Probe orderded into clinical trial deaths in AIIMSAugust 18th, 2008 - 11:21 pm ICT by IANS
New Delhi, Aug 18 (IANS) The health ministry Monday ordered a high-level inquiry into the death of 49 infants during clinical trials at the All India Institute of Medical Sciences (AIIMS).“We have asked the AIIMS director for a high-level inquiry into the whole matter,” Health Secretary Naresh Dayal told reporters.
In a reply to a right to information (RTI) query, the AIIMS said 49 babies have died during clinical trials over the past two-and-a-half years.
The AIIMS paediatrics department conducted 42 sets of trials on 4,142 babies - 2,728 of them below the age of one - since Jan 1, 2006.
However, AIIMS authorities said the deaths were not due to medicines used in the clinical trials but because of the diseases that the children were suffering from.
“We want to clarify that none of the deaths was due to the medication or interventions used in clinical trials,” V.K. Paul, head of the paediatrics department, told reporters.
“Clinical research is the mandate of the AIIMS clinicians. Novel therapies are examined keeping in mind the utmost safety for all patients,” he said.
“The research protocol undergoes intense scrutiny by the internationally recognised Institute Ethics Committee. Written informed consent is taken (from parents and guardians),” Paul added.
“Most of the 42 clinical trials have reported no deaths. The deaths are mainly due to inherent disease and not due to medicines used,” he said.