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.
> 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.
Yes, 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...
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.
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.
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.
> 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.
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.
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.
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?
Why 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.
I 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...
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.