Probe Ordered into 49 Children's Death During Clinical Trials in AIIMS

by Thilaka Ravi on  August 19, 2008 at 5:23 PM Hospital News   - G J E 4
 Probe Ordered into 49 Children's Death During Clinical Trials in AIIMS
The Centre today directed the All India Institute of Medical Sciences (AIIMS) Director to order a high-level inquiry into the circustances leading to the deaths of 49 children during clinical trials at the premier institute.

However, the AIIMS administration claimed that all the 49 children were mortally sick and died naturally and not due to any drugs used in the trials.

Head of the Paediatric Department V K Paul said, "We are very happy to announce that after an afternoon faculty review meeting of all available data, we found out that none of the deaths can be attributed to drugs."

According to sources, a total of 4,142 children, of whom 2,728 were aged below a year, had enrolled for the clinical trials of new drugs and therapies by the Department of Pediatrics since January one, 2006.

Left parties and the Congress had demanded an inquiry into the episode.

Earlier in the day at a press conference, the AIIMS administration explained that the children on whom the tests were conducted were already suffering from diseases, which were irrecoverable and would have led to mortality.

In its reply to the RTI application filed by Uday Foundation, an NGO, the institution had said 42 clinical trials were conducted during the given period using various medicines of which five were foreign-made.

The institute also said that the Indian Council of Medical Research, Department of Biotechnology, World Health Organisation and John Hopkins Bloomberg School of Public Health in USA and by AIIMS itself funded the studies.

"All the clinical trials, sponsored by national agencies such as ICMR, were conducted after getting clearance from the institute's Ethics Committee, whose approval is a pre-requisite for such studies, AIIMS said and added that additional clearances from the Health Ministry Steering Committee were obtained for the studies sponsored by agencies like WHO.

AIIMS also stated that the consent of parents and guardians concerned was also taken before conducting such studies as per the direction of its Ethics Committee.

Source: ANI

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