Context:

In January, 2021, a letter was written to the Prime Minister and the then Health Minister, representing various groups related to the Bhopal Gas tragedy alleging ethical violations in the clinical trials for Bharat Biotech’s Covaxin in Bhopal, Madhya Pradesh and demanding the trial’s suspension, punishment for those responsible, and compensation for affected participants.

Regulatory Approval and the Role of Whistle-blowers

• Regulatory Approval and Ethical Concerns
  • The Central Drugs Standard Control Organisation approved Covaxin for "Restricted Use under Clinical Trial Mode" before completing Phase III recruitment, with a term that finds no mention in India’s Drug Regulatory Framework, the Drugs and Cosmetics Act and its accompanying Drugs and Cosmetics Rules, 2019. The ethical issues raised call into question the functioning of trial sites and their ethics committees.
• Role of Whistle-blowers
  • The Occasional Human Sacrifice : Whistle-blowers play a critical role in highlighting ethical violations. Carl Elliott's book, "The Occasional Human Sacrifice," discusses the challenges faced by whistle-blowers and the complex ethical questions surrounding their actions with references to several historical cases of unethical medical experimentation in the West and emphasizes the moral courage required to speak out against such practices.
  • Protecting Participants : Whistleblowers can bring to light issues like coercion of participants, falsification of data, or inadequate safety measures. This ensures the well-being of research subjects and prevents potential harm. They can expose situations where participants are not fully informed about potential risks or have not given genuine consent. This upholds the ethical principle of patient autonomy.
  • Maintaining Research Integrity : Whistleblowers can reveal manipulation of data, plagiarism, or biased research practices. This helps maintain the integrity of scientific findings and promotes public trust in clinical trials. By exposing unethical behaviour, whistleblowers can encourage a culture that prioritises ethical research conduct and responsible practices.

The Challenge of Whistle-blowing in India

• Lacking Strong Laws: India lacks strong whistle-blower protection laws, unlike the United States. The existing law, limited to public servants, was weakened in 2015. Understanding groupthink, organisational wrongdoing, loyalty to power, fear of retribution, social conformity, and status hierarchies are essential to addressing why few individuals choose to become whistle-blowers in India.
• Lack of Effective Reporting Systems: Internal reporting mechanisms within hospitals, universities, or pharmaceutical companies might be ineffective, weak or biased, discouraging whistleblowers from reporting concerns through official channels. These systems may not offer anonymity or guarantee a fair investigation.
• Isolation and Lack of Support: Whistleblowing can be a lonely experience. Colleagues may be reluctant to get involved, fearing repercussions themselves. Finding support networks or legal representation can be challenging for them.
• Burden of Proof: The onus often falls on the whistleblower to provide concrete evidence of wrongdoing. Difficulty in dealing with issues like data manipulation or hidden financial conflicts.

Path Forward for Ethical Clinical Trials

• Development of Innovative Therapies: India has a vibrant generic drug industry but lacks expertise in developing innovative therapies. Drug development requires specialized knowledge and balancing risks with potential benefits. Appointing medical doctors without this expertise to oversee therapeutic development leads to ethical violations, as seen during the COVID-19 pandemic.
• Informed Consent and Clinical Studies: Informed consent violations are rampant in Indian clinical studies, particularly among poor and uneducated participants. Institutional ethics committees, meant to safeguard against such abuses, often function inadequately.
• Respect for Persons: Uphold participant autonomy through informed consent. Providing clear, unbiased information about the trial, potential risks and benefits, and alternatives. Ensuring participants understand their right to withdraw at any time.
• Fair Selection: Ensuring fair selection of participants and avoiding exploitation of vulnerable populations. Developing clear inclusion/exclusion criteria and establish diverse recruitment strategies to avoid bias.
• Beneficence to Participants: Maximise potential benefits for participants and society while minimising risks. Conduct thorough risk-benefit analysis, prioritize participant safety with robust monitoring procedures, and have a clear plan for post-trial care.
• Scientific Rigor: Ensuring sound scientific design, data integrity, and unbiased analysis. Establish independent review boards, implement data management protocols, and promote transparency in reporting results.
• Whistleblower Protection: Encourage ethical conduct by protecting those who report wrongdoing. Implement strong whistleblower protection laws and anonymous reporting mechanisms.

Conclusion

Elliott's book highlights how even robust systems of accountability can be undermined by those in power. India is far from achieving effective checks on medical ethics abuses. Significant improvements are needed to establish a functional and ethical framework for clinical trials and drug development to foster trust, protect participants, and promote the development of safe and effective medical treatments.

Source: The Hindu