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.