FDA ends emergency use of hydroxychloroquine for coronavirus
S E E D E D C O N T E N T
Health Care
FDA ends emergency use of hydroxychloroquine for coronavirus
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.
A bottle of hydroxychloroquine tablets. | David J. Phillip, File/AP Photo
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.
Critics have accused the agency of caving to political pressurewhen 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.
Drugmakers donated millions of the pill to the government's strategic national stockpile after Bright wrote to the FDA requesting for emergency use, a move he now says he was pressured to make.
In April, roughly a month after the FDA authorized emergency use of the drugs, the agency warned against using hydroxychloroquine outside of hospitals and clinical trials because of potentially fatal cardiac side effects. Trump toned down on mentions of the pills during his White House briefings around the same time, but in May told reporters he was taking a course of hydroxychloroquine after a White House aide was diagnosed with the coronavirus.
This month two randomized controlled trials, considered the gold standard for determining whether a drug is effective, concluded that the drug does not prevent coronavirus infection and did not help hospitalized patients.
Another study based on tens of thousands of patient records linked hydroxychloroquine to a higher risk of heart problems, but it was withdrawn after questions arose about the quality of the data it used. Doctors have anecdotally reported that the pills, especially when paired with antibiotic azithromycin, can cause heart problems like arrhythmia.
Though drugmakers have donated millions of pills to federal and state governments, it is not clear how many have even been used. Florida, for instance, is sitting on more than 980,000 unused doses from an April donation after just six hospitals put in requests for the drug.
Senate Democrats grilled FDA officials on the emergency use authorization during a Finance Committee hearing this month. Sen. Tammy Baldwin (D-Wisc.) later wrote to Commissioner Stephen Hahn demanding answers on the decision and reasons why it had not been revoked.
POLITICO
Tags
Who is online
100 visitors
The President* of the United States promoted this drug as a cure for coronavirus. By all evidence, he was completely wrong.
Where is the repercussion to Trump for trying to perpetrate false information to gullible people ?
His promotion of this drug was a disgrace, and in other, earlier times would have been a huge scandal in and of itself. Our national discourse related to the actions of this president* have deteriorated so badly no one even cares.
He can't be gone too soon, so we can start to put our country on a better path.
But they tried it did they not? Had to be a reason other than POTUS's suggestion.
Trump cheerleaded the drug in order to make people think the virus wouldnt be that bad since we had a cure at hand.
No one needed his suggestions in order to test the drug.
Was it already on their radar to test then? Seems to me he possibly turned a little light bulb on above their heads if yours is the case.
What an utterly laughable notion. Trump, king of the dunces, turned a light on in someone else's head? Unless it was perhaps the frequent light bulb that lights up in anyone with more than a room temperature IQ who interacts with him and realizes "Eureka! This guy is a total dumb ass!".
"A top Health and Human Services official who said he was transferred from his post for pushing back on "efforts to fund potentially dangerous drugs promoted by those with political connections" felt pressured to rush access to chloroquine treatments for the coronavirus after President Donald Trump had a conversation about it with a mega-rich donor , a source close to the doctor told NBC News."
Trump pushed an unproven and possibly deadly drug that had ZERO evidence of efficacy in regards to Covid-19 all because he spoke to a billionaire donor.
Another question would be, what study prompted the FDA to approve the drug initially?
No real study showed it any better than aspirin to treat Coronavirus, yet some studies showed it infinitely more dangerous to take.
I wonder what Brazil will do with the 2 million HCQ pills that the President gifted to Brazilian President Jair Bolsonaro on May 31,2020.
Well, hydroxychloroquine didn't work in Brazil since their confirmed cases and deaths are skyrocketing. Of course, it was their president that said the COVID19 was a ''little flu'', fired his minister of health, and when asked about the number of deaths said ''so what''.
Strange thing is, you can't get malaria if you have sickle cell anemia.
Largest concentration of sickle cell anemia in the world? Brazilian Amazon...
Early false claims about the efficacy of hydroxychloroquine to treat Covid-19 were exceedingly, um, fishy...
Now we know what Trump's going to do with the extra doses of HCQS that he had the government buy....
Nah, less than 1% of Brazilians get malaria and it is 99% confined to in the 9 northern states of the Amazon region.
They are also the poorest regions. Bolsonaro could care less. In all likely hood they will waste the HCQ on his political allies
as an internationally acclaimed prophylactic. /s
the resistance strikes again... but we know their game.
I have news for the obama leftovers in the fda that did this..... this too shall fail in the end.
but in the meantime.... [ deleted ]
The Association of American Physicians and Surgeons (AAPS) has filed a lawsuit against the heads of the FDA, HHS and the Biomedical Advanced Research and Development Authority (BARDA) over what they call “irrational interference” to limit the use of hydroxychloroquine (HCQ) for treating COVID-19 patients
FDA officials left over from President Barack Obama’s administration acted arbitrarily, unlawfully, and contrary to Trump’s wishes when they approved access to the drug only for adults and adolescents hospitalized with Covid-19 who aren’t able to participate in clinical trials studying the drug’s use as a treatment for the disease.
[ deleted ]