Posted on 06/19/2020 7:52:31 AM PDT by SeekAndFind
Despite therapeutic successes with hydroxychloroquine around the world, and significant usage by many doctors in the US, who regularly report success in using the drug, and despite the support for the drug by the US president, the Food and Drugs Administration today revoked its emergency authorization for COVID-19.
The decision relies on “recent results from a large randomized clinical trial in hospitalized patients.”
UPDATE: It appears the announcement will not prevent prescriptions of HCQ outside hospital settings. Check this video:
There is no reference to early treatment, where the therapy has been scientifically shown to work at IHU-Marseille, in Sao Paulo, and elsewhere.
Meanwhile, the competitor of hydroxychloroquine, remdesivir, remains authorized despite the absence of studies showing benefits in terms of mortality reduction.
See our previous reporting about how remdesivir was authorized.
COVID-19 has already claimed over 100,000 lives in the US, and remains very active, with rising numbers of new infections in some 20 states.
See FDA Media Release
Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine
For Immediate Release:
June 15, 2020
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. This is the statutory standard for issuance of an EUA. The Biomedical Advanced Research and Development
Authority (BARDA) within the U.S. Department of Health and Human Services originally requested the EUA covering chloroquine and hydroxychloroquine, and the FDA granted the EUA on March 28, 2020 based on the science and data available at the time. Today, in consultation with the FDA, BARDA sent a letter to the FDA requesting revocation of the EUA based on up to date science and data.
“We’ve made clear throughout the public health emergency that our actions will be guided by science and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data, and consider the balance of risks versus benefits of treatments for COVID-19,” said FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D. “The FDA always underpins its decision-making with the most trustworthy, high-quality, up-to-date evidence available. We will continue to examine all of the emergency use authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence.”
The FDA has a responsibility to regularly review the appropriateness of an EUA, and as such, the agency will review emerging information associated with the emergency uses for the authorized products. Recent results from a large randomized clinical trial in hospitalized patients, a population similar to the population for which chloroquine and hydroxychloroquine were authorized for emergency use, demonstrated that hydroxychloroquine showed no benefit on mortality or in speeding recovery. This outcome was consistent with other new data, including data showing that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19. The totality of scientific evidence currently available indicate a lack of benefit.
“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate. This action was taken following a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation. “We remain committed to using every tool at our disposal in collaboration with innovators and researchers to provide sick patients timely access to appropriate new therapies. Our decisions will always be based on objective and rigorous evaluation of the scientific data.This will never change.”
Chloroquine and hydroxychloroquine are both FDA-approved to treat or prevent malaria. Hydroxychloroquine is also approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis. Both drugs have been prescribed for years to help patients with these debilitating, or even deadly, diseases, and FDA has determined that these drugs are safe and effective when used for these diseases in accordance with their FDA-approved labeling. Of note, FDA approved products may be prescribed by physicians for off-label uses if they determine it is appropriate for treating their patients, including during COVID.
well, that’s one way to ‘fix’ Social Security...................
for those that think they will get access to the meds they need if they end up in the hospital..here is one example of the rationing
from tex ags site:
Marcus Aurelius8:02p, 6/18/20AG
I have posted on this before. But I’m on call and experiencing it again tonight first hand. I post because I’m frustrated. So I’ve have 2 new COVID patients today admitted to ICU. One - 47 male HTN o/w healthy. Sick. Requiring high level HFNC. Severe viral pneumonia. Another - 80 y/o NH female DNR, intubated max vent severe viral pneumonia/ARDS, renal failure. Family reversed DNR to “give her a shot.”
Remdisivir requires infectious disease approval. We have one dose of remdisivir (x 5 d) left in pharmacy. ID doc approves for 80 y/o but not for the 47 y/o.
We discussed and he won’t budge. Tough call but would treat the 47 y/o IMO.
Dealing with this day to day.
and as an update...they reversed course,,now the Vent lady doesnt get it
Marcus Aurelius9:54p, 6/18/20AG
Real time. Just re talked to ID doc. He is holding remdisivir for 47 y/o. Yes.
Any “ study” done without using hydroxy and ZINC...was designed to fail
depending upon the payoffs (illegal, actually)
the sick patients will be refused HCQ,Zn,macrolide
until ventilated (BIG payoff, illegal, too)
and then triaged to the highest payoff of
antiviral du jour, vaccine/retrovirus of FauXi,
rat poison, and Viagra.
Zinc crushes the covid; hydroxy provides the pathway.
You got it. The hacks in FDA WANT this hysteria to continue.
A friend of mine was treated with a type of this drug four years ago when she was suffering from pneumonia. She said it made her feel deathly ill for a few days while she was taking it, but it helped cure her.
This FDA director is a swamp bureaucrat and a flake. He insisted that the FDA is the only entity who could develop a COVID-19 test in the U.S. He is the reason why development of an effective test was delayed by 2-3 weeks. Trump invoked the private sector, and they developed effective tests rapidly.
You’re right. The FDA needs to be given this reality check: withholding HCQ w/Zinc can be a death sentence to some patients.
I thought I read somewhere this is being misrepresented in the media. That the emergency declaration in place was restricting doctors use/prescription of HCL, but this reverses that and frees doctors up to use it?
And as usual Donald Trump is mum about it. He won’t say anything about this politically motivated crap. He won’t take any action to stop it.
All this because ORANGE MAN BAD! These are deep state Stalinists. If Trump loses, we will be in deep shit. Think President Kamala Harris.
U.S. Secretary of Health and Human Services Alex Azar stated the following:
The drug can still be used with a doctor’s prescription. Any drug with U.S. approval can be used in any way a doctor sees fit regardless of what it has been approved for.
Take a look at this...
https://www.earthclinic.com/remedies/bht.html
https://www.youtube.com/watch?time_continue=1&v=v1QS7znKL_0&feature=emb_logo
.
I interpret the purpose for this order as simply prioritizing still-limited quantities of hydroxychloroquine for those victims who need it the most. Same thing happened a few months ago if I recall correctly.
Corrections, insights welcome.
The major constitutional problem with this policy is that the non-elected federal bureaucrats running the FDA in this example shouldn’t be making such orders. Elected officials need to be making such orders so that disgruntled voters can kick them out of office in November.
Speaking of which...
Send “Orange Man Bad” federal and state government Democrats and RINOs home in November!
Supporting PDJT with a new patriot Congress and state government leaders that will promise to fully support his already excellent work for MAGA and stopping SARS-CoV-2 will effectively give fast-working Trump a “third term” in office imo.
This is all about maximum death rates, trashing Trump, big government control of who lives and dies, and big money.
Literally all the above.
As has been said here, the hydroxychloroquine unlocks the cell for the zinc, the zinc then cuts protein off from the virus, so the virus both starves, and cannot replicate. The virus simply dies at the cellular level, and is passed out of the system.
And, unlike a remotely possible vaccine, which would only likely deal with a previous virus strain, and likely only address one receptor mutation at a time, the Hydroxychloroquine and Zinc act to block protein and replication of any mutated COVID strain, and mutation toward attacking different receptors, as the protein for the virus is simply blocked off.
For me personally, I would set differences aside, and go through Jerome Corsi’s specific TELEMED link (there is a more than one site using that name), get an appointment to speak with one of their many actual MD’s, and go for the prescription, (as they are writing for a number of people), and before the Fed’s act under Fauci, to knock them out.
This is all about maximum death rates, trashing Trump, big government control of who lives and dies, and big money.
Literally all the above.
As has been said here, the hydroxychloroquine unlocks the cell for the zinc, the zinc then cuts protein off from the virus, so the virus both starves, and cannot replicate. The virus simply dies at the cellular level, and is passed out of the system.
And, unlike a remotely possible vaccine, which would only likely deal with a previous virus strain, and likely only address one receptor mutation at a time, the Hydroxychloroquine and Zinc act to block protein and replication of any mutated COVID strain, and mutation toward attacking different receptors, as the protein for the virus is simply blocked off.
For me personally, I would set differences aside, and go through Jerome Corsi’s specific TELEMED link (there is a more than one site using that name), get an appointment to speak with one of their many actual MD’s, and go for the prescription, (as they are writing for a number of people), and before the Fed’s act under Fauci, to knock them out.
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