ANAND ZACHARIAH

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The question is not whether AIDS has priority over other diseases and public health issues, such as water, food, housing and sanitation. It is obvious that AIDS cannot have greater priority in India. However, if good quality and expensive treatment can be made available for one disease, then surely the same can happen for other common diseases which are less expensive. What can we learn from history of AIDS – about how to make a disease important enough politically and to ensure access for all to healthcare.

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Treatment and HAARTTreatment and HAARTTreatment and HAARTTreatment and HAARTTreatment and HAART

The development of highly active antiretroviral therapy (HAART), is the story of how understanding of the basic biology of the virus has enabled drug development and trials towards successful treatment regimens. The knowledge of critical enzymes in the virus life cycle, reverse transcriptase and protease have enabled the development of drugs that target these enzymes. The first anti-retroviral drug developed in 1987, zidovudine, a nucleoside reverse transcriptase inhibitor (NRTI), was found to temporarily reduce morbidity and mortality. In 1994 it was shown that a combination of two NRTIs was superior to zidovudine, but still of short-lived benefit. In 1995, David Ho suggested that intensive treatment if started early, could eradicate the virus in a few years, with the slogan, “hit early, hit hard”. In 1997, trials of a combination of two NRTIs with one protease inhibitors (PI) achieved maximal and durable suppression of viral replication. This three drug combination came to be known as highly active anti-retroviral therapy (HAART) and became the standard of therapy. In 2001 it was shown that combination therapy of one non-nucleoside reverse transcriptase inhibitor (NNRTI), Nevirapine and Efavirenz with two NRTIs was equally efficacious as PI-based HAART regimens.

Following the advent of HAART in the US in 1996, hospital admissions and AIDS deaths immediately declined and AIDS wards were closed down. We now know that for these drugs to be effective, 95 per cent adherence is required and a range of drug toxicities are recognised. These drugs are not curative because of a reservoir of inactive cells, which are latently infected with the virus. Resistance to anti-retroviral drugs occurs over time, resulting in treatment failure and necessitating change in regimens.

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Gay activism in the US was crucial in defining research policy, ensuring that trials addressed concerns of the gay community, facilitating drug licensing and also in promoting access to drugs for affected people.

Committees which defined research policy required representatives of affected groups. Research guidelines required that HIV positive peoples’ groups were involved in trial planning, execution and dissemination. Concepts such as compassionate use, expanded access, accelerated access and parallel track came into use in drug trials research as a result of AIDS activism. Peoples’ groups negotiated directly with companies to promote their research priorities and with Food and Drug Administration (FDA) to facilitate drug licensing. Scientific writings today do not acknowledge the crucial role of gay community activism in ensuring the development of effective treatment and enabling access to anti-retroviral treatment for all who needed it in the US.

From the development of HAART till about 2000, the cost of drug treatment was the equivalent of about Rs 40,000 per month. Outside the western world, only the wealthiest had access to such treatment. The governments and people of Brazil and Thailand and Indian pharmaceuticals were crucial in changing this status quo.

Brazilian ExperienceBrazilian ExperienceBrazilian ExperienceBrazilian ExperienceBrazilian Experience

Brazil’s freedom struggle from dictatorship, the formation of the democratic constitution in 1988 and the first election in 1990 were closely linked to the AIDS issue. The first cases of AIDS were detected in 1983, and health officials and affected people in Sao Paulo (which was

In an act which indicated the mood of that moment, South Africa’s high court justice Edwin Cameroon described his own story of developing AIDS at the conference: “Amidst the poverty of Africa I stand before you because I am able to purchase health and vigour. I am here because I can pay for life itself.” The speech crystallised sentiments in favour of providing treatment to countries who could not then access care, and the need to cut drug prices. A consensus formed at the Durban conference, that if prevention was to succeed it must be integrated with care, and treatment must become available to all who need it. There was rejection of the thinking at that time, that treatment should be available only to people and countries who could afford it, that the poor and the developing world must only focus on prevention. International funding must be found to support drug treatment and companies should be forced to reduce the cost of drugs.

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IndustryIndustryIndustryIndustryIndustry

Soon after this, Brazil offered to export medicines to Africa and transfer technology for local drug manufacture. In response to this, five major pharmaceutical industries offered to reduce prices to sub-Saharan African countries. In March 2001, the Indian firm Cipla offered to sell three anti-retroviral drugs at US $ 350 per patient per year. The companies responded by further price cuts (see the figure). This 40-fold reduction of drug costs has been possible because of wars between proprietary manufacturers in western countries and generic manufacturers in Brazil and India who have used patent laws strategically to their advantage.

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The Durban conference was a turning point. In response to it, Kofi Annan provided a vision for taking these ideas forward. At the United Nations general assembly special session (UNGASS) on HIV/AIDS in 2001, he suggested that a global effort which linked care and prevention must be initiated and that we should work towards providing ART to all people who need it. A global fund should be created to provide universal access to HIV treatment to 3 million people by 2005. All WHO countries supported this proposal at the UNGASS.

In December 2003 the WHO and UNAIDS came out with the “3 by 5 initiative”, which envisaged use of common and simplified guidelines, reliable supply of medication, better diagnostics, training and national advocacy. This strategy was endorsed by 192-member countries. The WHO soon after sent missions to individual countries to lobby for and assess their readiness in setting up local ART programmes. Subsequent to this, the WHO has been working with individual countries to set up local ART programmes.

As a result of this strategy, by June 2005, the number of people on ART had doubled

– increasing from 4,00,000 to 1 million. About 14 countries are providing ART to 50 per cent of persons who are in need of it. In Africa about 5,00,000 people are receiving treatment (a threefold increase), 1,55,000 in Asia, 20,000 in central Europe and 2,90,000 in South America. In many areas the demand outstrips supply. Thirtyfour countries are implementing national treatment programmes for ART. Therefore, although the programme falls short of its target, it has shown that such large-scale treatment initiative is achievable, effective and affordable.

Indian AIDS ProgrammeIndian AIDS ProgrammeIndian AIDS ProgrammeIndian AIDS ProgrammeIndian AIDS Programme

On World AIDS Day 2003, the government of India announced its decision to provide ART, free of cost to people living with HIV/AIDS in the six HIV high prevalence states of Tamil Nadu, Andhra Pradesh, Karnataka, Maharashtra, Manipur, and Nagaland and the state of Delhi. Since then several other state governments have also decided to provide ART with their own resources. Twenty-five larger hospitals are currently involved in ART treatment and many other district level hospitals have been identified. Large-scale training is being conducted for personnel involved in this programme. Currently it is estimated that about 30,000 persons are receiving ART on the government programme. The government programme aims to provide ART to 1,00,000 persons by 2007.

ConclusionConclusionConclusionConclusionConclusion

What can we learn from the history AIDS treatment? In order for governments to have legitimacy, they have to respond to the perceived welfare of people. In US, Brazil, Thailand and South Africa, the decision to provide ART was a result of concerted action by the people, putting pressure on governments to respond. The UN conferences in Durban and Bangkok, and information sharing of local experiences, have been critical in generating such a response. Lobbying

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Economic and Political Weekly June 24, 2006

with WHO and UN to develop international initiatives and the impact these have on local governments have been important. Pharmaceutical companies are not immune to the pressure of people’s groups, governments and international agencies. Concerted action can reduce costs of drug treatment.

As justice Cameroon said in an interview in 2002, “the question is not whether treatment is affordable. It is a question of will to provide treatment. It really is. Seven to nine billion dollars is not a great amount by any metric”.

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Email: zachariah@cmcvellore.ac.in

Médicins Sans Frontières, Paris, www.accessmed-msf.org.