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America's FDA Halts Bill Gates-Backed Coronavirus Testing Program (digitaltrends.com) 105

America's Food and Drug Administration "halted, at least temporarily, a Seattle-based at-home coronavirus testing program backed by Bill Gates," reports Digital Trends: "Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained," the FDA told the Seattle Coronavirus Assessment Network (SCAN) in a memo, according to The New York Times.

"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," according to an update on the SCAN website.

The delay "is the latest evidence of how a splintered national effort to develop, distribute and ramp up testing has left federal regulators struggling to keep up," reports the New York Times: Dr. Eric Topol, the director of the Scripps Research Translational Institute, who is not involved in the Seattle group, said it was "bizarre" that the F.D.A. would halt such a project. The Seattle partnership that is conducting the testing, the Seattle Coronavirus Assessment Network, said in a statement that it had been in conversation with the Food and Drug Administration about its program for about 10 weeks and submitted data a month ago. "We are actively working to address their questions," the group said...

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 two kinds of testing — surveillance and diagnostic — fall under different F.D.A. standards.... "We had previously understood that SCAN was being conducted as a surveillance study," the spokesperson said.

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America's FDA Halts Bill Gates-Backed Coronavirus Testing Program

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  • Regulations (Score:5, Funny)

    by alvinrod ( 889928 ) on Friday May 15, 2020 @10:43PM (#60066304)
    Why doesn't the FDA just halt the coronavirus? I'm sure that it's violating some kind of regulation as well.

    I'm beginning to understand why both Musk and Bezos are sinking so much money into space travel.
    • And they will be space emperors. What makes you think they will handle a pandemic any better?

      Herding cats is difficult, and much much worse in humans.

      • And they will be space emperors. What makes you think they will handle a pandemic any better?

        Well for one thing, they would be social distancing a whole planet away...

        For another, Musk and Bezos would just make whatever the hell was needed immediately, and probably already have warehouses of it to start.

        What on earth makes you think they would not be vastly better than any government has done?

    • Migratory birds and ducks can also possibly spread it, FDA needs to warn those feathered fiends,Actually they need to research what a swallow can carry. Red-capped plovers - well those birds came from China. Thus Covid could just maybe have Alaskan roots.
      • If it were me I wouldn't even be joking about things like that because too many people are too much in a state of total internal panic that their higher brain functions are severely impaired and they're believing anything and everything they're hearing. For fuck's sake if you believed some people we're already 9/10ths of the way to living in a Mad Max movie and the virus is literally on the wind to the point where you could be in the middle of the desert and still catch the goddamned thing. The 'Keep Calm a
  • Microsoft is asking for the FDA to do additional testing on their application. FWIW.
  • You have to have a different set of regulatory loopholes to inform the infected that they are actually infected and a potential risk to others?!?!?
    WTF!
    That is horrifically stupid!
    • by makomk ( 752139 )

      Yes, because doing so also tells all the other people you're testing that they're probably not infected and not a potential risk to others. Which as you can imagine is not a good thing if you get it wrong.

    • There needs to be regulation around it.
      If it returns negative when you are positive, then you may go around spreading the virus.
      If it returns positive when you are negative, then you will overburden the healthcare system, especially when you catch your seasonal allergies.

      The American FDA is a very slow agency, and conservative (not the political term) in its approach to allowing thing. I expect things are already going too fast for normal FDA processes.

      • by ceoyoyo ( 59147 )

        The FDA is slow and conservative until they approve something that turns out to have problems. Then they're reckless cowboys.

        Kinda like the FAA....

      • Solution seems quite simple to me. Simply shoot everyone tested in the head just because it is safer to be dead. This then leads to the obvious conclusion that there is no point in actually carrying out an expensive test, since it is irrelevant. Merely announce that you are offering "free testing" and kill anyone who shows up. Since bullets are significantly less expensive than actual tests, many more "tests" can be performed for the same amount of money expended.

        Plus, the dead can be used for fuel to g

  • What do you say -- this regulation seems intended to centralize and control the flow of medical information.

    The entire Covid-19 affair shows how lacking the medical profession is in many areas.

    What are emergency authorisations for, if not this?

    • This is an antibody test. It will tell how many people already had the virus and some politicians don't want that to be known. If the percentage of people who already had the virus is very high - say 30% or more, then it dilutes the death rates by a large factor, which will disrupt the Oh My God The Sky Is Falling narrative, which the politicians need to justify the lockdowns.
      • by cardpuncher ( 713057 ) on Saturday May 16, 2020 @07:12AM (#60066910)

        It will tell how many people already had the virus and some politicians don't want that to be known. .

        Actually, most politicians are desperate to find out because it is key to determining when the lockdowns can safely be lifted and how quickly. There's been a reasonably robust study across Spain that suggests around 5% of the population may have been infected - Spain currently has around twice the deaths per million population as the US, though the US rate is ticking up fast. Other studies have come up with similar rates. The highest rate found anywhere yet was New York City with around 20%, though the State average was closer to 10%. Nowhere has a figure as high as 30% yet been found. Of course, you probably believe the numbers are all fake but I'm afraid speculation does not trump data.

        Lockdowns are a sign of public health failure - they could largely have been avoided if proper testing and tracing had been implemented early. Having failed once it would be particularly stupid to fail a second time by prematurely encouraging phsyical proximity while infections continue at a high rate.

    • There's actually a good reason to restrict the use of diagnostic screening tests -- they give misleading results, even when the tests are excellent.

      It has to do with the base rate fallacy. Right now the number of officially reported cases in the US amounts to 0.45% of the population; let's say the actual number of people who have antibodies was 5%. Supposed you administered a 95% accurate antibody test on this hypothetical population, what is the probability someone with a positive result has antibodies?

      The answer isn't 0.95; it's 0.48. More than half the people running around thinking they were immune because of their test results would actually not be. And false positive rates for many of these tests are a lot higher than 5% -- 29% is the highest I've seen.

      That doesn't mean that screening is useless. It means it has dangerous unintended consequences. Whether or not to screen depends on how you plan to use the results; if you haven't thought that part through, it's better not to screen.

      • by ceoyoyo ( 59147 )

        It's also worth noting that the majority of physicians can't correctly work the calculation you just did, so "anyone with half a fucking brain understands" (quote from comment on this story) is dangerously incorrect.

  • Shouldnt a regulation that prevents patients to be informed, which this appears to boil down to. Be violating some regulation, law or constitution? At least to me it feels unethical to test patients and then not inform them about the results, And no test is 100% accurate. But i just got out of bed and maybe iam still too tired to understand the logic behind this.
  • The FDA has shut down every single home testing kit that was seeking approval. ALL of them. And the antibody tests that have approved have some oneruous restrictions on them.

    The Mt. Sinai developed test kit can only be used at Mt. Sinai hospital. Hospitals can only Abbott Labs antibody test kits after they seek and receive FDA approval to use the kits.

    I tried to get a LabCorp antibody test, but you can't just go and get one. You have to take a survey. And after they survey they told me I was not eligib

    • by PPH ( 736903 )

      We can't let uncontrolled testing mess up our carefully crafted statistics.

  • The delay "is the latest evidence of how a splintered national effort to develop, distribute and ramp up testing has left federal regulators struggling to keep up," OPINES the New York Times FTFY.

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