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