June 15, 2020

At the request of Gary Disbrow, the acting director of the Biomedical Advanced Research and Development Authority, the Food and Drug Administration on Monday withdrew emergency use authorizations for hydroxychloroquine and chloroquine related to coronavirus treatment.

The authorizations were controversial, as many skeptics believed they were made because President Trump had touted the malaria drugs as effective treatments against COVID-19, despite researchers concerns about potential heart-related side effects. Ultimately, after reviewing new information from large clinical trials, the FDA said it does not believe the drugs are likely "to produce an antiviral effect" against the novel virus.

Hydroxychloroquine is approved for several uses like treating arthritis and lupus, so doctors could still use it "off label" to treat coronavirus patients, and clinical trials examining its effect against COVID-19 can continue, Politico reports. The version of chloroquine temporarily authorized by the FDA, however, is not approved in the U.S., so all use of it will end. Read more at Politico. Tim O'Donnell

May 21, 2020

Brazilian President Jair Bolsonaro announced Wednesday that the Health Ministry had expanded approved uses of the anti-malaria drug chloroquine to treat milder cases of COVID-19. Brazil now has the world's third-largest coronavirus recorded outbreak, after the U.S. and Russia, and hospitals and health systems in several states have gone over capacity. "There is still no scientific evidence, but it is being monitored and used in Brazil and worldwide," Bolsonaro said on his Facebook page.

Chloroquine is the predecessor of hydroxychloroquine, which President Trump says he is now taking in a preventative capacity. Bolsonaro, a conservative populist and admirer of Trump, has continually downplayed the severity of COVID-19 and is clashing with cities and states that have enacted lockdowns and other coronavirus mitigation efforts. Brazil ended one study of chloroquine after detecting an increase in heart arrhythmia, and several large observational studies have found no positive effect of the drug on COVID-19 patients and some negative outcomes.

The order to expand approved use of chloroquine was signed by interim Health Minister Gen. Eduardo Pazuello, who had no health experience when Bolsonaro made him the No. 2 official at the ministry in April. His appointment followed Bolsonaro's firing of Health Minister Luiz Henrique Mandetta after he publicly supported governors pursuing mitigation measures, and Pazuello got the top job when Mandetta's successor, Nelson Teich, resigned last week after he publicly clashed with Bolsonaro over chloroquine.

Utah, meanwhile, caught hydroxychlorquine fever early, preparing plans to allow the drug to be distributed without prescription and ordering at least $800,000 worth of chloroquine and hydroxychloroquine from a pharmacist who was helping draw up those plans, Stat News reported Sunday. Utah canceled the order in late April and got a refund.

Hydroxychloroquine's rise and fall in Utah "provides a case study of what happens when hope and excitement about therapies outpace the evidence," Stat reports. "It underscores the pressure officials felt to demonstrate they were on top of the response, even as such efforts sowed confusion among the medical community and led them into initiatives they came to regret. And, mirroring the hydroxychloroquine debate in the Trump administration, it shows how experts scrambled to inject restraint and plead for leaders to follow evidence at a time when promises of easy remedies were more enticing." Read more about Utah's experience at Stat News. Peter Weber

May 19, 2020

President Trump's announcement Monday that he has been taking hydroxycholorquine as a prophylactic to ward off the COVID-19 coronavirus had its skeptics, including Senate Minority Leader Chuck Schumer (D-N.Y.). "Maybe he's really not taking it because the president lies about things characteristically," Schumer told MSNBC. So the White House released a letter from White House physician Dr. Sean Conley.

Trump "is in very good health" and has tested negative for COVID-19 in his regular testing, Conley wrote. "After numerous discussions he and I had for and against the use of hydroxychloroquine, we concluded the potential benefit from treatment outweighed the relative risks." The letter did not actually say Conley had prescribed hydroxychlorquine to Trump or that Trump was taking it, but White House spokeswoman Alyssa Farah said Trump is taking the malaria drug.

Hydroxychloroquine has well-documented risks, including causing dangerous heart arrhythmia even in healthy people, and multiple studies have shown it has no apparent benefit for COVID-19 patients. The FDA granted emergency authorization to use hydroxycholorquine to treat hospitalized COVID-19 patients before later issuing a safely advisory on April 24 warning of serious side effects and recommending its use only under close supervision of a doctor in a hospital or clinical trial.

House Speaker Nancy Pelosi (D-Calif.) expressed concern about Trump's risk-taking on CNN. "He's our president, and I would rather he not be taking something that has not been approved by the scientists, especially in his age group and his, shall we say, weight group — morbidly obese, they say," she told Anderson Cooper. (Trump, 73, is technically obese but not severely or morbidly so, The Associated Press notes.)

New York's Olivia Nuzzi had a more practical critique.

"Here's my evidence: I get a lot of positive calls about it," Trump told reporters. "The only negative I've heard was the study where they gave it — was it the VA with, you know, people that aren't big Trump fans gave it." Peter Weber

May 18, 2020

President Trump is apparently no longer simply touting the controversial malaria drug hydroxychloroquine as an effective coronavirus treatment — he says he's actually taking it as a preventative measure.

Trump told reporters Monday that he's been taking the medication, which hasn't been proven to effectively treat COVID-19 and has been warned to come with potentially serious side effects, for about a week and a half, with the permission of a White House physician.

The president's reasoning is that he's apparently heard stories about "many, many" frontline workers and doctors who are taking it themselves or prescribing it to their patients with success. Trump said he began taking the drug as a preventative measure after he got "a lot of positive calls about it."

"So far, I seem to be ok," Trump said. Tim O'Donnell

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