A vaccine manufacturer based in India launched defamation proceedings against researchers who published a study that reported adverse events in people following Covid-19 vaccination.
The manufacturer also sued the editor of the international journal that published the study and demanded that the offending article be retracted immediately.
The Peer-Reviewed Study
The study at the centre of the controversy is a post-marketing safety analysis (phase IV) of Covaxin, one of India’s homegrown Covid-19 vaccines.
The researchers concluded that serious adverse events of special interest (AESI) after vaccination “might not be uncommon” and that the majority of AESIs in people persisted “for a significant period.”
Of the 635 participants involved, one-third reported developing AESIs such as new-onset skin disorders, nervous system disorders, and menstrual and ocular abnormalities.
Serious AESI, such as stroke and Guillain-Barre syndrome, were experienced by 1% of participants, but no causal link could be established in the study.
The researchers called for “enhanced awareness and larger studies” to carefully examine the potential for long-term harms of the vaccine.
The study was published in the journal Drug Safety on May 13, 2024, after it was examined by two independent peer-reviewers and the editor of the journal.
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Mayhem Ensues
Within days of its publication, the government’s premier biomedical research organisation, the Indian Council of Medical Research (ICMR), which co-developed Covaxin, quickly distanced itself from the study.
On May 18, 2024, ICMR wrote to the journal wanting a retraction of the article and of the “acknowledgement” the researchers made to ICMR for its support.
The letter criticised the rigour of the study – it said there was no control arm, there were no baseline values of participants, and that collecting participant data by telephone interviews created a “high risk of bias.”
These limitations, however, are well-known in post-marketing studies. In fact, the authors went to great lengths to discuss the limitations of the study in the article, as well as recommend larger studies to elucidate harms.
The ICMR did not respond to repeated media enquiries.
The Lawsuit
In July 2024, the vaccine manufacturer, Bharat Biotech International Limited (BBIL) launched defamation proceedings in the civil court of Hyderabad, India, against the 11 study authors (6 are students) and the chief editor of Drug Safety, Mr Nitin Joshi.
The lawsuit claimed the study was “poorly designed with a flawed methodology” and therefore the conclusions drawn about the safety of Covaxin were “unreliable and defective.”
BBIL accused the authors of making “irresponsible and misleading” statements that had “a malicious intent” designed to be “defamatory,” which in turn, led to unfavourable media headlines that “irreversibly damaged the reputation” of BBIL.
The lawsuit alleges that the unflattering and false claims about Covaxin allowed BBIL’s competitors to “capture its customers” and hinder its business by “driving away potential customers and business partners.” It also alleged that the study was performed at the behest of competitors of the BBIL.
BBIL demanded a retraction of the study, noting that the researchers should refrain from any further publications of their research on the vaccine and sought damages to the tune of 50 million rupees ($US 600,000).
No attempt was made by BBIL to approach the authors and discuss alternatives prior to suing them.
BBIL did not respond to repeated media requests.
Sworn Statement by Authors
All authors have submitted a sworn statement under oath, refuting the allegations levelled against them.
It stated that there were no “nefarious objectives” in carrying out the study and that “it was conducted purely in the service of scientific enquiry.”
In the statement, the authors argued the study did not draw a “definitive link with the vaccine” and that this was stated clearly in the abstract of the journal article.
The authors called for further studies and said they couldn’t be held responsible for the way journalists reported on the study in the media.
They pointed out that it is standard practice to publish a “letter to the editor” of the journal to express a difference of opinion instead of lambasting the researchers in the media. BBIL chose not to take this route.
“This is nothing but an act of intimidation in coercing the [authors] to withdraw their article,” explained the authors in their statement.
It was pointed out that the ICMR is not a “neutral” government agency. It co-developed Covaxin and received royalties from BBIL for the sale of the product to the tune of 1.7 billion rupees ($US 20 million).
BBIL’s claim that it “suffered any loss of contracts for the supply of the vaccine” was entirely vague and unsubstantiated, said the authors.
In summary, they “rigorously followed the protocols of scientific investigation,” and stand by the integrity of the data, denying they were incorrect and flawed and therefore could not be deemed defamatory.
The Journal Caves
On Aug 28, 2024, Nitin Joshi, chief editor of Drug Safety, wrote to the authors to say a “post-publication review” had been conducted and that he now agreed with the criticisms of the paper.
Joshi, despite reviewing the study before it was published, stated that he intended to retract the article because he “no longer has confidence in the conclusions.”
In private emails, all authors were asked to agree or disagree with the decision to retract the article, but those reasons would not be included in the public retraction notice.
In response, the authors implored Joshi to reconsider his decision because it violated the editorial policies of the publisher (Springer) as well as COPE guidelines, a set of practices globally adopted for ethical publication of scientific papers.
“Removing/retracting the Article from the Journal without due process completely arbitrarily and unilaterally without even seeking any explanation from the Authors, suggests that the Journal is acting hastily,” wrote the authors.
They also suggested to Joshi that BBIL’s lawsuit merely served to intimidate the journal into retracting the article and “muffle or stifle any type of criticism/research about the vaccine.”
The authors went on to explain that retracting the study would “harm the credibility of their research, resulting in irreparable damage and defamation that cannot be compensated.”
On Sept 17, 2024, Joshi confirmed in an email to the authors that his decision to retract the paper was “final.” He denied being pressured by the defamation proceedings.
“I would like to emphasize that the decision to retract is an editorial decision, informed by a further evaluation of your article after concerns have been raised. In doing so we believe that the journal has followed COPE guidance appropriately,” wrote Joshi in the email.
Neither Joshi, nor the journal’s publisher (Springer), responded to media enquiries and it is assumed that the retraction of the article is imminent.
The defamation proceedings continue in the civil court of Hyderabad, India and the senior researchers are funding their own legal defence, as well as the legal defence of the student researchers.
So far, over 250 scientists, researchers, ethicists, doctors, and patients have signed an open letter addressed to BBIL, ICMR and the editor at Drug Safety, demanding the lawsuit be withdrawn, and the study remains published.
Republished from the author’s Substack
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