US suspected of using Nepal soldiers as guinea pigs
Sudeshna Sarkar | 09.01.2006 16:21 | Anti-militarism | Bio-technology | Health
A fresh outcry has risen in the US and Nepal over what could be the American government's exploitation of Nepali soldiers as human guinea pigs to find a Hepatitis vaccine.
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
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
Sudeshna Sarkar
Comments
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Important question
10.01.2006 01:18
The safety testing comes first and since the "guinea pigs" in this case are not necessarily at risk from the disease they derive no benefit and there are SERIOUS consent issues.
Assuming a vaccine has been judged "safe" (that's a relative term with vaccines) it is then tested to see if it works. After all, might be perfectly safe but perfectly useless. In the case of non-deadly diseases one can have volunteers who are vaccinated and then intentionally exposed to the disease. But this is scarcely practical when the disease is truly serious. Besides, a vaccine that is only partially effective against direct(intentional) infection might nevertheless be quite effective against the more casual situation of normal "casual" infection. To test effectiveness, ideally you have a test environamnt where there is a reasonably high chance of natural infection within a given amoun of time.
Notice here that IF the vaccine test is successful (the vaccine works) the human guinea pigs involved HAVE received a benefit --- 1/2 x infected in the placebo group / infected in the vaccine group (the 1/2 because it is 50-50 whethter they recioeve the benefit or not.
Mike
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