Experimental, unestablished drugs didn’t kill any of the children registered for clinical trials at the All India Institute of Medical Sciences (AIIMS), according to V.K. Paul, head of the paediatrics department at the hospital.
Paul was responding to a statement by Uday, a non-governmental organization, that said 49 children died during these trials conducted between 1 January 2006 and June 2008. The statement put the infant mortality rate (IMR) of trial participants at 1.18%, twice more than the 0.56% IMR for the country, according to the latest figures by the health ministry.
However, Rahul Varma of Uday, who obtained these figures from AIIMS through a right to information or RTI, query, hadn’t mentioned that the children who died also included those in a so-called control group—those that were not being administered the test drug.
“It’s a gross misrepresentation of facts,” said Paul. “These were different trials testing a range of therapies and each study has different, designated outcomes. Depending on the complexity of the disease and the patient’s condition, each therapy may have different mortality rates. So there are deaths even in standard therapies.” Paul, however, didn’t give a figure on how many of the deceased children fell within the control groups.
The drugs tested included tablets for treating brain inflammation, blood-pressure related complications, cancer and liver problems.
India is increasingly becoming a preferred destination for drug trials. Arun Bhatt, president of ClinInvent Research Pvt. Ltd, a contract research organization, had previously told Mint that this business is expected to grow at 25-30% annually to touch over $600 million (Rs2,590 crore) by 2010.
However, access to a varied gene pool in India, at a fraction of similar testing costs in the US and some European countries, has led to frequent ethical conflicts regarding the manner in which these trials are conducted.
“There were several issues that weren’t addressed in our RTI query,” said Varma, “ We’d asked how many of the children were below the poverty line, which wasn’t addressed. How can such parents, generally illiterate, understand the intricacies of clinical trials and thus, informed consent?”
Paul says that all trials conducted by the institute were cleared by the AIIMS ethics committee, and if the trials involved international agencies, they were cleared by a separate committee constituted by the health ministry. “We need the consent of parents, and we explicitly tell them what an experimental drug is, and that it is still being tested. They always know that they can opt out,” he added.