Thread on #Favipiravir and the data on which approvals are being granted to it across the world. First used in Japan, then China, and in other countries: all on “compassionate grounds”. But does it really work? Read this paper. kansensho.or.jp/uploads/files/… details follow. 1/n
Favipiravir study in China: “primary endpoint of better clinical improvement at 7 days was not met” but still goes on to claim that fever and cough were reduced. So why that doesn’t count as clinical improvement?? Or was it just subjective opinion unsupported by data? 
These are the details of improved, unchanged or worsened cases from the study, which suffers from extremely serious flaws. No control and test group for comparison, no comparison with known rates at which improvement or deterioration occurs without medicines.
Here are some shockers on the safety front: a staggering 24.65% incidence of adverse effects, including liver damage, skin rashes and elevated uric acid levels. But there’s worse to come. It’s a teratogen: a drug known to cause serious birth abnormalities if given in pregnancy.
The research paper itself carries the disclaimer: “given that over 80% or patients have mild disease which often improves by supportive therapy, caution is required in interpreting efficacy of favipiravir based on the data presented here”. Would you still use it knowing all this?
Now let’s see the Indian study being done by Glenmark. 150 patients enrolled in this phase 3 clinical trial of which only 75 are receiving favipiravir. Here’s the kicker: the study only started last month and it’s results won’t be known till August. theprint.in/health/glenmar…
Lets examine the original study from China. What sort of numbers were involved? 40. Yes, just forty patients of which 65% tested negative after 5 days - a grand number of 26 patients. What about the Russian study? It’s being conducted on 330 patients and isn’t concluded yet.
Chinese study was also seriously flawed: the patients weren’t randomised. The researchers weren’t sure whether patients were doing better because treatments had evolved or due to the drug. 14% of patients had to discontinue it due to severe side effects. bloomberg.com/news/articles/…
The Russian study of 330 patients was launched on 21st May. Russian govt claimed it cured 90% of patients within ten days and granted approval on 1st June: just 9 days after launch of the study, which is still in progress. Was approval pre-decided?
dailymail.co.uk/news/article-8…
dailymail.co.uk/news/article-8…
