(07-29-2020 03:44 PM)bobdizole Wrote: From the FDA themselves Link
Quote:June 15, 2020 Update: Based on ongoing analysis and emerging scientific data, FDA has revoked the emergency use authorization (EUA) to use hydroxychloroquine and chloroquine to treat COVID-19 in certain hospitalized patients when a clinical trial is unavailable or participation is not feasible. We made this determination based on recent results from a large, randomized clinical trial in hospitalized patients that found these medicines showed no benefit for decreasing the likelihood of death or speeding recovery. This outcome was consistent with other new data, including those showing the suggested dosing for these medicines are unlikely to kill or inhibit the virus that causes COVID-19. As a result, we determined that the legal criteria for the EUA are no longer met. Please refer to the Revocation of the EUA Letter and FAQs on the Revocation of the EUA for Hydroxychloroquine Sulfate and Chloroquine Phosphate for more information.
Hambone, you certainly seem to be very knowledgeable in the field of medicine and I promise I'm not trying to be contrarian. I am genuinely curious to see if I am misunderstanding their statement. Does the bolded part from their decision to reverse the EUA not say they determined it was ineffective? Or are they simply saying due to the risk of complications it has been deemed ineffective for PCPs handing them out as prophylactics and it should only be used in a controlled environment?
I answered this in an earlier post... but look at your quote... the key comment is:
FDA has revoked the
emergency use authorization (EUA) to use hydroxychloroquine and chloroquine to treat COVID-19
in certain hospitalized patients when a clinical trial is unavailable or participation is not feasible.
I'm trying to be as brief as I can. Let me give an example...
Fluzone is a medication that has been approved by the FDA for use to shorten the duration of flu symptoms 'if administered within iirc, 48 hours of the first symptom'... That is the 'on-label use'. The OFF label use might be to prescribe it anyway to someone who is 49 hours in... and an EUA might approve trying fluzone for terminal covid patients who don't have access to clinical trials.
Because this is an 'emergency' action that 'ignores' the rules of the FDA, the EUA requires a few things.
1) it requires no additional comorbidities... and a few were found. They don't know without more testing if those were related to covid, or the medication.
2) it requires pretty significant efficacy.
The lack of significant efficacy on this population doesn't mean it didn't work at all. It just means that it didn't work well enough on this population for us to ignore the potential risks. The drug could easily be approved if we discover that those new risks were related to the disease, not the drug. It also doesn't mean that it wouldn't work better on a different population... hence more studies.
This is about liability and safety which is the FDA's job... not 'patient treatment' which is doctor's job. The whole idea of 'well, if they're terminal anyway' is what allows EUAs... and not merely 'let's try it on otherwise healthy people'.... EUA's are like allowing drug companies/scientists to use people as guinea pigs without the normal processes and protections of a clinical trial.... which is a MAJOR breach of their practice. The revocation of the EUA merely means that doctors can do so, and formal trials can do so... but not just anybody.