FDA SAYS HYDROXYCHLOROQUINE AND CHLOROQUINE CAN BE USED TO TREAT CORONAVIRUS

Newsweek ^ | 3/30/20 AT 4:12 AM EDT | KASHMIRA GANDER

[nickcarraway]

The U.S. Food and Drug Administration (FDA) has approved the use of two anti-malaria drugs to treat patients infected by the new coronavirus.

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.

Currently, there are no specific drugs for COVID-19 which, as shown in the Statista graph below (accurate as of March 26), has sickened over half a million people. According to Johns Hopkins University, over 720,000 cases have been confirmed, more than 34,000 people have died, and over 152,000 have recovered since the pandemic started in China late last year.

[SteveH]

> I think he was referring to the fact it had been approved in general, but not specifically for use against this virus.

If one goes to the msn video link, trump refers to the fda approval as being “immediate” and comments that “it normally takes months” to approve. So in context, it would seem (at least to me in this case) that trump was referring to a *new* (and discrete from the old) fda approval for use with covid-19 patients in the context of current events. I suppose potential caveats could be that trump could have been talking about the start of a process which nevertheless could be expected to take a few days to complete all the paperwork, and/or that this particular fda approval did not necessarily imply that doctors could actually prescribe it yet since it might require additional approvals before that could (imaginably) happen (yikes).

[SteveH]

> Dunno about that. Their drug won’t be approved for months and they donated it to the US DoD.

Aha. OK, thanks for the corrections!

[SteveH]

> On March 28, 2020, FDA issued an EUA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19.

Aha, so on March 19 trump stated “immediately” by which he may actually have intended to convey (but did not explicitly state) a somewhat later date, which turned out to be March 28.

First, I note in passing that this time delay may have had ramifications for some patients in the time period between March 19 and March 28.

Second, I think Trump has a habit of announcing the completion of some tasks slightly before their actual completion. (Personally, I am not an advocate of this habit.)

Thirdly, this may still render medically “inoperative” the Nevada and Michigan Governors’ orders concerning HCQ...

...Anyway, thanks for the info, correction and link!

[shalom aleichem]

President “was trying to say” that the FDA had approved the drug a long time ago as safe and effective for malaria, but in this world of Tweets and sound bites (and our boy not always being careful in his language, assuming that people will “get it”) left it go at FDA approved. FDA must approve for a given disease treatment and first find the drug (a) safe and (b) effective in treating that disease.
As weasel Fauci was quick to point out, the FDA had yet to find it “effective” for CORVID-10. Why? Because no trials yet. This Newsweak article points out that FDA is allowing doctors and hospitals to use it for CORVID-19, but still needs the trials to show it is effective. Trials take time, and they are on-going.

If doctors prescribe off-label drugs they are often questioned for payment by insurance companies, but that is another issue. If Biden is elected, it will all be “free” anyway. JK

[ETCM]

Aha, so on March 19 trump stated “immediately” by which he may actually have intended to convey (but did not explicitly state) a somewhat later date, which turned out to be March 28.

Following Trump's direction, the FDA approved a "Compassionate Use" exemption for hydroxychloroquine to be used to treat COVID-19 patients on March 19. 10 days later, that was expanded to "emergency use authorization", effectively allowing doctors to prescribe the drug to COVID-19 patients as they see fit.

[SteveH]

> Hard to say. Who do you treat? Even if the drugs “work” the people who arrive “turning blue” are decompensating quickly.

Short answer- according to Dr. Zelenko’s regimen. Or according to any number of foreign countries already using a similar regimen. Are you referring to eye side effect problems, plus some kind of temporary dementia? Or something else? (Sorry, I do not have a background in medicine.)

> There won’t be time to do a G6PD Def. Test

OK but is one really needed? In an emergency situation? Is a potentially fatal pandemic enough of an emergency situation to justify prophylactic regimen? Is G6PD condition very selective and/or related to rare genetics? I have been prescribed this in the past on a prophylactic basis for travel to a malaria infested area (Ecuador), and never heard of that test... and I am still alive... so, can you please explain why I am still alive?

> so you risk killing a dying patient with the treatment.

What is the risk of that, specifically, given that death is inevitable?

> So “Urgent” patients are logistically never going to be realistically treated.

Dr. Zelenko IIRC mentions that it probably won’t work with advanced cases... if so, then so what? Personally were I an MD I might consider another experimental alternative such as Remdesivir if experimental evidence supports such treatment, or else nothing.

> Sure, you draw the blood and send it but by the time you get an answer many of them will be beyond help.

OK. However, isn’t there the AVID 15 minute test coming online shortly that the President mentioned in yesterday’s COVID-19 briefing? And there are IIRC other relatively quick turnaround tests available now? So, now (or very shortly) won’t this be just some kind of a red herring argument?

> If you’ve never seen it you perhaps can’t understand it but patients like that are “crashing”. Even if you could just blindly give it to them all it may not do much good at that point, which has been my objection all along.

Please see my earlier remarks on Dr. Zelenko’s experimental treatment above. IIRC he states that his recommended regimen has no effect for patients beyond a certain point, where lung damage has considerably progressed.

Thanks for your questions.

[FreedomPoster]

The drugs were already FDA approved and therefore available for off-label use. This approval appears to be more of an emergency on-label approval. I would welcome more informed commentary on that.

[SteveH]

HCL -> HCQ

(no one should ever take HCl. LOL)

[wastoute]

The announcement is more political than medical, seems to me. As you say, anyone could get the Rx. After reading Dr Raoult’s paper (which I am still digesting) it occurs to me the real role of the drugs may be reducing the burden on the healthcare system by reducing length of stay. Which is a worthwhile goal, but as I said in the beginning “the drugs could well have an effect and still not decrease mortality”.

This disease is just turning everything upside down. If you read the Flexner Report carefully one goal was to restrict the practice of Medicine to “The Patient”, not “The Community”. Ethical considerations absolutely flow from the difference.

[wastoute]

there are absolute contraindications to using quinines. Ones you can’t know by “looking at the patient”.

[upchuck]

... the National Institutes of Health and ASPR's Biomedical Advanced Research and Development Authority (BARDA), are working together to plan clinical trials.

Gee, where were you guys last month? Or the month before that? HCL has been used, off label, for months.

I bet Dr. Fauchi and friends are beside themselves. We've got something that works and it doesn't cost $1000/pill to use. Big Pharma must be going nuts.

Where is the zinc? I've read several places that zinc should be mixed with HCL to be really effective.

[Chickensoup]

why am I not finding this headline anywhere else??

Is it real?

[SteveH]

> The drugs were already FDA approved and therefore available for off-label use. This approval appears to be more of an emergency on-label approval. I would welcome more informed commentary on that.

This was IIRC at least somewhat covered in discussions on FR several days ago.

In short, chloroquine has been used against malaria since at least 1945. Hydrochloroquine has been used against malaria since 1955.

HCQ is approved for prophylactic use against malaria, again since about 1955. Someone alleged that it was given out by the U.S. military to all troups going to the jungle country during the Vietnam War.

So, one surreptitous way to get HCQ in theory might be to claim something such as an upcoming trip to a malaria infested region to a doctor and then ask for a prophylactic HCQ treatment. The doctor would allegedly then prescribe HCQ to the patient, even though he or she does not actually have any disease at the moment that the drug is prescribed. If one is desperate and prepared to fib to one’s doctor, then one can in theory obtain HCQ in this manner, if the doctor agrees and if there is an adequate supply at the pharmacy. (Note: I am not recommending that anyone do this. I am just paraphrasing the prior discussions.) Anyway, this would then constitute one form of off-label use. Another variant of off-label use might be if the doctor is a personal friend/relative of the patient and/or agrees with the Zelenko style experimental regimen on a prophylactic basis. Off label use is nominally OK so long as it is prescribed and ideally monitored in some way by the prescribing doctor, unless prohibited by local law, such as allegedly is the currently case in Nevada or Michigan. The motivation of the Nevada Governor’s order is nominally to prevent hoarding (which according to Scott Adams and others is a very real concern). So the emergency approval makes the off-label prescription more legitimate, with the possible exception of local laws such as the above examples. I would imagine that those local laws now are either rendered inoperative or fall into a legal limbo. However, explicit FDA/HHS approval would imaginably imho mean just that— it’s now approved, and so does not come under the category of a (disapprovable) off-label use. Formally that is a legal question and I am not a lawyer (nor any kind of other specialist such as doctor or pharmacist for that matter.)

[a little elbow grease]

Paging Half Witt Governor of Michigan!!

_________________

Half "wit' .......... yes. Bufffooon for sure.

Gretchen could be sued sometime in the future.

[null and void]

Good. Fast. Cheap.
Pick any two...

Bring Out Your Dead

Post to me or FReep mail to be on/off the Bring Out Your Dead ping list.

The purpose of the “Bring Out Your Dead” ping list (formerly the “Ebola” ping list) is very early warning of emerging pandemics, as such it has a high false positive rate.

The false positive rate was 100%.

At some point we may well have a high mortality pandemic, and likely as not the “Bring Out Your Dead” threads will miss the beginning entirely.

*sigh* Such is life, and death...

If a quarantine saves just one child's or one old fart’s life, it's worth it.

[upchuck]

Re: post #31 I wrote HCL when I meant HCQ. Sorry.

[SteveH]

> Where is the zinc?

Zinc supplements are available at local health supplement stores or online. Prescriptions are not needed.

> I’ve read several places that zinc should be mixed with HCL to be really effective.

I believe that zinc sulphate may be part of Dr. Zelenko’s experimental regimen.

[CommieCutter]

We’re told to drink water too. That doesn’t mean I go take a glassful from a swamp.

[mad_as_he$$]

Around here there has already been a run on zinc of/in all forms in the stores.

[Sirius Lee]

Trumpiclllin! MAWA