# Most recents (8)

1/n
Forget #Coronil. Forget #Itolizumab.
There is a new player in town for #coronavirus and #COVID19 treatment. Introducing #Zingivir @Pankajakasthuri made from some herbs and mercuric and arsenic sulfide to fight the #pandemic. Sounds too good. But there are issues.
2/n
They claim to have tested the product for safety in animal and cell lines. However, no data shown, only media mouthing. Half of the ingredients look like they make a good sambar chutney. But the drug manufacturer claim the following 👇#herbal #pseudoscience
3/n
In a letter 😳😳😳 the CEO of the company asks the President of India @rashtrapatibhvn to start trials and clinical studies. This was in April 2020. Now fast forward to July 2020. Let's see how things went.
Okay, here we go! Gather round!!
Ive got some simple stochastic modelling to share with y'all interested in the statistical apects of @Bioconlimited's trial of #Itolizumab. Bear with me while I put on my best Professorial air. Computer code and charts coming up, all in R.
Pay attention now, class! silence please there in the back row, yes you guys from #'BigPharma, put away your iPhones and listen.
Here is the Q. If A) the background mortality is 10% and I treat 'em all with 1 ml of pure saline. how many out of 20 wud die? Let's model this.
Look at this simple computer code in R. I am simulating what would happen in real life - stochastic modeling at its simplest. I am going to pretend I can take 10,000 samples each of size 20. and let R tell me how many in each sample will die given the background Prob(Death) = 0.1
Clinical trials :-
Research studies aimed at evaluating a surgical or medical intervention efficacy in people
Used to evaluate whether a new drug,device is safe for human use
Scientists perform lab tests 1st on animals for testing efficacy & safety before FDA approves human test
Trials proceed through 4 phases to evaluate adequate doses,side effects
If after 3 phases FDA approves a drug intervention safe ,it gives approval for clinical use

Phase 1
New experimental drug,treatment
Small group of people 20 to 80
Test for dose safety,efficacy,side effects
Phase 2
Larger group 100 to 300 people
Emphasis in phase 1 is on safety,phase 2 is on effectiveness
Evaluate whether a treatment,drug device works in a disease or medical condition
Look for safety,side effects
Last many years
Investigating the extent of acceptance worldwide of the role of @Bioconlimited's #Itolizumab in the treatment of #Psoriasis - a disease that afflicts upto 2% of the population. I conducted a search on PubMed.
The search strategy was:
((Psoriasis[MeSH Major Topic]) AND (systematic review[Publication Type])) AND (itolizumab[Text Word])
Yielded 2 results. To be continued soon
I'll pick this threade up now.
One of those papers was a Cochrane review. Reliable, authoritative and influential. It always pays to check Cochrane Library for a review first.
Just want to put this out there for more discerning readers not easily swayed by @Bioconlimited hype on #Itolizumab.. two huge issues with their pivotal trial. First a very small sample size of 21 Rx arm and 10 control arm is underpowered to detect any significant effect size.1/3
A 'power' calculation is a basic step prior to any study to make sure you enrol enough subjects to actually statistically prove that a drug is effective. For showing a 50% benefit for example, assuming a 30% mortality, and a power of 80% you wld need a sample size of 100. 2/4
2nd, thanks to this their reported outcomes are going to have wide confidence intervals for their effect estimates. Here is my calculation for their press release reported mortality benefit (no deaths in 21 rxed Vs 3 deaths in 10 control). Gr8 RR (93% reduction in death) but 3/4
Restricted Use of #Itolizumab for CRS in moderate to severe ARDS patients due to #COVID19. No peer-review.

❗️Phase III clinical trial exempted, to go for Phase IV.

Wordings of SEC meeting & Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics, have similar tone. 👇
To understand how HUGE scientific rationale can be, check her discussion w/ @SadhguruJV, a repeat offender. She speaks on DATA as well.

Both spewed lot of misinformation & judgement that could endanger public health & lives.

How are major arguments used by @kiranshaw here not different than arguments made by @yogrishiramdev on #CORONIL? Both playing on emotions like "made in India", "used since ages", "rigorous clinical trials not so relevant in pandemic". @CDSCO_INDIA_INF

#Thread on clinical trials of #Itolizumab - 20 patients received the drug, another 10 patients (three died) received supportive care, four doses were given, 32 patients were randomized, two patients discontinued. says Dr Sandeep Athalye @Bioconlimited
Predominantly male participation with comorbidities like diabetes, thyroid and blood pressure issues. All 20 patients who were given the drug died. In the arm which did not receive the drug, 3 patients died and 2 needed invasive ventilation before they died. #Itolizumab
Key markers for inflammation IL 6 aand TNF alpha came down in those who received the drug. Serum Ferritin levels also came down. Even D Dimer markers which indicate clotting or coagulopathy #Itolizumab