I received from a friend a PDF which happened to be Glenmark's press release about Favipiravir. The release is full of claims that make it sound like Favipiravir is a wonder drug that is going to solve COVID problems. It becomes my responsibility to refute some of these claims, considering how majority media outlets are doing what they're best at - exaggerating an already exaggerated PR claim.
Firstly, we have to verify the claim whether India's drug controller did approve the drug. The way to do that is visit CDSCO's website and navigate to approvals -> new drugs. And as per that, "Favipiravir bulk and Favipiravir film coated tablet 200mg" did in fact receive approval on 19th of June for "the treatment of patients with mild to moderate Covid-19 disease" as the 18th entry.
I do not think CDSCO publishes details of the approval process, about what evidence they considered for approval, etc. Making these processes transparent would be useful for avoiding putting people in great danger.
The deceptions start from the title itself. "Glenmark becomes the first pharmaceutical company in India [..] blah blah blah [..] COVID" - what does it mean to say "first pharmaceutical company in India in this context? They just want it to sound like this is the first drug for COVID.
They then start with a bullet point about accelerated approval process which makes it sound like it was CDSCO who wanted the approval to be accelerated so that the "benefit" of Favipiravir can reach everyone. I doubt that's what really happened.
They then talk about "responsible medication use" and informed consent. The reality is that this informed consent is necessary because there is no way to know if Favipiravir is really useful in COVID. According to the Telegraph article, the approval was based on a trial on 150 patients. (The CDSCO website does list approval for a Favipiravir trial in May, although this was given to Cipla. Interestingly, the CDSCO website seems to be missing details of any approvals given in April (and Glenmark received approval in late April, as per them))
In that last pdf they do share the details of the clinical trial. They say they would enroll exactly 150 patients and give Favipiravir to half of them. 75 people!
Now, next in their bullet point they come up with the ridiculous and unsupported claim that Favipiravir shows clinical improvements of 88% and rapid reduction in viral load. In the text, they do add a citation which points to this PDF report of an observational study done in Japan. This was an observational study with no control arm or anything to compare with. The report itself states this:
It should be noted, however, that this study only captures patients who received favipiravir, which precludes direct comparison of the clinical course with those who did not receive the agent. Given that over 80% of COVID-19 patients have mild disease which often improves by supportive therapy6), caution is required in interpreting efficacy of favipiravir based on the data presented here
And this is what is cited to support the ridiculous claim in the PR.
I'm not going to go ahead and waste my time talking about each point made in the PDF.
But the fact is that saying Favipiravir is useful for treating COVID is as correct as this claim by Patanjali:
#WATCH We appointed a team of scientists after #COVID19 outbreak. Firstly, simulation was done&compounds were identified which can fight the virus. Then, we conducted clinical case study on many positive patients&we've got 100% favourable results: Acharya Balkrishna,CEO Patanjali pic.twitter.com/3kiZB6Nk2o
— ANI (@ANI) June 13, 2020
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Conflict of interest disclosure: I have 2 shares in Natco pharma worth about 1000 rupees the last time I checked.
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