On Aug. 10 the FDA denied the urgent request for emergency approval for COVID-19 outpatient preventive and early treatment use of hydroxychloroquine (HCQ) filed July 1 by Dr. John McKinnon's team at Henry Ford Hospital in Detroit, supported by Dr. Peter McCullough's cardiology team at Baylor Heart and Vascular Institute in Dallas.
Approximately 48,000 more Americans have died during the FDA's 48-day delay since this Emergency Use Authorization (EUA) was requested on July 1. Dr. McKinnon's clinical trial found an impressive 51% reduction in deaths if HCQ was begun within 24 hours of admission to the hospital.
An outpatient primary care study by Dr. Vladimir Zelenko, using HCQ, azithromycin and zinc given within less than seven days of COVID-19 symptoms, showed approximately 80% decrease in deaths, and less than 1% of his patients needed to be hospitalized. These 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 HCQ could have saved 100,000 American lives.
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 worldwide 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.