1. Nonsensical Liberal Brouhaha over "Immediate Availability" of Hydroxychloroquine for COVID-19
Allow me to explain how deranged this storm in a tea-cup attempt by liberals truly is, as they willfully try to miss the forest for the trees.
Allow me to explain how deranged this storm in a tea-cup attempt by liberals truly is, as they willfully try to miss the forest for the trees.
2. Technically, this MD friend of @ChrisJansing (possibly fictitious) is correct, but what the f*ck is s/he really livid about? His/her own willful ignorance! What does s/he think FDA's job is? FDA is not a papal organization that blesses and canonizes drugs in a ritualized way.
3. FDA approval is given based on the results of clinical trials that have been conducted in accordance with some rigorous, scientific rules. Every drug has to demonstrate sufficient safety and efficacy to be approved. That is the only way FDA is supposed to approve drugs.
4. As for Chloroquine, it is a 70+ years old approved anti-malarial drug that has been used worldwide for generations. It is demonstrably safe, within reason. I have used it myself as a child. It is effective to treat for malaria.
5. Limited studies have shown the drug is remarkably effective against COVID-19. Here is one such study:
6. The only rub is that in order to gain FDA approval for such a broad use, there would have to be a much larger clinical trial. An FDA approval of this drug specifically for COVID-19 would imply that the drug has been tested as broadly for COVID-19 as it has been for malaria.
7. Well, COVID-19 has not even been around for all that long. So clearly a robust, large-scale study of Chroloquine as a treatment/cure for COVID-19 naturally does not exist. It would take a larger number of patients and more time to gather the requisite clinical results.
8. But we don't have time. So the President's team worked with the FDA to come up with a reasonable solution. Since the drug is known to be safe, let it be used off-label (i.e. without specific FDA approval of the drug for COVID-19) for critical cases, per physician discretion.
9. This is totally in keeping with current medical practices. Physicians prescribe off-label use of FDA approved drugs all the time.
10. A drug cannot be marketed for a particular disease without FDA approval for use of the drug for that particular disease, but physicians are not prohibited from off-label use of an FDA drug. All this is neither necessary nor easy to explain to the public at large.
11. Physicians (other than MSNBC journalists' possibly fictitious MD friends) understand this perfectly well. President Trump tried to communicate with the public at large, in terms relevant to the nation on a big picture level.
12. The big picture is the drug is immediately available to physicians who, in their judgment, would prescribe it to a patient in a critical condition for whom the advantage of an off-label use far outweighs the risks. In parallel, FDA will gather and review clinical data.
13. Once FDA has obtained and reviewed sufficient data to feel scientifically confident in approving the drug for COVID-19, they will do so. There is no need for FDA to jump the gun. Emergency use, under strict supervision, is all we need for now. And we have it.
The End
The End
