arguments to support his conclusion that the South African government could feasibly begin widespread provision of HAART in the near future. First, he noted that, in cost analyses, "HAART is often described as a uniform entity," and that the costs of different implementation scenarios were not taken into account. His analysis included variables such as provision of only one drug regimen option versus making available a second more costly option if the first failed; different staffing options in service delivery (e.g., employing allied health professionals for services that do not require a physician, such as counseling); and the use of generic medications.
Secondly, Boulle argued that determining the feasibility of supplying HAART need not reflect provision of treatment to all infected persons in a given country. The study authors pointed out that the numbers treated would be limited by human resources and other factors, just as all healthcare provision in poor countries is limited. "In resource-poor settings, there is implicit rationing anyway," he said. Moreover, Boulle suggested that if governments invest at least a portion of their HIV care expenditure in HAART, they will show commitment that might leverage resources from other players.
At a press conference in Barcelona, the International Association of Physicians in AIDS Care (IAPAC) announced two initiatives designed to address capacity issues in countries with limited resources. The Global AIDS Learning & Evaluation Network (GALEN), and the Joint HIV/AIDS Care Initiative (JHACI) will provide much needed medical education to HIV care providers and ensure the ability of clinicians in resource-limited countries to administer effective antiretroviral treatment as drugs are made available and scaled up. Both initiatives are driven by the very practical strategy to ensure that infrastructure concerns precede, or at least accompany, the introduction of antiretroviral drugs into settings that can ill-afford their mismanagement.
In further support of this strategy, and opening an oral session dedicated to the issues of capacity and policy prerequisites for antiretroviral access, Joseph Saba of Ireland advocated encouraging resource-challenged countries to establish sound policies that would enable them to effectively administer antiretroviral distribution. He pointed out that increasing capacity to provide antiretroviral treatment increases the capacity of the entire HIV care system and, indeed, the country's whole health-care system. He stated that he believed the lack of sound policies in many countries was a "lack of will" on the part of some governments, challenging them with the task at hand: "It is not very expensive to improve policy." He listed training guidelines, policies on pricing and procuring supply, and accounting mechanisms as examples of the types of measures he felt countries considering antiretroviral provision should prioritize.
Making specific country references were Kriengkrai Srithanaviboochai, who presented an example of capacity-building efforts being undertaken by the government of Thailand in preparation for implementation of HAART, at no out-of-pocket expense to the patient [TuOrG1246], and Paul Farmer, who presented a case study from Haiti. The process of integrating HAART into the current healthcare system in Thailand, as Srithanaviboochai told the audience, included active participation by community advisory boards. The advisory boards developed selection criteria, to determine which patients would receive the medications, and guidelines for distribution, ensuring continuous adequate supply at each site. A "focus person" was assigned at each of 54 participating hospitals, and each focus person led a HAART team that included a minimum of five specially trained professionals: a physician, a nurse, a pharmacist, an HIV counselor, and a lab technician.
Paul Farmer of Harvard Medical School related experiences of a rural study in Haiti, intended to demonstrate the feasibility of antiretroviral treatment in even the poorest of settings. "No one seems to have actually done such projects in the world's poorest communities, although HIV is now the leading cause of young-adult death in almost all of them. There's thus a lack of know-how regarding who should receive HAART, what the enrollment criteria would be, how to manage the drug supply, and how best to monitor therapy in resource-poor settings. There is much speculation but little experience in linking prevention to care in the poorest communities." Farmer said that recruiting major institutional donors for a treatment pilot project had been difficult.
This Haiti project, termed the "HIV Equity Initiative," complemented ongoing prevention efforts with "antiretroviral treatments for those patients in greatest need and who were soon to die, in our opinion, without these drugs," said Farmer. Ten to 12 percent of the over 2,000 HIV-infected patients examined in the clinic are now receiving antiretroviral treatment, and the project relies heavily on therapy methods borrowed from an earlier tuberculosis/HIV program, as well as on community health workers who deliver domiciliary care.
Farmer and colleagues concluded that antiretroviral treatment in rural Haiti was possible and effective, although Farmer stated that effectiveness was hard to measure using traditional evaluation criteria. "The gold standards for assessing efficacy of AIDS prevention and care are quite different, and both are largely beyond the reach of healthcare facilities in regions most affected by HIV. In Haiti or comparably poor countries in Africa, even university-affiliated projects would have as much or more difficulty measuring HIV incidence as they would measuring viral load." Farmer suggested biosocial measures of success, including patient outcomes (such as body weight) and chart review; reduced rates of hospitalization; and increased demand for voluntary counseling and testing.
In all, these various capacity-building initiatives were heralded as critical and irreplaceable elements in the strategy necessary to ensure that more positive news regarding treatment and survival rates would be possible two years from now at the XV International AIDS Conference in Bangkok.
Many speakers at the Barcelona conference expressed frustration with wealthy countries that have not met their pledges. Graça Machel, advocate for children's rights, commended "the sterling efforts of Sweden, Norway, Denmark, and the Netherlands, the only countries to regularly meet the [promised] 0.7 percent mark," contrasting them to the United States and the rest of Western Europe, which linger far short of promised contribution levels. In recognition of this failure to pay promised dues, activist Terje Anderson of the United States said, "We have heard a lot about which countries are shouldering their share of the burden for the response to this crisis, and which countries, like my own, are not." Brazil's Paolo Teixeira admonished wealthy countries in his plenary address: "We need the United States, along with Japan and Western Europe, to assume, at last, their responsibility in changing, or not, this dramatic situation."
On the same topic, Julio Frenk, Mexico's Minister of Health, said, "It is important that we make this fund truly global. Middle-income countries that can afford to contribute to the fund must make that contribution. My country, Mexico, will make a contribution." He explained that even if the contribution is symbolic, it is important that the Global Fund not become another model of the richest helping the poorest. ICASO reports that of the 48 countries determined to have a high human development index, 28 have made no contribution to the Global Fund. Most agreed that this is unacceptable, given that the disease amounts to such a great collective burden.
This article was provided by International Association of Physicians in AIDS Care. It is a part of the publication IAPAC Monthly.