Why the Top-Down Approach Has Failed
JOHANNESBURG, South Africa -- Another World AIDS Day has arrived (Dec. 1) and with it more HIV cases than ever before—over 40 million. The World Health Organization's target of treating three million people by the end of this month has failed by about two thirds. Until very recently we heard little remorse, and still haven't had a proper assessment of whether the original target made any sense. But in true Stalinist Plan mode, a five year target—of access for all by 2010—is the new mantra.
In the urgency of scaling up much needed treatment for people living with HIV/AIDS, setting targets is a natural and central prescription; however targets are political tools and should be used with extreme caution by international technical bureaucracies. Although targets can be successful in attracting attention and funding, unless a robust plan underpins a target there is a real risk that political and financial capital will be squandered. There is great sympathy and desire among the general public to care for those affected by AIDS, but few have a realistic notion of the difficulty of rolling out AIDS treatment. A key problem is that many of the countries hardest hit by HIV/AIDS barely have the infrastructure, expertise and finances to provide even the most basic healthcare, such as vaccinations. Even preventable and wholly curable diseases like malaria still ravage many sub-Saharan countries, partly because doctors are so scarce that sick people often have to walk for many hours to visit a clinic, where the only drugs available may not be effective. A hospital stay is beyond the resources of many because a family member must stay with the patient to provide food, personal care and laundry services. Although the antiretroviral drug regimens for HIV have been greatly simplified in recent years, doctors and nurses need specific training in order to dispense them properly. Ensuring that patients are treated regularly and can rely on good stocks of medicines requires reliable drug procurement and logistics and good storage facilities, including continuous cold storage during transport and at the treatment centers. In addition, patients need to see physicians and other trained medical personnel several times before they begin treatment, several times during the first 3 months of treatment and then at regular 3 month intervals. Patients should still have a good support network at home so as to ensure that they take the right drugs at the right time and stick rigorously to the treatment requirements. In addition, patients should have support at home to assist with the side effects of treatment. In reality, not a single one of these requirements for best practice can be relied upon in southern Africa, where the burden of disease is greatest. What, Then, To Do? There are many groups attempting to address these difficult issues and some do better than others.
This brief overview of two current approaches shows that those that are able to adapt best to local conditions and give more power and respect to local health workers stand the best chance of actually working. Approach 1: A two-year, extremely bold, broad-ranging plan was quickly put together to massively increase distribution of low-cost drugs to existing primary health care facilities. The goal of treating three million people by 2005 called for a sharp increase in drug production, which would result from allowing certain multi-drug therapies to be fast-tracked through the drug evaluation procedures. It was expected that prices would be reduced based on bulk production and that medical facilities could then ramp up patient numbers.
What this campaign, in its enthusiasm, failed to take into account was that drug companies expected to capitalize the expansion of production without guaranteed orders, were reluctant to take the risk. The distribution logistics of the drugs were haphazard—with shipments being held up at customs and stock-outs lasting for several months.
The campaign also ignored the evident and long-standing lack of medical and infrastructural capacity in target populations, where clinicians and all other health workers were already overstretched, understaffed and under-resourced in terms of facilities. They risked compromising care if they took on any more patients.
Lastly, the equally-evident risk that was taken in pre-approving drugs for the campaign backfired catastrophically as, failing tests of quality or efficacy, 18 drug products were suddenly withdrawn.
It will dismay many who have faith in international organizations and their ability to mount large-scale campaigns to learn that this approach was designed and coordinated by the World Health Organization. The campaign is fading to a close, having reached maybe a third of the target set, but with little guarantee that treatment is of high quality or is sustainable. Instead of setting grand targets, the WHO would have been wise to see what other programs were achieving in some of the most resource-poor environments, such as that described in Approach 2 below. Approach 2: Bristol-Myers Squibb initiated Secure the Future in 1999. This 5-year project set out to provide a platform from which local initiatives could be developed, sustained and replicated through training and networking among many groups—drug companies, governments, medical schools, auditors and non-governmental and community-based organizations. Planning, integration, training and evaluation were established before treatment began. The project has produced several outcomes.
A new, fast, low-cost CD-4 count test for HIV was developed. A study establishing an effectual treatment for mother-to-child transmission of HIV received the Nelson Mandela Award for Health and Human Rights and another study on AIDS mortality data is attracting a high level of interest.
In addition, two "legacy programs" will remain up and running long after the sponsor has gone have been established. A Community-Based Treatment Support Program has opened six model collaborative centers in South Africa, Swaziland, Lesotho, Botswana, Namibia and Mali, to provide medical treatment combined with care and support beyond the clinics, including home-based care, psychosocial counseling, food security, orphan care, and income-generating projects. Another legacy program is a training institute designed to develop management, good governance and leadership capacity among NGOs to enable them to develop, execute and scale-up programs. In 2004, there were more than 1700 participants in pilot training courses in five southern African countries. Approach 1 or 2? WHO's 3 by 5 Campaign has attracted $27 billion in funding pledges, but with the major constraint to treating patients being the lack of medical personnel and infrastructure, which take time to build up, it is difficult to see how such a sum could be usefully absorbed in such short timeframe.
The legacy of WHO's 3 by 5 campaign will be disappointment for the patients who received the drugs that had to be withdrawn. HIV is highly adaptable and goes through several stages of development. Each stage must be attacked in strict sequence with specialized drugs in particular quantities. If any phase is attacked with a sub-lethal dose the virus can mutate and become resistant. This is why special training must be given to those dispensing treatment. Patients who started a course of the generic drugs that were discontinued are at great risk.
Furthermore, the drugs in question were not fully tested, and in some cases were not bio-equivalent to the branded versions. Some actually had new ingredients altogether which means that nobody knows exactly what effect they had. This leaves doctors having to guess what to prescribe next. Pre-qualifying copycat drugs was a known and foreseeable risk taken by the WHO for the sake of achieving a target that was too short-term and ambitious. On a recent visit to various AIDS facilities in Lesotho, including the Secure the Future clinical center mentioned above, I was shown evidence that sub-optimal single, dual and poorly monitored triple ARV therapy all occur throughout government programs. In one report, of 24 patients seen by a doctor, six were on inappropriate mono or dual therapy and a different patient had been prescribed just 10 doses of Nevirapine, which is meant to be taken indefinitely in conjunction with other drugs.
Local doctors estimated that of a total of 2000 patients perhaps 800 were on suitable, sustainable treatment. One doctor said that if the government pressured them to cut corners, they could manage perhaps 5,000 patients by end 2005. But it would be under protest. The point here is that the target set by WHO under 3 by 5 was to treat 28,000 by the end of the year. This may mean either that the organization did not have a realistic idea of what could be achieved or that it thought the clinical staff could do better if they really tried. Neither option is acceptable.
Meanwhile Stephen Lewis, the UN Special Envoy on AIDS said after WHO's admission that it would miss the 3 by 5 global target that the present time constituted "one of the UN's finest hours" claiming it "has unleashed an irreversible momentum for treatment". Having met doctors in the field who have been utterly demoralized by the 3 by 5 experience, it is hard to agree with this rosy interpretation. Certainly, the patients deserved better. And 3 by 5's failure has simply been replaced with a new target of universal access by 2010 - is this also meaningless? Meanwhile Secure the Future has spent $115 million, coordinated a broad-reaching and effective partnership with researchers, universities, doctors, faith based groups, nutritionists and local NGOs.
This partnership has achieved its aim of leaving in place sustainable, dynamic and replicable systems, such as the Baylor International Pediatric AIDS initiative. This effort coordinates a nurse education and physician exchange program between five African countries and the U.S. and provides a model which could be scaled up appreciably and make very good use of large sums of money. Perhaps a national program could offer to pay part of the loans of newly-graduated medics in return for service in Africa.
Indeed, Dr. Bill Frist the Senate Majority Leader and a medical doctor spends an annual working holiday in African clinics and could perhaps be encouraged to lead such an effort. Building From the Bottom Up There are many such collaborations among business, academia and the Bill and Melinda Gates Foundation that are making cost-effective breakthroughs in treating diseases of the developing world. In controlling and treating a far more manageable disease, like malaria, partnerships between the private sector, academia and governments have delivered impressive results.
Clearly, it is difficult for large organizations to be flexible, transparent and responsive, but it shouldn't be impossible. In particular USAID's renowned technical expertise is exactly what is needed to build local capacity and infrastructure. The key is to ensure that assistance and expertise will equip poor countries to deal with their AIDS problem better. Of course, the WHO is charged with looking at the global AIDS problem and projects like Secure the Future only treat a few thousand people. But it is the small projects, that have been adopted and adapted to local cultures and expectations, that encourage and inspire others. This is where momentum is built and health workers in the field—such as those with MSF, Anglo-American, AHF—are all doing admirable work along these lines. A heavy-handed target imposed from outside will never be successfully accommodated in the short-term, no matter how much money is thrown at it, and leaves feelings of failure among recipients and waste among donors.
At the same time, the WHO is perfectly placed, with a truly global network, vast knowledge and expertise among its staff and access to substantial funds, to take on the intricate and demanding role of steadily building capacity from the bottom up through the multi-partner groupings described in approach 2 above. Target setting is the political approach—it gives a good impression but is likely to do more harm than good—and the WHO has such great potential as a technical body that it is a pity to see it wasting its talents.