Paul Herrling, in his Commentary article “Experiments in social responsibility” (Nature 439, 267–268; 2006), describes pharmaceutical companies moving towards a more progressive approach to drug development and distribution in poor countries. But it is important to note that, even when research in developing nations leads to effective treatments, there is still the danger of local populations being exploited.
Recent clinical trials of a hepatitis E vaccine in Nepal are a case in point. Run by GlaxoSmithKline and the US government Armed Forces Research Institute of Medical Sciences, the trials showed an impressive on-treatment efficacy for the experimental vaccine (see M. P. Shrestha and R. N. Scott's report to the American Society for Tropical Medicine and Hygiene at http://www.astmh.org/meetings_new/ASTMH_05_FP2.pdf). But the methodology of the trial raises questions about the ethics of clinical-trial conduct among vulnerable populations. The research team had to drop original plans to test civilian volunteers in the city of Lalitpur, after local people objected to a lack of informed consent or participation in trial design (for details of these events, see J. Andrews Am. J. Bioethics 5, W1; 2005). Instead, they gave the experimental vaccine to soldiers in the Royal Nepalese Army, who are vulnerable as members of the armed forces and as some of the poorest people in a ‘least-developed’ country.
These ethical issues take on greater importance now that the hepatitis E vaccine may have public-health usefulness. Will the Nepalese community benefit? Or will the results be used only to develop a profitable vaccine for (mainly Western) travellers and US soldiers? We hope that GlaxoSmithKline and its collaborators make this vaccine accessible to the populations placed at risk by the trial, in line with the well-intentioned humanitarianism that Herrling describes.