
FDA issues emergency use authorization for convalescent plasma - tempsy
https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment
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hwillis
I've donated convalescent plasma for covid antibodies through the red cross
twice now. In Boston at least, it's booked out about a month, so sign up asap
if you can. From what I can figure -assuming your donation goes to the very
sickest- you'll save a life roughly every donation, and you'll very certainly
ease recovery for several people. Mine went to California.

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.

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vmception
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 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.

~~~
bardworx
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?

~~~
vmception
Okay, its because the public cant tell the difference on the utility.

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

~~~
bardworx
Thanks. From reading the announcement, it read like a PR piece for a co.

Your explanation creates better context.

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JohnTHaller
Full title: "FDA Issues Emergency Use Authorization for Convalescent Plasma as
Potential Promising COVID–19 Treatment, Another Achievement in
Administration’s Fight Against Pandemic"

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.

~~~
newacct583
To be clear, also: there's really sketchy evidence that it works. Just four
days (!!) ago, the administrative decision was halted due to concerns within
the department, see: [https://www.nytimes.com/2020/08/19/us/politics/blood-
plasma-...](https://www.nytimes.com/2020/08/19/us/politics/blood-plasma-
covid-19.html)

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.

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sonicggg
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?

~~~
ekianjo
It was done so far with "right to use" exceptions, and I believe that now
"emergency authorization" will broaden the usage and collection of plasma,
while I am not sure how much that will change.

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Animats
From the FDA site: _" Another Achievement in Administration’s Fight Against
Pandemic"_.

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stilley2
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.

~~~
codezero
It is absolutely a tactic of this admin and others to erode the trust of
institutions they want to undermine.

It’s working too.

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joubert
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?

~~~
ekianjo
to 1, check the actual data available - it's not final since the clinical
trials are still ongoing, but the benefits shown so far is significant enough
to allow emergency use. This also happens typically for cancer treatments
where survival rates look significantly better vs gold standard treatments.
See the evidence from the announcement below.

> 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)

~~~
joubert
Thanks.

I found the following explanation at [https://www.statnews.com/2020/08/23/is-
convalescent-plasma-s...](https://www.statnews.com/2020/08/23/is-convalescent-
plasma-safe-and-effective/)

"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."

