6 ms·

Scientists baffled by decision to stop a pioneering coronavirus testing project

119 points by Reedx 6y ago

lambdasquirrel 6y ago
It's really hard not to wonder if there is a political motivation to break the Federal government so that even the U.S. left would seek to devolve it.
- deleted 6y ago
  [deleted]
- James_Henry 6y ago
  I'm willing to guess that many of the issues in the FDA are not caused by normal left/right politics but by bureaucracy, tradition, and other more behind the scenes issues.
- aaronbrethorst 6y ago
  This has been an explicit aim of the American right since the Reagan administration. https://en.wikipedia.org/wiki/Starve_the_beast https://en.wikipedia.org/wiki/Starve_the_beast
  - James_Henry 6y ago
    Issues like the one posted don't seem to be consequences of financial or other neglect from the federal government thought. There is definitely something else going on here.
  - so33 6y ago
    > The nine most terrifying words in the English language are "I'm from the government, and I'm here to help." - Ronald Reagan > In this present crisis, government is not the solution to our problem; government is the problem. - Ronald Reagan https://en.m.wikiquote.org/wiki/Ronald_Reagan https://en.m.wikiquote.org/wiki/Ronald_Reagan
  - roenxi 6y ago
    I wasn't following politics in the Regan administration, but I assumed destroying the government's competence was potentially the right wing's response to the total failure of the Starve the Beast strategy. Starving the Beast as a strategy just led to very high government borrowing, which is even worse for taxpayers - now they theoretically have to pay for government spending, plus a real rate interest.
    - sfj 6y ago
      We're they starving the beast? I hadn't noticed...
  - rayiner 6y ago
    Reagan was in office almost 40 years ago. We have had 24 years of Republican Presidents during that time. Have we: 1) Rolled back social security or Medicare? 2) Rolled back the administrative state in any respect? 3) Developed any significant power back to the states? None of that happened. Government spending as a percentage of GDP increased, from 30% to 35%. Just more slowly than in the immediate post-New Deal era. Characterizing attempts to hold the line or make modest reforms as wanting to “break the federal government” is a cute bit of rhetoric, but you’d have to be very gullible to believe it. We’re about to go into an election where 2 of 3 leading Democratic candidates proposed new programs that would take US government spending as a percentage of GDP past that of Sweden. More than half of the economy would be the government, versus a mere third today. By contrast, did any serious Republican candidate propose a corresponding opposite movement? Decreasing total government spending by 15 points to 20% would take us into the 1940s and 1950s (so still post New Deal). No? That should tell you a lot about how much basis your assertion has in reality.
    - lambdasquirrel 6y ago
      Is that so? I recall a strong push to get rid of "ObamaCare." The suggestion here is that the Republicans aren't able to pull back these social programs because even their own constituents would be up in arms. The next best strategy is to so thoroughly break the Federal Government that no one would support it anymore.
- SpicyLemonZest 6y ago
  The FDA is pointlessly obstructing our coronavirus response, everyone knows they're doing this, but there are no serious proposals to do so much as temporarily bench them. If it's an accelerationist strategy, it's not a very good one because we're not accelerating towards devolution.
vorpalhex 6y ago
> An FDA spokesperson explains that anything that requires a person to take samples themselves, at home, raises concerns. For example, the agency wants to ensure that samples remain stable if they end up spending a long time in a hot vehicle on the way to a lab. Not exactly a baffling secret. At home sample collection wasn't included in the guidelines, sounds like FDA is evaluating and may still give a go ahead.
- Lazare 6y ago
  I think that point was addressed fairly well in the linked article.
  - vorpalhex 6y ago
    That would be why I quoted the linked article. That doesn't excuse the clickbait headline.
    - James_Henry 6y ago
      I think that the article made it clear that there is such a great need for at-home specimen collection that it is baffling that the FDA is going so slow.
      - vorpalhex 6y ago
        1. I take a sample collection at home, as an average-person 2. I leave it on my hot porch for a few days before FedEx picks it up, the sample is invalid 3. Lab tests sample, calls me and tells me I'm clear even when I'm actually sick 4. I go to my favorite bar and decide to intimately swing dance with all the patrons, causing a super spreader event The only thing worse than not having a test is having a faulty test. The FDA is very worried about faulty tests, or in this case, bad sample collection leading to faulty tests.
- djsumdog 6y ago
  Yea it seems pretty clear to me. If samples degrade during transport, you could get false negatives. I can understand the FDAs concern here.
colordrops 6y ago
It's typically the territory of the ignorant and uneducated to peddle in conspiracy theories around Bill Gates' philanthropic efforts, but let's take a different angle here for a moment and discuss his motivations. He has clearly demonstrated severe sociopathic tendencies in the past that had the potential for catastrophic effect on the public good. For instance, he secretly backed SCO in an attempt to destroy Linux through BS copyright infringement claims. This is just one of countless ugly acts that he executed without pause. He has not gone through some dramatic epiphany that changed his world view, so why should we trust him now?
- deleted 6y ago
  [deleted]
bryanrasmussen 6y ago
In this case I guess the use of the word baffled is a good one, because they are not baffled by a matter of science but by a matter of politics.
- James_Henry 6y ago
  I don't know that it is political, but may be seen as bad decision science.
James_Henry 6y ago
I hope that even after the coronavirus pandemic has passed people keep calling out the burdens to society and progress caused by the FDA. I do hope that people notice that there are more life and death situations outside of pandemics that are, perhaps for fewer people, still very urgent. FDA regulation is often in the way of individuals getting the care they need, making decisions about life and death, and following and creating best practices in medicine.
- deleted 6y ago
  [deleted]
baggy_trough 6y ago
The health and welfare of Americans would be greatly improved if the FDA was abolished.
- AbrahamParangi 6y ago
  I've noticed that this is a position which many people will reflexively consider nuts. I think this may change over time and turn into a partisan issue. Probably one in which the left takes the wrong side, sadly.
  - SpicyLemonZest 6y ago
    I think communicating positions like this is a major unsolved political messaging issue. How do you say "this government agency is unreformable and we need to get rid of it" without implying that the government should completely ignore the agency's responsibilities? It'd make things a lot easier if there were a good way to phrase that.
    - watwut 6y ago
      You would need to at least hint on how what to do about that agency responsibilities. If you said that you want to abolish agency and not a single word about what to replace it with, people rightfully assume you plan to abolish agency.
    - Godel_unicode 6y ago
      By having an actual plan for the second half. Someone has to bell the cat, and people are rightly sceptical of hand waving there. It's never the messaging that's the hard part, it's the planning that's the hard part. Especially since the messenger always gets the credit.
- dmitriid 6y ago
  https://en.wikipedia.org/wiki/Jim_(horse) https://en.wikipedia.org/wiki/Jim_(horse)
blargmaster33 6y ago
Government gonna government
numpad0 6y ago
So this is mass non professional nasal swab testing and FDA don’t like it. I see.
osamagirl69 6y ago
Wasn't this the result of the project changing its scope to be outside of what the FDA authorized? They put out a press release [1] on May 14 which explained why they were being shutdown--the FDA authorization allowed them to collect samples but not to return the results. By starting to share the individual test results back to those who provided the samples the program was no longer operating within its authorization and was shut down until a new authorization could be secured. While I don't agree with the FDA on their response, it seems disingenuous that this article doesn't mention the reason why the program was shut down. It is clearly much riskier to provide individuals with their test results than to collect aggregate data. Consider for example if you gave 1 false negative, and that person then took that false negative as an excuse to return to work -- potentially infecting many more. With aggregate data a few false positives/negatives could throw off the statistics but the standards the tests need to be held to for survey purposes are certainly different than those being used for diagnostic purposes. [1] https://scanpublichealth.org/updates/2020-05-13 https://scanpublichealth.org/updates/2020-05-13
- kjaftaedi 6y ago
  I agree with everything you've said, but I'd like to add a couple of counterpoints. (1) The FDA is currently allowing some testing to continue despite the fact that they know the results are not fully accurate. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-informs-public-about-possible-accuracy-concerns-abbott-id-now-point https://www.fda.gov/news-events/press-announcements/coronavi... (2) It's unlikely the company was willingly not complying with the FDA and common sense here would dictate a formal warning first.
  - unishark 6y ago
    The FDA only paused the study. They are expected to approve the home collection after analyzing the data.
  - boomboomsubban 6y ago
    The FDA knows that virtually every test is not fully accurate. The issue here was that their approval had been based on a misunderstanding of how the study operates. >2) It's unlikely the company was willingly not complying with the FDA and common sense here would dictate a formal warning first Halting until authorization is a formal warning, you can't just allow human experimentation without knowing they meet the requirements.
djsumdog 6y ago
I can understand the FDAs reluctance for home tests. They do want to make sure people aren't getting false negatives from degradation during transport. That seems like a legitimate concern. But what I think is a greater concern, are civil rights. Several states are now giving the addresses, and sometimes names, of people who test positive for CoV-2 to law enforcement officials[0,1], and apparently health an human services used some legal gymnastics to claim that this somehow doesn't violate HIPPA[2]. You might be tempted to say "Well this situation is special," but before you do, imagine if we started doing contact tracing on people infected with HIV. [0] https://tennesseelookout.com/2020/05/08/health-department-gives-names-addresses-of-tennesseans-with-covid-19-to-law-enforcement/ https://tennesseelookout.com/2020/05/08/health-department-gi... [1] https://www.msn.com/en-us/news/us/most-states-sharing-coronavirus-patients-addresses-with-law-enforcement-report-says/ar-BB14kBGn https://www.msn.com/en-us/news/us/most-states-sharing-corona... [2] https://www.hhs.gov/sites/default/files/covid-19-hipaa-and-first-responders-508.pdf https://www.hhs.gov/sites/default/files/covid-19-hipaa-and-f...
- SpicyLemonZest 6y ago
  We do contact tracing on people infected with HIV. It would be a public health disaster if we didn’t.
  - djsumdog 6y ago
    We do? I thought with HIV in the US, the patient has to voluntarily notify partners. I guess that's technically contact tracing, but does it involve health departments keeping a registry of infected individuals?
    - watwut 6y ago
      > I guess that's technically contact tracing, It is contract tracing. No technically modifier needed. > the patient has to voluntarily notify partners It is either "has to" or "voluntary" depending on state. It can be crime not to notify past partners. It can also be a crime to not warn people about your HIV positive test or otherwise put them at risk of getting it.
mjevans 6y ago
I understand their concern; however I don't agree that the remedy mentioned in the article is the only path. Knowing a sample is rendered invalid by mishandling or age might be accomplished by packaging an indicator with it which reacts when exposed to extreme temperatures and/or a chemical timer once packed. The samples could also be delivered via drop-off to collection stations at hub facilities (E.G. medical clinics or hospitals) and stored in controlled environments for the rest of the process.
- unishark 6y ago
  There were two remedies in the article that I saw, one is wait for the FDA to approve the protocol, and the other is to change to what I assume is a research study which would. Is there technology already available for your idea that would make it easier than those? Such as a swab that changes color when exposed to the air for more than 30 minutes or something.
trelonid 6y ago
What happened to "we have all the test kits we need"? This is why so many medical experts are screaming for an increase in testing capability.
- hprotagonist 6y ago
  the truth of the world will out the obvious lie. what else was going to happen?
dopylitty 6y ago
The key point that seems to be missed by people is that SCAN was one of the first to identify that coronavirus was spreading in the Seattle area and the US. This was deeply embarrassing to the Trump administration which was trying everything it could at the time to act like there was no issue. Shutting down SCAN under a flimsy regulatory argument should be seen as similar political punishment to the doctors early on in China who were muzzled because they were embarrassing the government by admitting the situation wasn’t under control. The FDA and CDC need much stronger protections from political meddling if they are to keep America safe from disease. Their scientists are still great but the disease at the top is spreading down at a worrying pace.

119 points by Reedx 6y ago

It's really hard not to wonder if there is a political motivation to break the Federal government so that even the U.S. left would seek to devolve it.

deleted 6y ago
[deleted]
James_Henry 6y ago
I'm willing to guess that many of the issues in the FDA are not caused by normal left/right politics but by bureaucracy, tradition, and other more behind the scenes issues.
aaronbrethorst 6y ago
This has been an explicit aim of the American right since the Reagan administration. https://en.wikipedia.org/wiki/Starve_the_beast https://en.wikipedia.org/wiki/Starve_the_beast
- James_Henry 6y ago
  Issues like the one posted don't seem to be consequences of financial or other neglect from the federal government thought. There is definitely something else going on here.
- so33 6y ago
  > The nine most terrifying words in the English language are "I'm from the government, and I'm here to help." - Ronald Reagan > In this present crisis, government is not the solution to our problem; government is the problem. - Ronald Reagan https://en.m.wikiquote.org/wiki/Ronald_Reagan https://en.m.wikiquote.org/wiki/Ronald_Reagan
- roenxi 6y ago
  I wasn't following politics in the Regan administration, but I assumed destroying the government's competence was potentially the right wing's response to the total failure of the Starve the Beast strategy. Starving the Beast as a strategy just led to very high government borrowing, which is even worse for taxpayers - now they theoretically have to pay for government spending, plus a real rate interest.
  - sfj 6y ago
    We're they starving the beast? I hadn't noticed...
- rayiner 6y ago
  Reagan was in office almost 40 years ago. We have had 24 years of Republican Presidents during that time. Have we: 1) Rolled back social security or Medicare? 2) Rolled back the administrative state in any respect? 3) Developed any significant power back to the states? None of that happened. Government spending as a percentage of GDP increased, from 30% to 35%. Just more slowly than in the immediate post-New Deal era. Characterizing attempts to hold the line or make modest reforms as wanting to “break the federal government” is a cute bit of rhetoric, but you’d have to be very gullible to believe it. We’re about to go into an election where 2 of 3 leading Democratic candidates proposed new programs that would take US government spending as a percentage of GDP past that of Sweden. More than half of the economy would be the government, versus a mere third today. By contrast, did any serious Republican candidate propose a corresponding opposite movement? Decreasing total government spending by 15 points to 20% would take us into the 1940s and 1950s (so still post New Deal). No? That should tell you a lot about how much basis your assertion has in reality.
  - lambdasquirrel 6y ago
    Is that so? I recall a strong push to get rid of "ObamaCare." The suggestion here is that the Republicans aren't able to pull back these social programs because even their own constituents would be up in arms. The next best strategy is to so thoroughly break the Federal Government that no one would support it anymore.
SpicyLemonZest 6y ago
The FDA is pointlessly obstructing our coronavirus response, everyone knows they're doing this, but there are no serious proposals to do so much as temporarily bench them. If it's an accelerationist strategy, it's not a very good one because we're not accelerating towards devolution.

vorpalhex 6y ago

> An FDA spokesperson explains that anything that requires a person to take samples themselves, at home, raises concerns. For example, the agency wants to ensure that samples remain stable if they end up spending a long time in a hot vehicle on the way to a lab. Not exactly a baffling secret. At home sample collection wasn't included in the guidelines, sounds like FDA is evaluating and may still give a go ahead.

Lazare 6y ago
I think that point was addressed fairly well in the linked article.
- vorpalhex 6y ago
  That would be why I quoted the linked article. That doesn't excuse the clickbait headline.
  - James_Henry 6y ago
    I think that the article made it clear that there is such a great need for at-home specimen collection that it is baffling that the FDA is going so slow.
    - vorpalhex 6y ago
      1. I take a sample collection at home, as an average-person 2. I leave it on my hot porch for a few days before FedEx picks it up, the sample is invalid 3. Lab tests sample, calls me and tells me I'm clear even when I'm actually sick 4. I go to my favorite bar and decide to intimately swing dance with all the patrons, causing a super spreader event The only thing worse than not having a test is having a faulty test. The FDA is very worried about faulty tests, or in this case, bad sample collection leading to faulty tests.
djsumdog 6y ago
Yea it seems pretty clear to me. If samples degrade during transport, you could get false negatives. I can understand the FDAs concern here.

colordrops 6y ago

It's typically the territory of the ignorant and uneducated to peddle in conspiracy theories around Bill Gates' philanthropic efforts, but let's take a different angle here for a moment and discuss his motivations. He has clearly demonstrated severe sociopathic tendencies in the past that had the potential for catastrophic effect on the public good. For instance, he secretly backed SCO in an attempt to destroy Linux through BS copyright infringement claims. This is just one of countless ugly acts that he executed without pause. He has not gone through some dramatic epiphany that changed his world view, so why should we trust him now?

deleted 6y ago
[deleted]

bryanrasmussen 6y ago

In this case I guess the use of the word baffled is a good one, because they are not baffled by a matter of science but by a matter of politics.

James_Henry 6y ago
I don't know that it is political, but may be seen as bad decision science.

James_Henry 6y ago

I hope that even after the coronavirus pandemic has passed people keep calling out the burdens to society and progress caused by the FDA. I do hope that people notice that there are more life and death situations outside of pandemics that are, perhaps for fewer people, still very urgent. FDA regulation is often in the way of individuals getting the care they need, making decisions about life and death, and following and creating best practices in medicine.

deleted 6y ago
[deleted]

baggy_trough 6y ago

The health and welfare of Americans would be greatly improved if the FDA was abolished.

AbrahamParangi 6y ago
I've noticed that this is a position which many people will reflexively consider nuts. I think this may change over time and turn into a partisan issue. Probably one in which the left takes the wrong side, sadly.
- SpicyLemonZest 6y ago
  I think communicating positions like this is a major unsolved political messaging issue. How do you say "this government agency is unreformable and we need to get rid of it" without implying that the government should completely ignore the agency's responsibilities? It'd make things a lot easier if there were a good way to phrase that.
  - watwut 6y ago
    You would need to at least hint on how what to do about that agency responsibilities. If you said that you want to abolish agency and not a single word about what to replace it with, people rightfully assume you plan to abolish agency.
  - Godel_unicode 6y ago
    By having an actual plan for the second half. Someone has to bell the cat, and people are rightly sceptical of hand waving there. It's never the messaging that's the hard part, it's the planning that's the hard part. Especially since the messenger always gets the credit.
dmitriid 6y ago
https://en.wikipedia.org/wiki/Jim_(horse) https://en.wikipedia.org/wiki/Jim_(horse)

blargmaster33 6y ago

Government gonna government

numpad0 6y ago

So this is mass non professional nasal swab testing and FDA don’t like it. I see.

osamagirl69 6y ago

Wasn't this the result of the project changing its scope to be outside of what the FDA authorized? They put out a press release [1] on May 14 which explained why they were being shutdown--the FDA authorization allowed them to collect samples but not to return the results. By starting to share the individual test results back to those who provided the samples the program was no longer operating within its authorization and was shut down until a new authorization could be secured. While I don't agree with the FDA on their response, it seems disingenuous that this article doesn't mention the reason why the program was shut down. It is clearly much riskier to provide individuals with their test results than to collect aggregate data. Consider for example if you gave 1 false negative, and that person then took that false negative as an excuse to return to work -- potentially infecting many more. With aggregate data a few false positives/negatives could throw off the statistics but the standards the tests need to be held to for survey purposes are certainly different than those being used for diagnostic purposes. [1] https://scanpublichealth.org/updates/2020-05-13 https://scanpublichealth.org/updates/2020-05-13

kjaftaedi 6y ago
I agree with everything you've said, but I'd like to add a couple of counterpoints. (1) The FDA is currently allowing some testing to continue despite the fact that they know the results are not fully accurate. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-informs-public-about-possible-accuracy-concerns-abbott-id-now-point https://www.fda.gov/news-events/press-announcements/coronavi... (2) It's unlikely the company was willingly not complying with the FDA and common sense here would dictate a formal warning first.
- unishark 6y ago
  The FDA only paused the study. They are expected to approve the home collection after analyzing the data.
- boomboomsubban 6y ago
  The FDA knows that virtually every test is not fully accurate. The issue here was that their approval had been based on a misunderstanding of how the study operates. >2) It's unlikely the company was willingly not complying with the FDA and common sense here would dictate a formal warning first Halting until authorization is a formal warning, you can't just allow human experimentation without knowing they meet the requirements.

djsumdog 6y ago

I can understand the FDAs reluctance for home tests. They do want to make sure people aren't getting false negatives from degradation during transport. That seems like a legitimate concern. But what I think is a greater concern, are civil rights. Several states are now giving the addresses, and sometimes names, of people who test positive for CoV-2 to law enforcement officials[0,1], and apparently health an human services used some legal gymnastics to claim that this somehow doesn't violate HIPPA[2]. You might be tempted to say "Well this situation is special," but before you do, imagine if we started doing contact tracing on people infected with HIV. [0] https://tennesseelookout.com/2020/05/08/health-department-gives-names-addresses-of-tennesseans-with-covid-19-to-law-enforcement/ https://tennesseelookout.com/2020/05/08/health-department-gi... [1] https://www.msn.com/en-us/news/us/most-states-sharing-coronavirus-patients-addresses-with-law-enforcement-report-says/ar-BB14kBGn https://www.msn.com/en-us/news/us/most-states-sharing-corona... [2] https://www.hhs.gov/sites/default/files/covid-19-hipaa-and-first-responders-508.pdf https://www.hhs.gov/sites/default/files/covid-19-hipaa-and-f...

SpicyLemonZest 6y ago
We do contact tracing on people infected with HIV. It would be a public health disaster if we didn’t.
- djsumdog 6y ago
  We do? I thought with HIV in the US, the patient has to voluntarily notify partners. I guess that's technically contact tracing, but does it involve health departments keeping a registry of infected individuals?
  - watwut 6y ago
    > I guess that's technically contact tracing, It is contract tracing. No technically modifier needed. > the patient has to voluntarily notify partners It is either "has to" or "voluntary" depending on state. It can be crime not to notify past partners. It can also be a crime to not warn people about your HIV positive test or otherwise put them at risk of getting it.

mjevans 6y ago

I understand their concern; however I don't agree that the remedy mentioned in the article is the only path. Knowing a sample is rendered invalid by mishandling or age might be accomplished by packaging an indicator with it which reacts when exposed to extreme temperatures and/or a chemical timer once packed. The samples could also be delivered via drop-off to collection stations at hub facilities (E.G. medical clinics or hospitals) and stored in controlled environments for the rest of the process.

unishark 6y ago
There were two remedies in the article that I saw, one is wait for the FDA to approve the protocol, and the other is to change to what I assume is a research study which would. Is there technology already available for your idea that would make it easier than those? Such as a swab that changes color when exposed to the air for more than 30 minutes or something.

trelonid 6y ago

What happened to "we have all the test kits we need"? This is why so many medical experts are screaming for an increase in testing capability.

hprotagonist 6y ago
the truth of the world will out the obvious lie. what else was going to happen?

dopylitty 6y ago

The key point that seems to be missed by people is that SCAN was one of the first to identify that coronavirus was spreading in the Seattle area and the US. This was deeply embarrassing to the Trump administration which was trying everything it could at the time to act like there was no issue. Shutting down SCAN under a flimsy regulatory argument should be seen as similar political punishment to the doctors early on in China who were muzzled because they were embarrassing the government by admitting the situation wasn’t under control. The FDA and CDC need much stronger protections from political meddling if they are to keep America safe from disease. Their scientists are still great but the disease at the top is spreading down at a worrying pace.