As the US closes in on 120,000 COVID-19 deaths and growing spikes in a dozen-plus states, the FDA is quietly pulling emergency use of hydroxychroloquine because it's not an effective treatment of the virus.
The Food and Drug Administration on Monday withdrew emergency use authorizations for two coronavirus treatments that President Donald Trump promoted despite concerns about their safety and effectiveness.
The agency revoked the authorizations for hydroxychloroquine and chloroquine after a request from Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority.
After reviewing new information from large clinical trials the agency now believes that the suggested dosing regimens "are unlikely to produce an antiviral effect," FDA chief scientist Denise Hinton said in a letter announcing the decision.
Critics have accused the agency of caving to political pressure when it authorized use of hydroxychloroquine and chloroquine in hospitalized Covid-19 patients in late March despite thin evidence. More recent randomized controlled trials have found the drugs do not benefit coronavirus patients, and doctors have reported that hydroxychloroquine can cause heart problems.
Because hydroxychloroquine is approved for other uses — treating lupus and arthritis — doctors could still use it "off label" to treat coronavirus patients, and clinical trials examining their use against Covid-19 can continue. The FDA noted that the version of chloroquine that had been authorized for emergency use is not approved in the U.S. so all use of that drug, donated by Bayer, will now end.
The administration’s focus on the malaria medicines in the early months of the pandemic deepened a divide between the White House and its health agencies. Several administration officials told POLITICO they felt the drugs got outsized attention while FDA scrambled for solutions in March. Other current and former Health and Human Services officials later said that the emergency authorities and White House demands cast a shadow on FDA as it struggled to remain independent.
Rick Bright, the former BARDA director whom Disbrow replaced, has accused health officials of removing him from his role overseeing millions of dollars to develop treatments and vaccines because he raised health concerns about hydroxychloroquine and resisted its widespread use.
Trump pushed the drug as a treatment and the right latched onto it, declaring the pandemic over in dozens of states and ending social distancing. Bright was fired for raising questions. Now, Bright's replacement has done the same thing, and I fully expect Trump to fire him as well and to demand the FDA reinstate the drug's emergency use status from the FDA before the end of the week.
If he doesn't, Trump admits defeat and that he utterly failed on COVID-19 in every concievable way. The micron-thin hope that hydroxycholroquine actually was effective was the last hope Trump had politically to salvage this disaster, not to mention a path to actually helping sick Americans.
It's gone now.
Trump should resign, for the 419th time, but he won't.