Trump Touts Malaria Drug That FDA Says Isn't Approved for Virus
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.
Its been around for a long time, so we know that if things dont go as planned its 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 Trumps remarks at the press conference. Doctors in the U.S. are allowed to prescribe drugs for uses that havent been approved by the FDA, in whats 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
(95,255 posts)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
(5,952 posts)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
(24,259 posts)Thanks for the reminder and link.
FM123
(10,054 posts)We need to get this show on the road. Now.
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
(20,878 posts)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
(5,952 posts)Demsrule86
(68,667 posts)It was used in an area which did pretty well.
GumboYaYa
(5,952 posts)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
(268 posts)Someone needs to stop him from spewing these random medical treatment ideas.
Hope the FDA pushes back.
CountAllVotes
(20,878 posts)He is an idiot! A damned idiot!
WestLosAngelesGal
(268 posts)Yes!
jmowreader
(50,562 posts)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
(5,952 posts)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
(268 posts)p.s. I do not see that the U.S. has even joined the Solidarity trial.
GumboYaYa
(5,952 posts)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
(68,667 posts)GumboYaYa
(5,952 posts)the issue here is that the FDA is moving too slowly to approve it in the US.
MineralMan
(146,329 posts)is not an accurate source of news of any kind. Normally, it is not used as a source on DU.
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
(68,667 posts)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
(146,329 posts)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
(5,952 posts)MineralMan
(146,329 posts)In the British Colonial days, more was in the typical tonic water, to be sure.
WestLosAngelesGal
(268 posts)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
(146,329 posts)that has ever been developed.
jayfish
(10,039 posts)GumboYaYa
(5,952 posts)Politcal bias can't drive opinions now, science matters.
scrabblequeen40
(334 posts)Citing it makes you less credible... but more suspicious
GumboYaYa
(5,952 posts)GumboYaYa
(5,952 posts)jayfish
(10,039 posts)I don't want to be Debbie Downer but come on man.
GumboYaYa
(5,952 posts)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
(68,667 posts)help? This is the synthetic version.
jayfish
(10,039 posts)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
(5,952 posts)CountAllVotes
(20,878 posts)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
(10,039 posts)CountAllVotes
(20,878 posts)I hope this is not the case.
jayfish
(10,039 posts)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
(20,878 posts)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
(20,018 posts)(we don't have a cure for the cold)
jayfish
(10,039 posts)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
(5,952 posts)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
(68,667 posts)Botany
(70,581 posts)... microscopic parasite can no be used for viral infection according to Donald Trump PhD & M.D..
PaulRevere08
(449 posts)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
(54,770 posts)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., theyll open up the spigots. Assuming it pans out, of course.
GumboYaYa
(5,952 posts)I just wish they would speed up the process.
hardluck
(640 posts)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
(54,770 posts)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
(5,952 posts)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
(224 posts)His videos are well done.
Javaman
(62,534 posts)he's a fucking moron.
standingtall
(2,787 posts)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
(12,634 posts)Plaqunil- can always be used for off label treatment.
GumboYaYa
(5,952 posts)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
(13,551 posts)for many years
marybourg
(12,634 posts)Tommy_Carcetti
(43,198 posts)"I mean, she speaks 20 languages. I'm sure Chinese is one of them."
Midnightwalk
(3,131 posts)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 thats pence at least on days that jared is tied up doing other crap.
Putting out disinformation like trump did making it sound like theres 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
(26,319 posts)standingtall
(2,787 posts)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
(5,952 posts)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
(429 posts)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
(15,290 posts)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
(5,952 posts)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
(15,290 posts)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.