Thread by @GorwayGlobal

In one of my earliest columns in 2020 I looked critically at the 30 patient trial of Itolizumab in severe Covid-19 and found it scientifically statistically deficient. It is here: science.thewire.in/the-sciences/b…

I concluded that Op-Ed piece as follows: "The irony is that Itolizumab may well be a breakthrough. If it is and if its real effects can be shown conclusively in a large trial, then Biocon would be able to boast of an unbeatable product."

and with the last sentence: "As things stand, it is unlikely to make that breakthrough without much greater rigor in the science of clinical trials. India’s pharmaceutical industry cannot become world-class on the back of shoddy clinical trials."

The manufacturer got their emergency use approval, stareted making sales of the drug (INR 40,000 per patient) and promised to collect real world data. Even this was a bad idea I argued in this Column in @TheWireScience . science.thewire.in/the-sciences/i…

Up to this time there was no paper, not even a pre print publication. Then, when a paper did appear in @medrxivpreprint it turned out to be less than robust from the standpoint of trial reporting standards. I reviewed it here: science.thewire.in/health/itolizu…

In this Opinion piece I said, "But there was – and still remains – a decided lack of willingness on the part of big and rich pharmaceutical companies to fund proper, scientifically robust, statistically meaningful clinical trials."

Why is all this important now? Simply because a very similar drug to Itolizumab, called Tocilizumab and another, Sarilumab, both also, like #Itolizumab, IL-6 inhibitors have been tried in a large trial involving 803 patients has reported, albeit not yet peer reviewed.

You can read it here: doi.org/10.1101/2021.0…
But this was a large trial involving 353 patients treated with tocilizumab, 48 with sarilumab and 402 with placebo. The results: hospital mortality rates were respectively, 28%, 22.2% and 35.8%

As headline results these may not sound miraculous but because of the large sample size they are reliable. What is the relevance of this, now, in relation to #Itolizumab? Simply this: if @Bioconlimited was serious about its global ambitions then it let itself down.

Instead of batting off scientific criticism, and being smugly satisfied with the emergency use authorization that it won from a pliant regulator, it should have gone for the really big international, esp. the US, market. where deaths touched 4000 a day.

But to do that, it would have had to sponsor really LARGE trials and done them to a standard beyond reproach. In fact @Bioconlimited did enter into a tie-up with a US company called Equillium to do US trials and market it in that territory, a deal that fell thru on Nov 25.

The narrow point is that those of us who were critical of the rushed and premature Emergency Use license way back in July 2020 were not as some called me antinational or anti-India. Far from it. I was urging India to do better, raise the bar, set the standard not circumvent it.

#India has the expertise, staffing levels, financial muscle, clinical load. All we need is the dedication to excellence in clinical trials.