Boca Regional Participating in Trial of New COVID Treatment

Boca Raton Regional Hospital is participating in the clinical trial of a promising COVID-19 therapy.

Patients enrolled in the trial will receive a low dose of whole-lung radiation to reduce the potentially lethal inflammation that the virus can cause. If successful, the treatment prevents patients from needing a ventilator.

Dr. Michael Kasper is director of radiation oncology at Boca Regional’s Lynn Cancer Institute. In an interview Wednesday, Kasper explained that the treatment–labeled PREVENT–produces the opposite effect from cancer patients, whose lungs get inflamed from radiation treatments because of the powerful doses they must get.

Trial patients, Kasper said, will get doses that are one-15^th or even one-50^th “of what children can tolerate.” Cancer patients also have to receive daily treatments for eight to nine weeks. Trial patients will get just one treatment of the low-dose radiation.

Boca Regional, Kasper said, has screened about 20 patients but has not enrolled one. One reason is that the hospital got approval to enter the trial just three weeks ago. Another is the screening process.

The treatment is for patients at least 50 years old who have not had symptoms longer than nine days. By that point, the virus could have spread, putting it beyond the reach of the treatment. “We need to get to it early,” Kasper said. “Some patients are staying home, trying to treat the symptoms” and thus are being admitted too late to be eligible. Yet he believes that Boca Regional is “very close” to enrolling its first patients.

As with so much about COVID-19, the radiation treatment arose as doctors learned more about the virus and talked among themselves. Kasper said he participated in a Zoom call last April with like-minded physicians. The first trial started at Indiana State University in July.

Also as with so much about the virus, the radiation therapy is being repurposed. Doctors already use it on patients who have cancer, which kills more than 500,000 Americans each year. Similarly, studies have shown that dexamethasone–a steroid that we gave our son three decades ago for bronchitis–can cut the mortality rate among COVID-19 patients.

Ohio State University is the coordinating center for the low-dose radiation trial. Early estimates were that 20 hospitals would participate, but Kasper said Boca Regional is one of only about five to have received approval.

Unlike COVID-19 vaccines, human treatment trials don’t go through the Food and Drug Administration. Approval must come from an Institutional Review Board, which follows FDA regulations. Kasper said the board includes community leaders, clergy, medical professionals and administrators who “examine the pros and cons of the treatment, using high standards” to determine the potential benefits and protect those who enroll. Boca Regional’s approval, Kasper said, took about three months.

Despite the FDA authorizing two vaccines for emergency use, Kasper said the trial remains important because the need for therapies won’t go away soon. It could take six months for “full rollout” of the vaccine, and cases and hospitalizations have been rising.

Covid Act Now rates Florida and Palm Beach County as “active or imminent outbreak.” In addition, polls show that too few Americans will get the vaccine, which could leave the state and nation short of herd immunity.

“There is solid science” behind the treatment, Kasper said. COVID-19 causes the immune system to overreact, leading to that dangerous inflammation in the lungs. The low-dose radiation seeks to stop that overreaction.

The other reason Boca Regional hasn’t enrolled a patient, Kasper said, is that “many doctors aren’t aware” that the treatment is available here. Now they know.

And the vaccine

Kasper was leaving our interview to drive to Miami and receive his first vaccine dose. A hospital spokesman, however, did not know when Boca Raton Regional itself might receive doses of the vaccine.

Kasper said the potential refusal among high numbers of people to get the vaccine is frustrating. If 70 percent of Americans get vaccinated, that would be enough to create herd immunity. “We could shut (the virus) down.”

If too many people delay, the virus could mutate. Think of firefighters making sure that no hot spots remain after a wildfire. We don’t need COVID-19 hot spots.

 BH3 submits changes to CRA

BH3 has proposed changes to its request from the Delray Beach Community Redevelopment Agency for a 10-month extension of approvals for Fabrik. That’s the company’s project east of the Fairfield Inn.

Neil Schiller, BH3’s attorney, told me Wednesday that the developer proposes a $250,000 penalty for failure to meet the new deadlines. BH3 could recoup some or all of that money for getting through each approval phase.

In addition, BH3 would pay the CRA $100,000 toward what Schiller said could be a fund to create more parking. BH3 would make the payment upon receiving the first building permit.

BH3 also would earmark the five townhomes in Fabrik for purchase by first-time homeowners who live in the Northwest/Southwest neighborhoods. And BH3 would waive the “Act of God” clause in the purchase and sale contract with regard to the COVID-19 pandemic.

The extension and all the changes BH3 proposes would be in the fourth amendment to the contract. The CRA is holding a special meeting at 4 p.m. today to discuss the amendment.

RoofClaim.com also wanted to sponsor FAU

The new sponsor of the Boca Bowl at Florida Atlantic University Stadium wanted to be an FAU sponsor. The insurance industry got state legislators to kill the deal.

Last December, FAU announced a $5 million, 10-year deal with RoofClaim.com to sponsor the arena where the basketball team plays. Athletic Director Brian White said, “This partnership is transformational for our student-athletes and fans, as well as the community. We are thrilled about the opportunities provided to FAU and our athletics department from this investment.”

Meanwhile, RoofClaim.com had struck another, even more lucrative deal with the University of Central Florida for naming rights to the football stadium. UCF would have received $35 million over 15 years.

Then the politics started.

RoofClaim.com and its parent company, Jasper Contractors, negotiate directly with homeowners who are filing claims with insurance companies for roof damage. This practice of engaging a third party to negotiate is known as assignment of benefits.

Insurers contend that such companies, which sometimes file lawsuits, inflate costs and cause unnecessarily high payments. The companies contend that they get business only because some insurers refuse to pay claims or lowball policyholders.

Insurance lobbyists have great influence in Tallahassee. According to reports in the Orlando Sentinel, the Legislature responded by filing a bill that would have required legislative approval of such naming rights. RoofClaim.com then killed the FAU and UCF deals.

FAU still has no deal for naming rights to the arena or the football stadium. Interestingly, the Legislature did not intervene in early 2013 when FAU approved a deal with Boca Raton-based GEO Group for rights to the stadium.

That move drew controversy because of what critics called the company’s problematic record at its private prisons and detention centers. The Legislature did not intervene at that time. Nor has the Legislature approved insurance reform that might remove the need for homeowners to use companies like RoofClaim.com.

 Surcharge on track

Despite the COVID-19 pandemic, Palm Beach County’s 2016 sales-tax surcharge remains on track to raise its projected $2.7 billion over 10 years.

That’s according to a recent report from the county’s Office of Inspector General. Fifty percent—or $1.35 billion—of revenue from that one-cent increase will go to the school district. The county will get $810 million and the cities will share $540 million. Revenue can go only for infrastructure work.

Boca Raton received roughly $16.5 million from the tax through the first three budget years years. The projection for this year is $6.5 million.

Boca Raton has allocated that money toward a list of projects that includes, among other things, Wildflower/Silver Palm Park, waterfront restoration of Lake Wyman and Rutherford Park, road paving and the waterfront master plan. Boca Raton didn’t add projects that the surcharge would finance. It used the revenue to issue $20 million in bonds to get planned projects done faster.

Delray Beach received about $12 million over the first three years and is projected to get $4.6 million this year. According to the OIG report, Delray Beach did not submit a list of projects that will get money from the surcharge.

Boca Raton is benefiting greatly from school district projects. The surcharge financed the new and expanded Verde Elementary, which opened this year, and Addison Mizner Elementary, which will open next year. Other projects at Spanish River and Olympic Heights high schools will relieve crowding at Boca Raton High.

DeCoste withdraws, Katz is in

Tennille DeCoste has withdrawn from the race for mayor of Delray Beach. That leaves it a two-woman campaign between incumbent Shelly Petrolia and Tracy Caruso, who chairs the historic preservation board.

In other election news, former City Commissioner Mitch Katz has qualified to challenge Seat 3 incumbent Ryan Boylston. He defeated Katz in 2018.