It is becoming increasingly evident that vaccinated and unvaccinated Americans who are infected with COVID-19 need early outpatient treatment for COVID-19. When the Department of Health and Human Services (HHS) decided to ration monoclonal antibodies, Florida Governor Ron DeSantis noted that even many Floridians who did precisely what the government has asked them to do require the treatment. In a September 16 press conference, DeSantis said, “At our Broward site, 52% of the patients that have received treatment have been vaccinated, 69% of those over 60 that have received treatment at the Broward site had been vaccinated.”
He continued, “In Miami Dade, almost 60% of everybody that’s been treated at the Tropical Park site has been vaccinated. And 73% of the patients treated at the state site in Tropical Park that are over the age of 60 have been vaccinated. I think that the message is you do need to have treatment as an important component when you’re dealing with COVID.”
Unfortunately, institutions are preventing doctors across the country and globally from providing treatment before hospitalization for an illness with pretty common symptoms, such as inflammation and viral replication. There are existing medications that improve both. In the United States, doctors are being threatened and intimidated by state medical boards, being overruled by hospital administrators and chain pharmacies, being censored by the media, and being investigated or even disciplined by their universities for recommending early treatment. This unprecedented interference in clinical practice motivated frontline clinicians and researchers worldwide to meet recently in Rome, Italy.
The result is the Rome Declaration, posted on September 23, with 7,200 signatures from doctors and researchers. They are demanding a restoration of the doctor/patient relationship, an end to political intrusion into the practice of medicine, and a restoration of their rights to prescribe treatment under the principle of “First do no harm.” Republican governors should immediately move to restore autonomy in the practice of medicine within their borders. The regulation of licensure and the practice of medicine is primarily a state responsibility, and governors need to act like it.
In the United States, a lack of guidance from our health bureaucracies does not mean that doctors can’t look at treatments, research, and results and choose to prescribe an FDA-approved medicine in light of their findings. Even the FDA says so:
From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.
You may be asking yourself why your healthcare provider would want to prescribe a drug to treat a disease or medical condition that the drug is not approved for. One reason is that there might not be an approved drug to treat your disease or medical condition. Another is that you may have tried all approved treatments without seeing any benefits. In situations like these, you and your healthcare provider may talk about using an approved drug for an unapproved use to treat your disease or medical condition.
Unfortunately, doctors are being threatened and intimidated into providing only treatments recommended by federal agencies for COVID-19. This paradigm is unprecedented. GOP governors should take immediate executive action to prohibit harassment from state medical boards when a doctor provides a patient with informed consent and prescribes an otherwise approved drug to treat the symptoms of COVID-19 or assist in prevention. Further, governors should use every tool possible to prevent chain pharmacies and hospital administrators from interfering in the practice of medicine.
There are some indications that Pfizer and Merck will receive emergency use authorizations for antiviral medications to treat COVID-19 in the next several months. Purportedly, these drugs prevent transmission. So did the vaccines until five minutes ago. The availability of these drugs should not preclude patients from choosing to take medications with known actions and longer safety records. Nor should politics and institutional capture.
Until these new drugs are available, vaccinated and unvaccinated patients will need treatment. HHS is rationing monoclonal antibodies, the only approved outpatient medication for COVID-19. Governors need to free doctors to provide relief and hope using existing drugs known to treat the common symptoms of COVID-19, such as inflammation. At worst, they won’t help but won’t hurt. At best, they will continue to disconnect illness from hospitalization. If these governors don’t restore autonomy in the practice of medicine now, it may disappear for good.
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