Tens of thousands of deaths from COVID annually in the U.S, mostly in the elderly -- and we wring our hands over methodological flaws and lower event rates vs 2-3 years ago and exclaim if ONLY there was SOMETHING that might reduce the number of these deaths!! (see the Kaplan Meier curves in link 2) Or worse, shrug and mutter 'this is the new normal -- move on folks...'
Hooray, Adam. Good for you. As I go to the airport and interface with healthcare institutions in Houston, there is clearly very inconsistent concerns about COVID in Houston. Some of my physicians are choosing to wear masks but most do not. There is inadequate data available to make truly informed decisions. Many of our fellow citizens are choosing NOT to pursue regular boosters despite the endorsement of CDC, FDA, and speciality societies. We clarification which can come with data. Sadly, our national leaders have lost the respect of many of the lay public.
This will be a front burner issue for some time, the duration of which should approximate the number of winter seasons where FDA continues to push boosters absent high quality evidence showing benefit.
I was all in with primary series and initial boosters, when we were dealing with COVId classic and variants up to delta. Once we got to omicron, it has been a much different story. And the extension of use to young children has been quite appalling imo given the (lack of) data available.
As has been said, practice of EBM is in extrapolating average results from study populations onto individual patients. In this case, we have no reliable representation of what those average results might be. And that’s a dereliction of duty by the FDA. As you say, there’s no incentive for vaccine makers to do the hard work, unless the regulator mandates it.
"I would have preferred overall hospitalization and overall mortality, but you get you get what you get…"
Am I reading this wrong? Isn't what you got only hospitalization and death by Covid?
I think your argument with your friend is missing the point. The problem with vaccines is that they affect overall hospitalization and overall mortality. I don't want a booster if it's going to raise my risk of having a heart attack or cancer 3 fold. And in fact, I ended up with a noticable arrythmia after my first Pfizer vaccine. The reason people are questioning effectiveness is because they already question the safety. I think overall mortality and hospitalization as well as long-term overall mortality are essential to making a decision about boosters.
You're not really asking for effectiveness data to be redone every 6 month, you're asking for people to stop pushing a product you know to be unsafe if it's not going to be effective enough to warrant the risk, and you're hoping that effectiveness data will be their wake up call.
The true strength of sensible medicine is, it’s humility. All authors write without the impression of dogma. You guys welcome opposing viewpoints, which is what I admire. Nobody is right all the time, nor wrong all the time. The best we can do is draw correlations and gestalt , but never causation. The most important part of any study is the limitations section. That’s assuming that the authors are honest about the results. That’s why outside reviews are imperative.
The most important part of an analysis of a medical study is the quality of the data. Covid data is so bad that it would be laughable if the consequences from it weren't so horrendous. First of all, no virus was ever isolated---the genome selected was computer generated from several short nucleotide chains from the secretions of a single patient in Wuhan; known as an "in silico" genome. Secondly, the tests are wildly inaccurate. So all the time and effort put in to analyze the data is a colossal waste. But there is one possibly beneficial aspect to all of this. Doctors used to be criticized as being unable to cure even the common cold. We have now eliminated the common cold and flu by renaming it as Covid.
As a numbers person, the table clearly indicates that the 80/20 rule applies. The highest proportion of the cases affect the over 75 group, so why are all the resources being pushed to vaccinate everyone multiple times. It is time we human beings reject fear as the motivator for our decisions.
It is not wrong to keep covid on the front burner. The lessons of recent history strike at the heart of a wide array of issues in medicine and the larger non-medical media, and so are worth discussing. A few examples of a very long list:
- The major public health institutions in the USA (NIH, FDA, CDC) have rightfully lost trust due to their insistence on pushing a narrative based on power and whim. Regarding medical studies and internet platforms, they have transparently put their finger on the balance to support their narrative by suppressing unfavorable studies and censoring views and opinions that challenge their narrative.
- These institutions are a textbook example of regulatory capture: They do the bidding of the organizations they are supposed to regulate at the expense of the general public.
- Way beyond covid, FDA approval of all new pharmaceuticals and devices should be suspect.
- The legacy media are very much guilty of cooperating with the PH narrative of fear and ignorance. It's a head scratcher that the polemics are framed as left wing vs right wing. Aren't the left wing supposed to be anti-corporation and anti-government intrusions into personal affairs? It seems that the left wing has become "the man" these days.
- By throwing objectivity and neutrality out the window, medical journals are as guilty of manipulation as the other spheres of activity mentioned above.
- The similarities of the covid story to climate alarmism and the DEI metastasis is striking, and not in a good way.
I think the way to look at things now with regard to covid boosters, and for that matter the RSV vaccine is that : (1) these are just 2 viruses among many that result in an ILI; (2) both viruses result in mild disease with the usual spectrum for all ILIs; (3) the adverse events surrounding both vaccines, and especially the COVID one are substantial and common, and some adverse events are really severe; and (4) multiple boosting, if anything, deadens one's immune response (original antigenic sin); (5) there is a very sizable shift towards IgG4 which does not protect one against foreign agents but rather allows one to tolerate them; and (6) the duration of any potential efficacy is very short-lived for the COVID vaccine and boosters. Bottom line: there is absolutely no evidence that COVID boosters protect against hospitalization and death and the risks vastly outweigh any possible benefits. In fact, the original Pfizer and Moderna RCTs provided absolutely no evidence that the vaccines reduced death since there were in fact slightly more deaths in the vaccinated arm than the control arm – there is no point in having a vaccine that may protect against COVID if it increases one's chance of death for adverse events such as myocraditis. The second bottom line is that Vinay is absolutely correct in regard to the current status of COVID vaccines.
I am 70 years old; no comorbidities (other than age) and quit after one booster (and three months after that got my first case of COVID; mild). No more boosters for me until someone explains how the observed class shift to IgG4 after repeated immunization is not a bad thing...not to mention the Cleveland Clinic study seeming to indicate that repeat boosting increased the likelihood of infection.
I appreciate Dr. Cifu's careful analysis of the Lancet paper. However, given 1) 1500 COVID deaths weekly in the US early this winter; 2) strong data from countries with robust national EMRs that a booster mRNA reduces COVID admits and mortality, and 3) recent Kaiser system data showing little lasting protection from prior infection or remote COVID vaccination, for me the case for encouraging booster vaccination in older and immunocompromised folks remains strong. https://abcnews.go.com/Health/1500-americans-dying-covid-week/story?id=106237143 https://www.bmj.com/content/bmj/382/bmj-2022-075286.full.pdf https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(23)00306-5/fulltext
Tens of thousands of deaths from COVID annually in the U.S, mostly in the elderly -- and we wring our hands over methodological flaws and lower event rates vs 2-3 years ago and exclaim if ONLY there was SOMETHING that might reduce the number of these deaths!! (see the Kaplan Meier curves in link 2) Or worse, shrug and mutter 'this is the new normal -- move on folks...'
Hooray, Adam. Good for you. As I go to the airport and interface with healthcare institutions in Houston, there is clearly very inconsistent concerns about COVID in Houston. Some of my physicians are choosing to wear masks but most do not. There is inadequate data available to make truly informed decisions. Many of our fellow citizens are choosing NOT to pursue regular boosters despite the endorsement of CDC, FDA, and speciality societies. We clarification which can come with data. Sadly, our national leaders have lost the respect of many of the lay public.
This will be a front burner issue for some time, the duration of which should approximate the number of winter seasons where FDA continues to push boosters absent high quality evidence showing benefit.
I was all in with primary series and initial boosters, when we were dealing with COVId classic and variants up to delta. Once we got to omicron, it has been a much different story. And the extension of use to young children has been quite appalling imo given the (lack of) data available.
As has been said, practice of EBM is in extrapolating average results from study populations onto individual patients. In this case, we have no reliable representation of what those average results might be. And that’s a dereliction of duty by the FDA. As you say, there’s no incentive for vaccine makers to do the hard work, unless the regulator mandates it.
If the vaccine was both perfectly safe and free this would mostly be a moot point. One could say: why not?
As it is neither, other considerations must come into play.
Imagine it is perfectly safe but costs $100/shot. In this scenario we might calculate cost effectiveness and compare to other uses of the money.
But is it perfectly safe?
Adam, you said
"I would have preferred overall hospitalization and overall mortality, but you get you get what you get…"
Am I reading this wrong? Isn't what you got only hospitalization and death by Covid?
I think your argument with your friend is missing the point. The problem with vaccines is that they affect overall hospitalization and overall mortality. I don't want a booster if it's going to raise my risk of having a heart attack or cancer 3 fold. And in fact, I ended up with a noticable arrythmia after my first Pfizer vaccine. The reason people are questioning effectiveness is because they already question the safety. I think overall mortality and hospitalization as well as long-term overall mortality are essential to making a decision about boosters.
You're not really asking for effectiveness data to be redone every 6 month, you're asking for people to stop pushing a product you know to be unsafe if it's not going to be effective enough to warrant the risk, and you're hoping that effectiveness data will be their wake up call.
The true strength of sensible medicine is, it’s humility. All authors write without the impression of dogma. You guys welcome opposing viewpoints, which is what I admire. Nobody is right all the time, nor wrong all the time. The best we can do is draw correlations and gestalt , but never causation. The most important part of any study is the limitations section. That’s assuming that the authors are honest about the results. That’s why outside reviews are imperative.
Ben Hourani.
The most important part of an analysis of a medical study is the quality of the data. Covid data is so bad that it would be laughable if the consequences from it weren't so horrendous. First of all, no virus was ever isolated---the genome selected was computer generated from several short nucleotide chains from the secretions of a single patient in Wuhan; known as an "in silico" genome. Secondly, the tests are wildly inaccurate. So all the time and effort put in to analyze the data is a colossal waste. But there is one possibly beneficial aspect to all of this. Doctors used to be criticized as being unable to cure even the common cold. We have now eliminated the common cold and flu by renaming it as Covid.
As a numbers person, the table clearly indicates that the 80/20 rule applies. The highest proportion of the cases affect the over 75 group, so why are all the resources being pushed to vaccinate everyone multiple times. It is time we human beings reject fear as the motivator for our decisions.
.
It is not wrong to keep covid on the front burner. The lessons of recent history strike at the heart of a wide array of issues in medicine and the larger non-medical media, and so are worth discussing. A few examples of a very long list:
- The major public health institutions in the USA (NIH, FDA, CDC) have rightfully lost trust due to their insistence on pushing a narrative based on power and whim. Regarding medical studies and internet platforms, they have transparently put their finger on the balance to support their narrative by suppressing unfavorable studies and censoring views and opinions that challenge their narrative.
- These institutions are a textbook example of regulatory capture: They do the bidding of the organizations they are supposed to regulate at the expense of the general public.
- Way beyond covid, FDA approval of all new pharmaceuticals and devices should be suspect.
- The legacy media are very much guilty of cooperating with the PH narrative of fear and ignorance. It's a head scratcher that the polemics are framed as left wing vs right wing. Aren't the left wing supposed to be anti-corporation and anti-government intrusions into personal affairs? It seems that the left wing has become "the man" these days.
- By throwing objectivity and neutrality out the window, medical journals are as guilty of manipulation as the other spheres of activity mentioned above.
- The similarities of the covid story to climate alarmism and the DEI metastasis is striking, and not in a good way.
I think the way to look at things now with regard to covid boosters, and for that matter the RSV vaccine is that : (1) these are just 2 viruses among many that result in an ILI; (2) both viruses result in mild disease with the usual spectrum for all ILIs; (3) the adverse events surrounding both vaccines, and especially the COVID one are substantial and common, and some adverse events are really severe; and (4) multiple boosting, if anything, deadens one's immune response (original antigenic sin); (5) there is a very sizable shift towards IgG4 which does not protect one against foreign agents but rather allows one to tolerate them; and (6) the duration of any potential efficacy is very short-lived for the COVID vaccine and boosters. Bottom line: there is absolutely no evidence that COVID boosters protect against hospitalization and death and the risks vastly outweigh any possible benefits. In fact, the original Pfizer and Moderna RCTs provided absolutely no evidence that the vaccines reduced death since there were in fact slightly more deaths in the vaccinated arm than the control arm – there is no point in having a vaccine that may protect against COVID if it increases one's chance of death for adverse events such as myocraditis. The second bottom line is that Vinay is absolutely correct in regard to the current status of COVID vaccines.
I am 70 years old; no comorbidities (other than age) and quit after one booster (and three months after that got my first case of COVID; mild). No more boosters for me until someone explains how the observed class shift to IgG4 after repeated immunization is not a bad thing...not to mention the Cleveland Clinic study seeming to indicate that repeat boosting increased the likelihood of infection.