Trials, medical ethics and the orbit of power Premium

An issue of concern is the functioning of the trial sites and their respective ethics committees

On January 10, 2021, Rashida Bee (representing the Bhopal Gas Peedit Mahila Stationary Karmchari Sangh), Nawab Khan (representing Bhopal Gas Peedit Mahila Purush Sangharsh Morcha), Rachna Dhingra (representing the Bhopal Group for Information and Action) and Nausheen Khan (representing Children Against Dow Carbide) wrote a letter to Prime Minister Narendra Modi and the then Minister of Health and Family Welfare, Dr. Harsh Vardhan. In the letter, they alleged irregularities and ethical violations in the conduct of the clinical trial for Bharat Biotech’s Covaxin (a COVID-19 vaccine) by the People’s Hospital in Bhopal, Madhya Pradesh and the resultant exploitation of trial participants belonging to vulnerable groups demanding stoppage, punishment and compensation.

The letter further alleged gross violations of ethics guidelines including violations of informed consent procedures, enrolment of vulnerable population among study participants, non-reporting of adverse events and a lack of monitoring and follow-up of study participants among others.

The writers sought urgent intervention to stop the study at the trial site and for investigation by an independent body. What became of the letter and any consequential actions are unknown. The Indian drug regulator, Central Drugs Standard Control Organisation had approved the vaccine candidate prior to the completion of the recruitment for the vaccine candidate’s Phase III study for “Restricted Use of Covaxin under Clinical Trial Mode” — a term and process that finds no mention in India’s Drug Regulatory Framework, the Drugs and Cosmetics Act and its accompanying Drugs and Cosmetics Rules, 2019.

One of the issues that stands out in this case is the functioning of the trial sites and their respective ethics committees. Dr. Jacob Puliyel, a member of the National Technical Advisory Group on Immunization (NTAGI) filed a writ petition in the Supreme Court of India where the Court said “subject to the protection of privacy of individual subjects and to the extent permissible by the 2019 Rules, the relevant data which is required to be published under the statutory regime and the WHO [World Health Organization] Statement on Clinical Trials shall be made available to the public without undue delay”.

The development of potential therapeutic agents is often complicated by subjective and sometimes objective violations of ethical guidelines. The role of conscientious insiders, and sometimes outsiders, who have unique knowledge of such violations is the subject of a recent book, The Occasional Human Sacrifice – Medical Experimentation and the Price of Saying No, by bioethicist, philosopher and whistle-blower at the University of Minnesota, Carl Elliott. The book details several such incidents in the western world, starting with the Tuskegee Syphilis Study to the Willowbrook Hepatitis Study.

It also looks at what happened with Protocol 126 for cancer study of bone marrow transplantation at the Fred Hutchinson Cancer Center and at the Eugene Sanger Radioisotope Laboratory, Cincinnati Medical Center, to study the effect of radiation on humans among others. Driven by his own experience to understand the suicide of Dan Markingson at the university, Elliot traverses some very difficult and human questions such as what makes someone speak out, the ethics of dissent, honour, respect, guilt and shame, and the concepts of dignity and integrity told through the journey of whistle-blowers. As Nancy Olivieri, a whistle-blower, recounts in her review, threats of legal action and, worse, often resulting in destroying the whistle-blower’s life are far too common in such cases.

While one often wonders why such instances of moral courage are few and far between in our society, Satyendra Dubey, Shanmugam Manjunath, Sanjiv Chaturvedi and a few other named exceptions notwithstanding, lack of strong whistle-blower protection statutes is only a part of the problem. Unlike the United States, India does not have a law that protects those who take great personal risks to bring wrongdoing to public notice. The existing law, whose scope is limited to public servants to begin with, was further diluted in 2015, making it a dead letter law.