Breaking News: FDA Denies HCQ Approval for Early Outpatient Covid Therapy

by | Aug 16, 2020 |

Print Friendly, PDF & Email

The death toll mounts with the FDA’s denial of HCQ for early outpatient COVID-19 therapy. Approximately 48,000 more Americans have died during the FDA’s 48-day delay since the Emergency Use Authorization (EUA) was filed July 1.
The FDA denied on August 10 the urgent request for emergency approval for outpatient preventive and early treatment use of hydroxychloroquine (HCQ) filed July 1 by physician researchers at Henry Ford Hospital in Detroit, supported by Dr. Peter McCullough’s cardiology team at Baylor Heart and Vascular Institute in Dallas.
The physician head of the FDA, Dr. Steven Hahn, has again betrayed physicians and patients by preventing Americans from having the “right to try” HCQ for early COVID-19 treatment. Dr. Hahn knows full well the FDA approved HCQ as safe in 1955, and it has been used in millions of patients around the world for 65 years with an impressive track record of safety in patients of all ages, all ethnic groups, and even pregnant women and nursing mothers.
Dr. McKinnon’s clinical trial at Henry Ford found an impressive 51% reduction in deaths if HCQ was begun within 24 hours of admission to hospital. An outpatient primary care study by Dr. Vladimir Zelenko, using HCQ, azithromycin and zinc given within less than 7 days of COVID-19 symptoms, showed approximately 80% decrease in deaths, and less than 1% of his patients needed to be admitted to hospital. These U.S. early intervention studies extraordinary results show how many lives can be saved with early HCQ treatment.
Dr. Harvey Risch, Yale epidemiologist, projected that widespread early treatment for COVID-19 with the already FDA-approved HCQ could have saved 100,000 lives.
In denying the EUA for early outpatient use, the FDA has continued to maintain a claim of outpatient harm for HCQ, based on inpatient data in critically ill patients, in spite of established facts of effectiveness and lack of harm for outpatients that have been established beyond a shadow of a doubt in a multitude of worldwide clinical studies and controlled clinical trials.
The FDA used a standard of “may be effective” for the emergency approval given to the experimental anti-viral remdesivir on May 1, 2020, based on one controlled clinical trial terminated early. Yet FDA is now requiring a higher standard of a randomized controlled clinical trial for the already FDA-approved HCQ in safe use for 65 years and shown to cut deaths in COVID-19 80% or better if used early.

Remdesivir showed very little benefit shown in hospitalized COVID patients and had serious side effects. Of course, it helped that nine of the experts on the NIH panel were supported financially by Gilead Sciences, maker of remdesivir.

The newly released study from Turkey found no cardiac abnormalities with HCQ given at therapeutic doses for 5 days in early COVID patients. There was no significant QT prolongation or other adverse conduction defects in the heart that varied from the patient’s baseline ECG before HCQ administration. Attributing any late-stage patient cardiac effects due to the virus is not only NOT warranted, but medically totally improper. Their conclusion: HCQ is safe for early use.
What amount of “data” will ever satisfy Dr. Hahn?
As a cancer specialist, Dr. Hahn knows early treatment of any disease is critical, especially viral illness. But it is more critical with COVID-19, or SARS CoV-2, as we learned in 2005 when National Institutes of Health (NIH) and Centers for Disease Control (CDC) published their studies begun in 2002 with SARS-CoV-1 broke out in China and spread around the world. These in-vitro tests of possible anti-viral medicines clearly showed potent antiviral effects of chloroquine (CQ) against SARS-CoV-1 to block the SARS-CoV-1 infection at the earliest stage. Dr. Fauci was at NIH then, so he also has known for the last 15-18 years that chloroquine and hydroxychloroquine are effective against SARS-Co-V-1, which shares 79% of the viral genome with SARS-CoV-2, the cause of COVID-19 disease.
It is crucial to start HCQ early, during days 1-7 of symptoms. By day 6-7, the viral load explodes and then triggers an exaggerated inflammatory response that can lead to the severe phase called Cytokine Storm, which severely damages critical organs: lungs, kidneys, heart, brain, liver and intestines. This severe complication doesn’t occur in all COVID-19 patients, but often is fatal when it does.
HCQ is most potent as an anti-viral agent in two critical ways if given with zinc between days 1-5 of symptoms:

    • to stop viral entry into our cells, and
    • block the virus from multiplying using the cell’s machinery.

The lessons we learned 18 years ago⏤key lessons about CQ/HCQ anti-viral effectiveness:

    • Early treatment keeps infected people from spreading the virus to others.
    • Early treatment is crucial to prevent progression of the disease that damages critical organs, and helps keep people out of hospitals and off ventilators.
    • Availability of early treatment is the pathway to more safely keep businesses, schools, and churches open, and help relieve public anxiety and fear during a pandemic.

Then in 2020, Dr. Peter McCullough’s team at Baylor showed prophylactic benefits of HCQ given to hospital workers who were exposed to COVID daily in their work, just as found in India, South Korea, China, and multiple other countries.
This preventive (prophylactic) benefit is profoundly important, not only for front-line medical workers, but also for law enforcement officers, paramedics, clergy, dentists/dental hygienists, truck drivers, food-processing workers, teachers, behavioral health professionals, factory and grocery store workers, flight attendants, and many others. We could more safely re-open America’s businesses, schools and churches with doctors and patients having widespread, early access to HCQ.
HCQ is a safe, effective, low cost, outpatient treatment we have NOW. Doctors treating COVID-19 patients see lives being saved by cheap, safe, FDA-approved medicines—hydroxychloroquine, azithromycin, doxycycline with the supplements zinc, vitamin C and vitamin D.

Why don’t Americans have the freedom to use it here as in other countries? FDA’s misleading statements about HCQ have led to dangerous, unprecedented restrictions on physicians’ off-label prescribing rights imposed by state governors, medical boards and pharmacy boards.

Americans are dying needlessly for political and financial agendas, not due to lack of available treatment for COVID-19. We cannot afford more preventable deaths waiting for some “magic bullet” of a vaccine. Even IF we have a vaccine that works, and even IF it is actually safe, we still need therapeutics, such as HCQ.
Testing is inaccurate and often unavailable, and HCQ dispensing must not be limited to persons with a positive test. Such limits also prevent prophylactic use. Governors and other officials must not be allowed to arbitrarily restrict life-saving HCQ treatment.
Front-line doctors and patient advocacy groups have been pleading with the FDA and State officials since March to open access to early treatment with HCQ. The supply of HCQ has been ramped up to handle its use in early treatment of COVID. The Strategic National Stockpile has millions of doses deteriorating in government warehouses that are not being distributed because doctors are prevented from prescribing for outpatients with COVID-19.
Generic HCQ with azithromycin or doxycycline plus zinc is taken by mouth. Total treatment cost is about $30 cash price for the 5-7 day course used in COVID-19. Remdesivir, the experimental anti-viral developed by Gilead Sciences, must be given intravenously to patients in hospital, at a cost of about $3,500. Its serious side effects include respiratory failure, the very condition it is supposed to treat. It has shown limited success: it shortened hospital stays by only 4 days and has not been clearly shown to reduce deaths.
The Fauci-Hahn strategies of suppressing the positive studies of HCQ effectiveness for outpatient use, while focusing on mandatory mask edits and continued shutdowns of businesses, schools, churches forcing masks and lockdowns are not controlling the pandemic. Meanwhile, these political agendas have eroded our constitutional freedoms, and devastated our financial, psychological, physical, and spiritual well-being.
Dr. Hahn’s FDA delays and denials of HCQ EUA for use in COVID-19 costs1000 more American lives every day. The deaths and collateral damage of the Fauci-Hahn mismanagement of the COVID-19 pandemic has to stop NOW.
Dr. Hahn needs to be held accountable for the preventable deaths caused on his watch. He should immediately be called before the Senate Oversight Committee on Homeland Security and Governmental Affairs to produce the data on which the FDA is claiming that there is “harm” in using HCQ for outpatients in the mild stage of COVID infections, but not for outpatients with Lupus, Rheumatoid Arthritis and malaria. The FDA’s hypocrisy ignores their own safety data, basic science and clinical studies, as well as common sense.
Americans must speak out now and demand the medical freedom to decide to consult their physicians and freely decide treatment without government interference.

DrLee4America

Elizabeth Lee Vliet MD is President and CEO of Truth for Health Foundation, a 501(c)(3) public charity (www.TruthForHealth.org) advocating for early COVID home-based treatment, vaccine risks updates, and medical freedom. Dr. Vliet is also an independent practicing physician founder of Vive Life Center in Tucson and Dallas treating COVID patients and vaccine-injured patients. She is co-author with Peter A. McCullough MD MPH of the COVID Early Treatment Guide: Options to Stay Out of Hospital and Save Your Life (https://www.truthforhealth.org/patientguide/patient-treatment-guide/). Dr. Vliet is a 2014 Ellis Island Medal of Honor recipient, a past Board of Directors member of The Association of American Physicians and Surgeons (AAPS), and member of AAPS editorial writing team since 2009.

Use the code ‘OUTLOUD’ and save 15%
Subscribe
Notify of
guest
9 Comments
Most Voted
Newest Oldest
Inline Feedbacks
View all comments
Rose Ciochetti
Rose Ciochetti
1 year ago

We need President Trump to override the FDA with an Executive Order allowing the use of HCQ because it SAVES LIVES!!!

Kamesha
Kamesha
Reply to  Rose Ciochetti
1 year ago

I agree..!!

Stephen
Stephen
1 year ago

The biggest Hoax in history.

Noelle DePaula
Noelle DePaula
1 year ago

How can I get my doctor to proscribe it to me for prophylactic use?
I’m 65 with mild asthma and must travel on the NY subway system.
What argument can they use to deny me?
What argument can I use to demand it?

Marie Rodriguez
Marie Rodriguez
1 year ago

This is a heartbreakingly, frustrating issue. I can not process how top medical providers are preventing patients from obtaining the hydroxychloroquine regimen.

Lermont
Lermont
1 year ago

My daughter’s 56-year-old-tenant just died of Covid-19 today. He had been in ICU since early July. Hospital doctors didn’t give him hydroxychloroquine at all. They waited for more than a month until organ damage became so severe in his lungs, kidneys, and liver that they told his wife 3 days ago that they wanted to take him off the ventilator and just let him die. She asked them to keep him on the ventilator a little bit longer, which they did. My daughter had found a good family doctor who had already prescribed hydroxychloroquine and zinc for her as a prophylaxis. She gave that doctor’s phone number to her tenant’s wife and son, and urged them to call that doctor right away, because he could step in and administer an emergency HCQ protocol to aggressively confront the virus even at such a late stage. Unfortunately, the wife and the son declined to call that doctor, even though they knew he was available 24/7 and waiting for their call. He even called them, and they didn’t pick up the phone, even though they knew he’d call. Instead, they stuck with the hospital doctors who were already giving them no hope and were ready to let him die. They had nothing to lose but they still didn’t give it a shot. I really don’t understand that, especially since they’ve always been such a loving family. Another needless Covid death. My daughter even tried to connect her doctor with the hospital doctor but her tenant’s son replied that the hospital doctor doesn’t want to talk to anybody else. My daughter’s doctor even called the hospital to find the name of her tenant’s doctor, but the hospital refused to tell him the name. It was impossible for my daughter to visit her tenant because the hospital had very strict no-visit rules. They only talked to her tenant’s wife and no one else. So frustrating. I myself met her tenant several times. He was a nice guy. Tenant’s wife finally told the doctors to take her husband off the ventilator today, and he died a few hours later. While the father was still alive, his son told us that the hospital doctors didn’t want to give him HCQ because of the extensive organ damage that had already taken place, and that he “didn’t need it or can’t take it”, whatever that means, as if he was going to be more dead with HCQ than without. So ridiculous. It’s so sad that people get paralyzed with fear and excessive respect for doctors who offer no solution. Those doctors don’t want to risk losing their jobs by prescribing HCQ. The whole system is rigged. Just like the cytokine storm that killed my daughter’s tenant turned his immune system against his own body, Big Pharma is turning doctors into their Covid patients’ callous killers. They know the cure is in their hands but they prefer to play it safe to keep their jobs and stay out of trouble. They will still have to stand before God someday and tell Him why they chose their jobs over their patients’ lives while they kew the cure was there all along…

Beth
Beth
1 year ago

This is outrageously demonic and satanic massacre of innocents because of political agenda and FDA must be charged with crimes against humanity.Who is benefiting from deaths of innocents patients as FDA drags its feet.We resist and say enough is enough.lets arise before lives are lost????

Fuck off white supremacists
Fuck off white supremacists
1 year ago

Where are your sources to anything here?

Danielle
Danielle
1 year ago

I have looked at all the research and watched these doctors give interviews and beg the FDA. Now these doctors are being threated by the government for speaking up, we live in America the right of free speech. Our doctors are suppose to give us their honest medical opinion and now they are being forced to do what certain government officials what them to do. Or what the big Pharma wants them to do because its all an agenda and its all money, alot of people want Trump out and they have turned this in to something political rather than saving lives. I completely agree with this article and ive seen several documentaries about covid coming from doctors and scientists who want the truth out and have no political agenda but the truth and saving lives. It makes me sad that this is the world i brought children into, look around at whats going on everywhere right now. Teach your children to love Jesus Christ and how to live in his word, and pray this next generation will teach these greedy governments why were here on earth and who put us here.

Disclaimer: The information contained in this website is for educational, general information, and entertainment purposes only and is never intended to constitute medical or legal advice or to replace the personalized care of a primary care practitioner or legal expert.

While we endeavor to keep this information up to date and correct, the information provided by America Out Loud, its website(s), and any properties (including its radio shows and podcasts) makes no representations, or warranties of any kind, expressed, or implied, about the completeness, accuracy, reliability, suitability, or availability with respect to its website(s) or the information, products, services or related graphics and images contained on the website(s) for any purpose.

The opinions expressed on the website(s), and the opinions expressed on the radio shows and podcasts, are the opinions of the show hosts and do not necessarily represent the opinions, beliefs, or policies of anyone or any entity we may endorse. Any reliance you place on such information is therefore strictly at your own risk.

At no time, nor in any event, will we be liable for any loss, or damage, including without limitation, indirect or consequential loss of data or profits arising out of, in an association of, or connection with the use of this website.

Through this website, users can link to other websites that may be listed. Those websites are not under the control of America Out Loud or its brands. We have no control over the nature, content, or availability of those sites. America Out Loud has no control over what the sites do with the information they collect. The inclusion of any links does not necessarily imply a recommendation, nor does it endorse the views expressed with or by them.

Every effort is made to keep the website up and running smoothly. However, America Out Loud takes no responsibility for, nor are we, and will not be liable for being temporarily unavailable due to technical difficulties beyond our control. America Out Loud does not sell, trade, nor market email addresses or other personal data.

Take a Look at the Positive Side of Anarchy

Take a Look at the Positive Side of Anarchy

The only way to achieve liberty and peace is to restore law and order. And the only way to restore law and order is to literally crush the forces of evil. When that begins to happen, we do actually see the positive side of tyranny and anarchy. Conflict is a bedfellow of oppression. Therefore we must end the conflict and, in doing so, end the tyranny. Here’s the positive side of this war…

It’s a LONG-HAUL with COVID-19

It’s a LONG-HAUL with COVID-19

The context is that about 50% of those hospitalized with COVID-19 develop post-COVID symptoms. Severe outpatients also are affected. Characteristic symptoms include headache, hearing loss, tinnitus, loss of olfactory function, sleep disturbance, muscle aches, weakness, fatigue, and chest or abdominal pain…

Be the One.

Be the One.

Be the one — no longer willing to huddle together in the helpless band — the one who dares to join the fight. Another will follow you and then another, and in a flash of time, that bleeding hulk of our nation — once the great light of liberty to the world, now barely flickering — will rise again to throw off the wolves like it has done before, sending them scurrying for safety…

Major Medical Mystery: Why Some People Despite Exposure Don’t Get COVID

Major Medical Mystery: Why Some People Despite Exposure Don’t Get COVID

A small fraction of Americans have escaped COVID infection. CDC uses a figure of 60% for those infected, while the Institute for Health Metrics and Evaluation at the University of Washington says that 76% have been infected. The remainder may have escaped exposure or been exposed but escaped infection. The latter people are the subject of the medical mystery…

Correcting America’s Course Back to the Constitutional Rule of Law

Correcting America’s Course Back to the Constitutional Rule of Law

The US Constitution must scrupulously be followed, especially by the judiciary. It is not for judges to make laws; it is for them to observe and rule on the constitutionality of issues before them. Their oaths, taken upon their confirmations, should include the understanding that their failures to follow judicial protocols would end in their termination…

Does Joe Biden Aspire to be America’s Last President?

Does Joe Biden Aspire to be America’s Last President?

Most ominously, no American administration has ever seemed so entirely unconcerned about hemorrhaging political capital. And that lack of concern about voters’ approval can only mean that this administration no longer believes it relies on political capital (the consent of the governed) for power. We can only assume that this Marxist-aligned administration intends to authorize itself with whatever power it requires to achieve its ends…

Criminal Intimidation Led By Schumer and Pelosi are America’s Domestic Terrorists

Criminal Intimidation Led By Schumer and Pelosi are America’s Domestic Terrorists

The SCOTUS leak was explicitly designed to tip the balance back to Progressivisms demands and rally the Democrat base to intimidate conservatives, political and business leaders by threats of violence because the country is in a Biden mess, one he created in January 2021 to reflect his party’s image as one that clings to the failed philosophy of Marx and Engles…

Pennsylvania Races Plunge to Swampy Politics 

Pennsylvania Races Plunge to Swampy Politics 

The establishment has money and counts itself as power brokers. They love the status quo, the “don’t rock the boat” mentality. They pronounce, “This is our guy!” and expect the masses to get in line. However, many are standing up and deciding to vote conscience over party or affiliation – regardless. But aren’t those the same “stand up” attitude and actions that formed this great nation?

America Out Loud 6 years

Celebrating 6 incredible years fighting to restore liberty and justice to our beloved America.

Your Source for Free Speech, Talk Radio, Podcasts, and News.

 

Here we take on the challenges of our generation so that we can preserve future generations. Please consider making a contribution in the fight for liberty!

iHeartRadio

The APPS are free; the mission is priceless!

Free APP
Healthycell

Podcast Networks

Apple Podcasts
Google Podcasts
Spotify
Pandora
Tunein
iHeart
Stitcher

Subscribe and Listen on Your Favorite APP

Our Columnists and Show Hosts

Truth For Health

Apple Podcasts

COVID Solution Summit

Apple Podcasts

Evacuating Americans & fully-vetted Afghan's at Risk - Help Us!

Apple Podcasts

Empowering and mentoring conservative trailblazers from Generation Z to win!

Apple Podcasts

Turning Point Action is Recruiting Precinct Chairs - Become a Grassroots Warrior Today!

Apple Podcasts

URGENT - KEEP NINE
Please join us to protect the Supreme Court:
Sign the Petition!

Apple Podcasts

The LATINO USA EXIT from the Democrat Party, click for details...

Apple Podcasts

Fighting corporate censorship and ensuring voter integrity...

Apple Podcasts

Support wounded and fallen police officers. The Wounded Blue.

Wounded Blue
Share via
Copy link