15 votes

‘It’s just everywhere already’: How delays in testing set back the US coronavirus response

14 comments

  1. [13]
    Death
    Link
    This is a very interesting read because as I've seen commentators note elsewhere this is something of an ethical conundrum: [...] The ethical rules concerning informed are consent which are...

    This is a very interesting read because as I've seen commentators note elsewhere this is something of an ethical conundrum:

    Federal and state officials said the flu study could not be repurposed because it did not have explicit permission from research subjects; the labs were also not certified for clinical work. While acknowledging the ethical questions, Dr. Chu and others argued there should be more flexibility in an emergency during which so many lives could be lost. On Monday night, state regulators told them to stop testing altogether.

    [...]

    But the Seattle Flu Study illustrates how existing regulations and red tape — sometimes designed to protect privacy and health — have impeded the rapid rollout of testing nationally, while other countries ramped up much earlier and faster. Faced with a public health emergency on a scale potentially not seen in a century, the United States has not responded nimbly.

    The ethical rules concerning informed are consent which are impeding these tests are in no small part designed to protect people's privacy and prevent abusive or harmful research practices. So the question becomes at which point does this security measure actually create more danger for the population? And to what extent can we allow legal loopholes to exist? It would seem self-evident for a fast-spreading pandemic but can this procedure be invoked in other cases as well, granted an argument for public safety is provided?

    9 votes
    1. [5]
      Gaywallet
      (edited )
      Link Parent
      To be frank, the US government has close to zero trust from the American populace right now and historically has had a problem with trust. EDIT: it would appear there is more trust than I...

      It would seem self-evident for a fast-spreading pandemic but can this procedure be invoked in other cases as well, granted an argument for public safety is provided?

      To be frank, the US government has close to zero trust from the American populace right now and historically has had a problem with trust.

      EDIT: it would appear there is more trust than I previously thought, in particular with regard to how the US gov't will handle the corona virus. See Deimos's response below.

      Trump tried to call a state of emergency in order to fund his border wall not even a month ago. If they're going to use what should be apolitical means in a political way, they simply cannot be trusted to run this appropriately and effectively.

      12 votes
      1. [4]
        Deimos
        Link Parent
        That's very exaggerated. A Quinnipiac University poll from last week included fairly high approval numbers for many questions about the government, including 53% saying they have confidence in the...

        To be frank, the US government has close to zero trust from the American populace right now and historically has had a problem with trust.

        That's very exaggerated. A Quinnipiac University poll from last week included fairly high approval numbers for many questions about the government, including 53% saying they have confidence in the federal government to handle the response to the coronavirus (very last question at the bottom). Note that 81% of Republicans said they were confident but only 33% of Democrats, so it's very much split on party lines.

        11 votes
        1. [2]
          kfwyre
          Link Parent
          I work with a lot of right-leaning people, and the general consensus among them seems to be that this isn't something to worry about. Several shared with me today, independently of one another,...

          Note that 81% of Republicans said they were confident but only 33% of Democrats, so it's very much split on party lines.

          I work with a lot of right-leaning people, and the general consensus among them seems to be that this isn't something to worry about. Several shared with me today, independently of one another, that they believe coverage of it is overblown in an attempt to smear Trump or potentially sway public sentiment in favor of the Democrats ahead of the election. They seem so thoroughly unconcerned, while all week I've been strongly encouraging everyone to limit risk behaviors and prepare for potential disruption or quarantine. They politely abide my warnings, but I get the feeling I'm seen by mostly everyone as a liberal Chicken Little. It's made me question who's living in an informational bubble: me on a digest of doom and gloom, or them, on a digest of measured skepticism?

          Our district has done nothing to prepare for it -- no laying the groundwork for online/distance learning, no distribution of cleaning supplies to classrooms, no cancellation of events or programs, no messaging of any kind to parents or even internally to just staff. I asked an administrator directly about contingency plans today and he said that they weren't presently concerned about any potential impact to the school year. This is both baffling and frustrating to me, but it's also hard to tell if I'm letting anxiety get the better of me right now. I'm deeply worried.

          8 votes
          1. kfwyre
            Link Parent
            Update: what a difference a day makes. Everyone went from almost flippant to serious literally overnight. I think the widespread sports cancellations and the news about Tom Hanks and Rita Wilson...

            Update: what a difference a day makes.

            Everyone went from almost flippant to serious literally overnight. I think the widespread sports cancellations and the news about Tom Hanks and Rita Wilson made it "real" for a lot of people.

            One coworker, who previously had been skeptical of my warnings, told me "this whole time I thought you were overdoing it, but I think you might actually be right." Everyone's now making plans and taking things like social distance and handwashing seriously. Before they were just making jokes about stocking up on beer.

            We still don't have a solid plan as a district but it looks like leadership is starting to formulate one. This is positive forward motion but I really hope we're not too late.

            7 votes
        2. Gaywallet
          Link Parent
          Thanks for a proper source! I hadn't seen a poll on corona virus yet. I'll go update my post.

          Thanks for a proper source! I hadn't seen a poll on corona virus yet. I'll go update my post.

          4 votes
    2. [7]
      skybrian
      (edited )
      Link Parent
      Yes, this is the price we pay for not trusting researchers to do the right thing, due to being a low-trust society, due to previous ethics violations. With better leadership pushing from the top,...

      Yes, this is the price we pay for not trusting researchers to do the right thing, due to being a low-trust society, due to previous ethics violations.

      With better leadership pushing from the top, perhaps exceptions could be made faster? But we don't have that right now.

      8 votes
      1. [6]
        Death
        Link Parent
        It's a difficult tightrope to walk because dividing a line between researchers doing the right thing and them doing the wrong thing while believing it to be right is incredibly complex and subjective.

        It's a difficult tightrope to walk because dividing a line between researchers doing the right thing and them doing the wrong thing while believing it to be right is incredibly complex and subjective.

        5 votes
        1. [4]
          Gaywallet
          Link Parent
          This is problematic for a variety of reasons, but one other issue I'd like to bring up is a historical reason why we tend to move very slow in the US when it comes to certain health regulation,...

          This is problematic for a variety of reasons, but one other issue I'd like to bring up is a historical reason why we tend to move very slow in the US when it comes to certain health regulation, thalidomide.

          At the time that thalidomide was going around as a new medication, the FDA was still fairly new and they didn't have the resources to review the drug appropriately. To be fair, there was potentially concerning evidence emerging from the animal trials, but the reality is they mostly just dragged their feet due to being under-resourced. Well, it turns out dragging their feet was a good thing, because the drug turned out to be pretty harmful for entirely different reasons than was showing up during animal testing. The long term effects and effects in particular to pregnant women were horrific.

          The US celebrated this 'victory' of being one of the few countries to not approve the medical use of Thalidomide, and because of this it cemented a very controlled and slow research method. It also helped to reinforce the importance of human trials, and in particular human trials with a lot of humans.

          This is both good and bad in many ways that would take thousands of words to expand upon so I'm going to simply point out that it's a huge contributing factor to how we approach medical research in particular in the US - slowly. We have a lot of red tape and we often make things incredibly difficult in order to slow it down. This isn't necessarily a good thing - modern techniques such as cross-over studies allow us to provide just as much statistical validity with a much smaller n, but are simply not allowed by the FDA.

          8 votes
          1. [3]
            patience_limited
            (edited )
            Link Parent
            I broadly agree with you about the FDA, but there've been Stage I clinical trials where the results would have been catastrophic with faster broad deployment. Even now, there are genuine risks...

            I broadly agree with you about the FDA, but there've been Stage I clinical trials where the results would have been catastrophic with faster broad deployment.

            Even now, there are genuine risks with some vaccines. Guillian-Barre syndrome is an extremely rare event, but if something like that occurs when a billion people need vaccinations for COVID-19, it's going to create a huge obstacle in future, even more dangerous pandemics.

            As to the mentioned Seattle Flu Study, it seems like consent for 'flu virus testing of a biological sample should have been construed to imply consent to screen for other viruses. Not anything else to which HIPAA rules might apply, such as DNA, but a proper study with influenza testing should rule out other viruses with similar symptoms.

            6 votes
            1. Gaywallet
              Link Parent
              Oh yeah, absolutely. It's not as black and white as it may have come off and thank you for providing the counter point. There's a correct level of red tape, and I think it's less than we currently...

              I broadly agree with you about the FDA, but there've been Stage I clinical trials where the results would have been catastrophic with faster broad deployment.

              Oh yeah, absolutely. It's not as black and white as it may have come off and thank you for providing the counter point. There's a correct level of red tape, and I think it's less than we currently have, but we absolutely do need safeguards we just need to update them for modern techniques.

              if something like that occurs when a billion people need vaccinations for COVID-19, it's going to create a huge obstacle in future, even more dangerous pandemics.

              Yeah I think there needs to be discussions about how to properly explain risks to individuals and what should be considered a tolerable risk. This is frankly quite mild when compared to some drugs that have made it through FDA approval, such as some SSRIs which have fairly low rates of actually working.

              it seems like consent for 'flu virus testing of a biological sample should have been construed to imply consent to screen for other viruses. Not anything else to which HIPAA rules might apply, such as DNA, but a proper study with influenza testing should rule out other viruses with similar symptoms.

              Completely agreed and likely an artifact of how the study proposal was worded.

              4 votes
            2. skybrian
              Link Parent
              I know hardly anything about it, but it seems like there should be a broad exemption in HIPAA for studying any new infectious disease. I wonder if there is anything similar already?

              I know hardly anything about it, but it seems like there should be a broad exemption in HIPAA for studying any new infectious disease. I wonder if there is anything similar already?

              1 vote
        2. skybrian
          Link Parent
          This is true, but there is no hope that mechanical rules set up in advance will get it right. A competent, timely outside review is probably the best you could do.

          This is true, but there is no hope that mechanical rules set up in advance will get it right. A competent, timely outside review is probably the best you could do.

          2 votes
  2. skybrian
    (edited )
    Link
    From the article: [...] [...]

    From the article:

    As luck would have it, Dr. Chu had a way to monitor the region. For months, as part of a research project into the flu, she and a team of researchers had been collecting nasal swabs from residents experiencing symptoms throughout the Puget Sound region.

    To repurpose the tests for monitoring the coronavirus, they would need the support of state and federal officials. But nearly everywhere Dr. Chu turned, officials repeatedly rejected the idea, interviews and emails show, even as weeks crawled by and outbreaks emerged in countries outside of China, where the infection began.

    By Feb. 25, Dr. Chu and her colleagues could not bear to wait any longer. They began performing coronavirus tests, without government approval.

    What came back confirmed their worst fear. They quickly had a positive test from a local teenager with no recent travel history. The coronavirus had already established itself on American soil without anybody realizing it.

    [...]

    Dr. Alex Greninger, an assistant professor at the University of Washington Medical Center in Seattle, said he became exasperated in mid-February as he communicated with the F.D.A. over getting his application ready to begin testing. “This virus is faster than the F.D.A.,” he said, adding that at one point the agency required him to submit materials through the mail in addition to over email.

    [...]

    On a phone call the day after the C.D.C. and F.D.A. had told Dr. Chu to stop, officials relented, but only partially, the researchers recalled. They would allow the study’s laboratories to test cases and report the results only in future samples. They would need to use a new consent form that explicitly mentioned that results of the coronavirus tests might be shared with the local health department.

    They were not to test the thousands of samples that had already been collected.

    The same day, the F.D.A. said it would relax its rules and allow clinical labs to begin using their own coronavirus tests as long as they submitted evidence that they worked to the agency. Under that new policy, according to an agency representative on Tuesday, it had heard from 14 labs, with 10 already beginning patient testing.

    6 votes