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Chloroquine is also used for the treatment of lupus, but for a different reason.  This drug is pretty remarkable in terms of how many ways it affect cellular processes in the human body.

It looks pretty promising as a treatment for corona virus.  I hope they get enough clinical data pretty damn quick.

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1 hour ago, Kevin125 said:

I hope they get enough clinical data pretty damn quick.

Bayer dropped 3 million Chloroquine tablets on the federal government.  There's going to be more clinical data than you can shake a spreadsheet at very soon.

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8 minutes ago, Scorpio64 said:

Bayer dropped 3 million Chloroquine tablets on the federal government.  There's going to be more clinical data than you can shake a spreadsheet at very soon.

Indeed.  What the head of the FDA was saying today......but not saying... ..is that people are getting that drug now.....as volunteers under the compassionate care protocol.....and the data is being gathered ....now.

I understand his reluctance to spell it out.  The FDA’s primary mission is to protect Americans.  But given the need to get ahead of this, bypassing some safety protocols is warranted.  Especially since we already know a remarkable amount about this drug.

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34 minutes ago, Scorpio64 said:

Bayer dropped 3 million Chloroquine tablets on the federal government.  There's going to be more clinical data than you can shake a spreadsheet at very soon.

It all depends on how fast they re-write the protocol, get the clinical trial data, and get the approvals through the FDA. Right now, it can't be prescribed for Covid.

27 minutes ago, Kevin125 said:

But given the need to get ahead of this, bypassing some safety protocols is warranted.  Especially since we already know a remarkable amount about this drug.

You willing to volunteer to be a clinical guinea pig?

28 minutes ago, Kevin125 said:

Especially since we already know a remarkable amount about this drug.

Not how it relates to Covid and side affects yet.

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10 minutes ago, Sniper said:

It all depends on how fast they re-write the protocol, get the clinical trial data, and get the approvals through the FDA. Right now, it can't be prescribed for Covid.

You willing to volunteer to be a clinical guinea pig?

Not how it relates to Covid and side affects yet.

Are you not familiar with off label perscribing?

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MD's prescribe off-label all the time.  It can be hard to get insurance to cover off-label prescriptions, and I understand that, but chloroquine is off-patent and cheap.

To add the novel coronavirus as an indication, they might be able to skip phase 1 clinical trials altogether, since those have already been done, unless they want to change the demographics of the trial, perhaps to include an older population.   Phase 2 trials would take time, but wouldn't have to be large, since the therapeutic index for chloroquine is pretty narrow--they wouldn't be testing a wide range of doses.  Phase 3 would still be phase 3, big, expensive and slow...

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1 hour ago, Sniper said:

It all depends on how fast they re-write the protocol, get the clinical trial data, and get the approvals through the FDA. Right now, it can't be prescribed for Covid.

You willing to volunteer to be a clinical guinea pig?

Not how it relates to Covid and side affects yet.

#2. Yup. 100%. Light the candle capcom.

#3  we will learn quickly doomsayer.

Also, the form of chloroquine Bayer donated is chloroquine phosphate which is not yet approved for use in the US.  But the FDA will likely fast track that as their clinical trials yield more information.

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1 hour ago, 10X said:

MD's prescribe off-label all the time.  It can be hard to get insurance to cover off-label prescriptions, and I understand that, but chloroquine is off-patent and cheap.

To add the novel coronavirus as an indication, they might be able to skip phase 1 clinical trials altogether, since those have already been done, unless they want to change the demographics of the trial, perhaps to include an older population.   Phase 2 trials would take time, but wouldn't have to be large, since the therapeutic index for chloroquine is pretty narrow--they wouldn't be testing a wide range of doses.  Phase 3 would still be phase 3, big, expensive and slow...

It appears to be the case its already being administered widely under the compassionate care rule/law.

Renovir is being administered and reports are out that is has cases where it was very effective.

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53 minutes ago, Kevin125 said:

Also, the form of chloroquine Bayer donated is chloroquine phosphate which is not yet approved for use in the US.  But the FDA will likely fast track that as their clinical trials yield more information.

Exactly what I was referring to above. Doctors just can't write Rx off-label for a drug not approved here until it goes through clinical trials and gets approved by the FDA. Some people are confused with doctor's writing off-label for approved FDA drugs for similar conditions, like arthritis or cancer drugs.

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43 minutes ago, Old Glock guy said:

If it turns out to be effective, which looks likely at this point, good luck getting it.  It's hard to even find water in my neighborhood.  

Why are you stressing over WATER ?- it is not going off anytime soon...........if it goes off - your few cases will not help you survive.... 

Do you have a well?  Do you have a genny?  do you have gas on hand?  If you do you have water.

The drugs will be available for those that need it - if you are not sick, you wont need it, so no worry about getting it.

 

Let's get some perspective here - like with the testing - they need to test the symptomatic first to filter out the Flu patients, then once the Flu fizzles a bit they can sort those from the covid folks - *then* with more testing they get find those that have no viral load and those that have it but have no symptoms....  If you have NO symptoms at this time there is no reason to test you, in a perfect world you would be, but we cannot at this time

 

Not my quotation - " Do not worry about what you do not know - worry about what you can control..."

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Did I say I was stressing over water?  I could just as easily have mentioned toilet paper  I was merely making the point that people have been needlessly panic buying those items, so why wouldn't they hoard a drug that could provide a potential cure?

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10 minutes ago, Old Glock guy said:

Did I say I was stressing over water?  I could just as easily have mentioned toilet paper  I was merely making the point that people have been needlessly panic buying those items, so why wouldn't they hoard a drug that could provide a potential cure?

I inferred that you were by your statement - good don't stress

Can you as non doctor, prescribe medicines?  

Do non-doctors have access to prescription only medicines?

If no to either, how can anyone hoard?

I am just trying to rationalize and understand statements that to me seem odd to me.

I find that the usage of pronouns, especially like 'they', really muddies the waters - they being whom?

Normal Citizens?

 

Not trying to pick a fight, I just don't see citizens being able to hoard a prescription drug - see the idiots trying to get the aquarium form of it - some will probably take it - ... darwinism at it's finest.

 

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Give people the choice:

Opt in to take the drug, at no cost to them, and with a no-harm clause so they can't sue if it does something wonky, only recover/get paid for side effect care.

there will be enough willing volunteers.

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2 minutes ago, USRifle30Cal said:

I inferred that you were by your statement - good don't stress

Can you as non doctor, prescribe medicines?  

Do non-doctors have access to prescription only medicines?

If no to either, how can anyone hoard?

I am just trying to rationalize and understand statements that to me seem odd to me.

I find that the usage of pronouns, especially like 'they', really muddies the waters - they being whom?

Normal Citizens?

 

Not trying to pick a fight, I just don't see citizens being able to hoard a prescription drug - see the idiots trying to get the aquarium form of it - some will probably take it - ... darwinism at it's finest.

 

I fully expect every pharmacy in the country to pull it off the shelf.  "They", meaning the FDA will sequester it.   My cynical conspiratorial self figures they will come back in a month or two with a cure that involves something similar, but not the same.  It will have a trivial molecule change that can be re-patented so they can charge $2000 per treatment.   Just like that, something that cost the rest of the world $15 bucks will cost us a $100 co-pay or full boat if you have an HDHP and our insurance companies will pass the cost on to everyone.  "WE CURED IT, THOSE STINKY FRENCH HAD THE RIGHT IDEA, BUT WE MADE IT BETTER".   Yeah, you sure did.

 

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18 minutes ago, Malsua said:

I fully expect every pharmacy in the country to pull it off the shelf.  "They", meaning the FDA will sequester it.   My cynical conspiratorial self figures they will come back in a month or two with a cure that involves something similar, but not the same.  It will have a trivial molecule change that can be re-patented so they can charge $2000 per treatment.   Just like that, something that cost the rest of the world $15 bucks will cost us a $100 co-pay or full boat if you have an HDHP and our insurance companies will pass the cost on to everyone.  "WE CURED IT, THOSE STINKY FRENCH HAD THE RIGHT IDEA, BUT WE MADE IT BETTER".   Yeah, you sure did.

 

And this is probably 100% correct............................

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10 hours ago, Sniper said:

Exactly what I was referring to above. Doctors just can't write Rx off-label for a drug not approved here until it goes through clinical trials and gets approved by the FDA. Some people are confused with doctor's writing off-label for approved FDA drugs for similar conditions, like arthritis or cancer drugs.

If its approved for a condition, it's "on' label.. 

If it's not listed as an approved FDA treatment, it doesnt matter how similar it is.. it's off label.

 

There is  nothing to be confused here, a doctor can write a prescription off label for anything if they feel its medically appropriate.

 

There are drugs out there being used for psychiatric condition's that are not FDA approved for mental health at all, or unrelated mental health disorders.

 

Similarity has nothing to do with this. Doctors read clinical studies all the time to keep up with how a drug can be used to treat a patient, if there is good data on a alread FDA approved drug.. nothing says they cant use it.

There is no confusion. The APPROVED drug can be prescribed off label..  if Bayer wants to produce a novel form of the drug to repatent it... that's their business but the government can still solicit any number of pharmaceutical companies to produce the generic APPROVED form. And why wouldnt a company jump on that? 

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Imo, Beyer donated all those pill for a reason.. they want what ever government contract is being put together for medical treatment.. if their drug dominates clinical studies.. well that's the name that gets printed on all the literature. 

If their "novel" form of a generic drug shows promise, the government is more likely to fast track the drugs approval and give them all the money to supply meds.. its get "on label" perscibing authority and the rest is history.

Since our government loves to waste money, and loves the pharma industry... my guess is it will work.

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9 minutes ago, JackDaWack said:

Imo, Beyer donated all those pill for a reason.. they want what ever government contract is being put together for medical treatment.. if their drug dominates clinical studies.. well that's the name that gets printed on all the literature. 

If their "novel" form of a generic drug shows promise, the government is more likely to fast track the drugs approval and give them all the money to supply meds.. its get "on label" perscibing authority and the rest is history.

Since our government loves to waste money, and loves the pharma industry... my guess is it will work.

If the drug proves effective, it will work out well for Bayer AND the patients.

What would you have had them do instead?  Sit on the 3 million pills and refuse to allow them to be tested?

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31 minutes ago, JackDaWack said:

There is no confusion. The APPROVED drug can be prescribed off label.. 

There seems to be confusion (on your part). I was specifically referring to the Bayer drug, as per the FDA director, is NOT approved in the US, and he said it needs clinical trials here.. Do you want to continue to go off into the weeds, or maybe you just know more than he does?

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3 minutes ago, Sniper said:

There seems to be confusion (on your part). I was specifically referring to the Bayer drug, as per the FDA director, is NOT approved in the US, and he said it needs clinical trials here.. Do you want to continue to go off into the weeds, or maybe you just know more than he does?

I'm confused because youre talking about off label prescriptions for non approved FDA drugs... 

 

Why don't you just say the drug cant be prescribed, at all, for anything. 

 

You've been making claims about off label prescriptions well before Beyer came up..

 

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5 minutes ago, 10X said:

If the drug proves effective, it will work out well for Bayer AND the patients.

What would you have had them do instead?  Sit on the 3 million pills and refuse to allow them to be tested?

Not really the point I was making... I'm more interested to know why Beyer has been spending time trying to redevelop a drug that already has a high degree of effective for it's intended use.

Why not donate 3 million pill of the already approved drug? 

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16 minutes ago, JackDaWack said:

Not really the point I was making... I'm more interested to know why Beyer has been spending time trying to redevelop a drug that already has a high degree of effective for it's intended use.

Why not donate 3 million pill of the already approved drug? 

Got it.   I don't know any specifics about the Bayer donation; didn't know of it at all until Scorpio mentioned in in this thread, but I'd think the donation was for testing to confirm if the early, small scale results against the novel coronavirus could be confirmed, and to make sure there weren't any unexpected side effects in COVID-19 patients, since there wouldn't have been any of those in the earlier clinical testing against malaria.

I also don't know if there were any restrictions on the donation; like if the tablets can be used only for testing, or if the Feds, if convinced of their safety, can start to distribute them as they see fit.

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Just a heads up, coming here momentarily by Murphy...

....."The morning after California laid out the most restrictive measures to combat the virus in the US, NY Gov. Andrew Cuomo on Friday laid out new measures for New York State to combat the coronavirus outbreak, imposing new restrictions like ordering "100% of the workforce" to stay home.

During this time, Cuomo is order all businesses in the state that aren't deemed "essential" to close, and added that though public transit will remain open for people who need it to travel to their 'essential' jobs, and to get to places like hospitals and doctors offices and grocery stores and pharmacies, he urged New Yorkers to only take the trains if absolutely necessary.

He threatened to fine businesses and individuals caught breaking the rules.

"These are not helpful hints...they will be enforced. There will be a civil fine and mandatory closure for any business that is not in compliance.

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