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FDA Says OOOPSIE, Pulls Emergency Hydroxychloroquine, And Fox News Is PISSED
Turns out the Fox News green room does not count as a clinical trial.
Yesterday, the FDA formally revoked the Emergency Use Authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate AKA Hydroxybonercream 3000 , AKA the supposed "game changer" in the treatment of COVID-19. In a letter to Department of Health and Human Services official Gary Disbrow, the FDA's Chief Scientist Denise Hinton wrote that there was no evidence the drug sped recovery or increased survival rates among coronavirus patients, and in fact its use is associated with a statistically significant increase in cardiac risk for patients.
"FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks," she wrote.
Which is some very careful language to wrap around an authorization that appears to have been based on political rather than scientific considerations and will undoubtedly be the subject of House investigations for the foreseeable future. Because President Trump admitted publicly that he was the one who forced the Biomedical Advanced Research and Development Authority (BARDA) to issue the EUA, and also forced it to override the standard review process.
As the Washington Post 's Aaron Blake notes , Trump bragged to his pals at "Fox and Friends" on March 30 that "hydroxychloroquine is something that I have been pushing very hard. I got the very early approval from the FDA. It was going to take a long time, and Dr. Stephen Hahn, the head of the FDA, gave us an early approval, a very quick approval, a 24-hour approval."
At his March 19 daily coronavirus briefing — remember when that was a thing? — he gushed , "We have a drug called chloroquine. A derivation would be hydroxychloroquine, which I hear even better about. It's a common malaria drug. It's been available, so therefore the safety level we understand very well. It's been relatively safe. And it showed very encouraging early results. Really encouraging." Later he boasted about cutting through the red tape to get the medication approved for use as a coronavirus treatment, crediting FDA head Dr. Stephen Hahn: "He got it approved very quickly. I won't even tell you how quickly, but let's put it this way: It's approved. And we're encouraging you to take a look at it. We have ordered a lot of it, and you can too. It's by prescription."
Remember when the president encouraged Americans to just try it, what the hell?
"What do you have to lose? Take it. I really think they should take it," Trump said of an untested drug treatment f… https: //t.co/L8MInokUS6
— Robert Mackey (@Robert Mackey) 1586143701.0
Don't you feel safer knowing that the drug approval process is being vetted by the crack team of scientists at Fox, who have been flogging this drug for months and always have President Couch Potato's ear? No? Well then definitely don't read the whistleblower complaint by former BARDA official Dr. Rick Bright, who was screaming bloody murder that denying pills to lupus patients who need the drug, sourcing millions of doses to unlicensed facilities in Pakistan, and then jamming them down the throats of thousands of Americans who might have heart conditions was a REALLY BAD IDEA.
Lest we forget, one of those Americans was Donald Trump himself, who apparently took a course of hydroxychloroquine after members of the White House staff tested positive for the disease.
"I asked [my doctor], 'What do you think?' He said, 'Well if you'd like it.'" I said. 'Yeah I'd like it. I'd like to take it,'" Trump arglebargled in May. "So, I'm taking the zinc and the hydroxy. And all I can tell you is, so far I seem to be okay."
But while there was some anecdotal evidence suggesting that the drug might speed recovery in hospitalized patients, there was never any indication that it would act as a magical prophylactic shield against infection the way Trump was using it. Which we should probably keep in mind since the doctors who prescribed it to him are the same ones assuring the country that our leader is the perfect specimen of health, genetically gifted with arteries unaffected by cheeseburgers, and able to leap tall buildings in a single bound.
Yesterday the White House downplayed the FDA decision, with HHS Secretary Alex Azar barfing out some nonsense to imply that the revocation would make the drug even more widely available, saying , "They took the emergency use authorization off. At this point it's just like any other approved drug in the United States. They may be used in hospitals, they may be used as out-patient, at home, all subject to a doctor's prescription."
"So, it actually uncomplicated it in a way," Trump added. As if he hadn't just engineered a massive, scandalous nationwide drug trial to feed untested medication to sick Americans. In fact, hydroxychloroquine may actually interfere with the efficacy of the antiviral remdesivir, the only drug which has been clinically proven to speed recovery in hospitalized coronavirus patients. But, you know, that's complicated.
Over at Fox, the FDA's revocation of the EUA is not landing well.
Laura Ingraham on FDA revoking hydroxychloroquine for emergency use: "Why did the FDA even inject itself in a debat… https://t.co/jcjgCJvNFd
— Justin Baragona (@Justin Baragona) 1592274624.0
Why even would the Food and DRUG Administration "inject itself" into the widespread experimental use of a drug with known, serious side effects, that's what Laura Ingraham wants to know. Obviously the FDA is "corrupt to the core," intones Dr. Ramin Oskoui, a cardiologist who has appeared on Ingraham's show for months now to promote the drug.
"A lot of these hospitals have researchers who get a lot of grant money from pharma and this endangers those grants, and I get that," he continued. "But to restrict my use as a clinician, to restrict it to patients is tragic. It's something the FDA should never have gotten into." Then he referred to his peer-reviewed (no, not really) article "Hydroxy Hysteria," which appeared in the well-respected medical journal The Hill. Hard to know who to trust: some Fox dipshit's op-ed in The Hill, or the FDA which cites actual clinical studies saying Hydroxybonercream 3000 didn't work to treat coronavirus?
Yeah, it's a tough one!
But it's not all bad news. Researchers in England have discovered that use of the steroid dexamethasone, which is cheap and widely available, may cut coronavirus deaths by a third. The AP reports:
The study is a large, strict test that randomly assigned 2,104 patients to get the drug and compared them with 4,321 patients getting only usual care.
The drug was given either orally or through an IV. After 28 days, it had reduced deaths by 35% in patients who needed treatment with breathing machines and by 20% in those only needing supplemental oxygen. It did not appear to help less ill patients.
Not as sexy as some Magic Bullet Rona Shield. But it actually seems to work, so there's that.
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