COVID-19

[GATTACA!]

<blockquote class="twitter-tweet"><p lang="en" dir="ltr">The US govt has declared a few times that they are ready to help <a href="https://twitter.com/hashtag/Iran?src=hash&ref_src=twsrc%5Etfw">#Iran</a> with medicines to fight the <a href="https://twitter.com/hashtag/CoronaOutbreak?src=hash&ref_src=twsrc%5Etfw">#CoronaOutbreak</a>. That's strange. Firstly, based on the words of your own officials, you face shortages in the US. So use what you have for your own patients./1</p>— Khamenei.ir (@khamenei_ir) <a href="https://twitter.com/khamenei_ir/status/1241640461602881536?ref_src=twsrc%5Etfw">March 22, 2020</a></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>

<blockquote class="twitter-tweet"><p lang="en" dir="ltr">2nd, you're accused of having created <a href="https://twitter.com/hashtag/Coronavirus?src=hash&ref_src=twsrc%5Etfw">#Coronavirus</a>. I don't know how true it is. But when there's such an allegation, can a wise man trust you? You could be giving medicines that spread the virus or cause it to remain. Experience shows you can’t be trusted & you do such things./2</p>— Khamenei.ir (@khamenei_ir) <a href="https://twitter.com/khamenei_ir/status/1241642515943620610?ref_src=twsrc%5Etfw">March 22, 2020</a></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>

Iran could use some serious serious population control.

 

[Irish YJ]

Sorry to get a little technical, but I worked in the pharmaceutical industry for most of my carrier and the process basically is that the FDA approves a drug for a specific purpose generally after data from phase III trials are completed, submitted to the FDA and reviewed. Once approval is granted the drug can only be marketed for use to treat the condition for which it was initially intended. However since the drug was approved as safe to prescribe, the FDA has no restrictions on prescribing the drug for any purpose, even if that purpose is to treat a condition that it was not specifically approved to treat Using the drug to treat a condition for which it was not initially approved is called “off‐​label” because the label is only allowed to state the condition for which its use was FDA‐​approved and the manufacturer cannot market the drug for any other purpose without facing severe civil penalties. So technically the FDA would not approve the off-label use of Chloroquine as they cannot prevent it.

As I understand it, FDA approval for off label removes liability. Many doctors prescribe off label to be creative when on label treatments don't work, but most doctors are afraid/hesitant to do so. Approval removes that fear. IDK, I'm not a doctor or drug manufacturer. Just repeating what Pence said, and new sources have reported.

 

[Irish YJ]

Bye Felicia.

They even refused a pop up hospital from an NGO to add beds to the 2nd hardest hit city in Iran. Called them spies...

 

[Irishize]

Sorry to get a little technical, but I worked in the pharmaceutical industry for most of my carrier and the process basically is that the FDA approves a drug for a specific purpose generally after data from phase III trials are completed, submitted to the FDA and reviewed. Once approval is granted the drug can only be marketed for use to treat the condition for which it was initially intended. However since the drug was approved as safe to prescribe, the FDA has no restrictions on prescribing the drug for any purpose, even if that purpose is to treat a condition that it was not specifically approved to treat Using the drug to treat a condition for which it was not initially approved is called “off‐​label” because the label is only allowed to state the condition for which its use was FDA‐​approved and the manufacturer cannot market the drug for any other purpose without facing severe civil penalties. So technically the FDA would not approve the off-label use of Chloroquine as they cannot prevent it.

That’s true. You can pretty much use anything off-label (other than REMS drugs, etc) but Medicaid & private insurance are not obliged to reimburse for it which usually is only an issue when you’re talking about an oncolytic, infusion or other specialty drug that requires a PA & is purchased through a specialty distributor/specialty pharmacy.

As I mentioned earlier though, this is a generic product so it should be able to be obtained in a relatively inexpensive manner...even for cash patients. You can fill a Plaquenil script at any local pharmacy so once an HCP prescribes it, the pharmacy will fill it.

Right now there is very promising anecdotal data to show that Plaquenil works well in treating COVID-19. What will be interesting is when the pandemic is over going back retrospectively and seeing how many/if any patients who were taking Plaquenil for RA, Lupus or other autoimmune diseases actually contracted COVID-19. That may shed some light on if the drug could be used in the prevention of the viruse...not just the treatment.

 

[MJ12666]

As I understand it, FDA approval for off label removes liability. Many doctors prescribe off label to be creative when on label treatments don't work, but most doctors are afraid/hesitant to do so. Approval removes that fear. IDK, I'm not a doctor or drug manufacturer. Just repeating what Pence said, and new sources have reported.

Do you happen to have any links to news stories on this? I have looked but cannot find anything and I have never heard of this being done (the FDA "approving" off-label use). I would be interested in reading this as I have never actually heard of doctors or pharm companies being sued for off-label use of a drug; other then being sued civally by the FDA for "marketing" a drug for a purpose that it did not receive FDA approval.

 

[SouthSideChiDomer]

They even refused a pop up hospital from an NGO to add beds to the 2nd hardest hit city in Iran. Called them spies...

I mean I'm pretty sure we have sent a spy disguised as a NGO worker before, so its not like its a baseless accusation. That's why I'm pretty sure its frowned upon to do that. And really its not like we can offer much support. Its probably just a PR thing so they are screwed if they accept help (because they look weak) or reject help (because they look like they don't care about their citizens). I mean its probably the same thing China is doing with us, offering tons of support because it makes our government look incompetent (regardless of their actual level of competency).

As for the off label drug use, I thought I heard that the declaration of a national emergency gave greater leniency for off label use. I don't know if that's true or if it has to do with this situation, I just wanted to put it out there as a possibility.

I have a question for anyone in pharmaceuticals or anyone else who would know. They keep saying a vaccine will take 12 months to get out even if we have already started the human trials. What part of that 12 month time is the trials and how much is actually producing it? I know it was reported they are doing human trials at the same time as animal trials, but is there anything else they can do at the same time to cut down that time? Like could they start producing some amount now so that they can get it out right away when its approved?

 

[Pops Freshenmeyer]

As I understand it, FDA approval for off label removes liability. Many doctors prescribe off label to be creative when on label treatments don't work, but most doctors are afraid/hesitant to do so. Approval removes that fear. IDK, I'm not a doctor or drug manufacturer. Just repeating what Pence said, and new sources have reported.

The FDA does not have the authority to remove tort liability for pharma manufacturers or for doctors.

Taken together, maybe they removed some marketing restrictions? IDK.

 

[SouthSideChiDomer]

Tests should be available now. I read that the damn has broke on tests, and we've tested more in the last 8 days than SKO's total. Something like 250k in the last week. FDA just approved a very simple/quick test too.

I don't know if they have the fast ones out there yet. A family member just got tested today and they won't be getting results for 5 days.

 

[Pops Freshenmeyer]

Do you happen to have any links to news stories on this? I have looked but cannot find anything and I have never heard of this being done (the FDA "approving" off-label use). I would be interested in reading this as I have never actually heard of doctors or pharm companies being sued for off-label use of a drug; other then being sued civally by the FDA for "marketing" a drug for a purpose that it did not receive FDA approval.

It looks like a Fox News interview with Dr. Oz

https://video.foxnews.com/v/6144388404001#sp=show-clips

 

[Irish YJ]

Do you happen to have any links to news stories on this? I have looked but cannot find anything and I have never heard of this being done (the FDA "approving" off-label use). I would be interested in reading this as I have never actually heard of doctors or pharm companies being sued for off-label use of a drug; other then being sued civally by the FDA for "marketing" a drug for a purpose that it did not receive FDA approval.

see the section talking about legalities regarding liability
https://journalofethics.ama-assn.or...-label-what-should-physician-disclose/2016-06

here's the article with Pence's verbiage. the embedded vid also talks about the FDA trials and situation.
https://www.foxnews.com/media/pence-fda-hydroxychloroquine-off-label-coronavirus

 

[Irish YJ]

I mean I'm pretty sure we have sent a spy disguised as a NGO worker before, so its not like its a baseless accusation. That's why I'm pretty sure its frowned upon to do that. And really its not like we can offer much support. Its probably just a PR thing so they are screwed if they accept help (because they look weak) or reject help (because they look like they don't care about their citizens). I mean its probably the same thing China is doing with us, offering tons of support because it makes our government look incompetent (regardless of their actual level of competency).

As for the off label drug use, I thought I heard that the declaration of a national emergency gave greater leniency for off label use. I don't know if that's true or if it has to do with this situation, I just wanted to put it out there as a possibility.

I have a question for anyone in pharmaceuticals or anyone else who would know. They keep saying a vaccine will take 12 months to get out even if we have already started the human trials. What part of that 12 month time is the trials and how much is actually producing it? I know it was reported they are doing human trials at the same time as animal trials, but is there anything else they can do at the same time to cut down that time? Like could they start producing some amount now so that they can get it out right away when its approved?

The NGO was Doctors Without Borders (Médecins sans frontières) based in Switzerland, so doubt it was a PR move.... That was something different than the aid the US offered.

 

[SouthSideChiDomer]

The recovery rate shown on that graph was pretty incredible if true. Sure hope it's the real deal. Many places are now trying it. Glad the FDA didn't hold up things due to the off-label use. Read that some were putting up a huge fight.

I won't say the numbers weren't true, but apparently they didn't tell the whole story. A couple different reporters looked in to the study and all basically said the same thing: it shows potential, but its not as good as first glance. IIRC, besides it being a single small study, there were some "dropouts" that would have made the numbers not as good and the benchmarks they used were different than what is normally used and if the normal ones had been used the numbers wouldn't have been as good. All that said, it still did have some effect, so it is definitely worth looking in to, but it didn't seem like something we should drop everything else for especially considering there are (cardiac I think?) risks with the drug combo. I think there were at least two other drugs that were being looked at as well as anti-body treatments that should also be studied with the anti-malarial drug.

 

[Irish YJ]

I don't know if they have the fast ones out there yet. A family member just got tested today and they won't be getting results for 5 days.

I've read a few different stories. One said the FDA finally OK'd existing self swab tests, which will be deployed quickly. Another said newer non-self swab test that were quicker than the original ones already deployed, have been delivered or are being delivered depending on area.
https://techcrunch.com/2020/03/23/fda-updates-covid-19-testing-guidelines-to-allow-self-swab-tests/

The FDA does not have the authority to remove tort liability for pharma manufacturers or for doctors.

Taken together, maybe they removed some marketing restrictions? IDK.

See the link regarding legality I posted above. Anecdotally speaking, doctors that go off script can be easier held liable. Not really talking about the manufacturers.

 

[Irish2155]

Fortunately he is one that can work from home as he doesn't have much face to face interaction with users. Two of the ladies I expected to work from home said they want to come into the office. One has her mother living with them. Her husband is working from home and her DIL and three grandkids are there for a couple of months. Coming to work is something of a relief for her. The second one also wants a break from her two kids. lol

Happy that it worked out for him. I’m sure he’s tying one on right now celebrating his new found freedom.

I learned today that I have to layoff a team member on Friday and cut another one down to 20 hours a week. We’ll bring them both back into the full time fold though once this all passes.

 

[Irish YJ]

I won't say the numbers weren't true, but apparently they didn't tell the whole story. A couple different reporters looked in to the study and all basically said the same thing: it shows potential, but its not as good as first glance. IIRC, besides it being a single small study, there were some "dropouts" that would have made the numbers not as good and the benchmarks they used were different than what is normally used and if the normal ones had been used the numbers wouldn't have been as good. All that said, it still did have some effect, so it is definitely worth looking in to, but it didn't seem like something we should drop everything else for especially considering there are (cardiac I think?) risks with the drug combo. I think there were at least two other drugs that were being looked at as well as anti-body treatments that should also be studied with the anti-malarial drug.

I posted a link from the French medical authority or whatever they are called, that were very strong on what they have found, and said basically it was immoral to not use the cocktail. Given China and SKO are using it with success, it's not dropping everything, it's using what other govs are already using and having success with. All that said, without an alternative, to me it's a no brainer that it should be used given it's an already approved drug.

 

[MJ12666]

see the section talking about legalities regarding liability
https://journalofethics.ama-assn.or...-label-what-should-physician-disclose/2016-06

here's the article with Pence's verbiage. the embedded vid also talks about the FDA trials and situation.
https://www.foxnews.com/media/pence-fda-hydroxychloroquine-off-label-coronavirus

Thanks. I listened to the interview and the question was phrased very poorly coming from a "doctor" who should know that a doctor does not need FDA approval for prescribing a drug "off-label". Pence stating that the FDA has given approval to off-label use of Chloroquine is true only because, as I previously stated, once a drug is approved by the FDA it is automatically approved for "off-label" use and not because the FDA "officially" approve Chloroquine for the treatment of the coronavirus. Now God knows that I am not infallible but I really would need to see a statement directly from the FDA that they are approving the use of Chloroquine to treat the coronavirus, but since Pence (I believe) also stated in the interview that trials are already underway to determine if it is effective, I really find it hard to believe the FDA will make such a statement. With that said, again, that will not inhibit doctors from using the drug as I suspect they will and hopefully it will prove to be effective.

 

[Irish YJ]

Thanks. I listened to the interview and the question was phrased very poorly coming from a "doctor" who should know that a doctor does not need FDA approval for prescribing a drug "off-label". Pence stating that the FDA has given approval to off-label use of Chloroquine is true only because, as I previously stated, once a drug is approved by the FDA it is automatically approved for "off-label" use and not because the FDA "officially" approve Chloroquine for the treatment of the coronavirus. Now God knows that I am not infallible but I really would need to see a statement directly from the FDA that they are approving the use of Chloroquine to treat the coronavirus, but since Pence (I believe) also stated in the interview that trials are already underway to determine if it is effective, I really find it hard to believe the FDA will make such a statement. With that said, again, that will not inhibit doctors from using the drug as I suspect they will and hopefully it will prove to be effective.

There were more articles than just the Pence/Fox one. I'll try to find them.
Here's an article I'm reading right now about the FDA clearing hurdles to allow an Indian manufacturer to import the drugs (after they banned the manufacturer). So whatever is happening, the FDA seems to moving fast to make it easier. The article also talks about state boards restricting the use of the cocktail for treatment, and not prevention. So logically speaking, if state boards can restrict off label use, I'm guessing an FDA approval would supersede state restrictions.

https://www.fiercepharma.com/manufa...ipca-so-can-ship-unproven-covid-19-treatments

 

[MJ12666]

There were more articles than just the Pence/Fox one. I'll try to find them.
Here's an article I'm reading right now about the FDA clearing hurdles to allow an Indian manufacturer to import the drugs (after they banned the manufacturer). So whatever is happening, the FDA seems to moving fast to make it easier. The article also talks about state boards restricting the use of the cocktail for treatment, and not prevention. So logically speaking, if state boards can restrict off label use, I'm guessing an FDA approval would supersede state restrictions.

https://www.fiercepharma.com/manufa...ipca-so-can-ship-unproven-covid-19-treatments

Thanks. Based on the FDA allowing imports of chloroquine tablets produced by Ipca Labs plants in India is an indication that FDA is leaning in its belief that this may be a drug that is effective in combating the virus. But believe me, they are not "officially" approving chloroquine off-label treatment of the virus. And also believe me, even if they did so it would not limit any liability for any adverse effects of the drug. Heck all you need to do is look at a pharma companies annual financial statement and read the notes and you will see pages of descriptions of pending lawsuits; and these are for drugs used for treatments specifically approved by the FDA.

 

[MJ12666]

On a different issue:

Some six in 10 Americans approve of the job Donald Trump is doing to combat the coronavirus crisis, pushing the president’s approval rating – 49% - to the highest of his presidency, according to a poll released Tuesday by Gallup.

Trump’s gains come as his standing has improved among Democrats and independents amid the viral outbreak, which has killed more than 660 people even as the nation has adopted strict rules limiting public gatherings. Trump’s job approval numbers are up 6 points among Democrats and 8 points among independents, according to the survey.

And voters are largely giving Trump positive marks for his handling of the pandemic, with 94% of Republicans, 60% of independents, and 27% of Democrats approving of his efforts. That’s higher than his general approval rating among each group.

https://www.bloomberg.com/news/arti...avirus-approved-by-60-in-gallup-poll-k86e29ot

 

[Irish YJ]

Thanks. Based on the FDA allowing imports of chloroquine tablets produced by Ipca Labs plants in India is an indication that FDA is leaning in its belief that this may be a drug that is effective in combating the virus. But believe me, they are not "officially" approving chloroquine off-label treatment of the virus. And also believe me, even if they did so it would not limit any liability for any adverse effects of the drug. Heck all you need to do is look at a pharma companies annual financial statement and read the notes and you will see pages of descriptions of pending lawsuits; and these are for drugs used for treatments specifically approved by the FDA.

Like I said, not really talking about drug manufacturer liability. More relevant to doctor liability. They're the ones that might be hesitant to use. Bottom line, whatever is going on, the FDA is being un-FDA like, and like you said, is leaning in. And apparently leaning in pretty hard.

 

[Irish YJ]

On a different issue:


https://www.bloomberg.com/news/arti...avirus-approved-by-60-in-gallup-poll-k86e29ot

You would never ever think this watching MSM.

 

[MJ12666]

You would never ever think this watching MSM.

lol - you got that right. If my local paper reports this it will be buried someplace you would never find it. But I can guarantee on the front page tomorrow if congress does not pass the coronavirus stimulative package it will because of republican obstinacy.

 

[Irish YJ]

lol - you got that right. If my local paper reports this it will be buried someplace you would never find it. But I can guarantee on the front page tomorrow if congress does not pass the coronavirus stimulative package it will because of republican obstinacy.

Since it's borderline political, I just posted it in the Trump thread so we don't get to far off topic here. It deserves some discussion lol

 

[Irish#1]

Happy that it worked out for him. I’m sure he’s tying one on right now celebrating his new found freedom.

I learned today that I have to layoff a team member on Friday and cut another one down to 20 hours a week. We’ll bring them both back into the full time fold though once this all passes.

That sucks. Never easy to do. Hope we don’t get to where I have to do the same thing.

 

[Bishop2b5]

I can't get the pic to embed, but look at the first pic in the link below.

https://www.al.com/news/j66j-2020/0...g-test-kits-online-learning-toilet-paper.html

It says, "The whole country would be tested by midnight if Chick-fil-A was running the drive-thru testing centers. @eatmorchickin

 

[Irish YJ]

I can't get the pic to embed, but look at the first pic in the link below.

https://www.al.com/news/j66j-2020/0...g-test-kits-online-learning-toilet-paper.html

It says, "The whole country would be tested by midnight if Chick-fil-A was running the drive-thru testing centers. @eatmorchickin

 

[loomis41973]

I'm expecting the looting to start very soon.

 

[PerthDomer]

The only real data for Chloroquine is in the lab. Poorly done study out of asia. It should only be prescribed in conjunction with clinical trials. I'm an intensivist and that's the only way I'd want it. Even the chloroquine demand present now has made the drug unavailable for people who need it... hence finding new sources.

 

[Irishize]

I can't get the pic to embed, but look at the first pic in the link below.

https://www.al.com/news/j66j-2020/0...g-test-kits-online-learning-toilet-paper.html

It says, "The whole country would be tested by midnight if Chick-fil-A was running the drive-thru testing centers. @eatmorchickin

It’s funny b/c it’s true. Let CFA do the drive-thru & In-&-Out handle the indoor foot traffic. No one is as efficient as those two corps.

 

[Irish YJ]

China ambassador to the US is now walking the BS back

<blockquote class="twitter-tweet"><p lang="en" dir="ltr">We welcome Ambassador Cui's comments calling the Chinese Foreign Ministry's statement a “crazy thing” that blamed the U.S. Army for the <a href="https://twitter.com/hashtag/coronavirus?src=hash&ref_src=twsrc%5Etfw">#coronavirus</a> outbreak in Wuhan. Saving lives is more important than saving face.</p>— Morgan Ortagus (@statedeptspox) <a href="https://twitter.com/statedeptspox/status/1242447245716447235?ref_src=twsrc%5Etfw">March 24, 2020</a></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>