Hundreds of Victims of Bhopal Gas Leak Tragedy Recruited To India’s Covaxin Clinical Trials – Civil Society Groups Say
Medicines & Vaccines 14/01/2021 •

DELHI, INDIA – In the last week of December 2020, Chanda Devi heard a truck roll into her neighborhood in North Bhopal, Central India.

Residents were called outside by a voice, booming through loudspeakers. They were eligible to collect Rs 750 (about US$10) to receive a “corona vaccine”. The people said that they were recruiters, representing the People’s Hospital, Bhopal.

“They told us that we can get the Corona vaccine now,” Devi, 60, said. “Later we may have to pay for it. They told us that if we take the vaccine we won’t get corona disease.”

Devi, 60, sells costume jewellery house-to-house for a living, making about US$2-6 a day. She also lives in one of the areas worst affected by the 1984 Bhopal gas tragedy – widely regarded as the worst industrial disaster of modern times – whose impacts echoed around a globalizing world.

The disaster took place on 3 December 1984, when about 45 tonnes of methyl isocyanate, an input in the manufacture of pesticides, leaked from the American-owned Union Carbide Corporation plant, exposing 500,000 of the city’s residents to the highly toxic gas. The leak killed nearly 4,000 people immediately and upwards of 20,000 people in subsequent years.

Many of those who survived, like Devi who was 24 at the time, have continued to live in slums just behind the now-abandoned plant. Some have suffered from long-term disabilities, such as blindness and respiratory complications. Compounding those problems, the community was also exposed for decades to groundwater contamination from years of toxic waste dumping on the site.

It was against this difficult background that Devi presented herself at the People’s Hospital, Bhopal, on December 19 2020, to take part in the randomised double-blinded Phase 3 trials for India’s leading domestically-created vaccine candidate, Covaxin, developed by the pharma company Bharat Biotech together with India’s National Institute of Virology.

Devi, who is also illiterate, did not understand, however, that she was being recruited as a clinical trial participant. She was under the impression she was going to receive an already approved COVID-19 vaccine.

Participant Death Adds To Questions About Clinical Trial Recruitment Process

An estimated 700-800 vulnerable victims of the Bhopal gas tragedy have been recruited for the Covaxin trial since early December, allege community activists, like Rachna Dhingra, who work with gas leak victims.

Questions were amplified when, in the last week of December, one trial participant – Deepak Marawi, a 45-year old daily wage labourer – died after receiving the first dose of Covaxin. The deceased Mawari was a participant at a trial site of People’s Hospital, Bhopal. He got his first dose on 12 December and died on 21 December.

A postmortem has since suggested the death was unrelated to the clinical trial, but it has sparked alarm regardless.

In a statement, Bharat Biotech said that “the probable cause of death was due to cardio respiratory failure as a result of suspected poisoning”.

It added: “The volunteer passed away nine days after the dosing and preliminary reviews by the site indicate that the death is unrelated to the study dosing. We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.”

His family alleged that he was not followed up regularly after he received the dose.

Ethical Questions Emerge Over Recruitment of Bhopal Community Members ‘Whose Health is Compromised’

Even so, the circumstances around Mawari’s death have raised broader ethical questions about Covaxin’s clinical trial process.

Concerns are even greater since the Indian Health Ministry recently approved the Covaxin vaccine for restricted emergency use despite the fact that Phase 3 trials are not even concluded – in a process that was obscure and under terms that are still unclear.

Following that approval, Covaxin is due to be administered to members of the broader public beginning 16 January, at the launch of India’s vaccination programme. Alongside Covaxin, the AstraZeneca vaccine, already approved by British regulators, is also due to begin rollout at the same time.

On Sunday 10 January 2021, Devi and three other trial participants spoke about their clinical trial recruitment experiences during a virtual conference, organised with the support of a network of nonprofits that work with victims of the 1984 gas leak – and in which Health Policy Watch participated.

The four participants said they were led to believe they were receiving the vaccine as a part of the government’s vaccination drive, and were not clearly told that they were taking part in a clinical trial. They were not provided with any informed consent forms to review and sign, alone or with a literate family member. Nor was their consent video-recorded, in the case of people like Devi who are illiterate. In other  words, they said that they did not provide their informed consent.

Despite being illiterate, Devi and other participants in the video conference said that they received sheaves of papers to record any symptoms they experience after they receive their dose – even though they would not know how to fill them out.

On the same day that Marawi died, a group of NGOs wrote to both the Indian Prime Minister and Indian Health Minister, Narendra Modi and Dr Harsh Vardhan, to stop the trial and conduct a detailed inquiry into the incidents.

“Evidence has emerged that the trial in Bhopal is being conducted in gross violation of laws and guidelines governing clinical trials in India,” the letter stated.

“This is leading to exploitation and harm to a community of people that are not just economically and socially deprived but whose health is compromised owing to the destructive impact of the Bhopal gas tragedy and its consequences.”

In response, Bharat Biotech in a statement that the trials were conducted “in compliance with the study protocol, Good Clinical Practices (GCP) Guidelines as well as with all applicable statutory provisions and the focus at all times is on patient safety. It is this intent on compliance, quality and ethics, that we have enlisted the services of an international contract research organization to conduct our phase III clinical trials”.

Trial Participants Include At Least 700-800 People From the Bhopal Communities Affected By the Gas Leak

At least 700-800 people were recruited from the communities in the areas affected by the gas leak, and related groundwater contamination, said Rachna Dhingra, an activist who works with victims of the Bhopal gas tragedy, at the briefing.

“Almost all these communities drank contaminated ground water,” she notes. “There are persistent organic pollutants in the water. People here suffer from a range of health problems. Instead of paying attention to their problems, they have been used,” she said.

“Most of the people living in this area have one phone between five people,” Dhingra said, speaking at the video conference. “The phone is only with the head of the family who is often out of the house during day time. If someone (from the hospital) has to follow up [with a participant] in these areas, they have to go to their homes.”

Some Trial Participants Say They Fell Ill – But Had No Recourse

Some of the trial participants who fell sick after being administered either the vaccine or a placebo, said that they had to seek treatment on their own, with their limited income. The day wage earners became stuck at home, unable to work.

Twenty-six year-old Chotu Das Bairagi said that he was diagnosed with COVID-19 only a few days after receiving the first vaccine dose.

“When I went to get treatment, they just prescribed some medicines. I was asked to buy them myself,” said Bairagi. Only after he posted a video about his illness, the hospital called him back and provided some treatment.

“They did not know that it is their right to receive free treatment when they participate in a trial. Some of them are scared of going back to the hospital,” said Dhingra.

While other participants said that they were told they were participating in a “trial”, they said that they did not really understand the meaning of the English word. And additionally, the Hindi poster published to recruit participants said that participating would be “beneficial”.

“Why do you need to conduct a clinical trial if they know that the product is beneficial. Why were consent forms not given to them?” said Anant Bhan, a researcher in bioethics and global health in the video conference.

“These are vulnerable populations. There are special provisions under the  New Drugs and Clinical Trial Rules, 2019 and national ethical guidelines for clinical trials which say that the informed consent needs to be audio-visually recorded.”

Dr Anil Dixit, the dean of the hospital conducting the trial said that the trial site had followed all the norms and said in a video statement: “The signed consent forms can be given to the participants if they wish. They are kept in the hospital usually.”

Critics Attacked For ‘Sullying Name’ of India’s R&D

Dhingra said that the stories about the participation of Bhopal gas victims in the Covaxin trial shed concerns on broader issues associated with the clinical trial process.

“These people are saying that the adverse events they suffered were not recorded properly. They were not followed up regularly. Their data is not being recorded. How do we know about the efficacy of the vaccine?” she asked.

In a tweeted response, People’s Hospital’s called the attempts to sully the trial “pathetic” and said that instead of applauding the Indian’ government’s endeavour in developing vaccines, some people are making “spurious comments to be in public attention.”

So far Ministry of Health regulators have not addressed the allegations around the Covaxin clinical trial processes in Bhopal. Nor has Bharat Biotech made any statement – beyond the one referring to the death of Marawi.

That silence has added to the concerns around the transparency and safety of clinical trial processes – and with that, of the vaccine that is due to be rolled out at a much larger scale in just two days time.

“By ignoring the ongoing criminal irregularities in the Covaxin trial in Bhopal, the Government is potentially unleashing a public health disaster on the 16th of this month”, said Nousheen Khan of the Children Against Dow Carbide.

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