Tag: phase 3 clinical trials

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: A world-building exercise

First, there was light news of a vaccine against COVID-19 nearing the end of its phase 3 clinical trials with very promising results, accompanied with breezy speculations (often tied to the stock prices of a certain drug-maker) about how it’s going to end the pandemic in six months.

An Indian disease-transmission modeller – of the sort who often purport to be value-free ‘quants’ interested in solving mathematical puzzles that don’t impinge on the real world – reads about the vaccine and begins to tweak his models accordingly. Soon, he has a projection that shines bright in the dense gloom of bad news.

One day, as the world is surely hurtling towards a functional vaccine, it becomes known that some of the world’s richest countries – representing an eighth of the planet’s human population – have secreted more than half of the world’s supply of the vaccine.

Then, a poll finds that over half of all Americans wouldn’t trust a COVID-19 vaccine when it becomes available. The poll hasn’t been conducted in other countries.

A glut of companies around the world have invested heavily in various COVID-19 vaccine candidates, even as the latter are yet to complete phase 3 clinical trials. Should a candidate not clear its trial, a corresponding company could lose its investment without insurance or some form of underwriting by the corresponding government.

Taken together, these scenarios portend a significant delay between a vaccine successfully completing its clinical trials and becoming available to the population, and another delay between general availability and adoption.

The press glosses over these offsets, developing among its readers a distorted impression of the pandemic’s progression – an awkward blend of two images, really: one in which the richer countries are rapidly approaching herd immunity while, in the other, there is a shortage of vaccines.

Sooner or later, a right-wing commentator notices there is a commensurately increasing risk of these poorer countries ‘re-exporting’ the virus around the world. Politicians hear him and further stigmatise these countries, and build support for xenophobic and/or supremacist policies.

Meanwhile, the modeller notices the delays as well. When he revises his model, he finds that as governments relax lockdowns and reopen airports for international travel, differences in screening procedures in different countries could allow the case load to rise and fall around the world in waves – in effect ensuring the pandemic will take longer to end.

His new paper isn’t taken very seriously. It’s near the end of the pandemic, everyone has been told, and he’s being a buzzkill. (It’s also a preprint, and that, a senior scientist in government nearing his retirement remarks, “is all you need to know”.) Distrust of his results morphs slowly into a distrust towards scientists’ predictions, and becomes ground to dismiss most discomfiting findings.

The vaccine is finally available in middle- and low-income countries. But in India, this bigger picture plays out at smaller scales, like a fractal. Neither the modeller nor the head of state included the social realities of Indian society in their plans – but no one noticed because both had conducted science by press release.

As they scratch their heads, they also swat away at people at the outer limits of the country’s caste and class groups clutching at them in desperation. A migrant worker walks past unnoticed. One of them wonders if he needs to privatise healthcare more. The other is examining his paper for arithmetic mistakes.