MD Mandeep Mehra, MD Frank Ruschitzka
Trump's 63 Million Doses of Hydroxychloroquine Could Have Been Great for America brownstone.org/articles/trumps-63-million-doses-of-hydroxychloroquine-could-have-been-great-for-america/ Early in the pandemic, President Donald Trump and White House senior official Peter Navarro arranged the donation of 63 million doses of hydroxychloroquine (HCQ) to America's strategic drug stockpile to combat Covid-19. The government began securing HCQ in March 2020, after Trump, on the advice of his medical and scientific advisors, lauded HCQ as "very encouraging," "very powerful," and a "game-changer." While HCQ (and its structurally similar analogue chloroquine) was not FDA-indicated for Covid-19, it was well-known to have specific off-label pharmacological functionality for preventing viral particle entry into cells, chemical derivatives of which have been utilized for antiviral use as far back as 1934. Following Trump's proposal, HCQ suddenly came under an unwarranted full-scale attack from federal officials, the press, so-called "fact-checkers," and university professors. Many of the attacks contained outright falsehoods about HCQ's pharmacology and safety or Trump's endeavor to make HCQ available to eligible patients. The FDA initially issued an emergency use authorization (EUA) for HCQ in March 2020, but withdrew authorization on June 15th 2020, stating the drug is "unlikely to be effective in treating COVID-19 for the [EUA] authorized uses." Around the same time, the FDA also wrote a methodologically questionable report criticizing HCQ's safety. The FDA's narrative was based on preliminary and time-compartmentalized findings, and not a reflection of historical safety or based on the appropriate clinical use of HCQ dosing, prescribing, timing, and duration. The FDA then seemed to label its findings as conclusive, figuratively slamming the door shut on the consideration of new findings.
FDA Hydroxychloroquine Safety Assessment Based on: Known Overdoses, and Clinically Unsupervised Uses According to its uncharacteristically brief 15-page safety review memorandum of HCQ published on May 19, 2020, the FDA considered data from the National Poison Data System (NPDS) which means it seems to have included the use of non-pharmaceuticalgrade and/or self-administered HCQ and/or overdose data in its clinical evaluation. Obviously, overdose or any non-medically supervised, self-diagnosis, and/or self-dosing of any prescription drug has a higher potential to result in adverse events, especially because the antiviral dose/duration of HCQ and/or chloroquine were not immediately obvious to the lay public. Of note, "if it bleeds it leads"-type sensationalized news reporting caused anxious and desperate Americans with incomplete or incorrect transmission and mortality information to go so far as to self-administer "fish tank" chloroquine-containing cleaning products of containing other chemicals to..
Simone, P. Chiara, R. Francesca, S. Maria, S. Massimiliano, and S. Stefano, Role of low-molecular weight heparin in hospitalized patients with SARS-CoV-2 pneumonia: a prospective observational study Nov 2020, Open Forum Infectious Diseases, Volume 7, Issue 12 LATE TREATMENT 315 patient HCQ late treatment PSM study: 65% lower mortality (p=0.2). Prospective observational study of 315 hospitalized patients in Italy showing 65% lower mortality with HCQ. The median treatment delay was 6 days for survivors and 6. Retrospective 258 hospitalized patients in Italy showing lower mortality with HCQ treatment, unadjusted relative risk RR 0.455, p<0.001. Data is in the supplementary appendix. https://c19p.org/boari 144. D. Águila-Gordo, J. Martínez-del Río, V. Mazoteras-Muñoz, M. Negreira-Caamaño, P. Nieto-Sandoval Martín de la Sierra, and J. Piqueras-Flores, Mortality and associated prognostic factors in elderly and very elderly hospitalized patients with respiratory disease COVID-19 Nov 2020, Revista Española de Geriatría y Gerontología, Volume 56, Issue 5, Page 259-267 LATE TREATMENT 416 patient HCQ late treatment study: 67% lower mortality (p=0.1). 67% lower mortality with HCQ. Retrospective 416 elderly patients in Spain showing adjusted HCQ mortality hazard ratio HR 0.33, p = 0.1. https://c19p.org/aguilagordo 145. E. Coll, M. Fernández-Ruiz, J. Sánchez-Álvarez, J. Martínez-Fernández, M. Crespo, J. Gayoso, T. Bada-Bosch, F. Oppenheimer, F. Moreso, M. López-Oliva, E. Melilli, M...
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