Guinea pigs in human form: clinical trials in unethical settings
By Subrata Chattopadhyay
In her World Report (Feb 4, p 397),1 Amy Yee describes how alleged ethical violations have raised controversy over clinical trials in India and that regulations have been “failing to keep up with India's trials boom”.
The facts speak for themselves: nearly 1600 people reportedly died in India during “clinical trials of drugs conducted by various multinational pharmaceutical companies” in 2008—10.2 Cases of ethical violations are not new; victims of the 1984 Bhopal gas tragedy were also enrolled—without their knowledge or consent to participation—in clinical trials sponsored by pharmaceutical companies.3 Further, as revealed in 2008, 49 babies died during clinical trials for new drugs at India's premier medical institution over a period of 2·5 years.4 Several published reports, taken together, thus confirm that clinical trials are taking a toll on human life in India and raise some disturbing ethical questions.2—5
Part of the ethical crisis that the clinical trials industry poses to the Indian setting stems from the fact that India lacks effective regulatory mechanisms for oversight of clinical trials. The crisis is worsened by the all-pervasive reality of corruption in India's social institutions, including health care. Questions thus arise about the real efficacy of ethics guidelines and certification of good clinical practice in morally compromised health-care institutions. It is time to acknowledge an ethical crisis in the clinical trials industry in India and to start thinking of creative solutions to tackle this menace.
I declare that I have no conflicts of interest.