Florida defies FDA warning on controversial COVID test with off-label use, but Miami-Dade reconsiders

By Daniel Ducassi, FloridaBulldog.org

Florida is dismissing a recent warning from federal regulators about the accuracy of a popular COVID-19 test from one of the state’s largest testing providers — and continuing to use the test in a way the FDA has advised against.

Meanwhile, the state’s most populous county, Miami-Dade, is reconsidering how it uses the test.

The U.S. Food and Drug Administration issued a warning last month alerting the public to “the risk of false results, particularly false negative results,” with the test made by an enormous San Dimas, CA-based testing start-up, Curative, noting that false negatives can mean people unknowingly spreading the virus to others. The risk of false negatives is higher, the FDA noted, when the test isn’t used correctly.

Florida’s top emergency management official, Jared Moskowitz, brushed off the FDA warning, telling Florida Bulldog he stands by Curative’s test — even for use outside of the FDA’s authorization — as long as federal institutions like the Department of Defense and Congress also continue to rely on the company’s tests.

Politico reported last month that the U.S. Department of Health and Human Services was looking to replace Curative’s test for Congress, but Moskowitz provided a Feb. 1 change order showing the House of Representatives extended its testing agreement with Gothams, another California-based company, to run until Feb. 26.

Huge state payouts

State contract records show Florida has inked more than $180 million in agreements with Curative through the firm’s partnership with Gothams, which handles the logistics side of the operation. A state transparency website shows the Executive Office of the Governor has paid Gothams nearly $168 million, including $5.1 million on Feb. 5. Though Moskowitz volunteered a federal purchase order record he had, neither he nor the division he oversees would make public copies of the state’s purchase orders with Gothams.

Meanwhile, Miami-Dade County has its own agreements with the company to provide testing, though it’s unclear how much they’re worth. After three days of inquiries from Florida Bulldog, county officials didn’t provide copies of any contracts with the company or explain how much the county has already paid, but did say they’re considering changing how they use Curative’s test.

Curative, co-founded last year by then 25-year-old CEO Fred Turner, has more than two dozen testing sites around the state, including more than a dozen in Miami-Dade. The company has reported more than 1.5 million test results to the Florida Department of Health, second only to lab testing behemoth LabCorp.

Miranda Gottlieb, Curative’s vice president of marketing, wrote in an email to Florida Bulldog that the company “continues to test approximately 50,000 people a week at Florida long-term-care facilities in addition to approximately 130,000 people a week accessing testing through public test sites.”

Moskowitz, director of the Florida Division of Emergency Management, said Curative is performing roughly 8,000 of the company’s tests per day for the state.

The FDA warning

Meanwhile, the spread of new genetic variants of the virus, which the FDA warning said also may lead to false negatives, underscores the need for reliable testing.

Florida was using Curative’s test, which detects the genetic material of the virus, last summer to screen staff at nursing homes and assisted- living facilities, though that contract ended after 90 days. The Division of Emergency Management still uses the test to screen its own staff of 250 at the State Emergency Operations Center weekly.

And Moskowitz, a Democrat from Coral Springs who previously served in the Florida House of Representatives, said the state continues to use the test at several sites open to the general public, including for people with no symptoms. Gottlieb claimed the company was primarily performing another company’s rapid antigen tests at these sites, and not broadly offering its PCR tests there, but did not respond to Florida Bulldog about the state’s conflicting claim involving what it expects Curative to be doing at those sites. Moskowitz reiterated that PCR testing “is available at all state sites and state supported sites.”

Miami-Dade County may be Curative’s biggest customer in Florida at the moment. The company continues to use the test at sites across the county that accept people with no symptoms, such as the Miami Beach Convention Center, Florida International University and Tropical Park.

Rachel Johnson, a spokeswoman for Mayor Daniella Levine Cava, told Florida Bulldog that the county is “currently considering transitioning use of the Curative PCR test to only symptomatic patients. Our Miami-Dade County COVID team and medical experts are currently reviewing this issue.”

The FDA first approved Curative’s test under what’s called an “Emergency Use Authorization” last year, and reiterated in its January warning that the authorization “is limited to individuals who have shown symptoms of COVID-19 within 14 days of onset of the symptoms.”

Undeterred by FDA warning

Undeterred by the limits of the FDA authorization, the state and county have continued to use the tests on people without symptoms.

The FDA’s alert last month stressed the importance of using the test in accordance with this authorization, adding that using the test in ways that aren’t authorized increases the risk of false negatives.

The problem with false negatives, the feds explained, is that if someone has COVID-19 but doesn’t know it because of an inaccurate result, that person could then spread the disease to other people in the community.

Despite the warning, Moskowitz, who holds a bachelor’s degree in political science from George Washington University and a law degree from Nova Southeastern University, said he’s comfortable with the state continuing to use the test, even outside of the FDA authorization.

“If it’s good enough for the Pentagon and Congress, shouldn’t it be good enough for the states?” Moskowitz wrote in a text message to a Florida Bulldog reporter. “And if there was a problem why didn’t the FDA remove their [Emergency Use Authorization]?”

In fact, the FDA threatened to do just that.

Neither Moskowitz nor a spokesman for the Division of Emergency Management named any physician or health care provider who signed off on using the tests outside of the FDA’s authorization.

Neither did Miami-Dade County.

Florida’s seldom seen surgeon general, Dr. Scott Rivkees, did not respond to Florida Bulldog  requests for comment on Curative’s tests and their widespread use in the state.

‘Unreasonable risk of harm’

The FDA’s concerns arose after Curative submitted data as part of a request to expand the test’s authorization to include use on people without symptoms. If Curative secured such approval, it would mean getting the FDA’s blessing for using the test in a way it’s already widely used under hundreds of millions of dollars in government contracts. If state and local governments were to use the tests strictly according to the FDA’s directions, it would mean a lot fewer Curative tests — and a lot less money flowing to the company’s bottom line.

Emails obtained by Florida Bulldog show an FDA official who looked over Curative’s submissions didn’t like what he saw.

FDA scientific reviewer Joseph Briggs sent an email Dec. 22 to Curative telling the company that the data they submitted to secure an expanded authorization didn’t even appear to support the test’s already authorized use on symptomatic people, let alone asymptomatic people.

The FDA disagreed with how the company was “arbitrarily” limiting how the comparison test was being used in its study, setting a lower bar for what’s called the “cycle threshold,” effectively lowering its sensitivity. The FDA reanalyzed the company’s data using a higher cycle threshold shown in the comparison test’s instructions and found Curative’s positive results only agreed with the positive results of the more accurate comparison test 72.3 percent of the time for oral swab samples and 79.3 percent of the time for nasal swab samples.

“Based on this information, we are concerned that your device may put patients at unreasonable risk of harm due to inaccurate results,” Briggs wrote. “Please take action to correct clinical performance of your device or provide clarifying information adequate to address the significant clinical performance issues.”

He also warned that if the company didn’t provide information showing the test is up to snuff by 6:30 p.m. on Dec. 24, that the FDA “likely would not be able to determine that the criteria for emergency use authorization have been met,” and if it makes that decision, he added, “we would expect you to suspend distribution of your test, and we may request that you take additional actions to protect the public health as appropriate.”

FDA stops short

The FDA stopped short of revoking authorization for the test, but made sure everyone knew the test shouldn’t be used on asymptomatic people.

The FDA emphasized those instructions in its Jan. 4 warning: “To reduce the risk of false negative results, it is important to perform the test in accordance with its authorization and as described in the authorized labeling,” that is, for people who are showing symptoms of infection.

Briggs wasn’t entirely satisfied with additional information that Curative sent. In a Jan. 18 email, he wrote that, “it does not appear that you have conducted a full accounting of the root cause(s) for the poor clinical performance” of the company’s test in its submission, nor had he noticed any changes to the test to address potential causes.

The company sent more information on Jan. 21 to bolster its defense of the test’s accuracy. It argued that much of the disagreement between its test and the comparison test was a result of patients with older infections that only showed up at higher cycle threshold counts — essentially, when the tests were conducted to be more sensitive — and were “highly likely to be non-infectious.”

The company also complained the FDA warning statements “are creating widespread confusion in the health care community. This confusion is having … a serious adverse effect on public health leading to the potential unavailability of testing in critical environments.”

Gothams CEO Matt Michelsen told Florida Bulldog that the FDA set a Feb. 10 meeting with Curative to discuss the matter.

Unnamed doctors

Curative’s Gottlieb didn’t explain what the company is doing to make sure the test is used in accordance with the FDA authorization.

On the contrary, the company has been openly performing tests on asymptomatic people under massive government contracts for months.

She wrote that “all Curative COVID-19 tests are ordered by an ordering physician,” explaining that, “in some locations, the county provides an ordering physician, in others, Curative works with a network of physicians to order the tests.” None of the doctors actually work for the company, she said.

Florida has not named any ordering physician who okayed using the tests on asymptomatic people, including on DEM’s own staff. Neither has Miami-Dade County.

Florida has struggled to secure timely and reliable testing, especially early on in the pandemic. Back in April, the governor announced two new testing contracts that were supposed to double the state’s testing capacity at the time, but neither resulted in a single test for the state. One deal was with an unqualified Texas company run by a man who pleaded guilty in 2019 to two financial felonies and is still on probation. The state canceled its contract with the other company after a major Florida hospital chain dropped its own deal amid doubts about the firm.

Other companies, like Miami Gardens-based Niznik Lab Corp and testing giant Quest Diagnostics, have drawn the state’s ire after failing to timely report sizable backlogs of results, leading the governor to order agencies to cut ties with Quest.

Moskowitz confident

Still, Moskowitz — who personally signed the contract with the unqualified company run by a confessed thief who has no medical credentials — said he’s confident in the accuracy of Curative’s test, including for use on asymptomatic people, and said he hadn’t seen anything in the state’s data to support the FDA’s concerns.

He also pointed to Curative’s short turnaround time compared to similar tests at other labs, which have often faced lengthy reporting delays when demand for tests has spiked. He argued that part of the equation is balancing “speed vs. accuracy.”

“Even if … it may not be as accurate,” he posited, there’s a “benefit” to how quickly results come back.

He’s not alone in defending the test.

Last month, Los Angeles Mayor Eric Garcetti lauded the test’s widespread use in his city: “This is something that has saved lives, will continue to save lives. And if we move away from it, I worry we would have a lot fewer people diagnosed and even more spread.”

However, some governments have taken a more cautious approach after the FDA warning. Days after Garcetti’s defense, Los Angeles County decided to cut back its use of the test.

Meanwhile, Colorado health officials announced last month that based on the FDA’s guidance, they’re “concerned about the accuracy” of Curative’s test, so the state will be “transitioning away from using Curative” and advised “that ONLY symptomatic individuals use” Curative’s testing.