Tag: Central Drug Standards Control Organisation

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.

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?”