The All India Institute of Medical Sciences (AIIMS) has rejected a non-governmental organization’s, or NGO’s, claims that 49 children died in its clinical trials and said not all were being treated with unestablished, new drugs. Responding to the furore raised by political parties after the NGO disclosed its findings from an RTI (right to information) filing, the health minister has ordered an inquiry. The Congress wants all clinical trials in the country to be suspended till the inquiry is completed.
The demand for suspension may well be seen as an over-reaction, but these developments call for honest introspection by all stakeholders in the clinical trials industry.
The gaps in the information in this case do add to civil society’s doubts about India’s ability to ensure that those participating in a trial are made aware of what the risks are and that they have the option of not participating.
First, while AIIMS said some of the deaths were of children in the control group — those not being given the test drug — it did not disclose how many. Second, while it said consent of the guardians concerned was taken, it added that forms were read out to those who couldn’t read. But it did not answer to the RTI query on how many participants came from below-poverty-line families. Given the limited access to proper treatment for this segment of Indians, there are strong chances that poor patients’ families are easy recruits for trials.
Let’s not forget easy recruitment, which is drying up in the West, is one of the big reasons why India is so attractive to global pharma for human tests of new drugs, apart from its diversified gene pool and a relatively limited exposure to various drugs. India is estimated to hold 50% of the global market for clinical trials and is projected to grow from the current $200 million to $1 billion by 2010. The government had introduced international norms for good clinical practices in 2005. But, given its lack of adequate trained staff, monitoring their implementation is constrained. Hence, the risk that the pressure to recruit dominates ethical concerns — there are claims that patients are not always told they are part of a trial.
While knee-jerk bans are no answer, it is important to let this industry grow only at the pace at which it can be effectively monitored.
What does the AIIMS case tell us? Write to us at firstname.lastname@example.org