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Here is the scandal. In 2016 under the Obama administration, Congress with strong bipartisan support passed the 21st Century Cures Act. It required the Food and Drug Administration to use “Real World Evidence,” or RWE, for approval of drugs. During the Trump administration, this statute was not invoked by the White House task force under Dr. Fauci. But it should have been used early in the pandemic.
Starting a year ago, courageous front-line doctors generated RWE because they were curing COVID patients with protocols that kept patients out of hospitals. Real world data showed the effectiveness of cheap generics like hydroxychloroquine and ivermectin to cure and prevent COVID-19. Dr. Vladimir Zelenko used RWE language early on and this February, in light of over 2 million COVID deaths globally, noted: “The problem is that the medical world and governments ignored REAL WORLD EVIDENCE.”
Other physicians and the organizations leading the cause did not invoke RWE, namely America’s Frontline Doctors, the Association of American Physicians and Surgeons, and the Front Line COVID-19 Critical Care Alliance. Nor have conservative and liberal media informed the public about the legal mandate to use RWE.
In my recent book, “Pandemic Blunder,” I used RWE to conclude that 70 to 80% of COVID deaths could have – and still can be – prevented by using the cheap and effective protocols.
This, too, was noted: “In a December 2016 article in the New England Journal of Medicine titled ‘Real World Evidence – What Is It and What Can It Tell Us?’ all twelve authors were from the FDA. A big point was that RWE would come from clinical care and home or community settings as opposed to research-intensive or academic environments. … In order to assess patient outcomes and to ensure that patients get treatment that is right for them, real-world data needs to be utilized.” Perfectly applicable for supporting use of hydroxychloroquine and ivermectin protocols.
Outrageously, despite huge numbers of hospitalizations and deaths, the government did not use RWE to support use of documented protocols for early home/outpatient COVID treatment and prophylactic use.