The American Defence Ministry is in process of developing a vaccine against Hepatitis E-- a much feared disease that frequently grips the Third World countries like Nepal. In this process, a sample vaccine against Hepatitis E was developed and a pilot testing was done on animals a few years back. Details of the testing, which is said to have showed positive results in animals are, however, not yet available in Nepal. Likewise, details of the second phase trial in which a total of 88 people, 44 Americans and 44 Nepalese, were made guinea pigs, also have been kept secret.

Recently, the test programme on the vaccination was strongly opposed and put on hold by the Lalitpur Sub Metropolitan City where second phase testing was done. The Municipality even chose to withdraw from the vaccination drive as the controversy mounted.

Last year, Walter Reed of Afrims Research Unit Nepal had carried out the test of the vaccine in some parts of the municipality. However, the locals protested, alleging that people were used as guinea pigs. The organisation was also accused of operating without the permission from the Municipality. A communiqu'e issued by an organisation called Lumanti, representing the voice of dissenting people, states that letters have been sent to all agencies involved in the 'research' to clarify on insurance policies, the programme's benefit on the people and to fully inform the general public on the details of the programme.

The community is also demanding that part of the profit from the research be returned to the people of the community. Unless positive assurance is received, no further "research" will be allowed, warn the members of the community.

The Walter Reed / Afrims Research Unit Nepal (WARUN) and Yala Urban Health Programme (YUHP) completed the first phase of the pilot testing in Patan (Lalitpur Sub Metro). Even as details have been kept secret, Ministry of Health is silent over the matter. The 44 people from Patan, who were tested, are now almost underground as they do not expose themselves due to certain kind of fear. The ward chief of the trial area now stands accused of giving permission to the test without knowing its pros and cons, while the innocent public were treated as guinea pig without knowing the process, terms and conditions, and the possible health hazards.

The WARUN and YUHP signed agreements with illiterate public in English language without mentioning what did the document actually contain. Now, even the Health Ministry has given green signals to the test on Hepatitis E vaccine, proposed to be conducted in eight different wards of Lalitpur. "During our series of meetings held with representatives of various organizations related to the issue, it has been concluded that the techniques used in the research and the vaccine are in accordance with national and international standards," claims Health Ministry spokesman Dr Benu Bahadur Karki. He claims the test/research programme to be "satisfactory" and "concluded without any hindrance." However, Deputy Mayor of Lalitpur, in a statement, had said people were strongly opposed to the vaccine test.

The pro-vaccine team has proposed that they will test the vaccine on at least 3000 people in Lalitpur. The volunteers to be included in the test will be vaccinated three times during the first one year of the 2-year test programme. Other process will include seven rounds of blood test and nine rounds of interviews. An additional lure is also offered: The volunteers will get Hepatitis B vaccination for free in case they caught the disease.

Lately, concern is being raised that the testing, if ever it is to be conducted, must follow the Helsinki declaration and Council for International Organisation for Medical Science guidelines. The test results from the earlier tests need to be made public before taking up the next testing. The detailed explanation of the foreseen piloting, with entire pros and cons, needs to be explained, in writing, to every person on whom the test is to be conducted, and the interaction and the deal should be in the languages most comfortable to the volunteers themselves.

Besides, the community people should not to be attracted by any kinds of misleading benefit packages, pressure or money. Any loss to health and life should be well insured, as the testing may cause harm even after more than 10 years. Even HIV/AIDS virus window period is more than 5-10 years in some cases. The test should be done simultaneously in developing and developed countries in equal numbers as per the international drug testing rules.

This apart, concerned agencies must also acquire research licence from respective governments as well as authentic research authority of the concerned country. Above all, the testing country or city or the person must also get proportionate royalties from the income derived from the sale and distribution of the vaccine.

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Mr Upadhyaya is a social activist based in Kathmandu. He can be reached at khemraju@hotmail.com