Primary outcomes of the phase 3 trial of the just approved drug, 2-DG. What's the point of CTRI if investigators report primary outcomes like this? This doesn't mean anything!!!
How exactly is CTRI accepting such nonsensical descriptions of primary outcomes?
So, even if the investigators began with 50 possible outcomes, waited to see which ones the drug impacted at the end of trial, and then cherry picked them to claim efficacy, nobody would ever know 👏👏

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More from @PriyankaPulla

8 May
Why is the world's most vaccinated nation seeing a surge bloomberg.com/news/articles/… (59% of the vaccinations in Seychelles were the poorly characterised Sinopharm vaccine, which has not published Phase 3 data yet)
I suspect that those who are confidently saying today that all approved vaccines across the world are the same will regret it at some point in future (it's an argument of expedience, just like the argument, a year ago, that everyone doesn't need masks)
My point is not that a vaccine with a lower efficacy estimate in a clinical trial is worse than one with a higher estimate(these estimates aren't comparable across trials). My argument is that poorly characterised vaccine is an unfair gamble to subject individuals/populations to.
Read 4 tweets
30 Apr
Good piece, although Mr Joshi has done worse than claiming we are the best. Including pushing favipiravir and Itolizumab, despite conflicts of interest.
While being an advisor to Biocon, he was also on Mumbai's Covid task force, which continues to prescribe Itolizumab.
How does one appear in a company's press conference for the launch of a drug, claim it is wonderful, and then also be a part of a state task force that prescribes the drug? Same applies to another noted pulmonologist.
Read 4 tweets
28 Apr
Someone I don't know from Adam wrote this email to Anvisa, demanding to know why they approved Sinovac, and not Sputnik/Covaxin, and marked me on it.
Naturally, I wasn't marked on any letter to CDSCO, demanding to know why Anvisa was saying what it is.
More from the genius. Pay particular attention to the part about how "most Indian companies probably don't follow GMP" and how Indian GMP is different from Western GMP 😂
Read 4 tweets
26 Apr
It seems like some of the unused doses of the AZ vaccine in USA were made in the Emergent Biosolutions plant, which was later found to have mixed up ingredients between AZ and J&J vaccine nytimes.com/2021/03/11/us/…
In discussions to import these doses, India must make sure that these doses were untouched by the significant manufacturing problems.
Read 4 tweets
16 Apr
Kinetics of inactivation and validation of proof of inactivation happen at multiple stages - during development and while scaling to manufacture. The jump in scale from development to manufacture is huge, and the whole process *must* be repeated
Simple example: The kinetics of inactivation that Jonas Salk plotted while developing the vaccine didn't work when it was scaled to manufacture. *A lot changes* during large scale production, including methods of inactivation. Repeated validation is *required*
So, *no*. The kinetics of inactivation you see in the Cell paper cannot be extrapolated to commercial manufacturing. And yes, I did see that paper.
Read 4 tweets
16 Apr
[New story] Two weeks ago, the Brazilian regulator Anvisa published a report listing a number of quality control problems with Covaxin, including that the company hadn't "validated the method to prove complete inactivation of the virus". thequint.com/coronavirus/ex…
The report looked pretty serious at first look. And yet, some commentators said the Anvisa's complaints were just a "bureaucratic" issue, or "just a documentation problem".
I spoke to Good Manufacturing Practices experts (people who routinely see such reports) to understand exactly what each term in the Anvisa report meant.
Read 5 tweets

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