.First, then, we must learn the truth about the soul divine and human by observing how it acts and is acted upon. And the beginning of our proof is as follows: Every soul is immortal.(245c)
Safety –a measure of the probability of an adverse outcome and its severity ... — McGraw-Hill Concise Dictionary of Modern Medicine
And the argument is that waiting will increase the safety by decreasing the uncertainty (risk). — Isaac
As I said, safety and efficacy are not binomial, everything is only ever some given level of safety. — Isaac
Because it has been shown to be safe and effective.
— Fooloso4
That doesn't make sense. It's not a binomial. — Isaac
I've presented evidence from experts who believe that vaccination does not significantly increase the chances of a good outcome. — Isaac
The question is what qualifies the FDA to determine what level of safety people ought to accept? — Isaac
Safety is entirely measured in terms of certainty. — Isaac
You suggested that it was evidence of the safety of the vaccine in the context of the FDAs work on safety... — Isaac
It is safer on Tuesday because by Tuesday we'll be less uncertain about it's effects than we were before Tuesday, because the FDA will have finished checking the safety data. — Isaac
In direct contradiction of the expert I cited explaining how those millions of shots do not provide the level of safety information the FDA require. — Isaac
You said...
At this point it is a matter of bureaucracy rather than safety or efficacy — Isaac
No one is denying it's safe and effective. — Isaac
Safety is entirely about uncertainty. — Isaac
but without making changes approving it does not render it more safe. It simply confirms that it is safe and effective. — Fooloso4
... you're making the argument that their specific motivation is not the EUA but the evidence from millions of vaccine shots (despite me posting a direct quote from Marks to the contrary, but hey, evidence seems to be irrelevant on this thread, so...) — Isaac
Because you said that despite their main work being about ensuring the safety and efficacy of medicines, their current work is not related to safety and efficacy. — Isaac
What's good about anti-vaxxers is they give a clear signal to the medical & scientific establishment that people won't tolerate substandard work/products. — TheMadFool
we don't have effective treatment modalities against viruses. — TheMadFool
None of that has any bearing on the matter of whether it will be rendered more safe by the work being done to complete the BLA approval. — Isaac
It's just a load of bizarre psychologising about the motives for advocacy without, again, a shred of evidence. — Isaac
What are the FDA doing, right now, and how is it that you know (when seemingly even experts in public health don't even know)? — Isaac
So confused. — Isaac
It's when the FDA decide that the risks from a new medicine are outweighed by the risks from the emergency - meaning that they think people ought to take it. It would have been rather foolish of them to give it EUA and then not endorse taking it, wouldn't it? /quote]
Wrong. The FDA issued EUA for hydroxychloroquine, but did not think people ought to take it. The EUA allowed its use, but they then revoked the EUA when the determined it was unlikely to be effective. The same happened with Bamlanivimab.
— Isaac
Marks and other experts...recommend getting the vaccine
— Fooloso4
I don't think you understand what a EUA is. — Isaac
...data relating to safety and efficacy, hence you are wrong to say the the work they're doing is other than safety and efficacy work, which is the sole point of disagreement. — Isaac
The role of the FDA is to verify that products are safe and effective. There is ample evidence that the vaccine is safe and effective. They are still required to do a thorough review of the data ... — Fooloso4
If we truly want our lives to return to normal, the fastest way to do so is simple — get vaccinated right now.
Secondly, you've still not given any detail on exactly what it is you think the FDA are doing over the next stage in their work (this mysterious 'bureaucracy' which is apparently unrelated to either safety or efficacy). — Isaac
And then claim that their main job is some other work rather than safety and efficacy work. — Isaac
At this point it is a matter of bureaucracy rather than safety or efficacy, which have been amply demonstrated. — Fooloso4
I'm disagreeing with the proposition that the FDA work does not relate to safety and efficacy. — Isaac
The role of the FDA is to verify that products are safe and effective. — Fooloso4
I don't see the justification for saying that the additional work of exactly the same form to meet the higher threshold is 'just bureaucracy'. — Isaac
The FDA will approve the vaccine. At this point it is a matter of bureaucracy rather than safety or efficacy, which have been amply demonstrated. — Fooloso4
No one is denying it's safe and effective. — Isaac
I was referring to when Critias related the story of what an Egyptian priest told Solon about ancient Athenians — Valentinus
What is one to make of the "fiction that becomes a fact" immediately before a creation story is told?
I meant to ask if Plato and Aristotle are using the same model despite taking such different approaches. Aristotle takes the cosmogony and edits it so that it can become an argument. — Valentinus
what would using the same or different model of the divine look like in their case? — Valentinus
It's just that in the TLP Witt is limiting the breadth of the world to what meets a certain criteria of logic — Antony Nickles
But to watch him write only what he knows to be absolutely true with such knowing restraint; you can feel his reaching but also never stepping beyond that discipline, so every statement captures his mind frame perfectly. — Antony Nickles
So, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research is lying — Isaac
https://www.washingtonpost.com/health/2021/08/02/coronavirus-vaccines-fda-full-approval-timeline/While each vaccine review is unique, the FDA aims to complete priority vaccine reviews within eight months of receiving an application for approval and standard reviews within 12 months of receipt.
It is your claim that the FDA work from this point does not address safety and effectiveness that I'm disputing. — Isaac
One way to express my uncertainty about interests can be observed at the beginning of the Timaeus. — Valentinus
... where storytelling is closely regulated, is inserted into a story about the distant past. That seems to complicate one's relationship to the cosmogony rather than provide orientation to our present endeavors. — Valentinus
Does that difference in approach mean Plato and Aristotle are using different models of the divine? — Valentinus
Are we just going to go through the whole dance again? — Isaac
Safe and effective are not binomial measures. — Isaac
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.htmlCOVID-19 vaccines are safe and effective.
https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/is-the-covid19-vaccine-safe#:~:text=Vaccine%20for%20Coronavirus%3A%20Is%20it,continuous%20and%20intense%20safety%20monitoring.All three vaccines authorized for emergency use by the Food and Drug Administration (FDA) have been thoroughly tested and found to be safe and effective in preventing severe COVID-19. They continue to undergo continuous and intense safety monitoring.
https://www.doh.wa.gov/Emergencies/COVID19/VaccineInformation/SafetyandEffectivenessSeveral COVID-19 vaccines are authorized for emergency use by the U.S. Food & Drug Administration (FDA). These vaccines were shown to be safe and effective in clinical trials. They were developed, tested and authorized using the same rigorous process used for other successful vaccines.
These vaccines also passed independent review by medical experts in the Scientific Safety Review Workgroup, as part of the Western States Pact (English only). See our FAQs for more information.
Data show the COVID-19 vaccines are safe, and serious side effects are rare.
https://healthy.kaiserpermanente.org/health-wellness/coronavirus-information/vaccine-learn/safe-and-effectiverigorous clinical trials have proven that they’re safe and effective.
The interest in understanding this place where we are born, taken by itself, argues against seeing them as separate sets of models. — Valentinus
The anthropomorphic element is an important criteria to employ when comparing models of the divine. — Valentinus
What’s the difference between full approval and an EUA?
It’s one of scale. FDA will review much more data, covering a longer period of time, before granting full approval. “It’s not a huge difference, but it is a real difference,” Goodman* says. The agency will analyze additional clinical trial data and consider real-world data on effectiveness and safety. It will inspect manufacturing facilities and make sure quality control is very strict. “It’s an exhaustive review,” Goodman says.
On Wednesday, President Joe Biden told CNN's Don Lemon during a CNN Townhall that he expects Covid-19 vaccines could get full approval "quickly."
"They're not promising me any specific date, but my expectation, talking to the group of scientists we put together... plus others in the field, is that sometime, maybe in the beginning of the school year, at the end of August, beginning September, October, they'll get a final approval," Biden said.
That relegates the work the FDA are doing to work that is of no consequence to the safety of the public. — Isaac
The matter at hand is whether the remaining work the FDA has to do prior to approval has any impact on reducing the risks faced by the public with regards to the vaccine. — Isaac
Again, the terms we use are irrelevant. — Isaac
Do you think the FDA are carrying out any work at all which reduces the risk to the public from the vaccines? — Isaac
I'm not sure what it is about my responses that's given you the impression I'm unaware of what the FDA's role is since I cited their own lawyer explaining it, but I appreciate the effort nonetheless. — Isaac
It was the relegation of important investigations by dedicated scientists to 'bureaucracy'. — Isaac
1. The FDA have yet to perform some of these checks which may lead to them rejecting the product on the basis of their evaluation of the trial results. — Isaac
2. The FDA have no more checks to do that could lead to them them rejecting the product on the basis of their evaluation of the trial results. They're just wasting time doing paperwork which cannot possibly make any difference to the decision. — Isaac
What, if not just documentation, do you think the FDA are doing in their full approval process? — Isaac
https://www.fda.gov/news-events/press-announcements/fda-brief-fda-provides-guidance-master-protocols-evaluating-prevention-treatment-options-covid-19#:~:text=%E2%80%9CDuring%20this%20global%20pandemic%2C%20the,a%20very%20time%2Dconsuming%20process.Conducting clinical trials to see if a drug is safe and effective can be a very time-consuming process. To meet the urgent demand for effective therapies, FDA has worked with clinical trial experts to rapidly advance best practices in the design and execution of clinical trials. Today, we’re providing industry guidance for creating master protocols (an overarching protocol designed to answer multiple questions) when evaluating drugs for the treatment or prevention of COVID-19.
"4.023...The proposition constructs a world with the help of a logical scaffolding" — Antony Nickles
so that one can actually see from the proposition how everything stands logically if it is true. One can draw inferences from a false proposition.
But he is not stating the "structure of the world" (a priori or otherwise), he is dictating the terms for the structure of language. — Antony Nickles
What every picture, of whatever form, must have in common with reality in order to be able to represent it at all—rightly or falsely—is the logical form, that is, the form of reality. (2.18)
"The world is the totality of facts, not of things." (1.1; Ogden) — Antony Nickles
A state of affairs (a state of things) is a combination of objects (things) (2.01).
The sense of "reality" is created by Witt's imposed criteria of logic. — Antony Nickles
But this sense of truth is a phantasm. As he will say later in PI — Antony Nickles
What source are you using for your assertion that the full approval process consists of only 'documenting' that which is already known. — Isaac
The point is simply that the absence of any negative reports is not the same thing as an investigation to determine safety. — Isaac
You said it had already been shown to be 'safe and effective' by the FDA. — Isaac
It's not that complicated, full approval checks... — Isaac
So the problems would be some limit to efficacy, a risk in the manufacturing process, or some methodological error in the follow up trials. — Isaac
this is not about competing opinions — Antony Nickles
take the criteria of logic and create a "world" from just that — Antony Nickles
Your definitions of "the world" and "existence" are stopping you from trying to learn anything before you even begin. — Antony Nickles
As with "exist"; something like: that you are not aware of, that does not/can not matter to you. — Antony Nickles
So they are wasting their time then? If what they'll find is already known. — Isaac
It is, but that's not what a phase IV trial is, nor is it the type of data the FDA are looking at. — Isaac
A EUA's terms are that... — Isaac
And you think that role a trivial foregone conclusion? — Isaac
Are the FDA just wasting time and money looking through data which cannot yield any useful information. — Isaac
Clinical trials don't just hand out the product and then stand back and wait to see if anyone calls them. — Isaac
'Safe and effective' is not a binomial status. Nothing is without risk. — Isaac
It's not the optimism I was questioning. It was the relegation of important investigations by dedicated scientists to 'bureaucracy'. — Isaac
I would grant that you are right that what can be expressed does not limit what can be seen; that is not the point. — Antony Nickles
being "seen" does not make the world "exist" in the way that Wittgenstein is talking about here — Antony Nickles
As an example, you may not exist to the extent you have not expressed anything to differentiate yourself--categorically (in the logic of living) you are "not alive" (living your life), to yourself or to us. — Antony Nickles
Why would you think that? — Isaac
