Wednesday, August 27, 2008

Drug Trials in India

India is developing drug trials as a budding industrial sector. It is predicted that trials outsourced from the U.S. and Europe will bring $1 billion to India by 2010. But unless institutional review boards and ethics committees get their act together quickly, what may happen instead is a series of political scandals.

Drug trials in India cost 40% - 60% less than in the U.S. or Europe. India offers an enormous, diverse population. Regulation of drug trials are much looser than in the U.S., and expectations about informed consent are not the same.

In 1989, on my first visit to India, I spent a day with a skillful, caring psychiatrist at Banaras Hindu University. He had the patients he saw who could speak English talk with me. After I had spent a half hour (a long time in his fast paced clinic session) talking with a family I asked my host if it would be acceptable to ask the family if I could take their picture. My kindly host, a genuinely compassionate man, said - "Don't ask, just take the picture!"

Earlier this month the World Health Organization Bulletin warned of the potential for an ethical crisis in the outsourcing of drug trials to India. The bulletin quoted Dr Ambujam Nair Kapoor, a senior scientist of the Indian Council of Medical Research, as saying: “Unless we put in place systems that ensure safety of patients and good quality of trials, people will get away with whatever they can get away with.”

It didn't take long for the WHO warning to hit the fan. The Uday Foundation for Congenital Defects and Rare Blood Groups, one of India's huge number of NGOs, obtained information suggesting that 49 infants at the All India Institute of Medical Sciences, a public hospital in Delhi, had died in the course of drug trials.

The report has become a hot political issue. The communist party (not a fringe group in India) has seized on the story as an example of capitalist exploitation of the poor (see here). The ruling Congress party (see here) demanded an independent investigation of the All India Institute of Medical Sciences drug trial situation.

I don't have an independent view of the rights and wrongs of the All India Institute situation. But I can see from the political reaction that public trust of the drug trial industry is fragile at best. India, and drug companies, are incurring a tremendous risk. Regulation in India is limited. The potential for major ethical lapses is large. Lots of money is at stake. Happily, the NGO sector is strong, and will be vigilant in monitoring what happens.

As Maurice Sendak wrote in "Where the Wild Things Are" - "Let the wild rumpus start!"