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. 👇
❗️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.
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
@CDSCO_INDIA_INF saved huge chunk of money for @Bioconlimited by exempting Phase III clinical trial of ITOLIZUMAB, approving Restricted Use w/ scarce RCT data not up for peer-review yet. Will increase sale also in foreign.
US estimation👇, cheaper in India
nature.com/articles/nrd.2…
US estimation👇, cheaper in India
nature.com/articles/nrd.2…
Clinical Trial Phase II registration by @Bioconlimited of Itolizumab for #COVID19.
Est duration was 3 months. SS: 30
Still recruiting on 10/06/20; Study completion 07/07/20.
Narayana Health registered but didn't conduct trial, its Ethics Committee didn't approve or what ??
Est duration was 3 months. SS: 30
Still recruiting on 10/06/20; Study completion 07/07/20.
Narayana Health registered but didn't conduct trial, its Ethics Committee didn't approve or what ??
CTRI/2020/05/024959 (ITOLI-C19-02-I-00, V3.0, 09/04/2020) has 6 sites w/ 6 PIs mentioned. BUT in press briefing, it said only 4 sites for trial. PI from KEM was Dr Hemant Deshmukh instead of what was mentioned in registration. @kiranshaw may you please clarify why such changes?
Comment thread by @giridar100 analyzing caveats in hasty inferences by @Bioconlimited w/o due diligence of basic statistics need in clinical trials.
When CTRI/2020/05/024959 was open to recruitment on 10/06/20 & trial study completion on 07/07/20, how did "Day 30" analysis happen? Isn't a month just of 30/31 days?
Are you sure, "Day 30" event happen, @kiranshaw?
@d_s_thakur @AnooBhu @giridar100
Are you sure, "Day 30" event happen, @kiranshaw?
@d_s_thakur @AnooBhu @giridar100
@kiranshaw said ~150 additional patients were treated outside clinical trial. Dr. Suresh Kumar (one of 4 PIs), "After COMPLETION of study, drug used on 20 more internal staffs w/ COVID19 infection. All recovered well, except one minor case."
WHAT?? see👆
WHAT?? see👆
A/c to Dr Suresh Kumar: Followed strict protocol so not used Itolizumab on ventilator patients. Too effective in patients w/ moderate severity, actually those not w/ Cytokine storm or organ damage/multi dysfunction. Used on moderately sick #COVID19 patients not on ventilators.
A/c to Dr Rosemary D'Souza: After trial approval, 1st recruitment on May 18. 10 enrolled but 1 screen failure due to low lymphocyte count, so 9 total (6 treatment arm+3 control arm). Enrolled patients w/ p/f < 200, BiPAP/CPAP NIV ventilation reqd. 2 in control arm died.
Brief summary of inclusion criteria & protocol as approved for RCT in CTRI/2020/05/024959 (ITOLI-C19-02-I-00, V3.0, 09/04/2020).
# of patients under trial of Dr. Suresh Kumar unknown to me, but recruitment process was BIASED & not random (IMHO), see👇👆
# of patients under trial of Dr. Suresh Kumar unknown to me, but recruitment process was BIASED & not random (IMHO), see👇👆
A/c to Dr Vishal Gore (Consulting physician, DNB Medicine), off-label use: since past 20-25 days in 23 patients. 1 out of 2 on ventilators died. Used on deteriorating cases, not deteriorated yet, for which Oxygen req suddenly rises & certain conditions check. W/in 24 hrs...
.. FiO2 req went down by ~20% in all 21 patients. No wait for IL-6 or inflammatory marker as no lab facility & possible delay. Had asked friend in Biocon for medicine as not accessible in Solapur. Dr Gore said he studied pathway of how drug works when possibility of its use for..
treatment was initially put. Team thought it was effective in those who are in stage of deterioration but haven't deteriorated yet (that part clicked).
❗️Were patients told or their consent taken? Off-label use & 1 out of 2 ventilator patient died! All this while trial was on.
❗️Were patients told or their consent taken? Off-label use & 1 out of 2 ventilator patient died! All this while trial was on.
❗️A/c to Dr Hemant Thacker (Breach Candy Hospital), not PI as per registration, hospital also missing from list: Dr. Shashank Joshi conceptualized. Both Dr. Shaw & Dr. Joshi approached Dr Thacker to discuss further course. Dr Thacker used drug in trial for 21 patients, plus 5 ..
patients independently. First patient on May 12. Better use as to prevent patient from getting into ventilator. For those on who were already on ventilator due to delay or some other issues, this drug was also tried on them. Mentioned some cautions too.
⚠️It appears that trial was rigged, probably suitable data picked out from multiple cases. Off-label use was going parallel to study & before DGCI approval by admittance of some members. Dr Thacker+Dr D'Souza had 21+9 patients, what did other PIs report?
Dr. Shashank Joshi clarifies that Dr Thacker was doing off-label use of drugs. Was it just based on "insightful" discussion b/n Drs. Joshi, Shaw, & Thacker? Dr. Thacker started his off-label trial even before Dr D'Souza. Why was Dr Thacker not part of clinical trial?
Dr D'Souza had first patient on May 18. So trial data would not have been possible by June 18 for certain. Recruitment open on June 10. How did Dr Suresh Kumar administered drugs on his ~20 hospital staffs after completion of study? This intervention protocol is of 30 days.
Here Dr Thacker clearly says that he was approached by both Dr Joshi & Dr Mazumdar for discussion of way forward w/ drug treatment & trial. He says to use drug in TRIAL (21 patients) & also independently (5 patients). Why did Dr Joshi later says it was off-label use?
Dr Suresh Kumar tried drug on moderate severe patients (not on vents) to follow protocol strictly BUT Dr Rosemary D'Souza enrolled patients who were also on ventilators? Who followed protocol & who didn't? How is it RCT, what was actual protocol?
+ to 👆 issues, gross misappropriation of clinical treatment during pandemic.
❗️Were off-label uses of Itolizumab strategic, question because Dr Thacker also involved who believed he was part of trial?
❗️Were patients informed being part of study???
❗️Were off-label uses of Itolizumab strategic, question because Dr Thacker also involved who believed he was part of trial?
❗️Were patients informed being part of study???
❗️How does timeline of observational study overlap w/ registered clinical trial? How did Dr Suresh Kumar manage observational study after completion of clinical trial when # of days required is 30?
@malini_aisola @giridar100 @AnantBhan @prat1112001
@malini_aisola @giridar100 @AnantBhan @prat1112001
❗️Dr Vishal Gore used drug on 2 ventilator patients, 1 died. Who's responsible? Any compensation?
❗️Why did doctors not from clinical trial not follow CLINICAL MANAGEMENT PROTOCOL: COVID19 by @MoHFW_INDIA?
❗️How much savings due to off-label study?
❗️Why did doctors not from clinical trial not follow CLINICAL MANAGEMENT PROTOCOL: COVID19 by @MoHFW_INDIA?
❗️How much savings due to off-label study?
In this video as well @Chaiti introduces Dr Hemant Thacker as one of the lead investigators in this breakthrough (#Itolizumab for #COVID19). He says that @kiranshaw approached him around 2 months ago & Dr Thacker "recruited" his first patient on May 12.
Dr Thacker wasn't PI as per clinical trial registration. How did @kiranshaw ask him to proceed w/ clinical trial & recruitment of patients as if he was PI? How can OFF-LABEL use be done on clinical trial patients? Who risked 21 lives? @d_s_thakur @pash22
❗️ @Bioconlimited PR says Dr Thacker did "OFF-LABEL COMPASSAIONATE USE" trial, not CLINICAL TRIAL. How can @kiranshaw ask doctor to do such trial w/o DCGI approval? Is Dr Thacker unaware of CLINICAL TRIAL meaning? What did he say to his patients???😨
Dr. Hemant Thacker categorically said that 5 patients were independent off 21 clinical trial recruitment. @SeemaAhuja1, may you clarify please.
*correction: Dr Suresh Kumar used #medical lingo. By not on ventilators, cases w/ non-invasive ventilators are included (not severe cases, see Dr D'Souza's precise statement in this regard).
Why did Dr Vishal Gore used #Itolizumab on 2 ventilated patients, 1 patient died?? Experiment? This was known to PIs in CLINICAL TRIAL, did he not read protocol?? Why???
ncbi.nlm.nih.gov/pmc/articles/P… evms.edu/media/evms_pub…
ncbi.nlm.nih.gov/pmc/articles/P… evms.edu/media/evms_pub…
