Author Topic: On what basis did FDA revoke Emergency Use Authorization for hydroxychloroquine?  (Read 2108 times)

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100% of studies done in the early outpatient setting of hydroxychloroquine+zinc+Azithromycin demonstrate the efficacy of this combination in curing COVID-19. And the studies that prescribe standard dosing for COVID treatment (that is also taken by millions of Americans daily for Lupus and rheumatoid arthritis) do not result in any significant side effects.
https://c19study.com/

The FDA having removed EUA for HCQ based on outright fraudulent, misguided and irrelevant (late patient) studies, discouraged entire nation states all around the world from continuing to make HCQ available. This also put prescribing it here in the U.S. outside the "standard of care", so the doctors of hundreds of thousands of suffering Americans won't prescribe it, because they are more concerned about covering their asses than they are about their patients dying[/b]. So the FDAs move in conjunction with Fauci's deadly advice to "go home and isolate" and NIH recommendations, effectively puts elderly and high-risk patients who get COVID on the highway to the cytokine storm and hospitalization, thus maximizing their odds of dying.
https://www.covid-19forum.org/index.php?topic=366.0

The demand for Remdesivir would be non-existent, if elderly and high-risk patients - and everybody else who became short of breath - were treated within the first 5 days (or close to it) of the presentation of symptoms, because nobody would have to go to the hospital since 99-100% would be getting cured within days, with a $14 outpatient treatment protocol that even citizens of poor countries all around the world could afford.
https://www.covid-19forum.org/index.php?board=3.0
While a giant WHO study of IV administered Remdesivir concluded that it did not result in significant reduction in death or even shorten the hospital stay, yet a 10-day course of treatment costs $4,600 to $6,400, while "We found the average charge per COVID-19 patient requiring a hospital stay to be $73,300. That charge is the estimated cost for a patient with no health insurance."
https://www.fairhealth.org/article/costs-for-a-hospital-stay-for-covid-19
What a perfect COVID solution for dirt poor countries around the world as an alternative after demonizing HCQ! Yet millions of Americans take HCQ daily over decades for Lupus and rheumatoid arthritis, in the same dosage that the Zelenko Protocol prescribes, over just 7 days.
https://www.covid-19forum.org/index.php?topic=366.0

From the FDA:

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and
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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.

Only if one pretends there is data in fraudulent, heavily flawed, or irrelevant studies and trials. Like this absolutely ridiculous one I was directed to most recently, done by 24 doctors and other professionals that was published in the New England Journal of Medicine.
https://www.covid-19forum.org/index.php?topic=154.0

Indeed the data to date in early treatment is overwhelmingly positive for HCQ.
https://c19study.com/

The studies the FDA and other Big Pharma owned government agencies cited most frequently, are the deadly "Solidarity" and "Recovery" trials that used dosages as high as 2400 mg per day (six times that prescribed to treat COVID) perhaps in order to cause the heart events. In France hospitalization for poisoning is directed if a person consumes over 1800 mg.
https://www.covid-19forum.org/index.php?topic=56.0
https://www.covid-19forum.org/index.php?topic=23.0

Compare those worthless and dangerous studies with the Henry Ford and Mt. Sinai studies that showed a 50% reduction in mortality even in the inpatient hospital setting if administered soon after admission.
https://www.covid-19forum.org/index.php?topic=77.0

The 99+% effective Zelenko protocol uses 400 mg per day for 5 days. Indeed all of the data does in fact point to HCQ being a major life saver. Dr Zelenko and his team saw 2,200 COVID-19 patients in all, sent 2/3 of the younger and healthier home to get better (with monitoring by phone), and treated 1/3 that were elderly or high-risk immediately upon presentation of symptoms or "clinical suspicion" of COVID-19.
https://www.covid-19forum.org/index.php?topic=18.0

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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.

They conveniently ignore the fact that COVID-19 itself causes heart issues, without HCQ:
https://www.covid-19forum.org/index.php?topic=182.0
Hydroxychloroquine has had a safety profile over the last 65 years that suggests it is safer than aspirin, Tylenol or Benadryl. It is available over the counter in many countries. Millions of people take it for malaria. In the U.S. people take HCQ every day over the course of many years for Lupus and rheumatoid arthritis, in the exact same daily dosage that the Zelenko protocol uses over 5 days, to treat COVID-19 patients. So if it's so dangerous, why didn't the FDA warn those citizens who take it every day?
If my math is correct extrapolating from Dr. Harry Risch's estimate on heart issues related to HCQ, an elderly or high-risk individual would have a 1667 times greater chance of dying of COVID-19 than of a heart issue caused by hydroxychloroquine.
https://www.covid-19forum.org/index.php?topic=182.0
But revoking the EUA for HCQ certainly gave Big Pharma more opportunity to peddle its inferior patented products.

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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.

And the data and evidence in HCQ's favor is far more convincing today than it was back then! With hundreds of thousands or perhaps millions of people having been saved by it. (see final paragraph and this link)
https://c19study.com/
Dr Zelenko only lost 2 COVID patients out of 2,200, by using HCQ+Zinc+azithromycin to treat the elderly and high-risk patients in that group.

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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.

It was not based on other than faulty science and data.
The following link reveals the real science behind a real cure for COVID-19.
https://www.covid-19forum.org/index.php?topic=222.0
Those agencies are quite conspicuously owned and populated by Big Pharma.
https://www.covid-19forum.org/index.php?topic=42.0

I invite any and all of the members of those government agencies to join us in discussion. Or perhaps they could just answer the well formed questions posed by three intelligent treating physicians asked in an open letter to Dr. Fauci, and I'll post their replies in the forum.
https://www.covid-19forum.org/index.php?topic=137.0

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“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.

They are quite obviously and specifically NOT guided by science or evidence when we compare truly ethical studies and trials.
https://c19study.com/

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We will continue to examine all of the emergency use authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence.”

They mean they will continue to shill for more dangerous Remdesivir, for as long as they can get away with it, for which the NIH's own study suggests that the "difference in mortality was not statistically significant".
https://www.covid-19forum.org/index.php?topic=19.0

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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.

There is a diminishing benefit for any anti-viral once a patient is hospitalized and heading into a full blown cytokine storm. That's perhaps why they favor studies on dying hospitalized inpatients rather than outpatients in the early stages of infection, that can be kept out of ever seeing the hospital, as a result of early treatment. Also no doubt so they don't have to admit that a $20 course of treatment that includes a 65 year old unpatented drug, that has been a stellar performer on COVID ever since before March, is by far the most effective when used within the Zelenko Protocol.
Find even one outpatient study that they cite. It's easy to see why some suggest their obfuscation and foot-dragging, on making available a tried and true highly effective world-wide proven remedy, is tantamount to outright genocide.
https://c19study.com/

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“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.”

If somebody lists those studies we can take them apart one by one. But after you see a few you realize you already know what you will find.
First, you can throw the first 99% out that did not use zinc along with the hydroxychloroquine. Since zinc is what actually kills the virus and hydroxychloroquine is the vehicle (ionophore) that allows it to penetrate the cell wall, any study on the benefits of HCQ for COVID treatment that does not also use zinc is not of much value.
Second, for treating COVID, any study that used HCQ+zinc but didn't use azithromycin as well, for preemptively treating secondary bacterial lung infections simultaneously, would fall short of the performance of the Zelenko protocol that uses all three can enjoy up to 99+% rates of recovery.
Third we can throw out nearly 100% of them again, for administering HCQ to patients after they are already too sick for an anti-viral to do much good, as a cytokine storm lays claim to their system.
Any honest trial of HCQ needs to begin administering the Zelenko Protocol or "HCQ cocktail", within 5-7 days from initial symptoms, or it is not giving HCQ a fair chance to produce optimal performance. Sometimes realized by the patient in as little as a few hours.
Yet even in the inpatient hospital setting it has been shown to reduce mortality by 50% if it is administered soon after admission.
Why wouldn't all studies use the Zelenko protocol as the "control" group of the trial, since it is the most effective treatment to date, and measure the other drugs they want to trial, against it? Wouldn't that make more sense? Wouldn't that be better for the patients? As soon as the group treated with the experimental medicine started to fade, they could stop the trial and switch them over and maybe save their lives. Is it hard to guess why they don't?
https://www.covid-19forum.org/index.php?topic=77.0

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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.

See how they just exposed themselves? Or do they think Americans are that stupid? Hydroxychloroquine is "safe and effective" when a person takes it for malaria, or every day for years on end for chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis, but when a person takes it for COVID-19 - in the very same dosages as people take it daily for those illnesses - but for only 7 days in the case of curing COVID with the Zelenko Protocol, then somehow it suddenly becomes dangerous for those people!

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products."Related Information

That could not be more false as even someone with a heavily compromised capacity for critical thought should have been able to plainly see from all of the above.

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Emergency Use Authorization Revocation
    Frequently Asked Questions on the Revocation of the Emergency Use Authorization for Hydroxychloroquine Sulfate and Chloroquine Phosphate
    Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic
    Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19
    Emergency Use Authorization: Drug Products
    Coronavirus Disease (COVID-19)

Which led me to this link: https://clinicaltrials.gov/ct2/results?cond=COVID-19
Of recruiting and completed drug trials of which I searched the first 400 and found:
https://www.covid-19forum.org/index.php?topic=210.0


The blessed truth is everywhere to be found. According to esteemed professor of epidemiology at Yale School of Public Health, Harvey A. Risch MD, PhD:
Full article here:
https://www.covid-19forum.org/index.php?topic=168.0
"Since publication of my May 27 article, seven more studies have demonstrated similar benefit. In a lengthy follow-up letter, also published by AJE, I discuss these seven studies and renew my call for the immediate early use of hydroxychloroquine in high-risk patients. These seven studies include: an additional 400 high-risk patients treated by Dr. Vladimir Zelenko, with zero deaths; four studies totaling almost 500 high-risk patients treated in nursing homes and clinics across the U.S., with no deaths; a controlled trial of more than 700 high-risk patients in Brazil, with significantly reduced risk of hospitalization and two deaths among 334 patients treated with hydroxychloroquine; and another study of 398 matched patients in France, also with significantly reduced hospitalization risk. Since my letter was published, even more doctors have reported to me their completely successful use."

The FDA used the fraudulent study that was published in The Lancet as an excuse to remove emergency use authorization for hydroxychloroquine, AFTER the study was retracted from The Lancet for being found out to be a fraud that used fictitious data.

« Last Edit: November 19, 2020, 03:33:16 PM by admin »
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