FDA approves COVID-19 fighting drugs
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Started by metmike - March 30, 2020, 11 p.m.

FDA Approves Anti-Malarial Drugs Chloroquine And Hydroxychloroquine For Emergency Coronavirus Treatment


https://www.forbes.com/sites/rachelsandler/2020/03/30/fda-approves-anti-malarial-drugs-chloroquine-and-hydroxychloroquine-for-emergency-coronavirus-treatment/#75c5f8655e5d

  • The Department of Health and Human Services said Sunday hydroxychloroquine and chloroquine products can “be distributed and prescribed by doctors to hospitalized teen and adult patients with Covid-19, as appropriate, when a clinical trial is not available or feasible.”

  

  • HHS said Germany’s Sandoz has already given 30 million doses of hydroxychloroquine to the Strategic National Stockpile, the federal government’s supply of medical supplies for public health emergencies, while Bayer has donated 1 million doses of chloroquine.

  

  • The agency is fast-tracking a process that usually takes years while the FDA conducts clinical trials in New York, a hotspot for the virus. 
Comments
By metmike - March 30, 2020, 11:02 p.m.
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metmike: Hydroxychloroquine Sulfate is currently being used in the treatment of lupus(as well as rheumatoid arthritis) in patients that other treatments have proven to be ineffective.  It's also used to treat and guard against malaria(which is caused by a parasite transmitted by mosquitoes).


The FDA just fast tracked approval for this drug to treat COVID-19  without the usual extensive studies that normally define protocol for drugs to be approved.  It's been in widespread use already for decades for the issues mentioned above, so we already know what sort of potential side effects that are associated with this drug. The letter is below.




https://www.fda.gov/media/136534/download

March 28, 2020 Dr. Rick Bright, Ph.D. Director Biomedical Advanced Research and Development Authority (BARDA) Office of Assistant Secretary for Preparedness and Response (ASPR) 330 Independence Ave, S.W. Room 640G - fda.gov
then declared that circumstances exist justifying the authorization of emergency use of drugs and biologics during the COVID-19 outbreak, pursuant to section 564 of the Act, subject to terms of
www.fda.gov


"I have concluded, pursuant to Section 564(d)(3) of theAct, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective forthe treatment of COVID-19,when used consistently with the Scopeof Authorization of this letter (SectionII), pursuant to Section 564(c)(2)(A)of the Act. Having reviewed the scientific info"

By metmike - March 30, 2020, 11:06 p.m.
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Hydroxychloroquine SULFATE


https://www.webmd.com/drugs/2/drug-5482/hydroxychloroquine-oral/details


Hydroxychloroquine Oral : Uses, Side Effects, Interactions, Pictures, Warnings & Dosing - WebMD
Find patient medical information for Hydroxychloroquine Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings.
www.webmd.com




Hydroxychloroquine is used to prevent or treat malaria infections caused by mosquito bites. It does not work against certain types of malaria (chloroquine-resistant). The United States Center for Disease Control provides updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs.
This medication is also used, usually with other medications, to treat certain auto-immune diseases (lupus, rheumatoid arthritis) when other medications have not worked or cannot be used. It belongs to a class of medications known as disease-modifying antirheumatic drugs (DMARDs). It can reduce skin problems in lupus and prevent swelling/pain in arthritis, though it is not known exactly how the drug works.

By metmike - March 30, 2020, 11:07 p.m.
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Malaria


https://www.healthline.com/health/malaria


Malaria: Causes, Symptoms, and Diagnosis - Healthline
Malaria is a life-threatening disease. It’s typically transmitted through the bite of an infected Anopheles mosquito. Infected mosquitoes carry the Plasmodium parasite. When this mosquito bites ...
www.healthline.com
By metmike - March 30, 2020, 11:11 p.m.
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https://www.fda.gov/media/136534/download


From the letter:

Re: Request for Emergency Use Authorization For Useof Chloroquine Phosphate or Hydroxychloroquine Sulfate Supplied From the Strategic National Stockpilefor Treatment of 2019 Coronavirus Disease.


"I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective for the treatment of COVID-19,when used consistently with the Scope of Authorization of this letter (SectionII), pursuant to Section 564(c)(2)(A)of the Act .Having reviewed the scientific info"



metmike:

Does this mean that it will work?


Probably for some to many patients. Maybe not for others. No way to know until its in widespread use. Looks like a lot of it is being donated right away, so maybe we will know within a month or so(me, wild guessing). Sounds very promising. 


"The U.S. Department of Health and Human Services (HHS) today accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalized with COVID-19or for use in clinical trials. These and other companies may donate additional doses, and companies have ramped up production to provide additional supplies of the medication to the commercial market."

HHS accepts donations of medicine to Strategic National Stockpile as possible treatments for COVID-19 patients

https://www.hhs.gov/about/news/2020/03/29/hhs-accepts-donations-of-medicine-to-strategic-national-stockpile-as-possible-treatments-for-covid-19-patients.html


HHS accepts donations of medicine to Strategic National Stockpile as possible treatments for COVID-19 patients | HHS.gov
The U.S. Department of Health and Human Services (HHS) today accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials.
www.hhs.gov
By TimNew - March 31, 2020, 8:52 a.m.
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I wonder when we'll be hearing from the people who ridiculed Trump for saying this drug would help?

By metmike - March 31, 2020, 12:38 p.m.
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 You can take it to the bank that CNN will find people that have side effects(including death) and look for reasons for this potential life saving medicine for COVID-19 patients to be a bad thing...........because President Trump said it was a good thing.

By metmike - March 31, 2020, 12:55 p.m.
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Trump says this drug has 'tremendous promise,' but Fauci's not spending money on it  

https://www.cnn.com/2020/03/28/health/coronavirus-hydroxychloroquine-trial/index.html


(CNN)Despite President Donald Trump's enthusiasm for the drug hydroxychloroquine to treat coronavirus, the federal funding powerhouse led by Dr. Anthony Fauci isn't spending any money on it, and clinical trials for it are lagging behind other drug studies, according to a CNN investigation.


At a White House briefing last week, Trump said hydroxychloroquine, which is used to treat malaria, lupus, and rheumatoid arthritis, shows "tremendous promise" of working against coronavirus as well.  

"I think it's going to be great," he said. "We're quickly studying this drug."  


"But the National Institute of Allergy and Infectious Diseases isn't sponsoring any studies on hydroxychloroquine, according to a statement from the agency, which added that the agency is "considering" trials that examine the drug or its analogue chloroquine as a potential treatment for Covid-19. studies. 

On its website, NIAID mentions several drug therapies it's supporting to fight coronavirus, but not hydroxychloroquine.  

The Biomedical Advanced Research and Development Authority, another federal agency, also lists its coronavirus measures on its website, but hydroxychloroquine is not among them. "


metmike: The FDA decision to fast track this drug because they believe it could help, exposes CNN's lack of objectivity and honesty and accuracy of reporting, along with their continued effort to magnify fear and pessimism in Americans as they broadcast a message of it being very bad, getting worse and no end in sight...........and its all Trumps fault.

I've tried to minimize the politics in this crisis but after watching CNN with their pathetic fake news intended to make things worse, the last several days(for instance, telling us that the new infection numbers in the US are doubling every 2 to 3 days-blatant lie) its hard to ignore it.

By metmike - March 31, 2020, 1:05 p.m.
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CNN gives us a reason for why using this drug for COVID-19 is bad. I agree that hoarding is bad and lupus patients need it but have over 30,000,000 additional doses being manufactured right now............and where is the balance?

Lupus survivor: Crucial drug can't be snatched away


https://www.cnn.com/2020/03/31/opinions/hydroxychloroquine-covid-19-and-lupus-fear-martin/index.html



By metmike - March 31, 2020, 1:25 p.m.
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metmike: This is how CNN told us about the FDA's decision to fast track this drug because the FDA feels there is compelling evidence to show that it works before going thru the normal testing protocol.  I don't know if the FDA has ever done this in history, so this is profound:


US FDA issues limited emergency use authorization for two drugs usually used to treat malaria

https://www.cnn.com/world/live-news/coronavirus-outbreak-03-30-20-intl-hnk/h_e3d184969ee949b7200a3361b6010bde


From CNN: "But thus far, there is little scientific evidence that chloroquine, or its closely-related analogue hydroxychloroquine, are effective in treating Covid-19."


metmike: Thank you Dr. CNN for your uneducated  fake news opinion to let viewers know that Trump continues to be wrong about everything, including this.


This is actually the statement from the scientific authority made to fast track this drug which is what this story/report from CNN is based on. 

"I have concluded, pursuant to Section 564(d)(3) of theAct, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective for the treatment of COVID-19,when used consistently with the Scopeof Authorization of this letter (SectionII), pursuant to Section 564(c)(2)(A)of the Act. Having reviewed the scientific info"


This comes from:

 Dr. Rick Bright, Ph.D. Director Biomedical Advanced Research and Development Authority (BARDA)Office of Assistant Secretary for Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS)

https://www.fda.gov/media/136534/download


metmike: Hmmmm.......who to believe..... the scientific experts and FDA?.........or the progressive activists at CNN that hate Trumps guts and want us to hate him and not believe in anything Trump does.

By metmike - March 31, 2020, 1:30 p.m.
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Macomb man with COVID-19 says Hydroxychloroquine, Azithromycin saved him


https://www.fox2detroit.com/news/macomb-man-with-covid-19-says-hydroxychloroquine-azithromycin-saved-him


"I was struggling to breathe. I felt like I was slowly drowning and I was sitting there thinking I'm not going to make it until midnight," he said.

Santilli says the experimental drugs Hydroxychloroquine and Azithromycin brought him back from the brink.  The 38-year old was prescribed the drugs a little more than a week ago at Henry Ford Macomb where he was hospitalized for COVID-19.

He says a doctor told him they'd exhausted treatment options. An infectious disease physician recommended he try both.

  

"He stated at that point for COVID-19 patients they saw a lot of positive results in China and South Korea it would be advantageous to try it," Santilli said. "Right away I saw improvements in a few hours: the gasping for air stopped; a lot of my symptoms went away, and really it was a turning point almost a 180 degree turn as to what I was experiencing."

metmike: Hmmmm...........who to believe. This man or CNN?

By metmike - April 1, 2020, 5:33 p.m.
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This tweet from President Obama below made me very sad. I voted for him in 2008 and have defended him here on several occasions, despite his supporting the fraudulent climate accord and fake climate crisis.


https://wattsupwiththat.com/2020/03/31/obama-ties-the-covid-19-pandemic-to-trumps-rollback-of-his-climate-change-initiatives/

"Shameless attempt by former President Obama to score political points from the misery of ordinary Americans."

Tweet

@BarackObama

·

We've seen all too terribly the consequences of those who denied warnings of a pandemic. We can't afford any more consequences of climate denial. All of us, especially young people, have to demand better of our government at every level and vote this fall.

Trump weakens fuel economy standards, rolling back key U.S. effort against climate changeThe Trump administration released weaker fuel economy standards for new cars and trucks, pitting the federal government against California on a policy key to combating climate change.latimes.com


metmike: This is the sort of tweet that President Trump makes that makes me cringe.....but President Obama?? 


C'mon president Obama...........we are in the biggest crisis for this country in our generation. You're much better than this.  Don't use the crisis for your political gain/agenda..........give Americans encouragement and HOPE, like you promised when you got my vote in 2008!


Liberals that believe strongly in you need you right now! Our country needs you right now.  Please don't let us down. 

https://en.wikipedia.org/wiki/Barack_Obama_%22Hope%22_poster

  The most widely distributed version of Shepard Fairey's Obama poster, featuring the word "hope". Other versions used the words "change" and "progress".

By metmike - April 2, 2020, 9:34 p.m.
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Hydroxychloroquine rated ‘most effective’ coronavirus treatment, poll of doctors finds


https://nypost.com/2020/04/02/hydroxychloroquine-most-effective-coronavirus-treatment-poll/


An international poll of thousands of doctors rated the Trump-touted anti-malarial drug hydroxychloroquine as the best treatment for the novel coronavirus.

Of the 6,227 physicians surveyed in 30 countries, 37 percent rated hydroxychloroquine as the “most effective therapy” for combating the potentially deadly illness, according to the results released Thursday.

The survey, conducted by the global health care polling company Sermo, also found that 23 percent of medical professionals had prescribed the drug in the US — far less than other countries.

“Outside the US, hydroxychloroquine was equally used for diagnosed patients with mild to severe symptoms whereas in the US it was most commonly used for high risk diagnosed patients,” the survey found.

The medicine was most widely used in Spain, where 72 percent of physicians said they had prescribed it.

A debate about hydroxychloroquine was sparked two weeks ago after President Trump touted the drug as a possible “game-changer” in the fight against the COVID-19 pandemic, prompting critics to accuse him of peddling unproven, untested remedies.

To date, “there is no evidence” that any medicine “can prevent or cure the disease,” according to the World Health Organization.

By metmike - April 7, 2020, 3:39 p.m.
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Dr. Oz catches Trump's attention as he pushes unproven drug to fight coronavirus


https://www.cnn.com/2020/04/07/media/dr-oz-trump-coronavirus/index.html


memike: Dr. Oz, like the FDA and many others feel that there is scientific evidence to support the use of this drug.

However, since Trump has been a cheerleader for its use, we know that CNN just has to take the complete opposite position and try to slam it and medical sources that promote it.


Dr. Oz likes the drug and is an ally of President Trump.............so CNN feels that they need to SMEAR Dr. Oz's reputation in this article:


CNN: Now Oz has become one of the most passionate and prominent backers of using hydroxychloroquine to fight coronavirus -- despite the lack of firm scientific evidence that it is an effective treatment.

Studies in humans have presented conflicting conclusions. A small Chinese study said the prognosis was "good" but the drug requires further investigation. Meanwhile, a French study combining the drug with a popular antibiotic showed "no evidence of rapid antiviral clearance or clinical benefit."

"The fact of the matter is we don't know if hydroxychloroquine works," CNN chief medical correspondent Sanjay Gupta said Monday.

Experts have also said that side effects from the drug are rare, and most commonly include nausea and diarrhea. Less common side effects can include skin rashes and hair changes.

Nevertheless, Oz has repeatedly touted hydroxychloroquine.

Oz has even called on New York Gov. Andrew Cuomo to lift restrictions on its potential use, despite acknowledging the lack of clinical evidence of whether or not it is effective against the coronavirus. 

"There's no question it's not proven to be beneficial in large clinical trials we expect in America, certainly that the FDA and medical societies would desire," Oz acknowledged Monday on Fox News. "But these have been supported with case studies."

In recent years, Oz appears to have developed a friendly relationship with Trump.

During the 2016 election, Trump sat down with Oz and revealed the results of his physical exam. Oz said at the time that if a patient of his had Trump's records he would "be very happy" and "send them on their way."

Trump in 2017 appointed Oz to the Department of Health and Human Services' council on sport, fitness, and nutrition. The council works to educate Americans on how to live a healthy lifestyle. 

The relationship between Trump and Oz seems to have benefited both parties: Oz has made headlines and Trump has received praise from one of the country's most famous physicians.

Oz, however, has been skewered by the medical community in the past for his recommendations.

In 2015, a group of physicians wrote Columbia University, saying they were "dismayed" Oz was a member of the school's faculty.

The physicians accused Oz of "manifesting an egregious lack of integrity by promoting quack treatments and cures in the interest of personal financial gain."


metmike: Instead of focusing on objective, useful news about this drug, this pathetic article tries to discredit the drug (because Trump supports it) and imply that there is some sort of unethical, hidden relationship between Trump and Oz and that Oz is a quack........just because CNN hates Trump so much that they try to spin every situation to get Trump. 

Seriously, what other reason would they have to go back 5 years ago to drag up(dig up dirt) comments made by some physicians that wrote a letter about Dr. Oz.? Pathetic news reporting by CNN. 

I get that some of his stuff is alternative medicine that does not always work but we know for certain, if Joe Biden was advocating hydroxychloroquine or if Trump was against it and Dr. Oz had the exact same position, they would never have used this article to dig up dirt on Oz.

If Trump was against hydroxychlorioquine, you can bet that CNN would be touting it. 


Let's be clear here on what they are suggesting.


That Dr. Oz is a quack and there is a conflicting, possibly unethical relationship between Trump and Oz and of course, that Trump is continuing to irresponsibly recommend the use of something that has no scientific evidence backing it......scroll up to see the FDA stating otherwise but CNN continues to ignore. 

So what should CNN be doing?

Report the authentic science on hydroxychloriquine independent of Trump.  It's ok to report the views of Oz but they make his relationship with Trump the MOST IMPORTANT PART of the story. In many CNN articles, on topics, when Trump should be an insignificant factor, they continue to make everything about what Trump's position is on it(and emphatically take the opposite side).



By metmike - April 8, 2020, 2:39 a.m.
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          Michigan Democrat thanks Trump, hydroxychloroquine for helping save her life from coronavirus

                  

            Karen Whitsett: 'It has a lot to do with the president'


https://www.washingtontimes.com/news/2020/apr/7/michigan-democrat-thanks-trump-hydroxychloroquine-/


https://www.freep.com/story/news/local/michigan/detroit/2020/04/06/democrat-karen-whitsett-coronavirus-hydroxychloroquine-trump/2955430001/

By metmike - April 8, 2020, 3:08 a.m.
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CNN hates president trump more than they care about the health and lives of the American people. More than they care about honesty or objectivity.

The hate they have for trump drives their actions more than professional journalism. It’s more important to them than their ethical standards or their reputation.

This is the quintessential,example of why hate is the most destructive emotion of all.

It will cause you to say and do things that embarrass yourself without you realizing how embarrassing you are acting because of being blinded by the hate.


                let justice be served            

                            2 responses |                

                Started by GunterK - April 6, 2020, 4:45 p.m.            

https://www.marketforum.com/forum/topic/50115/


Much of CNN’s programming and discussions are designed and focused on hurting president trump. 

They do a lot of really positive things outside of the realm of trump but the tremendous damage that they do to the country and minds of viewers and their own reputation while trying to obliterate president trump  is greater than the good that they do.

Thats hate for you.

We can learn from this. Look how hatred for one person has turned what used to be one of the most trusted news sources in the world into the fake news channel that uses yellow journalism and tabloid news  reporting every day and recently every hour.