Drugs used in clinical trials safe: AIIMS...

Under fire over the death of 49 children during clinical trials, AIIMS on Tuesday said the drugs used in the tests were found "safe" and that the children were not selected from a particular socio-economic group. Noting that the drugs used in the trials were found safe in earlier studies and "not known" to have fatal complications, the country's premier health institute said the deaths occurred as the children had "high risk and serious disease conditions".

"All studies had undergone scientific scrutiny and had all the required regulatory and ethical approvals," AIIMS said in a statement here. The statement came following a controversy over the reports of deaths of 49 children during clinical trials of new medicines in the premier institute during the last two-and -a-half years.

Refuting allegations that children who underwent the tests were from a poor socio-economic background, the AIIMS said the children enrolled for the trials represented the "prevailing mix" of patients treated at the premier institute. "There was no question of targeting any socio-economic group selectively," the statement said, adding that AIIMS would share all details on the issue upon the completion of the in-depth enquiry ordered by the Union Health Ministry.

Defending the trials, the AIIMS said that no death was "attributable to the study treatments used" as all children received the standard treatment and no medication or supportive care required for underlying condition withheld. "The deaths were due to the natural history of the severe disease that the children suffered from," the statement said adding the children selected for the trials had ailments like sepis and those with respiratory failure receiving life support.