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FDA issues emergency use authorization for convalescent plasma

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Re: FDA issues emergency use authorization for convalescent plasma

#41

Post by ekianjo »

mumblemumble wrote: post #35
ekianjo wrote: post #15

Earlier quoted context omitted.

> 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.

In the absence of sufficient science, doctors and patients are not particularly well-positioned to make these decisions, either. See, for example: off-label use of Vioxx.

COVID19 is potentially a lethal disease (in short order) especially for certain types of patients, so comparing it with for what Vioxx was used is kind of apples and oranges.

Re: FDA issues emergency use authorization for convalescent plasma

#42

Post by 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.

Re: FDA issues emergency use authorization for convalescent plasma

#43

Post by vmception »

bardworx wrote: post #4
vmception wrote: post #3

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?

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

Re: FDA issues emergency use authorization for convalescent plasma

#44

Post by mumblemumble »

cwhiz wrote: post #6
vmception wrote: post #3

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…

There is no risk in blood plasma treatment. The FDA did an analysis of 20,000 patients who received the treatment, out of 70,000 total. If it does not end up helping people it's much ado about nothing. There is no reason for the FDA to get in the way of a potentially helpful treatment with essentially zero risk. 180,000 Americans have died, let us try anything that we can.

> There is no risk in blood plasma treatment.

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.

Re: FDA issues emergency use authorization for convalescent plasma

#45

Post by 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.

Re: FDA issues emergency use authorization for convalescent plasma

#46

Post by bardworx »

vmception wrote: post #43
bardworx wrote: post #4

Earlier quoted context omitted.

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?

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

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

Your explanation creates better context.

Re: FDA issues emergency use authorization for convalescent plasma

#47

Post by newacct583 »

JohnTHaller wrote: post #42

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.

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-...

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.

Re: FDA issues emergency use authorization for convalescent plasma

#48

Post by joubert »

ekianjo wrote: post #36
joubert wrote: post #18

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?

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 as…

Thanks.

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."

Re: FDA issues emergency use authorization for convalescent plasma

#49

Post by Gibbon1 »

ponker wrote: post #19
vmception wrote: post #3

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…

All the great American agencies like FDA, FAA, USPS have been tarnished by politicization.

Politics is also the reason why we have treatments that are known to work instead of snake oil like we used to have.

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.

Re: FDA issues emergency use authorization for convalescent plasma

#50

Post by cwhiz »

JumpCrisscross wrote: post #13
cwhiz wrote: post #6

Earlier quoted context omitted.

There is no risk in blood plasma treatment. The FDA did an analysis of 20,000 patients who received the treatment, out of 70,000 total. If it does not end up helping people it's much ado about nothing. There is no reason for the FDA to get in the way of a potentially helpful treatment with essentially zero risk. 180,000 Americans have died, let us try anything that we can.

> 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.

Well, unfortunately, there aren’t any treatments for Covid-19. This is a shot in the dark for people who otherwise might just die.
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