Saturday, April 16, 2011

The globalization of research ethics committees: paternalism, ethical imperialism or partnership

Research, the story goes, has become increasing global: there is more clinical and behavioral research involving human participants in more places in the world now than ever before in human history. These things don't just happen, so it is interesting to reflect on the meaning of the march of research to all points of the compass. Is it because there is an overwhelming humanitarian concern about those who are sick in the most impoverished areas of the world? Or is it because far-flung (at least, from North America and Europe) countries are a friendly business environment as health-related research becomes more and more about developing profitable interventions and devices?

As research projects and institutions are rapidly springing up around the world like mushrooms, the development of ethics committees to review such research globally is moving at a much more leisurely pace. In many places in Africa, for instance, there is no local body with the authority or expertise to conduct an adequate ethical review of a scientific protocol. In this month's issue of Tropical Medicine and International Health (subscribers only, alas) Ravinetto et. al. argue that there always ought to be a double ethics review of research conducted/sponsored by foreign institutions in developing countries. The requirement for 'local' review -- in addition to review in the sponsor's institution -- appears in some ethics guidelines, and it does happen a good percentage of the time. But why ought it to happen? According to Ravinetto et. al., it ought to happen in order to produce a more comprehensive and balanced review process, which in turn better fulfills the central mission of ethics committees, i.e. to protect research participants and benefit communities affected by the research. A collaborative double review can avoid ethical imperialism (imposition of ethical standards of the richer countries on the poorer ones) and paternalism (in the assumption that only ethics committees in richer countries can really review research adequately). The current problem with double review (according to Ravinetto et. al.) is not just the unpleasant fact that some ethics committees in developing countries may be operating at a low standard. The problem is that ethics committees involved in the review of research often do not correspond with one another at all, and the possible benefits of collaboration are missed.

The points are well taken, but the paper seems to underrepresent some of the ethical challenges of ethical review in a context of global inequality. It should be remembered, for example, that sponsoring countries hold the purse-strings, including the portion of the budget that is supposed to go to the local institutions for administrative support (including financial support for the local ethics committee). When there are conflicts between foreign and local ethics committees, which one is more likely to have the greatest say? The ethical playing field, parallel to the political and socio-economic playing fields, is very uneven. What might help, besides greater collaboration between ethics committees, is greater investment in local scientific institutions in order to prevent the vast majority of research being funded and conducted by developed world institutions.

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Saturday, April 09, 2011

The unbearable fragility of HIV treatment access

It has taken a tremendous effort, over the course of many years, to give HIV-positive persons in sub-Saharan Africa access to antiretroviral treatment. On the World Health Organization's latest reckoning, over five million persons are now on treatment worldwide. However, the success is partial: another ten million persons in need of treatment currently do not receive it, and the pool of those who will need treatment in the future is expanding furiously -- over 7000 new HIV infections take place globally every day.

Even the partial success in access to treatment is very, very fragile. The global HIV treatment initiatives are generally bankrolled by the developed world's financial heavyweights who (after debilitating their own economies) are calling for austerity and belt-tightening, and programs supporting the lives of distant others are looking vulnerable.

But the challenges to maintaining and expanding HIV treatment programs apparently come from all angles. AllAfrica, that great warehouse of online African news, gives two recent examples. Kenya has been hit by a rise in food prices and a drought. Nearly two and a half million Kenyans are regarded as food-insecure, as prices have risen 15 percent; herders are losing their livestock in the dry north-east of the country, and some are fleeing to Uganda. For those who are food-insecure, HIV-positive and in need of antiretroviral treatment, the situation is grim: even for those who can access treatment, the pills are very hard to tolerate (and less effective) on an empty stomach. Some people would rather go off treatment than deal with the side-effects, though this could lead to resistant strains of HIV; others are reluctant to start treatment, which is likely to lead to poor clinical outcomes. In Tanzania, another twist: a sizable patients taking antiretroviral treatment may fail to adhere to treatment in their quest for the latest miraculous herbal cure. A former Lutheran pastor in the village of Loliondo has concocted something which has stirred a great deal of excitement, as would any substance promising to cure diabetes, tuberculosis and HIV. The ingredients are unknown, but the Tanzanian Drugs and Food Authority, the National Institute for Medical Research and the Muhimbili National Hospital endorse the herb as fit for human consumption. But there is no proof of its efficacy. No matter: people with HIV are flocking there by the thousands, some persons literally dying to get there. The Tanzanian authorities are struggling to convince people to continue taking their drugs, and not succumb to the siren song of an HIV/AIDS cure. (It is always more pleasant to imagine an indigenous cure than deal with the reality of depending on products of foreign multinational pharmaceutical companies.) With all these pressures -- economic crises, natural disasters, rising new infections, strange cultural manifestations -- is it reasonable to expect the pool of those accessing HIV treatment to continue to expand? What is the plan B if the bubble bursts?

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