Biden, DeSantis butt heads but agree on this: Vaccines, antibody therapy save lives

Will state allow pharmacies to administer safe, free COVID therapy?

By: - September 13, 2021 7:00 am

A clinical researcher examines a flask of COVID antibodies used to develop monoclonal antibodies therapies to treat early-stage COVID infections. Gianluca Panella/Getty Images 2021

While President Joe Biden and Gov. Ron DeSantis clash regularly over management of the deadly resurgence of COVID-19, they agree on this: Approved vaccines and monoclonal antibody therapy are the best medical tools for fighting coronavirus and its Delta variant.

The Democratic president and the Republican governor who might run against him in 2024 both call for more people to be vaccinated, stressing that approved vaccines are both safe and effective, and reduce the spread of the virus and development of new strains. They both promote monoclonal antibody therapy as a nearly miraculous treatment for people who get infected, as long as they get it early.

But the accord stops there. They strongly disagree about whether vaccines and COVID restrictions such as face-masking should be mandatory, with Biden using his federal authority to impose mandates under federal jurisdiction for the common good and DeSantis banning mandates in Florida in the name of personal choice.

DeSantis has conspicuously declined federal offers to send “COVID surge response” teams to Florida with supplies and personnel to help bring down the state’s high rates of infections and hospitalizations. When the Florida Department of Health confirmed it had, in fact, requested and received hundreds of ventilators and other equipment from the federal stockpile, as reported by CNN and other news media, DeSantis told reporters on Aug. 11 that he hadn’t known about or authorized the request.

Instead, DeSantis announced that same week that he was dispatching state “rapid response” teams to administer Regeneron’s brand of monoclonal antibody therapy in certain communities and nursing homes. In a flurry of press conferences since mid-August, he unveiled 25 Regeneron clinics where people can get the treatment, free of charge, without a prescription and with or without an appointment. The medicine can be administered by infusion (intravenously) or by subcutaneous injection (four shots given in various parts of the body).

On Thursday, President Biden announced a stepped-up anti-COVID campaign that includes what could be a big development for Florida and other states. Biden issued an amendment to the Public Readiness and Emergency Preparedness Act, or PREP Act, to allow pharmacies to administer monoclonal antibody therapy. That would dramatically expand access by offering the treatment through the broad network of pharmacies where vaccines are widely administered.

Florida Pharmacy Association Executive Vice President and CEO Michael Jackson said Florida pharmacies are interested in participating, especially in administering the therapy by way of shots, rather than infusion.

“That would expand the access. For a patient who has contracted COVID, having more options for treatment would be beneficial,” Jackson told the Phoenix. If antibody therapy helps reduce pressure on hospitals and intensive-care units “overflowing” with COVID patients, then the more access the better, he said.

However, it was not yet clear to Jackson whether pharmacists’ new authority under the amended PREP Act creates a clear “pathway” for them that overcomes any state laws in conflict with it.

“Florida law is probably not clear that pharmacists could [administer the therapy],” Jackson said. It also was not clear whether the sole distributor of Regeneron monoclonal antibody therapy — AmerisourceBergen — is required to supply it to any and all authorized pharmacies, he said.

CDC data trackers say Florida recorded 91,853 new COVID cases last week, high hospital utilization, and 193 fatalities. The death rate was relatively low compared with many states.

Pharmacy leaders elsewhere agree with Jackson that the situation is promising for COVID patients but still murky for pharmacists.

“I would surmise that all 50 states have pharmacists who will be offering the mAb [monoclonal antibody] treatments in their pharmacies or other locations,” said Joni Cover, vice president for strategic initiatives at the National Alliance of State Pharmacy Associations. “Pharmacists have been on the front lines of the pandemic since day one, and I don’t see them shying away from yet another opportunity to help the people in their communities.”

Lisa Johnson, communications director for the Alabama Pharmacy Association, said the organization alerted its members about the new authority right away and will evaluate how to exercise it.

Home remedies derail progress

Meanwhile, discredited and even dangerous treatments for COVID-19 such as ivermectin and hydroxychloroquine are gaining popularity in conservative circles that promote distrust of the nation’s top medical experts.

That leaves Florida nurses running the state-sponsored Regeneron clinics baffled, since the monoclonal antibody therapy they administer at no charge is proven to be safe and almost miraculously effective when taken as soon as one becomes infected (and no more than 10 days later).

For nurses Jill McElwee and Tiffany Brown, running such a clinic at Governor’s Square Mall in Tallahassee, easing patients’ suffering and reducing pressure on overworked hospitals and health-care providers is the two-fold name of the game.

Their team of 14 nurses and an incident manager — who work for the state Department of Health and the Division of Emergency Management — say they have plenty of medicine to give and more capacity than they’re using. They don’t debate the politics or optics of vaccines, masks, or quack therapies. McElwee said she welcomes the opportunity for pharmacies, too, to provide monoclonal antibody therapy.

“We’re nurses. We look at the big picture. There is no sense in people suffering,” said McElwee, the incident manager.

She questioned why any COVID-sick person would decline monoclonal antibody therapy, other than not knowing about it. (The therapy also is available in hospitals and infusion centers, many of which are listed here by the National Infusion Center Association. Find Florida state-run clinics on this webpage.) She said her team’s clinic in Tallahassee offers both infusion therapy and the four-shot series of injections in a comfortable setting, complete with TV and snacks. Nurses observe patients for for an hour, watching for rare adverse reactions, before sending them home.

The patients remain contagious after treatment, so the nurses remind them to follow CDC quarantine guidelines until they test negative. They also remind patients to protect themselves and others by following CDC guidelines to get vaccinated, wear masks, and practice safe distancing.

For the luxury class, at least one private company, CourMed, has launched “concierge” service: delivering monoclonal antibody therapy and a trained professional to administer it right to your home. The service, offered in Dade, Broward, and Palm Beach counties and soon to be expanded, costs $1,000, cash only, according to Anna Walsh with Pace PR, a public-relations firm for CourMed.

Ivermectin poisonings surged in August, following the resurgence of COVID-19 cases in July. Source: National Poison Data System

In contrast, people engaging in do-it-yourself treatments with ivermectin, hydroxychloroquine, and the like endanger themselves and add to the health-care burden, according to reports from hospitals around the country. The National Poison Data System reports 163 percent more ivermectin poisonings so far this year than in 2020, driven largely by a surge in August.

Ivermectin is an effective treatment for parasites in animals and for use by humans to treat parasites such as head lice and scabies, according to the National Institutes of Health (NIH) . It is not approved for treating coronavirus or any viral infection. Studies evaluated so far by the National Institutes of Health cite some potential for reducing COVID-like symptoms but only with doses 100 times higher than is considered safe for humans.

Hydroxychloroquine, long approved to treat malaria, was soundly rejected as a COVID treatment by scientists at the NIH after former President Donald Trump pitched it as a possible cure, along with disinfecting oneself with bleach.

Social media channels make clear that some Floridians turn to risky home remedies because they disdain scientists at the nation’s premier public-health centers. It’s not surprising, with slogans widely promoted by Friends of Ron DeSantis such as “Don’t Fauci My Florida,” referring to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and presidential adviser on the COVID-19 pandemic.

Polk County appeals to the governor

The Polk County Commission joined the home-remedies bandwagon on Sept. 7 in a draft letter to DeSantis.

“We are hearing from many of our citizens that larger hospital chains and some pharmacies are refusing to prescribe safe and effective therapeutics like hydroxychloroquine and ivermectin,” the commission wrote. “When a citizen is facing a potentially life-threatening case of COVID-19, he or she should receive the ‘right to try’ potentially life-saving therapeutics.”

The draft seeks DeSantis’ help in making those therapies available on demand, although it does not articulate what authority the governor may have to do that.

The idea, proposed by Commissioner Neil Combee, builds on a 2015 state law granting terminally ill patients a “right to try” unauthorized treatments. The letter fails to mention COVID infections need not become terminal.

“You have the right to try any drug regardless of whether your doctor agrees or not. The doctor’s opinion is not the final word, the citizens have the final word on their own health,” Combee said, as reported by the Lakeland Ledger.

The draft, which the commission opted to delay sending to the governor, doesn’t acknowledge the roles long played by state and federal agencies in evaluating the safety and effectiveness of various foods, drugs, and chemical products before they are legal to market to the public.

Polk County Health Department Director Dr. Joy Jackson told commissioners that patients would be wise to consult trained medical professionals rather than engage in dangerous home remedies such as ivermectin that are being pitched in amateur circles.

“People are experiencing adverse effects. I strongly advise the public not to self-medicate with ivermectin,” she said, according to the Ledger report.

Falsely believing that discredited remedies can cure COVID also can prove life-threatening by derailing a COVID-infected patient from seeking approved, appropriate care from health professionals, says Michael  Jackson, at the Florida Pharmacy Association.

“If a person is sick, they first thing they must do is seek help from a health-care provider. The worse thing is to delay. This is a terrible, terrible disease,” Jackson said.

He also urges people not to view therapy of any kind as an alternative to getting vaccinated, which prevents most infections from every occurring and reduces the severity of breakthrough cases. The vaccines — safe, effective, readily available, and free — prevent people from becoming ill, missing work, risking long-term side effects, and endangering others by helping spread the virus.

Jackson likened vaccination to driving as safely as possible, to avoid the dangers of being in a car wreck that could have long-term or fatal consequences for the driver and others.

Correction: Jill McElwee is a nurse and incident manager of an antibody site in Leon County. Her name was misspelled in this story. We are sorry and we’ve corrected the spelling.

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Laura Cassels
Laura Cassels

Laura Cassels is a reporter, former statehouse bureau chief, and former city editor. She is a classical pianist, a Florida State University graduate and proud alum of the Florida Flambeau, an independent college newspaper.