Delhi : 49 babies die during clinical trials at AIIMS

What kind of research and trial is this?
As many as 49 babies, many of whom hadn't even celebrated their first birthday, have died at the All India Institute of Medical Sciences while being subjected to clinical trials for testing new drugs and therapies over the last two and a half years. Responding to a Right to Information (RTI) query on clinical trials on babies, the AIIMS administration admitted that of the 4,142 babies — 2,728 of whom were below the age of one — who were enrolled for clinical trials by the institute's department of paediatrics, 49 had died since January 1, 2006. The department conducted 42 sets of trials on babies during this period. In its reply, AIIMS said the deaths amounted to a 1.18% mortality rate. The RTI query was filed by Rahul Verma of Uday Foundation for Congenital Defects and Rare Blood Groups, an NGO. Clinical trials are the final stage of research conducted to answer questions about safety and efficacy of vaccines, drugs and devices, new therapies and forms of care or new ways of using known treatments. Many of these trials are for foreign drugs. India recently pipped China to become Asia's most popular destination for conducting clinical trials. According to the Planning Commission, 139 new trials were outsourced to India recently compared with 98 in China. The cost of conducting trials in India is 20% to 60% of the cost in industrialized countries. The RTI query also digs out information on the top drugs (according to volume of consumption) made in a foreign country that were used during the trials on the babies. AIIMS has said five foreign-manufactured medicines were tested during the trials. They were zinc tablets for treating zinc deficiency and serving as a nutritional supplement, olmesartan and valsartan for treating blood pressure-related problems, rituximab for treating chronic focal encephalitis and gene-activated human glucocerebrosidase for treating Gaucher's disease, which affects the liver. AIIMS said it had taken clearance for the trials from its own ethics committee, the health ministry steering committee (HMSC) on ethics and the national ethics committees of ICMR and DBT. Speaking to TOI, Verma said, "This is shocking. We decided to file the RTI when we saw parents unable to admit their seriously ill children at AIIMS while children of some other poor and illiterate families were being kept in the hospital needlessly for a long time." He added, "AIIMS said in its reply that families of patients are given social counselling before trials are started. With most patients in AIIMS being illiterate and belonging to extremely poor families, I doubt if they even understand what a clinical trial is and what their children are being subjected to."