49 babies die during clinical trials
the Union health ministry has ordered an internal probe into the deaths of 49 infants who died during clinical drug trials conducted at the All India Institute of Medical Sciences (aiims) over the past two and a half years.
Responding to an rti query filed by an ngo, Uday Foundation for Congenital Defects and Rare Blood Groups, the administration of aiims had recently said that of the 4,142 infants enrolled for clinical trials, 49 have died since January 1, 2006; over 2,700 were under one year. The reply clarifies that all deaths were not due to clinical intervention; some happened in the controlled group (those who were not tried for new drugs) as well. It does not specify the numbers. The paediatrics department conducted 42 sets of trials and tested five foreign-manufactured drugs.
India is emerging as a favourite destination for clinical trials because of low costs. The trials are carried out as per icmr guidelines, which mandate the patient's consent for the trial of drug or therapy. According to aiims, families of children under clinical trial were given counselling and their consent was taken. But Verma doubts that: "Informed consent of people who don't understand the intricacies of clinical trials, doesn't hold any meaning."
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