teedubbya wrote:This came across my desk from the FDA today (EUA is Emergency Use Authorization)
On June 15, 2020, based on FDA’s continued review of the scientific evidence available for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) to treat COVID-19, FDA has determined that the statutory criteria for EUA as outlined in Section 564(c)(2) of the Food, Drug, and Cosmetic Act are no longer met. Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use. This warrants revocation of the EUA for HCQ and CQ for the treatment of COVID-19.
I know not everyone understands how medical studies and peer reviewed journals operate and why some may be pulled because of extremely stringent data specifications while others might still be out there that do not self impose those standards. You have to recognize them for what they are and are not instead of the knee jerk political crap we tend to make everything in here.
It is looking more and more like this particular drug is not pat of the solution. Hopefully it turns around and becomes the miracle drug the politicians pushed and shows benefit but it is not promising at the moment. No politics, just facts.
If it were a miracle drug, the tests would already point that out.
I work indirectly with the FDA (my customers submit medical devices for their 510k and we get involved at the materials level quite frequently). I hate their glacial pace, but I trust their motives and therefore their decisions. For the most part.
There was no harm in following up on the anecdotal evidence. But politics lead many to believe otherwise.