The burden of proof lies on the shoulders of those who want to impose the intervention, not on those questioning the necessity of the intervention. Why, since C19 pandemic inception, have we been assuming the opposite?
I've been asking the same thing myself. I can't help but believe it was a perfect storm of cultural-elitist influence, the average American's lack of ability to reason, and...as VP puts it...magical thinking. I held most of my fellow, local physicians in derision for their failure to act logically in light of masking's data (or lack thereof). They were the chief magical thinkers in our community...always pushing the face amulets for all people at all times. I was one of the only physicians who scoured pubmed for data, found none, and acted on it. Stopped masking immediately.
I think there rightly should be a double standard when interpreting CI's:
1) Efficacy: If the point estimate is favorable, but the CI is wide, we should not jump on it, although admitting an effect is possible.
2) Safety: If the point estimate is unfavorable, but the CI is wide, we should jump on it and vigorously examine it to see if there is a risk.
In other words, safety always comes first.
Something everyone seems to ignore is that it is also plausible that facemasks could *increase* both covid transmission and severity, which makes it totally unacceptable to presume the risks are not substantial:
"The Foegen Effect". This paper points out two simple mechanisms:
1) Not only do facemasks keep aerosols out, they also keep them *in*. So there may be a rebreathing of purified virus.
2) The facemask is not only a filter, but potentially a concentrator. The water in aerosols evaporates instantly, and now you have smaller viral particles that may be able to travel further into the lungs.
If a person wanted to deploy the logic of so-called experts, one could also say the Cochrane review's CI's are consistent with the hypothesis that facemasks are causing people to die from covid. I'm not saying that. Just pointing out how crazy the logic is.
The Foegen effect paper has only 4 PubMed citations after an entire year. And none of them critically discuss the hypothesis. It is one thing to erroneously treat a novel hypothesis. It is something else to not even acknowledge its existence.
The other risks of facemasks number in the dozens. The issue of CO2 inhalation for example is far from settled:
But what really makes the experts senseless is that they did not even jump on the best possible benefit of facemasks. It's not about preventing transmission. It's about reducing severity. Reducing viral dose and humidifying the lungs are two mechanisms to support that hypothesis. The masks promoters don't even know this...
As for the "we have physics" people: Physics says facemasks could make things better or worse. Therefore no RCTs are needed, cuz logic.
Edit: Also forgot to mention they never tested mask fitters like the Badger seal. These could drastically alter facemask efficacy and risks.
Ian Miller has been showing in charts on Twitter and Unmasked in SubStack and in his book that masking did little to stop or slow the spread. Aside from the RCT issue, that data from populations show masks don't help much if at all. The size of the RCT to show the small effect would need to be huge, say like between two nations with two matched populations - not likely.
"The size of the RCT to show the small effect would need to be huge" -
Please do the math and show us how allegedly huge it would have to be!
No hand waiving. Not as huge as you imagine.
The allegation without the math that an RCT would have to be "huge" Is the kind of statement that gets turned around against doing RCTs (ostensibly too hard).
Deming, et al brought sampling theory to the Census Bureau in ~1939. We do not have to reinvent the wheel to do all kinds of sufficiently powered studies.
The point of RCTs over sampling is potential bias creeping in a non uniform population. If the effect is small then larger samples are needed to reduce the variance. On the mask issue we might see an effect below < 10% reduction in spread. Aside from Ian Millers charts which show masking did little, the small RCTs have large confidence spreads. And the inability to prove a negative.
"Many experts are actively treating masks differently than any other medical intervention and inventing new standards to reject practices (the entire CI must be unfavorable), which have not been used in any aspect of medicine. It is hard to believe this is genuine trial interpretation and not a desire to preserve something that many people have faith in, believe in, trust in."
Yet more evidence (speaking of...) that masks are about religion, not science.
Most physicians have no idea what a confidence interval is !!!! They read the Title and maybe the abstract. The conclusion if they have a no show patient.
My general philosophy when it comes to understanding evidence comes from a great quote I heard a while back:
“The absence of evidence is not evidence of anything. It literally signifies nothing.”
The evidence in favour of masking is non-existent. So we should not conclude that they work. What little evidence does exist on their effectiveness is not encouraging.
I spent the pandemic arguing with people that they shouldn’t be required to wear masks. If they wanted to do it, they should be allowed to but it shouldn’t be required by the government or anyone else. The same way that women shouldn’t be required to wear certain types of clothing for religious or other reasons. They should have the choice.
Dr. Prasad, have you considered designing a course on how to read and analyze scientific evidence for lay people? I would love to study that! Thanks for spreading good information 🙏
What does the directive to "do no harm" really mean and what should it tell physicians about the burden of proof before any intervention?
I'd probably make the strong case that first the CI that medicine should be using is 99% not 95%! AND that no intervention should be used when then upper bound of the hazard ratio (HR) is >= 1, unless you've told the prospective patients that the proposed intervention is a placebo.
If the idea that medicine is art and science, means that that physicians must be human beings interacting with other humans. Ok. The human condition of our collective works, joys, and sufferings cannot be reduced to an algorithmic reduction of particles of matter knocking into each other. (No physicist believes that today and photons aren't even matter.)
BUT If the idea that medicine is art and science means that that physicians can sometimes be crypto-shamans or crystal waiving charlatans - HARD PASS! Let's try some eye of newt - it worked that one time - is not medicine.
Basically the authors took people with asthma and allergy to dust mites and made them *p*ut their bedding in impermeable bed covers or sham impermeable covers. The covers are supposed to stop the mites. The question was if this would lower exacerbations.
The burden of proof lies on the shoulders of those who want to impose the intervention, not on those questioning the necessity of the intervention. Why, since C19 pandemic inception, have we been assuming the opposite?
I've been asking the same thing myself. I can't help but believe it was a perfect storm of cultural-elitist influence, the average American's lack of ability to reason, and...as VP puts it...magical thinking. I held most of my fellow, local physicians in derision for their failure to act logically in light of masking's data (or lack thereof). They were the chief magical thinkers in our community...always pushing the face amulets for all people at all times. I was one of the only physicians who scoured pubmed for data, found none, and acted on it. Stopped masking immediately.
Trump.
I think there rightly should be a double standard when interpreting CI's:
1) Efficacy: If the point estimate is favorable, but the CI is wide, we should not jump on it, although admitting an effect is possible.
2) Safety: If the point estimate is unfavorable, but the CI is wide, we should jump on it and vigorously examine it to see if there is a risk.
In other words, safety always comes first.
Something everyone seems to ignore is that it is also plausible that facemasks could *increase* both covid transmission and severity, which makes it totally unacceptable to presume the risks are not substantial:
https://pubmed.ncbi.nlm.nih.gov/35363218/
"The Foegen Effect". This paper points out two simple mechanisms:
1) Not only do facemasks keep aerosols out, they also keep them *in*. So there may be a rebreathing of purified virus.
2) The facemask is not only a filter, but potentially a concentrator. The water in aerosols evaporates instantly, and now you have smaller viral particles that may be able to travel further into the lungs.
If a person wanted to deploy the logic of so-called experts, one could also say the Cochrane review's CI's are consistent with the hypothesis that facemasks are causing people to die from covid. I'm not saying that. Just pointing out how crazy the logic is.
The Foegen effect paper has only 4 PubMed citations after an entire year. And none of them critically discuss the hypothesis. It is one thing to erroneously treat a novel hypothesis. It is something else to not even acknowledge its existence.
The other risks of facemasks number in the dozens. The issue of CO2 inhalation for example is far from settled:
https://pubmed.ncbi.nlm.nih.gov/36133777/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9142210/
But what really makes the experts senseless is that they did not even jump on the best possible benefit of facemasks. It's not about preventing transmission. It's about reducing severity. Reducing viral dose and humidifying the lungs are two mechanisms to support that hypothesis. The masks promoters don't even know this...
As for the "we have physics" people: Physics says facemasks could make things better or worse. Therefore no RCTs are needed, cuz logic.
Edit: Also forgot to mention they never tested mask fitters like the Badger seal. These could drastically alter facemask efficacy and risks.
Ian Miller has been showing in charts on Twitter and Unmasked in SubStack and in his book that masking did little to stop or slow the spread. Aside from the RCT issue, that data from populations show masks don't help much if at all. The size of the RCT to show the small effect would need to be huge, say like between two nations with two matched populations - not likely.
"The size of the RCT to show the small effect would need to be huge" -
Please do the math and show us how allegedly huge it would have to be!
No hand waiving. Not as huge as you imagine.
The allegation without the math that an RCT would have to be "huge" Is the kind of statement that gets turned around against doing RCTs (ostensibly too hard).
Deming, et al brought sampling theory to the Census Bureau in ~1939. We do not have to reinvent the wheel to do all kinds of sufficiently powered studies.
The point of RCTs over sampling is potential bias creeping in a non uniform population. If the effect is small then larger samples are needed to reduce the variance. On the mask issue we might see an effect below < 10% reduction in spread. Aside from Ian Millers charts which show masking did little, the small RCTs have large confidence spreads. And the inability to prove a negative.
"Many experts are actively treating masks differently than any other medical intervention and inventing new standards to reject practices (the entire CI must be unfavorable), which have not been used in any aspect of medicine. It is hard to believe this is genuine trial interpretation and not a desire to preserve something that many people have faith in, believe in, trust in."
Yet more evidence (speaking of...) that masks are about religion, not science.
more politics than religion - probably.
Most physicians have no idea what a confidence interval is !!!! They read the Title and maybe the abstract. The conclusion if they have a no show patient.
They get their marching orders from the news.
Agreed 100%
Love it. Well done, VP.
My general philosophy when it comes to understanding evidence comes from a great quote I heard a while back:
“The absence of evidence is not evidence of anything. It literally signifies nothing.”
The evidence in favour of masking is non-existent. So we should not conclude that they work. What little evidence does exist on their effectiveness is not encouraging.
I spent the pandemic arguing with people that they shouldn’t be required to wear masks. If they wanted to do it, they should be allowed to but it shouldn’t be required by the government or anyone else. The same way that women shouldn’t be required to wear certain types of clothing for religious or other reasons. They should have the choice.
Think of masking as a religious belief. In that light it doesn't matter whether there is evidence, one just believes on faith.
"In God we trust, all others must bring data."
Stolen!
Dr. Prasad, have you considered designing a course on how to read and analyze scientific evidence for lay people? I would love to study that! Thanks for spreading good information 🙏
What does the directive to "do no harm" really mean and what should it tell physicians about the burden of proof before any intervention?
I'd probably make the strong case that first the CI that medicine should be using is 99% not 95%! AND that no intervention should be used when then upper bound of the hazard ratio (HR) is >= 1, unless you've told the prospective patients that the proposed intervention is a placebo.
If the idea that medicine is art and science, means that that physicians must be human beings interacting with other humans. Ok. The human condition of our collective works, joys, and sufferings cannot be reduced to an algorithmic reduction of particles of matter knocking into each other. (No physicist believes that today and photons aren't even matter.)
BUT If the idea that medicine is art and science means that that physicians can sometimes be crypto-shamans or crystal waiving charlatans - HARD PASS! Let's try some eye of newt - it worked that one time - is not medicine.
Such essays and discussions of studies are invaluable to the layman. Thank you once again for the ongoing education.
Autologous transplant for breast cancer. Oh what a delightful petard to hoist that mask study on. Oof
Dont you mean " the absence of evidence is not evidence of absence"?
Ask any engineer how they defined their safety margins. They just pick one that includes the possibility of safety.
errata corrected:
Basically the authors took people with asthma and allergy to dust mites and made them *p*ut their bedding in impermeable bed covers or sham impermeable covers. The covers are supposed to stop the mites. The question was if this would lower exacerbations.