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On 1 pm - Sunday - over six #Covaxin trial participants (gas tragedy victims) from poor neighbourhoods behind abandoned Union Carbide factory in Bhopal huddled into a tiny zoom call screen. Following death of 1 participant they recall how they were 'lured' to take the jab #thread
In Dec, a public announcement vehicle entered their narrow bylanes and blared - “Corona ka tika lagao, sade saatso rupaie paao,” loosely translated into get an injection against Covid and earn Rs 750. As the month went by, a few participants started experiencing adverse events.
A day after Bharat Biotech said a Bhopal gas tragedy victim's death who participated in clinical trials was 'unrelated' to vaccine, this has opened up a Pandora's box on ethics and legal issues surrounding clinical trials #COVID19 #vaccine
People's Hospital in Bhopal recruited 1700 candidates in a short time for Phase 3 trials of #Covaxin - those who experienced adverse events have now alleged that the principal investigators did not tend to their concerns adequately. [clinical trial site is supposed to]
Mansingh Pariyaar (70) for instance is a daily wage labourer and earns close to Rs 400 a day. Third day after his jab, he felt breathless. “I was unable to record my symptoms in the side-effects booklet as I am illiterate,” he said.
Pariyaar's oxygen levels hover around 92 and he feels weak. He has refused to take the second shot now. Jitendra Narvariya (38) took a shot on Dec 10 started experiencing problems from Dec 14 & is unable to join work, says his mother Gulab. He is a woodcutter, earns Rs 300 a day.
Chottu's (26) case was peculiar. They gave him a shot, and took his swab samples. [in phase 3, #covid test sample and shot is given on same day] - they later called him to tell him his test was #covid positive so he needn't come for second shot. He also has spinal pain now.
These people are unable to read & write so they are not logging in their symptoms in the booklet provided to them, unaffording they see quacks to alleviate their sickness, few got intervention after @RachnaDhingra intervened with hospital.
Jashoda Bai, a participant, found it particularly strange that they were asked to nominate someone for insurance while getting jabs but when further details were asked investigators asked them to not inquire much or they would not get their Rs 750 [paid in cash] after the jab
Mohan Sahu (57) sells roasted groundnuts in Garibnagar, one of the gas tragedy affected communities. He earns Rs 300 a day. Fascinated by the fact that he would receive Rs 750 he went total a jab. He has been feeling breathless and weak since.
Trial participants said that their consent forms have not been shared with them [this is not fair in any case] Ethicist @AnantBhan @malini_aisola and others have been mooting for this process to become more transparent.
These are poor people, they were not explained what a double blind placebo controlled trial is, and that they could either have gotten a placebo or a vaccine! Questions are now being raised whether the trial should be unblinded to investigate Serious Adverse Events in volunteers.
@AnantBhan stressed on Causality Assessment that should be done as per New Drugs and Clinical Trial Rules by investigator, ethics committee @CDSCO_INDIA_INF after which compensation is decided [but it is not only monetary, ancillary care not related to trial needs to be covered]
@AnantBhan - "This is a cross cutting emblematic issue, exposes larger oversight issues of the regulator. Causality Assessment from Serum Institute's Chennai participant adverse event has yet not been made public." Bhopal participants have demanded to stop trial and investigate.
We wrote about the consequences of loss of confidence of volunteers on Clinical Trials in @TheKenWeb daily newsletter #BeyondTheFirstOrder, while Bharat Biotech claims to have recruited over 22500 volunteers, some are scared to go in for a second shot. https://the-ken.com/bfo/198/
Ethical questions are also being raised on the recruitment of gas victims into clinical trials without adequate checks and balances in place. @RachnaDhingra recounts their health issues here.
[Letter to @PMOIndia @MoHFW_INDIA written by the victims to institute an investigation] https://twitter.com/AnantBhan/status/1348457955390148615?s=20
@AnantBhan in this viral thread explains succinctly ethical issues with clinical trials of such a nature. In India, life of the poor is cheap. it can be bought. such a shame. https://twitter.com/AnantBhan/status/1346393004601266176?s=20
