PHARMA, do it @Bioconlimited way!

Register trial for sample size X, do OFF-LABEL w/ sample size Y≫ X, e.g., Y=150, X=30.

SAVE LOT of MONEY. Stop clinical trial if OFF-LABEL is off your wish.

What an idea @kiranshaw ji!

@malini_aisola @prat1112001 @giridar100 @d_s_thakur https://twitter.com/das_seed/status/1283311436983402497
Unpopular opinion: @Bioconlimited did HUGE favor to Indian public by showing unethical @CDSCO_INDIA_INF could be 👏. It also shows why @ICMRDELHI has been LARGELY unscientific & callous during pandemic.

Mockery of LAW by the SYSTEM is a wake-up call. https://twitter.com/das_seed/status/1275646487909842944
@kiranshaw: who played w/ 21 lives? Dr Thacker called 1 of PIs by @Chaiti on @IndiaToday, while @TOIIndiaNews calls his OFF-LABEL study a CLINICAL TRIAL w/ 21 patients (1st RECRUITMENT on May 12 as Dr Thacker mentions) @d_s_thakur @VidyaKrishnan

https://twitter.com/das_seed/status/1283637685962387456
@kiranshaw: who played w/ 21 lives? Dr Thacker called 1 of PIs by @Chaiti on @IndiaToday, while @TOIIndiaNews calls his OFF-LABEL study a CLINICAL TRIAL w/ 21 patients (1st RECRUITMENT on May 12 as Dr Thacker mentions) @d_s_thakur @VidyaKrishnan https://twitter.com/das_seed/status/1283637685962387456
@kiranshaw: who played w/ 21 lives? Dr Thacker called 1 of PIs by @Chaiti on @IndiaToday, while @TOIIndiaNews calls his OFF-LABEL study a CLINICAL TRIAL w/ 21 patients (1st RECRUITMENT on May 12 as Dr Thacker mentions) @d_s_thakur @VidyaKrishnan https://twitter.com/das_seed/status/1283637685962387456
@kiranshaw: who played w/ 21 lives? Dr Thacker called 1 of PIs by @Chaiti on @IndiaToday, while @TOIIndiaNews calls his OFF-LABEL study a CLINICAL TRIAL w/ 21 patients (1st RECRUITMENT on May 12 as Dr Thacker mentions) @d_s_thakur @VidyaKrishnan https://twitter.com/das_seed/status/1283637685962387456
Does @CDSCO_INDIA_INF really apply @US_FDA norms when it comes to inspection of drug mfg plants of BIG pharma? NO. @US_FDA finds fault even for our local plants, what's our @CDSCO_INDIA_INF for?

❗️Our Parliamentary Committee had condemned DCGI in 2013.
https://twitter.com/kiranshaw/status/1283371081089216512
Example: Dates of Inspection by @US_FDA of @Bioconlimited (Biocon Sez Plot No. 3, Phase IV, Bommasandra-Jigani Link Road), Bangalore, India: 20/01/20-24/01/20.

Multiple violations found in API mfg plant. ( https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions)

What was DGCI doing?

https://twitter.com/das_seed/status/1283394662141693952
Example: Dates of Inspection by @US_FDA of @Bioconlimited (Biocon Sez Plot No. 3, Phase IV, Bommasandra-Jigani Link Road), Bangalore, India: 20/01/20-24/01/20. Multiple violations found in API mfg plant. ( https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions)What was DGCI doing? https://twitter.com/das_seed/status/1283394662141693952
Example: Dates of Inspection by @US_FDA of @Bioconlimited (Biocon Sez Plot No. 3, Phase IV, Bommasandra-Jigani Link Road), Bangalore, India: 20/01/20-24/01/20. Multiple violations found in API mfg plant. ( https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions)What was DGCI doing? https://twitter.com/das_seed/status/1283394662141693952
Inspection by @US_FDA on 25/05/17-01/06/17, 03/06/17 in @Bioconlimited Plot 2-4, Phase IV, Bommasandra-Jigani Link Road, Bangalore.

Multiple violations found in Sterile Drug Manufacturer. 8 observations were made in Form FDA 483.

What was DCGI doing?

https://twitter.com/das_seed/status/1261723367192887307
Inspection by @US_FDA on 25/05/17-01/06/17, 03/06/17 in @Bioconlimited Plot 2-4, Phase IV, Bommasandra-Jigani Link Road, Bangalore. Multiple violations found in Sterile Drug Manufacturer. 8 observations were made in Form FDA 483. What was DCGI doing? https://twitter.com/das_seed/status/1261723367192887307
Inspection by @US_FDA on 25/05/17-01/06/17, 03/06/17 in @Bioconlimited Plot 2-4, Phase IV, Bommasandra-Jigani Link Road, Bangalore. Multiple violations found in Sterile Drug Manufacturer. 8 observations were made in Form FDA 483. What was DCGI doing? https://twitter.com/das_seed/status/1261723367192887307
Inspection by @US_FDA on 25/05/17-01/06/17, 03/06/17 in @Bioconlimited Plot 2-4, Phase IV, Bommasandra-Jigani Link Road, Bangalore. Multiple violations found in Sterile Drug Manufacturer. 8 observations were made in Form FDA 483. What was DCGI doing? https://twitter.com/das_seed/status/1261723367192887307
Inspection by @US_FDA on 25/05/17-01/06/17, 03/06/17 in @Bioconlimited Plot 2-4, Phase IV, Bommasandra-Jigani Link Road, Bangalore. Multiple violations found in Sterile Drug Manufacturer. 8 observations were made in Form FDA 483. What was DCGI doing? https://twitter.com/das_seed/status/1261723367192887307
There's 1 death in off-label. There's off-label use on 20 patients by a PI after completion of study but trial itself got over on July 07. Recruitment was still on during June 06, 30 days trial it is. Who's lying, how to trust data https://threadreaderapp.com/thread/1282627953130704898.html https://twitter.com/das_seed/status/1283648661713559552
Here's brief summary of some major issues w/ #Itolizumab, @CDSCO_INDIA_INF, and @Bioconlimited. If they are not addressed, abuse of DRUG prescription will reach another scale. They are in conflict w/ spirit for which drug regulatory laws exist. https://twitter.com/das_seed/status/1284085493727207428
⚠️RIGHT time & RIGHT patient crucial, else #Itolizumab may backfire.
❗️LARGE CLINICAL TRIAL required, current evidence not statistically significant. Both advisor to @CSIR_IND & a #COVID19 taskforce member agree.

🧐When should drug be administered??? https://twitter.com/das_seed/status/1284371948093480960
Other than confusion around WHAT'S RIGHT TIME for #Itolizumab intervention, CLINICAL TRIAL seems rigged (unless queries answered satisfactorily) & misleading advertisement hampering public health. @CDSCO_INDIA_INF has LOT to answer. https://twitter.com/das_seed/status/1284085462223790080
@kiranshaw ma'am, do you even know what was protocol & objective of your CLINICAL TRIAL? How did you get your data? Why LIE to public that endangers public health and finance?

A\\c to @ICMRDELHI: There's NO evidence showing #Itolizumab reduces mortality.

https://twitter.com/das_seed/status/1284924927787884545
@kiranshaw, @Bioconlimited cherry picked data for clinical trial w/ 30 patients (20 w/ #Itolizumab). By July 13, you claimed 150 patients, now you claim 1000 patients off-trial. No papers, only media bytes. Are you eyeing investors or public health? @malini_aisola @d_s_thakur
Why doesn't @MOHFW_INDIA question @CDSCO_INDIA_INF as to how Phase III clinical trial exemption was given if data is too limited for satisfactory inference? Why @kiranshaw hasn't released rigged data yet? This is pandemic, not a circus. @malini_aisola @d_s_thakur @SeemaAhuja1
❗ #Itolizumab clinical trial in Cuba has no control group, a single arm study (not RCT). Only 60 enrolled so far instead of claimed 80. First publication w/in a week of registration, in May. Study not yet complete. First enrollment on March 28 itself. https://rpcec.sld.cu/en/trials/RPCEC00000311-En
#Itolizumab clinical trial in Cuba has no control group, a single arm study (not RCT). Only 60 enrolled so far instead of claimed 80. First publication w/in a week of registration, in May. Study not yet complete. First enrollment on March 28 itself. https://rpcec.sld.cu/en/trials/RPCEC00000311-En
#Itolizumab clinical trial in Cuba has no control group, a single arm study (not RCT). Only 60 enrolled so far instead of claimed 80. First publication w/in a week of registration, in May. Study not yet complete. First enrollment on March 28 itself. https://rpcec.sld.cu/en/trials/RPCEC00000311-En
#Itolizumab clinical trial in Cuba has no control group, a single arm study (not RCT). Only 60 enrolled so far instead of claimed 80. First publication w/in a week of registration, in May. Study not yet complete. First enrollment on March 28 itself. https://rpcec.sld.cu/en/trials/RPCEC00000311-En
#Itolizumab clinical trial in Cuba has no control group, a single arm study (not RCT). Only 60 enrolled so far instead of claimed 80. First publication w/in a week of registration, in May. Study not yet complete. First enrollment on March 28 itself. https://rpcec.sld.cu/en/trials/RPCEC00000311-En
❗Treatment of patients w/ severe SARS-CoV-2 pneumonia w/ the anti-CD6 monoclonal antibody itolizumab: Ethics com 👍 on March 27, 1st patient on March 28, sponsored by CIM & MINSAP, Cuba.

How can @Bioconlimited @kiranshaw claim conception of idea to be theirs? UNETHICAL.
Is it true? "City doctors are conducting trials w/ Itolizumab to help patients fight the final stages of Covid-19. Karnataka Govt will purchase the drug from Biocon, which has agreed to lower cost to Rs. 5,000 instead of Rs. 8,000 per vial." via @Mareeswj
"Dr CR Jayanthi, director-cum-dean of BMCRI, was one of members who approved this drug in a committee at DGCI." Did she? Any conflict of interest here? Can names of committee be disclosed, @CDSCO_INDIA_INF? Why cheap rate only to Karnataka? Pharma company or street vendor? 🙄
"Dr CR Jayanthi, director-cum-dean of BMCRI, was one of members who approved this drug in a committee at DGCI." Did she? Any conflict of interest here? Can names of committee be disclosed, @CDSCO_INDIA_INF? Why cheap rate only to Karnataka? Pharma company or street vendor?
"Dr CR Jayanthi, director-cum-dean of BMCRI, was one of members who approved this drug in a committee at DGCI." Did she? Any conflict of interest here? Can names of committee be disclosed, @CDSCO_INDIA_INF? Why cheap rate only to Karnataka? Pharma company or street vendor?
@sundarramanan (VP& Head, Global Regulatory Affairs, Biocon Biologics) intends to publish off-trial data, what about Phase II clinical trial? Protocols are different. Also, large size well-blind RCT only valid evidence for conclusive effectivity of drug. https://mobile.twitter.com/das_seed/status/1284371953571307520
@sundarramanan (VP& Head, Global Regulatory Affairs, Biocon Biologics) intends to publish off-trial data, what about Phase II clinical trial? Protocols are different. Also, large size well-blind RCT only valid evidence for conclusive effectivity of drug. https://mobile.twitter.com/das_seed/status/1284371953571307520
@sundarramanan (VP& Head, Global Regulatory Affairs, Biocon Biologics) intends to publish off-trial data, what about Phase II clinical trial? Protocols are different. Also, large size well-blind RCT only valid evidence for conclusive effectivity of drug. https://mobile.twitter.com/das_seed/status/1284371953571307520
Lack of proper paper on Phase II clinical trial of #Itolizumab has left even @Bioconlimited team confused. @SeemaAhuja1, indian trial excluded critically ill patients. Did you miss press brief on July 13? What Dr Thacker and Gore did was off trial, right? https://mobile.twitter.com/SeemaAhuja1/status/1288449113541840901
Pre-print of a Cuban #Itolizumab #COVID19 trial out. Ethics approval on April 4. Claims mortality reduction as well.

Different trial or data part of IIC RD-EC 179,
https://rpcec.sld.cu/en/trials/RPCEC00000311-En

https://www.medrxiv.org/content/10.1101/2020.07.24.20153833v1

https://mobile.twitter.com/das_seed/status/1288105916689195008

@pash22 @prat1112001 @dawalelo
https://www.medrxiv.org/content/10.1101/2020.07.24.20153833v1 part of #VICTORIA trial, IIC RD-EC 179 (Cuba) on #Itolizumab #COVID19. It's not RCT, claim of mortality reduction is HOAX. Initial protocol was for severe cases, later included moderate cases. Nothing conclusive, just observational. https://mobile.twitter.com/das_seed/status/1288105916689195008
https://www.medrxiv.org/content/10.1101/2020.07.24.20153833v1 part of #VICTORIA trial, IIC RD-EC 179 (Cuba) on #Itolizumab #COVID19. It's not RCT, claim of mortality reduction is HOAX. Initial protocol was for severe cases, later included moderate cases. Nothing conclusive, just observational. https://mobile.twitter.com/das_seed/status/1288105916689195008
https://www.medrxiv.org/content/10.1101/2020.07.24.20153833v1 part of #VICTORIA trial, IIC RD-EC 179 (Cuba) on #Itolizumab #COVID19. It's not RCT, claim of mortality reduction is HOAX. Initial protocol was for severe cases, later included moderate cases. Nothing conclusive, just observational. https://mobile.twitter.com/das_seed/status/1288105916689195008
@StephenPHansen public health ENDANGERING interview w/ @kiranshaw.

❗ #Itolizumab can be SERIOUSLY HARMING.
❗Phase II clinical TRIAL SHADY.
❗BIOCON has no clue of RIGHT patient/time.
❗NO clue for critical cases, shady trial ONLY for moderate cases.

https://mobile.twitter.com/das_seed/status/1284371955097964544
@StephenPHansen public health ENDANGERING interview w/ @kiranshaw. #Itolizumab can be SERIOUSLY HARMING. Phase II clinical TRIAL SHADY. BIOCON has no clue of RIGHT patient/time. NO clue for critical cases, shady trial ONLY for moderate cases. https://mobile.twitter.com/das_seed/status/1284371955097964544
@StephenPHansen public health ENDANGERING interview w/ @kiranshaw. #Itolizumab can be SERIOUSLY HARMING. Phase II clinical TRIAL SHADY. BIOCON has no clue of RIGHT patient/time. NO clue for critical cases, shady trial ONLY for moderate cases. https://mobile.twitter.com/das_seed/status/1284371955097964544
@StephenPHansen public health ENDANGERING interview w/ @kiranshaw. #Itolizumab can be SERIOUSLY HARMING. Phase II clinical TRIAL SHADY. BIOCON has no clue of RIGHT patient/time. NO clue for critical cases, shady trial ONLY for moderate cases. https://mobile.twitter.com/das_seed/status/1284371955097964544
@StephenPHansen public health ENDANGERING interview w/ @kiranshaw. #Itolizumab can be SERIOUSLY HARMING. Phase II clinical TRIAL SHADY. BIOCON has no clue of RIGHT patient/time. NO clue for critical cases, shady trial ONLY for moderate cases. https://mobile.twitter.com/das_seed/status/1284371955097964544
@StephenPHansen isn't it your responsibility as Associate Editor & journalist @ BioCentury to verify facts.

❗There's NO evidence that states #Itolizumab shows mortality benefit for #COVID19.

@sundarramanan @SeemaAhuja1 can verify what I said. https://mobile.twitter.com/das_seed/status/1284085489100881920
❗DCGI SEC suggested revision to Phase IV trial protocol of #Itolizumab for#COVID19 for review.

❗SAFETY to be primary objective, NOT mortality reduction.

No mention of peer review for report submission on Phase II trial.

https://mobile.twitter.com/das_seed/status/1282627953130704898

@sundarramanan @kiranshaw
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