Last week's news on the booster approvals and Florida's controversial vaccine mortality study was a low water mark for common sense and scientific reason.
OP: "The study design itself was puzzling, a lightly used method called a “Self-Controlled Case Series” which required about 30 minutes of reading and re-reading on my part to even comprehend what they had done."
Dr. Tracy Hoeg had an educational comment about the Florida study.
"Both on Twitter and in the mainstream media, people were quick to try to criticize the study design for inappropriate controls or for lack of information on benefits of the vaccine. But the so-called “self-controlled case series (SCCS)” method has a very smart built-in control group of only people who have experienced the adverse event and is simply not designed to assess benefits.
The SCCS method was actually created to assess vaccine safety. It was first introduced by Paddy Farrington, Elizabeth Miller and team in The Lancet in 1995 as a way to look for association of the adverse events of febrile seizure and immune thrombocytopenia from DPT and MMR vaccines.
It is a well-established epidemiologic method for evaluating safety and has been used numerous times already to evaluate the Covid-19 vaccines, in the UK (1,2), France and Nordic countries."
OP: "This is July 2020; hydroxychloroquine had already been roundly exposed as having minimal evidence for its use for months at this point, and this was a strange intellectual hill on which to die."
Ummm, what was the key takeaway from the link you posted? Was it this, "“This is not a treatment for COVID-19. It doesn’t work,” Martin Landray, an Oxford University professor who is co-leading the RECOVERY trial, told reporters?"
You are dealing with a controversial topic, so it's necessary to look at methods and data, including limitations. What was the key limitation from the RECOVERY trial of HCQ? In NEJM we read, "These findings indicate that hydroxychloroquine is not an effective treatment for hospitalized patients with Covid-19 but do not address its use as prophylaxis or in patients with less severe SARS-CoV-2 infection managed in the community."
What was the stated limitation from the NEJM article? "...do not address its use as prophylaxis or in patients with less severe SARS-CoV-2 infection managed in the community." What is that? A limitation? But Landray, one of the authors said that HCQ doesn't work? Maybe the reporter slightly took Landray's comment out of context. The reporter certainly was ignorant of the limitation stated in the NEJM article.
I agree that HCQ is not appropriate for use in hospitals, from the RECOVERY trial, but it is very effective when given early, within 72 hours of symptom onset, as Accinelli, et. al., found.
"Results
A total...No patient treated within the first 72 h of illness died. The factors associated with higher case fatality rate were age (OR = 1.06; 95% CI 1.01–1.11, p = 0.021), SpO2 (OR = 0.87; 95% CI 0.79–0.96, p = 0.005) and treatment onset (OR = 1.16; 95% CI 1.06–1.27, p = 0.002), being the latter the only associated in the multivariate analysis (OR = 1.18; 95% CI 1.05–1.32, p = 0.005). 0.6% of our patients died."
Time to treatment with HCQ was the most significant factor in mortality.
So Ladapo made the correct decision to support early treatment with HCQ, because he was following the best scientific evidence available. Then Accinelli came along in Dec. 2021 and clinched the nail. (There have been some 100 studies or so of early treatment with HCQ. Almost all show a signal of benefit, with signal strength depending on the median time of beginning of treatment of patients where the median was close to or within 72 hours of symptom onset.)
And Ladapo, in the case of HCQ, did a better job of understanding the literature than many doctors who were HCQ skeptics.
Now we have to wonder why it took until Dec. 2021 to get the Accinelli data. A Midwestern Doctor might have a clue about this question.
[In my methods, I expect to have to sift baby from bathwater no matter the source. That's simply due diligence that all adults should do. This means that controversial topics need more analysis. And I know when the game changes from science to politics, I need to switch from scientific methods to political/funding analysis.]
I'm not a medical person but I am a scientist and out of sheer curiosity I did take a look at the very large (now) research on HCQ, not in great detail but reasonably comprehensively. My clear impression was also that the findings do indicate efficacy when used at the recommended dosages and very early (ideally within a few days of symptom onset), and preferably combined with zinc. This does seem to make perfect sense, at least to me, if the effect is largely anti-viral. Too often the reaction to HCQ seems to be simply based on some kind of crazy media fueled prejudice, e.g., I asked my GP tentatively about HCQ and her disgusted response was: "That stuff - it's the stuff Trump was pushing!". That turned out to be the sole basis of her opinion: she knew absolutely nothing about the research. She's no longer my GP.
I'm non-medical, too, but I am well-read in the covid literature and am somewhat diligent in my reading (at least compared with the average MD, lol). I understand the course of covid, which is as follows:
1) initial infection
2) viremia occurs on day 2-3
3) covid symptoms begin on about day 4-5
4) max viral load is achieved in mild cases on about day 8
5) virus is cleared in mild cases on about day 13 (8 days post symptom onset)
6) if progression occurs, it will begin about day 15 and will be felt as fatigue; a pulse ox will show pO2 <94%; hospitalization is likely here; this is due to inflammation in the tissues and widespread microvascular damage from immune attack; there are microthrombi and resulting hypoxemia, but CO2 will diffuse out into the alveoli just fine; RBCs are jammed up in capillaries and can't carry oxygen away
7) progression may occur to sepsis or ARDS and possibly systemic organ failure and death; pulmonary emboli, stroke and MI are also potential causes of death
It seemed quite obvious to me that it's essential to prevent progression and that means treating with antiviral before max viral load is reached in mild cases. Even if max viral load is reached later in some immune-incompetent people, that makes it just more essential to treat within the 72-hour-post-symptom-onset antiviral treatment window for covid.
So the RECOVERY trial seemed totally irrelevant to the obvious treatment plan for covid.
You should read the Daily Sceptic which is a daily newsletter published in the UK. It has been providing chapter and verse on various studies that seek to answer the key questions (vaccine efficacy and vaccine side-effects) since mid 2020. For example, there is now a LOT of data that suggests that the vaccines are potentially more harmful to children than Covid. My wife and I have decided that, even though we are over 70, we will wait until they approve a conventionally developed vaccine and will not get a mNRA vaccine.
thank you for this. the divide keeps growing, and it's starting to see the lack of self-awareness to tribalism within the factions. that florida thing was so bad, it's hard not to view Ladapo's move as intentional sabotage, since there's so much other legitimate data to validate his direction of guidance.
and that's precisely what worries me = the truth will be obfuscated through (intentional) incompetence and discredit the legitimate concerns around safety signals.
i appreciate your diligent breakdown of the topic. we simply can't devolve into factions and isolated echo chambers, else we will never see the common ground, and escalation will inevitably lead to self-destruction.
This is no different from history. Having escaped contagious diseases like polio and smallpox because of "vaccines", is a tale of 2 different mindsets. This isn't as much about science as it is fear of the unknown, or misunderstanding the facts that do exist. Including facts that may be skewed by math tricks known as statistics.
In my years of researching why so many of my Indigenous and non Indigenous ancestors, the nay sayers of today are no different than the historical documents portray.
I support science over superstition or conspiracy,. Science is not perfect but it needs our support and oversight by people who are qualified for that oversight.
What one must realized is Tucker Carlson has traded his intellect for fortune. He confronts known authorities with nonsense questions as rhetorical questions, those that do not or cannot be answered.....I once admired him greatly. Now I know I must raise my standards.
"...to then recommend a Moderna booster, despite clear data that the risk is even higher with Moderna than Pfizer, is criminally ignorant."
Precisely -- and IMO, that's where the "right" v. "left" juxtaposition falls apart. At worst the so-called "right" position, represented by Ladapo, is ignorant.
The "left" position -- which forces injections upon people (and their goddamn children!) that many people don't want -- all the while refusing to provide a meaningful risk v. benefit analysis which takes into account the differences among products -- that's criminally ignorant...negligent...tyrannical -- the most powerful words are simultaneously applicable yet scarcely sufficient to convey what we're doing here.
J&J also uses a new approach albeit not mNRA. AFAIK, Novavax is the only reasonably conventional vaccine against Covid that has been approved but I have not seen a lot of real world analysis of its efficacy. Unless travel restrictions are reintroduced, we will avoid boosters.
Isn't your characterization of the "COVID left" all accurate except for one humorous exaggeration? Whereas your characterization of the "COVID right" is basically all humorous exaggeration except for equating it to the flu or a cold?
Incidentally: I've apparently had it twice. The first time it was almost exactly like the flu; the second time, just recently, it was exactly like a barely- detectable cold...so...
Anyway, the COVID left has been genuinely insane, and has done incalculable damage to the nation and the world...whereas the COVID right...really just hasn't. I'd have thought that their major error has been refusing the vax and refusing to take precautions even when old, overweight, plagued by comorbidity, etc. (RIP eg Howard Caine.)
And I'd say that, re: the c-left, you left out: used COVID as a stalking horse to achieve irrelevant, long-standing policy objectives (e.g.: get Trump, universal mail-in balloting), gleefully persecuted the unvaxxed, used COVID as yet another excuse to censor their politically enemies...just to name a few...
As long as public heath is, by law, the responsibility of the state(s) there will be political interference in hot button topics. This is not new. Covid has merely dragged the issue out into the open from the relative obscurity in which it languished.
That public health at the state and local level is seriously underfunded is another consequence, and also a longstanding and neglected problem.
I never heard any complaints outside of public health itself about these problems during my career. Perhaps something could have been done, though I am skeptical the problem admits to a solution. Complaining about it will do little good.
*** edited for clarity
OP: "The study design itself was puzzling, a lightly used method called a “Self-Controlled Case Series” which required about 30 minutes of reading and re-reading on my part to even comprehend what they had done."
Dr. Tracy Hoeg had an educational comment about the Florida study.
"Both on Twitter and in the mainstream media, people were quick to try to criticize the study design for inappropriate controls or for lack of information on benefits of the vaccine. But the so-called “self-controlled case series (SCCS)” method has a very smart built-in control group of only people who have experienced the adverse event and is simply not designed to assess benefits.
The SCCS method was actually created to assess vaccine safety. It was first introduced by Paddy Farrington, Elizabeth Miller and team in The Lancet in 1995 as a way to look for association of the adverse events of febrile seizure and immune thrombocytopenia from DPT and MMR vaccines.
It is a well-established epidemiologic method for evaluating safety and has been used numerous times already to evaluate the Covid-19 vaccines, in the UK (1,2), France and Nordic countries."
https://sensiblemed.substack.com/p/a-level-headed-look-at-the-florida-81a
OP: "This is July 2020; hydroxychloroquine had already been roundly exposed as having minimal evidence for its use for months at this point, and this was a strange intellectual hill on which to die."
Ummm, what was the key takeaway from the link you posted? Was it this, "“This is not a treatment for COVID-19. It doesn’t work,” Martin Landray, an Oxford University professor who is co-leading the RECOVERY trial, told reporters?"
You are dealing with a controversial topic, so it's necessary to look at methods and data, including limitations. What was the key limitation from the RECOVERY trial of HCQ? In NEJM we read, "These findings indicate that hydroxychloroquine is not an effective treatment for hospitalized patients with Covid-19 but do not address its use as prophylaxis or in patients with less severe SARS-CoV-2 infection managed in the community."
What was the stated limitation from the NEJM article? "...do not address its use as prophylaxis or in patients with less severe SARS-CoV-2 infection managed in the community." What is that? A limitation? But Landray, one of the authors said that HCQ doesn't work? Maybe the reporter slightly took Landray's comment out of context. The reporter certainly was ignorant of the limitation stated in the NEJM article.
I agree that HCQ is not appropriate for use in hospitals, from the RECOVERY trial, but it is very effective when given early, within 72 hours of symptom onset, as Accinelli, et. al., found.
"Results
A total...No patient treated within the first 72 h of illness died. The factors associated with higher case fatality rate were age (OR = 1.06; 95% CI 1.01–1.11, p = 0.021), SpO2 (OR = 0.87; 95% CI 0.79–0.96, p = 0.005) and treatment onset (OR = 1.16; 95% CI 1.06–1.27, p = 0.002), being the latter the only associated in the multivariate analysis (OR = 1.18; 95% CI 1.05–1.32, p = 0.005). 0.6% of our patients died."
Time to treatment with HCQ was the most significant factor in mortality.
https://www.sciencedirect.com/science/article/pii/S1477893921002040
So Ladapo made the correct decision to support early treatment with HCQ, because he was following the best scientific evidence available. Then Accinelli came along in Dec. 2021 and clinched the nail. (There have been some 100 studies or so of early treatment with HCQ. Almost all show a signal of benefit, with signal strength depending on the median time of beginning of treatment of patients where the median was close to or within 72 hours of symptom onset.)
And Ladapo, in the case of HCQ, did a better job of understanding the literature than many doctors who were HCQ skeptics.
Now we have to wonder why it took until Dec. 2021 to get the Accinelli data. A Midwestern Doctor might have a clue about this question.
[In my methods, I expect to have to sift baby from bathwater no matter the source. That's simply due diligence that all adults should do. This means that controversial topics need more analysis. And I know when the game changes from science to politics, I need to switch from scientific methods to political/funding analysis.]
https://amidwesterndoctor.substack.com/p/who-owns-the-cdc
I'm not a medical person but I am a scientist and out of sheer curiosity I did take a look at the very large (now) research on HCQ, not in great detail but reasonably comprehensively. My clear impression was also that the findings do indicate efficacy when used at the recommended dosages and very early (ideally within a few days of symptom onset), and preferably combined with zinc. This does seem to make perfect sense, at least to me, if the effect is largely anti-viral. Too often the reaction to HCQ seems to be simply based on some kind of crazy media fueled prejudice, e.g., I asked my GP tentatively about HCQ and her disgusted response was: "That stuff - it's the stuff Trump was pushing!". That turned out to be the sole basis of her opinion: she knew absolutely nothing about the research. She's no longer my GP.
I'm non-medical, too, but I am well-read in the covid literature and am somewhat diligent in my reading (at least compared with the average MD, lol). I understand the course of covid, which is as follows:
1) initial infection
2) viremia occurs on day 2-3
3) covid symptoms begin on about day 4-5
4) max viral load is achieved in mild cases on about day 8
5) virus is cleared in mild cases on about day 13 (8 days post symptom onset)
6) if progression occurs, it will begin about day 15 and will be felt as fatigue; a pulse ox will show pO2 <94%; hospitalization is likely here; this is due to inflammation in the tissues and widespread microvascular damage from immune attack; there are microthrombi and resulting hypoxemia, but CO2 will diffuse out into the alveoli just fine; RBCs are jammed up in capillaries and can't carry oxygen away
7) progression may occur to sepsis or ARDS and possibly systemic organ failure and death; pulmonary emboli, stroke and MI are also potential causes of death
It seemed quite obvious to me that it's essential to prevent progression and that means treating with antiviral before max viral load is reached in mild cases. Even if max viral load is reached later in some immune-incompetent people, that makes it just more essential to treat within the 72-hour-post-symptom-onset antiviral treatment window for covid.
So the RECOVERY trial seemed totally irrelevant to the obvious treatment plan for covid.
Am I confused, or is this solid thinking?
You should read the Daily Sceptic which is a daily newsletter published in the UK. It has been providing chapter and verse on various studies that seek to answer the key questions (vaccine efficacy and vaccine side-effects) since mid 2020. For example, there is now a LOT of data that suggests that the vaccines are potentially more harmful to children than Covid. My wife and I have decided that, even though we are over 70, we will wait until they approve a conventionally developed vaccine and will not get a mNRA vaccine.
I believe Johnson and Johnson is conventional. But only 70% effective last I checked
thank you for this. the divide keeps growing, and it's starting to see the lack of self-awareness to tribalism within the factions. that florida thing was so bad, it's hard not to view Ladapo's move as intentional sabotage, since there's so much other legitimate data to validate his direction of guidance.
and that's precisely what worries me = the truth will be obfuscated through (intentional) incompetence and discredit the legitimate concerns around safety signals.
i appreciate your diligent breakdown of the topic. we simply can't devolve into factions and isolated echo chambers, else we will never see the common ground, and escalation will inevitably lead to self-destruction.
https://gab.com/TommyRobinsonOfficial/posts/110570965155347351
This is no different from history. Having escaped contagious diseases like polio and smallpox because of "vaccines", is a tale of 2 different mindsets. This isn't as much about science as it is fear of the unknown, or misunderstanding the facts that do exist. Including facts that may be skewed by math tricks known as statistics.
In my years of researching why so many of my Indigenous and non Indigenous ancestors, the nay sayers of today are no different than the historical documents portray.
I support science over superstition or conspiracy,. Science is not perfect but it needs our support and oversight by people who are qualified for that oversight.
What one must realized is Tucker Carlson has traded his intellect for fortune. He confronts known authorities with nonsense questions as rhetorical questions, those that do not or cannot be answered.....I once admired him greatly. Now I know I must raise my standards.
An April ’22 Nature Sci Reports study raises serious concerns about Covid vaccines in young men. PMID: 35484304
Using a unique dataset from Israel EMS, found a 25% increase in
cardiac arrest and acute coronary syndrome EMS calls in the 16–39‐year‐old population when comparing January–May 2021with the years 2019–2020.
EMS calls were significantly associated with the rates of 1st and 2nd vaccine doses but were not associated with COVID‐19 infections.
Dr. Lapado’s Florida data is consistent with the Israeli report.
Taken together these studies justify a moratorium on Covid vaccines for healthy adult males under 40.
"...to then recommend a Moderna booster, despite clear data that the risk is even higher with Moderna than Pfizer, is criminally ignorant."
Precisely -- and IMO, that's where the "right" v. "left" juxtaposition falls apart. At worst the so-called "right" position, represented by Ladapo, is ignorant.
The "left" position -- which forces injections upon people (and their goddamn children!) that many people don't want -- all the while refusing to provide a meaningful risk v. benefit analysis which takes into account the differences among products -- that's criminally ignorant...negligent...tyrannical -- the most powerful words are simultaneously applicable yet scarcely sufficient to convey what we're doing here.
J&J also uses a new approach albeit not mNRA. AFAIK, Novavax is the only reasonably conventional vaccine against Covid that has been approved but I have not seen a lot of real world analysis of its efficacy. Unless travel restrictions are reintroduced, we will avoid boosters.
Isn't your characterization of the "COVID left" all accurate except for one humorous exaggeration? Whereas your characterization of the "COVID right" is basically all humorous exaggeration except for equating it to the flu or a cold?
Incidentally: I've apparently had it twice. The first time it was almost exactly like the flu; the second time, just recently, it was exactly like a barely- detectable cold...so...
Anyway, the COVID left has been genuinely insane, and has done incalculable damage to the nation and the world...whereas the COVID right...really just hasn't. I'd have thought that their major error has been refusing the vax and refusing to take precautions even when old, overweight, plagued by comorbidity, etc. (RIP eg Howard Caine.)
And I'd say that, re: the c-left, you left out: used COVID as a stalking horse to achieve irrelevant, long-standing policy objectives (e.g.: get Trump, universal mail-in balloting), gleefully persecuted the unvaxxed, used COVID as yet another excuse to censor their politically enemies...just to name a few...
As long as public heath is, by law, the responsibility of the state(s) there will be political interference in hot button topics. This is not new. Covid has merely dragged the issue out into the open from the relative obscurity in which it languished.
That public health at the state and local level is seriously underfunded is another consequence, and also a longstanding and neglected problem.
I never heard any complaints outside of public health itself about these problems during my career. Perhaps something could have been done, though I am skeptical the problem admits to a solution. Complaining about it will do little good.