The revelation that 49 infants died during clinical trials in India has sparked anger among the nation’s congress, with some calling for all studies to be stopped while investigations take place despite the trials having an infant mortality rate (IMR) below the national average.
A Right to Information (RTI) query filed by a non-governmental organisation (NGO) revealed that 49 infants have died during clinical trials at the All India Institute of Medical Sciences (AIIMS) in New Delhi since January 2006.
Contract research is conducted at AIIMS for pharmaceutical companies and the deaths have caused some to question the safety and morality of multinationals conducting clinical trials in India.
A five-person committee has been set up to investigate the deaths, although researchers are asserting there are no links to the drugs tested.
During the period covered by the RTI, 4,142 infants entered into a total of 42 clinical trials. Of these 2,728 were less than a year old. The RTI revealed that 49 infants died during their trial, resulting in a mortality rate of 1.18 per cent.
There is some variation in Indian state and national infant mortality rates (IMRs) depending upon the source used. The CIA World Factbook states it to be 3.23 per cent, while the Indian Ministry of Health (HFM) data for 2007 records it as 3.7 per cent for Delhi state and 5.7 per cent for India.
Despite this variability it is clear the IMR in the clinical trials is considerably lower than either the CIA’s or HFM’s available data.
Since the initial media furor it has emerged that patients taking placebos were among the dead, adding validity to AIIMS’ claims that the patients died for reasons unrelated to the clinical trials.
Dr V Paul, head of the paediatrics department at AIIMS, said: “Most of the 42 clinical trials have reported no deaths. The deaths are mainly due to inherent disease and not due to medicines used."
AIIMS set up its investigational panel after being requested to do so by the HFM. News of the deaths has sparked considerable debate among Indian politicians, with congress spokesman Manish Tiwari saying that ethical guidelines had been “grossly violated”, a claim disputed by AIIMS.
Tiwari went on to say: “There are 139 ongoing trials on human beings in the country. Pending the probe into the AIIMS trials, let all clinical trials be stopped.”
At present there is no indication that clinical trials will be stopped but it does serve to highlight the strength of feeling held by some.
Rahul Verma, founder of NGO Uday that filed the RTI, said that clinical trials target children of low socio-economic status whose parents do not comprehend what the study entails.
Verma believes that “the unquestionable ease which clinical trials can be conducted on human beings in India makes international agencies first test their products on the Indian population."
This viewpoint appears to have won support in some parts of the Indian congress, with Tiwari saying: “The practice of using infants like guinea-pigs for drug testing must end.”