This is a lie -
At least per http://clinicaltrials.gov site : sham surgery defined as “simulated surgical procedure with skin incisions only, “ .. specifically says : “ no intrastriatal injections and no burrholes through the skull”
Link to which fda official is demanding burrholes as sham?
https://clinicaltrials.gov/study/NCT04120493?tab=study
😂
Albert Bourla has your best interest at heart.
I swear.
I’m not sure it’s a bad thing that an industry CEO has a problem w a regulator. https://www.fiercepharma.com/pharma/pfizer-ceo-bourla-cber-chief-prasad-we-have-problem-leadership-cber
This is because it fundamentally cannot complete the single most important exam in all of medicine: does the patient look sick?
no, can't use survival
it bakes in lead time and length time biases and will always make screening look better, even if it doesn't change mortality at all
wrong metric
need to look at age-adjusted mortality
Something a little different today on @Sensible__Med
Diagnosing the Dead https://open.substack.com/pub/sensiblemed/p/diagnosing-the-dead?utm_campaign=post-expanded-share&utm_medium=web
@WSJ is unreliable and conflicted in its coverage of Vinay Prasad.
We appreciate the @WSJ making this important correction but they should have never published unverified hearsay in the first place. Smearing officials with false allegations and then issuing a quiet correction isn’t accountability. Your readers deserve better.
well I am just so shocked that this type of accusation was included when industry was mad at him, and it turned out .... not to be true 🤯
Nice for the false accusation to be corrected a month after posting and spreading it around.
when people don't like you, they come after you
the mob spares no one
having been targeted just once, its merciless and unrelentling by bad actors trying to score points for their sides
unfortunately those same people are disguised as experts, key opinion leaders, and media members
Losing my institutional email was the best thing that ever happened to me.
There’s a saying in journalism: you never want to have a permanent exclusive. Endpoints matched WSJ’s reporting on Vinay Prasad except for the sexual harassment accusation. Turns out that was part of the Murdoch smear operation, just as Marty Makary said. h/t @maxonwifi
Three weeks later, @WSJ finally corrects a vicious allegation of sexual harassment by @VPrasadMDMPH at @US_FDA
The poor participants in this study are the losers here.
There is no silver lining. The integrity of the whole study has been dragged through the mud.
If the study team can forget to blind the scans what else was forgotten??
I’m really sorry to say this but the only option is to retract the paper and to do the study again (this time with an appropriate control group)
@EvidenceOpen has already dethroned UpToDate. They now need to just design their own EMR which will retire Epic swiftly.
Another great essay by @adamcifu @Sensible__Med
Covid is a sticky subject because so many factual and policy issues remain unresolved and so many lessons remained to be learned.
For me, the most important is how easily too many Americans were deceived and frightened into throwing away our freedoms and turning against one another, following charlatans and demogogues making false promises of "safety." Our leaders failed miserably and betrayed America's ethos.
It’s just hard to stop thinking about COVID.
https://open.substack.com/pub/sensiblemed/p/friday-reflection-58-covid-19-six?r=n8zko&utm_medium=ios
The last surgeon general : a uniter, not a divider.
Reminder that the last surgeon general used his government perch to “urge” social media platforms to police misinformation.
Hands down the most dangerous surgeon general in recent history?
The @WSJ editorial page is an extension of the pharmaceutical lobby that controls both parties in Congress.
This translates to having therapies approved and paid for by taxpayers that that don’t work or having 4 tyrosine kinase inhibitors and 20 different statins.
👍🏻
Our 20th This Fortnight in Medicine. A couple of interesting articles and some heated (or at least warm) disagreement.
https://open.substack.com/pub/sensiblemed/p/this-fortnight-in-medicine-xx?r=n8zko&utm_medium=ios&shareImageVariant=split
I’ve said many times that statins are the most studied medicine ever and there is a consistent 25% relative risk reduction in major cardiac events. Close to certainty as it gets.
But. But. If you use the verb “need” and statins together you fail evidence based med
I can explain why 1500 things might help you live longer.
If I were making money from selling those things, I could sound really excited about them.
I can tell you 5 or 10 things that will make you live longer. They are not exciting, and you already know what they are.
Yeah, it just doesn’t raise my temperature too much given the recent and ongoing events.
There are truths that will get medical students kicked out of med school and federal agents at your doorstep if you publicly voice them.
Not hypothetical. Actually happened.
I'm quote, although I prefer scientist over sleuth :)
this was not some combing over statistical minutia in a Table
this was glaring epidemiologic and clinical trial concerns
weird how people like Topol are platformed as experts but can't tell fact from fiction
JAMA IM study has entered the conversation!
Funny timing
They use a 10-year time horizon (not a 5 year one from the podcast & BMJ study)
Value is in the eye of the beholder, especially at lower risk end
I doubt findings would change if you projected lifetime efficacy
Apple: our watch is the ultimate guardian of your health
Academics: no comment to media, but Mr. Apple can I sign up to be a part of this?
Cardiologist on Joe Rogan: fact stated to support a conclusion academics don't like
Academics: vile misinformation peddler!
* I believe statins are great drugs when used appropriately
An amazing thing happened after the wave of controversy about the Moderna flu vaccine died down: The pharma trade press admitted that it's not a very good vaccine because of tolerability (side effects). Their real opposition was the use of a legal tool (RTF) that massively shifts the balance of power away from Big Pharma to FDA. Pharma wanted to stigmatize that move as beyond the pale, and the press did so obediently.
Good piece on thinking about benefits for preventive therapy
Two tensions not often acknowledged
-Individual vs population
-Shorter vs longer time horizons
I'd push back on NNT = 1 for acute interventions though. I wish we could be as certain for benefit!
Good read via @drjohnm : saying average gains for statins is 4 days of life is distorted framing, not misinformation.
Small number will benefit a lot, most won’t benefit. Problem is we can only really figure out which group you’re in until after the event happens / or doesn’t.
I tried to expand my thoughts on this. On @Sensible__Med
https://open.substack.com/pub/sensiblemed/p/primary-prevention-statins-lottery
Gavin Newsom being mentored by a billionaire family (the Gettys) and coming to Atlanta and saying he can relate to ordinary people because he got a 960 on his SAT is quality 2028 comedy.
Because plenty of people have and can speak to the benefits of statins. I have myself many times.
Few will speak up to pull the reins back when academics charge towards censorship.
I think this is right and I agree in principle. I’ve said so. But we must also admit that extending KM curves past the trial length is speculation. Esp more than a decade.
You can fuss about the framing but this is NOT misinformation. See https://bmjopen.bmj.com/content/5/9/e007118
AM is really close to correct. Survival (on average) is smaller than you think
Even the ICD vs amio for sustained VT is months not years. In the old days authors stated it clearly
I used to really like it but I think I’ve found a few times when it didn’t really answer my question correctly and didn’t give any indication that there was any uncertainty and I’ve relied less on it since then. I question its reliability now
It pains me to say this but OpenEvidence AI is superior to UpToDate (and it’s free!)
@EvidenceOpen