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Tags: Coronavirus | Rand Paul | monoclonal | antibodies | cdc | fda | richard bartlett

Rand Paul and Richard Bartlett: Government Needs to Get Out of the Way on COVID Treatments

Rand Paul and Richard Bartlett: Government Needs to Get Out of the Way on COVID Treatments
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By    |   Tuesday, 28 September 2021 12:37 PM

Any rational person would think arbitrarily preventing those sick with COVID-19 from receiving potentially life-saving treatment is immoral. But that’s exactly what is happening to many patients who are seriously ill with COVID-19.

Mandates that lack nuance or physician discretion are preventing patients admitted to hospitals from getting monoclonal antibodies and inhaled steroids because the government has not approved these treatments for in-patient use.

Despite over 90% of people over 65 having received at least one dose of the COVID-19 vaccine, we are in the midst of yet another wave of infection. Many of the infected are unvaccinated but also a considerable number of the newly infected are fully vaccinated.

Yet, the government continues to place obstacles in the way of treatment. Studies have repeatedly shown that inhaled steroids prevent hospitalizations, but the government still has not approved inhaled steroids for hospitalized COVID-19 patients.

Specifically, the STOIC trial from University of Oxford showed a 90% reduction in hospitalizations using inhaled budesonide. In another randomized control trial found on the NIH from 2017, budesonide was found to vastly improve lung mechanics and oxygenation in patients with acute respiratory ailments who were ventilated.

Since the primary organ failure that causes death in COVID-19 is the lungs, one would think inhaled steroids, specifically inhaled budesonide, that are directly absorbed in the lungs would make eminent sense.

Rigid governmental mandates are deterring doctors from using inhaled budesonide in both the out-patient setting and the in-patient setting.

Likewise, monoclonal antibodies given as an outpatient greatly reduce hospitalization.

Monoclonal antibodies are one of the most promising treatments for the virus once the person has been infected. Recent data showed that monoclonal antibody treatment cuts the risk of death and hospitalization by 70% in high-risk patients and reduces the chance of infection among a household by 80%.

Yet, the government in its infinite wisdom, arbitrarily and capriciously bans doctors from using most monoclonal antibodies once you are an inpatient. According to Food and Drug Administration’s Emergency Use Authorization for monoclonal antibodies, “REGEN-COV (casirivimab and imdevimab) is not authorized for use in patients who are hospitalized due to COVID-19.”

The co-author of this piece, Dr. Richard Bartlett, has had hospital patients with COVID-19 calling and begging to help them be discharged from the main hospital into the emergency room so they can get the IV monoclonal antibody treatment. Recently, one of these patients had to threaten to leave the hospital, against medical advice to finally get a monoclonal treatment.

The government maintains that monoclonals lose their efficacy as the disease worsens. But if monoclonals reduce mortality on day seven by 70%, it’s hard to believe they would have no effect on day 11. Loss of efficacy typically looks like a curve, not a sudden plummeting to zero. Shouldn’t patients facing the prospect of being placed on the ventilator be given the option of trying the monoclonal treatment?

Furthermore, if you’re admitted to the hospital on day five of symptoms, you still meet the Center for Disease Control and Prevention’s window on symptoms but apparently you no longer qualify to receive the monoclonal treatment because you are now an in-patient. That reasoning makes no logical sense at all.

What kind of medical regime bans a treatment once a patient crosses the threshold of the hospital doors? You can get the monoclonals in the ER but verboten once you pass through the doors into the main hospital. That is insane.

While we understand there are risks inherent in any treatment, one-size-fits-all government rules should not be the reason why someone is prevented from receiving a potentially life-saving drug like monoclonal antibodies.

Let the physicians decide what’s best for their own patients.

Thankfully some smaller hospitals with local autonomy are allowing the use of monoclonal antibodies for in patients. (But don’t tell Big Brother or Dr. Fauci).

For now, patients are faced with a quandary. If you tell your doctor, you’ve had symptoms for 11 days, you won’t be eligible for monoclonals. If it just happens (accidentally, of course) that you forget to mention the first three days of symptoms, voila — you might just get the monoclonal antibodies.

In Florida, Governor DeSantis is no doubt saving lives by making monoclonal antibodies more accessible to the public. This, of course, infuriates the medical experts on Mt. Olympus, so they are now informing us that we are too zealous in our desire to save lives so Big Brother must step in and ration the supply.

Infuriating. Nevertheless, everyone needs to know the state of medical care in our country and advocate for your loved ones. Treatment is not being equally distributed. The informed and the most vocal are able to get treatment. So, we encourage you to ask your doctor about these treatments. It might just save your life.

We demand the FDA immediately issue EUA for inhaled budesonide to use for both early outpatient treatment as well as in-hospital treatment for COVID 19 as well as an EUA for monoclonal antibodies treatment to use for in-hospital treatment for Covid.

U.S. Sen. Rand Paul is a Kentucky senator and physician. Dr. Richard Bartlett is a primary care and emergency room doctor from Texas.

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Let the physicians decide what’s best for their own patients.
monoclonal, antibodies, cdc, fda, richard bartlett, government
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2021-37-28
Tuesday, 28 September 2021 12:37 PM
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