miércoles, 30 de mayo de 2012

Slumdog clinical trials (I)

"nearly 1600 people reportedly
died in India during
“clinical trials of drugs
conducted by various
multinational pharmaceutical companies”
in 2008–10."


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.


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Slumdog clinical trials

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