31–40 of 55 posts
Earlier quoted context omitted.
Your average joe doesn’t get to just decide what treatment they get. Doctors do, and those doctors assume liability for their decision. FDA decisions like this are for healthcare providers and hospital systems.
> Your average joe doesn’t get to just decide what treatment they get. That is flat wrong. Ever heard of getting a second opinion?
Earlier quoted context omitted.
> If it does not end up helping people it's much ado about nothing This is a frequent argument raised with respect to homeopathy and other quack cures. Unfortunately, unproven cures have a cost in avoided treatment and a false sense of security.
> a false sense of security You mean placebo effect ?
Not quite. Charitably, it’s like the seatbelt effect. With the advent of seatbelts, drivers were comfortable with riskier driving habits than they would have been otherwise.
This is a problem per se. Doubly so if the seatbelt is a sham.
It's unfortunate how (blatantly) political this announcement is written, as opposed to scientific. I think announcements from FDA/CDC etc should be about the science, not the politics. But maybe I'm just being naive.
It’s working too.
My issue with Emergency Use Authorization is by how many people use that to mean “FDA Approved”. The public is not smart enough to tell the difference between something that passed 3 clinical trials and things that did not but are available for use. The FDA brand is diluted now. I think this needs legislative intervention. Another damaging thing is that this is used outside of the country, people who shouldnt care wi…
The President should do something about this rampant confusion!
My issue with Emergency Use Authorization is by how many people use that to mean “FDA Approved”. The public is not smart enough to tell the difference between something that passed 3 clinical trials and things that did not but are available for use. The FDA brand is diluted now. I think this needs legislative intervention. Another damaging thing is that this is used outside of the country, people who shouldnt care wi…
> The public is not smart enough to tell the difference between something that passed 3 clinical trials and things that did not but are available for use. The public does not get the treatment by themselves in this case. This is not Over-The-Counter. A doctor would have to decide it's necessary and would have to agree with the patient - that's what an emergency authorization is about.
See, for example: off-label use of Vioxx.
Full title of FDA's announcement: "FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic". Note 1: "potential promising treatment" - why the caveating? Note 2: "another achievement in administration's fight against pandemic - sounds like PR; trying to score points?
> In these assays, an ID50 titer cutoff of 250 in the Broad Institute assay was chosen to distinguish between high titer and low titer plasma. This value correlated with an Ortho VITROS IgG assay signal to cutoff (S/C) of 12. Based on titer data using the Broad Institute assay, the data submitted in the EUA demonstrate the following findings: o There was no difference in 7-day survival in the overall population between subjects transfused with high versus low titer CCP. o In the subset of non-intubated patients, there was a 21% reduction in 7-day mortality (from 14% to 11%, p=0.03) in subjects transfused with high versus low titer CCP. o There was no apparent association between neutralizing antibody titers and 7-day mortality in intubated subjects. o In additional analyses of a post-hoc subgroup of patients less than 80 years of age who were not intubated and who were within 72 hours of diagnosis, a stronger relationship between neutralizing antibody titers and 7-day mortality is observed. When titers are binned to low versus high at a threshold of 250, the sponsor reports a significant reduction in 7-day mortality from 11.3 to 6.3% (p = 0.0008). o In additional analyses of survival using a Kaplan-Meier approach, the survival trends observed at 7 days persisted over a longer time period, with significantly improved survival in non-intubated patients (Figure 2, p=0.032) and a larger benefit in the subset of patients not intubated at the time of treatment, less than 80 years of age, who were treated within 72 hours of diagnosis (Figure 3, p=0.0081)
Am I missing something here? They've been using plasma ever since the early breakout in China. Why is this being treated as a breakthrough out of a sudden?
Earlier quoted context omitted.
Why is the FDA getting in the way of all these promising treatments? How is it 8 months into a pandemic and we still have little information about the efficacy of a century old therapy that has shown promise? The public has zero decision-making authority on the matter so who cares? Let the doctors decide.
Why is the FDA getting in the way of all these promising treatments? Citation please
My issue with Emergency Use Authorization is by how many people use that to mean “FDA Approved”. The public is not smart enough to tell the difference between something that passed 3 clinical trials and things that did not but are available for use. The FDA brand is diluted now. I think this needs legislative intervention. Another damaging thing is that this is used outside of the country, people who shouldnt care wi…
The President should do something about this rampant confusion!
My issue with Emergency Use Authorization is by how many people use that to mean “FDA Approved”. The public is not smart enough to tell the difference between something that passed 3 clinical trials and things that did not but are available for use. The FDA brand is diluted now. I think this needs legislative intervention. Another damaging thing is that this is used outside of the country, people who shouldnt care wi…
Can you expand on your comment. Why is this controversial? Is it because it’s in phase-3 vs approved or is it because there is hope but no concrete evidence that this treatment works?
https://www.aljazeera.com/news/2020/08/trump-accuses-deep-st...