Rema Nagarajan; TOI.in; December 01, 2020, 07:19 IST
Bioethicists and several scientists have expressed shock at the Serum Institute threatening to file for damages against a trial volunteer who went public about a severe adverse event (SAE) he suffered while he was part of the Covid vaccine trial. They warned that this could lead to people hesitating to volunteer for trials in future and dent trust in any vaccine that eventually gets approved. They were almost unanimous in stating that the trial should have been halted and the matter made public when the adverse event happened in October.
Meanwhile, all the authorities involved, including the Indian Council for Medical Research (ICMR), a co-sponsor of the trial, the Drugs Controller General of India and the health ministry have been conspicuously silent.
“This is the first time I have ever heard of a sponsor threatening a trial participant for raising the issue of any injury the person suffered. One and a half months after the severe adverse event, the company says the Central Drug Standards Control Organisation has been informed. But all this time it was kept under wraps. None of it might have come out if the volunteer had not gone public,” pointed out Dr Amar Jesani, editor of the Indian Journal of Medical Ethics. He added that this was “nothing but bullying of the participant” and that the firm should be forced to withdraw any notice issued against the volunteer.
“The company filing against the volunteer goes into adversarial territory, which is not the right thing. If an adverse event happens, there is the belief that the sponsors and the trial site will take care of me. Maybe there is no causality, but equally important is the issue of trust that you will be protected from any adverse event. To counter attack a trial participant, sue them for defamation etc, is not something that a trial sponsor should be indulging in. That also raises questions about the other co-sponsors like ICMR and what their take on this is,” said Dr Anant Bhan, former president of the International Association of Bioethics.
“The trial should have been halted the next day after the adverse event was reported. And within a week it could have been investigated. That would have instilled confidence and trust in the minds of people. Stonewalling, refusing to answer, waiting for a lawsuit to bring things out, it speaks volumes about the lack of professionalism in managing a vaccine trial,” said Dr Jacob John, a well known virologist.
“Why did the trial participant spill the beans one and a half months later? Because they are more concerned with the public interest, safety of the public, about other people getting the vaccine. Because all other parties failed to give seriousness to the occurrence of the adverse event. If the volunteer had said I fell ill, nobody would have taken notice. If no compensation of Rs five crore had been asked for, nobody would have probably paid any attention to it. How else could he have achieved a public debate?” asked Dr John.
The All India Drug Action Network issued a statement expressing shock at the “blatant attempt at intimidation of a clinical trial participant by Serum Institute”. “Given that the SAE took place in October, it is of serious concern that the CDSCO did not pause the trial to investigate the SAE when it was reported,” said the statement, accusing SII of trying to divert attention from scrutiny of its trial.