They compared 8400 pts vs 554,000 pts. That’s a ratio of 1:66.
I don’t have a huge problem with their concluding statements, which do not seem to be that much of an over-reach. “…..suggests….benefit….in select patients”. One out of every 67, actually.
The real problem is for the authors to simply stop there, rather than taking the next step, which could have reasonably included:
A) we will now try to better characterize those who received the device and enjoyed apparent benefit; then
B). We will now test with a proper RCT in the cohort with those characteristics to see if the device is actually causally responsible for the perceived benefits.
Interesting thoughts. I spend my recent epidemiologic time with Harvey, Jay and Garrett...I assume you know who they all are. But I generally assume there is an explanation to anything that happens. If I do not understand it, then I just assume there are facts not in evidence to me....but someone has them. In general, if you are not in control/understanding than someone else is.
MMWR, which I have read for years, became almost completely political with regard to COVID since the beginning of the covid mess. I cannot tell you why, but virtually everything back to the beginning, like the datacrimed school study in Arizona or the ridiculous Nebraska hairdresser piece has been fraud or near fraud. Nothing evidence based about any of it.
I was well steeped in the pandemic preparedness prior to 2020. (I was CSO of a very large healthcare organization at the time -- was important to have relevant plans for most everything.) No masks. No lockdowns. Well understood across the spectrum and around the world. There was, literally, endless data to back it up. Coronaviruses have also long been reasonably well understood -- responsible for, perhaps, a third of all your lifetime colds. Serious respiratory viruses have been common and understood as a typical cause of death for those infirm and elderly ("pneumonia" still the most common COD in the elderly).
I was heavily involved in HIV when it first reared its ugly head, and SARS as well. (Avoided MERS...lol.) Other than universal precautions in health care (when we had NO idea about how HIV was transmitted) the world went on as it should. The SARS-COV-2 virion is virtually the same size as the influenza virion. Physics properties are likely to be more or less the same.
So why do we abandon everything we know over a weekend and go a different direction? The FOIL'd evidence shows that Fauci changed his mind about masking (from "known to be useless" to "wear six if you can" -- yes, paraphrasing but correct) over an identifiable weekend. When asked about it in his deposition (which you should read if you want a lesson in dissembling) he said "I must have had a very good reason, but cannot remember what it is." This is Mr. Science? This is EBM of any sort?
Masking was what really sent me down the road of believing that something else was/is going on. The FOIL'd conversations about squelching the GBD (surely a reasonably sound epidemiologic piece written by three epidemiologists that merited discussion if nothing else) that was done by a concerted, world-wide network led by Collins in a very deliberate fashion ring utterly false to me. And Birx set much of this policy (if you do not know Scott Atlas, you should) even though she had zero training in anything relevant -- but the strong endorsement of the CIA.
I am far from a tinfoil hat guy -- I am a tenured full, sit on lots of committees that are quite mainstream, did all allowable terms on the board of my professional society. As noted, I was CSO of a major health care organization involving thousands and thousands of employees, their families and patients. Yet I was easily able to criticize the decisions that were being made AND DID SO AT THE TIME. My advice, since shown to be overwhelmingly correct, was it was all rubbish and I had lots of science to back me up. Previously unknown viruses arise all the time -- in our lifetimes we have seen many. And it really bothered me that much of the reaction was contrary to all Public Health principles which up to that point were to keep fear allayed -- the managed covid reaction was to magnify fear as much as possible. This just felt, and feels, like something that was being managed for some other purpose than public health or anyone's health. I have yet to see anyone show otherwise. Confused/worried people retreat to "the book of dealing with unplanned pandemics" -- they do not just throw it all way for interventions known not to work on a whim.
Do I have special insight as to what the actual covid agenda of someone was/is? Nope. And maybe you think it is just panic like the monkeys writing the Britannica...not impossible. There are as many theories out there as people. Sadly, many of the tinfoil hat ideas, rabidly squelched by the press and the government have turned out to be true.
Perhaps it is just the overwhelming government desire to get between patients and physicians driving this -- that has been a source of enormous distress to lots of bureaucrats and big government people forever. I spent a LOT of time fighting AB2098 in California because that seemed to be the natural outcome of the entire covid dance. An actual bill, passed into law, that says "You can only tell patients the government-approved diktats. This applies irrespective of whether they are true or false and/or whether they are good or bad for the patient." A governmental dream -- a patient care nightmare. I failed to stop it (no surprise) but luckily the courts have done so.
About as enlightened as I can put out there. Wish I had more answers. But I have been pretty deep in to this for three years now and still am confident I am missing something more than "scary reaction to unknown virus". One man's opinion.
Dr K, if you have not done so you may want to read the series of articles written by Debbie Lehrman and published on Brownstone.org. She has researched the question where the Covid response came from and documents that it was developed and led not by US Public Health authorities but by the National Security Council, in effect treating Covid as a bioweapon. Birx was put on the Covid committee by the NSC.
You have to be nuts to base any protocol on any of this silly studies. Here's a much more meaningful study that should be done.
Take 5,000 people ages 60-90 and put them on big pharma heart drugs. Monitor them for about 10 years minimum. Adjust for factors such as smoking or poor diet or previous heart episodes.
Take 5,000 people ages 60-90 and put them on a healthy diet adding in heart beneficial herbs and supplements. Make the same adjustments.
Maybe even add a placebo group of similar size.
Assess the data and go from there. You have to prove to me that big pharma drugs are more beneficial than doing other healthier things. I cannot blindly trust the medical community for anything anymore...especially after the pandemic fiasco.
If you expand your view beyond cardiology, you'll see the same pattern throughout many fields of medicine. Orthopedics has built its fortunes on bad science like this.
I love how you are naive, Dr. Mandrola and “don’t want to become” cynical. You can not be cynical enough. I would go so far as to say that all studies done today that point to benefits of a drug or treatment are tainted irredeemably. You can piece together theories of why things work or don’t work, using older studies, and animal studies that are not promoting a drug or treatment, and over time you will become very, very smart. I find raypeat.com a useful website for this. Anything on Youtube that Georgi Dinkov is discussing is useful. There are some smart guys all over. But you have to do your own thinking from now on, is my suggestion.
Thank you for your work, John. You have a unique and invaluable voice in speaking truth to the self-interested powers that be in the medical-industrial complex.
As a dermatologist, I am starting to use JAK inhibitors but am concerned about the CV risk. I learned a lot about non-inferiority trials in your presentation about Watchman and would love a similar analysis of CV risks for non-RA patients. Itching is bad but it won’t kill you. Hope you will entertain this idea because we Derms can’t get good info we can understand
The general problem: Data collected for other purposes is free and apparently irresistible. The false hope of "real world data" is biting us in the ... while delaying the launch of needed randomized trials.
Thank you for your fantastic explanations of this issue lately.
“they used claims data from a US administrative database, from OptumLabs.” This part stood out to me. Could it be as simple a matter as laziness? That is, in the old days, before fingertip access to huge online medical databases, you had to do the legwork of putting a study together, in which case if you’re putting in the effort might as well go the whole nine yards and do an RCT. But when you can get published in a major journal without leaving your desk, just running some opaque statistical tricks from someone else’s computer model on someone else’s database, it’s tempting to cut corners, no? Just a thought! I could be way off.
My suggestion would be to change the name of procedure from LAAO to LMAO!!
They compared 8400 pts vs 554,000 pts. That’s a ratio of 1:66.
I don’t have a huge problem with their concluding statements, which do not seem to be that much of an over-reach. “…..suggests….benefit….in select patients”. One out of every 67, actually.
The real problem is for the authors to simply stop there, rather than taking the next step, which could have reasonably included:
A) we will now try to better characterize those who received the device and enjoyed apparent benefit; then
B). We will now test with a proper RCT in the cohort with those characteristics to see if the device is actually causally responsible for the perceived benefits.
Interesting thoughts. I spend my recent epidemiologic time with Harvey, Jay and Garrett...I assume you know who they all are. But I generally assume there is an explanation to anything that happens. If I do not understand it, then I just assume there are facts not in evidence to me....but someone has them. In general, if you are not in control/understanding than someone else is.
MMWR, which I have read for years, became almost completely political with regard to COVID since the beginning of the covid mess. I cannot tell you why, but virtually everything back to the beginning, like the datacrimed school study in Arizona or the ridiculous Nebraska hairdresser piece has been fraud or near fraud. Nothing evidence based about any of it.
I was well steeped in the pandemic preparedness prior to 2020. (I was CSO of a very large healthcare organization at the time -- was important to have relevant plans for most everything.) No masks. No lockdowns. Well understood across the spectrum and around the world. There was, literally, endless data to back it up. Coronaviruses have also long been reasonably well understood -- responsible for, perhaps, a third of all your lifetime colds. Serious respiratory viruses have been common and understood as a typical cause of death for those infirm and elderly ("pneumonia" still the most common COD in the elderly).
I was heavily involved in HIV when it first reared its ugly head, and SARS as well. (Avoided MERS...lol.) Other than universal precautions in health care (when we had NO idea about how HIV was transmitted) the world went on as it should. The SARS-COV-2 virion is virtually the same size as the influenza virion. Physics properties are likely to be more or less the same.
So why do we abandon everything we know over a weekend and go a different direction? The FOIL'd evidence shows that Fauci changed his mind about masking (from "known to be useless" to "wear six if you can" -- yes, paraphrasing but correct) over an identifiable weekend. When asked about it in his deposition (which you should read if you want a lesson in dissembling) he said "I must have had a very good reason, but cannot remember what it is." This is Mr. Science? This is EBM of any sort?
Masking was what really sent me down the road of believing that something else was/is going on. The FOIL'd conversations about squelching the GBD (surely a reasonably sound epidemiologic piece written by three epidemiologists that merited discussion if nothing else) that was done by a concerted, world-wide network led by Collins in a very deliberate fashion ring utterly false to me. And Birx set much of this policy (if you do not know Scott Atlas, you should) even though she had zero training in anything relevant -- but the strong endorsement of the CIA.
I am far from a tinfoil hat guy -- I am a tenured full, sit on lots of committees that are quite mainstream, did all allowable terms on the board of my professional society. As noted, I was CSO of a major health care organization involving thousands and thousands of employees, their families and patients. Yet I was easily able to criticize the decisions that were being made AND DID SO AT THE TIME. My advice, since shown to be overwhelmingly correct, was it was all rubbish and I had lots of science to back me up. Previously unknown viruses arise all the time -- in our lifetimes we have seen many. And it really bothered me that much of the reaction was contrary to all Public Health principles which up to that point were to keep fear allayed -- the managed covid reaction was to magnify fear as much as possible. This just felt, and feels, like something that was being managed for some other purpose than public health or anyone's health. I have yet to see anyone show otherwise. Confused/worried people retreat to "the book of dealing with unplanned pandemics" -- they do not just throw it all way for interventions known not to work on a whim.
Do I have special insight as to what the actual covid agenda of someone was/is? Nope. And maybe you think it is just panic like the monkeys writing the Britannica...not impossible. There are as many theories out there as people. Sadly, many of the tinfoil hat ideas, rabidly squelched by the press and the government have turned out to be true.
Perhaps it is just the overwhelming government desire to get between patients and physicians driving this -- that has been a source of enormous distress to lots of bureaucrats and big government people forever. I spent a LOT of time fighting AB2098 in California because that seemed to be the natural outcome of the entire covid dance. An actual bill, passed into law, that says "You can only tell patients the government-approved diktats. This applies irrespective of whether they are true or false and/or whether they are good or bad for the patient." A governmental dream -- a patient care nightmare. I failed to stop it (no surprise) but luckily the courts have done so.
About as enlightened as I can put out there. Wish I had more answers. But I have been pretty deep in to this for three years now and still am confident I am missing something more than "scary reaction to unknown virus". One man's opinion.
Dr K, if you have not done so you may want to read the series of articles written by Debbie Lehrman and published on Brownstone.org. She has researched the question where the Covid response came from and documents that it was developed and led not by US Public Health authorities but by the National Security Council, in effect treating Covid as a bioweapon. Birx was put on the Covid committee by the NSC.
You have to be nuts to base any protocol on any of this silly studies. Here's a much more meaningful study that should be done.
Take 5,000 people ages 60-90 and put them on big pharma heart drugs. Monitor them for about 10 years minimum. Adjust for factors such as smoking or poor diet or previous heart episodes.
Take 5,000 people ages 60-90 and put them on a healthy diet adding in heart beneficial herbs and supplements. Make the same adjustments.
Maybe even add a placebo group of similar size.
Assess the data and go from there. You have to prove to me that big pharma drugs are more beneficial than doing other healthier things. I cannot blindly trust the medical community for anything anymore...especially after the pandemic fiasco.
If you expand your view beyond cardiology, you'll see the same pattern throughout many fields of medicine. Orthopedics has built its fortunes on bad science like this.
Before covid was there a med journal you trusted? After covid is there one?
I love how you are naive, Dr. Mandrola and “don’t want to become” cynical. You can not be cynical enough. I would go so far as to say that all studies done today that point to benefits of a drug or treatment are tainted irredeemably. You can piece together theories of why things work or don’t work, using older studies, and animal studies that are not promoting a drug or treatment, and over time you will become very, very smart. I find raypeat.com a useful website for this. Anything on Youtube that Georgi Dinkov is discussing is useful. There are some smart guys all over. But you have to do your own thinking from now on, is my suggestion.
Good work John
Thank you for your work, John. You have a unique and invaluable voice in speaking truth to the self-interested powers that be in the medical-industrial complex.
As a dermatologist, I am starting to use JAK inhibitors but am concerned about the CV risk. I learned a lot about non-inferiority trials in your presentation about Watchman and would love a similar analysis of CV risks for non-RA patients. Itching is bad but it won’t kill you. Hope you will entertain this idea because we Derms can’t get good info we can understand
The general problem: Data collected for other purposes is free and apparently irresistible. The false hope of "real world data" is biting us in the ... while delaying the launch of needed randomized trials.
Are they all captured?
And, is it true that the 3rd leading cause of death is MD directed treatment?
A great read slash great teaching material - as always. Thank you Doctor Mandrola.
Thank you for your fantastic explanations of this issue lately.
“they used claims data from a US administrative database, from OptumLabs.” This part stood out to me. Could it be as simple a matter as laziness? That is, in the old days, before fingertip access to huge online medical databases, you had to do the legwork of putting a study together, in which case if you’re putting in the effort might as well go the whole nine yards and do an RCT. But when you can get published in a major journal without leaving your desk, just running some opaque statistical tricks from someone else’s computer model on someone else’s database, it’s tempting to cut corners, no? Just a thought! I could be way off.
In medical science, to find a prince, you have to kiss a lot of frogs.
It's time to practice our kissing technique. Too often a frog is mistaken for a prince.