Experts decry FDA's decision to halt Seattle Covid-19 study over approvals - STAT

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.

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.

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 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 next day, the researchers received a notice telling them to stop returning results and immediately complied, the SCAN spokesperson said.

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

The conduct of both the CDC — they didn’t think “we needed somebody else’s test (obviously we did since their’s didn’t work), — and the FDA’s schizoid handling of diagnostic tests gives neither organization any credibility for ruling on the SCAN study