49 babies die during clinical trials at AIIMS

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49 babies die during clinical trials at AIIMS

NEW DELHI: As many as 49 babies, many of whom hadn't even celebrated

their first birthday, have died at the All India Institute of Med

ical 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 am ounted 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

industria lized 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. "

Nod from ethics panel: AIIMS

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 behavioural 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. "

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