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AIDS project throws up disturbing questions

By K Rajen Sharma

A Nevirapine therapy project, conducted in the state last year under the initiative of a Calcutta-based doctor has thrown up troubling questions of medical and research ethics after it emerged that the project was conducted without the approval of the Indian Council of Medical Research, ICMR or the National AIDS Control Organization, NACO.

The Mother-In-Need program, conducted under the initiative of one Dr. Sameran Pande of Calcutta, was conducted over a ten-month period, concluding in February 2001. Twenty-four pregnant women were administered Nevirapine anti-retroviral at eleven centers in the country, including one in Manipur (at JN Hospital) from June this year. The project came after another one-year pilot project to assess the feasibility of administration of Nevirapine orally to prevent mother to child transmission of HIV was concluded successfully.

Interestingly, according to a member of Social Awareness Services Organization, SASO, Hidungmayum Umesh Sharma, who served as coordinator for the Mother-In-Need program, the program, under the direct supervision of Dr S. Pande of Calcutta was carried out in the state on public health grounds to prevent HIV infection of the children. Nevirapine tablets were administered with the consent of the 24 pregnant women, he said.
He also disclosed that the Nevirapine used under the project was donated from the UK.

However, Umesh Sharma declined to comment on queries as to the place, clinic or hospital where the 24 women were administered Nevirapine, or who administered the anti-retroviral therapy to them.

Asked whether the Mother-In-Need program had been conducted with the permission of the concerned state AIDS authority, he said the project director of the Manipur AIDS Control Society, Dr Laishram Khomdon Singh was informed of the program in writing, though no written permission was given.
However, when contacted, Dr. Khomdon flatly denied that any written requests for permission to carry out the project had been received. He also said that any research work of administration of AZT, Nevirapine or any vaccine on HIV infected pregnant mothers should be carried out with the prior approval of the ICMR and NACO.

If any human rights violation happens, who will be liable and who will give compensation, he asked. He also wanted to know under whose medical supervision such Mother-In-need program had been carried out in the state.
On the other hand, Dr P.Narendra, superintendent of JN Hospital said that a research institute should have its own institutional ethical clearance committee. The committee should first give clearance of such research on living bodies after thorough understanding of the research work.

He however noted that as Nevirapine tablets is available at pharmaceutical shops here, it is up to one who wishes to take it at his or her own risk.

(Courtesy: The Imphal Free Press)

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