Balram Bhargava – Close Read

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).

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).

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.

Something more foolish than completing phase 3 trials in 1.5 months?

That the Union government and the Indian Space Research Organisation (ISRO) had entered into a more intimate, but not necessarily more beneficial, relationship became evident in 2019 when then ISRO chairman K. Sivan trotted out a series of dubious claims to massage the fate of the Chandrayaan 2 mission, whose lunar surface component had obviously failed. Anyone who follows Indian spaceflight news is familiar with the adage ‘space is hard’ and all of them abide by it (there’s an argument that we shouldn’t extend the same courtesy to more mature space programmes). Yet Sivan was determined to salvage even more, going so far at one point to call the whole mission (orbiter + lander) a “98% success”.

Shortly after news of the lander’s fate became clear to ground control, Prime Minister Narendra Modi, who was present as the chief guest, consoled Sivan with his customary hug even as ISRO at large withdrew into a shell of silence, offering only the occasional scrap of what it knew had happened to the lander. The vacuum of information allowed a trickle of speculation, but which was soon overwhelmed by a swell of conspiracies and, as is inevitable these days, a virtual barrier erected by right-wing commentators and bots that suppressed all questions asking for more information in the public domain. This ISRO, and the attendant public experience of India’s spaceflight programme, was markedly different from the ISRO of before – a feeling that Sivan deepened with other claims about the amount of time ISRO would need to realise its ‘Gaganyaan’ human spaceflight mission, which has already been delayed by three years. Sivan had unknowingly underestimated the amount, had deliberately communicated a shorter duration, had communicated the actual time but to which government officials couldn’t agree, or something else happened. The first possibility would’ve been unlikely were it not for the COVID-19 pandemic – but then it would seem that even if Sivan’s successor, S. Somanath, were to push back and ask for more time, the government has made up its mind: New Indian Express reported on December 8 that ISRO had received “instructions from the government” to send Indian astronauts to space on its GSLV Mk III rocket before the 2024 Lok Sabha elections! This has to be the second most unintelligent decision the government has made in the limited context of large-scale undertakings involving science and the lives of people, after Balram Bhargava’s subsequently rescinded threat in mid-2020 for researchers to complete the Covaxin phase 3 clinical trial in time for Prime Minister Modi’s Independence Day address less than two months away. It’s not clear if the government will rescind its demand of ISRO; the report itself is brief and doesn’t mention any resistance from the spaceflight mission team. But how this squares with minister Jitendra Singh’s statement in parliament last week, that the first crewed mission will only liftoff in late 2024 and that “crew safety is paramount”, is unclear. Assuming that the government will continue to push ISRO to launch in the first half of 2024, a flight based on a schedule modified to accommodate the demand may surpass the foolishness of Bhargava’s ask.

Every human spaceflight mission is inordinately complex. ISRO will have to design and test every component of the launch vehicle, crew capsule, mission profile, ground systems and crew management beforehand, in different conditions. It has to anticipate all possible failure scenarios and arrange for both failure-avoidance systems and failsafes. The timeline may have been more flexible in the early days of the undertaking, when the systems being tested were less composite, but not so today. When the government “instructs” ISRO to launch the ‘Gaganyaan’ crewed flight before the 2024 Lok Sabha elections (which are around 18 months away), it’s practically asking ISRO to devise a testing schedule that will be completed – irrespective of the tests’ outcomes – in this period all so it can use the mission’s outcomes (developed with government funds) as part of its election campaign. It’s effectively asking ISRO to sideline science, safety standards and good sense. Imagine one safety test going awry, and which ISRO might in other circumstances have liked to fix and redo. With “instructions” like those of the government, it won’t be able to – jeopardising the mission itself as well as the lives of the astronauts and the reputation of the Indian space programme in the international arena. The government simply shouldn’t make such a frighteningly asinine demand, and instead allow ISRO to take all the time it needs (within reasonable limits) to successfully complete its first human spaceflight mission.

ISRO has of late also embarked on programmes to increase its commercial revenue, even though it’s a “space research organisation”. If a crewed mission fails because the organisation let itself be cowed by the national government into trimming its testing process, all so a political party could use the launch as part of its poll propaganda, all of the organisation’s other rockets will confront doubts about their safety and whether they won’t threaten satellites worth hundreds of millions of dollars. A lot of ISRO’s work on ‘Gaganyaan’ has also happened to the exclusion of other launch vehicles and scientific missions, including (but not limited to) the reusable launch vehicle, the semi-cryogenic engine and the Aditya L1 space-probe. Its low rate of production of new rockets recently forced it to postpone the Chandrayaan 3 mission to accommodate the OneWeb satellites (in a commercial contract) in its launch manifest. Setting aside questions of ISRO’s relatively low funding and internal priorities, even if ‘Gaganyaan’ succeeds out of luck, the prospects of all of these adversely affected projects will suffer at least further reputational consequences. If ‘Gaganyaan’ fails, the future will be a lot worse.

Just as the Covaxin incident opened a window into how the Indian government was thinking about the COVID-19 vaccination drive and the role of science in shaping it, a demand of ISRO to launch realise its human spaceflight mission with a hard deadline opens a window into the Indian government’s considerations on ‘Gaganyaan’. The BJP government revived ISRO’s proposal for a human spaceflight mission in 2014, approved it in 2017 and allocated Rs 10,000 crore in 2018. Did it do so only because of how the mission’s success, should it come to pass, would help the party win elections? It’s desirable for a party’s goals and the country’s goals to be aligned – until the former crimps the latter. But more importantly, should we be concerned about the government’s heuristic for selecting and rejecting which spaceflight missions to fund? And should we be concerned about which publicly funded projects it will seek more accountability on?

There have been standing committee and audit reports calling ISRO out for slow work on this or that matter but the government at large, especially the incumbent one since 2019, has taken pains to maintain a front of amicability. It might be mildly amusing if a political party promises in its pre-poll manifesto to get ISRO in shape, and then in line, by readying a reusable launch vehicle for commercial missions by 2025 or launching five scientific missions in the next four years – but standing in the way of that is more than a knack to translate between public sentiment and technological achievement. It requires breaking a longstanding tradition of cosying up to ISRO as much as granting it autonomy while simultaneously underfunding it. We need the national government, most of all, to pay more attention to all ISRO projects on which there is evidence of dilly-dallying, and grapple honestly with the underlying issues, rather than poke its nose in the necessarily arduous safety-rating process of a crewed mission.

Featured image: A GSLV Mk III rocket lifts off on its first orbital flight, July 2017. Credit: ISRO.

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.