FDA terminates emergency use authorization of hydroxychloroquine for Covid-19 https://www.cnn.com/world/live-news...15-20-intl/h_38c75864285525451f1329d1dcbc0ab2 The US Food and Drug Administration has revoked its emergency use authorization for the drugs hydroxychloroquine and chloroquine for the treatment of Covid-19. After reviewing the current research available on the drugs, the FDA determined that the drugs do not meet "the statutory criteria" for emergency use authorization as they are unlikely to be effective in treating Covid-19 based on the latest scientific evidence, the agency noted on its website on Monday. "FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks," FDA chief scientist Denise Hinton wrote in a letter to Gary Disbrow of the Biomedical Advanced Research and Development Authority (BARDA) on Monday. "Accordingly, FDA revokes the EUA for emergency use of HCQ and CQ to treat COVID-19," Hinton wrote in the letter. "As of the date of this letter, the oral formulations of HCQ and CQ are no longer authorized by FDA to treat COVID-19." The FDA's emergency use authorization for hydroxychloroquine and chloroquine was narrow in scope, applying only to hospitalized Covid-19 patients and only to drugs donated to the Strategic National Stockpile. In an open letter published late last month, FDA commissioner Dr. Stephen Hahn appeared to defend the agency's decision to issue the authorization. "This decision was based on evaluation of the EUA criteria and the scientific evidence available at that time. We continue to look at the data on hydroxychloroquine and chloroquine and we will make future determinations on these products based on available evidence including ongoing clinical studies," Hahn said in the letter last month. The emergency use authorization, or EUA, made it easier for pills donated to the national stockpile to be distributed to coronavirus patients. Hahn added in the letter that "we also knew it was important to help ensure a stable supply of the drugs for patients with lupus and rheumatoid arthritis given the increased demand." In an interview with CNN last month, Hahn also defended his agency's handling of hydroxychloroquine. He acknowledged the political climate surrounding the drug, but said, "I stand by our decisions because I think they are rooted in science and data, and we'll continue to reevaluate."
As noted by the FDA hydroxychloroquine based therapy is useless for preventing or treating COVID-19 according to medical studies.
Imagine if we had gone through this trouble to secure PPE inb4 other forms of wasteful medical spending based on actual science https://www.nytimes.com/2020/06/16/us/politics/trump-hydroxychloroquine-coronavirus.html A Mad Scramble to Stock Millions of Malaria Pills, Likely for Nothing Before the F.D.A. withdrew its waiver to stockpile the drugs as coronavirus treatments, the Trump administration had embarked on a headlong effort to import tens of millions of doses. “This is a Deep State blindside by bureaucrats who hate the administration they work for more than they’re concerned about saving American lives,” Peter Navarro, Mr. Trump’s trade adviser, who helped distribute 19 million hydroxychloroquine pills, fumed in an interview Monday night. As of Monday, the government has distributed 31 million tablets of hydroxychloroquine to state and local health departments, hospitals and research institutions; 63 million tablets remain, according to Carol Danko, a spokeswoman for the Department of Health and Human Services. Officials are working with the companies that donated the drugs to “determine the available options” for the products. Dr. Bright, writing on Twitter on Monday night, offered his own idea: “The drugs should never have been brought into our country and should be destroyed. It took far too long for HHS to revoke this EUA.”
Study finds hydroxychloroquine helped coronavirus patients survive better By Maggie Fox, Andrea Kane, and Elizabeth Cohen, CNN Updated 11:24 PM EDT, Thu July 02, 2020 https://www.cnn.com/2020/07/02/health/hydroxychloroquine-corona
CNN Has Slammed the Usage of Hydroxychloroquine for Months — Until it Reversed Course In An Early Morning Tweet By Ben Wilson After months of claiming hydroxychloroquine is linked to a “greater risk of death” and “doesn’t work,” CNN admitted — at 4 am on the Friday before a holiday — that the drug is linked to significantly higher survival rates in hospitals. The quietly-announced new study by the Henry Ford Health System in Michigan questions the months of anti-hydroxychloroquine coverage showing that of the 2,541 patients observed, 26 percent of patients not given the drug died, compared to 13 percent of those who did receive hydroxychloroquine. The research — which is “surprising” according to CNN — was a multi-center retrospective observational study. The full results found that “overall crude mortality rates were 18.1% in the entire cohort, 13.5% in the hydroxychloroquine alone group, 20.1% among those receiving hydroxychloroquine + azithromycin, 22.4% among the azithromycin alone group, and 26.4% for neither drug,” according to the team’s study. The controversial anti-malaria drug, often touted by President Donald Trump as a potentially effective remedy for COVID-19, was mocked by CNN and other news agencies since mid-March when President Trump began pushing it — and admitting he takes it daily. The Washington Post claimed it was a “false hope” and the Philadelphia Inquirer said it was “the most disappointing, disavowed drug that researchers keep studying for COVID-19.” CNN wrote in it’s middle-of-the-night discovery that “it’s a surprising finding because several other studies have found no benefit from hydroxychloroquine, a drug originally developed to treat and prevent malaria.” “President Donald Trump touted the drug heavily, but later studies found not only did patients not do better if they got the drug, they were more likely to suffer cardiac side effects,” CNN said in this morning’s article. CEO of the Henry Ford Medical Group Dr. Steven Kalkanis, said “It’s important to note that in the right settings, this potentially could be a lifesaver for patients.” Dr. Marcus Zervos, division head of infectious disease for Henry Ford Health System, said in a news conference that “our results do differ from some other studies.” He noted an important factor is beginning treatment early. “For hydroxychloroquine to have a benefit, it needs to begin before the patients begin to suffer some of the severe immune reactions that patients can have with Covid,” Zervos told the press. Peter Navarro, the White House trade adviser, told CNN that “this is a big deal.” “This medicine can literally save tens of thousands, perhaps hundreds of thousands of American lives and maybe millions of people worldwide,” Navarro said. With this study shattering previous thought and talking points, perhaps a treatment or highly effective remedy can soon become available — with politics aside.