COVID-19

Irishize

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<blockquote class="twitter-tweet"><p lang="en" dir="ltr">This is the Best Day Ever for New York Twitter. &#55357;&#56834;&#55357;&#56448; <a href="https://t.co/xcdD9NZQI4">pic.twitter.com/xcdD9NZQI4</a></p>— Andrea Caruso (@AndreaNRuth) <a href="https://twitter.com/AndreaNRuth/status/1272309000361644043?ref_src=twsrc%5Etfw">June 14, 2020</a></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
 

Irish#1

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I got tested this week. Negative. I would've bet my left mut that I had it. Couldn't breathe, weak, nausea. No fever though. Wound up that I have had a couple heart attacks. One Saturday night. One Thursday night. Luckily survived them. Now I am waiting in Cardiac Care in St. Thomas hospital for ultrasound today and another test Monday. May be a long week.

Prayers to you my friend. Here's hoping for a speedy recovery.
 

TorontoGold

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FDA pulled the emergency use authorization for HCQ

Medical professionals, what does this mean?
 

Bishop2b5

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FDA pulled the emergency use authorization for HCQ

Medical professionals, what does this mean?

It essentially bans its use for treating or preventing Covid-19. Continuing to use it in for that is now forbidden by law.
 

Irishize

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FDA pulled the emergency use authorization for HCQ

Medical professionals, what does this mean?

My wife is a medical professional who also happens to take Plaquenil daily for an auto-immune disorder so it doesn’t affect it’s current FDA indications. It will just be blocked by HCPs in the treatment of COVID-19

FDA pulls emergency-use status for chloroquine, hydroxychloroquine in COVID-19
(Ref: Politico, MarketWatch, CNBC, This is Money, FDA, Financial Post)
June 15th, 2020
By: Anna Bratulic
Tags: Top Story chloroquine hydroxychloroquine FDA HHS COVID-19 Regulatory Affairs

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The FDA on Monday revoked the emergency-use authorisation (EUA) for malaria drugs chloroquine and hydroxychloroquine for COVID-19. According to the agency, new data, including clinical trial results, suggest the drugs "may not be effective to treat COVID-19" and their "potential benefits for such use do not outweigh…known and potential risks."

The EUA, issued in late March, permitted hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile (SNS) to be used for hospitalised adults and adolescents with COVID-19, when a clinical trial was not available or feasible. The agency noted that the drugs remain authorised for emergency use "to continue to treat any hospitalised patient to whom the authorised product has already been administered during the COVID-19 public health emergency, to the extent found necessary by such patient's attending physician."

The FDA said it revoked the EUA in consultation with the US Biomedical Advanced Research and Development Authority (BARDA), which had initially requested the emergency use. BARDA's former director Rick Bright claimed in April that he was removed from his post amid "clashes with political leadership" in the Trump administration for resisting widespread use of the malaria drugs.

Insufficient antiviral effect

In coming to its decision, the FDA said agency reviewers reassessed publications that were relied upon at the time the EUA was granted, and highlighted limitations with these studies. Specifically, new analyses suggest "it is unlikely that the dosing regimens in the EUA would be able to have an antiviral effect," and that "the substantial increase in dosing that would be needed to increase the likelihood of an antiviral effect would not be acceptable due to toxicity concerns," the regulator said.

Further, it pointed to earlier reports of decreased viral shedding, but said these findings "have not been consistently replicated," while data from the largest randomised controlled trial assessing probability of negative conversion "showed no difference between hydroxychloroquine and standard of care alone." The agency also cited recent results from the RECOVERY trial being run by Oxford University indicating that hydroxychloroquine showed no benefit for mortality or other outcomes, such as hospital stay or need for mechanical ventilation, in hospitalised patients with COVID-19.

"While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the [EUA] was no longer appropriate," commented Patrizia Cavazzoni, acting director of the FDA's Center for Drug Evaluation and Research.

New NIH guidelines

The FDA decision comes shortly after a US National Institutes of Health (NIH) panel of experts revised its advice to specifically come out against the use of chloroquine or hydroxychloroquine for COVID-19, except in formal studies, with Cleveland Clinic cardiologist Steven Nissen saying "that, I'm sure, had influence on the FDA." He agreed with the decision and said he would not have granted emergency access in the first place, as "there has never been any high-quality evidence suggesting that hyrdoxychloroquine is effective" for treating or preventing SARS-CoV-2 infection, but there is evidence of potentially serious side effects.

Still, a recent study published in The Lancet reporting that hydroxychloroquine was associated with higher rates of ventricular arrhythmia and death in COVID-19 patients was retracted earlier this month after some of the authors said they could "no longer vouch for the veracity of the primary data sources" used for the paper.
 

MJ12666

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It essentially bans its use for treating or preventing Covid-19. Continuing to use it in for that is now forbidden by law.

This is not correct. A doctor can still prescribe the drug "off label" for treating or preventing Covid-19 if they wish to.
 

ab2cmiller

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This is not correct. A doctor can still prescribe the drug "off label" for treating or preventing Covid-19 if they wish to.

https://www.cnn.com/2020/06/15/politics/fda-hydroxychloroquine-coronavirus/index.html

Doctors can continue to legally prescribe the drugs off-label, as they can with any drug that's approved for other conditions. The FDA's emergency use authorization for hydroxychloroquine and chloroquine was narrow in scope, applying only to hospitalized Covid-19 patients and only to drugs donated to the Strategic National Stockpile.
 

JurDocDuLac

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This is not correct. A doctor can still prescribe the drug "off label" for treating or preventing Covid-19 if they wish to.

Unfortunately, this decision now raises significant legal liability issues for doctors who prescribe it.

The EUA provided a liability shield, but no longer. And with the official statements by the FDA today, plaintiffs´counsels will have plenty of medical malpractice ammunition to go against prescribing doctors whose patients may be harmed or die (or who claim to have been harmed).

I doubt that many doctors will be prescribing it now. In fact, their insurers may be disallowing it.
 
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MJ12666

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Unfortunately, this decision now raises significant legal liability issues for doctors who prescribe it.

The EUA provided a liability shield, but no longer. And with the official statements by the FDA today, plaintiffs´counsels will have plenty of medical malpractice ammunition to go against prescribing doctors whose patients may be harmed or die (or who claim to have been harmed).

I doubt that many doctors will be prescribing it now. In fact, their insurers may be disallowing it.

I was not responding to the liability protections provided under the Pandemic and All-Hazards Preparedness Reauthorization Act. Rather I was simply responding to the following statement:

It essentially bans its use for treating or preventing Covid-19. Continuing to use it in for that is now forbidden by law.

This statement is false. The FDA revoking the EU for hydroxychloroquine does not make the prescribing or continued use of the drug illegal. This is not a matter for debate. Regardless of liability issues, a doctor can still prescribe this drug "off label" if they feel it would be helpful in combating an illness or condition, no matter what that condition or illness is. This is simply a fact.

With that said, you are correct in that the EU does provide liability protections but I doubt that this would be the only consideration as to whether the drug will be prescribed and nor would insurance coverage as a 30 day supply costs about $10.
 
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Bishop2b5

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This statement is false. The FDA revoking the EU for hydroxychloroquine does not make the prescribing or continued use of the drug illegal. This is not a matter for debate. Regardless of liability issues, a doctor can still prescribe this drug "off label" if they feel it would be helpful in combating an illness or condition, no matter what that condition or illness is. This is simply a fact.

I misspoke and should've looked into the matter before answering. In my defense, I knew we could still prescribe it for other medical issues. I did believe the FDA had banned it for Covid-19 though. My bad.
 

JurDocDuLac

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...the EU does provide liability protections but I doubt that this would be the only consideration as to whether the drug will be prescribed and nor would insurance coverage as a 30 day supply costs about $10.

I should have been more clear - I meant medical malpractice insurance, for prescribing doctors.

Do not underestimate personal injury and medical malpractice attorneys. It is a highly lucrative, well-financed and serious profession. They will go after doctors, period.

Most doctors want to stay away from those risks. And most of their insurers encourage them to avoid those risks, as well.

It is not going to be easy to get a prescription now.
 

Circa

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I misspoke and should've looked into the matter before answering. In my defense, I knew we could still prescribe it for other medical issues. I did believe the FDA had banned it for Covid-19 though. My bad.

Don't feel bad bud. The mainstream media gets everyone...
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They just wanna protect their interest In the Gates Vaccine. HXC cures it too easily.
 
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Irishize

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I should have been more clear - I meant medical malpractice insurance, for prescribing doctors.

Do not underestimate personal injury and medical malpractice attorneys. It is a highly lucrative, well-financed and serious profession. They will go after doctors, period.

Most doctors want to stay away from those risks. And most of their insurers encourage them to avoid those risks, as well.

It is not going to be easy to get a prescription now.

Most HCPs won’t touch this w/ a 10-ft pole unless it’s on-label. They’ve got better things to do than being deposed by some personal injury attorney.
 

GrangerIrish24

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I got tested this week. Negative. I would've bet my left mut that I had it. Couldn't breathe, weak, nausea. No fever though. Wound up that I have had a couple heart attacks. One Saturday night. One Thursday night. Luckily survived them. Now I am waiting in Cardiac Care in St. Thomas hospital for ultrasound today and another test Monday. May be a long week.

Wow. Stay strong. Prayers for quick recovery.
 

MJ12666

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I misspoke and should've looked into the matter before answering. In my defense, I knew we could still prescribe it for other medical issues. I did believe the FDA had banned it for Covid-19 though. My bad.

No need to apologize. I read some of the related articles and it was easy to interpret from them that the FDA banned its use.
 

Legacy93

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https://www.usatoday.com/story/news...ter-no-surge-in-coronavirus-cases/3208493001/


This is unacceptable, Ohio. You do not fit the desired narrative.

Indiana’s numbers also appear to be pretty similar to Ohio’s in that cases and hospitalizations have decreased since the phased reopening of the state. Great to see this good news.

I can't believe that somewhere between a complete lock-down and a free-for-all there was/is a solution that protects the vulnerable and maintains adequate emergency care capacity while allowing people to live their lives. I wish more people / institutions would be open to considering the merits of a contrary point of view. Plenty of smart people make good, value-based points on both sides of every argument.
 

ab2cmiller

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I can't believe that somewhere between a complete lock-down and a free-for-all there was/is a solution that protects the vulnerable and maintains adequate emergency care capacity while allowing people to live their lives. I wish more people / institutions would be open to considering the merits of a contrary point of view. Plenty of smart people make good, value-based points on both sides of every argument.

What's interesting is that most peoples reaction is to the extreme, almost mirroring what happened in February and March. People taking extreme positions just to make a point, even if what they truly feel is somewhere in the middle. People screaming that there will be huge spikes, just so that we stay vigilant. People saying there is absolutely nothing to worry about because they want to return to normal life sooner than later. The more people from one side screams with extreme opinions, the louder the other side feels compelled to scream.
 

yankeehater

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Legacy,

Here is more to go along with your article. I also posted a recent Tedx presentation from Dr. Bruce Patterson who has been on top of this from the start. He is a viroligist who worked at Stanford and has degrees from Northwestern and Michigan. At the end of the 21 minute presentation, he also discusses the long term complications they are seeing in patients. It is worth the time to watch. The drug Leronlimab he mentions is showing the most promise. It was also used by a doctor in that Atlantic Journal article.

https://www.ajc.com/lifestyles/heal...for-weeks-even-months/0rzLkWZWeXh0D2y3ezEqcN/

https://youtu.be/tPMHZiR_htQ
 
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Irish#1

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https://www.usatoday.com/story/news...ter-no-surge-in-coronavirus-cases/3208493001/


This is unacceptable, Ohio. You do not fit the desired narrative.

Indiana’s numbers also appear to be pretty similar to Ohio’s in that cases and hospitalizations have decreased since the phased reopening of the state. Great to see this good news.

Just looked at the Indiana dashboard and the number of reported cases too a huge jump on Wednesday. I know they opened a lot more testing centers, so this could be a result of more getting tested.
 

NDBoiler

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Just looked at the Indiana dashboard and the number of reported cases too a huge jump on Wednesday. I know they opened a lot more testing centers, so this could be a result of more getting tested.

Yes it was reported as due in large part to a new lab that started reporting results to the state. Some of the results provided by the new lab date back to March, so it’s a little misleading.
 

Rack Em

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https://www.usatoday.com/story/news...ter-no-surge-in-coronavirus-cases/3208493001/


This is unacceptable, Ohio. You do not fit the desired narrative.

Indiana’s numbers also appear to be pretty similar to Ohio’s in that cases and hospitalizations have decreased since the phased reopening of the state. Great to see this good news.

It is unacceptable because the governor didn't roll back the restrictions until the state legislature threatened to override his executive order.
 

Circa

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This might not land right, but Jimmy Dore has some opinions that are hard to dismiss.
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