I'm extremely critical of how poorly this CDC & FDA have handled myocarditis in young men (aka Worst Job Ever/ You Only Had 1 Job)

But I ALSO think this type of news reporting is HUGELY irresponsible 👇

Think about all the issues it raises... 🧵
theatlantic.com/science/archiv…
1. If it wasn't a rich, successful scientist in whom this happened in, they would never have covered it.

If it happened to an electrician, they would have said: its anti-vax nonsense; "shut up, anti-vaxxer!" they would say

How disturbing is that?
theatlantic.com/science/archiv…
2. Where is the evidence that mRNA vaccines fuel cancer growth even in a subset of people?

Case-reports don't count, obviously.

You need careful epidemiological evidence to make such a claim. Where is that?

Do that before you cover it in the news. Duh.
3. Now, it would be fair, and the article should discuss how the CDC's passive surveillance system is entirely byzantine and frankly shit, and that's why it can detect only the most blatantly obvious signal (ala VITT, ala myocarditis where baseline is a floor event)

but 🦗
4. The power of this anecdote will be to DISCOURAGE vaccination in the one group OVERWHELMINGLY likely to have the most favorable benefit/ risk balance-- B cell deplete people/ people w/ cancer

wtf!
5. Meanwhile, there is an ACTUAL safety signal, proven over and over in datasets-- myocarditis in men 12-40, which is a subgroup LEAST likely to derive benefit from perpetual boosting and no one has done anything to mitigate this risk

The CDC & FDA just keep failing
6. We are living in a mad world, where a speculative anecdote in an older person with cancer is the Atlantic, but there is little to no coverage of a serious, proven AE in young healthy people.

Why not cover the human story of a 22 year boy with myocarditis-- it won't be pretty
7. The evidence bar to boost a young healthy child is higher than an older vulnerable person, who is far more likely to embrace weaker data.
8. I remain open to the fact that current systems have missed other adverse events (AEs) of note, but the solution is better systems and to establish those AEs BEFORE YOU COVER THEM IN THE NEWS!

Meanwhile, you aren't covering a proven AE
9. None of this makes any sense.

The White House COVID policy is set by people too incompetent to tackle a PROVEN SAFETY issue, and the news is chasing ANECDOTES of something unrelated.

Rational scientists have our work cut out for us this century
10. Its entirely possible the cancer worsening had nothing to do with the booster-- it happens-- it also might be related, but no anecdote can ever sort it out

So why are you covering this, but not the actual proven AE!

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More from @VPrasadMDMPH

Sep 24
A lot of concern about this decision, but here are the facts

1. We actually don't know if making doctors or patients wear flimsy masks in gift shops and hallways slows nosocomial spread, or spread in general

Like many NPI Qs, we did not study it

2. 🧵

cbsnews.com/news/covid-19-…
2. As more people get COVID and recover, as variants become less lethal, the risks from COVID19 spread, nosocomial or community decline, and COVID19 begins to resemble the many other viruses we have dealt with for decades

We never masked in gift shops, team rooms and hallways
3. Outside the hospital, American is 99% normal-- no masks, massive gatherings, no testing, no vaccine passport. Very strict precautions in hospital hallways can at best have little impact on spread in the universe of interactions
Read 6 tweets
Sep 23
Two new peer review articles out this week by our research team @vkprasadlab

One is on relugolix, and the FDA again lowering the bar
authors.elsevier.com/a/1fo5b14kplrK…
The other is on crossover in Traztuzumab adjuvant trials
shorturl.at/klMOU
Here are the high points 🧵🧵
When the adjuvant trials for Traztuzumab were run, T was already standard of care for women presenting with recurrent, metastatic disease; Thus, any woman who relapsed should get T, and T upon relapse will affect OS

But strangely, trials report only 52% of women getting T
Worse.
The papers do not disambiguate Scenario A vs B.
We want scenario B (until OS proven), then and only then scenario A is acceptable
Read 11 tweets
Sep 16
This is a devastating re-analysis of the Bangladesh study. I'm going to try my best to explain it. I Will tag the authors to see if they think I do it justice. @beenwrekt
@WesPegden

Thread trialsjournal.biomedcentral.com/articles/10.11…
One question in randomized control trials is the issue of concealment. People should not know which arm they are getting assigned to. This is different than blinding

If you know what you might be getting, you might be more likely to enroll in and stick in the study.
The Bangladesh RCT has a big difference in enrolled population. With more people in the mask arm. This is beyond chance. This imbalance is due to something

The most plausible answer is that concealment was violated. People signed up more for freebie. This probably happened bc...
Read 14 tweets
Sep 13
An annual COVID19 mRNA not is *NOT AT ALL LIKE* an annual flu shot, a small list of differences

🧵
1. It is far more reactogenic
More people take a day off work/ way more AEs than flu

2. Flu vax tries to predict FUTURE North America strains, BA4/5 are PAST strains...
No one tries to vaccinate people who already just had the *exact same strain* of flu with the flu shot, and yet now CDC pushes BA4/5 in people who just had BA5

3. COVID19 IFR is currently LESS LETHAL than flu, particularly for the young

4. Maybe, just maybe, we could do...
A better job with flu. Each year, we rely of flawed test neg. case control studies to estimate flu vaccine efficacy, which often yield awful, pitifully low estimates despite the upwardly biased methodology.

Perhaps, just as phones advance, evidence can advance...
Read 12 tweets
Sep 5
Let me briefly explain why this article is ridiculous.

All of the things it says the government didn't do are unproven things

There are no good data to support masking kids in school....
The best studies from Spain and Finland show no effect. In the age group of five to six, and 10 to 12.
You could install $500,000 ventilation systems in schools. And you might affect the short-term transmission of COVID-19. But what's the point when 97% of kids will be sero prevalent in a few months anyway?

Ventilation actually is promising for other outcomes... But...
Read 11 tweets
Sep 3
Just out @OncologyAdvance !
Led by Anjali Bhatt, we ask how many limitations is too many? AGILE is riddled with flaws
Unethical control arm
Bad post progression care
Endpoint switching
Premature halting

It's actually pretty weird...
authors.elsevier.com/sd/article/S19…
The authors end up halting the trial for imbalance in deaths, but get this
The initially primary endpoint was mortality, and it would have tolerated more events before halting
then they switched to EFS, then they halt with fewer events on the old primary

authors.elsevier.com/sd/article/S19…
Their claims contradict the original trial protocol.

In short, the trial just works to enrich the company

it helps no one but shareholders

Authors claim that it is ok to provide bad post protocol care b/c we enrolled in Europe, yet US FDA used the trial for US approval. Sad
Read 4 tweets

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