FDA issues emergency use authorization for convalescent plasma
fda.gov
fda.gov
One bit of advice, especially if you are shorter or skinnier- if you start feeling a little unpleasant (tired, cold, fuzzy), ask them to turn down the citrate (an anticoagulant they add to returning blood) sooner rather than later. It kind of takes off quickly after a certain point. The first time I went, I did fine until the last ten minutes, when I started falling asleep and they ended the procedure early. Felt like crap for several hours after.
The second time, I asked for the citrate to be turned down and it went great. No issues at all, finished the donation and was able to stand right up and leave. The donation process itself takes roughly two hours and you won't be able to use either hand while you're hooked up. Whole thing takes less than three hours. The red cross is also testing temperatures at the door, so make sure you're hydrated, cool, and well-rested, which can lower body temp several degrees. I had to reschedule out a month the first time, when I failed the entry check because I rode my motorcycle in on a hot day- even after waiting in the AC for a while.
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 will look at the mere acknowledgement by the FDA as validation.
Its really shocking to me.
I’ve seen it ALOT amongst fly-by-night procurement brokers during the pandemic.
https://www.aljazeera.com/news/2020/08/trump-accuses-deep-st...
More prominent disclosure and terminology should be used such as
UNAPPROVED USE AUTHORIZATION UNDER THE WE ARE SCRAMBLING AND HAVE NO CLUE EXEMPTION
or
NOT TESTED USE AT YOUR OWN RISK COULD BE SNAKE OIL COULD BE WATER EXEMPTION
or
THE FDA HAS NOT REVIEWED THIS AT ALL INTRASTATE EXEMPTION
Your explanation creates better context.
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.
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.
Risks from blood plasma treatment include life-threatening allergic reactions and, hopefully less likely, transmission of bloodborne infections such as HIV and hepatitis.
The study that is driving this shoe an improvement in outcomes that was statistically significant, but, given that it was not placebo-controlled, there is a lot of room for that result to be a straight-up illusion. Given such weak evidence of benefit, these risks, though small, do loom large.
FDA decisions like this are for healthcare providers and hospital systems.
That is flat wrong. Ever heard of getting a second opinion?
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.
Rough quote from a 19th century doctor: The best thing to do for medicine would be to cut the page on opiates out of the Merck Manual and burn the rest.
The public has zero decision-making authority on the matter so who cares? Let the doctors decide.
Citation please
Convalescent plasma has been used throughout the nation for months now. I've got my 6th plasma donation scheduled for Tuesday. The reason for this 'breakthrough announcement' is the part of the title after the comment. Pure politics.
Needless to say, no science has been published in the interrim. This was just the white house needing to get the announcement into the news cycle.
It's also worth pointing out the ironic side of this: the only reason that plasma treatment is a feasible option in the US is because of the distressingly large population of recovered covid cases. Had we done our jobs correctly last spring and early summer, we actually wouldn't have enough plasma.
Guess what starts tomorrow?
It’s working too.
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)
I found the following explanation at https://www.statnews.com/2020/08/23/is-convalescent-plasma-s...
"A study released Aug. 13 — but not yet peer-reviewed — suggested that using convalescent plasma to treat patients with severe Covid-19 soon after their diagnosis was associated with a lower likelihood of death. But the study had serious scientific limitations that make interpreting the findings difficult.
The Mayo Clinic study, which enrolled more than 35,000 patients, showed that patients who received transfusions within three days of their Covid-19 diagnosis had a seven-day death rate of 8.7%, while patients who received plasma treatment after four or more days had a mortality rate of 11.9%. The difference met the standard for statistical significance.
The study didn’t include a placebo group for comparison, however, so it’s unclear exactly how impactful the plasma treatment might be. The study was sponsored by the National Institutes of Health and sought to broaden access to convalescent plasma, part of a so-called “expanded access” program not designed to definitively test how well the treatment works, but instead to quickly get it to patients.
More rigorous randomized, placebo-controlled studies of convalescent plasma are ongoing."