Ethics, epidemiology and access

Ethical considerations

Prevention trials are very different from those which text a curative method on those who are already ill. They have to be conducted in countries and populations which are severely affected, and therefore already vulnerable. Before trials can proceed they have to meet stringent international ethical criteria and guidelines, regardless of where they take place.

To avoid suspicion that the poor are being used as test cases, it is crucial that researchers engage in authentic and well-planned efforts to build partnerships with trial host communities. Researchers must collaborate with communities on designing and implementing clinical trials that are both scientifically rigorous and ethically sound. The scientific community must in turn be fully accountable for all HIV and AIDS research. The Global Campaign for Microbicides, for example, advocates the use of a ' community mobilisation framework' to achieve this levle of collaboration.

Epidemiological issues

As the second and third generation microbicides become available building on ARV technology, resistance issues will arise. Will prolonged use of a topical ARV microbicide increase a woman's resistance to a class of ARV drugs should she become positive? The answers to these questions will not be known until after the clinical trial stage.

Nonoxynol-9 (N9) is a spermicide that has been in use as a contraceptive for decades. Interest in N9 as a barrier against STIs led to various studies with discouraging results - N9, in some cases, actually increased the risk of HIV infection. This was especially true among women who used it frequently, such as sex workers. As a result, trials were halted and N9 is no longer indicated for use as a contraceptive by women at risk of HIV infection.

First generation microbicides have been developed for vaginal sex only. Moreover, the biological challenges of creating a rectal microbicide are more complicated than vaginal microbicides. Until appropriate rectal microbicides are developed, vaginal microbicides must be accurately labelled so that people are discouraged from using them rectally. As and when microbicides become available, whether vaginal or rectal, they must be clearly and completely labelled so that consumers are aware of how they should be used, what level of protection they provide, and what they protect against.

Ensuring access

Once microbicides have been approved for public use, there remains a number of challenges concerning their safe and effective implementation. A supportive policy and social environment will be required to ensure that microbicides can be distributed on a large scale. Health providers will need to be trained and the product must be acceptable to women and accessible to them at a price they can afford.

The regulatory capacity of developing countries also poses potential problems. Many developing country National Regulatory Authorities (NRAs) lack the capacity to regulate microbicides quickly and on such a large scale. It has been argued that international agencies should work with developing country NRAs to build capacity in this area through increased collaborative efforts.

Recommended readings

Regulatory challenges in microbicide development: ( P. Coplan; M. Mitchnick; Z. Rosenberg / Elsevier Science , 2004); This article outlines how microbicides offer the potential for women’s empowerment in HIV prevention. However, it notes that widespread use of these gels could be problematic due to major regulatory a...
Preparing for microbicide access and use: ( International Partnership for Microbicides , 2002); Recommended reading; This report from the Microbicides Initiative outlines key steps needed to ensure equitable access to microbicides. The paper sets out priorities that draw on five main dimensions of access: acceptabi...