
Scientists baffled by decision to stop a pioneering coronavirus testing project - Reedx
https://www.nature.com/articles/d41586-020-01543-x
======
osamagirl69
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
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...](https://www.fda.gov/news-events/press-
announcements/coronavirus-covid-19-update-fda-informs-public-about-possible-
accuracy-concerns-abbott-id-now-point)

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

~~~
akiselev
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
>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.

------
vorpalhex
> 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.

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

[https://news.yahoo.com/labcorp-expands-availability-home-
sam...](https://news.yahoo.com/labcorp-expands-availability-home-
sample-155040098.html)

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.

~~~
makomk
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.

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

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

------
numpad0
So this is mass non professional nasal swab testing and FDA don’t like it. I
see.

------
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.

------
mjevans
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
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.

------
lambdasquirrel
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.

~~~
aaronbrethorst
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)

~~~
rayiner
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
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.

------
James_Henry
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.

------
djsumdog
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-
gi...](https://tennesseelookout.com/2020/05/08/health-department-gives-names-
addresses-of-tennesseans-with-covid-19-to-law-enforcement/)

[1] [https://www.msn.com/en-us/news/us/most-states-sharing-
corona...](https://www.msn.com/en-us/news/us/most-states-sharing-coronavirus-
patients-addresses-with-law-enforcement-report-says/ar-BB14kBGn)

[2] [https://www.hhs.gov/sites/default/files/covid-19-hipaa-
and-f...](https://www.hhs.gov/sites/default/files/covid-19-hipaa-and-first-
responders-508.pdf)

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

~~~
djsumdog
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
> 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.

