https://spectator.org/the-20-solution-to-coronavirus-anecdotal-evidence-is-a-life-saver/
Read the whole thing.
Over the weekend, the Food and Drug Administration (FDA) issued an emergency authorization for the use of hydroxychloroquine (HCQ) and chloroquine (CQ) to treat hospitalized COVID-19 patients. Simultaneously, the Department of Health and Human Services (HHS) announced that Sandoz has donated 30 million doses of HCQ and Bayer one million doses of CQ to the Strategic National Stockpile. According to HHS, these drugs will be “distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available.”
The effect of the FDA’s emergency authorization is unclear. The FDA regulates the manner in which manufacturers of pharmaceuticals may advertise and sell their products. If, after testing and clinical trials, the FDA approves a drug for a particular use, then the manufacturer may market it for that purpose and no other.
The FDA, however, does not set the standard of care for physicians and does not regulate the practice of medicine. That is why, even before the FDA’s “emergency authorization,” physicians have been free to make “off-label” (non–FDA approved) use of HCQ and CQ to treat COVID-19 patients.
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But to the undoubted dismay of the media and all those who hope the pandemic will destroy Trump’s presidency, that pesky “anecdotal evidence” supporting the use of HCQ and CQ to successfully treat and possibly prevent COVID-19 infections continues to grow at an exponential rate.
For example, in a follow-up of its previously reported study recommending the use of HCQ and azithromycin to treat COVID-19 cases, researchers in France and Vietnam under the leadership of world-renowned infectious disease expert Professor Didier Raoult, the head of the Institut Hospitalo-Universitaire (IHU) Méditerranée Infection in Marseille, have reported another clinical trial in which that drug combination cured 79 out of 80 patients. Noting that “adverse events were rare and minor,” the researchers summarized their findings as follows:
In conclusion, we confirm the efficacy of hydroxychloroquine associated with azithromycin in the treatment of COVID-19 and its potential effectiveness in the early impairment of contagiousness. Given the urgent therapeutic need to manage this disease with effective and safe drugs and given the negligible cost of both hydroxychloroquine and azithromycin, we believe that other teams should urgently evaluate this therapeutic strategy both to avoid the spread of the disease and to treat patients before severe irreversible respiratory complications take hold.
As this report was issued, India’s Ministry of Health and Family Welfare issued a directive declaring that
Whereas, the Central Government is satisfied that the drug ‘Hydroxychloroquine’ is essential to meet the requirements of emergency arising due to pandemic COVID-19 and in the public interest, it is necessary and expedient to regulate and restrict the sale and distribution of the drug “Hydroxychloroquine” … (Emphasis added.)
Based on this finding, India has banned the export of HCQ and is recommending that health-care workers take HCQ prophylactically to avoid becoming infected while treating COVID-19 patients.
Similarly, Belgium and Bahrain are reporting that their hospitals are using HCQ to successfully treat COVID-19 patients. According to the Bahrain News Agency, the head of Bahrain’s National Taskforce for Combatting COVID-19 reports that HCQ has had a “profound impact” when used to treat COVID-19 patients. And Belgium has established a “strategic reserve” of HCQ to treat as many as 22,000 COVID-19 patients on an “off-label” basis.