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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

#51

Post by voxic11 »

unishark wrote: post #39
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.…

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

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

#52

Post by vorpalhex »

Lazare wrote: post #7
vorpalhex wrote: post #3

> 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.

I think that point was addressed fairly well in the linked article.

That would be why I quoted the linked article. That doesn't excuse the clickbait headline.

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

#53

Post by epistasis »

vorpalhex wrote: post #3

> 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.

LabCorps has been selling at-home collection kits according to this May 12 article:

https://news.yahoo.com/labcorp-expands-availability-home-sam...

If the scientists who have been combing through the documentation were baffled, and Nature News found it baffling enough to report on it, I'm going to need at least an appeal to authority of some sort to dismiss their views on this. Nature News is extremely reliable on these things, and does not do clickbait.

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

#54

Post by lostlogin »

djsumdog wrote: post #45
lostlogin wrote: post #30

Earlier quoted context omitted.

> 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]. 100,000 deaths in the US today. Presumably there is a point at which you would see it as ok to restric…

So what is the endgame again? Is it eradication? That seems completely non-feasible without truly draconian measures. If it's not eradication, if it's just "flattening the curve," that's already happened in most of the world: https://battlepenguin.com/politics/this-is-not-a-time-of-hon... Oncologists are talking about how they haven't seen new patients for two months or more. Even with clinics open, people are afraid…

> So what is the endgame again? Is it eradication? That seems completely non-feasible without truly draconian measures.

Eradication is the goal where I am in New Zealand. We have had 1 or 2 cases in the last week and seem on track to keep that up or improve. Restrictions are loosening fast now.

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

#55

Post by makomk »

epistasis wrote: post #53
vorpalhex wrote: post #3

> 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.

LabCorps has been selling at-home collection kits according to this May 12 article: https://news.yahoo.com/labcorp-expands-availability-home-sam... If the scientists who have been combing through the documentation were baffled, and Nature News found it baffling enough to report on it, I'm going to need at least an appeal to authority of some sort to dismiss their views on this. Nature News is extremely reliable on th…

LabCorp and the other providers of at-home testing actually went to the trouble of demonstrating that their at-home collection process worked and wouldn't affect reliablity, and then getting authorization from the FDA. This study didn't - they used an FDA exemption which specifically did not apply to at-home testing.

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

#56

Post by James_Henry »

ggreer wrote: post #47
boomboomsubban wrote: post #35

Earlier quoted context omitted.

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 re…

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 burea…

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.

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

#57

Post by James_Henry »

vorpalhex wrote: post #52
Lazare wrote: post #7

Earlier quoted context omitted.

I think that point was addressed fairly well in the linked article.

That would be why I quoted the linked article. That doesn't excuse the clickbait headline.

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.

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

#58

Post by James_Henry »

spockz wrote: post #26
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…

It is not just about degradation during transport. The samples need to be taken from deep in the throat and high up in the nasal cavity. This hurts quite badly. If the sample is taken from too low the chance on a false negative result are quite significant.

The FDA guidelines say that this isn't necessary, just preferred: https://www.fda.gov/medical-devices/emergency-situations-med...

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

#59

Post by James_Henry »

bryanrasmussen wrote: post #6

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.

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

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

#60

Post by vorpalhex »

James_Henry wrote: post #57
vorpalhex wrote: post #52

Earlier quoted context omitted.

That would be why I quoted the linked article. That doesn't excuse the clickbait headline.

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.

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.

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