Clinical trials or exploitation?

Abstract

The changing landscape of research and the market pressures are causing a shift of medical experiments by U.S. entities overseas, where bureaucracy is less rigorous, patients are more eager to enroll, and costs are significantly lower. Ethical concerns about international trials and the protection of subjects have been heightened ([1][1], [2][2]). Nonetheless, little has been done to prevent underprivileged communities from being left out of clinical and scientific benefits after having served as test subjects. This happens in 33% of the studies conducted overseas ([3][3]); after a successful trial, the sponsor does not market the product locally. In the United States, patients tested for a new product continue to receive it either through the market or by applying to special programs. Sponsors should be required to market the new drug in the country where the trial was carried out, and to do so considering local economy, health care coverage, and purchasing power. This calls for a more direct involvement of local institutions. This would allow such institutions to not only protect individual patient rights, but also gain expertise and become more competitive. We understand the economic and practical barriers faced by U.S. sponsors, as much as we acknowledge their need to maintain profits. Nonetheless, we see an urgent need for international consensus on ethical guidelines for entities conducting clinical experiments overseas. Such guidelines must cover all phases of a trial, from the design to the follow-up, through the review process, but they cannot be mere recommendations, as seen so far. Compliance with these rules must become a prior binding condition for the approval of any study proposal. This would constitute an important step taken against scientific capitalism, ethical relativism, and, in general, toward a fairer world. 1. 1.[↵][4] 1. The National Bioethics Advisory Commission (NBAC) , Ethical and Policy Issues in International Research (NBAC, Bethesda, MD, 2001). 2. 2.[↵][5] World Medical Association (WMA), “Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects,” adopted in June 1964; last note of clarification in 2002. 3. 3.[↵][6] 1. P. Lurie, 2. S. M. Wolfe , Letter to the National Bioethics Advisory Commission regarding their report on the challenges of conducting research in developing countries (Public Citizen Health Research Group Publication No. 1545), 13 Nov. 2000 (available at [www.citizen.org/publications/release.cfm?ID=6746][7]). [1]: #ref-1 [2]: #ref-2 [3]: #ref-3 [4]: #xref-ref-1-1 View reference 1. in text [5]: #xref-ref-2-1 View reference 2. in text [6]: #xref-ref-3-1 View reference 3. in text [7]: http://www.citizen.org/publications/release.cfm?ID=6746