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Scientists baffled by decision to stop a pioneering coronavirus testing project

nature.com

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Re: Scientists baffled by decision to stop a pioneering coronavirus testing project

#31

Post by djsumdog »

SpicyLemonZest wrote: post #22
djsumdog wrote: post #21

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 ser…

We do contact tracing on people infected with HIV. It would be a public health disaster if we didn’t.

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?

Re: Scientists baffled by decision to stop a pioneering coronavirus testing project

#32

Post by watwut »

osamagirl69 wrote: post #20

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 authorizatio…

> 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.

Re: Scientists baffled by decision to stop a pioneering coronavirus testing project

#33

Post by unishark »

mjevans wrote: post #27

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 clini…

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.

Re: Scientists baffled by decision to stop a pioneering coronavirus testing project

#34

Post by roenxi »

aaronbrethorst wrote: post #11
lambdasquirrel wrote: post #2

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.

This has been an explicit aim of the American right since the Reagan administration. https://en.wikipedia.org/wiki/Starve_the_beast

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.

Re: Scientists baffled by decision to stop a pioneering coronavirus testing project

#35

Post by boomboomsubban »

kjaftaedi wrote: post #28
osamagirl69 wrote: post #20

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 authorizatio…

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/coronavi... (2) It's unlikely the company was willingly not complying with the FDA and common sense here would dictate a formal warning first.

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.

Re: Scientists baffled by decision to stop a pioneering coronavirus testing project

#36

Post by watwut »

djsumdog wrote: post #31
SpicyLemonZest wrote: post #22

Earlier quoted context omitted.

We do contact tracing on people infected with HIV. It would be a public health disaster if we didn’t.

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?

> 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.

Re: Scientists baffled by decision to stop a pioneering coronavirus testing project

#37

Post by sfj »

roenxi wrote: post #34
aaronbrethorst wrote: post #11

Earlier quoted context omitted.

This has been an explicit aim of the American right since the Reagan administration. https://en.wikipedia.org/wiki/Starve_the_beast

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.

We're they starving the beast? I hadn't noticed...

Re: Scientists baffled by decision to stop a pioneering coronavirus testing project

#38

Post by akiselev »

kjaftaedi wrote: post #28
osamagirl69 wrote: post #20

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 authorizatio…

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/coronavi... (2) It's unlikely the company was willingly not complying with the FDA and common sense here would dictate a formal warning first.

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.

Re: Scientists baffled by decision to stop a pioneering coronavirus testing project

#39

Post by unishark »

osamagirl69 wrote: post #20

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 authorizatio…

> 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.

Re: Scientists baffled by decision to stop a pioneering coronavirus testing project

#40

Post by Godel_unicode »

SpicyLemonZest wrote: post #18
AbrahamParangi wrote: post #15

Earlier quoted context omitted.

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.

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.

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.

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