Posted on 03/30/2020 1:42:42 AM PDT by nickcarraway
The U.S. Food and Drug Administration (FDA) has approved the use of two anti-malaria drugs to treat patients infected by the new coronavirus.
On Sunday, the U.S. Department of Health and Human Services (HHS) said in a statement that chloroquine and hydroxychloroquine could be prescribed to teens and adults with COVID-19 "as appropriate, when a clinical trial is not available or feasible," after the FDA issued an Emergency Use Authorization. (EUA) That marked the first EUA for a drug related to COVID-19 in the U.S., according to the statement.
Currently, there are no specific drugs for COVID-19 which, as shown in the Statista graph below (accurate as of March 26), has sickened over half a million people. According to Johns Hopkins University, over 720,000 cases have been confirmed, more than 34,000 people have died, and over 152,000 have recovered since the pandemic started in China late last year.
(Excerpt) Read more at newsweek.com ...
“Also, Gilead deeply saddened.”
Also, Fauci deeply saddened. (Perhaps Gilead and Fauci are cohorts.)
“there are absolute contraindications to using quinines. Ones you can’t know by “looking at the patient”.”
true enough ... the biggie is heart disease, ESPECIALLY when the cardiac electrical system is damaged and/or abnormal, because Plaquinil widens the QTc interval, which can be fatal in such cases ... Azithromax has exactly the same issue, so the two together are a double-whammy from that perspective ...
so, while for most people those aren’t issues, a select group of cardiac patients should NOT be taking these drugs casually ... that’s why GOOD doctors must have a good understanding of the drugs they prescribe and their dangers and limitations, ESPECIALLY in the cases of polypharmacy and/or pre-existing chronic conditions ...
We could be looking at the beginning of the end of Corona.
FDA website re: Emergency use Authorizations relating to COVID-19
On March 28, 2020, FDA issued an EUA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19. These drugs will be distributed from the SNS to states for doctors to prescribe to adolescent and adult patients hospitalized with COVID-19, as appropriate, when a clinical trial is not available or feasible. The EUA requires that fact sheets that provide important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 be made available to health care providers and patients, including the known risks and drug interactions. The SNS, managed by ASPR, will work with the Federal Emergency Management Agency (FEMA) to ship donated doses to states.
More at Emergency Use Authorizations | FDA, including EUA's on ventilators, masks, in vitro diagnostic. Good level of detail that the press will never tell.
“Gee, where were you guys last month?”
because they had to have a big supply to do any of that, and the very limited normal pipeline supply for lupus and RA had been sucked dry, so none of that could be done until the big donations in the works by the manufacturers finally came through in the last couple of days ... no point in announcing big trials or plans when no drug was available ...
No, the “biggie” is G6PD Def. Hemolytic anemia is a pretty bad disease by itself.
I saw a post online from a pharmacy tech who said that they have several customers who get hydroxychloroquine scripts filled monthly, and that they generally paid about $10 per bottle of 100 pills. The same bottle is now $1000.
“While assumed nefariousness is common here, there’s a more charitable explanation for this delay readily at hand, that being the available supply. It would have done little good to “approve” the drug in advance of it being widely available as that would have simply led to more public panic as patients demanded what doctors could not give them because they didn’t have it. Per the article, at least 70 million doses of hydroxychloroquine should now be in the US pipeline, which should be sufficient to treat all current and at-risk patients, with global supply undoubtedly continuing to ramp.”
100% correct ... the normal limited pipeline supply for treating lupus and RA had been completely sucked dry (apparently mostly by doctor-hoarding), so no point in announcing big plans for trials or national treatment plans when there was no drug available ...
“No, the “biggie” is G6PD Def. Hemolytic anemia is a pretty bad disease by itself.”
well, another biggie, both will kill you ... Plaquinil is NOT a benign drug ...
btw, G6PD Def can kill you with YUGE doses of Vitamin C too ... my doc who treats a variety of illnesses (especially virus infections like West Nile and such) with IV infusions of HUGE doses of Vitamin C (25-50 grams) requires a G6PD test before preceding with therapy ...
Does this protocol include zinc?
Zelensky treated with 220mg q.d. X 5 days to be included.
https://m.youtube.com/watch?v=1TJdjhd_XG8&ebc=ANyPxKr-tw9Gd0wlS2einFYjF28k0IhOmrVUW-MKYM2tCUoqo1eOI8A-oGHpgI1-FrXE2Ej4zkY5KtGIBj5MdFhLEIAGH8rtYg&feature=emb_logo
What I said from Day #1. “If this is the cure we might pray for a better one.”
It’s disappointing that the NY trial has been delayed a week and will involve only ~1100 patients. On top of that, Cuomo ordered no HCQ prescriptions outside the trial. Thankfully Trump did an end run by having the FDA give emergency approval for use outside of clinical trials. The catch is the approval only covers patients who are hospitalized. This may be problematic since HCQ seems to work best when given soon after symptoms appear, not when they’ve progressed to the point where hospitalization is required.
Add that fake bisexual for marketing purposes governor of Oregon also
I do not understand what the FDA did or why.
The FDA does not “approve” the off label use of drugs, because no approval for this is required.
The FDA approved hydroxychloroquine in 1955. No further approval was required, and, in fact, asking the FDA to “approve” something which did not require their approval increases their bureaucratic standing and their power for all future cases.
The FDA COULD give hydroxychloroquine an “indication” for treatment of SARS-CoV-2, but they can’t do that now because the rules to do that are in statute which would have to be changed by Congress.
> true enough ... the biggie is heart disease, ...
good point. ok, agree on that (and analogous conditions from the perspective of unwanted side effects).
Doctors have always been allowed to prescribe hydroxychloroquine as we see fit, I have prescribed it for COVID-19 for two and a half weeks.
I do not understand why the FDA "approved" something that they already approved in 1955 and for which no further approval was required.
Yes but let’s make sure “the perfect isn’t the enemy of the good”.
One would think the media would get tired of being wrong 99 times out of the hundred (the 100th time was just dumb luck) but they don’t.
Or, they would at least have enough sense to stop repeatedly trying to prove Trump wrong. Especially after he is almost always right every time?
The language seemed a bit odd to me, glad it’s not just me.
BTW, you’ve probably already seen it, but there’s a link to the FDA’s announcement in my #18 in this thread.
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