Army Spc. Vivian Hobbs organizes COVID-19 test samples at Drawsko Pomorskie Training Area, Poland, July 15, 2020, during Phase II of Defender-Europe, an exercise used to build strategic readiness in support of the U.S. National Defense Strategy and NATO deterrence objectives. (U.S. Army photo by Jason Johnston)
The Food and Drug Administration has granted emergency use for a plasma treatment for COVID-19 before clinical trials, but the agency denied a request for the use of hydroxychloroquine after a clinical trial showed it to be effective.
The FDA "continues to obstruct the use of a long-established antimicrobial that can also be used in outpatients, to prevent the need for hospitalization," said Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons.
Orient noted a research team with the Henry Ford Health System in Detroit filed a request with the FDA for emergency use authorization for preventive and early treatment of COVID-19 with hydroxychloroquine. The request came after the researchers found hospitalized patients showed a 51% reduction in mortality.
"Because of FDA's negative statements about HCQ (hydroxychloroquine), patients are having great difficulty in obtaining HCQ," Orient said.
She pointed out that it could cost tens of thousands of lives, according to Yale professor of epidemiology Harvey Risch.
Risch told Fox News host Mark Levin on Sunday he has never seen anything like the current campaign to suppress the use of the life-saving treatment and even information about it.
A global analysis showed a 79% difference in mortality.
An FDA scientist prepares blood donation samples for testing (Wikimedia Commons)
Orient's Association of American Physicians and Surgeons filed suit against the FDA's restrictions in June.
It now has asked the Sixth Circuit Court of Appeals to order the FDA to release the Strategic National Stockpile of hydroxychloroquine to pharmacies willing to dispense it to the public.
The FDA has approved an EUA requested by the Mayo Clinic for use of plasma from patients who recovered from COVID-19 to treat hospitalized patients.
FDA Commissioner Stephen Hahn said 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.'"
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