Since the 1980s, the US Army had been studying Hepatitis E, said to account for 50 percent of hepatitis cases in developing countries, in order to come up with a vaccine for the protection of its troops abroad.

In 1995, the US Armed Forces Research Institute of Medical Sciences (AFRIMS), the Thai-based branch of Walter Reed Army Institute of Research, set up a unit in Kathmandu to conduct clinical trials.

Robert McNair-Scott of AFRIMS was the principal US investigator and Mrigendra Shrestha his counterpart in Nepal. Lt Col Robert Kuschner was the trial's project director from the Walter Reed Army Institute of Research.

The vaccine, patented by Californian company Genelabs and licensed by GlaxoSmithKline, is to hit the market in 2007.

In February 2000, the research unit announced a trial would be held with 8,000 volunteers from Lalitpur district adjoining Kathmandu, with 3,000 of them being administered the vaccine or placebo.

However, the plan was scuttled as the then deputy mayor, Ramesh Chitrakar, and other members of the local government body objected, saying the mayor had not consulted them.

They also expressed misgivings as to whether the volunteers knew what they were walking into. Chitrakar is reported to have alleged that the researchers offered him and other dissenters watches and luxury goods to go along with the plan.

However, the Nepali media and NGOs also took up the issue and the ensuing furore made the researchers abandon the idea of civilian volunteers.

Undeterred, the researchers then struck a deal with the Royal Nepalese Army (RNA) that 2,000 soldiers would "volunteer" to be the human guinea pigs.

Author Jason Andrews says in "The American Journal of Bioethics": "Noting the millions of dollars, military training, and arms that the (US) State Department and Military have been giving to the RNA to help them put down the Maoist rebellion, it seems plausible that the resultant military and economic dependence of the host institution/population (RNA) upon the research sponsor (the U.S. Military) threatened the voluntary nature of the institutional and individual participation in the trial."

Though the trial ended in 2003, it is not known who the "volunteer" soldiers are and what their present medical condition is.

Last week, Glaxo released information at a scientific meeting, saying the vaccine was successful, but kept silent about making it available in Nepal.

Now epidemiologists at Yale's School of Medicine and other activists have raised the issue afresh, expressing the fear that the trial might have been unethical.

"The poorest of the poor were used as subjects," a Yale project staff said on condition of anonymity.

"There's no plan for getting the vaccine to the (Nepali) population, despite clearly pitching the trial as an attempt to address this disease for Nepalis. It appears that the vaccine will be developed as a traveller's vaccine at best."

The fear seems plausible since in the 1980s, the same Walter Reed Army Institute of Research sponsored the development of a typhoid vaccine in Nepal. However, though typhoid is endemic in Nepal, one of the poorest countries in the world, the vaccine is not widely used.

 http://www.newkerala.com/news.php?action=fullnews&id=81839

More info here -  http://www.bioethics.net/journal/j_articles.php?aid=713