College Football Games Are Ad Hoc Covid-19 Testing Studies

(Bloomberg Opinion) -- This weekend, after a two-month delay, the 14 football teams that make up the Big 10 athletic conference will start their season. Illinois will travel to Wisconsin for a Friday night game, and the rest of the conference will play on Saturday. The stands will be empty, but all seven games will be televised.

The Big 10 had concluded over the summer that it was too risky to play sports during the pandemic, so it postponed all the fall sports, including football. On the West Coast, the Pac-12 conference came to the same conclusion for the same reason: “Our decision was guided by science,” the Pac-12 said in its news release.

When the two leagues reversed their positions a month later, neither mentioned the most obvious reason for restarting football: the millions of dollars in TV money they would otherwise lose. Instead, they stressed they had found a way to protect the players from the virus and to “significantly improve our ability to prevent transmission of Covid,” as the Pac-12 put it in a press release.

What the two conferences had discovered was rapid antigen tests that can detect the presence of Covid-19. They have both signed contracts with Quidel Corp., a midsize medical diagnostic company based in San Diego whose rapid antigen test was approved by the Food and Drug Administration.

Unlike PRC tests, which are highly accurate but can take days to return results, antigen tests need only about 15 minutes. The Big 10 and the Pac-12 said they would give a Quidel test to every football player every day. The coaches and others who worked with the team would also be tested daily; it would amount to about 15,000 tests a week for each conference. In addition, all the athletes would receive a PCR test once a week  to double-check the accuracy of the rapid antigen tests.

“This is a big breakthrough for us,” Pac-12 Commissioner Larry Scott told CNBC in early September. “It gives us near-immediate results. It will give us a high degree of confidence that … we are not promoting the spread of the virus.” Not only that, he added, but the data collected from the players would be used for research. “It is our hope that we are contributing to society’s return to work,” he said. “I think that is where this research could be very important.”

Quidel’s chief executive officer, Douglas Bryant, was also on the show. “We are sincerely interested in a large asymptomatic study — the first of its kind,” he told CNBC. “We’re going to be involved in research that is going to allow us to see what asymptomatic testing looks like in a large population.”

I had to wonder: Has anyone told the players they are test subjects?

Quidel received FDA approval for its Sofia SARS Antigen FIA test in May. It was one of those emergency use authorizations that have become so common during the pandemic. The Quidel device had not gone through the clinical trial gauntlet necessary to gain full FDA approval, but the data it had collected was enough for the agency to allow it to be used during the pandemic.

There was one catch: The FDA authorized the use of the Quidel test only on patients who were already showing symptoms of Covid-19. Yes, doctors could use it to test people with no symptoms, but there was not enough data on testing the asymptomatic to satisfy the government. As Dr. Susan Butler-Wu, an expert on diagnostic tests for infectious diseases, put it, using Quidel’s rapid antigen test on an asymptomatic population was an “off-label” use.

The Trump administration has embraced rapid antigen tests for much the same reason as Larry Scott: If they work, the tests would allow, say, nursing home workers to zero in on infected residents much more quickly than they could with a PCR test. And those people could then be quarantined before the virus spread to the rest of the population.

The federal government awarded a $760 million contract to Abbott Laboratories to distribute 150 million tests to schools and “other special needs populations.” Becton Dickinson received $24 million from the federal government to increase production of its rapid antigen test. Quidel received $71 million from the National Institutes of Health to expand its manufacturing capacity. The Trump administration even invoked the Defense Production Act to ensure that Becton Dickinson and Quidel prioritize deliveries of their antigen tests to nursing homes. In July, administration officials said they planned to distribute the tests to 14,000 long-term care facilities.

Not everybody has been as quick to embrace rapid antigen tests as Larry Scott and the Trump administration. Although some public health officials were enthusiastic about the potential of the tests to slow the spread of the virus, others worried that they gave too many false readings.

“It’s important always to use a diagnostic in the way that it has been designed to be used,” Elizabeth Talbot, New Hampshire’s deputy state epidemiologist, told Kaiser Health News. “We simply don’t know how [they] will perform in persons who are asymptomatic.”

“I’ll be blunt,” Geoffrey Baird, the acting laboratory-medicine chair at the University of Washington, told The Atlantic. “Antigen testing will not and cannot work for asymptomatic screening and [it] will probably kill a lot of people.”

Quidel says its rapid antigen test is 96.7% accurate. But in early August, Governor Mike DeWine of Ohio received a false positive using a Quidel test, according to Kaiser Health News. Then he took a PCR test and discovered he was negative.

And in Nevada earlier this month, the state health department ordered that nursing homes, which were using both Quidel and Becton Dickinson rapid antigen tests, stop using them “until the accuracy of the tests can be better evaluated.” After surveying the nursing homes, the health department discovered that the rate of false positives was a staggering 60%. In the case of Quidel, of the nine positive results, eight were shown to be false after a subsequent PCR test.

(Two days after Nevada issued its order, the federal government insisted that it resume the testing. Admiral Brett Giroir, an assistant secretary of Health and Human Services, declared Nevada’s action to be “unwise, uninformed and unlawful.” The state reversed course and allowed the tests to resume.)

Which brings me back to football.

When I spoke to the Pac-12 and Quidel, they quickly backed away from the notion that the athletes were going to be research subjects. “We are not going to be using athletes as guinea pigs,” said Kim Harmon, a doctor at the University of Washington who is also the research development director for the Pac-12. And despite what he had said on CNBC, Quidel’s Bryant insisted that the research that would take place would not be about gauging the accuracy of the tests on an asymptomatic population. (The Big 10 did not respond to my request to interview someone on its medical staff.)

Harmon said that the company would not have access to the data the Pac-12 collects and that the universities would publish any results. Bryant ticked off a variety of prospective research possibilities, none of which had anything to do with comparing Quidel’s accuracy with the accuracy of a PCR test. He said the company was conducting a different study to gain full FDA approval of its rapid antigen tests for both symptomatic and asymptomatic populations.

But given the controversy surrounding rapid antigen testing, the 2,600 or so football players who make up the Pac-12 and Big 10 rosters will most certainly be research subjects. Nobody yet knows how accurate the tests will be on an asymptomatic population — and giving daily tests to football players is a real-world crash trial, whether it’s a formal study or not.

And what if they’re not accurate enough? What if there are a slew of false positives as there were in Nevada? Far worse, what if there are false negatives? Infected players would remain in contact with their teammates, spreading the virus until their infection is caught by the next day’s test — or a PCR test a week later.

“There has been a suggestion in the media that daily antigen testing gives people a passport — they can go about their business,” Butler-Wu said. “But I don’t think it should work that way.” She mentioned a teenage girl who received a negative test despite being positive. Feeling safe, she went to a family event — and 14 out of the 15 people in attendance contracted Covid-19. “There is room for harm,” she said.

And while false positives are less dangerous, they are problematic too, according to Butler-Wu, because they erode trust in the testing.

For those of us who have long been critical of the way college sports is run, there is another troubling issue: The athletes really have no choice in the matter. Broadly speaking, their consent has not been sought. Even if it had been, the players are hardly in a position to say no; if they want to play football, they have to take the daily antigen tests. And it’s not even clear that the tests will provide the safety the Pac-12 and the Big 10 are promising. No matter what they say, using daily rapid antigen tests to make football possible is an experiment.

Accurate or not, the tests are giving cover to the Big 10 and Pac-12 so that their teams can once again take the field and appear on television. And that’s what really matters, right?

This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.

Joe Nocera is a Bloomberg Opinion columnist covering business. He has written business columns for Esquire, GQ and the New York Times, and is the former editorial director of Fortune. His latest project is the Bloomberg-Wondery podcast "The Shrink Next Door."

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