FDA Issues Emergency Use Order for Malaria Drug Hydroxychloroquine to Treat Coronavirus

Yay! Give it to every American, especially in the states that haven't been hit hard yet. I bet it's the perfect prophylactic!

I thought there was just a study on this and the results were not encouraging. Seems they were incorrect and it only worked on a small number of patients?

Big pharma looking for free guinea pigs for clinical trials.

A report published by the Journal of Zhejiang University in China showed that patients who got the medicine didn’t fight off the new coronavirus more often than those who did not get the medicine.

The study involved just 30 patients. Of the 15 patients given the malaria drug, 13 tested negative for the coronavirus after a week of treatment. Of the 15 patients who didn’t get hydroxychloroquine, 14 tested negative for the virus.

Hydroxychloroquine, particularly when given with the antibiotic azithromycin, has received widespread attention following a controversial, small study of about 40 patients hospitalized with Covid-19 in France. In that study, the drug appeared to help clear the virus from the bodies of 26 patients who were given the medication, based on samples taken from nasal swabs. Experts have criticized the design of the study, calling it interesting but far from definitive.

In the Chinese study, which was conducted by researchers from the department of infection and immunity at the Shanghai Public Health Clinical Center, the 15 patients who didn’t get hydroxychloroquine were treated with conventional care.

This includes bed rest, oxgen inhalation, and the use of anti-viral drugs recommended in China’s treatment guidelines like lopinavir and ritonavir, and antibiotics when necessary.

One patient treated with hydroxychloroquine progressed to severe disease during the study. Four patients given the medicine developed diarrhea and signs of potential liver damage, compared with three getting conventional treatment.

[bold]The researchers concluded that additional studies using larger numbers of patients are needed to fully investigate the drug’s risks and benefits.[/bold]

Enter Novartis AG and their offer to provide 30 million doses of hydroxychloroquine.

Guess who can order the FDA to start making a drug?

Hydroxychloroquine is actually a well studied and fairly old compound with a good antiviral history.

"Anti-viral" is overgeneralization, especially for an unknown virus. It may or may not be effective. That's what Novartis wants to find out. Using the American public as guinea pigs.

Chloroquine is derived from Methylene Blue which is one of the earliest synthetic drugs, it has an excellent safety record since it was discovered in 1891.

A little about Methylene Blue (for those who are into chemistry).

[quote] Methylene Blue

That was my stage name back when I used to strip.

Hydroxychloroquine contraindications:

low blood sugar

glucose-6-phosphate dehydrogenase (G6PD) deficiency

porphyria

anemia

low levels of a type of white blood cell called neutrophils

alcoholism

myasthenia gravis

a skeletal muscle disorder

maculopathy

changes in the visual field

liver problems

psoriasis

anemia from pyruvate kinase and G6PD deficiencies

Common hydroxychloroquine side effects may include:

headache, dizziness, ringing in your ears;

nausea, vomiting, stomach pain;

loss of appetite, weight loss;

mood changes, feeling nervous or irritable;

skin rash or itching; or. hair loss.

[quote]"Anti-viral" is overgeneralization, especially for an unknown virus. It may or may not be effective. That's what Novartis wants to find out. Using the American public as guinea pigs.

The drug is also being prescribed in France, Italy and Korea.

This is the drug study the results of which Dr. Oz said "blew his mind".

R8, when you say it has an excellent safety record, presumably you’re ignorant of the fact that the therapeutic, toxic and fatal doses are considered to be very close. See point 7.2.1.1 in the link below. And if people start self-medicating, that’s a significant risk.

[quote]The drug is also being prescribed in France, Italy and Korea.

And the trial results are? Successful? Not so much? Inconclusive? Data as yet unavailable?

The US, with a far more culturally diverse population, is the big market. Success in the US will mean billions to Novartis. That's why they're hot to test the effectiveness of hydroxychloroquine there. On millions of American guinea pigs.

[quote]And the trial results are? Successful? Not so much? Inconclusive? Data as yet unavailable?

Korea, France and Italy are prescribing it obviously because they have faith in it.

[quote]the therapeutic, toxic and fatal doses are considered to be very close

The study you posted mentioned the drug has a lethal dosage of 4g, they are looking at a therapeutic maintenance dose of only 200mg in the study.

[quote]Korea, France and Italy are prescribing it obviously because they have faith in it.

"Faith" is not medical science. It's desperation, especially in Italy.

And Germany has been using it since the French results. Very low dose but there is hope.

Still desperation. Without trial information, EVERYONE taking the drug is a guinea pig. And worse, an even more desperate guinea pig, if the drug turns out to be largely ineffective.

R18 You're tiring.

It's being prescribed throughout Europe because researches believe it can be effective.

Experts should be consulting R20.

"Belief" is not medical science. All it is is a boon for pharmaceutical companies like Novartis having a wealth of guinea pigs in a desperate public. If it works, great! If not, back to the drawing board and an even more desperate populace.

Hon, it's an emergency situation. Are you aware of that?

R24 So was thalidomide. Remember that? So was Salvarsan. Remember that?

Novartis is taking advantage of a desperate populace to increase its profits. No one knows how effective Hydroxychloroquine is or how people will react. It's the worst type of exploitation for profit.

"Clinical trials for experimental treatments against the new coronavirus (Covid-19) have begun in four European countries, including Belgium."

"The trials will use four antiviral drugs on 3,200 hospitalised coronavirus patients in Belgium, the Netherlands, Luxembourg, the United Kingdom, Germany, Spain and France."

Hydroxychloroquine is the AZT of this pandemic. A money making scam for big pharma. Pass.

Trump sure doesn't talk about it as much as he used to.

R26 Yep. That's the way to do it. Run clinical trials on people who know they are being used as guinea pigs, gather clinical evidence and findings based on medical science, not desperation.

Dr. Oz is a moronic quack so that does not inspire confidence r13.

I do really hope this works for people and maybe they should also use that other drug from the French study?

Oh please. The French can’t even finish constructing a tower.

Whether it works or not, at least a few countries are not pandering to pharma exploitation. Though a multicenter clinical trial with only 3,200 participants may not be definitive or conclusive.

[quote]Korea, France and Italy are prescribing it obviously because they have faith in it.

It is being presribed because this is an emergency situation so experimental treatments are allowed. It hasn't been studied as a treatment for coronavirus virus in any significant academic way. That's what has to happen, science doesn't work off "maybe this seems to work", real studies are required.

There are people hoping it doesn’t work. They are sick in the head.

[quote]I thought there was just a study on this and the results were not encouraging. Seems they were incorrect and it only worked on a small number of patients?

The limited research that has been does not support the idea that it does anything meaningful.

Human experiments and trials without adequate research methodologies and controls will not end well.

I hope that, if they're going to do it, they are pooling the data and a group of medical or pharma researchers are evaluating the results to determine its effectivenes.

[quote] There are people hoping it doesn’t work. They are sick in the head.

The groups desperately trying to scare people away from the drug have ulterior motives.

Belgium.

"The FAMHP has asked distributors of the product to reserve it for hospitals treating patients with the coronavirus, as well as pharmacies, where people with a medical prescription can obtain it."

Anyone in the Trump family is advising for or against any medicine, or any product of any kind, you can presume that they will be making money off of it. They are that corrupt and that evil. Which is not to say that the drug does or doesn't work just that he's Satan.

[quote] Anyone in the Trump family is advising for or against any medicine, or any product of any kind, you can presume that they will be making money off of it. They are that corrupt and that evil.

You must be one of the shills. There is NO active patent on the drug, which is why it is so cheap.

I’d be very interested to know if any Trump family members recently bought stock in certain pharmaceutical companies.

R36 Reminds me of Jude Law's character in contagion.

Mary R5, the FDA does not manufacture any drugs.

[quote] The US, with a far more culturally diverse population, is the big market. Success in the US will mean billions to Novartis. That's why they're hot to test the effectiveness of hydroxychloroquine there. On millions of American guinea pigs.

No, dear. Did you miss the part where NO PATENT exists on this drug?

Care to explain why you are trying to keep people from being cured?

[quote]Care to explain why you are trying to keep people from being cured?

Care to explain how YOU or anyone else knows it's a "CURE"? At least the Belgians are taking a step in the right direction and have begun multicenter clinical trials on a variety of anti-viral drugs. More medical science, less exploitation.

R44, care to explain where it states that this drug is a proven cure?

Are you selling that stuff out of your trunk? You apparently don’t need any studies or testing which show that chloroquinr is effective.

And what is it with people touting any medication as a cure for anything before we obtain enough clinical trial data to make that determination?

What’s the difference between chloroquine and hydrochloroquine?

> And what is it with people touting any medication as a cure for anything before we obtain enough clinical trial data to make that determination?

It's an old drug, and thus has the potential to be cheap & abundantly available within a few weeks.

Its safety profile is well known, as are its risks & how to identify people who'd BE at risk if they took it. So for this, there are literally DECADES worth of clinical data.

Frankly, at this point, that's good enough to use it when nothing likely to be better is available... especially for prophylaxis, which almost by definition requires cheap abundance & settles for "better than nothing" when the immediate alternative is LITERALLY "nothing".

Some people act like mass use of HCQ will somehow abolish research into better drugs. That's simply insane... their studies are going on anyway. As their superior safety & efficacy is established, they'll UNQUESTIONABLY become the standard of care. In the meantime (several months, at least), HCQ might save some lives anyway. Or at least, give people hope that they aren't automatically & hopelessly fucked.

Drug approval is a continuum. Dangerous drugs don't get approved unless the alternative is worse (ie, certain death). Drugs generally regarded as safe get a lot more leeway, even if they don't work well, until something significantly better comes along.

It's not either/or and black/white. We can take HCQ *now* and continue relentlessly searching for better drugs to take later.

And I can *guarantee* that the general public will never be taking a new drug that costs $2,000/month for prophylaxis on large scale. Back when Tamiflu was expensive, almost NOBODY took it for prophylaxis unless they were rich or facing certain death (and non-poor). Ditto, when Truvada *genuinely* cost $1,800+/month (vs its "real" post-rebate cost of ~$250 or less, and $30-50/month cost in countries where it was available as generic).

As for being a "guinea pig", I'd personally rather take a cheap drug known to be generally safe, even if its actual efficacy is unknown, but with a reasonable possibility of being beneficial, for prevention (or treatment, if nothing better is immediately available), than simply languish unmedicated because nothing has yet been *proven* to work with ironclad certainty.

And the hard fact is, most OTC "cold/flu" sold in the US have LITERALLY no evidence establishing anything beyond general safety. Go ahead, I dare you... cite ONE published journal article claiming that phenelyprine is an effective decongestant. Or that antihistamines aren't more likely to make someone with a cold/flu feel WORSE overall. Yet, nobody bitches about them, because they're cheap, generally safe, and give at least psychological comfort to people who take them. HCQ is no different.

Incidentally, US doctors were ALWAYS "allowed" to prescribe HCQ (with or without azithromycin) "off label" for C19... what the FDA ruling REALLY means is, if your doctor prescribes it for you NOW, your health insurance can't refuse to cover it.

I doubt whether any insurer would have risked backlash by openly refusing to cover prescriptions for two drugs that are cheap generics to begin with (and truthfully, have retail costs lower than some shitty insurance plans' copayments), but it still draws a bright line in the sand.

Likewise, if HCQ (+Az) ends up preventing even a small number of serious cases, I'd expect health insurers to broadly ENCOURAGE its use... its cost is a drop in the bucket compared to the cost of hospitalizing someone on a ventilator for a month in an ICU (literally, a quarter of a million dollars or more... at least, officially on the bill).

While I agree with the majority of what r47 is saying, none of it takes the place of actual research and testing to determine whether the drug(s) are effective or whether they might confer a false sense of security and/or hope to people.

It would be much more dangerous to operate believing that they are somehow protected or that there is now a "cure" so are not as concerned about getting sick in the first place.

[quote]It's an old drug, and thus has the potential to be cheap & abundantly available within a few weeks.

Which has nothing to do with the REALITY that NO ONE has a clue in hell if the drug is at all effective for Wuflu or its side effects for the infected. That's what clinical trials are for.

[quote]a cheap drug known to be generally safe, even if its actual efficacy is unknown,

R47 has no problem putting other's lives at risk and exploiting them to satisfy their desperation.

Look, r50, nobody is getting hydroxychloroquine, chloroquine, or azithromycin unwillingly shoved down their throats. Frankly, just *getting* it at this moment requires a fair degree of determination and good luck.

If you don't want to take it, that's fantastic, because someone ELSE can happily take it instead.

Some people firmly believe in "better living through chemistry". Some people would rather spend hours with a splitting headache than take ibuprofen. It's a free country. Either way, we'll have abundant data to analyze in the very near future, and 6 months from now the argument will be largely settled.

r50 - the fact that it is an older drug whose side effects are fairly well established makes it extremely unlikely that it's going to have specific and dangerous side effects when used to treat this illness.

As I noted in r49, the danger wouldn't be in side effects but in people operating as if there were a cure or were somehow protected. The actual drug is unlikely to be particularly dangerous.

If they decide to use it, data needs to be captured and analyzed to determine whether it has any palliative value.

I'm simply not seeing what excessive danger it poses. Now, if you want to argue that it sets an extremely dubious precedent with regard to using unproven drugs, that's a whole separate debate.

R51 Now I know you're a pharma troll. The relentless need to exploit the desperate. And no, no one is shoving anything down anyone's throat. . .yet. But wait until the PR commences, touting hydroxychloroquine, chloroquine, and azithromycin as potential "cures". The desperate of course overlook the word "potential", so yes, you are in essence shoving a possibly useless, dangerous remedy down someone's throat. Far better to wait for the clinical trials. But somehow, safety is far less important than exploitation in your peculiar worldview.

R53, I think you need meds for paranoia more than C19. For at least the immediate future, hydroxychloroquine is likely to be about as profitable to manufacturers as generic ibuprofen, or vitamin C.

There's no exclusivity, it's cheap & easy to manufacture, and aside from MAYBE a brief goldmine period when companies able to ramp up quickly & get it out the door can sell as much as they can make for any remotely sane price (keeping in mind the political & public relations consequences if they appear to be "profiteering"), it's unlikely to be more than a normally-profitable product beyond even the next few months.

EVEN IF it becomes a drug taken widely for prevention, which isn't guaranteed to happen if, in fact, the data shows it IS useless & market demand collapses.

How profitable do you think a 99c bottle of ibuprofen is at Walmart or Dollar Tree? That's the long-term BEST case for HCQ manufacturers. Pennies per tablet... or less.

So, it's AZT for straight people?

I'd roll the dice and take it if I had corona. It's a short term thing. Corona can kill you. Taking a drug for a few days, which has been in use for decades is worth whatever risk. And by the way I have taken this in the past, it didn't kill me, although it did give me the feeling of pressure in my eyes. But that's better than death from corona.

Good news for Michigan residents. Gov. Whitner is now ASKING for the dug, four days after threatening doctors.

It sucks that this drug has become yet another left and right issue.

[quote] Good news for Michigan residents. Gov. Whitner is now ASKING for the dug, four days after threatening doctors.

I feel bad for the people of Michigan with Half Whitmer in charge. She has no clue how to be a governor and is in way over her head.

R59= Donald J Trump

She was right to threaten the doctors. They were cleaning out the pharmacies, prescribing for themselves and their families.

Literally anyone could have seen this coming, what were journalists and Democrats thinking publicly opposing using an anti-viral medication to combat a virus?

Yet again cutting off their noses to spite their faces.

Trump promoted hydrchloroquine so now we're supposed to be praying it fails. The sweet kiss of mass death is preferable to Trump having done the bare minimum required of him by his office decently.

[quote] Literally anyone could have seen this coming, what were journalists and Democrats thinking publicly opposing using an anti-viral medication to combat a virus?

Huh??! WTF are you talking about?

[quote] Trump promoted hydrchloroquine so now we're supposed to be praying it fails. The sweet kiss of mass death is preferable to Trump having done the bare minimum required of him by his office decently.

Nevada has also reversed its decision to hide the cure from COVID-19 victims. Now everyone can get the drug!

The Democratic governors who blocked the drug for political reasons will have that come back to haunt them.

Looks like the group from R36 trying to keep this potentially life-saving cure from the public has been very busy.

The Daily Caller? Reichwing shitfuckers with no journalistic credentials. R66 might as well add a 6 to his reply number, the dumbass incel Trumpanzee.

The company's that make it are stepping up their production. They also donated a huge amount. So - the context of the use of this drug has changed.

As long as Lupus patients are also able to access it, I'm good. And certainly hoping it is a real treatment that helps.

[quote] The company's that make it

Oh, dear!