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FDA issues emergency use authorization for convalescent plasma
- deleted 6y ago[deleted]
- vmception 6y agoMy 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 6y agoCan 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?
- succulent_plant 6y agoBecause it sounds like communist propaganda.
- succulent_plant 6y agoSorry - Here is some context to this announcement from a day or two ago. https://www.aljazeera.com/news/2020/08/trump-accuses-deep-state-fda-slowing-vaccing-development-200822181947627.html https://www.aljazeera.com/news/2020/08/trump-accuses-deep-st...
- vmception 6y agoOkay, 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 6y agoThanks. From reading the announcement, it read like a PR piece for a co. Your explanation creates better context.
- legerdemain 6y agoThe President should do something about this rampant confusion!
- m0zg 6y agoHe could cure cancer and CNN will come out with an article on why cancer is good.
- achn 6y agoNo he would falsely claim that drinking paint thinner cures cancer, and sane people would argue he’s an idiot.
- evgen 6y agoI am anxiously awaiting the moment when he will tell us that by injecting bleach we can cure cancer and very good people have told him this treatment works and it is CNN and the deep state holding it back. What is truly sad is that I am not being sarcastic or hyperbolic, I am literally just waiting for him to say something this dumb...
- m0zg 6y agoExcept of course he never told anyone to "inject bleach". Jesus you people are gullible.
- pbreit 6y agoHe is. Trump pressured the FDA to allow the therapy. It's ridiculous that the FDA drags its feet on these things during a pandemic.
- JohnTHaller 6y agoPlease add a /s for the folks who won't notice the sarcasm.
- cwhiz 6y agoThere 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.
- JumpCrisscross 6y ago> 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.
- rubber_duck 6y ago> a false sense of security You mean placebo effect ?
- JumpCrisscross 6y ago> 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.
- cwhiz 6y agoWell, unfortunately, there aren’t any treatments for Covid-19. This is a shot in the dark for people who otherwise might just die.
- mumblemumble 6y ago> 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.
- teej 6y agoYour 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.
- ColanR 6y ago> Your average joe doesn’t get to just decide what treatment they get. That is flat wrong. Ever heard of getting a second opinion?
- ekianjo 6y ago> 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.
- mumblemumble 6y agoIn 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.
- ekianjo 6y agoCOVID19 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.
- DaiPlusPlus 6y agoYes, but there's a lot of "patient-driven" medicine lately - and doctors feeling pressured to prescribe something a patient saw advertised on TV if only to get them out of their office and/or not leave a bad review on HealthGrades...
- ekianjo 6y agoI don't think you will see anytime soon emergency authorized drugs being advertised on TV. This is not ED or something.
- DaiPlusPlus 6y agoMylan Epi-Pen is advertised on TV - that's definitely an emergency drug.
- deleted 6y ago[deleted]
- ponker 6y agoAll the great American agencies like FDA, FAA, USPS have been tarnished by politicization.
- Gibbon1 6y agoPolitics 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.
- pbreit 6y agoWhy 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.
- joezydeco 6y agoWhy is the FDA getting in the way of all these promising treatments? Citation please
- JohnTHaller 6y agoTrump tweeted about it. So, chances are, it's not grounded in facts.
- nikolay 6y agoThey've been using plasma since day 1 in Bulgaria and are not super impressed. It looks like FDA is doing a political stunt for Trump. Sad!
- Animats 6y agoFrom the FDA site: "Another Achievement in Administration’s Fight Against Pandemic".
- joubert 6y agoFull 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?
- kosei 6y agoHoly cow, if that doesn’t come off as biased, I don’t know what does.
- IgorPartola 6y agoSuuuure sounds like it’s politically motivated, no?
- ekianjo 6y agoto 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)
- stilley2 6y agoIt'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 6y agoIt is absolutely a tactic of this admin and others to erode the trust of institutions they want to undermine. It’s working too.
- sonicggg 6y agoAm 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 6y agoIt 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.
- hprotagonist 6y agohttps://youtu.be/DzPOvGro92Q https://youtu.be/DzPOvGro92Q Guess what starts tomorrow?
- JohnTHaller 6y agoFull 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 6y agoTo 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-covid-19.html 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.
- hwillis 6y agoI'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.