And if this one does hit the target ... is there any reason it couldn't be put into next year's flu shot? Or is it different enough from seasonal flu that this is not practical?
And if this one does hit the target ... is there any reason it
couldn't be put into next year's flu shot? Or is it different enough
from seasonal flu that this is not practical?
As you know, the cold storage requirements for the Pfizer vaccine in particular, and also to a lesser extent the Moderna vax, aren't such a problem for the flu vaccine. So why combine them when it sorts causes logistical problems
AstraZeneca/Oxford and others are a different animal. I don't know anything about that. It has been done before with MMR.
You're probably talking about something that would apply years down the line when all of this is more refined.
The word for today is ivermectin. Prescription for humans, you can get an apple-flavored paste for your horse.
It's not even like the AMA conveniently reversing their position on HCQ for some puzzling and mysterious reason. Ivermectin was never tainted by Orange Man association. It's just been ignored. Because it's cheap, and it works, AND IT IS ILLEGAL TO ISSUE AN EUA FOR THE VACCINE IF THERE IS A SAFE AND EFFECTIVE TREATMENT.
*sigh*
This small study found a huge confidence interval in the Cox Proportional Hazard: https://clinicaltrials.gov/ct2/show/results/NCT04523831?term=ivermectin&cond=Covid19&draw=2
This study lacked a control group: https://clinicaltrials.gov/ct2/show/results/NCT04343092?term=ivermectin&cond=Covid19&draw=2&rank=7
This study was only about post-expsure prophylaxis, and was quite small: https://clinicaltrials.gov/ct2/show/results/NCT04425850?term=ivermectin&cond=Covid19&draw=2&rank=10
Maybe some effect viral loads in this small study, but by no means a cure: https://clinicaltrials.gov/ct2/show/results/NCT04390022?term=ivermectin&cond=Covid19&draw=4
this study doesn't appear blinded or placebo controlled - https://clinicaltrials.gov/ct2/show/results/NCT04422561?term=ivermectin&cond=Covid19&draw=4&rank=28
another study with no control group: https://clinicaltrials.gov/ct2/show/results/NCT04425863?term=ivermectin&cond=Covid19&draw=5&rank=37
not a lot of strong evidence here. at best it kinda looks like one of those "might help a little" things, hardly a game changer. No link shown to mortality...
overall kinda similar to evidence around remdesivir. I wouldn't make too big of a deal about this one. The evidence base is small.
2020-12-21 12:52 from nonservator
Better than HCQ. And we saw how that went over.
No. YOU saw how that went over. I saw a bunch of unfounded hype for an ineffective treatment.
Loanshark, here is what you're up against here...
My anecdotal experience is that I was ahead of the curve - last January when we were dropping my kid off for her first semester, I was already well aware there was a pandemic novel coronavirus spreading in Wuhan. While we were in Chicago, the first cases in America were being quarantined in NYC, Florida, and O'Hare. When we were flying back, 3 or 4 days later, I went to Target to pick up masks, then CVS, then Walgreens, and they were all out. I thought at the time that it was weird. They were already redirecting supplies. They knew well ahead. Our Government knew and was aware how big this was going to be and was already and they were suppressing the news intentionally. For whatever reason. To try and get out ahead of it, to try and prevent mass panic - to delay the inevitable. They were not being honest with us about it.
Then, Fauci came out and said that masks wouldn't work in March. He reversed himself sometime late in 2020. His reason, "We didn't want the public to create a shortage of masks," doesn't hold up - because they had already created a shortage of masks for the general public by diverting supply chains. So - that is another lie.
In the meantime, I know a handful of people who got it, and the worst case went to ICU. Anecdotally I know of one person, my service adviser, who has an uncle who died. Of my entire family, of all my close circles, I know of probably less than a dozen people who caught it, and one of those, a 72 year old man with diabetes, was fine - all of them describe it from "less than a cold" to "a really terrible flu".
So all of this results in a personal analysis that your cited sources are no more trusted than any other information provided on what works, what doesn't. In fact, they've reduced themselves to the point where the more aggressively they try to debunk something - the less I trust *them* and their counterpoint.
Additionally, the counterpoints you make all seem to be,
"There were irregularities with these studies, let's throw the baby out with the bathwater and not waste our time here, and instead focusing on what we told you was the only reasonable response."
Which isn't *science*. I've been seeing a lot of this in "science," this year - where instead of going, "we noticed flaws, and tried to recreate the research while accounting for those methodology flaws, and these were our results,"
What I'm seeing is, "we noticed flaws, your study is bullshit. Listen to OUR studies and the narrative THAT creates instead."
Your points aren't invalid - and they deserve consideration - but they also come from a narrative that suffers a huge credibility issue on this topic, and thinking critically, I think one must weigh that into all the data presented.
You need better evidence that the apple butter paste DOESN'T help than you've provided me - and it would help if the source actually accounted for any flaws and retested, rather than just pointed out flaws and then called it done.
Looking at all the evidence, then trying to decide what the most likely scenario is based on the evidence available...
" It's just been ignored. Because it's cheap, and it works, AND IT IS ILLEGAL TO ISSUE AN EUA FOR THE VACCINE IF THERE IS A SAFE AND EFFECTIVE TREATMENT.
Mon Dec 21 2020 14:45:43 EST from ParanoidDelusionsLoanshark, here is what you're up against here...
My anecdotal experience is that I was ahead of the curve - last January when we were dropping my kid off for her first semester, I was already well aware there was a pandemic novel coronavirus spreading in Wuhan. While we were in Chicago, the first cases in America were being quarantined in NYC, Florida, and O'Hare. When we were flying back, 3 or 4 days later, I went to Target to pick up masks, then CVS, then Walgreens, and they were all out. I thought at the time that it was weird. They were already redirecting supplies. They knew well ahead. Our Government knew and was aware how big this was going to be and was already and they were suppressing the news intentionally. For whatever reason. To try and get out ahead of it, to try and prevent mass panic - to delay the inevitable. They were not being honest with us about it.
Then, Fauci came out and said that masks wouldn't work in March. He reversed himself sometime late in 2020. His reason, "We didn't want the public to create a shortage of masks," doesn't hold up - because they had already created a shortage of masks for the general public by diverting supply chains. So - that is another lie.
In the meantime, I know a handful of people who got it, and the worst case went to ICU. Anecdotally I know of one person, my service adviser, who has an uncle who died. Of my entire family, of all my close circles, I know of probably less than a dozen people who caught it, and one of those, a 72 year old man with diabetes, was fine - all of them describe it from "less than a cold" to "a really terrible flu".
So all of this results in a personal analysis that your cited sources are no more trusted than any other information provided on what works, what doesn't. In fact, they've reduced themselves to the point where the more aggressively they try to debunk something - the less I trust *them* and their counterpoint.
Additionally, the counterpoints you make all seem to be,
"There were irregularities with these studies, let's throw the baby out with the bathwater and not waste our time here, and instead focusing on what we told you was the only reasonable response."
Which isn't *science*. I've been seeing a lot of this in "science," this year - where instead of going, "we noticed flaws, and tried to recreate the research while accounting for those methodology flaws, and these were our results,"
What I'm seeing is, "we noticed flaws, your study is bullshit. Listen to OUR studies and the narrative THAT creates instead."
Your points aren't invalid - and they deserve consideration - but they also come from a narrative that suffers a huge credibility issue on this topic, and thinking critically, I think one must weigh that into all the data presented.
You need better evidence that the apple butter paste DOESN'T help than you've provided me - and it would help if the source actually accounted for any flaws and retested, rather than just pointed out flaws and then called it done.
Additionally, the counterpoints you make all seem to be,
"There were irregularities with these studies, let's throw the baby
out with the bathwater and not waste our time here, and instead
focusing on what we told you was the only reasonable response."
You're just misquoting me here. This thing needs to be studied more, that's all, because the level of evidence currently does not support even Emergency Use Authorization. The data does all slightly lean towards "might be effective", but that's as good as it gets right now. The statement nonservator made about how we don't need a vaccine if we have something like this is an example of the Dunning-Kruger effect in action.
It's quite clear to me that you guys just don't know how the FDA approval process works. These treatments can still be tried, in the context of a study. Until there is enough evidence, there won't be EUA. That's all there is to it. There are FAQ pages up on fda.gov that explain all this. Rest assured that the FDA staff are looking at all this data and would have issued an EUA if the data had accumulated to that level
Your points aren't invalid - and they deserve consideration - but
they also come from a narrative that suffers a huge credibility issue
on this topic, and thinking critically, I think one must weigh that
into all the data presented.
Check the credibility of the right-wingers in this very room before bash my credibility in a borderline personal-attack sort of way.
Some of the arguments I'm seeing from people in this room are hypcritical and anti-science. The hypocrisy stems from this: you guys will bend over backwards to claim that vaccines that have been tested in 30,000 or 60,000 subjects are "untested" while simultaneously shilling for relatively unproven treatments that have been studied in, about the order of magnitude of 300 subjects. That, dear friends, is garbage.
I do not believe, on the basis of the data I'm seeing presented here, and I just read *all* the studies I could find on the subject, that a strong case for game-changing effectiveness has been made for this treatment. Such a case *has* been made for vaccines, and you guys are going to have to get that through your heads sooner or later becuase it's simply the truth.
I think what's happening here is this: there's a certain viewpoint (which even tends to find support in places like Wall Street Journal opinion articles) that says the FDA should get out of the way and let doctors prescribe what they want.
Yeah, maybe, if most doctors wanted it that way? The doctors I'm hearing from largely have a different view. They don't want it to be their job to spend 100% of their time reading clinical studies and making up their own mind when they already have to struggle through 80 hour work weeks. There is simply a division of labor and it has to be somebody else's job to tell them whether some drug is worth prescribing. They want a source of informaion and analysis that they can trust.
Look, right now, we have the system that we have and we're not going to change it radically in the middle of a pandemic. The FDA's evidentiary standards have already been chipped-away-at over the past few years and that is the way that change tends to happen.
Whelp, my girlfriend just tested positive. She's on ~day 6. I already had it back in the spring, hope I'm protected. Evaluating what to do next. She was asymptomatic back in March/April when I had it, so this *might* be her first time.
I reached out to Karl Denninger, whose writings on ivermectin brought it to my attention. Here's his unedited response to your response.
This small study found a huge confidence interval in the Cox Proportional Hazard: https://clinicaltrials.gov/ct2/show/results/NCT04523831?term=ivermectin&cond=Covid19&draw=2
And did not cross 1.0 (null). Yes, small study; that's a problem with individual small groups; they produce wide Cox ratios.
This study lacked a control group: https://clinicaltrials.gov/ct2/show/results/NCT04343092?term=ivermectin&cond=Covid19&draw=2&rank=7
Ridiculously small study (16?!) Nice to pick on that one.
This study was only about post-expsure prophylaxis, and was quite small: https://clinicaltrials.gov/ct2/show/results/NCT04425850?term=ivermectin&cond=Covid19&draw=2&rank=10
And 100% effective. And zero side effects. Incidentally, this study looked at BOTH prophylaxis and treatment, and the p values were astounding. Note their control, SOC for the control arm included HCQ. This one, incidentally, is why I personally abandoned any intention to use HCQ since that was their control and the p values on clinical measurements (e.g. d-dimer, leukocytes, etc) were outrageously better on Ivermectin with many of those values having "p" values < 0.0001.
You can complain that this one was not double-blinded, but not much else.
https://assets.researchsquare.com/files/rs-100956/v1/682247ca-ef49-4d68-aa3f-493a8fc9a056.pdf
Maybe some effect viral loads in this small study, but by no means a cure: https://clinicaltrials.gov/ct2/show/results/NCT04390022?term=ivermectin&cond=Covid19&draw=4
You're arguing 24 people makes for a worthwhile study?
this study doesn't appear blinded or placebo controlled - https://clinicaltrials.gov/ct2/show/results/NCT04422561?term=ivermectin&cond=Covid19&draw=4&rank=28
Uh, how did they do follow up? History and clinical examination. Yes, no blinding but you went from 58.4% to 7.4% infection rates as prophylaxis and this is not significant? Oh, and zero significant adverse effects reported and none by systematic assessment.
another study with no control group: https://clinicaltrials.gov/ct2/show/results/NCT04425863?term=ivermectin&cond=Covid19&draw=5&rank=37
I'd love a control group here obviously -- but how many cases do you have that are "Severe" where the mortality is zero without an interventionary treatment? Show me one hospital with that record. I can show you mine here in town, which is losing 29% of those who are admitted -- which is "moderate + severe", since admission is based on desaturation.
not a lot of strong evidence here. at best it kinda looks like one of those "might help a little" things, hardly a game changer. No link shown to mortality... overall kinda similar to evidence around remdesivir. I wouldn't make too big of a deal about this one. The evidence base is small. * * *
80-100% reduction in transmission among households is "might help a little"?
Let's assume it only does HALF that well - - 50%.
Since the CDC says that enough Rt is found in households alone to keep the pandemic going (Rt > 1.0) if you only get half of the worst prophylaxis result in widescale use, and no other benefit at all, the entire pandemic collapses in five days.
That's the math.
Oh, and since there's no record of signifcant adverse events what's the risk?
In a pandemic you must balance risks and benefits. The issue is not individual outcome; that's a personal benefit. The public health issue is prophylaxis among household members with a confirmed case in the house, which is where the largest single vector is.
Cut it off and it's over.
That's why it will work -- it doesn't have to reach 80 or 100% effectiveness -- only 50% or half the lowest found effectiveness in these studies for post-exposure prophylaxis.
At the end of 2019 I was on a Hong Kong based meme website, they were posting pictures and stories about how China was dealing with the unnamed virus. Most stories were how wonderful China was for quickly erecting hospitals in Wuhan China and how it was caring for its people. I didn't think the rest of the world had any cases at the time.
Very early in the year before COVID-19 became a news story my niece who lives in South Carolina entire family became sick, sicker than they every had felt before. After the fact we wondered if it was COVID-19. About a month ago my niece's husband tested positive for COVID-19, he could barely get out of bed. He was isolated in the spare bed and bathroom. The rest of the family had some mild symptoms.
We're going to try consolidating the response to those responses down to one single reply. 1st off, when I make a post and I get several posts in response back from the same person - I tend to think that they're getting themselves more worked up as they read or think or process what I've said. I do that, myself.
I'm not quoting you at all. I'm tell you what it looks like from the opposition's perspective. What it sounds like to us. I'm not putting words INTO your mouth, I'm parsing what the words of your political ideology *sound* like to us.
You didn't say it like you said below, the first time around. You said something, I told you how that came across to my ears, and you restated your position in a way that is far clearer about your position.
Win-win.
We don't need a vaccine if we have something already out there that works. This is a true statement. The only people that need a vaccine if we have treatments that work are the people that make the vaccines and the lobbyists who they pay to make sure that their vaccine is approved and the alternative is buried. At least for something that is a serious as a bad flu in the worst case for most people. A vaccine is killing a black widow with a flame thrower. They're all speculative statements. The Apple paste MAY be an effective treatment. If it is good enough, it is a viable alternative to vaccination for the VAST majority of people. Why get so hostile about someone suggesting that? Why do the papers all seem aggressive in suggesting that this is meritless, rather than suggesting that faults in methodology should be identified and additional research should be conducted with an open mind? Combined with the other facts I've mentioned - it is why a lot of us do not trust this narrative that the vaccine is the silver bullet and anything else suggested is a waste of time and dangerous.
That by the way, isn't a personal attack on you - it is absolutely an attack of the credibility of the people pushing the narrative that you are also promoting, though.
Also - we don't CARE how the FDA approval process works. We've lost faith in the integrity and honesty of the entire bureaucratic process and of all of those organizations associated with it. For good reason. They seem to be full of shit. I could give a shit about the FAQs on fda.gov. The Government is on a very thin string with me in regards to me believing anything they tell me. It is like trusting your wife who has slept with every guy in town when the new guy moves into town and she promises, "not this time, honey."
They say things, and they're true things. It is the things they DON'T say that cause the problems.
"These treatments can still be tried, in the context of a study. Until there is enough evidence, there won't be EUA. That's all there is to it. There are FAQ pages up on fda.gov that explain all this. Rest assured that the FDA staff are looking at all this data and would have issued an EUA if the data had accumulated to that level "
But they won't be tried - because the FDA is in lockstep with a string of bureaucrats, politicians, and pharmaceuticals that have already decided there is one solution - and isn't interested in exploring any other alternatives. This isn't conspiracy theory or conjecture at this point - this isn't unwarranted distrust of the TLA orgs and the politicians. They've been doing it blatantly for the last 4 years. So - maybe we would have given your position more credit in the middle of Obama's administrations, or during the Bush Administration - but this kind of talk is worn out post Trump administration. Our Government is rotten. Especially on the Left. If the Government wants to suggest that these things CAN still be studied, rather than dismissing them - they've got to ensure that impartial 3rd party testing is being done.
It is like going, "I'd rather do this, and I'm saying what you are doing is a waste of time, and you're wrong - but, we're not going to STOP you from testing and coming back with better results - as long as you follow the specific methods I describe in performing your tests."
It *sounds* a lot like bullshit. It seems a lot like a gish gallop. "We'll just saying they're fucking wrong and making them go back to the drawing board until we get to the point where our way has gone through without any objections, and then their method won't matter, even if it was better at the time they originally presented it."
Because they seem to have a side, they seem to have a preference, and we've seen a number of cases with Covid-19 where they pushed forward with their direction without ANY objections being heard, while raising ALL kinds of roadblocks to any alternative direction. So yeah - that has been transparent to people who are reasonable and critical thinkers - and I think that applies to a LOT of people on your side who recognize this, and intentionally ignore and downplay it - or convince themselves through cognitive dissonance that this isn't what is actually happening. Either way makes no difference.
"Check the credibility of the right-wingers in this very room before bash my credibility in a borderline personal-attack sort of way."
I'm not concerned about anybody else's arguments in the room, regardless of what side they're on. I don't have to address if someone on the Right thinks this is a Communist plot by Obama who is really a Muslim in league with the Chinese in a nefarious plot to make America a Chinese territory. Let's get that off the table now. Right Wing fringe conspiracy theory is just that. Debating against your point does not constitute an ENDORSEMENT of *every* Right Wing argument against your point. So if there are other Right Wing arguments in this room that are not credible - that is immaterial to OUR discussion. This is a fallacious argument technique.
I do not believe, on the basis of the data I'm seeing presented here, and I just read *all* the studies I could find on the subject, that a strong case for game-changing effectiveness has been made for this treatment. Such a case *has* been made for vaccines, and you guys are going to have to get that through your heads sooner or later becuase it's simply the truth.
You BELIEVE. You're one opinion on the matter - and so far, your evidence and your approach has not convinced me that your opinion is any less biased or better grounded than any other I've seen in this room. In fact - you've kind of reaffirmed some of my beliefs about the dogmatic nature of the position you endorse, and the deceptive argument techniques your side employs to try and force your perspective through.
The third post - I don't really have a lot to say about. I think that is kind of thinking out loud, brainstorming. I don't know if it is part of the problem or not. I haven't put that much thought into it. There are several doctors in my family, I've watched a lot of practicing physicians on videos who do not seem to agree with you - and I worked in healthcare for Docs - so I've got a pretty good network of Physicians and other healthcare professionals who have a variety of opinions from the very Far Right to the very Far Left. Healthcare positions are not monolithic - I know that much. There are Doctors who lean Right politically and ones who lean Left - and they tend to follow party line ideologies on most issues, including ones like Covid-19.
I'm sorry your girlfriend is positive. I think the 2nd wave is a better time to come up positive than the 1st. I hope she is well.
Mon Dec 21 2020 15:09:31 EST from LoanSharkAdditionally, the counterpoints you make all seem to be,
"There were irregularities with these studies, let's throw the baby
out with the bathwater and not waste our time here, and instead
focusing on what we told you was the only reasonable response."
You're just misquoting me here. This thing needs to be studied more, that's all, because the level of evidence currently does not support even Emergency Use Authorization. The data does all slightly lean towards "might be effective", but that's as good as it gets right now. The statement nonservator made about how we don't need a vaccine if we have something like this is an example of the Dunning-Kruger effect in action.
It's quite clear to me that you guys just don't know how the FDA approval process works. These treatments can still be tried, in the context of a study. Until there is enough evidence, there won't be EUA. That's all there is to it. There are FAQ pages up on fda.gov that explain all this. Rest assured that the FDA staff are looking at all this data and would have issued an EUA if the data had accumulated to that level
Denninger is a loon. This thing will not "end the pandemic in 5 days"--how many millions or billions of dose would that require,
even if it were as effective as this very early, too early data shows. I'm reading more about the confounding factors of some of
these studies, including other interventions like dexamethasone. The consensus at FDA (and similar organizations at other countries)
is that there just isn't enough data yet. Unlike some of the Dunning-Kruger poster children out there, I don't think I'm better at
this than the FDA. They are very much looking at this, having discussions; the news articles are only hours old in some cases.
There are no "sides" here. This is a friendly (as friendly as possible/practical) discussion about how the fuck we survive the next
3 months.
End of the day - this thing will continue to be studied. That's what's appropriate, and that's *all* that's appropriate.
Yup. That convinced me. I'm all in on your side, now... even though there aren't sides here.
It *seems* like there are sides here though - and you're on one of 'em.
Anyhow, we survive the next 3 months probably like my 72 year old father-in-law with Diabetes did...
If we catch it, we seek treatment as soon as possible.
It appears the second spike in Arizona is in declining, looking at today's charts.
Or... we could over-react and live in crushing fear. I guess that is an option too...
Mon Dec 21 2020 21:23:01 EST from LoanShark
Denninger is a loon... ...Unlike some of the Dunning-Kruger poster children out there, I don't think I'm better at
this than the FDA. They are very much looking at this, having discussions; the news articles are only hours old in some cases.
There are no "sides" here. This is a friendly (as friendly as possible/practical) discussion about how the fuck we survive the next
3 months.
End of the day - this thing will continue to be studied. That's what's appropriate, and that's *all* that's appropriate.