terça-feira, 19 de maio de 2020

Coronavirus: Trump claims he takes hydroxychloroquine despite FDA warnings




Trump says he’s taking hydroxychloroquine against Covid-19 despite FDA warnings

President says he’s been taking drug for ‘a couple of weeks’ but FDA has issued repeated warning about the dangers of the drug

Tom McCarthy
 @TeeMcSee  Email
Mon 18 May 2020 23.22 BSTLast modified on Tue 19 May 2020 08.02 BST

Donald Trump has told reporters at the White House that for “a couple weeks” he has been taking a malaria drug as a defense against Covid-19 – despite warnings from his administration that it is dangerous.

Trump said he was taking hydroxychloroquine – a drug approved to treat malaria, lupus and rheumatoid arthritis – in response to the coronavirus threat.

But the Food and Drug Administration (FDA) has been warning since April that the drug should not be used for that purpose because it could cause irregular heartbeats and other cardiac trauma.

The drug is not approved as a treatment for Covid-19 and Trump has not been diagnosed with the disease, to public knowledge.

Trump’s claim to be taking the drug was made as he attacked an administration whistleblower who went before Congress last week and described internal pressure to endorse the drug as an effective coronavirus treatment.

The whistleblower, Rick Bright, was the former director of a federal agency in charge of vaccines.

On Monday, Trump called Bright a hypocrite and then riffed on the supposed benefits of the drug, which the FDA advised has “not been shown to be safe and effective for treating or preventing Covid-19”.

“You’d be surprised at how many people are taking it … The frontline workers many many are taking it,” Trump said.

“I happen to be taking it. I happen to be taking it. I’m taking it, hydroxychloroquine. Right now, yeah. A couple weeks ago I started taking it. Because I think it’s good, I heard a lot of good stories … I take a pill every day.”

Sean P Conley, Trump’s physician, said in a memo that after “numerous discussions” with the president “for and against the use of hydroxychloroquine, we concluded the potential benefit from treatment outweighed the relative risks”.

Previously, Trump had endorsed the injection of disinfectants or light into the body to fight coronavirus – recommendations that were followed by a spike in calls to poison control centers.

But Trump had never before claimed to be trying one of the home remedies himself.

A string of studies around the world have suggested that hydroxychloroquine or chloroquine do little to prevent or treat Covid-19, and the FDA has cautioned against the use of either drug for Covid-19 outside of the hospital setting or a clinical trial “due to risk of heart rhythm problems”.

The drugs “can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia”, the FDA said.

Dr Anthony Fauci, the country’s top infectious disease doctor and a member of the White House coronavirus taskforce, has repeatedly warned that there is no conclusive evidence to support using the drug.

The United States passed two grim milestones for coronavirus cases on Monday, surpassing 1.5m confirmed cases and 90,000 deaths, according to numbers recorded by Johns Hopkins University.

Trump touted hydroxychloroquine as a potential coronavirus treatment in March, a claim that was amplified for weeks on Fox News. But alarming reports in April about the health risks tied to the drug silenced that talk until the Bright episode.

Bright, the former director of the Biomedical Advanced Research and Development Authority, told Congress last week that he was removed from his post after resisting pressure by the administration to make “potentially harmful drugs widely available”, including chloroquine and hydroxychloroquine.

The FDA has issued repeated warnings about the dangers of the drugs in question.

“While clinical trials are ongoing to determine the safety and effectiveness of these drugs for Covid-19, there are known side effects of these medications that should be considered,” the FDA commissioner, Stephen M Hahn, said in a statement issued in late April. “The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available.”

Trump acknowledged research finding that US veterans treated with hydroxychloroquine didn’t seem to fare better than those who weren’t given the drug. The preliminary study found that those treated with hydroxychloroquine had a higher risk of death than those who were not. The pre-print of the study, which has been published online without peer review, comes with many caveats. None of those caveats include Trump’s analysis. Those behind the research “aren’t big Trump fans”, the president said as an explanation for why he’s taking the unproven drug. The research was a “a very unscientific report”, Trump said.

The research was conducted by the VA and academic institutions including the University of Virginia School of Medicine. It analyzed the cases of 368 male coronavirus patients nationwide, 97 receiving hydroxychloroquine, 113 receiving hydroxychloroquine in combination with the antibiotic azithromycin, and 158 not receiving any hydroxychloroquine. This was not a randomized clinical trial, the gold standard of drug testing, which would randomly assign hydroxychloroquine treatment to some patients and not to others. Instead, researchers looked back on cases – and weren’t able to account for why doctors chose to treat some patients with the antimalarial drug and not others. It could be that those treated with hydroxychloroquine had a higher chance of death because doctors chose to give the most severely ill patients the unproven drug.

Maanvi Singh contributed reporting

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