No consent, no follow-up, claim Bhopal gas tragedy victims in vax trial
Ahead of nationwide rollout of immunisation programme against COVID-19, alleged violations of protocol are coming to fore in clinical trials of one of vaccines approved for inoculation in country
Ahead of the nationwide rollout of the immunisation programme against the COVID-19, alleged violations of protocol are coming to the fore in the clinical trials of one of the vaccines approved for inoculation in the country.
Trial participants in Bhopal, who, incidentally, are also victims of the 1984 gas tragedy, told IANS of "severe violations" of the model code of conduct pertaining to trials including absence of consent and no follow-up on their health after developing adverse reactions post the first dose by a particular clinical trial site.
They alleged that the People's College of Medical Sciences and Research Centre, a private hospital, which is one of the 26 sites conducting Phase 3 trials of Bharat Biotech's Covid vaccine Covaxin, did not inform them that they were participating in trials.
Many of them, who have claimed to be illiterate, and belong to severely disadvantaged sections of the society, have said that they signed up after believing that they were getting vaccinated. They were also allured with a Rs 750 cash payment by the clinical site for enrolment.
Rashida Bee, President of the Bhopal Gas Peedit Mahila Stationery Karmchari Sangh and a recipient of the Goldman Environmental Prize, said that at least 700 of the 1,700 people on who this vaccine, with unknown efficacy, is being tested, are people poisoned by Union Carbide.
Man Singh Parihar, 70, who works as a construction worker, had volunteered for the trial on December 21 after he was told that he would be given a Covid vaccine for free in addition to Rs 750.
"I was not told that it was a trial or study. They told me that I won't catch corona after this injection and I was promised Rs 750 as well. They conducted a blood test and a general checkup and gave me a shot," he said.
"Three days after the shot, I suffered severe cold, fever, and dizziness. Till day, my appetite has not recovered," he added.
After developing the adverse reactions, Parihar's family took him to a local doctor. Asked why he didn't go to the hospital, he claimed that he was never told to report there if side effects occur. "The local doctor practices nearby my house. I chose to go there since he charges less money than the hospitals," he said.
Parihar also alleged that the trial site never followed up on his health.
Chanda Devi, 60, who sells artificial jewellery door to door, also suffered fever, vomiting, and dizziness days after taking the shot on December 19. "Due to illness, I am unable to go to work now. Had I known that it was a trial, I would have never taken the jab," she said while regretting for taking the shot.
The participants were provided forms to record the changes in their body post the jab. However, they alleged that the investigators assured them that no side effects would occur.
"Five members of my family volunteered for the trials including my ageing mother-in-law. We were assured about no side effects," said 45-year-old Jashoda Bai whose family members suffered similar complications to others after taking the first dose on December 7.
She alo alleged her family was not informed about the risks involved despite asking.
"They started to ask us about a nominee for an insurance policy. When I asked the purpose, I was told not to ask too many questions," Jashoda Bai said
While she went for the second dose, other volunteers said that they would never go for it.
Rachna Dhingra, a public health activist associated with Bhopal Group of Information, alleged that the People's Medical College exploited the vulnerability of the victims to achieve maximum recruitments in the trial.
"It has enrolled more than 1,700 participants in the Phase 3 trial, after meeting the initial target of 1,000 participants, at a time when it was reported that other sites were facing difficulties in recruiting volunteers. Most of them are gas tragedy victims from a poor background and are illiterate," she said.
She also said that communities from Gareeb Nagar, Shankar Nagar, Oriya Basta, Kainchi Chhola, JP Nagar, etc, situated behind the abandoned Union Carbide factory, were chosen for the trial since they are in vicinity to the site.
Dr Anant Bhan, researcher In Bioethics and Global Health Policy, said that it is against the rules to not take informed and electronically documented consent for the volunteers identified under vulnerable groups. "New Drugs and Clinical Trials Rules, 2019, clearly states to record audio or visual while taking consent from such volunteers," he said.
The trial site did not take IANS' queries regarding the allegations levelled against them. IANS contacted Bharat Biotech for comments but the firm refused to comment over the phone and instead asked to send the questions on mail.