Root Privileges

Tag: Bharat Biotech

  • A tale of two awardees

    In many respects Krishna Ella and Elon Musk are poles apart but on some they share a few similarities. Both of them have played along with nationalist elements in their respective national governments in order to further their agendas, if not profits. Both men are also at the helm of successful companies that build valuable products that a lot of people need, that the world needs. But while Elon Musk continues to be a despotic techbro, Krishna Ella is just a fellow who’s made some poor decisions.

    Recently, both men were also in the news for honours they’d received.

    The Royal Society in the UK continues to remain under pressure to rescind its fellowship of Musk, which it granted in 2018, owing to his attacks on free speech (ironically in the guise of protecting an absolute right to free speech), support for pseudoscientific ideas (including his antivaccine sentiments and support for climate denialism), and generally being unable to tell profundity from horseshit.

    At least one other fellow has resigned to protest the Royal Society’s unwillingness to suspend Musk’s membership: retired University of Oxford psychologist Dorothy Bishop. She wrote in November 2024 on her blog:

    There was no formal consultation of the Fellowship but via informal email contacts, a group of 74 Fellows formulated a letter of concern that was sent in early August [2024] to the President of the Royal Society, raising doubts as to whether he was “a fit and proper person to hold the considerable honour of being a Fellow of the Royal Society”. The letter specifically mentioned the way Musk had used his platform on X to make unjustified and divisive statements that served to inflame right-wing thuggery and racist violence in the UK. 

    Somebody (not me!) leaked the letter to the Guardian, who ran a story about it on 23rd August.

    I gather that at this point the Royal Society Council opted to consult a top lawyer to determine whether Musk’s behaviour breached their Code of Conduct. The problem with this course of action is that if you are uncertain about doing something that seems morally right but may have consequences, then it is easy to find a lawyer who will advise against doing it. … And, sure enough, the lawyer determined that Musk hadn’t breached the Code of Conduct.

    According to Bishop, Musk is in breach of sections 2.6, 2.10, and 2.11 of the ‘Code of Conduct’:

    2.6: Fellows and Foreign Members shall carry out their scientific research with regard to the Society’s statement on research integrity and to the highest standards.

    2.10: Fellows and Foreign Members shall treat all individuals in the scientific enterprise collegially and with courtesy, including supervisors, colleagues, other Society Fellows and Foreign Members, Society staff, students and other early‐career colleagues, technical and clerical staff, and interested members of the public.

    2.11: Fellows and Foreign Members shall not engage in any form of discrimination, harassment, or bullying.

    Seems fair. I reckon that together with the possibility of the unspecified “consequences” for the Royal Society Bishop has speculated, the body will also be mindful of being obligated to reassess the fellowship of many other individuals on its roster should it remove Musk on these grounds. (To be clear, this isn’t a defence of its position.)

    I’ve always held that awards are distinguished by their laureates and not the other way around. Fellowship of the Royal Society isn’t technically an award but for the most part it operates with the same incentives. Its code is thoughtful enough to not be limited to one’s conduct as a scientist. Just as the Millennium Plaque of Honour wouldn’t make a dent on the reputation of any scientist who wins it because it was awarded to Appa Rao Podile in 2017 — after he let police personnel lathi-charge the students in his care at the University of Hyderabad — it must be difficult to count Musk among one’s peers as fellows of the Royal Society.

    Consider Krishna Ella now. As part of its annual routine, the Indian National National Science Academy (INSA) handed out 61 fellowships last week, Ella among them. It’s the first time INSA has included industry leaders for this recognition. According to a statement on the INSA website:

    Dr. Krishna Ella, a prominent Indian scientist and entrepreneur, leads Bharat Biotech in ground-breaking vaccine development. His achievements include India’s Covaxin, the world’s first clinically proven conjugated Typhoid Vaccine, ROTAVAC, and the first preservative-free vaccine, Revac-B mcf Hepatitis B Vaccine. Bharat Biotech also introduced India’s first cell-cultured Swine Flu vaccine and manufactures the world’s most affordable Hepatitis vaccines. Additionally, they were the first globally to develop a vaccine for the Zika virus.

    Impressive achievements, right? But to me, Ella will equally be the man who filed defamation cases against me and many of my fellow journalists for publishing evidence-based articles critical of the manner in which the Indian government approved Covaxin for COVID-19 (with emphasis on the Indian government, not Bharat Biotech).

    I’m not at liberty to quote from these articles as Bharat Biotech was able to obtain an ex-parte injunction to take them offline until the proceedings concluded. But as with Bishop vis-à-vis Musk, here’s an instructive passage from the INSA ‘Code of Conduct’:

    All people associated with INSA are expected to adhere to certain minimal standards of ethical behaviour which include but are not limited to, honesty, integrity, and professional (sic). Integrity in the context of scientific research means trustworthiness of the data collected/presented, their interpretation, and the soundness of methodology/protocol followed in carrying out the research.

    At the time the Drugs Controller General of India (DGCI) signed off on the use of Covaxin and Covishield in “clinical trial mode” on the cusp of India’s drive to vaccinate against COVID-19, in January 2021, the country’s medico-legal doctrine didn’t recognise the term “trial mode” and phase III trials of both vaccines hadn’t been completed.

    To make matters worse, the DGCI said the vaccines were “110% safe” when the safety data hadn’t even been collected. AstraZeneca came through later with the complete safety and efficacy data for Covishield. In July 2021, Bharat Biotech researchers uploaded a preprint paper reporting safety data for only 56 days following vaccination with Covaxin. To this day, Bharat Biotech and the Union health ministry have yet to release the long-term safety data collected during Covaxin’s phase-III trial. Instead, both the company and the national government have simply expected people at large to trust them. Irrespective of whether the vaccine is safe, these actions are inimical to trustworthiness.

    I’m not opposed to Ella becoming an INSA fellow because I don’t care. Instead, my concerns are about INSA: I know it focuses on a prospective fellow’s scientific work at the time of granting the fellowship (see link below) and I suspect the Royal Society does too, but the latter also has a code of conduct that extends to fellows’ conduct beyond the scientific enterprise and other fellows who find value in all their peers adhering to it.

    The Royal Society fellows’ protests against sharing the honour with Musk is of a piece with his increasingly rightward turn in recent years being met with scientists speaking up against him in various fora. While there isn’t a correspondingly objectionable scientist in India, I also don’t recall members of the Indian scientific community speaking up in defence of science journalists who are speaking for science when they’re harassed by other members of the research enterprise, at least beyond the constant few I remain grateful for.

  • A tale of two awardees

    In many respects Krishna Ella and Elon Musk are poles apart but on some they share a few similarities. Both of them have played along with nationalist elements in their respective national governments in order to further their agendas, if not profits. Both men are also at the helm of successful companies that build valuable products that a lot of people need, that the world needs. But while Elon Musk continues to be a despotic techbro, Krishna Ella is just a fellow who’s made some detrimental decisions.

    Recently, both men were also in the news for honours they’d received.

    The Royal Society in the UK continues to remain under pressure to rescind its fellowship of Musk, which it granted in 2018, owing to his attacks on free speech (ironically in the guise of protecting an absolute right to free speech), support for pseudoscientific ideas (including his antivaccine sentiments and support for climate denialism), and generally being unable to tell profundity from horseshit.

    At least one other fellow has resigned to protest the Royal Society’s unwillingness to suspend Musk’s membership: retired University of Oxford psychologist Dorothy Bishop. She wrote in November 2024 on her blog:

    There was no formal consultation of the Fellowship but via informal email contacts, a group of 74 Fellows formulated a letter of concern that was sent in early August [2024] to the President of the Royal Society, raising doubts as to whether he was “a fit and proper person to hold the considerable honour of being a Fellow of the Royal Society”. The letter specifically mentioned the way Musk had used his platform on X to make unjustified and divisive statements that served to inflame right-wing thuggery and racist violence in the UK. 

    Somebody (not me!) leaked the letter to the Guardian, who ran a story about it on 23rd August.

    I gather that at this point the Royal Society Council opted to consult a top lawyer to determine whether Musk’s behaviour breached their Code of Conduct. The problem with this course of action is that if you are uncertain about doing something that seems morally right but may have consequences, then it is easy to find a lawyer who will advise against doing it. … And, sure enough, the lawyer determined that Musk hadn’t breached the Code of Conduct.

    According to Bishop, Musk is in breach of sections 2.6, 2.10, and 2.11 of the ‘Code of Conduct’:

    2.6: Fellows and Foreign Members shall carry out their scientific research with regard to the Society’s statement on research integrity and to the highest standards.

    2.10: Fellows and Foreign Members shall treat all individuals in the scientific enterprise collegially and with courtesy, including supervisors, colleagues, other Society Fellows and Foreign Members, Society staff, students and other early‐career colleagues, technical and clerical staff, and interested members of the public.

    2.11: Fellows and Foreign Members shall not engage in any form of discrimination, harassment, or bullying.

    Seems fair. I reckon that together with the possibility of the unspecified “consequences” for the Royal Society Bishop has speculated, the body will also be mindful of being obligated to reassess the fellowship of many other individuals on its roster should it remove Musk on these grounds. (To be clear, this isn’t a defence of its position.)

    I’ve always held that awards are distinguished by their laureates and not the other way around. Fellowship of the Royal Society isn’t technically an award but for the most part it operates with the same incentives. Its code is thoughtful enough to not be limited to one’s conduct as a scientist. Just as the Millennium Plaque of Honour wouldn’t make a dent on the reputation of any scientist who wins it because it was awarded to Appa Rao Podile in 2017 — after he let police personnel lathi-charge the students in his care at the University of Hyderabad — it must be difficult to count Musk among one’s peers as fellows of the Royal Society.

    Consider Krishna Ella now. As part of its annual routine, the Indian National National Science Academy (INSA) handed out 61 fellowships last week, Ella among them. It’s the first time INSA has included industry leaders for this recognition. According to a statement on the INSA website:

    Dr. Krishna Ella, a prominent Indian scientist and entrepreneur, leads Bharat Biotech in ground-breaking vaccine development. His achievements include India’s Covaxin, the world’s first clinically proven conjugated Typhoid Vaccine, ROTAVAC, and the first preservative-free vaccine, Revac-B mcf Hepatitis B Vaccine. Bharat Biotech also introduced India’s first cell-cultured Swine Flu vaccine and manufactures the world’s most affordable Hepatitis vaccines. Additionally, they were the first globally to develop a vaccine for the Zika virus.

    Impressive achievements, right? But to me, Ella will equally be the man who saw fit to file defamation cases against me and many of my fellow journalists for publishing evidence-based articles critical of the manner in which the Indian government approved Covaxin for COVID-19 (with emphasis on the Indian government, not Bharat Biotech).

    I’m not at liberty to quote from these articles as Bharat Biotech was able to obtain an ex-parte injunction to take them offline until the proceedings concluded. But as with Bishop vis-à-vis Musk, here’s an instructive passage from the INSA ‘Code of Conduct’:

    All people associated with INSA are expected to adhere to certain minimal standards of ethical behaviour which include but are not limited to, honesty, integrity, and professional (sic). Integrity in the context of scientific research means trustworthiness of the data collected/presented, their interpretation, and the soundness of methodology/protocol followed in carrying out the research.

    At the time the Drugs Controller General of India (DGCI) signed off on the use of Covaxin and Covishield in “clinical trial mode” on the cusp of India’s drive to vaccinate against COVID-19, in January 2021, the country’s medico-legal doctrine didn’t recognise the term “trial mode” and phase III trials of both vaccines hadn’t been completed.

    To make matters worse, the DGCI said the vaccines were “110% safe” when the safety data hadn’t even been collected. AstraZeneca came through later with the complete safety and efficacy data for Covishield. In July 2021, Bharat Biotech researchers uploaded a preprint paper reporting safety data for only 56 days following vaccination with Covaxin. To this day, Bharat Biotech and the Union health ministry have yet to release the long-term safety data collected during Covaxin’s phase-III trial. Instead, both the company and the national government have simply expected people at large to trust them. Irrespective of whether the vaccine is safe, these actions are inimical to trustworthiness.

    I’m not opposed to Ella becoming an INSA fellow because I don’t care. Instead, my concerns are about INSA: I know it focuses on a prospective fellow’s scientific work at the time of granting the fellowship (see link below) and I suspect the Royal Society does too, but the latter also has a code of conduct that extends to fellows’ conduct beyond the scientific enterprise and other fellows who find value in all their peers adhering to it.

    The Royal Society fellows’ protests against sharing the honour with Musk is of a piece with his increasingly rightward turn in recent years being met with scientists speaking up against him in various fora. While there isn’t a correspondingly objectionable scientist in India, I also don’t recall members of the Indian scientific community speaking up in defence of science journalists who are speaking for science when they’re harassed by other members of the research enterprise, at least beyond the constant few I remain grateful for.

  • A gentle push over the cliff

    From ‘Rotavirus vaccine: tortured data analyses raise false safety alarm’, The Hindu, June 22, 2024:

    Slamming the recently published paper by Dr. Jacob Puliyel from the International Institute of Health Management Research, New Delhi, on rotavirus vaccine safety, microbiologist Dr. Gagandeep Kang says: “If you do 20 different analyses, one of them will appear significant. This is truly cherry picking data, cherry picking analysis, changing the data around, adjusting the data, not using the whole data in order to find something [that shows the vaccine is not safe].” Dr. Kang was the principal investigator of the rotavirus vaccine trials and the corresponding author of the 2020 paper in The New England Journal of Medicine, the data of which was used by Dr. Puliyel for his reanalysis.

    This is an important rebuttal. I haven’t seen Puliyel’s study but Bharat Biotech’s conduct during and since the COVID-19 pandemic, especially that of its executive chairman Krishna Ella, plus its attitude towards public scrutiny of its Covaxin vaccine has rendered any criticism of the company or its products very believable, even if such criticism is unwarranted, misguided, or just nonsense.

    Puliyel’s study itself is a case in point: a quick search on Twitter reveals many strongly worded tweets, speaking to the availability of a mass of people that wants something to be true, and at the first appearance of even feeble evidence will seize on it. Of course The Hindu article found the evidence to not be feeble so much as contrived. Bharat Biotech isn’t “hiding” anything; Puliyel et al. aren’t “whistleblowers”.

    The article doesn’t mention the name of the journal that published Puliyel’s paper: International Journal of Risk and Safety in Medicine. It could have because journals that don’t keep against bad science out of the medical literature don’t just pollute the literature. By virtue of being journals, and in this case claiming to be peer-reviewed as well, they allow the claims they publish to be amplified by unsuspecting users on social media platforms.

    We saw something similar earlier this year in the political sphere when members of the Indian National Congress party and its allies as well as members of civil society cast doubt on electronic voting machines with little evidence, thus only undermining trust in the electoral process.

    To be sure, we’ve cried ourselves hoarse about the importance of every reader being sceptical about what appears in scientific journals (even peer-reviewed) as much as news articles, but because it’s a behavioural and cultural change it’s going to take time. Journals need to do their bit, too, yet they won’t because who needs scruples when you can have profits?

    The analytical methods Puliyel and his coauthor Brian Hooker reportedly employed in their new study is reminiscent of the work of Brian Wansink, who resigned from Cornell University five years ago this month after it concluded he’d committed scientific misconduct. In 2018, BuzzFeed published a deep-dive by Stephanie M. Lee on how the Wansink scandal was born. It gave the (well-referenced) impression that the scandal was a combination of a student’s relationship with a mentor renowned in her field of work and the mentor’s pursuit of headlines over science done properly. It’s hard to imagine Puliyel and Hooker were facing any kind of coercion, which leaves the headlines.

    This isn’t hard to believe considering it’s the second study to have been published recently that took a shot at Bharat Biotech based on shoddy research. It sucks that it’s become so easy to push people over the cliff, and into the ravenous maw of a conspiracy theory, but it sucks more that some people will push others even when they know better.

  • The BHU Covaxin study and ICMR bait

    Earlier this month, a study by a team at Banaras Hindu University (BHU) in Varanasi concluded that fully 1% of Covaxin recipients may suffer severe adverse events. One percent is a large number because the multiplier (x in 1/100 * x) is very large — several million people. The study first hit the headlines for claiming it had the support of the Indian Council of Medical Research (ICMR) and reporting that both Bharat Biotech and the ICMR are yet to publish long-term safety data for Covaxin. The latter is probably moot now, with the COVID-19 pandemic well behind us, but it’s the principle that matters. Let it go this time and who knows what else we’ll be prepared to let go.

    But more importantly, as The Hindu reported on May 25, the BHU study is too flawed to claim Covaxin is harmful, or claim anything for that matter. Here’s why (excerpt):

    Though the researchers acknowledge all the limitations of the study, which is published in the journal Drug Safety, many of the limitations are so critical that they defeat the very purpose of the study. “Ideally, this paper should have been rejected at the peer-review stage. Simply mentioning the limitations, some of them critical to arrive at any useful conclusion, defeats the whole purpose of undertaking the study,” Dr. Vipin M. Vashishtha, director and pediatrician, Mangla Hospital and Research Center, Bijnor, says in an email to The Hindu. Dr. Gautam Menon, Dean (Research) & Professor, Departments of Physics and Biology, Ashoka University shares the same view. Given the limitations of the study one can “certainly say that the study can’t be used to draw the conclusions it does,” Dr. Menon says in an email.

    Just because you’ve admitted your study has limitations doesn’t absolve you of the responsibility to interpret your research data with integrity. In fact, the journal needs to speak up here: why did Drug Safety publish the study manuscript? Too often when news of a controversial or bad study is published, the journal that published it stays out of the limelight. While the proximal cause is likely that journalists don’t think to ask journal editors and/or publishers tough questions about their publishing process, there is also a cultural problem here: when shit hits the fan, only the study’s authors are pulled up, but when things are rosy, the journals are out to take credit for the quality of the papers they publish. In either case, we must ask what they actually bring to the table other than capitalising on other scientists’ tendency to judge papers based on the journals they’re published in instead of their contents.

    Of course, it’s also possible to argue that unlike, say, journalistic material, research papers aren’t required to be in the public interest at the time of publication. Yet the BHU paper threatens to undermine public confidence in observational studies, and that can’t be in anyone’s interest. Even at the outset, experts and many health journalists knew observational studies don’t carry the same weight as randomised controlled trials as well as that such studies still serve a legitimate purpose, just not the one to which its conclusions were pressed in the BHU study.

    After the paper’s contents hit the headlines, the ICMR shot off a latter to the BHU research team saying it hasn’t “provided any financial or technical support” to the study and that the study is “poorly designed”. Curiously, the BHU team’s repartee to the ICMR’s makes repeated reference to Vivek Agnihotri’s film The Vaccine War. In the same point in which two of these references appear (no. 2), the team writes: “While a study with a control group would certainly be of higher quality, this immediately points to the fact that it is researchers from ICMR who have access to the data with the control group, i.e. the original phase-3 trials of Covaxin – as well publicized in ‘The Vaccine War’ movie. ICMR thus owes it to the people of India, that it publishes the long-term follow-up of phase-3 trials.”

    I’m not clear why the team saw fit to appeal to statements made in this of all films. As I’ve written earlier, The Vaccine War — which I haven’t watched but which directly references journalistic work by The Wire during and of the pandemic — is most likely a mix of truths and fictionalisation (and not in the clever, good-faith ways in which screenwriters adopt textual biographies for the big screen), with the fiction designed to serve the BJP’s nationalist political narratives. So when the letter says in its point no. 5 that the ICMR should apologise to a female member of the BHU team for allegedly “spreading a falsehood” about her and offers The Vaccine War as a counterexample (“While ‘The Vaccine War’ movie is celebrating women scientists…”), I can’t but retch.

    Together with another odd line in the latter — that the “ICMR owes it to the people of India” — the appeals read less like a debate between scientists on the merits and the demerits of the study and more like they’re trying to bait the ICMR into doing better. I’m not denying the ICMR started it, as a child might say, but saying that this shouldn’t have prevented the BHU team from keeping it dignified. For example, the BHU letter reads: “It is to be noted that interim results of the phase-3 trial, also cited by Dr. Priya Abraham in ‘The Vaccine War’ movie, had a mere 56 days of safety follow-up, much shorter than the one-year follow-up in the IMS-BHU study.” Surely the 56-day period finds mention in a more respectable and reliable medium than a film that confuses you about what’s real and what’s not?

    In all, the BHU study seems to have been designed to draw attention to gaps in the safety data for Covaxin — but by adopting such a provocative route, all that took centerstage was its spat with the ICMR plus its own flaws.

  • On Agnihotri’s Covaxin film, defamation, and false bravery

    Vivek Agnihotri’s next film, The Vaccine War, is set to be released on September 28. It is purportedly about the making of Covaxin, the COVID-19 vaccine made by Bharat Biotech, and claims to be based on real events. Based on watching the film’s trailer and snippets shared on Twitter, I can confidently state that while the basis of the film’s narrative may or may not be true, the narrative itself is not. The film’s principal antagonist appears to be a character named Rohini Singh Dhulia, played by Raima Sen, who is the science editor of a news organisation called The Daily Wire. Agnihotri has said that this character is based on his ‘research’ on the journalism of The Wire during, and about, the pandemic, presumably at the time of and immediately following the DCGI’s approval for Covaxin. Agnihotri and his followers on Twitter have also gone after science journalist Priyanka Pulla, who wrote many articles in this period for The Wire. At the time, I was the science editor of The Wire. Dhulia appears to have lovely lines in the film like “India can’t do this” and “the government will fail”, the latter uttered with visible glee.

    It has been terribly disappointing to see senior ICMR scientists promoting the film as well as the film (according to the trailer, at least) confidently retaining the name of Balram Bhargava for the character as well; for the uninitiated, Bhargava was the ICMR director-general during the pandemic. (One of his aides also has make-up strongly resembling Raman Gangakhedkar.) In Pulla’s words, “the political capture of this institution is complete”. The film has also been endorsed by Sudha Murthy and received a tone-deaf assessment by film critic Baradwaj Rangan, among other similar displays of support. One thing that caught my eye is that the film also retains the ICMR logo, logotype, and tagline as is (see screenshot below from the trailer).

    Source: YouTube

    The logo appears on the right of the screen as well as at the top-left, together with the name of NIV, the government facility that provided the viral material for and helped developed Covaxin. This is notable: AltBalaji, the producer of the TV show M.O.M. – The Women Behind Mission Mangal, was prevented from showing ISRO’s rockets as is because the show’s narrative was a fictionalised version of real events. A statement from AltBalaji to The Wire Science at the time, in 2019, when I asked why the show’s posters showed the Russian Soyuz rocket and the NASA Space Shuttle instead of the PSLV and the GSLV, said it was “legally bound not to use actual names or images of the people, objects or agencies involved”. I don’t know if the 2019 film Mission Mangal was bound by similar terms: its trailer shows a rocket very much resembling the GSLV Mk III (now called LVM-3) sporting the letters “S R O”, instead of “I S R O” ; the corresponding Hindi letters “स” and “रो”; and a different logo below the letters “G S L V” instead of the first “I” (screenshot below). GSLV is still the official designation of the launch vehicle, and a step further from what the TV show was allowed. And while the film also claims to be based on real events, its narrative is also fictionalised (read my review and fact-check).

    Source: YouTube

    Yet ICMR’s representation in The Vaccine War pulls no punches: its director-general at the time is represented by name and all its trademark assets are on display. It would seem the audience is to believe that they’re receiving a documentarian’s view of real events at ICMR. The film has destroyed the differences between being based on a true story and building on that to fictionalise for dramatic purposes. Perhaps more importantly: while AltBalaji was “legally bound” to not use official ISRO imagery, including those of the rockets, because it presented a fiction, The Vaccine War has been freed of the same legal obligation even though it seems to be operating on the same terms. This to me is my chief symptom of ICMR’s political capture.

    Of course, that Agnihotri is making a film based on a ‘story’ that might include a matter that is sub judice is also problematic. As you may know, Bharat Biotech filed a defamation case against the Foundation for Independent Journalism in early 2022; this foundation publishes The Wire and The Wire Science. I’m a defendant in the case, as are fellow journalists and science communicators Priyanka Pulla, Neeta Sanghi, Jammi Nagaraj Rao, and Banjot Kaur, among others. But while The Wire is fighting the case, it will be hard to say before watching The Vaccine War as to whether the film actually treads on forbidden ground. I’m also not familiar with the freedoms that filmmakers do and don’t have in Indian law (and the extent to which the law maps to common sense and intuition). That said, while we’re on the topic of the film, the vaccine, defamation, and the law, I’d like to highlight something important.

    In 2022, Bharat Biotech sought and received an ex parte injunction from a Telangana court against the allegedly offending articles published by The Wire and The Wire Science, and had them forcibly taken down. The court also prevented the co-defendants from publishing articles on Covaxin going forward and filed a civil defamation case, seeking Rs 100 crore in damages. As the legal proceedings got underway, I started to speak to lawyers and other journalists about implications of the orders, whether specific actions are disallowed on my part, and the way courts deal with such matters – and discovered something akin to a labyrinth that’s also a minefield. There’s a lot to learn. While the law may be clear about something, how a contention winds its way through the judicial system is both barely organised and uncodified. Rahul Gandhi’s own defamation case threw informative light on the role of judges’ discretion and the possibility of a jail term upon conviction, albeit for the criminal variety of the case.

    The thing I resented the most, on the part of sympathetic lawyers, legal scholars, and journalists alike, is the view that it’s the mark of a good journalist to face down a defamation case in their career. Whatever its origins, this belief’s time is up in a period when defamation cases are being filed at the drop of a hat. It’s no longer a specific mark of good journalism. Like The Wire, I and my co-defendants stand by the articles we wrote and published, but it remains good journalism irrespective of whether it has also been accused of defamation.

    Second, the process is the punishment, as the adage goes, yet by valorising the presence of a defamation case in a journalist’s record, it seeks to downplay the effects of the process itself. These effects include the inherent uncertainty; the unfamiliar procedures, documentation, and their contents and purposes; the travelling, especially to small towns, and planning ahead (taking time off work, availability of food, access to clean bathrooms, local transport, etc.); the obscure rules of conduct within courtrooms and the varying zeal with which they’re implemented; the variety and thus intractability of options for legal succour; and the stress, expenses, and the anxiety. So please, thanks for your help, but spare me the BS of how I’m officially a good journalist.

  • The biopolitics of Covaxin

    In a new investigation, STAT has reported fresh problems with Covaxin’s approval process in India, including the phase 2 trial dropping its placebo arm in favour of one preordained to make Covaxin look good and Bharat Biotech – the maker – commencing phase 3 trials based on results from animal studies. I’m also filing the report under “yet another instance of a pro-government Indian entity responding to the foreign press but not the local press” (following this). Krishna Mohan, one of the company’s directors, responded to STAT by admitting to a wrongdoing, massaging other similar actions, and pointing a finger at the Indian government.

    Is this spine? In response to similar evidence-based allegations of wrongdoing, Bharat Biotech met The Wire Science and The Wire with a defamation suit, a demand of Rs 100 crore and that the two sites not publish articles with “defamatory content” vis-à-vis the company, and obtained an ex parte injunction against 14 articles. This was in addition to the seemingly blanket refusal to respond to our questions for reports we were filing. Other senior Bharat Biotech officials also refused to communicate to anyone else asking probing questions about Covaxin’s clinical trials. No: his quote sounds more like Mohan trying to save Bharat Biotech’s face in front of a western audience (the one our government wants us to believe is inferior) while spinning India’s Bharat’s own take on the vaccine approval process.

    Mohan told STAT that they didn’t take any shortcuts – at least not those that weren’t first “vetted” by the Central Drug Standards Control Organisation (CDSCO), a.k.a. the drug regulator. That is to say, the shortcuts were CDSCO-approved, so they weren’t shortcuts. I’m inclined to agree: the rules are after all not based on principles of natural justice but on what the government deems acceptable. /s

    Of all the allegations, the one that irks me most is the modification to the phase 2 trial. It compromises our ability to learn anything useful about Covaxin, replacing that knowledge with knowledge of how much better one formulation of Covaxin is from another. The drug regulator should have known this is what the trial would have ended up checking, and if it approved this design anyway, it has engaged in wilful neglect – neglect of science, neglect of integrity, neglect of its mandate to look out for the people. But if we’re to believe Mohan, it’s just “product development” for an unprecedented time, not public health:

    “In a classic sense of product development, we would do everything the right way — play by the book and all the rules of the game would be followed. But here was a situation the world didn’t foresee. … Please don’t think there was any issue with the veracity of the data. Yes, it was an unusual approach, but it was dictated by the nature of the pandemic.”

    Ah, a classic tactic: Why did you burn down the forest? “It’s the climate crisis, which is unprecedented, and we needed land to erect smog towers.”

    Later in the article, in the face of a similar allegation – changing the phase 2 trial protocol – Mohan defends the regulator and blames discrepancies in trial numbers on a company struggling to coordinate multiple teams working separately from each other while being guided by the rule of “let’s get the data out”. I’d buy what he was saying if he was talking about his company HQ installing new air-conditioners and conducting tests of indoor air quality. But he’s talking about a clinical trial for a vaccine, placing misleading data in the public domain and – crucially – implicating a national drug regulator that he claims was in the know but didn’t act.

    To STAT, he’s saying they were distracted by the “safety of individuals”, the “ethics of handling subjects” and “manufacturing”, but to Indian journalists, he as well as the regulator have been mum on questions raised by the WHO and ANVISA on manufacturing practices and by almost everyone else about the People’s Hospital death and data.

    A (somehow) bigger problem arises soon after when Mohan says:

    “Whatever we did was with the clear intention of doing it right. There was no question of reducing sample sizes. … There were not off the cuff or random thoughts. … It was extensively debated with keeping the final objective in mind of getting a vaccine in time and not cutting any corners.”

    Getting a vaccine in time and not cutting any corners? It’s baffling that the last sentence is intended as clarification rather than as a potentially tacit admission of wrongdoing. I’m sure you remember when ICMR chief Balram Bhargava called on hospitals around India to complete Covaxin’s phase 3 trials in less than two months, in time for Prime Minister Narendra Modi to avail the vaccine for public use on Independence Day 2020. One independent scientist asked me what I thought Bhargava might have been smoking at the time; it was hard to say.

    But what’s tempting to speculate now is that the government realised, based on the backlash to Bhargava’s announcement, that a) a phase 3 trial in six weeks was a bigger problem than it believed, b) it wouldn’t work to have its vaccine development plan in public, c) it could accelerate Covaxin’s clinical trials by forcing Bharat Biotech to do so, and d) approve Covaxin without phase 3 trials by assimilating the drug regulator – all to achieve a similar outcome. Or at least I speculate in the absence of evidence. And until there is, we remain needles in veins.

  • About vaccines for children and Covaxin…

    I don’t understand his penchant for late-night announcements, much less one at 10 pm on Christmas night, but Prime Minister Narendra has just said the government will roll out vaccines for young adults aged 15-18 years from January 3, 2022 – around the same time I received a press release from Bharat Biotech saying the drug regulator had approved the company’s COVID-19 vaccine, Covaxin, for emergency-use among those aged 12-18 years.

    I think there’s a lot we don’t know about Covaxin at this time – similar to (but hopefully not to the same extent as) when the regulator approved it for emergency-use among adults on January 3, 2021. But what grates at me more now is this: more than being any other vaccine to protect against COVID-19, Covaxin has been the Indian government’s pet project.

    This favour has manifested in the form of numerous government officials supporting its use and advantages sans nearly sufficient supporting evidence, and in the form of help the vaccine hasn’t deserved at the time the government extended it – primarily the emergency-use approval for adults. Most of all, Covaxin has become a victim of India’s vaccine triumphalism.

    And I’m wary that Prime Minister Modi’s 10 pm announcement is a sign that a similar sort of help is in the offing. Until recently, up to December 24 in fact, officials including Rajesh Bhushan, Vinod K. Paul and Balram Bhargava said the government is being guided by science on the need to vaccinate children. Yet Modi’s announcement coincides with the drug regulator’s approval for Covaxin’s emergency-use among children.

    I admit this isn’t much to go on, but it isn’t an allegation either. It’s the following doubt: given the recent political history of Covaxin and its sorry relationship with the Indian government, will we stand to lose anything by ignoring the timing of the prime minister’s announcement? Put another way – and even if pulling at this thread turns out to be an abortive effort – did the government wait to change its policy on vaccinating those aged younger than 18 years until it could be sure Covaxin was in the running? (The drug regulator had approved another vaccine for children in August, Zydus Cadila’s ZyCoV-D – another train-wreck.)

    Modi’s announcement also has him making a deceptively off-handed comment that today is Atal Bihari Vajpayee’s birth anniversary. Such an alignment of dates has never been a coincidence in Modi’s term as prime minister. Makes one wonder what else isn’t a coincidence…

  • The toxic affair between Covaxin and The Lancet

    That Covaxin has been leading a ceaselessly beleaguered life is no mystery – but The Lancet journal may not know that it has been pressed into the questionable service of saving the vaccine’s reputation on at least three occasions. In the latest one, for example, Bharat Biotech, some clueless media outlets and their hordes of followers, assisted ably by the aptly named bhakts of India’s ruling party, have been hollering from rooftops high and low that The Lancet ‘has said’ Covaxin is 77.8% efficacious. Background: The Lancet medical journal has published the paper describing Covaxin’s phase 3 trial results. But to Covaxin’s misfortune, these people appear to be assuming, as they have many times before, that a journal publishing a paper is by all means synonymous to the journal itself speaking for, even endorsing, the paper’s contents.

    If you didn’t know better, you’d think The Lancet had pooled together all the evidence, comments and documents pertaining to Covaxin and pronounced its own verdict about the shot’s reputation. But because you know better, you know that a journal’s editors, and peer-reviewers if they were involved, only checked if the submitted paper’s data is consistent with the submitted paper’s statements and conclusions, and that it was free of research misconduct (although I’m wholly pessimistic about the latter).

    The problem is that the number of people who know better appears to be vanishingly small – so small, in fact, that it didn’t strike me until earlier this year that both clinical trials and scientific publishing involve the sort of specialised education that most people, including (seemingly) all engineers and exponents of many other fields of science, peeled away from many decades ago (depending on how old they are). Even what constitutes publishing or the qualitative differences between good and great papers varies from one specialisation to the next.

    As a result, when Bharat Biotech’s people cheer that The Lancet has ‘held up’ their findings, there’s both very few people to call out their bullshit – the journal published their paper, and didn’t wave a flag for them – and they’re met more often than you’d think with resistance from both Bharat Biotech’s and other scientists, typically because of vested interests. In fact, vested interest, singular: by publishing a paper in a journal, many scientists seek to partake of the journal’s prestige. Call this a nuanced take, but it has significant real-world effects, as we’re seeing with the strange but certainly myopic ways in which Bharat Biotech has sought to defend Covaxin (including, in the latest instance, by undermining the WHO’s approval for it).

    Of course, The Lancet itself, together with some other journals, including the New England Journal of Medicine, the Journal of the American Medical Association and Cell, has actively cultivated this notion of ‘prestige’ to pad its pockets as well as to passively silence questions about the many problematic papers it has published. Journals engaging in such practices together with the scientists who fall for them have thus contributed in a significant way to the idea that ‘prestige journals’ are in effect ‘prestige conferrers’, so perhaps The Lancet deserves its fate. But the many less- or entirely ill-informed people out there don’t, especially when they start to believe, “The Lancet has said Covaxin is safe, so it must be safe.”

    Medical journals, including The Lancet and the New England Journal of Medicine, have expressed opposition to the idea of releasing medical research papers as preprints, contending that unlike potentially incomplete papers on other topics, the ones they receive could cost lives if they’re published without independent checks first. An entirely reasonable argument. So what happens when The Lancet or the New England Journal of Medicine publish good papers about a vaccine that’s flawed in other ways, and whose authors then piggyback on the journals’ self-proclaimed superiority to toot their own horns, even as the journals all know that they’ve only checked the papers, not anything else? Apart from all the other problems with the notion of a journal’s isolated excellence, it’s ridiculous that journals accrue it the same way they’ve been accruing their profits: with no socially meaningful contribution of their own.

  • Is Covaxin’s WHO approval guaranteed?

    I suspect after reading this PTI report that the WHO is practically helping Bharat Biotech put together a better application to have its COVID-19 vaccine, Covaxin, get the body’s approval for international use, instead of simply considering what Bharat Biotech chooses to submit. The overall tone of the report is mollificatory – as if the WHO wishes to appease both the angry and the doubtful that the many months the relevant committee is taking to decide on Covaxin’s candidature shouldn’t be taken as a comment on the Indian vaccine-manufacturing industry. The biggest supplier of vaccines to the WHO’s COVAX initiative is Serum Institute of India, in Pune, so the WHO has a conflict of interest when it says it holds the industry in good esteem. But even vis-à-vis Bharat Biotech (whose production planning and output have both been disappointing), PTI writes:

    India’s Bharat Biotech has been submitting data on the EUL of Covaxin “regularly and very quickly” to a technical committee which hopes to have a final recommendation to the WHO next week, a top official of the global health agency said on Thursday, stressing that the UN body “trusts” the Indian industry that manufactures high quality vaccines.

    There is something of an analogy with customer service. Say two companies both sell the same product at the same price. Company A’s customer service is excellent and its product has a quality rating of 75%. Company B’s customer service is average and its product has a quality rating of 100%. Which company will you buy from? I’d pick Company B because being spared the trouble of having to contact customer service is more valuable than having to contact customer service and then having a good experience. The same goes for Bharat Biotech’s application with the WHO for Covaxin: the company has been submitting more information “regularly and very quickly”? Great. But why does it have to do this at all instead of keeping all the data ready before any kind of approval?

    This characterisation of Bharat Biotech by the “top official” also feeds into what the committee is prepared to do en route to Covaxin’s apparently impending approval. As the PTI report says later:

    [Bruce Aylward, senior advisor to the WHO chief,] added that WHO’s job is to save as many lives as possible and as fast as possible. This includes ensuring no product lies unused.

    Considering COVAX’s premise, to ensure everyone everywhere has access to vaccines instead of just the rich guys (and ignoring its inability to fulfill this mandate so far), what Aylward says is desirable, that all good vaccines should be used up. But this also raises a question about where the WHO draws the line between rejecting a bad application and accepting a bad application and helping to make it good.

    Covaxin is clearly a bad product – its clinical trial, its emergency-use approval, its rollout and the agonising wait for access to the trial data (followed subsequently by issues of trial ethics and data quality) threw up so many questions, but none of the Drug Controller General, Bharat Bitoech or the Indian Council of Medical Research (ICMR) have deigned to answer any of them, at least not honestly. This was followed later by questions about how Bharat Biotech, and the Indian government with it, estimated that the company would be able to produce X number of doses by certain dates, only to fall strikingly short on each occasion, so much so that together with Serum Institute’s failure to project output and demand, India – the “vaccine superpower” that ICMR’s Balram Bhargava recently said it was – had a shameful vaccine shortage for the first half of 2021.

    As good as the science underlying BBV152 may have been, Covaxin the product is untrustworthy. This isn’t a comment on the science so much as a reiteration of the oft-overlooked fact that science progressively gives away to social issues that emerge in non-linear fashion when science’s requirements collide with societal gradients, particularly once the giant phase 3 tests have begun.

    Given all of these issues, the WHO committee repeatedly asking for more data from Bharat Biotech regarding Covaxin served to highlight – loudly and effectively – an immutable fact: that the Indian government and Bharat Biotech didn’t have this data at the time the Drug Controller General approved the vaccine for emergency use (in “clinical trial mode” to boot) in January 2021, and probably that Bharat Biotech didn’t have this data ready when it claimed, on more than one occasion, that it had submitted all the info it had on Covaxin to the WHO.

    Now, with a WHO committee member seemingly suggesting that Covaxin’s approval is a question of when, not if, are we to believe that the vaccine is really good and that we’re all thinking about it wrong? This is an important question, to me at least, because one less-than-ideal alternative is to contemplate how one committee can ‘fix’ a vaccine – by legitimising it with its approval – that is so broken that even with the Indian government’s support, only some 11% of eligible Indians have taken it. Another is to confront the similarly dispiriting possibility that millions of people are so desperate for vaccines around the world that the WHO can no longer afford to stop at being a quality filter – and should step up to help insincere vaccine-makers over the fence. (Recall the ‘right to choose without choices’ from January?)

    Any which way, the implied promise of approval seems to me to be too much of an easy way out for Bharat Biotech, and the intractable, unabashed Indian government behind it.

  • It’s great that the WHO isn’t just ‘not cutting corners’

    Call me anti-national (and I’m sure many will) but I’m glad that the WHO isn’t just “not cutting corners” in the process of considering Bharat Biotech’s application for the UN body’s stamp of approval Covaxin but is also openly calling for more and more information from the company at periodic intervals.

    This isn’t just a validation process in the larger scheme of things – which could imply something as banal as the WHO considering a really complicated application – but has also served to humiliate the Indian government’s instruments, from the clinical trial regulation apparatus to the prime minister’s office (let’s not forget that the PM is indeed a tool). The WHO’s process is resistant to “diplomatic” and “political” inputs, even as every meeting of its vaccine approval committee has concluded thus far with demands for more information from Bharat Biotech. This doesn’t prove that the Drug Controller General of India and the Central Drug Standards Control Organisation screwed up their vetting process to push Covaxin’s emergency-use license through earlier this year – but surely suggests it, and that’s just as well.

    Everyone from Bharat Biotech’s upper management to Prime Minister Narendra Modi have failed to understand that bad data alone doesn’t cause vaccine hesitancy, that absent data has the same effect. The Indian government, specifically the Bharatiya Janata Party, dragged Covaxin to the centre of its vaccine triumphalism and afforded it the same privileges it has extended to other parts of government – trenchant opacity, approval sans data, vanishing accountability. As such, we were never talking about a product of the Indian medical research community as much as something resembling a corrupted political object, and that in turn should lead us to the conclusion that this vaccine deserved to be met with hesitancy, and the WHO’s repeated requests for more data indicates that it still deserves to be.

    Thus far, the current government has seemed most responsive (albeit like a child, lashing out and hurting someone else) to the threat of humiliation. So, glad, even if I’m sure it will be short-lived. Once the WHO grants its approval (although there’s no guarantee), the government will certainly embark on a past-washing campaign, pressing its ministers to the task of weaving together an alternative history of why the approval process was unusually protracted. Is there any way we can preempt that?