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(Page 2 of 3)
The complexities of these ethical requirements often lead to misunderstandings of research in poor countries. As the Cambodia trial was being organized in early 2004, a group of sex workers called Women's Network for Unity branded the trial unethical and announced their refusal to participate. The group demanded full health insurance coverage for thirty years and lifetime care for the women who became infected with HIV during the trial as a condition of participation. Representatives argued that if researchers were convinced the drug would be safe, they would not object to such coverage. Following a widely publicized demonstration at the Bangkok AIDS conference in July 2004, Cambodian Prime Minister Hun Sen ordered the trial to stop, stating that he opposes drug tests on Cambodians.
The controversy surrounding the drug test reflects common sentiments of fear and anger in the communities in the communities where they are conducted. Because multiple cases of HIV remain untreated over the course of the trial, both the research subjects and the community develop the impression that the researchers want the subjects to be infected, a disturbing image. These concerns are exacerbated by the general sense that the trials' benefits go directly to large pharmaceutical companies; protesting against trials is then seen as standing up to the corporate machine in the name of local interest.
Meanwhile, the members of WNU claim that the provision of free medical services during the one-year trial, plus a $3 per month stipend is inadequate compensation for trial participants. But the trial alone cannot tackle the immense structural problems of the Cambodian health system; it is meant only to gather information about the safety and efficacy of Viread.
And full informed consent, critical for a trial to meet basic ethics standards, requires not only that participants understand the nature of the trial, but also that they are not coerced into participating. Providing lifetime health care would inappropriately induce participation; no matter how concerned she is about potential side effects (or about whether the drug will even work) no potential participant would ever consider refusing free health care for life. Such negation of informed consent would be unquestionably exploitative.
Many of these negative perceptions of research could be dispelled if the populations involved were given more comprehensive information about research methods employed. This kind of empowerment of local communities would help clinical trials produce useful results more smoothly and at a lower cost. And removing some of the obstacles to conducting research in poor countries - namely, fear of controversy - can pave the way for productive local involvement in clinical research, allowing faster acceptance of trial results and speedier dissemination of benefits in the areas it is needed most.
The most serious objection to the trials, however, moves beyond a simple misunderstanding of the ethical guidelines involved. Trials are often conducted in developing countries because they are cheaper-standard-of-care requirements are lower, and participant compensation is less expensive due to lower relative standards of living. Furthermore, high HIV incidence in these countries means fewer participants need to be recruited. Some protestors view such considerations strategies which unforgivably take advantage of vulnerable populations.
Such objections ignore the simple fact that trials of adequate statistical power would be far too expensive in developed countries. The nonprofit and academic organizations involved - emphatically not the "big drug companies" - are committed to increasing developing-nation involvement in medical research. These trials are not attempts to exploit these countries, they would argue, but to involve them on-the-ground in taking steps toward improving health.
On the other hand, the fact remains in this case, that the trials are more likely to benefit individuals in rich countries, while the participants themselves might never gain anything at all. A year's supply of Viread costs $5000 in developed countries. Even when the company provides the drug "at cost" to certain poor countries, its price tag of $310 per year still represents a restrictive financial burden. How likely is it that a poor Cambodian prostitute could ever afford a daily supply of Viread? The potential harm of the trials to participants is never balanced by its potential benefits. No single coherent strategy has yet formulated to describe how Viread might be procured and distributed in poor countries. AIDS activists who want to see Viread in use must immediately acknowledge this inequality and mobilize to address it. The effort to involve developing countries directly in the fight against HIV/AIDS is admirable, but if they fail to benefit from this involvement, they will naturally feel exploited and be increasingly reluctant to participate in the future. This outcome would prove disastrous for health at a global level.
Continued
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