The latest industry being outsourced to India: clinical drug trials

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Mothers wait with their children in the halls of All India Institute of Medical Sciences in New Delhi. The deaths of 49 children during clinical trials at the hospital prompted questions about the latest outsourcing business to sweep India.


NEW DELHI

Two hours after opening, the pediatric waiting room at All India Institute of Medical Sciences is like the anteroom to hell. Families, anxious, restless, sweaty in the soupy air, cram into plastic chairs, crouch in corners, crowd doorways, clog up aisles. Cries jangle off the ceiling. Feces litter the floor. Signs in the corridor attempt to impose order on the chaos:

Don't spit.

Don't feed the monkeys.

Don't pay bribes.

This overstretched government hospital and medical college treats about 4-million people a year. It's also one of a growing number of Indian hospitals that use their patients to gather data on experimental drugs destined for Western markets. It recently was revealed that 49 children have died during clinical trials at the institute. Though the hospital blamed the deaths on underlying illnesses, the news triggered unease about a drug-testing phenomenon, propelled by mountains of money, that has swept India with little publicity. As the world flattens, India is not just answering our tech calls. Global drug companies are tapping its population of nearly 1.2-billion to test the safety and effectiveness of compounds that, if approved, will end up in medicine cabinets in the United States. The upshot: the distance has been compressed between a patient trying a new diabetes drug in New Delhi and the retiree who will buy that prescription in St. Petersburg.

"All the ingredients are there for a huge problem,'' said Dr. David Ross, a former FDA medical officer.

"First of all the data must be applicable to the U.S., where the population may differ in clinically significant ways," he said. "And the FDA has to have the capacity to go over and inspect the data. If not, you're asking for trouble."

In the past three years, the FDA has inspected just eight of the thousands of trial sites in India.

Poor oversight invites problems in an overseas drug pipeline, as Americans learned after deaths from Chinese-made blood thinners this year. In a rare proactive move, the FDA slammed the door on 30 generic drugs from one of India's biggest drug makers in September after finding problems at its factories.