Gov. DeSantis again bashes federal monoclonal squeeze, says tourists may be ‘bringing different delta’

Gov. Ron DeSantis continued his condemnation of President Joe Biden’s administration Wednesday for pinching the federal supply of two monoclonal antibody therapies, which has led to canceled treatment appointments for thousands of Floridians.

In a press conference at Miami Dade College’s North Campus, DeSantis called the move “a rash decision” not backed by clinical data and a dangerous choice because cases of the COVID-19 delta variant haven’t fully disappeared.

“You don’t know when somebody comes in, necessarily, whether they have the omicron infection or the delta infection, and we know definitively this stuff is great against the delta variant,” he said. “So, why would you take that out of play for somebody?”

As of Jan. 15, the omicron variant accounted for more than 99% of COVID-19 in the United States, according to the Centers for Disease Control and Prevention and the Food and Drug Administration.

That might not be the case in Florida, DeSantis said, noting the state’s high tourism levels.

“Maybe there’s not as much delta in our native communities who are Florida residents, but we have so many people cycling in and out,” he said. “Who’s to say that they’re not also bringing different delta? That could absolutely be the case.”

On Monday, the FDA barred doctors and other health care providers from administering monoclonal antibody therapies created by Regeneron and Eli Lilly, a major part of DeSantis’ effort to combat serious illness from the virus that has run rampant across Florida.

The FDA, as well as multiple studies and the drug companies themselves, say REGEN-COV and bamlanivimab “are highly unlikely to be active against the omicron variant” and “not medically appropriate” to use at this time.

DeSantis dismissed the studies as insufficient, noting they had been conducted using cells and not on humans.

“It has not been proven that this does not work against omicron,” he said. “That’s based on that one lab study. Time will tell. If you do clinical trials, who knows how it will end up working out? I don’t know. I wish I did. But when that is being said like that, that is not accurate, and that is misleading people.”

Florida as recently as last week opened additional monoclonal antibody treatment sites after receiving shipments of the drug. The Florida Department of Health website lists 46 such locations.

But on Tuesday, after the federal government said it would not send out any further monoclonal antibody therapies made by the two companies, Surgeon General Joseph Ladapo said treatment sites would be “closed until further notice.”

Forcing closures of treatment locations removes from health professionals’ hands a powerful tool to treat patients, said Dr. Kenneth Scheppke, deputy secretary of the Florida Department of Health.

“It’s a very well-tolerated, scientifically proven treatment against the virus, and what’s important (is that) it’s safe,” he said. “There’s very few side effects. Just about every person who meets emergency use authorization is a candidate for that. And what’s nice is that we’re seeing in the pipeline other various treatments that are coming through, but they have various problems with them.”

Without human testing, he said, the federal government is really only guessing as to whether the two monoclonal antibody therapies are effective.

“When a medication is approved to be used on humans, they might start off on cells to make a theory on whether it will work on humans,” he said. “We’ve got two pieces of conflicting data. We have this study on cells that suggests maybe it might be less effective on omicron, these particular monoclonals, but then we have real-world experience in humans, where we see excellent outcomes. And those two pieces of data conflict.”

DeSantis and Scheppke were joined by Dr. David Farcy, chair of the Mount Sinai Medical Center’s Department of Emergency Medicine; Dr. Dwight Reynolds, medical director and owner of Coral Springs-based Centers for Health Promotion; South Florida Realtor Scott Fortney, who caught the virus and recovered using monoclonal antibodies; and Nancy Schlotter and Frank Schlotter, a married couple participating remotely whose treatment appointments were canceled Tuesday.

Fortney said he became symptomatic for the virus a week and a half ago.

But after receiving monoclonal antibody treatment, he said, he felt far better but was “still a little tired.”

“And I will say I kind of have a control group I can share with you, because the person that I live with, she got COVID as well, elected not to have the monoclonal antibody treatments,” he said. “She tested positive the day following (and) still feels terrible.”

There are other COVID-19 therapies Florida can use that continue to have FDA approval and which scientists say work against the omicron variant, including Paxlovid, remdesivir, and sotrovimab, which is now the most recommended antibody treatment.

Florida’s supply of sotrovimab, however, isn’t “anywhere near enough,” said DeSantis, who bashed drug manufacturer Merck’s antiviral pill, molnupiravir, which the FDA authorized last month for use against COVID-19.

“Honestly, you look at that data — yikes,” he said, possibly referring to safety concerns raised recently in India and findings that the pill only reduces the risk of hospitalization from COVID-19 by 30%. “And yet that is the one they’re pushing.”