A meeting being held in Botswana will impact millions of people living with HIV. On March 29-30, drug regulatory authorities, public health leaders, health care providers, academics, procurement officials, pharmaceutical companies, and non-governmental organisations converged in Gaborone to deliberate on the safety of some anti-HIV drugs proposed for distribution in every nook and cranny of Africa.
In Africa, where the disease has reached an epidemic level, the World Health Organisation (WHO) plans to treat 3 million HIV/AIDS patients by the year 2005. Part of its strategy includes the development of fixed-dose combination (FDC) therapies. These are pills containing several different anti-retroviral (ARV) drugs that are usually administered separately. The aim is to simplify treatment regimens, improve patient adherence – thereby reducing the development of drug resistance – and reduce costs.
However, FDCs have not undergone the rigorous testing to which the individual pills have been subjected. Indeed, they have not really been tested at all. Rather, the WHO has granted them ‘pre-qualification’ status on the basis of the fact that the individual components have been tested. The meeting in Botswana is meant to address legitimate concerns about their safety and efficacy.
There is also the worry that rather than reduce drug resistance, FDCs may increase it. The reason is that many ARVs have side effects, but these vary from patient to patient. When individual drugs are administered, a doctor monitors the patient’s progress and gives the combination of drugs that best balances effectiveness and side-effects. This ensures that patients have an incentive to return to their doctor for check-ups and also reduces the likelihood that patients will give up mid-way through a course. But since such variation won’t be possible on the fixed dose regimen, some patients may forego the drugs altogether if side effects are too harsh.
Some suspect that the WHO’s main reason for promoting FDCs is that they are cheaper: two fixed-dose combination pills cost $140 per patient compared to about $600 per year for six pills per day. But the cost of the pills must not be the sole deciding factor in their use. Many are concerned that the WHO, in its attempt to provide anti-retroviral drugs to millions of AIDS victims, is glossing over safety and downplaying efficacy. Indeed, FDCs may well offer false economy: if the pills lead to increased resistance, then they will not be cost-effective because in the future more money will have to be spent on second-line therapies to treat resistant strains.
Health activists have hailed the use of FDCs, saying the all-in-one pill combinations will revolutionise people’s lives. Can these be the same activists who protested against the tests of new antibiotics carried out by a research-based pharmaceutical company in Northern Nigeria? This would be ironic. There, the main complaint was that the company did not tell patients about the risks and benefits of the drug. Yet activists are now proposing that untested FDCs be given to patients willy-nilly.
I agree with those activists who demand that treatments for illnesses in poor countries such as Nigeria must adhere to world class standards. This applies to ARVs just as much as antibiotics. The extent of the HIV epidemic and the emergence of resistant strains makes the need for testing more, not less, acute. HIV medicines, whether original or generic, should meet the most stringent, rigorous clinical and testing reviews. If the proposed drugs are rejected by the pharmacies in Brussels, Geneva, London or Washington, accepting the use of the same drugs in Africa, with little resources and a lack of equipment to do a proper clinical and scientific evaluation, may further compound the woes of HIV/AIDS victims.
Even if the FDCs do satisfy all the clinical tests, fundamental problems in health infrastructure will persist. This is not for lack of funding or lack of medicines.
African governments have done little to deliver medicines, even when they have been given the resources to do so, and the majority of drugs are off-patent. Loans and grants have been given on the basis that governments will invest in health infrastructure. But corruption and mismanagement have stymied such hopes. Poor wages in government jobs mean officials are eager to feather their own nests, for example, by paying inflated prices to contractors in return for kick-backs. A hospital may be built for twice the budgeted cost, meaning that there is no money left over to pay for equipment or staff.
Another visible problem in the fight against AIDS in Africa is the lack of information-sharing and low morale among health workers. Pharmacists, for instance, may not know which drugs are available in hospital stores. So the drugs languish in warehouses until they expire. In addition, the lack of regular payment of wages results in low morale among health workers, who then transfer their anger to patients. These factors mean that people are discouraged from seeking treatment for HIV/AIDS.
The WHO’s intention to help poor African countries tackle AIDS is appreciated and treatment is an important part of this. Given the problems faced in effectively delivering medicines in Africa, the WHO’s 3 by 5 AIDS plan is probably overly ambitious. But that excessive ambition is no excuse for providing inappropriate treatment. Whatever medicines are used to treat people must meet world class standards for quality, safety and efficacy. There should be no compromise over this.
Author: Thompson Ayodele (thompson@ippanigeria.org) is the Coordinator of the Institute of Public Policy Analysis based in Lagos, Nigeria, and a Fellow of International Policy Network, London. This article may be republished without prior consent but with acknowledgement to the author. The views expressed in the article are the author’s and are not necessarily shared by the members of the Free Market Foundation.
FMF Feature Article \30 March 2004