The problems with one-shot Covishield

NDTV quoted unnamed sources in the Indian government saying it will be conducting a study to assess the feasibility of deploying the Covishield vaccine in a single-dose regimen instead of continuing the extant double-dose regimen.

At any other time, such a statement may have been sufficient to believe the government would organise and conduct a well-designed trial, publicise the findings and revise policy (or not) to stay in line with the findings, informed by socio-economic considerations. But the last 15 months have thrown up enough incidents of public-health malpractice on the state’s part to make such hope outright stupid. I’m fairly certain, especially if the vaccine shortage persists and the outbreaks on an upward trajectory in some parts of the country at the moment aren’t tamped down quickly, that the government is going to conduct a trial, not publish its methods and findings and push through a policy to deploy Covishield as a single-dose shot.

Of course I would be happy to be proven wrong – but in the event that I’m not, I’m already filled with a mix of sadness and fury. The government seems set on finding new ways to play with our lives.

News that the government is going to conduct a feasibility study broke to the accompaniment of a suggestion, by NDTV’s same unnamed sources, that Covishield was originally intended as a single-dose vaccine and that it was later found to be better as a two-dose vaccine. This is ridiculous to begin with, considering Covishield’s phase 3 trials around the world, conducted by AstraZeneca and the University of Oxford, tested the two-dose regimen.

But it is rendered more ridiculous because Public Health England (PHE) reported just a week ago that two doses of Covishield are necessary for a recipient to be sufficiently protected against infections by the B.1.617.2 variant. The PHE study found that one dose of Covishield had an efficacy of 33% against symptomatic COVID-19 caused by the variant, increasing to 60% after both doses. Has the Indian government forgotten that B.1.617.2 is becoming the more common variant circulating in the country? Or is laundering the national party’s image more important than the safety of hundreds of millions? (The latter is entirely plausible: in the last seven years, the country has seldom been larger than the supreme leader’s ego.)

The PHE study isn’t without its shortcomings – but I’d be more inclined to pay attention to them at this moment if:

  1. I didn’t have to contend with the non-trivial possibility that the Indian government will bury, obfuscate and/or twist the data arising from its assessment, and therefore we (the public) need to bank on whatever else is available;
  2. I didn’t have to contend with the fact that data from Covaxin’s phase 3 trial (which apparently went past its final interim-analysis endpoint in April) and Covishield’s bridging trial (which IIRC concluded on March 24) are still missing from the public domain;
  3. If we could access large-scale effectiveness data of the two vaccines (the National Institute of Epidemiology, Chennai, is set to begin collecting such data this week); and
  4. If there was any other reliable data at the moment about the two vaccines vis-à-vis the different variants circulating in India.

There is another problem. If Covishield is administered as a single-dose vaccine, its efficacy against symptomatic COVID-19 caused by B.1.617.2 viral particles is 33% – which is below the WHO’s recommended efficacy threshold of 50% for these vaccines. If the Indian government formalises the ‘Covishield will be one dose’ policy and if the B.1.617.2 variant continues its conquest, will the vaccine, as it is used in India, lose its place on the WHO’s vaccine list? And what of the consequences that will follow, including other countries becoming reluctant to admit Indians who received one dose of Covishield and one dose of the BJP’s way of doing things?

I would be wary, too. The longer the particles of the novel coronavirus are able to circulate within a population, the more opportunities they will have to mutate, and the more mutations they will accumulate. So any population that allows the virus to persist for longer automatically increases the chance of engendering potentially deadlier variants within its borders. One-dose Covishield plus B.1.617.2, and other variants, will set just such a stage – compounded by the fact that Serum Institute, which makes Covishield, has a much larger production capacity than Bharat Biotech, the maker of Covaxin.

(The PHE study also found that Covishield and the Pfizer-BioNTech vaccine had an efficacy of “around 50%” against symptomatic COVID-19 caused by an infection of the B.1.1.7 variant.)

In fact, the government could have made more sense today by saying it would prioritise the delivery of the first dose to as many people as possible before helping people get the second one. This way the policy would be in line with the most recent scientific findings, be synonymous with a single-dose campaign and keep the door open to vaccinating people with both doses in a longer span of time (instead of closing that door entirely), while admitting that the vaccine shortage is real and crippling – something most of us know anyway. But no; Vishwaguru first.

Exporting risk

I’m torn between admitting that our cynicism about scientists’ solutions for the pandemic is warranted and the palliative effects of reading this Reuters report about seemingly nothing more than the benevolence of richer nations not wasting their vaccine doses:

Apart from all the other transgressions – rather business as usual practices – that have transpired thus far, this is one more testimony to all those instances of insisting “we’re all in this together” being just platitudes uttered to move things along. And if it weren’t enough already that poorer nations must make do with the leftovers of their richer counterparts that ordered not as many doses as they needed but as many as would reassure their egos (a form of pseudoscience not new to the western world), the doses they’re going to give away have been rejected for fear of leading to rare but life-threatening blood clots. To end the pandemic, what kills you can be given away?

COVID-19, due process and an SNR problem

At a press conference streamed live on March 18, the head of the European Medicines Agency (EMA) announced that the body – which serves as the European Union’s drug and vaccine regulator – had concluded that the AstraZeneca COVID-19 vaccine was not associated with unusual blood clots that some vaccine recipients had reported in multiple countries. The pronouncement marked yet another twist in the roller-coaster ride the embattled shot has experienced over the past few months. But it has also left bioethicists debating how it is that governments should respond to a perceived crisis over vaccines during a pandemic.

Over the last two weeks or so, a fierce debate raged after a relatively small subset of people who had received doses complained of developing blood clots related to potentially life-threatening conditions. AstraZeneca, a British-Swedish company, didn’t respond to the concerns at first even though the EMA and the WHO continued to hold their ground: that the vaccine’s benefits outweighed its risks, so people should continue to take it. However, a string of national governments, including those of Germany, France and Spain, responded by pausing its rollout while scientists assessed the risks of receiving the vaccine.

Aside from allegations that AstraZeneca tried to dress up a significant mistake during its clinical trials of the vaccine as a ‘discovery’ and cherry-picked data from the trials to have the shot approved in different countries, the company has also been grappling with the fact that the shot was less efficacious than is ideal against infections by new, more contagious variants of the novel coronavirus.

But at the same time, the AstraZeneca vaccine is also one of the more affordable ones that scientists around the world have developed to quell the COVID-19 pandemic – more so than the Pfizer and Moderna mRNA vaccines. AstraZeneca’s candidate is also easier to store and transport, and is therefore in high demand in developing and under-developed nations around the world. Its doses are being manufactured by two companies, in India and South Korea, although geographically asymmetric demand has forced an accelerating vaccination drive in one country to come at the cost of deceleration in another.

Shot in the arm

Now that the EMA has reached its verdict, most of the 20 countries who had hit the pause button have announced that they will resume use of the vaccine. However, the incident has spotlighted a not-unlikely problem with the global vaccination campaign, and which could recur if scientists, ethicists, medical workers and government officials don’t get together to decide where they can draw the line between abundant precaution and harm.

In fact, there are two versions of this problem: one in countries that have a functional surveillance system that responds to adverse events following immunisation (AEFIs) and one in countries that don’t. An example of the former is Germany, which, according to the New York Times, decided to pause the rollout based on seven reports of rare blood clots from a pool of 1.6 million recipients – a naïve incidence rate of 0.0004375%. But as rare disorders go, this isn’t a negligible figure.

One component of the post-AEFI response protocol is causality assessment, and one part of this is for experts to check if certain purported side-effects are clustered in time and then to compare those to the illness’s time distribution for a long time before the pandemic. It’s possible that such clustering could have prompted health officials in Germany and other countries to suspend the rollout.

The Times quoted a German health ministry statement saying, “The state provides the vaccine and therefore has special duties of care”. These care considerations include what the ministry understands to be the purpose of the rollout (to reduce deaths? To keep as many people healthy as possible?) read together with the fact that vaccines are like drugs except in one important way: they’re given to healthy – and not to sick – people. To quote Stephan Lewandowsky, an expert of risk communication at the University of Bristol, from Science:

“You’ve got to keep the public on board. And if the public is risk-averse, as it is in Europe … it may have been the right decision to stop, examine this carefully and then say, ‘The evidence, when considered transnationally, clearly indicates it is safe to go forward.’”

On the other hand is the simpler and opposing calculus of how many people didn’t develop blood clots after taking the vaccine, how many more people the virus is likely to have infected in the time the state withheld the vaccine, how many of them were at greater risk of developing complications due to COVID-19 – topped off by the fact of the vaccines being voluntary. On this side of the argument, the state’s carefulness is smothering, considering it’s using a top-down policy without accounting for local realities or the state’s citizens’ freedom to access or refuse the vaccine during a pandemic.

Ultimately there appears to be no one right answer, at least in a country where there’s a baseline level of trust that the decision-making process included a post-vaccination surveillance system that’s doing its job. Experts have also said governments should consider ‘mixed responses’ – like continuing rollouts while also continuing to examine the vaccines, given the possibility that a short-term review may have missed something a longer term exercise could find. One group of exerts in India has even offered a potential explanation.

The background rate

In countries where such a system doesn’t exist, or does but is broken, like India, there is actually one clear answer: to be transparent and accountable instead of opaque and intractable. For example, N.K. Arora, a member of India’s National COVID-19 Task Force, told The Hindu recently that while the body would consider post-vaccination data of AstraZeneca’s vaccine, it also believed the fraction of worrying cases to be “very, very low”. Herein lies the rub: how does it know?

As of early March, according to Arora, the Union health ministry had recorded “50-60” cases of AEFIs that may or may not be related to receiving either of the two vaccines in India’s drive, Covaxin and Covishield. (The latter is the name of AstraZeneca’s shot in India.) Reading this with Arora’s statements and some other facts of the case, four issues become pertinent.

First is the deceptively simple problem of the background rate. Journalist Priyanka Pulla’s tweets prompt multiple immediate concerns on this front. If India had reported 10 cases of disease X in 20 years, but 10 more cases show up within two weeks after receiving one dose of a vaccine, should we assume the vaccine caused them? No – but it’s a signal that we should check for the existence of a causal link.

Experts will need to answer a variety of questions here: How many people have disease X in India? How many people of a certain age-group and gender have disease X? How many people of different religious and/or ethnic groups have disease X? How many cases of disease X are we likely to have missed (considering disease-underreporting is a hallmark of Indian healthcare)? How many cases of disease X should we expect to find in the population being vaccinated in the absence of a vaccine? Do the 10 new cases, or any subset of them, have a common but invisible cause unrelated to the vaccine? Do we have the data for all these considerations?

Cornelia Betsch, a psychologist at the University of Erfurt, told Science that “most of the cases of rare blood disorders were among young women, the group where vaccine hesitancy already runs highest”. Can India confirm or deny that this trend is reflected in its domestic data as well? This seems doubtful. Sarah Iqbal reported for The Wire Science in September 2020 that “unequal access to health”, unequal exposure to potentially disease-causing situations, unequal representation in healthcare data and unequal understanding of diseases in non-cis-male bodies together already render statements like ‘women have better resistance to COVID-19’ ignorant at best. Being able to reliably determine and tackle sex-wise vaccine hesitancy seems like a tall order.

The second issue is easy to capture in one question, which also makes it harder to ignore: why hasn’t the government released reports or data about AEFIs in India’s COVID-19 vaccination drive after February 26, 2021?

On March 16, a group of 29 experts from around the country – including virologist T. Jacob John, who has worked with the Indian Council of Medical Research on seroprevalence surveys and has said skeptics of the Indian drug regulator’s Covaxin approval were “prejudiced against Indian science/product” – wrote to government officials asking for AEFI data. They said in their letter:

We note with concern that critical updates to the fact sheets recommended by the CDSCO’s Subject Expert Committee have not been issued, even though they are meant to provide additional guidance and clarify use of the vaccines in persons such as those with allergies, who are immunocompromised or using immunosuppressants, or using blood thinners/anticoagulants. There are gaps in AEFI investigations at the local level, affecting the quality of evidence submitted to State and National AEFI Committees who depend on these findings for making causality assessments. The National AEFI Committee also has a critical role in assessing cases that present as a cluster and to explore potential common pathways. In our letter dated January 31, 2021, we asked for details of all investigations into deaths and other serious AEFIs, as well as the minutes of AEFI monitoring committees, and details of all AEFI committee members and other experts overseeing the vaccine rollout. We have not received any response.

City of Omelas

The third issue is India’s compliance with AEFI protocols – which, when read together with Pulla’s investigation of Bharat Biotech’s response to a severe adverse event in its phase 3 trials for Covaxin, doesn’t inspire much confidence. For example, media reports suggest that medical workers around the country aren’t treating all post-vaccination complaints of ill-health, but especially deaths, on equal footing. “Currently, we are observing gaps in how serious adverse events are being investigated at the district level,” New Delhi-based health activist Malini Aisola told IndiaSpend on March 9. “In many instances local authorities have been quick to make public statements that there is no link to the vaccine, even before investigations and post mortem have taken place. In some cases there is a post mortem, in some cases there isn’t.”

Some news reports of people having died of heart-related issues at a point of time after taking Covishield also include quotes from doctors saying the victims were known to have heart ailments – as if to say their deaths were not related to the vaccine.

But in the early days of India’s COVID-19 epidemic, experts told The Wire that even when people with comorbidities, like impaired kidney function, died due to renal failure and tested positive for COVID-19 at the time of death, their passing could be excluded from the official deaths tally only if experts had made sure the two conditions were unrelated – and this is difficult. Having a life-threatening illness doesn’t automatically make it the cause of death, especially since COVID-19 is also known to affect or exacerbate some existing ailments, and vice versa.

Similarly, today, is the National AEFI Committee for the COVID-19 vaccination drive writing off deaths as being unrelated to the vaccine or are they being considered to be potential AEFIs? And is the committee deliberating on these possibilities before making a decision? The body needs to be transparent on this front a.s.a.p. – especially since the government has been gifting AstraZeneca’s shots to other countries and there’s a real possibility of it suppressing information about potential problems with the vaccine to secure its “can do no wrong” position.

Finally, there’s the ‘trolley problem’, as the Times also reported – an ethical dilemma that applies in India as well as other countries: if you do nothing, three people will get hit by a train and die; if you pull a lever, the train will switch tracks and kill one person. What do you do?

But in India specifically, this dilemma is modified by the fact that due process is missing; this changes the problem to one that finds better, more evocative expression in Ursula K. Le Guin’s short story The Ones Who Walk Away from Omelas (1973). Omelas is a fictitious place, like paradise on Earth, where everyone is happy and content. But by some magic, this is only possible if the city can keep a child absolutely miserable, wretched, with no hope of a better life whatsoever. The story ends by contemplating the fate of those who discover the city’s gory secret and decide to leave.

The child in distress is someone – even just one person – who has reported an AEFI that could be related to the vaccine they took. When due process plays truant, when a twisted magic that promises bliss in return for ignorance takes shape, would you walk away from Omelas? And can you freely blame those who hesitate about staying back? Because this is how vaccine hesitancy takes root.

The Wire
March 20, 2021

Magic bridges

The last two episodes of the second season of House, the TV series starring Hugh Laurie as a misanthropic doctor at a facility in Princeton, have been playing on my mind off and on during the COVID-19 pandemic. One of its principal points (insofar as Dr Gregory House can admit points to the story of his life) is that it’s ridiculous to expect the families of patients to make informed decisions about whether to sign off on a life-threatening surgical procedure, say, within a few hours when in fact medical workers might struggle to make those choices even after many years of specific training.

The line struck me to be a chasm stretching between two points on the healthcare landscape – so wide as to be insurmountable by anything except magic, in the form of decisions that can never be grounded entirely in logic and reason. Families of very sick patients are frequently able to conjure a bridge out of thin with the power of hope alone, or – more often – desperation. As such, we all understand that these ‘free and informed consent’ forms exist to protect care-providers against litigation as well as, by the same token, to allow them to freely exercise their technical judgments – somewhat like how it’s impossible to physically denote an imaginary number (√-1) while still understanding why they must exist. For completeness.

Sometimes, it’s also interesting to ask if anything meaningful could get done without these bridges, especially since they’re fairly common in the real world and people often tend to overlook them.

I’ve had reason to think of these two House episodes because one of the dominant narratives of the COVID-19 pandemic has been one of uncertainty. The novel coronavirus is, as the name suggests, a new creature – something that evolved in the relatively recent past and assailed the human species before the latter had time to understand its features using techniques and theories honed over centuries. This in turn predicated a cascade of uncertainties as far as knowledge of the virus was concerned: scientists knew something, but not everything, about the virus; science journalists and policymakers knew a subset of that; and untrained people at large (“the masses”) knew a subset of that.

But even though more than a year has passed since the virus first infected humans, the forces of human geography, technology, politics, culture and society have together ensured not everyone knows what there is currently to know about the virus, even as the virus’s interactions with these forces in different contexts continues to birth even more information, more knowledge, by the day. As a result, when an arbitrary person in an arbitrary city in India has to decide whether they’d rather be inoculated with Covaxin or Covishield, they – and in fact the journalists tasked with informing them – are confronted by an unlikely, if also conceptual, problem: to make a rational choice where one is simply and technically impossible.

How then do they and we make these choices? We erect magic bridges. We think we know more than we really do, so even as the bridge we walk on is made of nothing, our belief in its existence holds it up and stiff beneath our feet. This isn’t as bad as I’m making it seem; it seems like the human thing to do. In fact, I think we should be clearer about the terms on which we make these decisions so that we can improve on them and make them better.

For example, all frontline workers who received Covaxin in the first phase of India’s vaccination drive had to read and sign off on an ‘informed consent’ form that included potential side effects of receiving a dose of the vaccine, its basic mechanism of action and how it was developed. These documents tread a fine line between being informative and being useful (in the specific sense of the risk of debilitating action by informing too much and of withholding important information in order to skip to seemingly useful ‘advice’): they don’t tell you everything they can about the vaccine, nor can they assert the decision you should make.

In this context, and assuming the potential recipient of the vaccine doesn’t have the education or training to understand how exactly vaccines work, a magic bridge is almost inevitable. So in this context, the recipient could be better served by a bridge erected on the right priorities and principles, instead of willy-nilly and sans thought for medium- or long-term consequences.

There’s perhaps an instructive analogy here with software programming, in the form of the concept of anti-patterns. An anti-pattern is a counterproductive solution to a recurrent problem. Say you’ve written some code that generates a webpage every time a user selects a number from a list of numbers. The algorithm is dynamic: the script takes the user-provided input, performs a series of calculations on it and based on the results produces the final output. However, you notice that your code has a mistake due to which one particular element on the final webpage is always 10 pixels to the left of where it should be. Being unable to identify the problem, you take the easy way out: you add a line right at the end of the script to shift that element 10 pixels to the right, once it has been rendered.

This is a primitive example of an anti-pattern, an action that can’t be determined by the principles governing the overall system and which exists nonetheless because you put it there. Andrew Koenig introduced the concept in 1995 to identify software programs that are unreliable in some way, and which could be made reliable by ensuring the program conforms to some known principles. Magic bridges are currently such objects, whose existence we deny often because we think they’re non-magical. However, they shouldn’t have to be anti-patterns so much as precursors of a hitherto unknown design en route to completeness.

What the DNA Bill needs

The following article has been published in The Wire, but since it began as a blog post and because I haven’t published anything else in a while, I’m using it here as well.

The Parliamentary Standing Committee on S&T, Forests and Climate Change has submitted its review on the DNA Technology (Use and Application) Regulation Bill 2019 to parliament. On page 9, the report considers the lack of “academic work” on the use of “scientific evidence” in Indian courts and writes:

The Committee, therefore, underlines with utmost importance that it is essential the Bill enables the creation of an ecosystem that benefits from scientific evidence like DNA, therefore allowing the legal system to become experienced in the use and appreciation of DNA evidence. This will enable the legal system to understand the technology’s limitations, identify when it is appropriate to use DNA technology to solve crimes appropriate and over time, substantially minimise all possible errors. Widespread and extensive training is of paramount importance.

These are sage words – but the “creation of an ecosystem that benefits from scientific evidence” requires one more thing that the committee’s report doesn’t mention: humility, of sorts.

At the outset, any ecosystem that upholds the dignity of both science and the law must also accommodate conditions in which scientists can develop a deeper understanding, free of any interference, of the instruments and methods underlying evidence. They must be free to speak up as often as they’re required to do so in the public domain, and, finally, be heard instead of silenced. In addition, given the revolutionary nature of DNA profiling vis-à-vis forensic science, and its vaunted feature of being accurate 99.x% of the time, it takes a certain humility to be able to identify the exceptional instances before it is too late.

The COVID-19 pandemic has taught us many things, including the fact that even when the government is confronted with good science, it will not tolerate disagreement, and dissent even less. In the past 10 months, a small clutch of scientists and other experts have repeatedly spoken up against government mistakes and deceptions while the wider community of experts has stayed noticeably quiet. In turn, the government has pushed back against comments from senior, well-regarded scientists by attacking their credentials instead of their arguments, orchestrating signature campaigns against them and, in one case, going so far as to dismiss legitimate questions because the scientist in question had disagreed with the government’s Citizenship (Amendment) Act 2019.

In addition, no court’s judgment is pronounced in a vacuum. Even if scientists are called to consult on a case, to advise a judge or weigh in for a report, the context in which the scientist discusses a problem, the information that has been shared with them as well as the information based on which they supply their own wisdom matters – especially if the defendant faces many years of imprisonment or the death penalty.

For example, it used to be that investigators could check for the presence of seminal fluid in a given sample; if it was present, the court could conclude the fluid came from the suspect. Today, investigators can – and thus need to – extract Y chromosomes from the seminal fluid, ascertain a match with the suspect, and submit it in court with the caveat that the fluid could have come from the suspect, his father or his grandfather, etc.

But one forensic scientist in the US told The Wire that investigators often skip the seminal-fluid check and jump to a DNA analysis to cut time. This could be a problem if the suspect has aspermia: a condition in which a person’s semen doesn’t have sperm. In such cases, an investigator running a DNA test on some semen will get no results – i.e. a false negative.

More broadly, she continued, there are two new problems today, among others: of analysts exaggerating their results in court, and of investigators overestimating what DNA analysis can tell us. For example, she said, microscopic analysis of hair used to be the norm but today DNA analysis has taken its place. However, only hair root contains nuclear DNA, which can help identify specific people. The rest of the hair contains mitochondrial DNA, which can only say if it came from the suspect, their mother or her grandmother, etc. (even if the suspect is male).

In addition, studying the DNA can’t tell us if the hair has been damaged in a particular way. That information can come only from microscopic analysis – which investigators have been neglecting.

“It’s not the science that’s flawed. It’s the people that claim to be scientists who are often the problem,” the scientist said. “Many investigators in the US have no more than a high-school diploma – but unless they go through rigorous training at the UG level in science, they may not even understand hypothesis testing” to eliminate biases.

So deliberation and accountability are paramount. Transparency will help but simply sharing information may not help so much when complex technical information is involved. Independent experts will need data, and independence itself. And observers such as politicians and policymakers will need to pay close attention to debates between scientists – and listen to them.

In turn, the people at large must be sufficiently informed to understand a verdict and question it if necessary. A topical example where public mobilisation matters is that of air pollution in North India. The Supreme Court of India has on more than one occasion asked the Delhi government why it isn’t installing more smog towers in the city. But as multiple experts have written, smog towers are useless, a waste of money and only perpetuate a fetish with technological solutions that are not designed to solve what remains a deeply regulatory problem.

Finally, an honest appreciation of scientific evidence requires one to admit that one may not know something in the first place, instead of bristling at presumed accusations of ignorance or even impudence, as more than a few members of the judicial system have done of late. Science in particular requires its exponents to begin by acknowledging that they may not know something, and to graduate from this position to learning about it while constantly eliminating biases along the way.

A direct consequence of this process is a heightened appreciation for what science can’t tell us. Until the Supreme Court banned the practice in 2013, for example, officials in India had deemed the two-finger test to be a ‘scientific’ check of whether a victim of rape had been “habituated to sex”, based on digitally probing the laxity of the victim’s vaginal muscles. But the test has nothing to do with science, of course, let alone the possibility of rape having been committed. Instead, it’s rooted in the cultural idea that only those women who don’t have sexual intercourse until after marriage are of ‘good character’ and can therefore be violated at all.

Humility offers a way to negotiate all of these issues – if it existed. India, especially the Government of India, currently has a ‘jagatguru’ complex, presuming to know everything worth knowing before anyone else, thanks to the mythological feats of Hindus who lived here thousands of years ago. This attitude is deeply antithetical to the humility required in a given moment to consider the evidence, set aside any other claims, and determine – in a necessarily limited amount of time – if one is addressing the 99.8% or the 0.2%.

Many experts have previously written that DNA data alone shouldn’t be used to open or close cases, and that it is at best complementary in nature. If followed, this precept should offer a valuable safeguard against overstating the importance of genetic evidence over, say, physical evidence. Another safeguard comes from the judicial system as it is: the integrity of the various courts and their staff members, including the judges, and their daily interpretation of the law.

But having said all this, the possibility exists in India’s wider political climate for judgments to be misled by half-baked science, half-baked scientists, government interference and either public indifference or public arrogance. This is more so since the room to disagree with the government has practically vanished, and those who still disagree are threatened with disproportionate consequences.

In addition, as the forensic scientist said, the science is comfortable with its limitations; it is its practitioners that are often the problem. Just last month, nearly 50 “eminent scientists and doctors” signed a letter saying they were okay with the national drug regulator’s decision to approve two COVID-19 vaccine candidates: one had no efficacy data and the other was confused about the interdose gap. In addition to such unabashed sycophancy, bad journalism has often contributed to the impression that scientists themselves don’t know what they are doing, frequently confusing debate for rhetoric.

As the committee’s report on the DNA Bill says, “widespread and extensive training is of paramount importance.” These words are well-taken but a lot needs to change – more than whatever the Bill by itself could ever manage – for the system to appreciate and use ‘scientific evidence’ right.

Pandemic: Science > politics?

By Mukunth and Madhusudhan Raman

Former Union health secretary K. Sujatha Rao had a great piece in The Indian Express on January 14, whose takeaway she summarised in the following line:

Science, evidence and data analytics need to be the bedrock of the roll-out policy, not politics and scoring brownie points for electoral advantages.

However, we can’t help but be reminded of the difference between what should be and what will be. We all (at least those of us who have been on the same side since 2014) know what should be. But as we’ve seen with the National Registry of Citizens (NRC), the Citizenship (Amendment) Act (CAA) 2019 and most recently the farm laws, our present government doesn’t change its mind.

In the last example, the Supreme Court intervened to stay the laws’ implementation but the mediation committee it put together somehow wound up with most members being known to be sympathetic to the government’s position. So what will be, will be – and this is likely to be true vis-à-vis Covaxin as well.

Prime Minister Narendra Modi has already guaranteed as much by determining to foot the cost of 5.5 million doses of Covaxin using the PM CARES fund, which lies beyond public oversight. The Central Drug Standards Control Organisation also played its part by pushing through Covaxin’s approval on terms no one has heard of – and which no one can therefore falsify.

However, this isn’t a pitch for a nihilist position. When Sujatha Rao writes that the government should prize science, evidence and data more than politics and elections, she is right – but we must also ask why. The government has clear incentives to prioritise politics. By thrusting Bharat Biotech – Covaxin’s maker – to the forefront, Modi can claim his ‘Atma Nirbhar’ and ‘Make in India’ schemes have been successful. Also, two important state elections are around the corner: West Bengal and Tamil Nadu.

These are issues that people, but especially ‘Middle Indians’, have an eye on and according to which they vote. The government has also said it is approving Covaxin because it is concerned with the ‘UK variant’. While no reason can be good enough to justify the use of a vaccine candidate in the population sans data from phase 3 clinical trials, the government has effectively set up Covaxin to be failure-proof: if it works, it works; if it doesn’t, it becomes the fault of the variant.

Taken together, Modi’s biggest mistake here is criminal negligence – for pushing Covaxin in the absence of efficacy data (which leads to a cascade of ethical dilemmas) – especially since there are fewer questions over Covaxin’s safety. And negligence is a difficult case to stick to this party or in fact to many people.

Granted, public-spirited science teachers, communicators and journalists can take it upon themselves (ourselves) to persuade readers as to why Covaxin’s approval is really bad – that though everything may turn out okay, it sets a terrible precedent for what this government is allowed to do, how such unchecked power may wreak deadly havoc in future crises, and ultimately that we become a people okay with settling for less, increasingly blind to the banal incrementalism of evil.

In fact, if the mainstream press manages to forget concerns about vaccine apartheid within the country, the dominant narrative as the vaccine roll-out is a few months in is going to be: “India is doing just fine, thank you very much.”

But while the Modi government’s actions may only be negligent – albeit criminally so – in the domains of public healthcare and ‘scientific temper’, they amount to something more egregious if we include the political dimensions of our present moment as well.

None of this means words like those of Sujatha Rao are unnecessary. We need to never forget what should be, and we need to keep protesting for our own sakes. (“Protests sometimes look like failures in the short term, but much of the power of protests is in their long-term effects, on both the protesters themselves and the rest of society.” – Zeynep Tufekci) If we don’t, this government might pretend even less than it currently does that it is following some rules or guidelines from time to time.

However, limiting our exhortations to insist at every turn that “science is more important than politics during a pandemic” risks playing down the importance and influence of political motivations altogether – as well as assuming that the state machinery will automatically give way to scientific ones when lives are at stake.

A politician’s principal responsibility is not to govern but to win elections; good governance is a means to this electoral end. And the way people have voted for many decades attests to the reality of this incentive. While this claim may not be palatable from a theoretical point of view, consider it empirically: the Indian government has seldom responded to national crises to the detriment of potential electoral gains. Examples of such crises include the 1962, 1971 and 1999 conflicts, the nuclear tests and economic liberalisation. During the Emergency, the government itself embodied this crisis.

More recently, numerous ministers and diplomats urged the India and Pakistan governments to find diplomatic solutions after the Pulwama attack and also after the questionable Balakot airstrike, in early 2019. In previous years, they had been preceded by the disagreeable events of Aadhaar implementation, demonetisation and the Goods and Services Tax. But Modi and his fellows won by a bigger margin in 2019 than they had five years earlier.

This happened partly because his success in elections rests on his impression as the Strongman of India, so his resolutions of choice involve flashy displays of strength and machismo.

Against this background: we need to admit political factors into the conversations we – rather, experts like health policymakers, heads of institutions, epidemiologists, healthcare workers, etc. – have from the beginning, instead of ruing the inevitable influence of politics later, so that we may anticipate it and take advantage of it.

For example, consider the conversation surrounding academic publishing. Academics perform most of the work that goes into publishing an academic paper (research, writing and reviewing). Publishing houses add only marginal value to journals – yet publishers charge exorbitant fees to access the results of publicly funded research once it is published. This is unfair, and many academics have said so.

However, the fact that publishing conglomerates are publicly traded companies whose primary responsibility is to generate profits for their shareholders finds little mention in conversations. In this case, the publishers’ profit-seeking motives are fundamental to the problem at hand – but are often disregarded in the first analysis (what should be) and subsequently bemoaned (what will be). For this to happen once is tragic; for it to repeat itself every few months is wasteful.

Similarly, the nationwide lockdown from March to July 2020 served a political purpose: it was a grand gesture, decisive, appealing to ‘Middle Indians’, in addition to supplying the government a pretext to disband protests against the CAA and the NRC. Just before the lockdown, the public conversation had been centred on what the government should be doing. However, most scientists and economists didn’t engage with the political dimension of this decision.

If we had, we may not have been side-tracked into conversations about weekend curfew versus night curfew, or cash transfers versus vouchers, etc. We would perhaps have recognised that our responsibility is not to operate within the parameters set by the government (“How effective was the lockdown?”) but instead recognise that the government’s decisions are politically motivated – so we can ask “Why lock down in the first place?”