Regulators at the Food and Drug Administration told STAT the agency’s decision this month to halt a high-profile, Bill Gates-backed effort to study the spread of coronavirus in the Seattle area came after the researchers involved failed to secure two kinds of needed approval.
The program, called the Seattle Coronavirus Assessment Network, or SCAN, was initially focused on studying the flu but quickly pivoted to track the coronavirus at the outset of the pandemic, making inroads in tracking the spread of the virus and attracting high-profile support from companies like shipping giant Amazon, whose health care arm picked up and delivered Covid-19 tests to healthy and infected people. But the FDA stopped the effort suddenly last week, the New York Times reported.
The study lacked two kinds of clearance from the agency, the FDA said: a federal emergency use authorization, a type of pandemic-era green light used to speedily clear tests and medical devices during an emergency, and approval from an outside group of experts tasked with providing ethical oversight for research, known as an institutional review board.
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Outside experts decried FDA’s decision, saying the abrupt move was unnecessary, confusing, and counterproductive. Rather than shutting down the SCAN effort, the agency could have asked them to re-apply for approval from the ethics board, for example.
“The FDA’s position here is untenable,” said Eric Topol, director of the Scripps Research Translational Institute, which is also tracking the spread of coronavirus. “If they really wanted to foster progress rather than take down our best academic effort to study this virus, that’s what they would do.”
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The SCAN program — which was spun out of the Seattle Flu Study — is a joint effort between researchers and Seattle and King County’s public health department to capture the spread of the virus across the community.
The SCAN effort received emergency clearance for its work from Washington state in March, and was processing test results at certified clinical labs. Back when SCAN researchers were focused on the flu, SCAN received institutional review board approval as well, a SCAN spokesperson told STAT. But SCAN let the approval lapse when it transitioned to coronavirus, the person said, viewing its new efforts more as a part of the public health response, rather than a scientific study.
The researchers also appear to have misinterpreted the FDA’s guidance on home testing, which has shifted throughout the pandemic. The agency has sought to clamp down on such tests for months, at times sowing confusion in the market among startups. Many of the companies aimed to offer the tests as a partial solution to the nationwide testing shortage but ultimately pulled them from the market after the agency said in March it had not authorized any home test available for purchase.
But on May 11, after a series of updates to its home testing policy, the FDA again clarified its guidance, noting that even tests previously approved by states — including those that processed results in certified labs — needed express authorization from the federal government to continue their work. The next day, the researchers received a notice telling them to stop returning results and immediately complied, the SCAN spokesperson said.
Experts said it wasn’t clear why the agency took such drastic action, instead of pursuing other avenues to make sure the work secured the needed approvals.
“One thing that is crystal clear to me is that this is confusing.”
Hank Greely, director of the Stanford Center for Law and the Biosciences
“One thing that is crystal clear to me is that this is confusing,” said Hank Greely, director of the Stanford Center for Law and the Biosciences and the Stanford Program in Neuroscience and Society.
“When this is all over someone needs to develop a better protocol,” Greely added. “They need to figure out a clear set of protocols. They’re not there yet.”
There are other Covid-19 research efforts that involve home testing, suggesting that the work can continue, assuming organizations have the right authorizations in hand.
For example, researchers at the Fred Hutchinson Cancer Research Center who are studying the virus’ spread ship home coronavirus tests to participants and process the results. The study has institutional review board approval.
The SCAN researchers are currently exploring what path they’ll take to resume the research and are in ongoing discussions with the FDA, the SCAN spokesperson said. Before pausing the study, the researchers tested 8,443 samples from volunteers and, with the exception of a small number of inconclusive results, returned results to everyone involved.
