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Members of the scientific and research community have called on the need for “scientific disagreements,” in the interest of science.
Over 600 voices including doctors and civil society representatives have signed an open letter that is addressed to Bharat Biotech and the Indian Council of Medical Research (ICMR), calling on them to withdraw a case filed against the authors of a study paper that documented adverse events of special interest (AESI) reported by people a year after they took Covaxin. The letter was also addressed to the Editor, Drug Safety, Official Journal of the International Society of Pharmacovigilance.
“Scientific disagreements have to be articulated as counterpoints in scientific fora. Forcing the journal to retract the paper, or filing a 5 crore defamation suit leads to a chilling effect on researchers, and is harmful for science and the trust people have on the institution of science” the letter said, calling for the lawsuit to be withdrawn, paper be reinstated in the journal, and for constructive engagement from all stakeholders.
Vaccine in question
The letter comes against the backdrop of a suit by Bharat Biotech, at the City Civil Court (Hyderabad), where the vaccine maker has alleged that claims by the study had created “shock, alarm and hesitancy” regarding its vaccine and other products made by them.
Meanwhile, the letter said, “Like most research studies, this study has various limitations which the authors acknowledge within the paper. It is common in science for starting from broad, simple studies and drawing on the results of these to go into more targeted and directed studies.” The open letter is signed by Amar Jesani, Editor, Indian Journal of Medical Ethics, lawyer Veena Johari, Veena Shatrugna, retired scientist with National Institute of Nutrition, independent researcher Ravi Duggal and Amulya Nidhi, National co convenor Swasthya Adhikar Manch, among several others.
The call is to allow scientific discussions to take the process without being influenced by anyone, Dr Jesani told businessline. The right way to have proceeded would have been for the company and ICMR to publish a paper pointing to the flaws in this study and allow the authors to reply, he said. The journal could have done another review of the academic study, he added.
A businessline query on the call to withdraw the defamation case was sent to Bharat Biotech, a response is awaited. In May, the company had responded saying, any study on the safety of Covaxin and AESI, should have examined a wider range of data to avoid investigator bias and ensure effective findings. The ICMR too had then distanced itself from the “poorly designed study” by researchers from the Banaras Hindu University.
Approved study
The letter further said, the study documented AESI’s report by people in a telephonic follow-up one year after vaccination. “As a phase IV clinical research using an observational method, it was conducted after obtaining the relevant approval from the Institutional Ethics Committee. The results were published in Drug Safety, the official journal of the International Society of Pharmacovigilance after a peer review process required and facilitated by the journal itself. And unsurprisingly, the study showed that 99 percent of the people did not have any serious events,” it noted.
A signatory to the letter, Veena Johari added, the study was academic and people and doctors are encouraged to report adverse events, that are then followed-up by the Centre to establish causal links to the said medical product.
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