Wednesday, August 16, 2023
Doctors Can Prescribe Ivermectin for COVID-19: FDA Lawyer
Doctors are free to prescribe ivermectin to treat COVID-19, a lawyer representing the U.S. Food and Drug Administration (FDA) said this week.
“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said during oral arguments on Aug. 8 in the U.S. Court of Appeals for the 5th Circuit.
The government is defending the FDA’s repeated exhortations to people to not take ivermectin for COVID-19, including a post that said “Stop it.”
The case was brought by three doctors who allege the FDA unlawfully interfered with their practice of medicine with the statements. A federal judge dismissed the case in 2022, prompting an appeal.
“The fundamental issue in this case is straightforward. After the FDA approves the human drug for sale, does it then have the authority to interfere with how that drug is used within the doctor-patient relationship? The answer is no,” Jared Kelson, representing the doctors, told the appeals court.
The FDA on Aug. 21, 2021, wrote on X, formerly known as Twitter: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The post, which linked to an FDA page that says people shouldn’t use ivermectin to prevent or treat COVID-19, went viral.
In other statements, the FDA said that ivermectin “isn’t authorized or approved to treat COVID-19” and “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”
Command or Not
“FDA made these statements in response to multiple reports of consumers being hospitalized, after self medicating with ivermectin intended for horses, which is available for purchase over the counter without the need for prescription,” Ms. Honold said.
A version of the drug for animals is available, but ivermectin is approved by the FDA for human use against diseases caused by parasites.
Ms. Honold said that the FDA didn’t purport to require anyone to do anything or to prohibit anyone from doing anything.
“What about when it said, ‘No, stop it’?” Circuit Judge Jennifer Walker Elrod, on the panel that is hearing the appeal, asked. “Why isn’t that a command? If you were in English class, they would say that was a command.”
Ms. Honold described the statements as “merely quips.”
“Can you answer the question, please? Is that a command, ‘Stop it’?” Judge Elrod asked.
“In some contexts, those words could be construed as a command,” Ms. Honold said. “But in this context, where FDA was simply using these words in the context of a quippy tweet meant to share its informational article, those statements do not rise to the level of a command.”
The statements “don’t prohibit doctors from prescribing ivermectin to treat COVID or for any other purpose” Ms. Honold said. She noted that the FDA, along with the statements, said that people should consult their health care providers about COVID-19 treatments and that they could take medicine if it was prescribed by the provider.
“FDA is clearly acknowledging that doctors have the authority to prescribe human ivermectin to treat COVID. So they are not interfering with the authority of doctors to prescribe drugs or to practice medicine,” she said.
Judge Elrod is on the panel with Circuit Judges Edith Brown Clement and Don Willett. All three were appointed under President Donald Trump.
Federal Law
The plaintiffs are Drs. Paul Marik, Mary Bowden, and Robert Apter. They say they were professionally harmed by the FDA’s statements, including being terminated over efforts to prescribe ivermectin to patients.
Dr. Marik has noted that a number of studies support using ivermectin against COVID-19, as the FDA itself has acknowledged. Some other studies show little to no effect.
Federal law enables the FDA to provide information, such as reports of adverse reactions to drugs, but not medical advice, Mr. Kelson said.
“This is something the FDA has never been able to do. And it’s a bright line,” he told the court, adding later: “The clearest examples of where they have gone over the line are when they say things like, ‘You are not a horse, you are not a cow. Seriously, y’all. Stop it.'”
Judges indicated they agree that the FDA lacks the power to give medical advice; Judge Clement said, “You’re not authorized to give medical advice.”
But Ms. Honold said the government “isn’t conceding that in this case.”
She also argued that Congress has empowered the FDA to protect public health and make sure regulated products are safe and effective, giving it the “inherent authority to further its mission by communicating information to the public about safe uses of drugs.”
A ruling in favor of the doctors would prevent the FDA from reporting on consumers suffering after cooking chicken with NyQuil or that opioid addiction is a problem, she claimed.
Mr. Kelson said that wasn’t accurate. “It’s when they step beyond that [and] start telling people how they should or should not be using approved drugs,” he said.
Ms. Honold also said that the courts can’t hold agencies accountable when they provide false or misleading information: “The FDA is politically accountable, just like all other executive agencies.”
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COVID-19 Vagus Nerve Inflammation May Lead to Dysautonomia
New data may provide answers for those experiencing persistent symptoms long after their bout with COVID-19 has ended. These may include fatigue, lightheadedness, brain fog, cognitive issues, gastrointestinal problems, heart palpitations, shortness of breath, or an inability to tolerate upright postures.
A July 15 study published in Acta Neuropathologica suggests that SARS-CoV-2 infection may damage the nerves of the autonomic nervous system (ANS), causing an inflammatory response that can later lead to dysautonomia observed in long COVID patients.
Study Findings
Using several methods, researchers at the University Medical Center Hamburg-Eppendorf in Germany performed a microscopic analysis of the vagus nerves in 27 deceased patients with COVID-19 and five controls who died of other causes, without COVID-19.
The vagus nerve is a vital component of the ANS that regulates critical functions such as digestion, respiratory and heart rate, and immune response. Vagus nerve signaling to the brainstem also controls the “sickness behavior response,” where the brain mounts flu-like symptoms including nausea, fatigue, pain, and other chronic symptoms in response to inflammation.
The researchers detected SARS-CoV-2 RNA in vagus nerve samples obtained from deceased patients with severe COVID-19 showing direct infection of the nerve was accompanied by inflammatory cell infiltration composed mostly of monocytes—a type of white blood cell that finds and destroys germs and eliminates infected cells. Their analysis revealed a “strong enrichment of genes regulating antiviral responses and interferon signaling,” supporting the idea that vagus nerve inflammation is a common phenomenon with COVID-19.
The researchers also analyzed 23 vagus nerve samples of deceased COVID-19 patients grouped into low, intermediate, and high SARS-CoV-2 RNA viral load to determine if the virus was directly detectable in the vagus nerve and if the viral load correlated with vagus nerve dysfunction. Results showed the virus was present in the vagus nerve and also determined there was a direct correlation between SARS-CoV-2 viral RNA load and dysfunction of the central nervous system.
Researchers then screened a cohort of 323 patients admitted to the emergency room between Feb. 13, 2020, and Aug. 15, 2022, categorized by whether they had mild, moderate, severe, critical, or lethal COVID-19. They found that the respiratory rate increased in survivors but decreased in non-survivors of critical COVID-19. These results suggest SARS-CoV-2 induces vagus nerve inflammation followed by autonomic dysfunction (respiratory rate decrease), which “contributes to critical disease courses and might contribute to dysautonomia observed in long COVID.”
Responding to the study, microbiologist Amy Proal of PolyBio Research Foundation wrote on X, “Because the vagus nerve is an essential component of the #autonomic nervous system and regulates body functions such as heart rate, digestion, and respiratory rate, direct infection of the nerve by SARS-CoV-2 may contribute to related symptoms.” She added, “The findings beg the question: Could persistent SARS-CoV-2 infection of the vagus nerve contribute to dysautonomia in #LongCovid?”
What is Dysautonomia?
Nearly 1 in 5 people in the United States continue to experience unexplained symptoms of long COVID after their infection ends, with as many as 66 percent of patients suffering from moderate to severe dysfunction of the ANS known as dysautonomia.
Dysautonomia is a disorder of the ANS, a part of the central nervous system that controls vital involuntary functions such as breathing, heart rate, blood pressure, digestion, skin and body temperature regulation, salivating, hormonal and bladder function, and sexual function. The ANS also plays a role in the acute “fight or flight” stress response and sends messages to and from internal organs.
Dysautonomia causes the ANS—which consists of the sympathetic, parasympathetic, and enteric nervous systems—to malfunction, either through an inability to perform its tasks or by causing too much activity, resulting in high blood pressure or a rapid heart rate. The condition can be confined to the arms and legs or spread throughout the entire body. It can be severe or mild, and may be reversible or worsen over time.
Postural orthostatic tachycardia syndrome (POTS) is a common form of dysautonomia that has increased since the COVID-19 pandemic began and has been reported by those with long COVID and in those following COVID-19 vaccination.
Symptoms of POTS include but are not limited to lightheadedness, difficulty thinking or concentrating, severe and long-lasting fatigue, intolerance to exercise, blurred vision, low blood pressure, heart palpitations, tremors, and nausea.
Since the rollout of COVID-19 vaccines, 801 cases of POTS were reported to the Vaccine Adverse Events Reporting System as of July 28. This includes 597 cases attributed to Pfizer and 171 cases to Moderna.
Dysautonomia Associated With Long COVID or Post-Vaccine Syndromes
The Frontline COVID-19 Critical Care Alliance (FLCCC) has played a major role in treating long COVID and post-vaccine injuries, including people with dysautonomia.
Many long COVID patients are vaccinated, making it difficult to determine whether their prolonged symptoms are due to COVID-19 or vaccine injury. Regardless, both are manifestations of “spike protein-related disease” and share a significant overlap in symptoms, pathogenesis, and treatment, according to the FLCCC.
The FLCCC has developed protocols for people with long COVID and those experiencing post-vaccine injuries, including POTS.
They recommend patients undergo a series of initial tests to determine whether they have long COVID, and a chest scan for those who have respiratory symptoms to differentiate between long COVID and post-vaccine syndrome.
Protocols are geared towards either long COVID (pdf) or post-vaccine injuries (pdf)—including dysautonomia disorders such as POTS—exercised under the care of a practitioner.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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