Dear Journalists,
There is a story here πŸ‘‡ Phil Krause and Marion Gruber #2 &#1 at FDA vax have resigned over white house pressure on boosters.
Now FDA pushes this without advisory committee & with uncertain safety in boys.

Interview the 2 who resigned! 1/2
If a 12-15 year old boy already had 2 doses and has just had mild omicron what is the risk benefit of dose 3?

Ans: absolutely uncertain and possibly dangerous

Interview @walidgellad too

FOIA communication from WH to Peter Marks at FDA
The 2 people who resigned worked there for decades. They ar Director and Deputy Director. They are principled people.

And here is the shocker: they did NOT resign with the last guy!!
Here is some help...
A timeline
vinayprasadmdmph.substack.com/p/boosters-for…

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More from @VPrasadMDMPH

3 Jan
Every school district not open tomorrow has failed it's kids and society

Public schools will need total reform/ replacement in the future. Vouchers/ charter are coming

Teachers unions destroyed a generation.

As a life long liberal, it was sad to watch
Public health 'experts' who don't understand tradeoffs aided and abetted the unions

Some even took $$$ from them

Sad to watch
School board showed they are comprised of total failures who don't prioritize kids' interests

Some don't even live in the district

Sad
Read 7 tweets
2 Jan
Rates of myopericarditis s/p D2 COVID19 vax by @KPNorthwest
1 in 2700 Boys 12-17
1 in 1860 for Men 18-24

USA must suspend Moderna Men <40
Must reconsider or space dose 2
Needs VRBAC & ACIP prior to boosting 12-15
Interview Resigned FDA directors

medrxiv.org/content/10.110…
Numbers still small, but ballpark 1 in 3-5k is convergent estimate
Read 5 tweets
28 Dec 21
It's amazing we made children as young as 2 wear a mask that has no evidence of benefit for prolonged periods of time, inflicting harm without upside.

Total policy failure, I wrote about it for the Atlantic months ago and MedPage before that

google.com/amp/s/amp.thea…
The fact nearly no one would say that the AAP and CDC were off their rocker to defy the World Health Organization and UNICEF to push this foolish recommendation down to 2 will be a shameful blemish on their reputations, I doubt they will recover in next 25 yrs.
Data from Spain, of regression discontinuity design, showed it did not work months ago. Sadly CDC pushed embarrassingly flawed studies in MMWR to defend their failed policy instead.

See Zweig, Atlantic.
Read 5 tweets
23 Dec 21
Our new @vkprasadlab article is now out in Cancer Reports

We tackle the frequency (spoiler alert: BRISK) of assessment of progression in RCTs of cancer drugs

Want to learn more?
onlinelibrary.wiley.com/doi/epdf/10.10…
[thread]
First, remember that progression free survival is a time to event, composite endpoint

It is typically the time until 1 of 4 things happen
Death, New lesions, Growth (without shrinkage) or Growth (from Nadir).

Watch my free lecture series to learn more:
As a result PFS is binned

It has a stair-step pattern b/c imaging is assessed not continuously, but at pre-specified time points
Read 8 tweets
23 Dec 21
Our new paper is now out in European Journal of Cancer

We analyze 55 cancer drugs that target genomic abnormalities & assess the evidence

Only 24% reported an improvement in survival πŸ‘‡

A seductive mechanism of action apparently means low levels of evidence

[thread]
Modern oncology has several classes of drugs
Cytotoxic drugs
Checkpoint inhibitors
CAR-T therapies
General targeted drugs &
Drugs that target specific cancer genomic abnormalities
(Genome drugs!)
Genome drugs get outsized attention; Previously we found that (best case scenario) 13% of US cancer patients were eligible for these drugs; leaving 87% not eligible

pubmed.ncbi.nlm.nih.gov/33862157/
Read 10 tweets
21 Dec 21
In our new paper in @JAMANetworkOpen we take a deep look into cost-effectiveness (CEA) studies of cancer drugs

Bottom line: If a CEA study is funded by pharma, it is 40x (OMG!) more likely to find the drug is cost effective

A 🧡 explaining what we found
jamanetwork.com/journals/jaman…
For every cancer drug indication approved between 2015-20, we searched for cost-effectiveness studies

we found between 0 and 9 per drug!!

Some trials were industry sponsored & others neutral
Here are the baseline characteristics of the studies we looked it.

Only 1/2 to 2/3 of drugs have even shown they improve survival

The rest have unknown effects on survival

That is not good enough

It is FDA failure! (these days that's common)
Read 8 tweets

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