Now more than ever, drug companies are going outside of the United States to conduct clinical trials. This raises some important ethical concerns, especially when trials are conducted in developing counties, or in nations whose health care systems are very different from ours. Recent studies found low rates of ethical review of research in developing countries and in China. One of the most serious concerns regarding “outsourcing” clinical trials to less well-to-do countries is the possibility that these nations’ poor could be manipulated by financial incentives and inadequate information about the study.
We have seen this scenario before. Both the Declaration of Helsinki and the Belmont Report state that the exploitation of a “disadvantaged or vulnerable population or community” as an easy source of test subjects constitutes unethical research. In all of our class discussions on the topic, I don’t recall anyone mentioning that a rich country could take advantage of a poorer one for the purposes of medical research. As far as I remember, we confined the issue to within a particular nation. This problem, however, has been magnified to a global scale.
Selecting which nations are eligible to participate in US-based clinical trials would certainly be viewed as discriminatory. However, countries such as Canada and Sweden are believed by bioethicist Dr. Ezekeil Emanuel (and undoubtedly by others as well) to be consistently satisfactory locales for research, so banning clinical trials of American drugs in all foreign countries is not the answer, either. But how are we to ensure that the research is ethical if it takes place on foreign soil?
http://www.nytimes.com/2009/02/19/business/19clinic.html?hp
http://content.nejm.org/cgi/content/full/360/8/816
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This is a very interesting and controversial topic. I think that the fact that United States looks to other countries to test its own drugs, in itself, is ethically wrong. By the nature of the testing, using citizens from other nations as tools to find out whether our drugs are adequate for our nation’s citizens suggests that the government, or the pharmaceutical companies at the least, consider American citizens to be above citizens of other countries. In order to ensure that our drugs are safe for human, we first test a given drug on animals before we implement tests of the drug on human subjects. So, I am convinced that outsourcing research for United States drugs in order to ensure that the drugs are safe and effective for Americans is not much different from first testing drugs on animals in order to ensure the safety of the drug for humans.
Of course, an animal rights activist would strongly disagree with this statement. But, regarding this outsourcing issue, both the people in America who benefit from the results of the drug testing and those who are subjects of the testing oversees are humans. I agree with your point that allowing this procedure to continue will result in a phenomenon of rich nations taking advantage of poor nations. The rich and powerful nations will continually turn to the poorer, less developed nations not to aid them with their healthcare systems, but to exploit their sick and even healthy citizens who are most likely already exploited by the poor healthcare systems in these third world countries.
I do however see how the United States pharmaceuticals could attempt to justify outsourcing research. These companies could angle their procedures in a way that would make it seem as if they are doing a favor to these poorer nations, by coming up with drugs that may eventually heal certain worldwide epidemics. In the case that testing is being done on individuals who are already afflicted with a disease, like AIDS, then the argument can be made that these people are already sick, so the U.S. should use them in order to help find a cure for their illness. If pharmaceuticals were to appeal this case to the American public, I do not doubt that there would be a substantial amount of people who may agree with the fact that America is doing these poorer countries a favor by using their “sick” citizens as subjects for progressive research that may eventually produce cures for worldwide epidemics. For, this makes the goals and motives of the pharmaceuticals seem credible; they are attempting to cure diseases by using those who already have the disease, even if they are not in the U.S.
But, this angle is flawed for one main reason: there is an ongoing trend of those in poorer nations not having access to the new, expensive America drugs. So, even if this outsourced testing lead to a cure of some sort for a given disease, it is unlikely that those in the poorer nation who had undergone the testing would have access to this new drug. So, the common motive of pharmaceutical companies is very flawed. The bottom line is, outsourced research is a revolutionary way for rich nations to further take advantage of poorer nations and further increase the disparities in healthcare around the world.
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