The Food and Drug Administration (FDA) has approved an Emergency Use Authorization (EUA) requested by Mayo Clinic for use of plasma from patients who recovered from COVID-19 to treat hospitalized patients.
“The tipping point for the agency appeared to be that ‘optimal’ patients who were treated with ‘convalescent plasma at the highest [antibody] titers’ showed ‘significant clinical benefit’ of a 35% improvement in survival, which ‘clearly meets the criteria published for an EUA,’” stated FDA Commissioner Stephen Hahn.
The idea is not new. Before the discovery of antibiotics, type-specific serum from recovered patients was used to treat otherwise hopeless pneumococcal pneumonia.
Yet, while approving the plasma treatment before controlled clinical trials can be done, FDA continues to obstruct the use of a long-established antimicrobial that can also be used in outpatients, to prevent the need for hospitalization.
FDA denied a request for EUA of hydroxychloroquine (HCQ) for preventive and early treatment of COVID-19 filed 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.
A clinical trial of HCQ given early in hospitalized patients at Henry Ford Health System showed a 51% reduction in mortality.
Because of FDA’s negative statements about HCQ, patients are having great difficulty in obtaining HCQ. This could cost tens of thousands of lives, according to Yale professor of epidemiology Harvey Risch. Dr. Risch told Mark Levin he has never seen anything like the current campaign to suppress use of or even information about a life-saving treatment.
The Association of American Physicians and Surgeons filed suit against FDA’s arbitrary restrictions in June, and has now asked the Sixth Circuit Court of Appeals to order FDA to release the Strategic National Stockpile of HCQ to pharmacies willing to dispense it to the public.
For further information, see AAPS Emergency Motion.
For information on the “natural experiment” of early use vs. nonuse of HCQ—a 79% difference in mortality—see hcqtrial.com.