Tag: Drug Controller General of India

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.

Bharat Biotech gets 1/10 for tweet

If I had been Bharat Biotech’s teacher and “Where is your data?” had been an examination question, Bharat Biotech would have received 1 out of 10 marks.

The correct answer to where is your data can take one of two forms: either an update in the form of where the data is in the data-processing pipeline or to actually produce the data. The latter in fact would have deserved a bonus point, if only because the question wasn’t precise enough. The question should really have been a demand – “Submit your data” – instead of allowing the answerer, in its current form, to get away with simply stating where the data currently rests. Bharat Biotech gets 1/10 because it does neither; the 1 is for correct spelling.

In fact, the company’s chest-thumping based on publishing nine papers in 12 months is symptomatic of a larger problem with the student. He fails to understand that only data is data, and that the demand for data is a demand for data per se. It ought not to be confused with a demand for authority. Data accords authority in an object-oriented and democratic sense. With data, everyone else can see for themselves – whether by themselves or through the mouths and minds of independent experts they trust – if the student’s claims hold up. And if they do, they confer the object of the data, the COVID-19 vaccine named Covaxin, with attributes like reliability.

(Why ‘he’? The patriarchal conditions in and with which science has operated around the world, but especially in Europe and the US, in the last century or so have diffused into scientific practice itself, in terms of how the people at large have constituted – as well as have been expected to constitute, by the scientific community – scientific authority, expertise’s immunity to criticism and ownership of knowledge production and dissemination apparatuses, typically through “discrimination, socialisation and the gender division of labour”. Irrespective of the means – although both from the company’s and the government’s sides, very few women have fielded and responded to questions about drug/vaccine approvals – we already see these features in the manner in which ‘conventional’ scientific journals have sought to retain their place in the international knowledge production economy, and their tendency to resort to arguments that they serve an important role in it even as they push for anti-transparent practices, from the scientific papers’ contents to details about why they charge so much money.)

However, the student has confused authority of this kind with authority of a kind we more commonly associate with the conventional scientific publishing paradigm: in which journals are gatekeepers of scientific knowledge – both in terms of what topics they ‘accept’ manuscripts on and what they consider to be ‘good’ results; and in which a paper, once published, is placed behind a steeply priced paywall that keeps both knowledge of the paper’s contents and the terms of its ‘acceptance’ by the journal beyond public scrutiny – even when public money funded the research described therein. As such, his insistence that we be okay with his having published nine papers in 12 months is really his insistence that we vest our faith in scientific journals, and by extension their vaunted decision to ‘approve of’ his work. This confusion on his part is also reflected in what he offers as his explanation for the absence of data in the public domain, but which are really his excuses.

Our scientific commitment as a company stands firm with data generation, data transparency and peer-reviewed publications.

Sharing your data in a secluded channel with government bodies is not data transparency. That’s what the student needs for regulatory approval. Transparency applies when the data is available for everyone else to independently access, understand and check.

Phase 3 final analysis data will be available soon. Final analysis requires efficacy and 2 months safety follow-up data on all subjects. This is mandated by CDSCO and USFDA. Final analysis will first be submitted to CDSCO, followed by submissions to peer reviewed journals and media dissemination.

What is required by CDSCO does not matter to those allowing Bharat Biotech’s vaccines into the bloodstreams, and in fact every Indian on whom the student has inflicted this pseudo-choice. And at this point to invoke what the USFDA requires can only lead to a joke: studies of the vaccines involved in the formal vaccination drive have already been published in the US; even studies of new vaccines as well as follow-ups of existing formulations are being placed in the public domain through preprint papers that describe the data from soup to nuts. All we got from the student vis-à-vis Covaxin this year was interim phase 3 trial data in early March, announced through a press release, and devoid even of error bars for its most salient claims.

So even for an imprecisely worded question, it has done well to elicit a telling answer from the student: that the data does not exist, and the student believes he is too good for us all.

Thanks to Jahnavi Sen for reading the article before it was published.

The matter of a journal’s reputation

Apparently (and surprisingly) The Telegraph didn’t allow Dinesh Thakur to respond to an article by Biocon employee Sundar Ramanan, in which Ramanan deems Thakur’s article about the claims to efficacy of the Biocon drug Itolizumab not being backed by enough data to have received the DCGI’s approval to be inaccurate. Even notwithstanding The Telegraph‘s policy on how rebuttals are handled (I have no idea what it is), Ramanan – as a proxy for his employer – has everything to gain by defending Itolizumab’s approval and Thakur, nothing. This fact alone means Thakur should have been allowed to respond. As it stands, the issue has been reduced to a he-said-she-said event and I doubt that in reality it is. Thakur has since published his response at Newslaundry.

I’m no expert but there are many signs of whataboutery in Ramanan’s article. As Thakur writes, there’s also the matter of the DCGI waiving phase III clinical trials for Itolizumab, which can only be done if phase II trials were great – and this they’re unlikely to have been because of the ludicrous cohort size of 30 people. Kiran Mazumdar-Shaw and Seema Ahuja, the former the MD of and the latter a PR person affiliated with Biocon, have also resorted to ad hominem arguments on Twitter against Itolizumab’s critics, on more than one occasion have construed complaints about the drug approval process as expressions of anti-India sentiments, and have more recently begun to advance company-sponsored ‘expert opinions’ as “peer-reviewed” evidence of Itolizumab’s efficacy.

Even without presuming to know who’s ultimately right here, Mazumdar-Shaw and Ahuja don’t sound like the good guys, especially since their fiercest critics I’ve spotted thus far on Twitter are a bunch of highly qualified public health experts and medical researchers. Accusing them of ‘besmirching India’ inspires anything but confidence in Itolizumab’s phase II trial results.

It’s in this context that I want to draw attention to one particular word in Ramanan’s article in The Telegraph that I believe signals the ‘you scratch my back, I scratch yours’ relationship between many scientific journals and the accumulation of knowledge as a means to power – and in my view is a further sign that something’s rotten in the state of Denmark. Ramanan writes (underline added):

Itolizumab was first approved by the Drugs Controller General of India for the treatment of patients with active moderate to severe chronic plaque Psoriasis in 2013 based on “double-blind, randomized, placebo-controlled, Phase III study”. The safety and efficacy of the drug was published in globally reputed, peer-reviewed journals and in proceedings (Journal of the American Academy of Dermatology, and the 6th annual European Antibody Congress, respectively).

What does a journal’s reputation have to do with anything? The reason I keep repeating this point is not because you don’t get it – I’m sure you do; I do it to remind myself, and everyone else who may need to be reminded, of the different contexts in which the same issue repeatedly manifests. Invoking reputation, in this instance, smells of an argument grounded in authority instead of in evidence. Then again, this is a tautological statement considering Biocon issued a press release before the published results – preprint or post-print – were available (they still aren’t), but let’s bear on in an attempt to make sense of reputation itself.

The matter of a journal’s reputation, whether local or global, is grating because the journals for whom this attribute is germane have acquired it by publishing certain kinds of papers over others – papers that tend to describe positive results, sensational results, and by virtue of their reader-pays business model, results that are of greater interest to those likely to want to pay to access them. These details are important because it’s important to ask what ‘reputation’ means, and based on that we can then understand some of the choices of people for whom this ‘reputation’ matters.

Reputation is the outcome of gatekeeping, of deeming some papers as being worthy of publication according to metrics that have less to do with the contents of the paper* and more with the journal’s desirability and profitability. As Björn Brembs wrote in 2010:

It doesn’t matter where something is published – what matters is what is being published. Given the obscene subscription rates some of these journals charge, if anything, they should be held to a higher standard and their ‘reputation’ (i.e., their justification for charging these outrageous subscription fees!) being constantly questioned, rather than this unquestioning dogma that anything published there must be relevant, because it was published there.

However, by breaking into an élite club by publishing a paper in a particular journal, the reputation starts to matter to the scientist as well, and becomes synonymous with the scientist’s own aspirations of quality, rigour and academic power (look out for proclamations like “I have published 25 papers in journal X, which has an impact factor of 43″). This way, over time, the scientific literature becomes increasingly skewed in favour of some kinds of papers over others – especially of the positive, sensational variety – and leads to a vicious cycle.

The pressure in academia to ‘publish or perish’ also forces scientists to shoehorn themselves tighter into the journals’ definition of what a ‘good’ paper is, more so if publishing in some journals has seemingly become associated with increasing one’s likelihood of winning ‘reputed’ awards. As such, reputation is neither accidental nor innocent. From the point of view of the science that fills scientific journals, reputation is an arbitrary gatekeeper designed to disqualify an observer from calling the journal’s contents into question – which I’m sure you’ll understand is essentially antiscientific.

Ramanan’s appeal to the reputation of the journal that published the results of the tests of Itolizumab’s efficacy against cytokine release syndrome (CRS) in psoriasis patients is, in similar vein, an appeal to an entity that has nothing to do either with the study itself or the matter at hand. As Dr Jammi Nagaraj Rao wrote for The Wire Science, there’s no reason for us to believe knowing how Itolizumab works against CRS will help us understand how it will work against CRS in COVID-19 patients considering we’re not entirely sure how CRS plays out in COVID-19 patients – or if Itolizumab’s molecular mechanism of action can be directly translated to a statement of efficacy against a new disease.

In effect, the invitation to defer to a journal’s reputation is akin to an invitation to hide behind a cloak of superiority that would render scrutiny irrelevant. But that Ramanan used this word in this particular context is secondary**; the primary issue is that journals that pride such arbitrarily defined attributes as ‘reputation’ and ‘prestige’ also offer them as a defence against demands for transparency and access. Instead, why not let the contents of the paper speak up for themselves? Biocon should publish the paper pertaining to its controversial phase II trial of Itolizumab in COVID-19 patients and the DCGI should publicise the inner workings of its approval process asap. As they say: show us (the results), don’t tell us (the statement).

* Beyond determining if the paper is legitimate, has sound science and is free of mistakes, malpractice or fraud.

** There are also other words Ramanan uses to subtly delegitimise Thakur’s article – calling it an “opinion article” and presuming to “correct” Thakur’s arguments that constitute a “disservice to the public”.