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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
by vmception 6y ago
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 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!