fda approves cholorquine as covid19 treatment, sandoz makes 30mil doses for national stockpile

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The Food and Drug Administration on Sunday issued an emergency authorization for experimental coronavirus treatments using chloroquine and hydroxychloroquine, anti-malaria drugs touted by President Donald Trump despite inconclusive clinical proof of their effectiveness.

...

HHS said Germany’s Sandoz has already given 30 million doses of hydroxychloroquine to the Strategic National Stockpile, the federal government’s supply of medical supplies for public health emergencies, while Bayer has donated 1 million doses of chloroquine.

The agency is fast-tracking a process that usually takes years while the FDA conducts clinical trials in New York, a hotspot for the virus. 

HHS said the emergency authorization was issued because the potential benefits of the product outweigh the risks and acknowledged that “anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients, but “clinical trials are needed to provide scientific evidence that these treatments are effective.”

 

 https://www.forbes.com/sites/rachelsandler/2020/03/30/fda-approves-anti-...

sandoz to the rescue...again

Sounds like good news to me (as long as it's administered responsibly).

>>>     "despite inconclusive clinical proof of their effectiveness"

>>>     "clinical trials are needed to provide scientific evidence that these treatments are effective.”

 

 

 

And just to be clear, "experimental" treatment.   The thread title is somewhat misleading.

https://www.nejm.org/doi/full/10.1056/NEJMe2002387

Covid-19 — Navigating the Uncharted

Anthony S. Fauci, M.D., H. Clifford Lane, M.D., and Robert R. Redfield, M.D.

March 26, 2020

 

This is the only mention of chloroquine:

 "...robust research effort is currently under way to develop a vaccine against Covid-19.10 We anticipate that the first candidates will enter phase 1 trials by early spring. Therapy currently consists of supportive care while a variety of investigational approaches are being explored.11 Among these are the antiviral medication lopinavir–ritonavir, interferon-1β, the RNA polymerase inhibitor remdesivir, chloroquine, and a variety of traditional Chinese medicine products.11 Once available, intravenous hyperimmune globulin from recovered persons and monoclonal antibodies may be attractive candidates to study in early intervention. Critical to moving the field forward, even in the context of an outbreak, is ensuring that investigational products are evaluated in scientifically and ethically sound studies.12

liddle - clinical trials take years. if we follow the standard procedures for phase 3 clinical trials and fda approval, we wouldnt have any sort of treatment or vaccine for this for many, many years.

think about how long MAPS has been trying to get fda approval to treat ptsd with mdma.

there are only 2 options - do not treat coronavirus with drugs at all, or treat coronavirus with drugs that have not undergone clinical trials.

you spent the last thread ignoring medical literature by defaulting to the fact that its not fda approved - now its fda approved.

this is a question and issue that goes beyond coronavirus - should critically ill patients have access to potentially life saving treatments that have not undergone proper clinical trials and fda approval? if they will likely die anyway, why not try? this could apply to surgical procedures, physical treatments and medical devices as well as drugs.

First:  I'm OK with experimenting on willing guinea pigs.

Second, your threat title is misleading, the FDA approved experimenting with chloroquine, but there is no evidence chloroquine works.

Third, I did not "ignore the medical literature".  I pointed out that your claim that the literature supported chloroquine as a cure was incorrect, as that literature does not exist.  The article you just posted says the same thing, thus the quotes I selected:

>>>     "despite inconclusive clinical proof of their effectiveness"

>>>     "clinical trials are needed to provide scientific evidence that these treatments are effective.”

Finally, here's Fauci today saying the same damn thing I've been saying all along, which is that there is no scientific (as opposed to anecdotal) evidence that this is a useful treatment":

 

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https://twitter.com/ryanstruyk/status/1244991411512057858   (CNN)

https://omny.fm/shows/philadelphia-s-morning-answer-with-chris-stigall/p...

CHRIS STIGALL:If you’re a doctor listening to me right now and a patient with coronavirus feels like they want to try [Chloroquine] and you’re their doctor, you’re not Anthony Fauci the guy running the coronavirus task force, would you say ‘alright, we’ll give it a whirl’?

 

DR. ANTHONY FAUCI: Yeah, of course, particularly if people have no other option. You want to give them hope. In fact, for physicians in this country, these drugs are approved drugs for other reasons. They’re anti-malaria drugs and they’re drugs against certain autoimmune diseases, like lupus. Physicians throughout the country can prescribe that in an off-label way. Which means they can write it for something it was not originally approved for. People do that all the time, and it really is an individual choice between the physician and his or her patient as to whether or not they want to do that.

Second, your threat title is misleading, there is no evidence chloroquine works.

the thread is not claiming there is clinical evidence it works - the title just says the fda approved it for use, which is an objective fact. here is the EUA issued by the FDA - 

https://www.fda.gov/media/136534/download

Chloroquine phosphate and hydroxychloroquine sulfate are not FDA-approved for treatment of COVID-19. Some versions of chloroquine phosphate are approved by FDA for other indications—for prophylaxis and acute attacks of certain strains of malaria and for the treatment of extraintestinal amebiasis, but the chloroquine phosphate drug product covered by this letter has not been approved. Several versions of hydroxychloroquine sulfate are approved by FDA for prophylaxis of and treatment of malaria, treatment of lupus erythematosus, and treatment of rheumatoid arthritis. The safety profile of these drugs has only been studied for FDA approved indications, not COVID-19.

 

Based upon limited in-vitro and anecdotal clinical data in case series, chloroquine phosphate and hydroxychloroquine sulfate are currently recommended for treatment of hospitalized COVID-19 patients in several countries, and a number of national guidelines report incorporating recommendations regarding use of chloroquine phosphate or hydroxychloroquine sulfate in the setting of COVID-19. FDA encourages the conduct and participation in randomized controlled clinical trials that may produce evidence concerning the effectiveness of these products in treating COVID-19. FDA is issuing this EUA to facilitate the availability of chloroquine phosphate and hydroxychloroquine sulfate during the COVID-19 pandemic to treat patients for whom a clinical trial is not available, or participation is not feasible.

 

Having concluded that the criteria for issuance of this authorization under 564(c) of the Act are met, I am authorizing the emergency use of chloroquine phosphate and hydroxychloroquine sulfate, as described in the Scope of Authorization section of this letter (Section II) for treatment of COVID-19 when clinical trials are not available, or participation is not feasible, subject to theterms of this authorization.

since there is not fda approval or clinical trials, i can assume you also do not believe cannabis has any kind of medical benefits and should not be recommended or prescribed to anyone for any kind of medical condition?

sorry - "approved" is not the right term, use for covid19 treatment has been "authorized"

This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of 2019 coronavirus disease (COVID-19) when administered by a healthcare provider (HCP)1 pursuant to a valid prescription of a licensed practitioner as described in the Scope of Authorization (section II) of this letter.

...

Having concluded that the criteria for issuance of this authorization under 564(c) of the Act are met, I am authorizing the emergency use of chloroquine phosphate and hydroxychloroquine sulfate, as described in the Scope of Authorization section of this letter (Section II) for treatment of COVID-19 when clinical trials are not available, or participation is not feasible, subject to theterms of this authorization.

https://www.fda.gov/media/136534/download

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Summing up:

1)  We agree your thread title was inaccurate.

2)  I think we agree that the "medical literature" provides no scientific evidence that chloroquine works on COVID-19, so I think we agree that I did not ignore the medical literature. 

3)   We agree that allowing chloroqine's experimental use is fine.

4)   I think we would agree that the Government should experiment with a massive intakes of cannabis on a regular basis as a preventive measure for those who would be willing to be cannabis guinea pigs.  I have been running some experiments myself.

Heard this circulating in the Rose Garden lot:

Ger yer Kind Quine ('bunk' ) hits $3

2 For $5

per Woodstock...

Of course it's your own trip. So be my guest, but please be advised that there is a warning on that one, ok?

 

>>>>>the Government should experiment with a massive intakes of cannabis on a regular basis 

 

As should we all.

 

 

J/k - nothing optional is for everyone.

So we know one of the head people at the CDC indirectly....ie my wife knows his wife well.   As of this weekend he said he was convinced we'd have a vaccine but less convinced we'd have any treatment for symptoms - ie like a tamiflu type therapy. 

As a side note, he's worked with both Bush's and Obama's office and said they were supportive and easy to work with.   The direction from Pence's office has been avoid publishing facts at all cost and that it's sheer ineptitude.     

Take it with a grain of salt....but seems like a reasonable grain of salt.   Maybe like Himalayan Salt.

 

I already got my prescription last week.

 

Inconclusive.  I'd better keep administering.

My coworker knows a person well that is in the hospital with Covid. Things were not looking good at all last Friday the family was told to prepare for the worst. Apparently he got an experimental dose of lopinavir an AIDS drug, and today they are talking about releasing him this week. Who knows. If Covid doesn't mutate much more I think antivirals could bring down the mortality rate. Thanks to HIV research we are way better at today than we were 30 years ago. 

MarkD try a larger font...

 

j/k hope yer doing well 

ANYBODY can use a normal size font.....

 

 

but only an antivaxxer is dumb enough to use BIG  font

Summing up:

1 - insofar as words like "approved" has a very specific meaning when applied to medicine, yes

2 - id say no evidence it works in clinical trials - there is scientific evidence that it works on covid, it is just not enough evidence and not strong enough evidence for the fda to approve it yet, if it does at all

3+4 - yes

Poor folks with Lupus will face shortages of a medicine they need when as for as COVFEFE-19 goes you might as well be taking a sugar pill........

as for as COVFEFE-19 goes you might as well be taking a sugar pill........

woz...liddle and i just debated this for like two whole threads, and in a rare moment of internet glory, actually managed to have a productive and enjoyable debate and come to some kind of relative consensus - in both this thread and the older chloroquine thread i posted quite a bit of reputable studies and sources speaking positively about the potential of this drug, including from dr faucci. the issue, as liddle was pointing out, is that there have not been clinical trials to conclusively prove it will be effective or not - we are treading on unknown ground and hoping for the best. the idea that it might as well be a sugar pill is not the current medical consensus. 

yes

.

 

 

     This is a highly informative video, well worth your time if you're interested in the ongoing discussion of hydroxychloroquine and chloroquine in the treatment of COVID-19

     https://youtu.be/m3J_1B7kJbk

Maybe Quaaludes have a shot 

They should see if cannabis will work. 

https://apnews.com/a5077c7227b8eb8b0dc23423c0bbe2b2

 

A malaria drug widely touted by President Donald Trump for treating the new coronavirus showed no benefit in a large analysis of its use in U.S. veterans hospitals. There were more deaths among those given hydroxychloroquine versus standard care, researchers reported.

"I'm just saying... What have they got to lose?"

Is Chloriquine the same thing that hillary and bill patented and now have sex slaves making in the basement of a pizza restaurant? 

Coronavirus patients treated with malaria drug hydroxychloroquine

touted by Trump are MORE likely to die, new trial finds -- 

president says he is unaware of the new study

 

It's the largest study of the drug to-date in the US, where more than 45,000  people have died in the pandemic 

President Trump has hailed the drug a 'game-changer,' despite doctors' warnings that evidence it could treat coronavirus is anecdotal and thin 

On Tuesday, the NIH also warned against using the drug, citing concerns that in combination with azithromycin it may be toxic to COVID-19 patients 

 

 

https://www.dailymail.co.uk/health/article-8241855/More-deaths-no-benefi...

>>>> the idea that it might as well be a sugar pill is not the current medical consensus. 
 

>>>>On Tuesday, the NIH also warned against using the drug, citing concerns that in combination with azithromycin it may be toxic to COVID-19 patients 


Sounds more like a cyanide pill.