FDA APPROVES TWO DRUGS TO FIGHT CORONAVIRUS; DESPITE POLITICIZED OPPOSITION
BY STEVE BYAS
republished below in full unedited for informational, educational and research
purposes:
The Food and Drug Administration (FDA) has given a limited emergency use for two anti-malarial drugs that President Donald Trump has championed as potentially efficacious against the coronavirus (also called COVID-19), and that some Democratic governors have banned in what many regard as a politicized response. The federal Health and Human Services Department (HHS) made the announcement Sunday night that it was now in possession of 30 million doses of hydroxychloroquine sulfate and a million more doses of chloroquine phosphate.The drugs were donated to the Strategic National Stockpile, which stores potentially life-saving medicines and other supplies.In the statement, the FDA said that the two drugs can be “distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.”New York State had already allowed the medication to be used for treatment of seriously ill coronavirus patients.Hydroxychloroquine (sold under the brand name Plaquenil) has been used to treat malaria, rheumatoid arthritis, and systemic lupus, and has been killing the coronavirus in laboratory experiments, according to findings published March 9 in the Clinical Infectious Diseases journal. The study’s authors, from the Chinese Academy of Sciences in Wuhan, wrote in a letter published several days ago in Cell Discovery, “We predict that the drug has a good potential to combat the disease.”Another study in France found that in using the drug to treat confirmed cases of COVID-19, it was effective. In a controlled study, 20 patients were given 600 mg of Plaquenil each day, and found that half of the treated group went from positive (meaning they had the disease) to negative (meaning the disease had been eliminated from the patient’s system) for the virus by the third day. By the sixth day, that figure had increased to 70 percent.Gregory Rigano, an advisor to the Stanford University School of Medicine, is leading a program testing the effects of hydroxychloroquine for the treatment of COVID-19. He appeared on the Tucker Carlson Show and pleaded publicly with President Trump to authorize its use against coronavirus “immediately.”In response, Trump mentioned the drug and its potential during one of his daily press briefings on the coronavirus. Predictably, when Trump brought up the possible benefits of the drug, especially when combined with azithromycin, a reporter accused the president of giving the American people a “false hope.”Amazingly, despite the deep concern over the virus, it became almost a Democratic Party talking point to be against even trying the drug, with leading media figures on the Left often dismissing it as useless.The governor of Nevada, Democrat Steve Sisolak, even signed an emergency regulation last week banning its use against COVID-19. “This emergency regulation protects Nevadans who need these drugs for legitimate medical purposes,” Sisolak said in his order.“While studies are underway on the usefulness of these drugs in treating COVID-19, we must deal with facts, not fiction,” said Dr. Ishan Azzam, the chief medical officer for the state Division of Public and Behavioral Health. “Preserving these drugs for those who need it is the right decision.”In other words, Sisolak and Azzam are arguing that if the drugs were used to treat patients with COVID-19, other patients who have conditions such as arthritis, lupus, and malaria might not be able to get their doses in a timely manner.But the announcement by the FDA that there are now thirty million doses available at the Strategic National Stockpile would seem to put a huge question mark to that claim. While there are no doubt many Americans who have arthritis and lupus (not that many have malaria, fortunately), it is certainly far less than 30 million!Nine pharmaceutical companies are stepping up production of the drug.Put bluntly, the argument that using the drug to treat thousands of COVID-19 patients would somehow keep any drugs away from arthritis and lupus patients is dubious. And, keeping it away from Americans who need the drug, now, to potentially save their lives, is wrong.Hatred of Donald Trump is one thing. But to allow that hatred to keep a drug away from those who need it for partisan political reasons is beyond normal politics.It is evil.This also illustrates the dangers of what can happen when government makes medical decisions, instead of doctors and medical scientists. It should warn us away from any form of socialized medicine. Do we really want politicized doctors making medical decisions?
