The Indian media is abuzz with the shocking news of 49 infants who died at the New Delhi-based All India Institute of Medical Sciences (AIIMS). The country’s biggest medical institute, which often treats the poor for free, denies charges the babies died whilst undergoing clinical trials.
Pharmaceutical firms say clinical trials on human beings are sometimes imperative
A recent Right to Information petition filed by the Uday Foundation revealed that of over 4,000 babies admitted to the hospital’s paediatric department between January 2006 and June 2008, almost 3,000 had been enrolled for clinical trials.
Rahul Verma of the Uday Foundation accused the hospital of enrolling the children for clinical trials without informing the parents of the consequences.
He said the hospital had said that parents were counselled and had to fill in consent forms in English and in Hindi. “But the catch is when somebody is not able to read or write, they give a thumb impression. If you are not able to read the basic content form, how do you know what the clinical test is all about?”
The hospital denied charges that the babies’ deaths occurred whilst they were undergoing clinical trials, saying this was a “misrepresentation of facts”. The hospital insisted that the children were critically ill and died of natural causes.
Controversy of clinical trials
The contentious issue at stake is the practice of clinical trials, in which new drugs are tested on humans before being introduced on the market. Some clinical trials have to be conducted on humans because tests on animals do not always yield accurate results, say pharmaceutical companies.
Verma's petition listed international players such as the World Health Organization and the US-based John Hopkins Bloomberg School of Public Health as two of the funding agencies on whose behalf the trials were conducted, besides Indian organisations.
But Olivier Fontaine, a World Health Organisation spokesman, supported AIIM’s plea of innocence: “Clinical trials are very useful and I think quite unique methods to really evaluate the efficacy of new treatments. We have developed some very good ethical barriers to conduct these trials. The All-India institute has a very good ethical board that really reviews every project to make sure that the children involved in these studies are being protected and not abused by the investigators.”
A growing industry
Some media sources claim that clinical trials conducted in India can cost up to 60 percent of the cost of conducting them in the United States.
Leading US consultancy firm Ernst & Young estimates that clinical tests in India could grow to a two million US dollar industry in the next two years.
This is why NGOs have called for stricter controls, which the government is currently in the process of drafting. Until then, the controversy rages on.