Semi-OT: Coronavirus (COVID-19) Discussion Thread

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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#581 » by Bottomsouth » Sat Apr 18, 2020 5:20 am

bondom34 wrote:
One would think we’d need a vaccine, verify it works and confirm the side effects before lining up to get whatever comes out to market. But hey whoever wants to be a guinea pig, be my guest.


It's almost like it's going to take so long because they're testing something. Maybe in trials. Maybe clinically. They might even call them "clinical trials" and use them to test side effects and other possible issues.


Relieved. Now all doubt is gone.
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#582 » by Bottomsouth » Sat Apr 18, 2020 5:20 am

bondom34 wrote:
Tor_Raps wrote:
bondom34 wrote:That's what the 12-18 months are for. They'd be the same as any other drug, I don't think the FDA tends to flinch on their standards, that's why GMPs are set and followed, I'd say its the same for this if not stricter.


I recall hearing that those timelines might get pushed because of the urgent need. Now whether that actually happens remains to be seen. But with everything going on in the world and the economy, I'd bet my money that steps get skipped.

I'm nearly certain they can't skip a phase. That's legally not allowed and is exactly why the FDA exists. Before it existed there were issues with treatments and it's entire purpose as an agency is to be sure drugs are safe.

It's not legal for them to just "skip" stuff.


You are right, no reason to have any doubts.

https://www.mdlinx.com/internal-medicine/article/4008
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#583 » by bondom34 » Sat Apr 18, 2020 5:21 am

Bottomsouth wrote:
bondom34 wrote:
One would think we’d need a vaccine, verify it works and confirm the side effects before lining up to get whatever comes out to market. But hey whoever wants to be a guinea pig, be my guest.


It's almost like it's going to take so long because they're testing something. Maybe in trials. Maybe clinically. They might even call them "clinical trials" and use them to test side effects and other possible issues.


Relieved. Now all doubt is gone.

If you don't trust the FDA cool. I'd recommend you feel the same about any food, drink, or OTC treatment because they test those too.
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#584 » by bondom34 » Sat Apr 18, 2020 5:22 am

Bottomsouth wrote:
bondom34 wrote:
Tor_Raps wrote:
I recall hearing that those timelines might get pushed because of the urgent need. Now whether that actually happens remains to be seen. But with everything going on in the world and the economy, I'd bet my money that steps get skipped.

I'm nearly certain they can't skip a phase. That's legally not allowed and is exactly why the FDA exists. Before it existed there were issues with treatments and it's entire purpose as an agency is to be sure drugs are safe.

It's not legal for them to just "skip" stuff.


You are right, no reason to have any doubts.

https://www.mdlinx.com/internal-medicine/article/4008

You are right. We shouldn't eat either because food recall happens as well.
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#585 » by Bottomsouth » Sat Apr 18, 2020 5:22 am

bondom34 wrote:
Bottomsouth wrote:
bondom34 wrote:
It's almost like it's going to take so long because they're testing something. Maybe in trials. Maybe clinically. They might even call them "clinical trials" and use them to test side effects and other possible issues.


Relieved. Now all doubt is gone.

If you don't trust the FDA cool. I'd recommend you feel the same about any food, drink, or OTC treatment because they test those too.


Sure I do.

And those are not vaccines or drugs.
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#586 » by bondom34 » Sat Apr 18, 2020 5:23 am

Bottomsouth wrote:
bondom34 wrote:
Bottomsouth wrote:
Relieved. Now all doubt is gone.

If you don't trust the FDA cool. I'd recommend you feel the same about any food, drink, or OTC treatment because they test those too.


Sure I do.

And those are not vaccines or drugs.
OTC drugs are. And they test the food too

So either you do or don't. Or you're trying to be cute
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#587 » by Bottomsouth » Sat Apr 18, 2020 5:23 am

bondom34 wrote:
Bottomsouth wrote:
bondom34 wrote:I'm nearly certain they can't skip a phase. That's legally not allowed and is exactly why the FDA exists. Before it existed there were issues with treatments and it's entire purpose as an agency is to be sure drugs are safe.

It's not legal for them to just "skip" stuff.


You are right, no reason to have any doubts.

https://www.mdlinx.com/internal-medicine/article/4008

You are right. We shouldn't eat either because food recall happens as well.


Correct because eating food is the same as being first in line to put the vaccine of Covid in you because the FDA puts their stamp of approval.
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#588 » by Bottomsouth » Sat Apr 18, 2020 5:24 am

bondom34 wrote:
Bottomsouth wrote:
bondom34 wrote:If you don't trust the FDA cool. I'd recommend you feel the same about any food, drink, or OTC treatment because they test those too.


Sure I do.

And those are not vaccines or drugs.
OTC drugs are. And they test the food too

So either you do or don't. Or you're trying to be cute


Cute because you don’t like the response.
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#589 » by bondom34 » Sat Apr 18, 2020 5:25 am

Bottomsouth wrote:
bondom34 wrote:
Bottomsouth wrote:
You are right, no reason to have any doubts.

https://www.mdlinx.com/internal-medicine/article/4008

You are right. We shouldn't eat either because food recall happens as well.


Correct because eating food is the same as being first online to put the vaccine of Covid in you because the FDA puts their stamp of approval.

Good call. Nobody get treated, that's a brilliant plan
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#590 » by bondom34 » Sat Apr 18, 2020 5:26 am

Bottomsouth wrote:
bondom34 wrote:
Bottomsouth wrote:
Sure I do.

And those are not vaccines or drugs.
OTC drugs are. And they test the food too

So either you do or don't. Or you're trying to be cute


Cute because you don’t like the response.

Cute because bluntly it's **** stupid.

Nothing is perfect. If you'd rather risk death than take a proven treatment great. But over the counter medication is literally a drug
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#591 » by Bottomsouth » Sat Apr 18, 2020 5:27 am

bondom34 wrote:
Bottomsouth wrote:
bondom34 wrote:You are right. We shouldn't eat either because food recall happens as well.


Correct because eating food is the same as being first online to put the vaccine of Covid in you because the FDA puts their stamp of approval.

Good call. Nobody get treated, that's a brilliant plan


I previously said whoever wants to is welcome to. Just because I have my own reserves and questions doesn’t mean you or anyone else should take that as their own or that I am protesting against yours or anyone’s decision.
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#592 » by Bottomsouth » Sat Apr 18, 2020 5:29 am

bondom34 wrote:
Bottomsouth wrote:
bondom34 wrote: OTC drugs are. And they test the food too

So either you do or don't. Or you're trying to be cute


Cute because you don’t like the response.

Cute because bluntly it's **** stupid.

Nothing is perfect. If you'd rather risk death than take a proven treatment great. But over the counter medication is literally a drug


As I said, I am not stopping you or anyone. Have a great night.
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#593 » by bondom34 » Sat Apr 18, 2020 5:31 am

Bottomsouth wrote:
bondom34 wrote:
Bottomsouth wrote:
Cute because you don’t like the response.

Cute because bluntly it's **** stupid.

Nothing is perfect. If you'd rather risk death than take a proven treatment great. But over the counter medication is literally a drug


As I said, I am not stopping you or anyone. Have a great night.

You too. But don't eat or drink anything too soon. It might be recalled. You should have someone test it first, but wait a few months to be sure. You know, wouldn't want to eat or drink anything recalled.
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#594 » by Bottomsouth » Sat Apr 18, 2020 5:33 am

bondom34 wrote:
Bottomsouth wrote:
bondom34 wrote:Cute because bluntly it's **** stupid.

Nothing is perfect. If you'd rather risk death than take a proven treatment great. But over the counter medication is literally a drug


As I said, I am not stopping you or anyone. Have a great night.

You too. But don't eat or drink anything too soon. It might be recalled. You should have someone test it first, but wait a few months to be sure. You know, wouldn't want to eat or drink anything recalled.


:lol:

Wish me luck.
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#595 » by 13th Man » Sat Apr 18, 2020 5:50 am

bondom34 wrote:
Tor_Raps wrote:
bondom34 wrote:That's what the 12-18 months are for. They'd be the same as any other drug, I don't think the FDA tends to flinch on their standards, that's why GMPs are set and followed, I'd say its the same for this if not stricter.


I recall hearing that those timelines might get pushed because of the urgent need. Now whether that actually happens remains to be seen. But with everything going on in the world and the economy, I'd bet my money that steps get skipped.

I'm nearly certain they can't skip a phase. That's legally not allowed and is exactly why the FDA exists. Before it existed there were issues with treatments and it's entire purpose as an agency is to be sure drugs are safe.

It's not legal for them to just "skip" stuff.


I think they are able to skip steps though, bypassing the small animals and primates stage of testing in phase 1, going directly to humans. China is already on phase 2 of testing of a couple of vaccines and other countries are jumping on board with their own vaccine testing. The University of Oxford intends to start Phase 1 trials on 500 volunteers in May, skipping the animal phases of testing as well.

Every article that I've read cites that vaccine testing should not be rushed in theory, however I've read a couple such as these that suggest that a vaccine could be available by the fall. Sounds pretty optimistic, well ahead of Dr. Fauci's 12-18 months timeline, let's hope that they'd be able to do sufficient testing by then.

https://techcrunch.com/2020/04/17/university-of-oxford-coronavirus-vaccine-trial-aims-to-have-500-people-in-testing-by-mid-may/

https://www.bloomberg.com/news/articles/2020-04-17/oxford-vaccine-veteran-lays-out-coronavirus-immunization-plans
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#596 » by bondom34 » Sat Apr 18, 2020 6:05 am

13th Man wrote:
bondom34 wrote:
Tor_Raps wrote:
I recall hearing that those timelines might get pushed because of the urgent need. Now whether that actually happens remains to be seen. But with everything going on in the world and the economy, I'd bet my money that steps get skipped.

I'm nearly certain they can't skip a phase. That's legally not allowed and is exactly why the FDA exists. Before it existed there were issues with treatments and it's entire purpose as an agency is to be sure drugs are safe.

It's not legal for them to just "skip" stuff.


I think they are able to skip steps though, bypassing the small animals and primates stage of testing in phase 1, going directly to humans. China is already on phase 2 of testing of a couple of vaccines and other countries are jumping on board with their own vaccine testing. The University of Oxford intends to start Phase 1 trials on 500 volunteers in May, skipping the animal phases of testing as well.

Every article that I've read cites that vaccine testing should not be rushed in theory, however I've read a couple such as these that suggest that a vaccine could be available by the fall. Sounds pretty optimistic, well ahead of Dr. Fauci's 12-18 months timeline, let's hope that they'd be able to do sufficient testing by then.

https://techcrunch.com/2020/04/17/university-of-oxford-coronavirus-vaccine-trial-aims-to-have-500-people-in-testing-by-mid-may/

https://www.bloomberg.com/news/articles/2020-04-17/oxford-vaccine-veteran-lays-out-coronavirus-immunization-plans


I don't know how China would operate.

The FDA is US only, but I also don't read anything about skipping stages. Working quickly is possible, and legal.

Edit: Quick google, as it's late, but the only clinical trial I see able to be skipped is a very small sample one.
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#597 » by 13th Man » Sat Apr 18, 2020 6:10 am

Yeah, it's late will have to read up more tomorrow. Just mean that they're skipping the animal portion of testing in Phase 1 to go directly to humans. cheers.
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#598 » by bondom34 » Sat Apr 18, 2020 6:12 am

13th Man wrote:Yeah, it's late will have to read up more tomorrow. Just mean that they're skipping the animal portion of testing in Phase 1 to go directly to humans. cheers.

Same here.

I'm not in a clinical lab, so I'm not entirely familiar with details of all stages. I'd guess it's just a rush of each, but can't say for certain and late here too. Cheers my man, if you find it let me know, I'd love to learn something :D.

If I had to guess its "rush" in that they're doing things like adding extra workers or adding shifts (like adding 3rd shift work where it's not normal).

Ultimately the FDA isn't going to mass approve something too fast. It's why these things are in place, stuff used to happen faster and well...not good. To anyone who doesn't think so google elixer of sulfanilamide or thalidomide. That's why these trials are going on (among other reasons).
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#599 » by michaelm » Sat Apr 18, 2020 8:01 am

bondom34 wrote:
13th Man wrote:Yeah, it's late will have to read up more tomorrow. Just mean that they're skipping the animal portion of testing in Phase 1 to go directly to humans. cheers.

Same here.

I'm not in a clinical lab, so I'm not entirely familiar with details of all stages. I'd guess it's just a rush of each, but can't say for certain and late here too. Cheers my man, if you find it let me know, I'd love to learn something :D.

If I had to guess its "rush" in that they're doing things like adding extra workers or adding shifts (like adding 3rd shift work where it's not normal).

Ultimately the FDA isn't going to mass approve something too fast. It's why these things are in place, stuff used to happen faster and well...not good. To anyone who doesn't think so google elixer of sulfanilamide or thalidomide. That's why these trials are going on (among other reasons).

Just from googling myself I think they started using the Ebola vaccine early because of the particular circumstances which applied, but it was made clear it was still not completely out of the experimental stage, and was employed under a "compassionate use" protocol.
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Re: Semi-OT: Coronavirus (COVID-19) Discussion Thread 

Post#600 » by Promezclan » Sat Apr 18, 2020 9:18 am

zimpy27 wrote:
bidde wrote:
HotRocks34 wrote:Just a brief wrap-up on something touched upon a few pages ago in this thread. I'm putting this here to shoot down the more radical interpretation of events that was being considered. This is a new report on the investigation of the origins of the virus.

https://www.foxnews.com/politics/us-officials-investigation-coronavirus-wuhan-lab



So, the bioweapon hypothesis (and, apparently, the "altered virus structure" hypothesis) is now firmly returned to the conspiracy theory corner. It's official.


.
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Interesting study out of Stanford (Covid antibody testing in California):
https://www.medrxiv.org/content/10.1101/2020.04.14.20062463v1.full.pdf

Summary:
- Number of actual infected persons may be 50-85 times higher than known
- CFR (mortality rate) of Covid (at least in California) may be around .12% to .20%


This data is similar to what a German study found (0.37% CFR):
https://reason.com/2020/04/09/preliminary-german-study-shows-a-covid-19-infection-fatality-rate-of-about-0-4-percent/

It's also not so far off of the current figures in Iceland. Iceland is the most tested nation per capita in the world on the virus. That makes them possibly the best "not antibody researched" study of what the Covid CFR may be.

Iceland ----------> 9 deaths/1754 cases = 0.51% CFR

A virus with a .1% CFR will kill 1 in 1000 people who catch it. A virus with a .5% CFR will kill 5 in 1000 (1 in 200) people who catch it.

As many have suspected, there are likely a lot more people who have, or have had, the virus in the USA than we know about. The current "known" CFR of the virus in the USA is around 4.6% (30,449 deaths from 666,573 cases). Data from here:
https://covidtracking.com/data

Picking a number between 0.1% and 0.5%, let's just say that the virus CFR is 0.3%. That would make the virus about 15 times less deadly than it currently appears to be based on the known numbers. That's a welcome thought.

Of course, the CFR for the virus is a lot higher for certain populations (elderly, those with per-existing conditions).


Comparisons:
https://en.wikipedia.org/wiki/Pandemic_severity_index#Guidelines
https://en.wikipedia.org/wiki/1957%E2%80%9358_influenza_pandemic
https://www.medicinenet.com/script/main/art.asp?articlekey=208914

Average flu ----------> 0.1% CFR (or less; kills roughly 291,000 to 646,000 globally per year)
1957 flu --------------> 0.3% CFR (in the UK; killed 1-2 million people globally)
Spanish flu ----------> 2.0%+ CFR or higher (killed 17-100 million globally)


People usually differentiate between CFR (case fatality rate) and IFR (infection fatality rate). CFR uses confirmed cases as the denominator, while IFR uses all infected. So you can't really be wrong about the CFR. IFR is the more interesting and difficult question, but scientists believed it to be a lot lower than some of those CFRs for a while. For example the Imperial College Study (the one that predicted 2.2 million deaths in the US without intervention) was published a month ago and assumed an IFR of 0.9% and a study focused on estimating IFR published in late March found a 0.4 %- 1.3% confidence interval for IFR.

As far as the Stanford Study goes, ideally you would want a random sample of a population. But this is how they found their participants:
We recruited participants by placing targeted advertisements on Facebook aimed at residents of Santa Clara County.


The problem with an approach like this is that you might introduce a bias, for example you end up getting more people that are worried about having covid, because they had symptoms. That could lead to the prevalence being overestimated and the IFR being underestimated.

Also, I was kind of shocked to see those CIs on the sensitivity of the used test:
Our estimates of sensitivity based on the manufacturer’s and locally tested data were 91.8% (using the lower estimate based on IgM, 95 CI 83.8-96.6%) and 67.6% (95 CI 50.2-82.0%), respectively. Similarly, our estimates of specificity are 99.5% (95
CI 98.1-99.9%) and 100% (95 CI 90.5-100%).


At this point we can be pretty certain that the IFR is above 0.2% just by looking at the fatalities in NYC and some of the hard hit regions in Italy.


Imperial College Study:https://www.imperial.ac.uk/media/imperial-college/medicine/sph/ide/gida-fellowships/Imperial-College-COVID19-NPI-modelling-16-03-2020.pdf
Estimates of the severity of coronavirus disease 2019: a model-based analysis: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30243-7/fulltext


As we discussed before, 0.2% is what the Iceland data shows as the fatality rate but that is an ideal situation, SCC is similar base don this study of antibody tests.

I wouldn't be certain IFR is over 0.2% but IFR will be different in different cities based on population density, demographics, pollution, etc.

Scariest is Ecuador, which also shows that the numerator is inaccurate, not just the denominator.
Image
Around 6,000 people, or close to 0.2% of the entire population of Guayas (population 3.6 million) were killed by coronavirus in only 2 weeks, and that's with a very young population. So leaving it unchecked and hoping it will turn out like the flu just won't work.

In the chart, we have death totals by region per month, and for the first two weeks of April. Half of Zone 8/Guayas's death toll in January would be 970 - instead 6700 were killed in the first two weeks of April, an excess of more than 5,700 deaths. The other less-affected regions serve as perfect controls (for seasonality or deaths of despair from seeing the stock market drop), so it's really undeniable that coronavirus was the cause. In almost all zones (besides Zone 5, which is next to Guayas), the total for those two weeks in April is actually well under half of the totals for January or February (despite having some coronavirus deaths of their own), since social distancing stops traffic accidents and the spread of other diseases like flu.

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