/ 28 July 2000

Cherry-picking is the luxury of

researchers

Nono Simelela CROSSFIRE

Because the prevention of mother-to-child transmission of HIV is an issue involving the protection of innocent

unborn/newborn infants, debates on the matter can be clouded by emotion and sensationalism. This is illustrated by Howard Barrell’s article “R800m to let Aids babies die” (July 21 to 27).

It raises a number of methodo- logical queries which are likely to have an effect on the magnitude of the costs, effects and savings asserted by University of Cape Town researcher Jolene Skordis.

Most of these issues could be remedied by remodelling or using a wider range of assumptions, and are therefore not fundamental flaws in the study, but they do represent

legitimate concerns that mean the author’s stated estimates are open to debate. The author is certainly not the first to research issues relating to costs of interventions in mother-to-child

transmission of HIV/Aids. The 13th International Aids Conference held in Durban recently endorsed that fact that prevention should be the key goal in our response to this epidemic. Strategies to achieve this are varied and manifold, and include the effective management of sexually transmitted diseases (STDs), consistent use of condoms and an education campaign aimed at raising awareness and creating dialogue on the epidemic.

All of the above strategies are in place in South Africa and are being intensified. The benefits, however, will be clearly noticeable only at a later stage. While it is legitimate to highlight an issue, it is also equally honourable to state facts in an accurate and honest manner. We need to resist the temptation to make inaccurate assumptions on a matter of such gravity. Firstly, there has never been doubt or denial by the government of the true effect of this epidemic on health- care costs. We are well aware of the changing patterns of the disease across facilities in our country.

The morbidity and mortality reflected in the statistics of our medical and paediatric wards clearly captures the effect this epidemic is already having. Strategies to shift care from health facilities to communities are in place in some areas with plans to strengthen these and expand to other areas. Our government, however, remains conscious of the imperative to avoid simply shifting the cost to already poor communities and households.

Caution regarding the implementation of interventions to reduce mother-to-child transmission of HIV should therefore not be interpreted as a lack of understanding of the numbers game or a poor appreciation of the burden of this disease. Caution prevails precisely because not all is clear in the area of mother-to-child transmission. An appropriate and holistic approach is not about giving out the drug and walking away. First, the drug AZT. The calculations used in the article refer to a regimen started at 36 weeks of pregnancy, during labour and shortly after delivery. The reality is that a significant number of women book late for antenatal care and many more present in labour, and would therefore not benefit from this intervention.

Bar the issues of costs, provision of AZT to pregnant women four weeks prior to delivery will also necessitate the infrastructure necessary to monitor the women, provide support and ensure adherence to therapy. It is not an option to limit the use of this drug to the intrapartum period only. Research at the Chris Hani- Baragwanath hospital showed that limiting the use of AZT to an intrapartum intervention is not effective and is thus not an option. The drug Nevirapine presents different challenges. The widely acclaimed Ugandan study HIVNET 012 clearly

demonstrated the efficacy of two doses – one to the mother at the onset of labour and another to the baby within 72 hours of birth. The low costs, ease of administration and little need for monitoring make it an ideal choice for developing countries. Several problems, however, still need to be addressed.

Firstly, studies in Africa (including South Africa), where breastfeeding is culturally entrenched, showed some reversal of efficacy when women continued to breastfeed their infants.

Quite clearly this presents a major challenge where breastfeeding is culturally appropriate, socially acceptable and has always been the best option for infants given the socio-economic circumstances that often prevail. Fear of discrimination and stigma in the community can overshadow the effect of intermittent counselling on breastfeeding

options.

Is it ethically acceptable to provide drug interventions to women and then offer them counselling on what the options are for feeding their babies when we know that for many of them there is actually no option but the breast?

The challenge for us is to ensure that the full benefit accrued from our interventions are not reversed by morbidity and mortality caused by infant diarrhoeal diseases.

The second vexing problem related to the use of Nevirapine for prevention of mother-to-child transmission is the emergence of resistant virus strains in women exposed to a single dose of this drug. Research needs to continue on the transmissibility of resistant strains in the community as well as future anti-retroviral needs for the mother. The third issue relates to the regi- stration of the product for mother- to-child intervention. Although Boehringer Ingelheim

announced a free offer of the drug to developing countries, the company has yet to have this drug registered for this specific intervention. Registration of a drug needs to be supported by research to prove efficacy, safety and so on. Until recently only the Ugandan study could be used as a source for referral and lately additional data from the South African Intrapartum Nevirapine Trials has supported the findings in the Ugandan trial. In order to assist in collecting more data for this research, the Department of Health endorsed a request by the researchers for further funding to expand the pilot sites and the Medicines Control Council undertook to fast-track the evalu-ation of the application for registration of the drug which Boehringer Ingelheim has submitted.

Discussions on mother-to-child transmission between the South African researchers and officials of the Department of Health have been ongoing, even prior to the Durban Aids conference. At the last consultation on June 6 the researchers promised a full report of the results at the conference.

In reality the Department of Health officials, like all other delegates, were exposed to the full report for the first time in Durban. A follow-up meeting to review the full data, clarify outstanding issues and discuss other relevant matters has been scheduled for August 12. Barrell creates an impression that the provision of infant formula presents an instant solution to the problems of breastfeeding in the context of HIV infection.

Several presentations at the conference highlighted the challenges of breastfeeding in developing countries.

Exclusive breastfeeding is, in reality, a “dream”. A true analysis of the social and cultural context of how women live in Africa dispels the myth that it is possible to feed the baby nothing but the breast for three to four months. The reality is that more often than not the women do not have the luxury of staying home for 24 hours a day for four months. Many of them have no income and often have to leave their babies in the care of others while they eke out a living for their families. For a woman to breastfeed exclusively for four months she must have a good diet with enough nutrients to support milk production. She may be prone to infections due to her HIV status and could realistically not be able to carry out this task.

Equally challenging is the provision of infant formula under some of the prevailing socio-economic circumstances. In addition to the formula and bottles, we need to ensure that women have access to clean running water as well as the energy necessary to boil this water to prepare the feeds. What we need to aim for ideally is a total package of care for women in the context of this epidemic. The package should include appropriate information on the nature of the infection, access to voluntary counselling and testing even prior to contemplating pregnancy, counselling and continued psychological support throughout, vigorous management of opportunistic infections and appropriate interventions

during labour and delivery. This will ensure that women live longer to care for their babies. Partners and the community clearly have an important and significant role to play. All of these interventions

described above are incorporated in the HIV/Aids Strategic Plan for South Africa, 2000-2005. While we welcome the inputs from erudite researchers like Skordis, this epidemic presents different challenges for each of us. For those who have to find equitable, cost- effective and sustainable solutions, the luxury of cherry- picking remains the domain of researchers. The health sector needs to respond to the needs of not only HIV-positive women and their infants, but to the needs of all people who have HIV- related medical problems, as well as other South Africans who have non-HIV-related medical problems. Dr Nono Simelela is chief director (HIV/Aids and STDs) in the Department of Health