Deaths of Babies Raise Questions in India

Are unethical clinical trials occurring at India’s top public hospital?

The All India Institute of Medical Sciences (AIIMS) is under fire after a report indicated that 49 babies died in clinical trials at the hospital between January 2006 and August 2008. The deaths were among 4,142 infants used in 42 clinical trials, mostly for Western drug companies, according to the Times of London.

Known for providing free and low-cost treatment to the poor, AIIMS has been ranked the best medical college and public hospital in India in recent years. The government-funded hospital treats approximately 3.5 million patients per year, “achieving mortality and infection rates comparable to the best facilities in the developed world,” according to a 2006 Newsweek article. The average inpatient fee is just $1 per day.

So how did AIIMS end up in the news? India has become the world’s hotspot for clinical trials because of its large population and low costs. Clinical trials cost just 40 to 60 percent of what they would in developed countries, according to some estimates. So, along with other developing nations, India scrambles to “catch Big Pharma’s eye” in an outsourcing boom that characterizes the international drug industry.

The infant deaths at AIIMS have sparked concerns that poor and illiterate parents don’t understand the risks associated with drug trials. Questions have been raised about whether informed consent, the cornerstone of human clinical trials, was properly obtained. Researchers at AIIMS say an internal ethics committee cleared the trials, but an investigation is underway.

However, a BBC report in 2006 revealed that some patients in Indian clinical trials did not realize they were part of experiments. The report indicated that patients signed consent forms without understanding the nature of the clinical trials or the risks involved with participation.

Investigations will shed light in the coming weeks on whether the clinical trials at AIIMS were unethical, but one thing is clear: obtaining proper informed consent should be just as important to researchers as jumping on the “outsourcing boom.” Families who walk into AIIMS with the hope of medical aid for their children shouldn’t expect to find themselves the victims of ethics violations.