COVID-19 Update

Bhopal gas tragedy victims were used as guinea pigs for COVID vaccine trials

Print edition : February 12, 2021

Outside a designated centre for vaccine trials in Bhopal on January 8. The Phase 3 trial for Covaxin is going on. The lack of efficacy data has led to a trust deficit among the public. Photo: GAGAN NAYAR/AFP

Bhopal gas tragedy victims were used as guinea pigs for COVID vaccine trials in total violation of ethical and medical norms.

In early December last year, as the world battled the novel coronavirus, a van arrived at Garib Nagar, a slum in Bhopal, Madhya Pradesh, loudspeakers attached to it blaring an announcement: Come and get vaccinated for COVID. And get Rs.750 in exchange. For the survivors of the Union Carbide gas leak of 1984 who lived there, some of who could not even afford a rickshaw ride to the hospital, it seemed like an amazing offer. For 57-year-old Mohan Sahu, whose daily income from selling peanuts on a handcart is Rs.250, it was an opportunity not to be forgone. Since it looked very official, he did not think much of it and went to the designated People’s College of Medical Sciences & Research Centre on December 18 to get his first shot.

A lot of poor people were waiting in line to get the vaccine and all the procedures went like clockwork. He was asked to sign a form. The illiterate Sahu did not know what was written on it; neither did anyone explain it to him. Later he would get to know that it was a consent form to be on a clinical trial for Covaxin. Soon after returning home, he began to feel extreme breathlessness. Since he did not know he was a participant in a clinical trial, he did not understand that it was an adverse consequence of the vaccine dose.

Similarly, Ratan Lal of JP Nagar, the worst-affected community of the gas disaster, was also recruited for the Covaxin drug trial without his knowledge. He experienced extreme pain in his body for many days after receiving the shot. It was only after 26-year-old Chhotu Das Bairagi was denied a shot as he was found to be COVID positive and he informed a non-governmental organisation (NGO) working with people affected by the gas leak that the larger picture began to emerge.

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Said Rachna Dhingra of the Bhopal Group for Information & Action, who organised a virtual press meet to highlight the issue: “We had heard of vans coming into the colonies of the gas affected and making the announcements. Gradually, the people we work with began to complain of falling sick. As we talked to more and more people, we realised that the scale of the problem was massive.”

People’s College was one of the sites for the clinical trial of Covaxin, which has since January 16 been rolled out along with Covishield for a mass vaccination drive of front-line and health care workers. The Phase 3 trial for Covaxin is still under way and the lack of efficacy data has led to a trust deficit among the public. Covaxin is jointly developed by the Bharat Biotech International Ltd, Hyderabad, and the Indian Council of Medical Research (ICMR)-National Institute of Virology, Pune. Reports of the shoddy clinical trial from Bhopal has only added to the vaccine hesitancy.

As many as 1,700 people had been recruited for the trials in Bhopal, of which 700 belonged to the gas-affected communities whose health is already compromised. Groundwater in their area continues to be contaminated, and many of the current residents were born with congenital disorders.

Guidelines bypassed

Many of the trial participants claimed that they were not given the requisite information before getting the shot. Some of them were told they were getting an injection to protect them from COVID. Some, with whom the word “trial” was shared, revealed that they did not know what it meant. The New Drugs and Clinical Trials Rules, 2019, mandates that an audio-video recording of the informed consent process must be maintained by the investigator for record purposes in case of vulnerable subjects in clinical trials. The social, economic and educational status of many of the gas survivors classifies them as a vulnerable group as per ICMR guidelines. The participants were not provided copies of the signed participant information sheet or consent form; it was shared only if someone asked for it. Moreover, the presence of an impartial witness to co-sign the forms as mandated was also not maintained.

Many claimed that they were not informed that there could be adverse consequences. In one instance, Jashoda Bai, whose entire family of five members went to receive the vaccine, was asked to name a waris (inheritor). Three of the five members who received the first shot later experienced health complications, but the hospital did not respond to the many phone calls they made. In some cases, the participants did not go back to the trial site when they faced medical issues because they were not aware that they were entitled to free medical management. Bharat Biotech’s consent form talks of an insurance policy for participants, but no information or details were shared.

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Those who got sick after the vaccine shot were not attended to by doctors nor were their complaints recorded for the purpose of the trial. Jashoda and others who fell sick approached local doctors in their communities and paid for the medicines out of their own pocket.

There was no follow-up of the trial participants who refused to take the second shot as they were too scared by the health complications they suffered after the first dose. One of the recruits, Deepak Maravi, died nine days after getting the vaccine shot. His family was not aware that he had taken the shot and only came to know of it when he fell sick.

Lackadaisical defence

After the media reported his death, Bharat Biotech was forced to admit that Deepak had participated in its clinical trial. But the firm distanced itself from his death stating that it was unrelated to the study dosing. It insisted that his death was not related to the vaccine or placebo, but since the trial was blinded, it said that it could not ascertain whether he had received the vaccine or a placebo.

Rashida Bee, president of the Bhopal Gas Peedit Mahila Stationery Karmchari Sangh, said that survivors of the Bhopal gas tragedy were recruited for the trials since no one would care if they died. This was not the first time that the survivors had been left in the lurch. Twelve years ago, 13 gas victims died during trials by pharmaceutical companies at the Bhopal Memorial Hospital & Research Centre, but no one was punished. This set a tragic precedent of treating the survivors as guinea pigs, she said. Along with other survivors’ organisations, she has demanded that the family of Maravi be compensated with Rs.50 lakh as is done in the case of deceased coronavirus warriors. The organisation asked for a thorough and impartial audit, criminal punishment of officials and institutions responsible for this public health disaster and compensation for injuries caused from trial vaccines. By ignoring the ongoing criminal irregularities in the Covaxin trial in Bhopal, the government was potentially unleashing a public health disaster with the rollout of a mass vaccination drive, said Nousheen Khan of the Children Against Dow Carbide.

Ethically wrong

Anant Bhan, a researcher in bioethics, said that advertising for the trial and the offer of Rs.750 was ethically wrong and a breach of the tenet of voluntary participation without inducement or coercion. He explained that consent was not a one-time signing of document. It is an ongoing dynamic process which includes full disclosure of all the study-related information to prospective research participants, comprehension of the information given to participants by researchers, voluntary participation without inducement or coercion, and appropriate documentation of consent. In case of vulnerable populations there are additional mechanisms and due diligence mandated both in the regulatory framework and the ICMR Ethics Guidelines 2017.

Said Anant Bhan: “If there are so many problems in one site, then what kind of oversight is there on a large scale? Why are these shortcuts being taken? What is happening in other sites? Why is there no transparency? Who is in the ethics committee? There are legal violations as well apart from violations in ICMR’s own regulations.”

Also read: Quest for COVID-19 vaccine

A civil society statement said that there had been gross violations of laws and guidelines governing clinical trials, namely, the New Drugs and Clinical Trials Rules, 2019; the National Ethical Guidelines for Biomedical and Health Research involving Human Participant, 2017; and the National Guidelines for Ethics Committees Reviewing Biomedical and Health Research During COVID-19 Pandemic, April 2020, published by the ICMR.

The selection of a vulnerable community for the trial made the entire trial questionable, the statement said, adding that it was important to investigate on what grounds the ethics review boards permitted the inclusion of these and similar communities in the trials, and what protection mechanisms were made necessary for them to avert exploitation of vulnerable participants in the trial as per the ICMR Ethics Guidelines 2017.

“Considering that these participants belong to a vulnerable group, the investigators were duty-bound to enquire about their vulnerability and education status, and in compliance with the law to ensure audio-visual recording of the informed consent process, an impartial witness to co-sign the informed consent form and implement other safeguards to protect the rights of the participants,” the statement said.

Binoy Viswam, leader of the Communist Party of India’s Parliamentary Party, wrote to Prime Minister Narendra Modi insisting that the ethical violations reported from People’s Hospital “cast great doubt on the ongoing clinical trial” in Bhopal and demanded that the trial be halted. There are doubts as to whether data from this trial site should be included for the Phase 3 trial analysis of this vaccine, he said.

He said: “The COVID-19 pandemic has undoubtedly caused great devastation in the country and a need for a vaccine is the most important need of the hour. However, the preying on marginalised communities and the complete disregard for their dignity, safety and rights compromises the capacity of the trial to truly measure the safety and efficacy of the vaccine. It is a matter of great national shame that such an absolute abuse of power and unethical way of operating is taking place in the development of the COVID-19 vaccine in a trial where an apex government body is a co-sponsor, and immediate steps must be taken by the government to redress these issues.”

Also read: Challenges and opportunities presented by the vaccine

Meanwhile, deaths following vaccination with Covishield from Moradabad in Uttar Pradesh and Bellary in Karnataka have added to the vaccine hesitancy in India. In several places, including Delhi’s Ram Manohar Lohia Hospital, healthcare workers have refused to take Covaxin without more efficacy reports.

To a query by independent journalist Saurav Das as to who would be held liable for any adverse impact of the COVID vaccine, the Central Drugs Standard Control Organisation responded on January 15 that any “individual has to assess the risks and benefits before using COVID-19 vaccine” themselves.

With the government itself unable to or unwilling to take responsibility for the vaccine, it remains to be seen how many people will come forward for the vaccination drive.

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