by Roger Stanev
The number of clinical trials outsourced by pharmaceutical companies to developing countries has surged since the mid-1990s. Current estimates suggest that 40% of the total number of trials are now conducted in less developed regions of the world, e.g., India, Brazil, Mexico, South Africa, and Eastern Europe. The situation has raised important questions about the ethics of clinical research, including the question of whether or not such trials are exploitative.
On one side of the debate, some argue that outsourcing is not exploitative because it brings global benefits by allowing pharmaceutical companies to test new drugs more quickly, cheaply and effectively than they can in the U.S. (or other developed countries). It is cited, for instance, that the average cost of running a phase-III clinical trial in developing countries is approximately 70% cheaper than in the U.S., and that this is beneficial because cheaper research leads to cheaper drugs, which would mean more affordable drugs for impoverished populations. Proponents of outsourcing also argue that it transfers resources and expertise to less developed regions of the world while also providing researchers with access to a larger, more genetically diverse population, as well as ‘clean-patients,’ i.e., participants who are less likely to have been treated with other drugs or by other clinical trials.
On the other side of the debate, some argue that outsourced trials are exploitative because these populations are poor, with low levels of literacy, and often powerless to defend their own interests; the trials are exploitative because they exploit the vulnerability of people in the developing world. There is also a concern that, because necessary legal and ethical institutions safeguarding the interests of trial participants are not in place in many of these countries—e.g., less stringent ethical reviews, the under-reporting of side effects, and lower risks of litigation—there is an increased likelihood of research ethical misconduct.
If we suppose, as Emanuel et al does, that “the fundamental ethical challenge of all research with humans is to avoid exploitation”, then it is reasonable to say that our first order of business should be determining whether any outsourced clinical trial is exploitative. (In this case, we should focus on the moral sense of ‘exploitation’ as wrongful or impermissible exploitation.) What makes a clinical trial wrongfully exploitative? Consider accounts of exploitation that appear to give us truth conditions for wrongful exploitation claims, such as: a clinical trial is exploitative if the distribution of risks and potential benefits to trial participants is unfair. For example, if potential trial participants take most of the risks (e.g., possible serious side effects, undue burdens) but little expected benefits (e.g., cannot afford the drug if proven effective), whereas Glaxo Smith Kline (GSK) takes little risks but high potential benefits (e.g., high profit margins under low risk), then the trial is exploitative. So, if the drug being tested is not likely to be affordable in the host country or if the health care infrastructure cannot support its proper distribution and use, then it is exploitative. It would be exploitative to ask individuals in a developing country to participate in research, since they will not enjoy any of its potential benefits. But is this right?
Let’s look at a specific case. In the 1990s, GSK conducted clinical trials of a short-regimen of AZT in Uganda. These placebo controlled trials assessed whether lower doses of AZT than those used in rich countries (such as the U.S.) could reduce the rate of mother-to-child transmission of HIV. The existing normal regimen of AZT which was previously evaluated and approved in the U.S. (protocol 076) was deemed too costly for needy African populations. The average cost for the full regimen was over $1K per woman per year, whereas the annual health budget of African countries was under $10 per person—Uganda’s health budget at the time was estimated to be under $3 per person per year.
Even though GSK was taking advantage of the unfair situation in which trial participants found themselves in Uganda (i.e., poor and without routine access to healthcare), GSK could argue that it was not taking unfair advantage of the trial participants per se. They could further argue that, if the pharmaceutical market in which GSK and Ugandans operate is competitive, GSK does not exploit Ugandans if GSK pays Ugandans the ‘market’ price to participate in the trials, and that Ugandan participants should complain to their government representatives, not GSK, if their country cannot afford to pay for the healthcare infrastructure required for its citizens to afford and access the drug’s potential benefits. Moreover, what if GSK wanted to pay for the health care infrastructure required for Ugandans, but said it couldn’t because of alleged highly competitive market GSK finds itself in?
But, in my opinion, this trial was exploitative because the Ugandans were unable to afford and access the drugs they tested. Even if competitive market pressures made it unfeasible for GSK to pay for more, the trial was still exploitative. A clinical trial outsourced to the developing world is exploitative unless the trial’s sponsors provide actual benefits to the vulnerable population, including raising the host country’s health infrastructure baseline—raising it in ways that make the potential drug affordable and accessible to the needy.
Department of Philosophy
University of South Florida