Texas Doctor Warns Florida and Others: Feds May Ration Monoclonal Antibodies

BY TYLER DURDENTHURSDAY, SEP 09, 2021 – 09:52 AM

Authored by Jannis Falkenstern via The Epoch Times,

News of monoclonal antibody therapy is spreading as fast as the COVID-19 virus in Florida, but one Texas physician warns of the federal government’s plans to “ration” the treatment, especially in states with low vaccination rates.

On Tuesday, Florida Governor Ron DeSantis opened up another infusion center in St. Cloud, making it the 23rd site for the stateMore than 63,000 doses of the treatment have been given to Floridians so far.

However, a new ordering protocol from the Department of Health and Human Services has one Texas doctor wondering why the federal government would want to ration treatments.

Jim Jackson, a Houston urgent care specialist, recently took to Twitter to voice concerns about the federal government’s interference in ordering Regeneron, the manufacturer of the monoclonal antibodies. Jackson orders his supply through Amerisource, a third-party affiliate for Regeneron. He was surprised to find out that he had to provide the company with other information besides ordering the product.

“This is what happens when government gets involved in things. Before I just told Amerisource how many doses I wanted and they sent them,” Jackson told The Epoch Times.

“Now I have to inventory my entire supply room to count masks and gloves.”

Creating Red Tape

Jackson said he has noticed since the Florida governor has gotten a lot of media attention for his state-sponsored sites, the federal government has stepped in and created a lot of “red tape” where there wasn’t any before. Last week, the doctor took to Twitter and vented his frustration.

“So now the government is getting involved in monoclonal antibody distribution,” Jackson said in a Twitter feed.

“Before I could just order as much as we needed and they shipped it next day air. Now a government commission will decide when, if, and how much I will be able to get for my patients.”

The Department of Health and Human Services website updated their COVID-19 Monoclonal Antibody (mAb) ordering process on Sept. 3.

The statement indicated the department had received a “surge in the utilization of monoclonal antibody drugs” and implemented changes to “help promote optimal and equitable use of the available supply.”

The use of the word “equitable” was what disturbed Jackson.

“This word suggests to me that they’re [federal government] trying to manipulate distribution of who they think should get this,” Jackson said.

“I think they will divert doses from under-vaccinated states like Texas and Florida.”

HHS, under the new ordering process, limits immediate orders and will only ship to administration sites with HHSProtect accounts and current utilization reporting. In addition, HHS will review all orders for alignment with utilization, currently estimated at 70 percent of orders. Although the department says that the measures are temporary and it will continue to “monitor product utilization rates, variant prevalence and overall availability of mAb” to determine when they would return to the “original ordering process.”

Jackson placed an order on Monday and said the site was not “user friendly” and he worries that health clinics like his will simply “give up” because of the lengthy process it takes to order the product.

“It took me almost two hours to navigate the form,” Jackson said. “It is very complex and I almost gave up.”

Jackson said that he hopes this doesn’t deter other physicians from getting the treatments for patients who need them and said that the form was “data driven.”

“I think the form was geared more toward hospitals because of the questions they were asking,” he said.

“They’re after data, I get that, but the length of the form was complex and I had to inventory my supply room just to answer the questions. They wanted to know how many hospital beds I had.  I’m a doctor’s office, not a hospital.”

Forty-eight treatments were ordered by Jackson on Monday, and he said that normally Amerisource sends them next day air, but he wonders what if the new form required by the government will slow down the process and delay treatment for his patients.

‘Ahead of the Curve’

Jackson gave praise to the Florida governor and said that because of his efforts, it put Florida “ahead of the curve.”

“Texans still don’t know about it (monoclonal antibodies),” he said.

“It has not been widely reported; this is a lifesaving treatment.”

“Today I estimate that for every 10 patients, nine of them were either positive for COVID or were worried they had the virus,” he said.

“Most of patients—more than half—has never heard of the monoclonals.”

Currently, Florida is utilizing the Regeneron monoclonal antibodies treatment. Regeneron’s treatment, called REGN-COV2, is a combination of two types of monoclonal antibodies. Monoclonal antibodies work by targeting the coronavirus spike protein, blocking the virus from entering your body’s cells, and stopping the infection from spreading, according to the Health and Human Services website.

Since August, DeSantis has been introducing Regeneron infusion centers for COVID-positive patients to seek treatment. On Tuesday, DeSantis opened up another monoclonal antibodies site he had targeted as a need area. More are scheduled to be opened this week. The governor said as time goes on, the sites will need to be “adjusted as the need for the treatments” increases or subsides.

“The state of Florida is working to ensure all the monoclonal antibody treatment sites have adequate supply to meet the needs of our communities,” said Christina Pushaw, DeSantis’s press secretary.

“At this time, the sites do have sufficient supply, and DOH will continue monitoring this closely.”

Regeneron’s Effectiveness

In January 2021 under Operation Warp Speed, an agreement between Regeneron and the U.S. government was reached in which 1.25 million additional doses of monoclonal antibodies cocktail were purchased, bringing the total supply to 1.5 million to be delivered by June 30, 2021.

The treatments, that the federal government pays for and makes free to patients, have been shown to sharply reduce hospitalizations and deaths when given to patients within a 10-day window of experiencing symptoms, via intravenous infusion or injections. That’s the timeframe in which they have been shown to cut rates of hospitalization and death by roughly 70 percent, according to DeSantis, who says he has “heavily researched and read data” on the virus and treatment options.

Currently, the governor reports that the hospital admission rates have decreased, indicating that vaccinations coupled with the monoclonal treatments have played a part in this reduction.

“COVID is not going away,” DeSantis said at the press conference.

“We just have to learn how to live with it; we are still dealing with the 1918 flu, so I know this will hang on as well.”

Tammy Allen, spokesperson for Regeneron, said she has seen a demand from not only Florida, but other states as well.

“We have seen an increase in demand in recent weeks,” she said in a written statement to The Epoch Times.

“They are largely located in the Southeast—Florida, Texas, Louisiana, Mississippi, and Alabama.”

Allen did not have the data on how many doses were distributed to each state, but said the product that has been distributed has a “shelf life and expiration date of 2023.”

At Tuesday’s press conference, the Florida governor promoted the vaccine but said it could take as long as six weeks to provide full protection.

“The antibody treatments can be given to patients who are already sick, with a more immediate effect,” DeSantis said.

The federal government has been distributing monoclonal antibody drugs to the states since last winter, but the treatments were underused due to a lack of awareness from physicians, low interest among the public, and the logistics of setting up areas to give them to patients via IV infusion. But DeSantis had different ideas and launched a monoclonal pilot program in Jacksonville. Because of its popularity and success rate, more sites were opened and now the governor and his team are marching closer to 32 site goals.

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