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The Association of Clinical Research Organizations, whose members conduct an estimated two-thirds of the clinical trials in India, strongly disagrees with the premises and conclusions of “India’s drug trials fuel consent controversy”. Unfortunately, Ms. Lakshmi did not bother to contact us for comment.
Ms. Lakshmi states that “(a)cross India, 1,700 people who participated in clinical drug trials died between 2007 and 2010...although no autopsies were carried out to determine the causes of death.” The second part of the sentence is key as it partially addresses the necessary context for a discussion of clinical trials in India, or anywhere else. Many of the people who enroll in clinical trials suffer from terminal illnesses, like cancer and advanced forms of cardiovascular disease and diabetes - common areas of study in India. People enroll in these trials with the hope of extending their lives and with the knowledge that they are contributing to science.
The real question, then, is how many deaths occurred as a direct result of the clinical trial. For journalists – and Indian politicians - this is an inconveniently smaller number. Ms. Lakshmi notes that 22 families were paid compensation for deaths that occurred during a clinical trial. Our understanding is that even in some of these 22 cases, there was not clear causation between participation in the clinical trial and death. Nevertheless, compensation was paid under threat of sanctions from the Government of India.
ACRO has been working assiduously with the Government of India for several years to ensure a regulatory framework that protects patients’ safety and promotes ethical clinical research. Unfortunately, this issue has become highly politicized and recent regulatory proposals have taken a step backwards, sacrificing sound ethical and scientific principles for populist expediency.
But this discussion should not be limited to India. For additional context we note that, as the Post recently reported, volunteers participating in research funded by the U.S. Government, and conducted mostly through the National Institutes of Health, are not entitled to any compensation for study-related injuries or death (“Bioethics panel urges system to compensate those hurt in medical research”, 12/15/11). This is in distinct contrast to industry-sponsored research where compensation is always available for trial-related injuries. ACRO strongly endorses the recommendation of the Presidential Commission for the Study of Bioethical Issues that a compensation system be developed for Federally-funded research.
In fact, ACRO advocates globally for high ethical standards, scientific integrity and regulatory predictability. All participants in medical research should have the same rights and protections regardless of where in the world the research takes place or the source of funding. Because disease knows no boundaries, anything less is unacceptable.
VP, Public Affairs
Washington, DCDownload as PDF