FDA ends emergency use of hydroxychloroquine for coronavirus

  

Category:  News & Politics

Via:  john-russell  •  one month ago  •  31 comments

By:   POLITICO

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.

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.

?url=https%3A%2F%2Fstatic.politico.com%2F80%2F6b%2F67bcc6344cf3bd1506b3ff3a2c65%2Fhydroxy-ap-773.jpg

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


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JohnRussell
1  seeder  JohnRussell    one month ago

The President* of the United States promoted this drug as a cure for coronavirus. By all evidence, he was completely wrong. 

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.

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. 

 
 
 
Just Jim NC TttH
1.1  Just Jim NC TttH  replied to  JohnRussell @1    one month ago
By all evidence, he was completely wrong.

But they tried it did they not? Had to be a reason other than POTUS's suggestion. 

 
 
 
JohnRussell
1.1.1  seeder  JohnRussell  replied to  Just Jim NC TttH @1.1    one month ago

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. 

 
 
 
Just Jim NC TttH
1.1.2  Just Jim NC TttH  replied to  JohnRussell @1.1.1    one month ago

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.

 
 
 
Dismayed Patriot
1.1.3  Dismayed Patriot  replied to  Just Jim NC TttH @1.1.2    4 weeks ago
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."

https://www.nbcnews.com/politics/donald-trump/trump-chloroquine-push-came-after-talk-donor-source-says-n1190771

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.

 
 
 
Tessylo
1.1.4  Tessylo  replied to  Just Jim NC TttH @1.1.2    4 weeks ago
'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.'

jrSmiley_10_smiley_image.gifjrSmiley_10_smiley_image.gifjrSmiley_10_smiley_image.gif

 
 
 
Ozzwald
1.2  Ozzwald  replied to  JohnRussell @1    4 weeks ago
Where is the repercussion to Trump for trying to perpetrate false information to gullible people ?

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.

 
 
 
Split Personality
2  Split Personality    one month ago
 
 
 
Kavika
2.1  Kavika   replied to  Split Personality @2    4 weeks ago

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''.

 

 
 
 
Split Personality
2.1.1  Split Personality  replied to  Kavika @2.1    4 weeks ago

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...

 
 
 
loki12
2.2  loki12  replied to  Split Personality @2    4 weeks ago

Treat Malaria in the Amazon region, But Trump! 

 
 
 
MUVA
2.2.1  MUVA  replied to  loki12 @2.2    4 weeks ago

Yep

 
 
 
JBB
3  JBB    4 weeks ago

Early false claims about the efficacy of hydroxychloroquine to treat Covid-19 were exceedingly, um, fishy...

 
 
 
1776  Traditional American
3.1  1776 Traditional American  replied to  JBB @3    4 weeks ago

The bottom line is that this only affects Bayer imported from Pakistan donations of the drug being used in hospitals on near death patients.  This has no impact at all on a doctor being able to prescribe it to his or her patient early in the disease or as a preventative.  Basically a nothing burger story as we knew already that the drug wouldn’t do much for someone already on deaths doorstep.  

 
 
 
JohnRussell
3.1.1  seeder  JohnRussell  replied to  1776 Traditional American @3.1    4 weeks ago
This has no impact at all on a doctor being able to prescribe it to his or her patient early in the disease or as a preventative.

"the drug does not prevent coronavirus infection "

What the hell is wrong with you? 

 
 
 
Gazoo
3.1.2  Gazoo  replied to  1776 Traditional American @3.1    4 weeks ago

“This has no impact at all on a doctor being able to prescribe it to his or her patient early in the disease or as a preventative.”

and that’s when it’s most effective, early on.

 
 
 
JBB
3.1.3  JBB  replied to  1776 Traditional American @3.1    4 weeks ago

No, the bottom line is that Trump hawked a ineffective drug to treat Covid-19 because he and some of his supporters saw an exceptional profit to be made off the suffering of others. Except, that drug, Hydroxychloroquine, is not only ineffective against Covid-19 but it is actually harmful in many cases. The whole thing is a scandal that would require the immediate removal of any other President. He should resign...

 
 
 
Texan1211
3.1.4  Texan1211  replied to  JBB @3.1.3    4 weeks ago
No, the bottom line is that Trump hawked a ineffective drug to treat Covid-19 because he and some of his supporters saw an exceptional profit to be made off the suffering of others. Except, that drug, Hydroxychloroquine, is not only ineffective against Covid-19 but it is actually harmful in many cases. The whole thing is a scandal that would require the immediate removal of any other President. He should resign..

What a crock of shit!

You just still mad Trump is your President.

 
 
 
JBB
3.1.5  JBB  replied to  Texan1211 @3.1.4    4 weeks ago

I stand by every word. Apparently you've got zip!

 
 
 
Split Personality
3.1.6  Split Personality  replied to  Gazoo @3.1.2    4 weeks ago
and that’s when it’s most effective, early on.

That should be easy enough to prove. 

So far, there is no consensus, that the drug, which attacks living parasites in the liver,  does anything to halt a virus. 

But if you have the links, please provide them and try to convince someone...

that HCQ was something other than Presidential shark bait.

 
 
 
Ozzwald
3.1.7  Ozzwald  replied to  Texan1211 @3.1.4    4 weeks ago
You just still mad Trump is your President.

But there are approximately 118,000+ fewer people in America that are no longer mad at Trump.  That is the only way Trump's COVID-19 strategy is helping him at all.

 
 
 
JohnRussell
4  seeder  JohnRussell    4 weeks ago
Timothy Aeppel
@TimAeppel
·
59m
Oklahoma reported 644 new cases in the week ending June 7--that's a 37.3% increase over the previous week .
Quote Tweet
aGIAz8Qe_normal.jpg
Aaron Rupar
@atrupar
· 56m
Trump defends plan to hold political rally in Oklahoma on Saturday, despite local officials urging him to postpone it, with a lie: "Oklahoma is at a very low number." (Cases are actually rising there https:// tulsaworld.com/news/local/tul sa-health-department-director-wishes-trump-rally-would-be-postponed-as-local-covid-cases-surge/article_bac51435-a5d0-5b5c-ba74-182047453d53.html )
 
 
 
FLYNAVY1
4.1  FLYNAVY1  replied to  JohnRussell @4    4 weeks ago

Now we know what Trump's going to do with the extra doses of HCQS that he had the government buy....

https://www.newsweek.com/trump-says-us-has-stockpiled-29m-hydroxychloroquine-pills-amid-pandemic-it-may-not-work-then-1496232

 
 
 
Split Personality
4.1.1  Split Personality  replied to  FLYNAVY1 @4.1    4 weeks ago

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

 
 
 
1776  Traditional American
4.2  1776 Traditional American  replied to  JohnRussell @4    4 weeks ago

Yay!  Progressive lefties can riot and loot and burn things down in large numbers without criticism yet a peaceable assembly of Trump supporters gets covid shamed for meeting.  A repeat of the intolerance of the re open protests.  The issue isn’t whether people should be able to gather together but the reason why they are doing so.  

 
 
 
Texan1211
4.2.1  Texan1211  replied to  1776 Traditional American @4.2    4 weeks ago

You know they hold double standards. Anything even remotely to do with Trump, they hate.

Anything even remotely related to any "progressive" cause, they are all for it!

Anyways, don't you know by now that Covid-19 can only be spread at Trump rallies, not at mass protests!

 
 
 
Tessylo
5  Tessylo    4 weeks ago

The only standards republicans have are double standards.  

 
 
 
Texan1211
5.1  Texan1211  replied to  Tessylo @5    4 weeks ago

At least that IS a standard as opposed to having NONE.

 
 
 
Tessylo
5.1.1  Tessylo  replied to  Texan1211 @5.1    4 weeks ago

Makes no sense, as usual.  

 
 
 
Texan1211
5.1.2  Texan1211  replied to  Tessylo @5.1.1    4 weeks ago
Makes no sense, as usual.  

Only to a select few.

Most people can easily understand it.

 
 
 
The Magic Eight Ball
6  The Magic Eight Ball    4 weeks ago

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 ]

https://www.google.com/search?q=american+physicians+sue+fda+irrational+interference


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

https://aapsonline.org/aaps-news-june-2020-aaps-sues-fda/


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.

https://news.bloomberglaw.com/health-law-and-business/physicians-group-sues-fda-to-widen-access-to-hydroxychloroquine


[ deleted ]

 
 
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