Clinical trials
July 27, 2012
Prabha Devi's son Manish is yet to fully recover after developing white spots on his skin which he developed after undergoing a clinical trial in a private hospital in the northern Haryana state of India.
"Medical workers came to our village and spoke of a new vaccine for newborn babies. What was tempting about it was that the vaccine was free, which otherwise would have cost us 6000 Rupees (80 Euros)," Devi's husband Jagan Das told DW. Manish, he said, was now being treated by doctors so that his spots could be removed.
In another incident in the southern Andhra Pradesh state, some 35 women, all limekiln workers from Guntur district, were allegedly put through clinical trials to test a breast cancer drug. The women were paid money to undergo these tests. But the doctors had to abruptly stop the tests after the women complained about nausea, joint and chest pains.
“Unfortunate”
The Indian Supreme Court has recently asked the Madhya Pradesh state government to explain its position on why it allowed large-scale illegal drug trials in the state.
"Human beings are being treated as animals. This is unfortunate," Justice R M Lodha told DW.
Experts blame the lack of proper laws and regulations to hold multinational pharmaceutical companies accountable for the deaths allegedly caused by unauthorized clinical trials.
“Things are getting worse. Between 2004 and 2006, many pharmaceutical companies carried out clinical trials on patients and repeatedly violated the prescribed guidelines and regulations. Sadly, no hospital or doctor was ever penalized,” Puneet Singh of the Swasthya Adhikar Manch (Health Rights Forum) told DW.
According to the World Health Organization (WHO), in India, on an average 10 people have died every week in clinical trials since 2006.
Between 2008 and 2011, 2,031 deaths were reported during these trials, forcing the Indian government to set up a committee to review clinical trial approval procedures in the country. However, the number of deaths remained high despite the public outcry with 438 deaths reported in 2011 - preceded by 668 in 2010; 637 in 2009; and 228 in 2008.
“The lack of supervision by Indian health officials has created a culture of impunity for drug research companies and the doctors who work for them,” said Dr Lalit Kumar.
International standards
Drug companies say they conduct trials on people suffering from serious ailments with limited or no cure, and that they should not be blamed for the deaths.
“The standards applicable to clinical trials in India are no different from those in the US, the EU, or elsewhere in the world,” a spokesperson of a multinational company told DW on conditions of anonymity.
But it is not enough to convince the Indian activists who demand that a committee of experts consisting of members of civil society and the All India Drug Action Network be formed to examine existing legal provisions related to clinical trials in India and abroad.
Author: Murali Krishnan
Editor: Shamil Shams