Trump Touts Malaria Drug That FDA Says Isn't Approved for Virus

[Mrs. Overall]

Source: Bloomberg

The Food and Drug Administration has been told by President Donald Trump to see if it can expand the use of an experimental malaria drug, chloroquine, to treat patients in the middle of the U.S. coronavirus outbreak.

At a press conference at the White House Thursday, Trump and the head of the FDA gave apparently conflicting comments about the availability of the drug. Trump said chloroquine had been approved and could be given to patients by doctors with a prescription.

“It’s been around for a long time, so we know that if things don’t go as planned it’s not going to kill anybody,” Trump said.

Minutes later, FDA Commissioner Stephen Hahn, said that use of the drug would be in a clinical trial to find out whether or not it works, and if so, what dose would safe and effective. “Again, we want to do that in a setting of a clinical trial,” Hahn said, following up on Trump’s remarks at the press conference. Doctors in the U.S. are allowed to prescribe drugs for uses that haven’t been approved by the FDA, in what’s called off-label use.

An FDA spokesperson said the drug had not been approved for use in Covid-19 patients.





Read more: https://www.bloomberg.com/news/articles/2020-03-19/trump-touts-malaria-drug-as-potential-coronavirus-treatment

[The Magistrate]

1. The Drug's Use Is Merely Under Trial, Ma'am

I have read it shows some promise in a test tube, but not so much in living cells. Certainly worth testing, but pretending it is ready to go a treatment is despicable.

"When things are not called by their right names, what is said cannot make sense. When what is said does not make sense, what is planned cannot succeed. When plans do not succeed, people become uneasy. When people are uneasy, punishments do not fit crimes. When punishments do not fit crimes, people cannot know where to put hand or foot."

[GumboYaYa]

2. Hydroxychloroquine became standard of care in South Korea.

They give 500mg daily and their death rate becme the lowest of any country. A doctor in France did a trial and had great results.

https://www.connexionfrance.com/French-news/French-researcher-in-Marseille-posts-successful-Covid-19-coronavirus-drug-trial-results?fbclid=IwAR0mu-5-w6YXunZ7tufGGMBRrWuI3dTuc0OTxQo_3FidTM8eL7FutYYuUMA

The drug is a zinc ionophore, which means it helps cells absorb zinc. Zinc in the cytoplasm has been shown to reduce the action of RdRP (RNA dependent RNA Polymerase or replicase) from working in other coronaviruses.

Stanford also apparently did an in human study with covid-19 and got almost 100% cure rates.

FDA needs to stop dragging its feet and approve the drug for use in coronavirus.

[WePurrsevere]

22. I seem to remember reading about this before...

Thanks for the reminder and link.

[FM123]

56. "Stanford also apparently did an in human study with covid-19 and got almost 100% cure rates."

We need to get this show on the road. Now.

[Rebl2]

61. I used

to take that for rheumatoid arthritis until it started affecting my eyes. My retina specialist told me to quit taking it. My rheumatologist was not happy. In fact she disagreed at first. She did finally come around and said yes my eyesight was more important. I took 200mg a day and took it from 1980-2016. I would guess a short course of it would not be a problem for your eyes. In fact I would take it again if it really does fight off this virus. I also want to say not long- maybe 3 months-after I quit taking it I had a flare of my RA and have been fighting flares ever since. So it really did help me.

[CountAllVotes]

3. This will only cause more death!

His MAGAt followers will believe that quinine will take care of this.

There is no proof that it does and quinine is not a cure. It helps those with malaria A BIT but does not cure it.

I know, my father had malaria from WWII and he used to have supplies of it on hand as it used to be in tonic water. Today's version of tonic water is different and not effective. He quit using it as a treatment for malaria in fact.

He died in the hospital and that oh so familiar fever I'd seen so many times was present. The doctors did not know what the fever was from as he never told them that he had malaria! I was the one that told the doctors what the fevers were from. So much for this great malaria cure.

It is a treatment and nothing more.

It is disgusting that this idiot would make such a statement! It will only cause more death!

[GumboYaYa]

4. This is wrong.

[Demsrule86]

34. It is synthetic quinine...and I was impressed enough to by tonic water... can't hurt.

It was used in an area which did pretty well.

[GumboYaYa]

37. Try to find some quercetin

It is a polyphenol that has a similar mechanism of action as far as being a zinc ionophore. I have been taking it and zinc for the past week.

[WestLosAngelesGal]

5. It usually takes months or years of clinical trials to get a treatment or drug approved

Someone needs to stop him from spewing these random medical treatment ideas.

Hope the FDA pushes back.

[CountAllVotes]

6. Since when is dump a scientist

He is an idiot! A damned idiot!

[WestLosAngelesGal]

9. Agreed!

Yes!

[jmowreader]

47. HIs uncle John was a scientist, so now Trump thinks he is too

Of course, his uncle was an electrical engineer, not a biologist...so even if John Trump was alive today, he would ask you to find a qualified person to ask.

[GumboYaYa]

7. This is wrong also.

We know the mechanism of action for this drug and it has been used for years. We have lots of human data already gathered in other countries.

[WestLosAngelesGal]

10. Testing to begin soon for coronavirus drugs...

https://www.statnews.com/2020/03/18/who-to-launch-multinational-trial-to-jumpstart-search-for-coronavirus-drugs/

p.s. I do not see that the U.S. has even joined the Solidarity trial.

[GumboYaYa]

14. This is an off target use for a known drug.

that means no tox studies and only look at efficacy. in emergency FDA should use in human use from other jurisdictions to speed up efficacy. If done right approval can be done very quickly here.

[Demsrule86]

35. This is quinine ...not a new drug...it is synthetically made.

[GumboYaYa]

8. Three separate in human studies have shown this drug to be effective

https://www.theblaze.com/news/studies-find-potentially-effective-medicine-for-coronavirus-treatment-and-prevention-thats-readily-available

the issue here is that the FDA is moving too slowly to approve it in the US.

[MineralMan]

11. I'm sorry, but The Blaze, Glenn Beck's clickbait site,

is not an accurate source of news of any kind. Normally, it is not used as a source on DU.

[kiri]

33. sickened

I was sickened by the fawning repetition of 'Great", great scientists, great Americans, great president.

Great god of golf! do we have to hear this crap, keep America great--every damn sentence?

Have to run...need to vomit.

[Demsrule86]

36. No it is not a good source, but I have seen better sources...it is synthetic Quinine.

People are buying tonic water but don't know if would be enough...of course it won't hurt you and mixed with Gin and...lime tastes fine!

[MineralMan]

38. Yes, indeed. I am a fan of the classic Gin and Tonic, made of course

with tonic water that states on its label, "contains Quinine." However, I do not expect my adult beverage of choice to protect me from any virus.

[GumboYaYa]

41. You would need quite a bit of tonic!

[MineralMan]

44. Yes, I think so.

In the British Colonial days, more was in the typical tonic water, to be sure.

[WestLosAngelesGal]

62. Some people can have a reaction to quinine

It's apparently not completely safe for every person (especially pregnant women or children):

https://www.medicalnewstoday.com/articles/323692#is-quinine-safe

https://www.livescience.com/36536-tonic-water-quinine-malaria-health.html

[MineralMan]

66. Some people have adverse reactions to every medication

that has ever been developed.

[jayfish]

12. The Fucking Blaze!? -NT-

[GumboYaYa]

17. How about some more sources....

https://techstartups.com/2020/03/16/new-academic-study-reveals-counter-anti-malaria-pill-chloroquine-may-highly-effective-treating-coronavirus/?fbclid=IwAR3FwL8kS-u24hzJo0QqefGfYr8-4Jn92ep9j-aNqDwNqlZ-ojUMnLFL8-k

Politcal bias can't drive opinions now, science matters.

[scrabblequeen40]

13. "the blaze" is not a legitimate news outlet... part of RW network.

Citing it makes you less credible... but more suspicious

[GumboYaYa]

19. More sources....

https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa237/5801998

[GumboYaYa]

21. Still more sources....

https://www.nature.com/articles/s41422-020-0282-0

[jayfish]

27. Testing Something On A Culture And Extrapolating That To A Living Human?

I don't want to be Debbie Downer but come on man.

[GumboYaYa]

28. It is standard of care in South Korea

everyone who tests positive there now gets prescribed 500mg daily for ten days and their severe cases and deaths have plummeted. A doctor in France used it an got great results with expedited cure rates. Stanford just did a study and found 100% cure rates in humans given hydroxychlrorquine for coronavirus. We actually understand the mechanism of actin for this pretty well.

[Demsrule86]

39. It is quinine and has been used forever to treat Malaria...should we allow folks to die if it might

help? This is the synthetic version.

[jayfish]

42. No, But Conversly...

we shouldn't encourage people to pin thier hopes on something tested on cultures in a petri dish and then have them get sick anyways.

[GumboYaYa]

23. Another source.....

https://www.jstage.jst.go.jp/article/bst/advpub/0/advpub_2020.01047/_pdf/-char/en

[CountAllVotes]

15. Potential

That is the word I see, potential.

They have no proof.

This is a new virus.

Adequate studies and research have not been done.

It takes years to find a vaccine or a viable treatment. That is how it works.

Do you remember AIDS by chance? Has it been cured? Is there a vaccine?

NO. Period.

It took years to be able to treat AIDS so people can live longer HOPEFULLY.

[jayfish]

16. Does Anyone Remember The Common Cold? -NT-

[CountAllVotes]

24. Are you comparing COVID & AIDS to the common cold?

I hope this is not the case.

[jayfish]

29. No.

I'm saying we've been searching for a cure/vaccine for the common cold for centuries and don't have it. We aren't going to miraculously have one for this in a month. I would love to be proven wrong though.

[CountAllVotes]

31. Exactly

You can't just push these treatments through, it takes years of study and research.

What they need to do is CONTROL this outbreak.

If everyone must stay indoors to do it, so be it! They have nothing else to go by other than the lies from China and whatever legitimacy Korean research, etc. may hold. These are two resources that you cannot believe!

Just because some news source somewhere says something doesn't mean a lot to me, esp. in the form of click-bait!

That is the problem with Americans. They want everything NOW, yes NOW.

They will learn what the word wait means real soon.

[FiveGoodMen]

43. By that reasoning, we will never have a treatment for this

(we don't have a cure for the cold)

[jayfish]

45. Oh Dear, Sweet, Baby Jesus.

That's not my reasoning at all. I think I'm going to take a hiatus from posting for the rest of the day. I, apparently, am making even less sense than usual.

[GumboYaYa]

26. That is true for a new drug

you have to go through three phases at the FDA. First is toxicity (Phase 1), Phase 2 is preliminary efficacy (small human trials) and phase 3 is large scale human trials.

This is an existing approved drug being used for an off target condition. It can be approved quickly. The issue here is that the FDA is not moving fast enough to approve this drug.

[Demsrule86]

40. We don't have years and this is not a new drug.

[Botany]

18. So a treatment for a disease that is transmitted by mosquito bites which infects the person with ...

... microscopic parasite can no be used for viral infection according to Donald Trump PhD & M.D..

[PaulRevere08]

20. It's frightening to think that tRump will glom onto anything that might

be a "silver bullet" and pull his ass out of the fire. It has the potential to be a great distraction from the real work that needs to get done.

[Hoyt]

25. I think it's common for docs to use drug approved for one condition in other cases.

The FDA is right to say they want some evidence that it is worthwhile for CV19. Once they see a few patients improve, consider S Korean experience, etc., they’ll open up the spigots. Assuming it pans out, of course.

[GumboYaYa]

30. this is correct.

I just wish they would speed up the process.

[hardluck]

48. That's correct

It's called off-label use. The drug company cannot market the drug for that use but once the drug is approved by the FDA a doctor can prescribe it for any purpose that they feel is warranted based on their opinion and experience. This might increase the potential for liability for a doctor should there be an issue.

[Hoyt]

49. Thanks. If I were on a jury in a liability case where docs were forced into trying anything vs.

letting a patient die; although sympathetic, I'd have a hard time finding for the patient's family unless the doc drown them with Clorox or something.

[GumboYaYa]

32. This guy does a good job of explaining the science behind chloroquine:

The issue with Trump here is that we have know for several months that this drug shows promise and other countries were using it with good results, but we just caught on and started trials today. it is infuriating.

[davepdx]

60. That's an excellent source GumboYaYa

His videos are well done.

[Javaman]

46. what? bleach doesn't work anymore?? (drinking that is)

he's a fucking moron.

[standingtall]

50. Could try doubt it would work though

This drug has been around for awhile to treat malaria and what I've heard it really isn't even all the effect in treating malaria.

[marybourg]

51. Approved drugs, such hydroxychloraquine-

Plaqunil- can always be used for off label treatment.

[GumboYaYa]

52. FDA is just trying to get a dosage recommendation for doctors and confirm efficacy at that dosage

But the frustrating thing is we have a lot of data from Asia. China was dosing 400mg twice a day and South Korea was dosing 500mg once a day. there was not a lot of divergence in efficacy, so we know we can dose 500mg a day and get results. I wishthey would just tell docs they can do 500mg daily now so we can start seeing some relief. We have been trying to get the FDA to use control arm data like this for years in emergency and orphan drug situations. If there was ever a case for that it is now.

[Rebl2]

64. Used in RA

for many years

[marybourg]

65. And lupus

[Tommy_Carcetti]

53. "My wife Malaria is very qualified to handle the Chinese Virus."

"I mean, she speaks 20 languages. I'm sure Chinese is one of them."

[Midnightwalk]

54. There will need to be expedited trials

Of more than chloroquine. The experts should have been watching developments and working with the FDA and the person the president put in charge.

Oh that’s pence at least on days that jared is tied up doing other crap.

Putting out disinformation like trump did making it sound like there’s a treatment is counterproductive.

The right message is that treatments will be fast pathed into trials using scientific advice and that treatments that show promise will be made available. Tell us how many months to hope for.

Telling people that chloroquine works will drive too much demand, take the focus off needing several trials and encourage people to stop isolating themselves.

It also creates fear to hear the president say something immediately contradicted by his head of the fda.

[cstanleytech]

55. While both are quacks i would trust Donald Duck before Donald Trump.

[standingtall]

57. Could be that big pharma has a huge stock pile

of chloroquine drugs and want use the covid 19 virus to unload it. They been used to treat malaria and autoimmune diseases, but haven't really been all that effective for either one of them.

[GumboYaYa]

58. It's a generic pharmaceutical product, which is a great thing from a cost and available perspective,

or at least it should be. It is also easy to produce in large quantities. The rumor floating around in pharmaceutical world is that Bayer is about to make a large donation of the drug to the US.

[Dios Mio]

59. Chloroquine

Is not an experimental drug. The the off label usage may be referred to as experimental. The off label usage of medication for conditions not indicated by the manufacturers is fairly common. Results of off label results are then published in professional journals and the decision to use the drug rests with the physician.

[DeminPennswoods]

63. Off label use

That's what happened with Avastin for treating wet macular degeneration. It helped some patients so opthalmologists started using it off label (it was originally developed to treat colon cancer by interfering with the tumor's ability to generate blood vessels).

On MSNBC one of the docs, who is also a rheumatologist, said the current theory as to why this might help is that the virus needs an either more or less acidic environment to flourish and this class of drugs makes the body less of whichever one the virus needs.

[GumboYaYa]

67. My understanding is that it has to do with zinc absorption by cells in the lungs.

We have data that shows that hydroxychloroquine and cholorquine increase zinc absorption. Hydroxy does better. Those trials were in vitro (in test tubes). We also have in vitro studies that showed hydroxychloroquine slows replication of Sars-Cov (the Sars virus, not covid 19). We also know that zinc in the cytoplasm slows the action the RdRP (replicase) for Sars-Cov and other coronaviruses. So the theory is that hydroxychloroquine is a zinc ionophore, meaning it helps increase zinc absorption and that slows virus replication..

Based on this China started dosing 40 mg twice a day and saw improvement in Covid-19 patients. South Korea made it standard of care at 50 mg a day for 10 days and has the lowest death rates of anyplace.

I am frustrated that the FDA waited this long to start examining this drug. Trump is touting things that he should have done two months ago as achievements today.

[DeminPennswoods]

68. That is interesting

I understand the FDA wants more controlled testing, but sometimes there is a need to fast track a use that might prove helpful.

The rheumatologist who was on MSNBC said a drug that's used for RA has also shown some positive results. It would be really interesting to know how many of the people who have been tested for covid-19 have lupus or are being treated for other auto-immune diseases like RA and if they tested positive or not.