Sen. Paul, Dr. Bartlett & Dr. Watkins: FDA should grant budesonide emergency use authorization to treat COVID

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    A worldwide health care crisis demands agility and common sense, both in short supply in America these days. 

    As COVID-19 case numbers and hospitalizations rise throughout the nation, doctors continue to battle this virus. In this environment of fear and death, a most unlikely tool has surfaced in the maelstrom, giving hope and life in a most desperate time. 

    What is showing efficacy? Nebulized budesonide.  

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    The Food and Drug Administration (FDA) granted emergency use authorizations (EUAs) for PCR tests, monoclonal antibodies, and vaccines. It is time to add a new weapon in this war and grant a similar EUA for this effective, inexpensive and widely available, therapy that has been FDA-approved for other purposes for over four decades.   

    What is budesonide?

    Budesonide has been utilized for over 40 years to help treat and prevent the symptoms of asthma in even our most vulnerable members of society – premature infants. The Mayo Clinic states that budesonide “is used to help prevent the symptoms of asthma.” According to WebMD, budesonide “is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This medication belongs to a class of drugs known as corticosteroids. It works directly in the lungs to make breathing easier by reducing the irritation and swelling of the airways.”

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    That is exactly what we need to fight COVID-19 – a drug that works directly in the lungs. Nebulized budesonide is a steroid that targets the impacted lung tissue. This is not rocket science. Just maybe there is a simple solution to a devastating and complex virus.

    How has Budesonide been used to treat COVID-19?

    Hospital systems and clinics are generally refusing to prescribe nebulized Budesonide in the United States, even when patients’ families request it after being told their loved ones will not recover. Yet the few studies that have been conducted all concur that nebulized Budesonide is a definite treatment option and should be considered. 

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    In a July 2021 article, the National Institutes of Health (NIH) stated, “Early administration of inhaled budesonide reduced the likelihood of needing urgent medical care and reduced time to recovery after early COVID-19.” In another July 2021 article titled “Antiviral Effect of Budesonide against SARS-CoV-2,” the NIH stated, “In conclusion, we hereby provide evidence that budesonide can significantly reduce SARS-CoV-2 titers in vitro.”

    Budesonide was approved in April of 2021 by the United Kingdom’s NHS to treat COVID-19 on a case-by-case basis. Joint Chief Investigator Chris Butler, a South Wales general practitioner and professor of primary care from the University of Oxford’s Nuffield Department of Primary Care Health Sciences, said, “A relatively cheap, widely available drug with very few side effects helps people at higher risk of worse outcomes from COVID-19 recover quicker, stay better once they feel recovered, and improves their well-being. We therefore anticipate that medical practitioners around the world caring for people with COVID-19 in the community may wish to consider this evidence when making treatment decisions, as it should help people with COVID-19 recover quicker.”

    Americans should not be living in fear and anxiety. This deadly virus can be treated, and treated effectively.  

    Just because a drug has been around for four decades and no longer contributes to the bottom line does not mean it should be written off when doctors prescribe it off-label with great success.

    What is the FDA’s job?

    According to the FDA’s own mission statement, it is “responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.” 

    What exactly does it mean to “advance the public health”? With a budget of $5.9 billion, the taxpayers should be getting a lot in a pandemic! Eighteen months into this COVID-19 crisis, certainly the FDA should be providing up-to-date information to Americans that includes effective outpatient therapies as well as a proven plan of attack for hospitalized patients.     

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    Americans should not be living in fear and anxiety. This deadly virus can be treated, and treated effectively.  

    We demand that the FDA do its job and grant an EUA for nebulized budesonide (1 mg every four hours) for the treatment of COVID-19.  

    CLICK HERE TO READ MORE FROM SEN. RAND PAUL

    Dr. Richard Bartlett is a primary care physician who specializes in family medicine and is a veteran emergency room doctor from Odessa, Texas.

    Dr. Alexandria Watkins is a family nurse practitioner from Big Spring, Texas.

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