FDA SAYS HYDROXYCHLOROQUINE AND CHLOROQUINE CAN BE USED TO TREAT CORONAVIRUS

[catsudon]

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

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are they trying to circumvent the governors' ban?

[mucifer]

1. I'm just gonna hope it's working for some people. We need something that works

[ChiTownDenny]

43. Agreed.

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]

53. Off label use is a gamble

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]

2. That means it can be prescribed as part of a trial, without patient full consent or knowledge. n/t

[SCantiGOP]

39. No it doesn't mean that at all

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

[5X]

41. Will the patients be told it is experimental and part of a trial with no proven effectiveness?

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

[SCantiGOP]

42. Yes

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.

[Steelrolled]

66. I imagine they will have to agree a 100 times over to get it.

[Submariner]

3. It's too bad the Trump FDA can't be trusted

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

[captain queeg]

52. It's gotten to the point it's hard to trust things coming out of the federal government

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.

[KWR65]

4. This is Trump propaganda at work.

They might as well as say that M&M's will treat COVID-19.

[FarPoint]

8. I agree..

It's another " pie in the sky".

[LastLiberal in PalmSprings]

65. Fat Donnie needs a miracle cure he can sell at his rallies -- er, pressers.

"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.

[Hugin]

5. Does anyone else smell a fresh Sharpie?

I swear I smell Sharpie ink. *sniff*

[bronxiteforever]

6. +1 absolutely.

[Rebl2]

33. Yep I smell

it and it stinks!

[SheltieLover]

51. Definately!

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.

[Devil Child]

7. Good n/t

[lark]

9. drumpf made them say this, I don't believe it how low they have gone.

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]

10. This isn't science - it's propaganda.

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]

15. Did you see the latest from Didier

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]

17. IOW, A Placebo

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]

21. It's up there with

plasma-antibody treatments as far as evidence goes.

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

[karynnj]

40. However, with the plasma antibody treatments, no one is claiming they will definately

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.

[GoneOffShore]

26. Didier has been dealing with dodgy data for years, by all accounts.

[jberryhill]

28. Yep, I saw those as well

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".

[Bernardo de La Paz]

37. Thank you for that tip about N-rays. An interesting episode in science history

... and a cautionary tale.

[GoneOffShore]

60. Here's something more on Didier

https://blogs.sciencemag.org/pipeline/archives/2020/03/29/more-on-cloroquine-azithromycin-and-on-dr-raoult?utm_source=quora&utm_medium=referral

[jberryhill]

61. Ah, I just caught that one

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]

64. He wants to be 'The Guy'.

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]

11. Medical experiment for the collection of statistics ... laetrile of the COVID-19 era

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

[Scruffy1]

46. You must be my age.

I've been comparing it to laetril for a while.

[bucolic_frolic]

47. I recall a big 60 Minutes piece on laetrile in the 1970s, about 1977-78

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]

54. Hopefully fewer people die from vtach/torsades de pointes....

... 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]

12. Caution. Trump toady at work.

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.

[samnsara]

13. its a hail mary

[PSPS]

14. Hardly. It's what happens when you have a trump toady at the helm.

[catsudon]

16. conspiracy time

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]

18. I think it's time to look into the stock trades

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

[DenverJared]

19. Trump pushed them after several doctors including the surgeon general

asked to hold their horses

[DeminPennswoods]

20. The fact is these drugs are already approved for use to

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]

23. Now its not available for things it actually helps

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]

25. How about the other side of the coin?

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]

45. Think this is more of a last resort rather than the

"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)?

[forgotmylogin]

44. Big difference between "prescribed by a physician" and "grab it out of your aquarium." (n/t)

[MosheFeingold]

62. Concur

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]

22. This'll make the wingers happy...

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

[IronLionZion]

24. I couldn't find the full text of this EUA on FDA.gov

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.

[Hoyt]

27. Since day one, it could be prescribed as off-label use.

[paleotn]

29. They can also prescribe.....

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.

[marble falls]

30. How about gris gris bags? Or Mentos in Diet Coke?

[Metatron]

31. Or the classic

PopRocks!

[marble falls]

32. Old school, or aspirin and coke, or banana peel scrapings.

[ananda]

34. Remember Trump is a mob boss. The FDA are toadies.

Do not take those drugs under any circumstances.

[thecrow]

38. But but but...

He’s mixing it in Koolaid. Cherry koolaid.......!!!

[IronLionZion]

35. HHS letter requesting it

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]

36. What this is

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]

48. Someone in one of my FB groups posted that one of

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

[roscoeroscoe]

56. Please

I mean, Facebook?

[jberryhill]

57. 85% of cases resolve without serious symptoms

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]

58. I don't know. He said she was on a vent and things

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]

59. You don't seem to get the point

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.

[Raine]

49. Good 👍 nt

[Sapient Donkey]

50. I hope it helps some people.

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

[procon]

55. Did Trump pressure them into prematurely approving

these drugs tp give himself bragging rights,

[bluestarone]

63. MY thoughts!!

That's what is happening!

[Steelrolled]

67. Key paragraphs from the FDA letter...

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.