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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 wh

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.
  - ggreer 6y ago
    This is the same FDA that forbade researchers from running their own tests in January and February[1], squandering our chance to prevent this catastrophe. It's only because researchers broke the law that we discovered community spread when we did. 100,000 Americans have died from this disease in the past 8 weeks. We can't afford to be cautious. Imperfect tests are better than nothing, especially if there are no bureaucratic hurdles to prevent the deployment of refined versions (such as saliva samples instead of nose swabs). If not for the FDA, we would have an order of magnitude more testing. We'd have human challenge trials. We might even have variolation experiments. All of these could reduce the death rate by an order of magnitude. At this point it is no exaggeration to say that the FDA is responsible for mass death. 1. https://www.nytimes.com/2020/03/10/us/coronavirus-testing-delays.html https://www.nytimes.com/2020/03/10/us/coronavirus-testing-de...
    - James_Henry 6y ago
      I don't think that people realize the magnitude of the number of deaths that are directly due to unnecessary FDA regulation. The only reason that they found community spread in Washington when they did (a whole month after it had been spreading) is because of researchers who went around the regulations and then got shut down. If they had started their testing a week earlier, and if other states were allowed to test earlier, there would have been quicker lock downs across the country and NYC might have not been hit so devastatingly. I had hoped that people would see what has happened with the coronavirus testing and realize that these issues are systemic and have far reaching consequences beyond the current crisis.
- akiselev 6y ago
  They either knew what they were doing and were doing it willingly or they had no idea no business doing it at all. This isn't rocket science, it's basic regulatory compliance in clinical diagnostics. Comparing SCAN's situation to a QC problem at Abbott, which has been in the business of medicine for over a century and modern clinical diagnostics for decades, is disingenuous. I think the FDA has done an overall shit job at managing this crisis but everyone needs to keep the bigger picture in mind. It might seem like a really good idea to bypass a whole slew regulations right now but it has to be done carefully because those regulations have been written in blood of countless individuals. With over four million confirmed cases, any mitigation or response will be deployed at a massive scale. Any mistake, any oversight will be magnified across tens perhaps even hundreds of millions of people. Over four million are infected now. A lot more could suffer at the hands of eager arrogance.
  - NohatCoder 6y ago
    >This isn't rocket science, it's basic regulatory compliance You think rocket science is harder than regulatory compliance? At least the rules of physics don't change all the time. The majority of US health regulations have been written by medical corporations in order to keep competition out. While no regulation is certainly bad, current regulation for a large part simply drives up prices and lowers availability. Far more people in the US are killed by red tape than medical quacks.
watwut 6y ago
> 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 With opening of economy, default will be to go to work. People will need excuse to stay at home and no test means they go to work. And sooner or later, opening of economy must happen.
unishark 6y ago
> 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. Conversely if they are positive and you don't tell them then they are spreading disease unknowingly. That was what happened with the Tuskegee study. Either way, the solution is to get informed consent. At least that is for an experimental study. Apparently an additional issue here is that this project wants its data to be reported and used by govt agencies. Which means their protocol must also be approved as good enough for that by the FDA. And the FDA decided on May 11 that swabs taken at home requires further analysis as you say.
- voxic11 6y ago
  How do you get informed consent from all the people they are possibly spreading disease to?

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.
- ggreer 6y ago
  This is the same FDA that forbade researchers from running their own tests in January and February[1], squandering our chance to prevent this catastrophe. It's only because researchers broke the law that we discovered community spread when we did. 100,000 Americans have died from this disease in the past 8 weeks. We can't afford to be cautious. Imperfect tests are better than nothing, especially if there are no bureaucratic hurdles to prevent the deployment of refined versions (such as saliva samples instead of nose swabs). If not for the FDA, we would have an order of magnitude more testing. We'd have human challenge trials. We might even have variolation experiments. All of these could reduce the death rate by an order of magnitude. At this point it is no exaggeration to say that the FDA is responsible for mass death. 1. https://www.nytimes.com/2020/03/10/us/coronavirus-testing-delays.html https://www.nytimes.com/2020/03/10/us/coronavirus-testing-de...
  - James_Henry 6y ago
    I don't think that people realize the magnitude of the number of deaths that are directly due to unnecessary FDA regulation. The only reason that they found community spread in Washington when they did (a whole month after it had been spreading) is because of researchers who went around the regulations and then got shut down. If they had started their testing a week earlier, and if other states were allowed to test earlier, there would have been quicker lock downs across the country and NYC might have not been hit so devastatingly. I had hoped that people would see what has happened with the coronavirus testing and realize that these issues are systemic and have far reaching consequences beyond the current crisis.
akiselev 6y ago
They either knew what they were doing and were doing it willingly or they had no idea no business doing it at all. This isn't rocket science, it's basic regulatory compliance in clinical diagnostics. Comparing SCAN's situation to a QC problem at Abbott, which has been in the business of medicine for over a century and modern clinical diagnostics for decades, is disingenuous. I think the FDA has done an overall shit job at managing this crisis but everyone needs to keep the bigger picture in mind. It might seem like a really good idea to bypass a whole slew regulations right now but it has to be done carefully because those regulations have been written in blood of countless individuals. With over four million confirmed cases, any mitigation or response will be deployed at a massive scale. Any mistake, any oversight will be magnified across tens perhaps even hundreds of millions of people. Over four million are infected now. A lot more could suffer at the hands of eager arrogance.
- NohatCoder 6y ago
  >This isn't rocket science, it's basic regulatory compliance You think rocket science is harder than regulatory compliance? At least the rules of physics don't change all the time. The majority of US health regulations have been written by medical corporations in order to keep competition out. While no regulation is certainly bad, current regulation for a large part simply drives up prices and lowers availability. Far more people in the US are killed by red tape than medical quacks.

watwut 6y ago

> 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 With opening of economy, default will be to go to work. People will need excuse to stay at home and no test means they go to work. And sooner or later, opening of economy must happen.

unishark 6y ago

> 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. Conversely if they are positive and you don't tell them then they are spreading disease unknowingly. That was what happened with the Tuskegee study. Either way, the solution is to get informed consent. At least that is for an experimental study. Apparently an additional issue here is that this project wants its data to be reported and used by govt agencies. Which means their protocol must also be approved as good enough for that by the FDA. And the FDA decided on May 11 that swabs taken at home requires further analysis as you say.

voxic11 6y ago
How do you get informed consent from all the people they are possibly spreading disease to?