Inquiry on into death of 49 kids, AIIMS says tragedy wasn’t due to new drugs’ trial

Head of the Department of Paediatrics Dr V K Paul said all 49 kids were mortally sick and died naturally, not due to any drugs used in the trials. “The trials would have been stopped in between if the children had died due to the drug intervention. The data safety management board, which comprises experts, keeps a regular check on the trials,” he added.

In reply to an RTI application filed by Udyog Foundation, an NGO, the AIIMS administration said as many as 49 children had died during clinical trials of new medicines in the premier institute during the past two-and-a-half years.

A total of 4,142 children, of whom 2,728 were aged below a year, had been enrolled for clinical trials of new drugs and therapies by the Department of Paediatrics since January 1, 2006. However, the total number of deaths includes both the kids who were on standard drug management and those who were given new intervention along with the standard medication. “This doesn’t mean that all those children who were tested for new drugs have died,” added a doctor.

ICMR guidelines, however, say children should not be included in the studies if these can be conducted on adults. “There are certain diseases like jaundice in children, neonatology highline membrane disease, sepsis where inclusion of children becomes mandatory as the diseases involve children,” added Dr Paul.

Once the inclusion criteria of the subjects is reviewed by the ethics committee, the funding agency gets it reviewed by their set of experts which is then followed by funds provided by them. The parents are also brought into the loop for including their children in the trials. “Parents are given a consent form by the ethics committee. A patient information sheet is developed in which study risks are also mentioned. The children are included only when the parents give their written consent,” said Dr Shinjini Bhatnagar of AIIMS.

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