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”.