1. Ethics And Clinical Trials

• Recently an RTI response, received by NGO Swasthya Adhikar Manch, revealed that a total of 24,117 cases of deaths and SAEs due to clinical trials occurred between January 2005 and September 2016. The compensation has been given to a very small fraction of these people. This situation points out toward the crisis in clinical trials in India

• There are various established ethical principles to be followed during the conduct of such trials such as

• Fair Subject selection - People should be chosen in a way that minimizes risks and enhances benefits to individuals and society. They should appropriately represents the set of people who are going to use those medicines

• Scientific validity - the study is designed with a clear scientific objective and using accepted principles, methods, and reliable practices.

• Informed consent – The subjects should be informed of the purpose, method, risks and benefits.

• Respect for potential and enrolled subjects – This includes respecting their privacy, their right to change of mind, right to information is some new and unusual findings are made, right of treatment of any side-effects due to the study etc.

• Other principles include – favourable risk-benefit ratio and independent review.

• Although clinical trials aim at improving human health and well-being by identifying better methods to treat, cure or prevent illnesses, yet various ethical issues are also associated with this process:

• Emphasis on Utilitarian approach: Here some people are exposed to risks and burdens for the benefit of society at large.

• Absence of informed consent: In 2009, an international NGO had launched a $3.6 million human papillomavirus (HPV) trial in India and tested two vaccines on 16,000 tribal girls in Andhra Pradesh and Gujarat, apparently without informed consent from the girls’ parents.

• Problem with ethics committee: Ethics committees are constituted to monitor the ongoing drug trials. However, it is often found that in most cases ethics committee is not constituted. Further people on such committees are not well trained nor these committees work independently and there are issues of conflict of interest

• Commerce without morality: Pharmaceutical companies focus on maximising profits through shoddy trials and instances have been found where there was no compensation paid to victims of bad trials

• Corruption: The Indian Parliamentary Committee, in its 59th report on family and healthcare, had established collusive nexus between drug manufacturers, some functionaries of regulatory bodies and some medical experts

• Absence of Transparency and Accountability: Results of trails are withheld by corporates. Also when things go wrong there is little regard given to the people on whom trial is conducted.

• Exploiting vulnerabilities: There is an over-representation of low-income groups among trial subjects. This shows that subjects are being chosen on the basis of their vulnerability and need of money rather than scientific reasons. At times, there is an element of coercion and non-voluntariness in their participation

• Clinical trials are a necessity in times of rising number of diseases and growing need of better and effective drugs. However, it is equally important that such trials are better regulated with the patient or the subject at the center stage of all policy considerations in this respect. All the personnel involved in the process should be trained and qualified and have strong sense of ethics. The responsibilities should be fixed with all the aspects of study out in the public domain while keeping the principles of privacy and confidentiality of subjects intact.