Clinical Trials and Tribulations: A Look at Overseas Clinical Trials

Making sure that clinical trials are ethical is a classical problem in the study of bioethics. How do we properly regulate, however, for trials done in foreign countries? This is an increasing problem, as many pharmaceutical companies have shipped their clinical trials almost exclusively overseas, particularly to countries that have less stringent ethical boundaries. One possible benefit of this idea is to check the effectiveness of drugs on variety of racial backgrounds. That being said, this is clearly not what companies are after. With fewer ethical restrictions in place in poorer countries, the companies can pay their test subjects less, and it is easier to gather information if the wellbeing and ethical treatment of a patient is less of a concern. Ideally medical ethics should be applied uniformly regardless of geographic boundaries, but there is an issue; how can we enforce our brand of ethics in countries where the same standards don’t apply? One possible way to check that standard medical procedures are followed in these foreign trials is for the FDA to conduct audits of the companies before allowing their drug to appear on the market. These audits, however, are extremely expensive, and the FDA has been long strapped for cash. One possible solution to this problem (besides somehow finding more governmental funding, which I don’t see happening) is to be less accommodating to the drug companies. For example, rather than just approving drugs with clinical trials that don’t adhere to standard formats, we can force them to standardize, making the databases of clinical data more complete. In addition, attempts to force companies to register their foreign trials would make monitoring for unethical behavior much simpler and more organized. In these extenuating circumstances, this seems to be the best option.

http://www.nytimes.com/2010/06/22/health/research/22trial.html