As many as 49 babies, many of whom had not even celebrated their first birthday, have died at the All India Institute of Medical Sciences(AIIMS) 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 on Monday 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 pediatrics, 49 had died since Jan. 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 percent 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 became Asia's most popular destination for conducting clinical trials. According to the Planning Commission, 139 new trials were outsourced to India recently.
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 andvalsartan 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.
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 counseling 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."
In reply, an AIIMS official said, "All the deaths can't be attributed to the trials. Some patients were suffering from conditions in which mortality was the normal outcome and we were trying to see whether a drug could improve the situation. Some other trials didn't even use medications. They involved behavioral methods like nursing care."
He added, "Trials in AIIMS are conducted under strict protocol and every step is scrutinized through faculty presentations and data safety management groups before ethical clearances are received."
Asked about the socio-economic status of patients on whom clinical trials were conducted, AIIMS replied, "The children eligible for trials represent a mix of patients attending the outpatient and in-patient services. The eligibility is based on the aims of respective studies. The department provides detailed information on the inclusion and exclusion criteria to the AIIMS ethics committee and sponsors."
Verma said the consent form that has to be filled by parents was read out by the treating physician for parents who were not able to read it themselves. "The question is, if the parents can’t read or write, do you really expect them to understand the implications of these trials?" Verma asked.
(Xinhua News Agency August 18, 2008)