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FDA orders halt to Bill Gates’ coronavirus testing program

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The Trump administration has ordered Seattle officials to halt a coronavirus testing program promoted by billionaire software developer Bill Gates over concerns that it’s gone beyond its original scope.

A Federal Drug Administration spokesperson told The New York Times that the agency had thought the Seattle Coronavirus Assessment Network (or SCAN) project was being conducted purely for surveillance reasons so that local officials could track the virus’s spread.

“The issue in the Seattle case appears to be that the test results are being used not only by researchers for surveillance of the virus in the community but that the results are also being returned to patients to inform them,” the Times reported Friday.

“The two kinds of testing — surveillance and diagnostic — fall under different F.D.A. standards. In a pure surveillance study, the researchers may keep the results just for themselves. But coronavirus testing has largely revolved around getting results returned to doctors who can share the results with patients.”

It’s kind of like former special counsel Robert Mueller’s investigation. While everybody thought his job was only to root out Russian collusion, he wound up going beyond his scope by, as an example, targeting Michael Flynn over an innocuous “lie.”

The difference is that, unlike Mueller, who was apparently allowed to extend as beyond his scope as he wanted, Seattle officials are actually being held accountable.

“We had previously understood that SCAN was being conducted as a surveillance study,” an FDA spokesperson bluntly said to the Times.

So had Gates, it would appear.

In a personal blog post published this past Tuesday, he described the program as a surveillance one, not a diagnostic one.

“As a surveillance program, SCAN’s goal isn’t to test every person or serve as a replacement for medical care,” he wrote. “Instead, SCAN is testing a sample of people in the Seattle region, including those who are healthy as well as those who are feeling sick.”

“The test results and other data (like a person’s age, gender, race, zip code, and any underlying health conditions) are used by researchers, data modelers, and public health officials to paint a clearer picture of how COVID-19 is moving through the community, who is at greatest risk, and whether physical distancing measures are working.”

The program launched two months ago thanks to financial support from him.

“SCAN is being funded by Gates Ventures, the private office of Bill Gates, and is getting technical guidance from the Bill & Melinda Gates Foundation and other public health experts,” GeekWire reported at the time.

“Gates is also a supporter of the Seattle Flu Study, which was developed by the Brotman Baty Institute in collaboration with UW Medicine, Fred Hutchinson Cancer Research Center and Seattle Children’s.”

The halting of SCAN doesn’t mean it won’t be reauthorized soon. It probably will, given that according to Dr. Eric Topol, the director of the Scripps Research Translational Institute, it makes sense to run SCAN as both a surveillance and diagnostic project.

“To withhold that information from people is downright absurd,” he said to the Times regarding the unauthorized diagnostic aspects of the project.

Fair enough, but rules are rules …

In a statement, SCAN revealed that the specific authorization needed is known as an emergency use authorization.

“We have been notified that a separate federal emergency use authorization (EUA) is required to return results for self-collected tests,” the statement reads.

This authorization wasn’t originally needed, but the agency changed course after concerns about the reliability of at-home coronavirus tests were raised.

(Source: SCAN)

“The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test, but we have been asked to pause testing until we receive that additional authorization,” SCAN’s statement continued.

But according to The Seattle Times, the FDA also has concerns about the at-home collection process.

“The agency needs to determine whether people can safely and properly collect their own specimens, whether the media used to transport the specimens are safe and whether the specimens remain stable during shipment, no matter the temperature,” the outlet reported after speaking with a spokesperson.

Despite the problems being faced by the program, it has reportedly been successful in proving that the coronavirus is likely far more widespread than thought.

“The SCAN program has tested more than 8,500 specimens from volunteers so far, with a 1.3% positive rate among people with symptoms,” The Seattle Times noted.

“At least five people with no symptoms also tested positive. The results confirmed that many infections are not being diagnosed and that the number of known cases represents the tip of a much bigger iceberg.”

A much bigger iceberg indeed.

Vivek Saxena

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