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.

The problem with rooting for science

The idea that trusting in science involves a lot of faith, instead of reason, is lost on most people. More often than not, as a science journalist, I encounter faith through extreme examples – such as the Bloch sphere (used to represent the state of a qubit) or wave functions (‘mathematical objects’ used to understand the evolution of certain simple quantum systems). These and other similar concepts require years of training in physics and mathematics to understand. At the same time, science writers are often confronted with the challenge of making these concepts sensible to an audience that seldom has this training.

More importantly, how are science writers to understand them? They don’t. Instead, they implicitly trust scientists they’re talking to to make sense. If I know that a black hole curves spacetime to such an extent that pairs of virtual particles created near its surface are torn apart – one particle entering the black hole never to exit and the other sent off into space – it’s not because I’m familiar with the work of Stephen Hawking. It’s because I read his books, read some blogs and scientific papers, spoke to physicists, and decided to trust them all. Every science journalist, in fact, has a set of sources they’re likely to trust over others. I even place my faith in some people over others, based on factors like personal character, past record, transparency, reflexivity, etc., so that what they produce I take only with the smallest pinch of salt, and build on their findings to develop my own. And this way, I’m already creating an interface between science and society – by matching scientific knowledge with the socially developed markers of reliability.

I choose to trust those people, processes and institutions that display these markers. I call this an act of faith for two reasons: 1) it’s an empirical method, so to speak; there is no proof in theory that such ‘matching’ will always work; and 2) I believe it’s instructive to think of this relationship as being mediated by faith if only to amplify its anti-polarity with reason. Most of us understand science through faith, not reason. Even scientists who are experts on one thing take the word of scientists on completely different things, instead of trying to study those things themselves (see ad verecundiam fallacy).

Sometimes, such faith is (mostly) harmless, such as in the ‘extreme’ cases of the Bloch sphere and the wave function. It is both inexact and incomplete to think that quantum superposition means an object is in two states at once. The human brain hasn’t evolved to cognate superposition exactly; this is why physicists use the language of mathematics to make sense of this strange existential phenomenon. The problem – i.e. the inexactitude and the incompleteness – arises when a communicator translates the mathematics to a metaphor. Equally importantly, physicists are describing whereas the rest of us are thinking. There is a crucial difference between these activities that illustrates, among other things, the fundamental incompatibility between scientific research and science communication that communicators must first surmount.

As physicists over the past three or four centuries have relied increasingly on mathematics rather than the word to describe the world, physics, like mathematics itself, has made a “retreat from the word,” as literary scholar George Steiner put it. In a 1961 Kenyon Review article, Steiner wrote, “It is, on the whole, true to say that until the seventeenth century the predominant bias and content of the natural sciences were descriptive.” Mathematics used to be “anchored to the material conditions of experience,” and so was largely susceptible to being expressed in ordinary language. But this changed with the advances of modern mathematicians such as Descartes, Newton, and Leibniz, whose work in geometry, algebra, and calculus helped to distance mathematical notation from ordinary language, such that the history of how mathematics is expressed has become “one of progressive untranslatability.” It is easier to translate between Chinese and English — both express human experience, the vast majority of which is shared — than it is to translate advanced mathematics into a spoken language, because the world that mathematics expresses is theoretical and for the most part not available to our lived experience.

Samuel Matlack, ‘Quantum Poetics’, The New Atlantic, 2017

However, the faith becomes more harmful the further we move away from the ‘extreme’ examples – of things we’re unlikely to stumble on in our daily lives – and towards more commonplace ideas, such as ‘how vaccines work’ or ‘why GM foods are not inherently bad’. The harm emerges from the assumption that we think we know something when in fact we’re in denial about how it is that we know that thing. Many of us think it’s reason; most of the time it’s faith. Remember when, in Friends, Monica Geller and Chandler Bing ask David the Scientist Guy how airplanes fly, and David says it has to do with Bernoulli’s principle and Newton’s third law? Monica then turns to Chandler with a knowing look and says, “See?!” To which Chandler says, “Yeah, that’s the same as ‘it has something to do with wind’!”

The harm is to root for science, to endorse the scientific enterprise and vest our faith in its fruits, without really understanding how these fruits are produced. Such understanding is important for two reasons.

First, if we trust scientists, instead of presuming to know or actually knowing that we can vouch for their work. It would be vacuous to claim science is superior in any way to another enterprise that demands our faith when science itself also receives our faith. Perhaps more fundamentally, we like to believe that science is trustworthy because it is evidence-based and it is tested – but the COVID-19 pandemic should have clarified, if it hasn’t already, the continuous (as opposed to discrete) nature of scientific evidence, especially if we also acknowledge that scientific progress is almost always incremental. Evidence can be singular and thus clear – like a new avian species, graphene layers superconducting electrons or tuned lasers cooling down atoms – or it can be necessary but insufficient, and therefore on a slippery slope – such as repeated genetic components in viral RNA, a cigar-shaped asteroid or water shortage in the time of climate change.

Physicists working with giant machines to spot new particles and reactions – all of which are detected indirectly, through their imprints on other well-understood phenomena – have two important thresholds for the reliability of their findings: if the chance of X (say, “spotting a particle of energy 100 GeV”) being false is 0.27%, it’s good enough to be evidence; if the chance of X being false is 0.00006%, then it’s a discovery (i.e., “we have found the particle”). But at what point can we be sure that we’ve indeed found the particle we were looking for if the chance of being false will never reach 0%? One way, for physicists specifically, is to combine the experiment’s results with what they expect to happen according to theory; if the two match, it’s okay to think that even a less reliable result will likely be borne out. Another possibility (in the line of Karl Popper’s philosophy) is that a result expected to be true, and is subsequently found to be true, is true until we have evidence to the contrary. But as suitable as this answer may be, it still doesn’t neatly fit the binary ‘yes’/’no’ we’re used to, and which we often expect from scientific endeavours as well (see experience v. reality).

(Minor detour: While rational solutions are ideally refutable, faith-based solutions are not. Instead, the simplest way to reject their validity is to use extra-scientific methods, and more broadly deny them power. For example, if two people were offering me drugs to suppress the pain of a headache, I would trust the one who has a state-sanctioned license to practice medicine and is likely to lose that license, even temporarily, if his prescription is found to have been mistaken – that is, by asserting the doctor as the subject of democratic power. Axiomatically, if I know that Crocin helps manage headaches, it’s because, first, I trusted the doctor who prescribed it and, second, Crocin has helped me multiple times before, so empirical experience is on my side.)

Second, if we don’t know how science works, we become vulnerable to believing pseudoscience to be science as long as the two share some superficial characteristics, like, say, the presence and frequency of jargon or a claim’s originator being affiliated with a ‘top’ institute. The authors of a scientific paper to be published in a forthcoming edition of the Journal of Experimental Social Psychology write:

We identify two critical determinants of vulnerability to pseudoscience. First, participants who trust science are more likely to believe and disseminate false claims that contain scientific references than false claims that do not. Second, reminding participants of the value of critical evaluation reduces belief in false claims, whereas reminders of the value of trusting science do not.

(Caveats: 1. We could apply the point of this post to this study itself; 2. I haven’t checked the study’s methods and results with an independent expert, and I’m also mindful that this is psychology research and that its conclusions should be taken with salt until independent scientists have successfully replicated them.)

Later from the same paper:

Our four experiments and meta-analysis demonstrated that people, and in particular people with higher trust in science (Experiments 1-3), are vulnerable to misinformation that contains pseudoscientific content. Among participants who reported high trust in science, the mere presence of scientific labels in the article facilitated belief in the misinformation and increased the probability of dissemination. Thus, this research highlights that trust in science ironically increases vulnerability to pseudoscience, a finding that conflicts with campaigns that promote broad trust in science as an antidote to misinformation but does not conflict with efforts to install trust in conclusions about the specific science about COVID-19 or climate change.

In terms of the process, the findings of Experiments 1-3 may reflect a form of heuristic processing. Complex topics such as the origins of a virus or potential harms of GMOs to human health include information that is difficult for a lay audience to comprehend, and requires acquiring background knowledge when reading news. For most participants, seeing scientists as the source of the information may act as an expertise cue in some conditions, although source cues are well known to also be processed systematically. However, when participants have higher levels of methodological literacy, they may be more able to bring relevant knowledge to bear and scrutinise the misinformation. The consistent negative association between methodological literacy and both belief and dissemination across Experiments 1-3 suggests that one antidote to the influence of pseudoscience is methodological literacy. The meta-analysis supports this.

So rooting for science per se is not just not enough, it could be harmful vis-à-vis the public support for science itself. For example (and without taking names), in response to right-wing propaganda related to India’s COVID-19 epidemic, quite a few videos produced by YouTube ‘stars’ have advanced dubious claims. They’re not dubious at first glance, if also because they purport to counter pseudoscientific claims with scientific knowledge, but they are – either for insisting a measure of certainty in the results that neither exist nor are achievable, or for making pseudoscientific claims of their own, just wrapped up in technical lingo so they’re more palatable to those supporting science over critical thinking. Some of these YouTubers, and in fact writers, podcasters, etc., are even blissfully unaware of how wrong they often are. (At least one of them was also reluctant to edit a ‘finished’ video to make it less sensational despite repeated requests.)

Now, where do these ideas leave (other) science communicators? In attempting to bridge a nearly unbridgeable gap, are we doomed to swing only between most and least unsuccessful? I personally think that this problem, such as it is, is comparable to Zeno’s arrow paradox. To use Wikipedia’s words:

He states that in any one (duration-less) instant of time, the arrow is neither moving to where it is, nor to where it is not. It cannot move to where it is not, because no time elapses for it to move there; it cannot move to where it is, because it is already there. In other words, at every instant of time there is no motion occurring. If everything is motionless at every instant, and time is entirely composed of instants, then motion is impossible.

To ‘break’ the paradox, we need to identify and discard one or more primitive assumptions. In the arrow paradox, for example, one could argue that time is not composed of a stream of “duration-less” instants, that each instant – no matter how small – encompasses a vanishingly short but not nonexistent passage of time. With popular science communication (in the limited context of translating something that is untranslatable sans inexactitude and/or incompleteness), I’d contend the following:

  • Awareness: ‘Knowing’ and ‘knowing of’ are significantly different and, I hope, self-explanatory also. Example: I’m not fluent with the physics of cryogenic engines but I’m aware that they’re desirable because liquefied hydrogen has the highest specific impulse of all rocket fuels.
  • Context: As I’ve written before, a unit of scientific knowledge that exists in relation to other units of scientific knowledge is a different object from the same unit of scientific knowledge existing in relation to society.
  • Abstraction: 1. perfect can be the enemy of the good, and imperfect knowledge of an object – especially a complicated compound one – can still be useful; 2. when multiple components come together to form a larger entity, the entity can exhibit some emergent properties that one can’t derive entirely from the properties of the individual components. Example: one doesn’t have to understand semiconductor physics to understand what a computer does.

An introduction to physics that contains no equations is like an introduction to French that contains no French words, but tries instead to capture the essence of the language by discussing it in English. Of course, popular writers on physics must abide by that constraint because they are writing for mathematical illiterates, like me, who wouldn’t be able to understand the equations. (Sometimes I browse math articles in Wikipedia simply to immerse myself in their majestic incomprehensibility, like visiting a foreign planet.)

Such books don’t teach physical truths; what they teach is that physical truth is knowable in principle, because physicists know it. Ironically, this means that a layperson in science is in basically the same position as a layperson in religion.

Adam Kirsch, ‘The Ontology of Pop Physics’, Tablet Magazine, 2020

But by offering these reasons, I don’t intend to over-qualify science communication – i.e. claim that, given enough time and/or other resources, a suitably skilled science communicator will be able to produce a non-mathematical description of, say, quantum superposition that is comprehensible, exact and complete. Instead, it may be useful for communicators to acknowledge that there is an immutable gap between common English (the language of modern science) and mathematics, beyond which scientific expertise is unavoidable – in much the same way communicators must insist that the farther the expert strays into the realm of communication, the closer they’re bound to get to a boundary beyond which they must defer to the communicator.

Homo medicatis

With Covishield in my body, I feel like there is a capillary tube erupting from the Ministry of Health and Family Welfare, and its panoply of attendant bodies vis-à-vis India’s COVID-19 response, soaring across the length of India and plunging into my veins, somewhere in Bangalore. And with every tug away from the compulsions of public healthcare and towards petty politics, the needle tugs at me in turn, its point dragging through my flesh, the blunt cylinder of its form cutting through my skin. I feel a bloodless injury on my body inflicted by an apathetic actor hundreds of leagues distant, and utterly powerless for it. Can you imagine the assault of such a foe? There’s the simple brutality of its strength and then there’s the ignominy of being told that your wounds are accidental, that you deserved neither the attention of your alleged assailant nor the consideration that everyone else has reserved for designated survivors. There is even pain but I cannot hear its wail clearly; it seems to originate from somewhere deep within me, so deep I can only hear its fading screams for help. I am doused in a sourceless, timeless numbness – the site of a revolution that is both ongoing and dead. I am the foregone conclusion of the state’s subjection, the fixed destination – one of many millions, of course – of whatever vaccines, drugs, therapies and philosophies it is determined to wreak; I am simultaneously the constant source of its strength. Imagine a god sustained by the faith of the dying-but-never-dead; does it take not their submission or prayers but their persistence in the face of diseases it will unleash for granted? When it increased the dose gap for Covishield from four to fix, then eight, then twelve and finally to sixteen weeks, the needle tore and tore and tore. Every change was a humiliating reminder of the control the state has grown to exert on me, on the fundamental biochemical defences millennia of evolution has instilled in my body, your body, our bodies. It is unacceptable at this point to insist that one dose of Covishield later, we are X% protected against mild disease and Y% against disease-requiring-hospitalisation by the delta variant. The variant has little to do with why I am reluctant to catch a flight to Delhi, where I long to be, or why the first thought when I wake in the morning is to wonder which member of my extended family has become the latest to succumb this year. Why, even before the vaccine, I was rendered mad ahead of choosing between Covaxin and Covishield. There was, and still is, no data in support of one and the other was, and still is, triggering terrifying – yet rare – blood-related consequences in some people, and both sat poorly with my knowledge of my own illnesses. And this was just me, a person aware of and able to navigate this swamp of nefarious possibilities; what of those who knew less, or knew but could do little to ensure the best outcomes for themselves? Would they be the triply ignominious, the triply neglected? Such foul and abject degradation. I have friends and family who expect to hear from me answers to their questions about how the vaccines work, what the new variants of concern are, and what they themselves ought and ought not to do. But even as I prepare, I become keenly aware of being conscripted to the state’s myth-machine – with the first utterance of “don’t worry” to fall in line with the other GI Joes. But only one misstep and the state waits, on the other side of the road, with irons at the ready to accuse us of lying, or of course seceding. And so the path ahead, the path of a free and unfettered citizen, becomes narrower and narrower, until we are all just needles in veins.

What is more, his entire existence is reduced to a bare life stripped of every right by virtue of the fact that anyone can kill him without committing homicide; he can save himself only in perpetual flight or a foreign land.

Homo Sacer: Sovereign Power and Bare Life (1995), Giorgio Agamben