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 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, 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. Obtaining either clearance could have allowed the effort to go forward, according to the FDA.
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.”
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 elected to pause the approval when it transitioned to coronavirus, the person said, seeing its new efforts more as a part of the public health response to the crisis, rather than a simple research 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.
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I know I’m in the minority here, but seriously, conducting a clinical trial with testing and reporting to subjects with an unproven test without getting IRB approval? What were they thinking? (Short answer, they weren’t.) Completely unethical, and FDA was right to tell them to put a pause on it until they got their ducks in a row. IRB approval is not merely a “paper trail”, nor is an EUA when you’re going to be reporting results to test subjects. Frankly, they should have been able to complete the necessary tasks by now, and be back up and running. FDA is responsible for the accuracy of tests and the health of patients in the US, and has been doing an incredible, though not flawless, job of modifying processes and making exceptions and expediting products for this pandemic. Sometimes they have offered too much leeway, realized it, and ratcheted it back. This is not the time to have the wild, wild west out there, when we want to have certainty that our test results mean what they say. Some of the comments say that this is Trumpian behavior, but it’s exactly the opposite: his position is always to kill the regulation, whereas FDA knows that will result in uncertainty that puts people at risk. We have to follow the science, and that includes the scientific process.
I served on a University IRB for over 10 years and was chair of the Adverse Events Review subcomitte of that IRB. We had protocols for expedited reviews of pressing issues (brain surgery, heart transplants, Sepsis etc). Given what is printed here, IRB review could have been done in a day or less and independent of political/institutional pressures. I wonder if there were political interests in remaining ignorant?
Scary that there is confusion and fighting over protocol and who was first when an entire country is shut down and people are dying.
Stopping a valuable endeavour like SCAN abruptly, no FDA leeway in allowing SCAN to get the “required” paper-trail approvals, is another prime example of US tampering. Guaranteed someone told someone, and ALL those not “Friends of Trump” get trampled. The US is a total ZOO. It is preposterous that this utter gong-show is allowed to go on. Power-crazed (or dumb or scared) Republicans are letting a stupid canon run loose.
Trump freedumbs: don’t wanna do testing cuz it increases numbers infected in murica 😤
Just when I’ve lost respect for science and politicians’ handling of this fandemic, the two convened to block useful information!
Clearly Trump is trying to punish Gates
No surprise there. That’s what happen when something could go against the administration narrative. And pretty sure they have been doing far worse
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. And you’re right about Trump and Gates.