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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

#41

Post by makomk »

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.

It's not that baffling or secret at all. The only baffling part is how they thought the FDA's specific ban on doing at-home testing under this provision wasn't actually a ban on at-home testing because people were only taking the samples at home, as though this wasn't explicitly the exact, specific thing this ban was created to stop, and how Nature are going along with this narrative.

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

#42

Post by [deleted] »

James_Henry wrote: post #9

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…

[deleted]

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

#43

Post by NohatCoder »

akiselev wrote: post #38
kjaftaedi wrote: post #28

Earlier quoted context omitted.

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 j…

>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.

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

#44

Post by rayiner »

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

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.

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

#45

Post by djsumdog »

lostlogin wrote: post #30
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…

> 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 to come in. Time is critical in some cancers. How many people will die because they've progressed to stage 2 cancers without diagnosis? How many people have already died from heart conditions because they were afraid to go to hospital. What happens when the 2nd order effects hit half of that 100,000 number?

This thing is most likely going to be a part of our environment and ecosystem. People are going to continue to die until this burns out, and that might happen before Gavi/Gates/whoever gets their vaccine through clinical trials.

So far, people have mostly been doing what has been asked, not by force. But we've been fed so much conflicting information, we are so scared and risk adverse, and our governments seek so many more powers in order to protect us, and so many people have lost their jobs, savings, businesses and livings, that there is justification for peoples' concerns.

When it comes to civil liberties, we're talking about basic rights. We're talking about the question: Who owns you?

Liberty isn't some hobby or thought experiment. Liberty is most precious in times like these, when people frame claiming one's liberty as selfishness and a threat to order.

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

#47

Post by ggreer »

boomboomsubban wrote: post #35
kjaftaedi wrote: post #28

Earlier quoted context omitted.

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 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 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-de...

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

#48

Post by anon102010 »

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.

Most places do partner notification vs provider contract tracing for HIV.

Other diseases such as TB generally get contact tracing under CDC guidelines - more effective and there is less stigma.

Partner notification in some countries with high HIV rates have shown somewhat poor behavior changes and/or notification rates - but health authorities there dont trace TB or HIV regularly given limited resources

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

#49

Post by dopylitty »

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.

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

#50

Post by hprotagonist »

trelonid wrote: post #46

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.

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