Over the last month, the media attacked comedian and podcaster Joe Rogan after he announced he had a bout of Coronavirus, even though he said he felt better in less than a week thanks to a cocktail of medical treatments. 

In an Instagram video, the unvaccinated 54-year-old host of The Joe Rogan Experience told his 13.1 million followers that on a Saturday “I got fevers, sweats, and I knew what was going on.” 

After the diagnosis, Rogan said he “immediately threw the kitchen sink at it,” which included taking the human version of ivermectin, which was prescribed by his physician. The drug was almost immediately mischaracterized by news outlets like CNN as merely a veterinary drug that is formulated for use in cows and horses. Rogan added that his treatments also included monoclonal antibodies, Z-pack antibiotics and a vitamin drip for “three days in a row.” 

“Here we are on Wednesday, and I feel great,” Rogan said.

Almost as if in response to the Rogan controversy, the White House announced that it was going to control the distribution of Covid-19 treatments like monoclonal antibodies, choking their supply to numerous states by up to 50%. This comes despite the fact that federal leaders say the treatments reduce the risk of hospitalization among Covid-19 patients by more than 70 percent. 

The optics make it look like the Biden administration is creating federal barriers to Covid-19 treatments to promote Covid-19 vaccines by making it difficult to obtain vaccine alternatives. This may result in infected patients becoming sick and even dying when treatments become unavailable. 

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Kentucky Gov. Andy Beshear (D) said the federal government announced a change in the way Covid-19 monoclonal antibody treatments will be distributed among states due to supply shortages and extraordinary demand across the country. Meanwhile, Florida Gov. Ron DeSantis (R), refutes those claims as his state had purchased a stockpile of both vaccines and monoclonal antibody treatments which has enabled Florida to administer more than 90,000 monoclonal antibody treatments this year.  

Gov. DeSantis said the new plans by the Biden administration and the U.S. Department of Health and Human Services could slow down the state’s ability to provide those treatments.

“We are very, very concerned with the Biden administration and the HHS’ recent, abrupt, sudden announcement that they are going to dramatically cut the number of monoclonal antibodies that are going to be sent to the state of Florida,” DeSantis said.

White House Press Secretary Jen Psaki said HHS is taking over distribution of monoclonal antibody treatments in order to maintain “equitable” distribution across the country, noting that Florida is one of seven states accounting for 70 percent of orders for the therapy. 

The Biden Administration plan does raise legal and ethical questions as well as why there are so few treatments available in a country that just broke scientific records for the speed in which the Covid-19 vaccines were developed and distributed. 

While off-label use of drugs like remdesivir and ivermectin is being used, the FDA has only provided emergency use authorization for three monoclonal antibody treatments. Meanwhile, the approval of drugs from smaller companies like CytoDyn’s Leronlimab and Relief Theraputics’ aviptadil have not received an Emergency Use Authorization (EUA) or full FDA approval, despite their having far better safety profiles in clinical trials for other uses.

Any layman knows that the fastest way to get society back to normal is with vaccines to prevent severe illness and a combination of treatments for those who unfortunately catch the virus. However, biotech companies with breakthrough treatments are finding it increasingly difficult to wade through the FDA bureaucracy without the benefit of resources that big pharma has to enroll thousands in domestic trials.  

Any layman knows that the fastest way to get society back to normal is with vaccines to prevent severe illness and a combination of treatments for those who unfortunately catch the virus.

Meanwhile, health care providers in states like Texas, Florida, and Kentucky will no longer be able to order their patients’ COVID-19 treatments directly. Instead, state governments will supervise the distribution of a capped number of treatments delivered to them each week. 

“I have a concern that some Kentuckians who are hesitant about the vaccine are placing faith in monoclonal antibodies,” Governor Beshear said. 

“What this shortage ought to tell you is that if you’re unvaccinated and you get really sick, not only might there not be a bed in the hospital for you because they are so full, but that monoclonal antibody treatment might not be there for you either,” Beshear added. “That thing you’re counting on might not be available. What is available, and there are no supply issues at all, are these safe and effective vaccines.”

Demand for Covid-19 treatments is surging as the Delta variant spreads throughout a now-open America. By treating mild-to-moderate cases of Covid-19, patients are kept out of the hospital, where they can have access to treatments at home where they recover faster. 

Initially, the Biden administration purchased another 1.4 million doses of Regeneron‘s monoclonal antibody treatment, but the move to fight off a perceived, potential shortage of the treatment has resulted in the questionable new policy to control distribution to states, even when states want to purchase treatments directly.

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Increased ordering of these treatments from low-vaccination states like Alabama, Mississippi, Louisiana, Tennessee and Georgia prompted HHS to put a temporary allocation on ordering. While the Biden administration states the goal of their plan is to ensure equitable distribution and ensure future patients nationwide have access to the potentially life-saving treatment, they have also vocally criticized vaccine skeptics.

There’s no set timeline for when the allocation will be lifted so states can receive their full orders again and the decision to limit supplies prompted some criticism. Dr. Aruna Arora, president of the Medical Association of the State of Alabama, called for an increase in supplies, not a limitation, and Representative Chip Roy (R – Texas) pressed HHS Secretary Xavier Becerra for answers as to why the limit was put in place and if a shortage was expected.

While the nation’s initial response to the pandemic, through initiatives like Operation Warp Speed that led to the fastest vaccine development in history were effective in making the virus less lethal, the FDA’s failure to grant EUAs and off-label use approvals for safe, effective treatments is part of why the virus continues to keep our country from returning to normal. While the issue of vaccine hesitancy continues to be in the national spotlight, the Biden administration should have the FDA prioritize the approval of treatments to give physicians options to best treat all Americans regardless of their vaccine status. 

What our federal government should not be doing is creating and endorsing policies that discriminate against Americans by violating the Americans with Disabilities Act (ADA) and Health Insurance Portability and Accountability Act (HIPAA).

DISCLOSURE: The author is vaccinated and owns stock in several biotech companies developing treatments for inflammatory diseases, cancer, and HIV that have also been found effective in Covid-19 treatment.

Editors Note: A prior version of this article stated that Andy Beshear is a Republican.

A. Benjamin Mannes, MA, CPP, CESP, is a Subject Matter Expert in Security & Criminal Justice Reform based on his own experiences on both sides of the criminal justice system. He has served as a federal and municipal law enforcement officer and was the former Director, Office of Investigations with the American Board of Internal Medicine. @PublicSafetySME

3 thoughts on “Ben Mannes: Did controversy over Covid-19 treatments reveal the FDA’s “Vaccine Bias”?”

    1. Agree. Same with vyrologix! Charlie Sheen took it for HIV for years, and it’s just been given fast track for Cancer. It had a good safety profile for COVID, but the FDA picked apart it’s trial for a small sample size (even though it was given compassionate use for COVID all over America in 2020). WHY WASN’T IT GIVEN AN EUA?
      Somebody needs to tell Biden that you can have both.

  1. leronlimab is a monoclonal antibody and needs to be in a separate class of its own, as people are using the “MAB” term like those drugs are all interchangeable. they are not. most current “MABS” only are for immediate use when you first get sick, and have no effect on severe/critical patients that are hospitalized. aviptadil is a great hope also, these both need to be approved pronto. when they both are, they could easily and safely be used together (they both have no side effects or conflicts with other drugs) and they both address different elements of covid sickness, for the moderate to severe to critical patients. leronlimab for the “cytokine storm” and aviptadil to clear the lungs.

    the combo will be Leronlimab + Aviptadil = the L.A. one-two punch!

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