Tuesday - June 16, 2020

FDA HCQ EUA BS

“FDA Revokes Emergency Use Authorization For HCQ”

And the media spin shifts into overdrive. Pity these Trump hating fools have the reading comprehension level of a barnacle. Or they have an axe to grind, and are willing to play extra stupid to shape your unthinking opinion. Or both, because feelz and reasons.

The U.S. Food and Drug Administration (FDA) on Monday revoked the emergency use authorization (EUA) for chloroquine and hydroxychloroquine donated to the Strategic National Stockpile to treat certain hospitalized coronavirus patients, according to a new statement.

The FDA decided the legal criteria for issuing an EUA were “no longer met.”

Further, the FDA determined, based on ongoing analysis of the EUA and emerging scientific data, that the two drugs are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. While the drugs are deemed generally safe when prescribed for patients with malaria or an autoimmune disease, little was otherwise known about the potential effects they had in COVID-19 patients.

“In light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use,” according to an FDA press release issued on Monday.

FoxNews gives you the information fairly straight up (you don’t want to see how the NYT handled this story), but they don’t explain it to the reader at all.

What it actually means is that the FDA’s edict that limited the use of the federal stockpiles of this drug to hospitalized COVID patients has been rescinded. Which means that those stockpiles are now available on the open market for any authorized medical person.

It does NOT mean that HCQ has been banned, or that it will no longer be used for patients in hospitals. All it means is that the mountains of pills that were donated to the government are no longer limited exclusively to hospitalized patients who were not part of a clinical trial.

Possibly because there aren’t that many hospitalized patients left. Or because there are millions and millions of these pills available. Or because nearly all of the clinical trials were built to fail from the outset. Or because it was known from the beginning that this approach really worked best on people who weren’t yet sick enough to be sent to the hospital.

You just have to remember that the FDA is just as filled with lawyers as every other part of the government, and they write statements filled with weasel words, caveats, innuendo, and ultra-specific subjects.

Today, the U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. The agency determined that the legal criteria for issuing an EUA are no longer met. Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine 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 potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.

“unlikely to be effective ... for the authorized uses”. Which means “duh, the stuff doesn’t do much when the patient is already nearly dead”.

“the known and potential risks for the authorized uses”. Note the weasel-ocity. “known” and “potential” risks. Well, which one? The ones you think are there, or the ones you have TDS circle jerk fantasies about? Yes, if you have a pre-existing heart condition, HCQ can temporarily give you the dreaded “QT extension”. Which means the valves in your heart don’t open and close at quite the right speed, so your heart isn’t working as efficiently as it ought to. Arrhythmia is another one; heavy doses of the drug can speed up your heartbeat in an irregular manner. Very few people actually die from this, or have a stroke, or a heart attack. But it’s one of the known side effects of the medicine that has been taken by tens of millions of people, billions of times, for over 70 years. Also note the other weasel-ness, “for the authorized uses”, which means that these side effects are perhaps more common in the hospitalized patients ... many of whom got there because they had all kinds of nasty pre-existing conditions. Could HCQ have helped them if it was taken before they became deathly ill? How many licks does it take to get to the center of a Tootsie Pop? The world may never know.

The news media has missed the truth in this story: the FDA is almost admitting that their directive, their EUA, was improper to begin with. This missive is almosta mea culpa.

And being good journalists who are on top of the Big Picture and the Back Story, they completely drop the ball concerning the poor neglected put upon maligned Dr. Bright, aka the COVID whistleblower, who’s story broke just less than 2 weeks ago. Poor guy upset the big shots, and was “relegated” to some obscure corner of the project, where he merely was in charge of A BILLION DOLLARS worth of research spending.

PS - Now guess WHO (hur hur) was behind the EUA to begin with, which appears to have been a compromise action (set up to fail) between Big Pharma and President Trump. You win: it was Dr. Bright. The EUA was a directive that severely LIMITED the use of HCQ.

In fact, the EUA was put in place to improperly restrict use of the donated drugs to only hospitalized patients. The now infamous “whistle-blower” Rick Bright, PhD, admits that he pushed for the EUA to impede use (not expand it).

A good outcome of today’s FDA order is that it states that the NSS supply of HCQ “can be distributed in interstate commerce.” This means it could be available for off-label early treatment, instead of limited to only hospitalized patients.

Today’s revocation of the EUA by the FDA is, in a sense, an admission that the agency erred by limiting the supply in the NSS to use in hospitalized patients.

The Trump Administration wanted to make the donated HCQ available for early treatment outside of hospital settings, but Rick Bright pushed for an EUA to restrict use to hospitals where it is often too late for the treatment to be beneficial.

In fact, the EUA was put in place to improperly restrict use of the donated drugs to only hospitalized patients.  The now infamous “whistle-blower” Rick Bright, PhD, admits that he pushed for the EUA to impede use (not expand it).

Deep State much? TDS? Sounds like it to me. Dr. Zelenko agrees, calling the FDA statement misleading and Nazi-level propaganda.

Meanwhile the spin gets worse by the hour.  Let’s go to the video.

President Donald Trump continued to tout the benefits of the malaria drug hydroxychloroquine for coronavirus patients on Monday, despite word from the Food and Drug Administration Monday that regulators are revoking emergency authorization for it.

The FDA said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus and could cause serious side effects.

Trump said he hadn’t seen the statement from his own administration but maintained he’s had many people tell him they are “thrilled” with the drug’s results in reducing COVID symptoms.

Posted by Drew458     on 06/16/2020 at 11:24 AM   
Filed Under: • pandemic and epidemic diseases •  
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