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    Wuhan Virus Watch: FDA Issues Emergency Authorization of Two Anti-Malaria Drugs for Coronavirus treatment

    Wuhan Virus Watch: FDA Issues Emergency Authorization of Two Anti-Malaria Drugs for Coronavirus treatment

    Novartis CEO says malaria drug is biggest hope against coronavirus

    CDC Image https://www.cdc.gov/coronavirus/2019-ncov/images/2019-coronavirus.png

    I reported yesterday that Italy and France officially authorized the use of chloroquine and hydroxychloroquine to treat severe cases of Wuhan coronavirus.

    Now, the US Food and Drug Administration has issued its own emergency authorization.

    The authorization came in a letter dated Saturday, but the US Department of Health and Human Services (HHS) acknowledged the FDA’s action in a Sunday news release. The FDA limited the scope of its authorization to drugs supplied from the Strategic National Stockpile. The HHS announced that two pharmaceutical companies — Bayer and a division of Novartis — had donated the drugs to the stockpile.

    Do the drugs work? In its statement, HHS said:

    “Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients.
    “The safety profile of these drugs has only been studied for FDA approved indications, not COVID-19.”

    While there’s limited evidence on the efficacy of chloroquine, or hydroxychloroquine, the FDA said the drugs’ benefits outweighed their risk. In its letter, the FDA encouraged randomized clinical trials that could assess the effectiveness of the drugs. It also noted that the known and potential benefits outweigh the risks.

    Who can the drugs be used to treat? The authorization is limited to patients who are currently hospitalized and weigh at least 50kg, or about 110 pounds. Under the emergency use authorization, health care providers must contact their local or state health department to access the drugs.

    As a reminder, these “anecdotal reports” include 2 studies by a French team that had tremendous success using these drugs to ease the effects of the viral infection.

    Novartis CEO says malaria drug is the biggest hope against coronavirus

    One big name in the pharmaceutical industry supports the use of anti-malarial drugs as part of the COVID-19 treatment plans.

    Novartis Chief Executive Vas Narasimhan said his Sandoz generics unit’s malaria, lupus and arthritis drug hydroxychloroquine is the company’s biggest hope against the coronavirus, Swiss newspaper SonntagsZeitung reported on Sunday.

    Novartis has pledged to donate 130 million doses and is supporting clinical trials needed before the medicine, which U.S. President Donald Trump also has been promoting, can be approved for use against the coronavirus.

    Other companies including Bayer and Teva have also agreed to donate hydroxychloroquine or similar drugs, while Gilead Sciences is testing its experimental drug remdesivir against coronavirus.

    “Pre-clinical studies in animals as well as the first data from clinical studies show that hydroxychloroquine kills the coronavirus,” Narasimhan told the newspaper. “We’re working with Swiss hospitals on possible treatment protocols for the clinical use of the drug, but it’s too early to say anything definitively.”

    Israeli doctor in Italy says innovative treatments offering hopes of recovery

    An Israeli doctor in northern Italy says several new procedures appear to be helping some COVID-19 patients. Carmi Sheffer, a doctor at the University Hospital of Padua, told The Times of Israel’s Hebrew-language sister site, Zman Yisrael, that at the onset of the nation’s outbreaks, he had been pessimistic.

    ..One technique he said had yielded dramatic results was to have patients lie on their stomach instead of on their back while on a ventilator. “Suddenly the oxygen level in the blood jumped by hundreds of percents,” he said.

    “I think the worst is behind us. We will control the virus and flatten the curve within a few weeks, but the closure will continue until June,” he predicted. “Italy is ahead of Israel by something like a month, so in my opinion, [in Israel] it will end only in July.”

    Why Germany’s Coronavirus Death Rate Is Far Lower Than In Other Countries

    Early testing is part of the success.

    As Europe has become the epicenter of the global coronavirus pandemic, Italy’s fatality rate hovers around 10%. France’s is around 5%. Yet Germany’s fatality rate from COVID-19 has remained remarkably low since cases started showing up there more than a month ago. As of March 25, there were 175 deaths and 34,055 cases.

    [Christian Drosten, director of the institute of virology at Berlin’s Charité hospital], whose team of researchers developed the first COVID-19 test used in the public domain, said Germany’s low fatality rate is because of his country’s ability to test early and often. He estimates Germany has been testing around 120,000 people a week for COVID-19 during the monthlong period from late February to now, when it’s reached epidemic proportions in the country, the most extensive testing regimen in the world.

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    Comments


    OK doctors – do you have an opinion why putting a person on a ventilator on their stomach improves the O2 levels? I know this is just “anecdotal evidence”. But, the theory is easily tested by having the patient in both positions and checking O2 levels.

    The ventilator is providing oxygen under pressure to get more O2 throughout the lung and into the bloodstream. Right?

    It seems that being on your back, the lungs are expanding, but there is no strong external pressure as an assist. Being on your stomach, your body weight is providing some additional pressure to get more oxygen into your blood stream.

    Any opinions?


       
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      stevewhitemd in reply to Liz. | March 30, 2020 at 12:16 pm

      Yes (I’m a pulmonary physician). “Proning” a patient for periods of time (2 hours prone, 2 hours supine, etc) leads to better matching up of ventilation (air going into the lungs) and perfusion (blood going through the lungs). We refer to this as the V/Q ratio (Q for perfusion because ‘P’ was already taken for pressure).

      If V/Q is too high, we ventilate lung that isn’t being perfused.

      If V/Q is too low we perfuse lung that isn’t being ventilated.

      So we want a proper blend.

      Right now you and I sitting in our chairs have a blend of all three regions, but most of our lung is of the proper V/Q ratio. That’s how we get oxygen into our blood.

      A critically ill person with ARDS has damaged lungs, and more of the lung has V/Q ratios that are off (too high and too low). Leaving them supine all the time makes that worse. Proning them helps to fix that. It’s well demonstrated in clinical trials in ICUs and is now standard practice.


         
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        Liz in reply to stevewhitemd. | March 30, 2020 at 12:57 pm

        Thanks for the explanation. The doctor referenced in the article was an Israeli taking care of people in Italy. So, I wonder if the advice is just a reminder for the rest of the world.

        I checked out some training videos about how to move a patient on the ventilator from prone to supine positions. The process included changing out the linens and used three people for the head and both sides. So, very labor and supply intensive process. I wonder if that is impacting patient care in some countries?


     
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    danvillemom | March 30, 2020 at 1:26 pm

    I have a question – does the FDA approval override the threat to the MI Doctors by their governor?


     
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    heyjoojoo | March 30, 2020 at 4:32 pm

    How can a governor block drug use in a state. I guess they can do that since there was no federal law being applied here?


     
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    guyjones | March 30, 2020 at 5:44 pm

    Ponder how the vicious, deranged and truly contemptible American mainstream media, Dhimmi-crat prostitute-propagandists immediately leaped to condemn Trump, for merely expressing an aspiration, born of optimism, that anti-malaria drugs MIGHT be of some use.

    If the sainted Obama had stated the same thing, these utterly vile hypocrites would be swooning at his feet and singing hosannas to his alleged sagacity, for giving people hope.


     
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    Milhouse | March 30, 2020 at 7:36 pm

    Note that the limitations on the FDA authorization don’t mean you can’t use it for anything else. Doctors are entitled to prescribe it for anything they like, if they believe it can help. They don’t need the FDA’s permission.

    I don’t understand how a state governor can interfere with that. If someone can explain that, please do.

    Note that Dr Zelenko has been treating people before they are hospitalized, and has so far had 100% success in keeping people from needing to be hospitalized. This authorization doesn’t help with that.

    HOWEVER. Watch this video from an expert on chlorinique, warning of a risk that Dr Zelenko and some others pushing this cocktail seem unaware of. The combination of chlorinique and Z-Pak can cause heart attacks. Still, at a time like this that may be a risk people are willing to take.


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