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Anish Koka, MD Profile picture
@anish_koka
Nov 24, 2021 • 14 tweets • 6 min read • Read on X
Scrolly
Appreciate authors of the 🇧🇩 RCT finally releasing raw data.

Dismayed at their topline conclusion on mask effectiveness that generated so much buzz

Out of ~340,000 ppl in mask and control arm.. the difference in symptomatic cases was 20 over 8 weeks.

benjamin-recht.github.io/2021/11/23/mas…
Brief summary for those interested. Bangladesh mask was a cluster RCT, (cluster because unit of randomization was a village) Treatment group had public policy intervention to increase use of masks, Control group was basically a poorly enforced govt. mask mandate)
Per pre-print 342,126 individuals in study. Endpoint was COVID 19 +ve symptoms AND positive antibodies.
Key Table shows of ~150k pts in each arm, blood samples could only be collect from ~5k patients in each arm.

poverty-action.org/sites/default/…
Unfortunately, nowhere in the paper is it noted how many of those tested were +ve for SarsCov2 Antibody. Weird. Since that is the primary endpoint.

This graph that made the rounds when the preprint came out? The #s used are coefficients from a model. They aren't 'real'
The raw data was finally released. @beenwrekt 'crunched' the data to find the elusive raw # of symptomatic positives in treatment and control arm.

So of the ~10k blood samples available . 1086 were +ve in the treatment arm, 1106 +ve in the control arm

gitlab.com/emily-crawford…
It would appear that the primary endpoint differs by 20 cases from the data provided. (Is poxXsymp the right column heading @Jabaluck ?).

One of the problems of the study is that despite the vast size of the study, the primary endpoint depends on ~5000 blood samples collected.
So we are left to extrapolate from a 20 case difference tested in ~10,000 patients to a 300,000 patient study.. which gets us to a discussion made for headlines --> A policy intervention that increased mask wearing 29%, reduces symptomatic Sars COV2 by 9%!
But how robust can this possibly be? It seems a bit much to go from these small differences to the police tracking down and fining people who don't mask in public.. (this from the author of the Bangladesh RCT)
I wish I could say most health policy was based on stronger sauce than this.. What's a billion here or there when the taxpayer foots the bill?
By the way, most of these incidents that the US Attorney General, and almost Supreme Court Judge Merrick Garland wants to make a federal crime involve face covering incidents.
I find it pretty disconcerting as well that disagreeing with the conclusions of the Bangladesh RCT is disqualifying in some way when arguing in court!

The judge should have asked for the raw data!

Statistical significance matters little when the outcomes isn't clinically significant. Especially relevant in very large trials when even small differences in 2 groups give highly statistically significant differences which may be clinically irrelevant.
This is a much smarter take.
Another very smart take by @contrarian4data and @VPrasadMDMPH

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More from @anish_koka

Anish Koka, MD Profile picture
Mar 23
Comments / summary on Pfizer subclinical myocarditis study

Overall really confusing

Group 1: 1487 total randomized to Pfizer vs placebo, troponin done at baseline, post usual dose (30mg)

Group 2 : Broken into 2 bc EUA for 12-15 arrived during trial, so majority of 12-15 unblinded and took Pfizer vaccine
🧵Image
Troponin tested pre and post vaccine dose.

Rather than show individual baseline troponin and rise after placebo vs drug , results shown in summary format, so cannot track individual rise In tn
1st study eligibility criteria is Pts who had received 2 or 3 doses of Pfizer > 4 months prior.

I assume patients who had myocarditis with 1st 2 doses are not rushing to enroll in this trial
Read 8 tweets
Anish Koka, MD Profile picture
Mar 8
Ok. So my summary on the @Change_HC @Optum @UHC cyberattack debacle.

TL,DR : Govt. regulation creates billion dollar revenue streams for large corporations. Regulatory capture by large organizations means a healthcare system that is incredibly susceptible to single points of failure, and most of the players in the space have no clue/ don't really care!

🧵
Feb 21, 2024, cyberhackers compromise @Change_HC (formerly Emdeon, acquired a few years prior by @UHC for $13billion).

@Change_HC is the largest medical clearing house that takes electronic claims generated by hospitals and doctors offices , scrubs them, and puts them in a format that insurance companies accept. Insurance companies process claims, and make payments to hospitals and doctors.
The first reaction of @Change_HC is to disconnect from all of its clients, which means, no medical claims are processed to be delivered to insurance companies.

Change HC / United then proceeds to say absolutely nothing of substance for the next 2 weeks with regards to any timeline of coming back online
Read 15 tweets
Anish Koka, MD Profile picture
Oct 2, 2023
If you have a deep seated fear of COVID you will instinctually seize on any study that confirms that bias.

If you fear the vaccines, you instinctually will want to believe data that confirms that bias.

Neither approach will get you close to the truth

🧵
If the goal is truth, then the real bias everyone should lean into is against the academic-peer-review industrial complex that spends most of its time generating data that doesn’t replicate and then exacerbates the problem with hyperbolic conclusions
“If the only tool you have is a hammer, you tend to see every problem as a nail.”

Academia is full of people who have spent 20 years becoming masters of a particular domain that usually has no practical, real world application.
Read 14 tweets
Anish Koka, MD Profile picture
Sep 30, 2023
The coverage of this wildly speculative paper linking sars-cov2 is much worse than the actual paper is.

To give you a flavor.

The study is based on 8 autopsies of patients with a diagnosis of COVID.

Let’s take Patient 1.

🧵
Image
Image
59 year old black man with a history of CAD.

He was admitted to the hospital 3 times before dying.

Hospitalizations 1 was with a clot in his lungs. His only treatment was heparin and xarelto. This means he didn’t present with a COVID pneumonia.

Hospitalization 2 was listed for heart failure. His ejection fraction was 40-45%. He spent 5 days in the hospital. He was still COVID positive.

Hospitalization 3 was with an acute heart attack. A circumflex artery occlusion associated with rupture of a component of the mitral valve — the papillary muscle. He was now COVID negative. He died of the heart attack and resultant heart failure, I assume.


Image
The authors of this study took coronary artery tissue and looked for evidence of sars-cov2

They show representative samples of tissue in their main figure. They do not , even in their supplement, show all tissue sampled and stained.

The presence of sars-cov2 rna In patients who were infected by itself doesn’t mean much, but researchers probed tissue for the antisense strand of the S gene (S antisense), which is only produced during viral replication.
Image
Read 10 tweets
Anish Koka, MD Profile picture
Sep 29, 2023
One of the major issues of the last 3 years has been a seeming inability of US institutions to seek to answer basic questions like how extensive and how long a novel vaccine administered to humans lasts.

Well, these researchers tried to answer this question, and the results are really interesting!
Image
Human bio-distribution studies are hard by nature.. it requires specimens of a variety of organs at various time point after administration of a therapeutic.

Preclinical animal studies of the mrna/LNP construct suggested a short duration (days)

The few human studies have suggested a much longer duration of action.

“Using human axillary lymph node biopsies, spike protein and vaccine mRNA were reported to persist up to 60 days from vaccination with either BNT162b2 or mRNA-1273 as detected by immunohistochem- istry and in-situ hybridization. In that study spike protein was also detected in the plasma up to 7 days from vaccination. BNT162b2 mRNA was detected in patients by PCR in circulating leukocytes up to 6 days from vaccination and in the plasma up to 15 days from vaccination. Using highly sensitive single-molecule array assays, spike protein derived from mRNA-1273 was detected in the plasma of patients up to 28 days from most recent vaccination20. Circulating exosomes containing spike protein derived from BNT162b2 were detected in patients 4 months after vaccination”
This study in Nature went one step further, comprehensively studying human tissue In patients dying after vaccination.

Importantly, NONE of the patients were deemed to have died from the vaccination.
Read 18 tweets
Anish Koka, MD Profile picture
Jul 26, 2023
Study from Basel, Switzerland that looks at myocardial injury as measured by routine measurements of cardiac biomarker (HsTn) after healthcare employees received a booster.

Obvious big limitations :

https://t.co/Gdffqn93jSonlinelibrary.wiley.com/doi/epdf/10.10…
Image
1. Excludes anyone who had myocarditis after dose 1 or dose 2
2. No baseline troponin checked prior to booster administration
3. 1871 Screened ---> 777 evaluated in trial
4. Average age 37, only 30% male

(Peak clinical myocarditis to date has been seen in 16-17 year old boys)
But still super useful to see how "cardioactive" booster is, grateful to researchers for taking a look.

20 women and 2 men had HsTn levels that were above the population reference ranges.

Most had repeat troponin levels done at 30 days (makes up a little for no baseline) Image
Read 8 tweets

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