In an analysis of multiple studies, a case is being made for Hydroxychloroquine being made widely available for the treatment of hospitalized COVID-19 patients and for the FDA warning label to be removed from the drug. The mortality rate reduction for those treated with the drug is shown to be 75%, and for those who use the drug therapeutically at the start, it reduces their chances of hospitalization by 44%.
From doctorsandscientistsdeclaration.org – Early COVID Treatment Works
It is readily apparent that every one of the studies of high-risk outpatient HCQ use has shown
risk reduction for hospitalization or mortality, averaging 44% for the former and 75% for the
latter, and that the numerous systematic case-series studies have shown exceedingly good
treatment benefit vs mortality. The “natural experiment” studies of population responses
provide compelling evidence of temporal relations between medication use and mortality. The
RCT studies proclaimed as definitively showing no benefit of HCQ use in outpatients have all
involved almost entirely low-risk subjects with virtually no information about risks of
hospitalization and mortality and are irrelevant for bearing upon HCQ use in high-risk
outpatients. The totality of fatal cardiac arrhythmia events among more than 8,000 patients
treated with HCQ and HCQ+azithromycin is zero. The large database study of more than
320,000 older patients taking HCQ+azithromycin shows no excess all-cause mortality (Risch
2020b) and minuscule excess fatal arrhythmia frequency, 9/100,000 patients, compared to the
large number of patients whose lives will be saved by outpatient use of these medications. I
have not discussed all of the other even lesser-frequent adverse events than the arrhythmias,
but these are equally minuscule, and the FDA did not invoke them for its warning about
outpatient use in the title statement of the warning. The FDA has stated publicly that it relied
upon adverse event data from hospital inpatients to make policy applying to outpatient use.
There are no systematic adverse event arrhythmia data of US outpatients from the beginning
of 2020 through the present. The FDA website also publicly cautions that only (i.e., “due to”)
arrhythmia data are relevant to its warning, by omitting from the title any assertions that other
potential adverse events were important or frequent enough to be determinative. The FDA’s
extrapolation from adverse events in hospitalized patients to supposed risks in outpatients is
flagrantly unwarranted. Outpatient viral replication is an entirely different disease than
inpatient florid cytokine-driven pneumonia (Park et al., 2020) and the treatments are different.
The need for outpatient use of HCQ is crucial for saving the lives of high-risk COVID-19
patients. The most recent published recommendations for early treatment of COVID-19
outpatients (McCullough et al., 2020) consider HCQ use and related medications of critical
importance and is authored by some 50 clinicians providing this treatment. There is no
comparison between the number of lives to be saved with early outpatient treatment and the
minuscule numbers addressed in the analyses of adverse events, even what would be
postulated to occur with widespread outpatient use. All of these data have been available to
the FDA for some time. The improper warning on the FDA website must be removed
immediately, and widespread early outpatient treatment must start immediately.