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catsudon

(864 posts)
Mon Mar 30, 2020, 07:15 AM Mar 2020

FDA SAYS HYDROXYCHLOROQUINE AND CHLOROQUINE CAN BE USED TO TREAT CORONAVIRUS

Source: newsweek

On Sunday, the U.S. Department of Health and Human Services (HHS) said in a statement that chloroquine and hydroxychloroquine could be prescribed to teens and adults with COVID-19 "as appropriate, when a clinical trial is not available or feasible," after the FDA issued an Emergency Use Authorization. (EUA) That marked the first EUA for a drug related to COVID-19 in the U.S., according to the statement.

Read more: https://www.newsweek.com/fda-says-hydroxychloroquine-chloroquine-can-used-treat-coronavirus-1494925



are they trying to circumvent the governors' ban?
67 replies = new reply since forum marked as read
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FDA SAYS HYDROXYCHLOROQUINE AND CHLOROQUINE CAN BE USED TO TREAT CORONAVIRUS (Original Post) catsudon Mar 2020 OP
I'm just gonna hope it's working for some people. We need something that works mucifer Mar 2020 #1
Agreed. ChiTownDenny Mar 2020 #43
Off label use is a gamble Warpy Mar 2020 #53
That means it can be prescribed as part of a trial, without patient full consent or knowledge. n/t 5X Mar 2020 #2
No it doesn't mean that at all SCantiGOP Mar 2020 #39
Will the patients be told it is experimental and part of a trial with no proven effectiveness? 5X Mar 2020 #41
Yes SCantiGOP Mar 2020 #42
I imagine they will have to agree a 100 times over to get it. Steelrolled Mar 2020 #66
It's too bad the Trump FDA can't be trusted Submariner Mar 2020 #3
It's gotten to the point it's hard to trust things coming out of the federal government captain queeg Mar 2020 #52
This is Trump propaganda at work. KWR65 Mar 2020 #4
I agree.. FarPoint Mar 2020 #8
Fat Donnie needs a miracle cure he can sell at his rallies -- er, pressers. LastLiberal in PalmSprings Mar 2020 #65
Does anyone else smell a fresh Sharpie? Hugin Mar 2020 #5
+1 absolutely. bronxiteforever Mar 2020 #6
Yep I smell Rebl2 Mar 2020 #33
Definately! SheltieLover Mar 2020 #51
Good n/t Devil Child Mar 2020 #7
drumpf made them say this, I don't believe it how low they have gone. lark Mar 2020 #9
This isn't science - it's propaganda. Ramsey Barner Mar 2020 #10
Did you see the latest from Didier jberryhill Mar 2020 #15
IOW, A Placebo ProfessorGAC Mar 2020 #17
It's up there with Igel Mar 2020 #21
However, with the plasma antibody treatments, no one is claiming they will definately karynnj Mar 2020 #40
Didier has been dealing with dodgy data for years, by all accounts. GoneOffShore Mar 2020 #26
Yep, I saw those as well jberryhill Mar 2020 #28
Thank you for that tip about N-rays. An interesting episode in science history Bernardo de La Paz Mar 2020 #37
Here's something more on Didier GoneOffShore Mar 2020 #60
Ah, I just caught that one jberryhill Mar 2020 #61
He wants to be 'The Guy'. GoneOffShore Mar 2020 #64
Medical experiment for the collection of statistics ... laetrile of the COVID-19 era bucolic_frolic Mar 2020 #11
You must be my age. Scruffy1 Mar 2020 #46
I recall a big 60 Minutes piece on laetrile in the 1970s, about 1977-78 bucolic_frolic Mar 2020 #47
Hopefully fewer people die from vtach/torsades de pointes.... moriah Mar 2020 #54
Caution. Trump toady at work. PSPS Mar 2020 #12
its a hail mary samnsara Mar 2020 #13
Hardly. It's what happens when you have a trump toady at the helm. PSPS Mar 2020 #14
conspiracy time catsudon Mar 2020 #16
I think it's time to look into the stock trades kellytore Mar 2020 #18
Trump pushed them after several doctors including the surgeon general DenverJared Mar 2020 #19
The fact is these drugs are already approved for use to DeminPennswoods Mar 2020 #20
Now its not available for things it actually helps Bmoboy Mar 2020 #23
How about the other side of the coin? gab13by13 Mar 2020 #25
Think this is more of a last resort rather than the DeminPennswoods Mar 2020 #45
Big difference between "prescribed by a physician" and "grab it out of your aquarium." (n/t) forgotmylogin Mar 2020 #44
Concur MosheFeingold Mar 2020 #62
This'll make the wingers happy... Maxheader Mar 2020 #22
I couldn't find the full text of this EUA on FDA.gov IronLionZion Mar 2020 #24
Since day one, it could be prescribed as off-label use. Hoyt Mar 2020 #27
They can also prescribe..... paleotn Mar 2020 #29
How about gris gris bags? Or Mentos in Diet Coke? marble falls Mar 2020 #30
Or the classic Metatron Mar 2020 #31
Old school, or aspirin and coke, or banana peel scrapings. marble falls Mar 2020 #32
Remember Trump is a mob boss. The FDA are toadies. ananda Mar 2020 #34
But but but... thecrow Mar 2020 #38
HHS letter requesting it IronLionZion Mar 2020 #35
What this is Rebl2 Mar 2020 #36
Someone in one of my FB groups posted that one of helpisontheway Mar 2020 #48
Please roscoeroscoe Mar 2020 #56
85% of cases resolve without serious symptoms jberryhill Mar 2020 #57
I don't know. He said she was on a vent and things helpisontheway Mar 2020 #58
You don't seem to get the point jberryhill Mar 2020 #59
Good 👍 nt Raine Mar 2020 #49
I hope it helps some people. Sapient Donkey Mar 2020 #50
Did Trump pressure them into prematurely approving procon Mar 2020 #55
MY thoughts!! bluestarone Mar 2020 #63
Key paragraphs from the FDA letter... Steelrolled Mar 2020 #67
 

ChiTownDenny

(747 posts)
43. Agreed.
Mon Mar 30, 2020, 12:06 PM
Mar 2020

And I hope it's not a political ploy meant to support the president's hyperbole. What a shame that one has to be skeptical of our government's actions these days.

Warpy

(112,196 posts)
53. Off label use is a gamble
Tue Mar 31, 2020, 02:42 AM
Mar 2020

but you can expect them to try a lot of things off label to try to keep people alive.

I think they'll have a bit more success with antiretrovirals they use for HIV, but what do I know?

Other than respiratory support, they have nothing proven to treat this thing.

Chloroquine and hydroxychloroquine both have some pretty serious side effects. People with mild cases can expect to get neither. It's too risky for people who are expected to recover without heroics.

5X

(3,972 posts)
2. That means it can be prescribed as part of a trial, without patient full consent or knowledge. n/t
Mon Mar 30, 2020, 07:23 AM
Mar 2020

SCantiGOP

(13,957 posts)
39. No it doesn't mean that at all
Reply to 5X (Reply #2)
Mon Mar 30, 2020, 11:04 AM
Mar 2020

Administering a drug without consent would subject the person to civil and criminal penalties.

5X

(3,972 posts)
41. Will the patients be told it is experimental and part of a trial with no proven effectiveness?
Mon Mar 30, 2020, 11:20 AM
Mar 2020

Because, that is what it will be under these conditions.

SCantiGOP

(13,957 posts)
42. Yes
Mon Mar 30, 2020, 11:37 AM
Mar 2020

From the attached article:
“Under the EUA, health care providers and patients must be given fact sheets outlining the known risks and drug interactions of the medications.”

There are very tight regulations in this country preventing people from being used as unwitting test subjects. We had our shameful Tuskegee Airmen episode, and of course the horrific Nazi medical experiments were extreme examples of how uninformed medical treatment is totally beyond the bounds of medical ethics and legality.

Submariner

(12,549 posts)
3. It's too bad the Trump FDA can't be trusted
Mon Mar 30, 2020, 07:34 AM
Mar 2020

the shitbag may be forcing his FDA to lay some lies on the public for political reasons.

captain queeg

(11,084 posts)
52. It's gotten to the point it's hard to trust things coming out of the federal government
Tue Mar 31, 2020, 02:33 AM
Mar 2020

Corona is a prime example but look at the way shit-for-brains has forced federal scientists to not even use the term global warming. There’s other things I can’t think of right at the moment.

65. Fat Donnie needs a miracle cure he can sell at his rallies -- er, pressers.
Tue Mar 31, 2020, 04:53 PM
Mar 2020

"Look at what I did. You are all going to live because of me, and me alone! Only I can fix it! Where's my Nobel Prize?"

He's a con man through and through. No wonder he brings the "MyPillow" jerk to his presser. Like attracts like.

SheltieLover

(57,073 posts)
51. Definately!
Tue Mar 31, 2020, 02:10 AM
Mar 2020

I wonder if anyone has investigated whether shitstain & company has bought controlling interests in company(ies) that make this drug?

He sure is pushing something that has no known clinical basis that I am aware of.

lark

(23,554 posts)
9. drumpf made them say this, I don't believe it how low they have gone.
Mon Mar 30, 2020, 08:09 AM
Mar 2020

They KNOW for sure that this kills people, WTF are they allowing it on the market, and for children no less. They are fucking killing us on purpose to change our country to full on fascist mode.

Ramsey Barner

(357 posts)
10. This isn't science - it's propaganda.
Mon Mar 30, 2020, 08:19 AM
Mar 2020

Article: "Last week, the authors of a paper published in the Journal of Zhejiang University concluded that hydroxychloroquine is no better a treatment for coronavirus than currently used methods."

 

jberryhill

(62,444 posts)
15. Did you see the latest from Didier
Mon Mar 30, 2020, 08:31 AM
Mar 2020

After it was pointed out that his 24 person "study" involved cherry picked data, he published new data claiming an 80% cure rate - which is the rate at which untreated covid-19 resolves with no to moderate symptoms.

ProfessorGAC

(66,815 posts)
17. IOW, A Placebo
Mon Mar 30, 2020, 08:35 AM
Mar 2020

4 in 5 with no drug recover well. 4 in 5 with drug recover well.
Let's declare water as a treatment that allows 80% to recover well.
Think the FDA will approve that?

Igel

(35,742 posts)
21. It's up there with
Mon Mar 30, 2020, 08:52 AM
Mar 2020

plasma-antibody treatments as far as evidence goes.

That's the problem--lack of actual data. For either plasma transfusion or these drugs.

karynnj

(59,637 posts)
40. However, with the plasma antibody treatments, no one is claiming they will definately
Mon Mar 30, 2020, 11:06 AM
Mar 2020

work. There are studies being designed to identify survivors, test if their blood has antibodies and for them to donate plasma. They have said that this has been beneficial for SOME other infections and they are testing to see if it works for Covid 19. The last I read was at least one study did give the plasma to seriously ill covid patients. As these were studies, at some point, we will get results.

A big difference is that people can likely get that plasma only if they are part of a study.

 

jberryhill

(62,444 posts)
28. Yep, I saw those as well
Mon Mar 30, 2020, 09:23 AM
Mar 2020

One might think most charitably that, as head of the institute, he is prone to rubber-stamping the work of others without looking to closely.

It's unfortunate that his work seems to have generated more heat than light.

But it has an eerie resemblance to "N-rays".
 

jberryhill

(62,444 posts)
61. Ah, I just caught that one
Tue Mar 31, 2020, 11:54 AM
Mar 2020

This is really troubling.

It's almost as if he is trying to muddy the waters while others are trying to figure out if there is or is not any therapeutic value here.

GoneOffShore

(17,391 posts)
64. He wants to be 'The Guy'.
Tue Mar 31, 2020, 02:29 PM
Mar 2020

Did you ever read - 'And The Band Played On' by Randy Shilts?

There was 'a guy' who wanted to be 'The Guy' when it came to discovering a cure. Raoult probably took lessons from him. Or Andrew Wakefield.

bucolic_frolic

(44,642 posts)
11. Medical experiment for the collection of statistics ... laetrile of the COVID-19 era
Mon Mar 30, 2020, 08:27 AM
Mar 2020

But if it's all you got and it helps a bit here or there .... the laetrile of the COVID-19 era

bucolic_frolic

(44,642 posts)
47. I recall a big 60 Minutes piece on laetrile in the 1970s, about 1977-78
Mon Mar 30, 2020, 07:14 PM
Mar 2020

I don't think the general public had much of an idea of what the patients were talking about. This was like the first wave of Americans living into old age and experiencing cancer as a generational issue. Was laetrile the first chemo? Was that their point? Or was it viewed as a cure ... the cyanide in the apricot pits would go to the cancer and kill it.

How accurate was diagnosis pre-1960? Was it cancer, was it worms? Radical excision was a remedy. Not sure they knew about immunity. Did a large part of the population have it but didn't know about it because few lived into their 70s and 80s? I have no idea.

Sorry for the rant.

moriah

(8,312 posts)
54. Hopefully fewer people die from vtach/torsades de pointes....
Tue Mar 31, 2020, 04:15 AM
Mar 2020

... than died of cyanide from laetrile. Glad it did not say that the combo of that and Zithromax was recommended -- both drugs prolong the QT interval, taking them together can be dangerous for some patients.

In a hospitalized patient? At least they'll have them on a cardiac monitor. They're likely sick enough already that any abnormal rhythms can be treated and hopefully the risk is worth the potential cure.

But PCPs prescribing that combination to community patients who don't yet need hospitalization need to warn their patients that if they have sudden heart palpations or increased shortness of breath should get themselves to an ER.

PSPS

(13,787 posts)
12. Caution. Trump toady at work.
Mon Mar 30, 2020, 08:28 AM
Mar 2020
Vineet Menachery, Assistant Professor in the Department of Microbiology & Immunology at the University of Texas Medical Branch who was not involved in the research, cautioned to Newsweek last week that the paper involved a small number of participants. And while the patients didn't improve and it doesn't appear to worsen COVID-19, there are concerns about its side effects.


In other words, if done carefully, it won't really help but it probably won't kill you either. In other words, snake oil. This is likely just to stimulate sales of the snake oil "treatments" being pimped online by trump sycophants.

catsudon

(864 posts)
16. conspiracy time
Mon Mar 30, 2020, 08:34 AM
Mar 2020

I think trump already knows fda was going to approve this since he know dem wills do a push back on everything he says.

then he slip this in hoping dems will reject this completely

if he pushes a 'real cure' same thing will happen, so even if he is telling the truth, once out of 1000, he will kill people

kellytore

(186 posts)
18. I think it's time to look into the stock trades
Mon Mar 30, 2020, 08:44 AM
Mar 2020

Of Trump's family. They could have purchased stock in the pharmaceutical companies that make this drug.

DeminPennswoods

(15,584 posts)
20. The fact is these drugs are already approved for use to
Mon Mar 30, 2020, 08:50 AM
Mar 2020

treat other diseases, they've been around for years and the side effects are well-known. Doctors can and do use drugs "off label" if they appear to help people with a different condition. This is how Avastin got approved as a treatment for wet macular degeneration, another disease for which there was no good treatment available. Avastin doesn't work for eveyone who gets it, but it does work for some in slowing or holding off the disease. It's the same thing here.

Bmoboy

(310 posts)
23. Now its not available for things it actually helps
Mon Mar 30, 2020, 08:56 AM
Mar 2020

People with Lupus have used this drug with good results.Now they cannot get anymore since Trump's FDA has ruled it must be reserved for Covid only.

It doesn't help with Covid and may kill the patient.

The patient that it really helps can't get it.

Crazytown.

gab13by13

(22,746 posts)
25. How about the other side of the coin?
Mon Mar 30, 2020, 09:00 AM
Mar 2020

Some drugs that work for one sickness may be harmful for a different sickness. Just because it is safe for malaria doesn't necessarily make it safe for coronavirus.

DeminPennswoods

(15,584 posts)
45. Think this is more of a last resort rather than the
Mon Mar 30, 2020, 06:26 PM
Mar 2020

"go to" treatment. If your loved one was dying, wouldn't you want to try anything to save them (in accordance with any advance directive they might have)?

MosheFeingold

(3,051 posts)
62. Concur
Tue Mar 31, 2020, 12:44 PM
Mar 2020

This is wonderful if it works.

And from studies in France and India it apparently does work.

My son is a doctor and he believes this so strongly that he (and actually all the hospital staff) are taking HCQ as a preventative.

Maxheader

(4,388 posts)
22. This'll make the wingers happy...
Mon Mar 30, 2020, 08:53 AM
Mar 2020


that stumpy inadvertently and accidentally stumbled upon these meds...

IronLionZion

(46,028 posts)
24. I couldn't find the full text of this EUA on FDA.gov
Mon Mar 30, 2020, 08:57 AM
Mar 2020

so it looks like they're just winging it like the rest of the Trump administration since there isn't time for clinical trials to collect adequate data on safety and effectiveness first. So if you're facing death, they figure you might as well try it and see.

There are people out there still thinking lemons and garlic will save them. Maybe the power of prayer can save some people.

paleotn

(18,440 posts)
29. They can also prescribe.....
Mon Mar 30, 2020, 09:44 AM
Mar 2020

garlic, juju beans and a visit to the local witch doctor....."as appropriate, when a clinical trial is not available or feasible."

If the science isn't there, folks, the science isn't there. It may yet prove effective, but right now we don't know. Exposing people to the side effects without evidence of efficacy is dumb, if not outright criminal. Our FDA has been co opted and is now a propaganda machine.

ananda

(29,271 posts)
34. Remember Trump is a mob boss. The FDA are toadies.
Mon Mar 30, 2020, 10:26 AM
Mar 2020

Do not take those drugs under any circumstances.

IronLionZion

(46,028 posts)
35. HHS letter requesting it
Mon Mar 30, 2020, 10:28 AM
Mar 2020
https://www.fda.gov/media/136534/download

Sounds pretty desperate. They're waiving a lot of important requirements to rush this through.

There is no adequate, approved, and available alternative to the emergency use of
chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID19.



fact sheets on the 2 drugs
https://www.fda.gov/media/136538/download
https://www.fda.gov/media/136536/download

When they approve cyanide, then we can really worry.

Rebl2

(14,040 posts)
36. What this is
Mon Mar 30, 2020, 10:36 AM
Mar 2020

doing is hurting people that need this drug for lupus and rheumatoid arthritis and malaria. I know it has been used for at least 40 years for RA and much longer for malaria. I know because I took it for 36 years. I had to stop because it started effecting my eyesight. (It is possible this drug can cause loss of eyesight after long term use). Now there is such a run on this drug those patients can’t get the drug or a minimal amount. I’ve been hearing stories of doctors prescribing it for themselves and their families and friends. They should NEVER, NEVER be allowed to do this and should lose their license to practice! There is NO proof yet that it will work on this virus. We won’t know until real and reliable studies have been completed.

helpisontheway

(5,024 posts)
48. Someone in one of my FB groups posted that one of
Mon Mar 30, 2020, 07:15 PM
Mar 2020

those drugs helped their grandmother that lives in Florida. I hope it is true and that lives can be saved.

 

jberryhill

(62,444 posts)
57. 85% of cases resolve without serious symptoms
Tue Mar 31, 2020, 08:19 AM
Mar 2020

30% of covid-19 cases resolve with no symptoms.

55% have mild to moderate symptoms.

10% have serious symptoms.

5% require ventilation and about half of them die.

What makes you believe the drugs made any difference to the grandmother of someone in your Facebook group?

The fact that 85% of cases resolve on their own means that the field is ripe for snake oil here.

helpisontheway

(5,024 posts)
58. I don't know. He said she was on a vent and things
Tue Mar 31, 2020, 10:27 AM
Mar 2020

were not looking good. He said she turned a corner once they gave her the meds. I don’t know if it was true but I hope it is true. I hope it can save lives.

 

jberryhill

(62,444 posts)
59. You don't seem to get the point
Tue Mar 31, 2020, 10:29 AM
Mar 2020

50% of people on a vent, for whom things don't look good, will get better.

Simply because she was given something at that time, does not mean that the drug caused her to get better.

Sapient Donkey

(1,568 posts)
50. I hope it helps some people.
Tue Mar 31, 2020, 02:01 AM
Mar 2020

I wish there were some accepted clinical trials that would complete to give us more insight on how well it works, though.

 

Steelrolled

(2,022 posts)
67. Key paragraphs from the FDA letter...
Tue Mar 31, 2020, 09:03 PM
Mar 2020

I recommend reading the letter (see post above).


I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific
evidence available to FDA, that it is reasonable to believe that chloroquine phosphate and
hydroxychloroquine sulfate may be effective for the treatment of COVID-19, when used
consistently with the Scope of Authorization of this letter (Section II), pursuant to Section
564(c)(2)(A) of the Act.

Having reviewed the scientific information available to FDA, including the information
supporting the conclusions described in Section I of this letter, I have concluded that chloroquine
phosphate and hydroxychloroquine sulfate (as described in the Scope of Authorization of this letter
(Section II)) meets the criteria set forth in Section 564(c) of the Act concerning safety and potential
effectiveness.
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