
FDA halts coronavirus testing program backed by Bill Gates - pulisse
https://www.nytimes.com/2020/05/15/us/coronavirus-testing-seattle-bill-gates.html
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rkagerer
[http://archive.is/O2x4U](http://archive.is/O2x4U)

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anonymouswacker
So it was halted because the original requirement for this sort of testing
program was for surveillance, not diagnosis. Washington's public health
authorities chose to change its intention and purpose (to instead provide the
results immediately to patients, also known as diagnoisis) while still
expecting the FDA to approve it. This is just a case of one bureaucracy not
being forthright with another one, and I don't see why the fact that Bill
Gates "backs" it has anything to do with the program.

Is Bill Gates somehow involved in this decision? Because one would hope that a
private individual would not be have undue influence on public health
organizations' decisions, especially when he has much of his wealth invested
in the very industry that is likely to be affected by the results of this
Coronavirus study. It's an overt conflict of interest.

~~~
boomboomsubban
>I don't see why the fact that Bill Gates "backs" it has anything to do with
the program

I doubt the FDA's decision had anything to do with the Gates connection, but
most study rejections don't get articles in the NYT. His backing is why it's
"news," he spend/gives millions to the press to ensure it.

~~~
loeg
> His backing is why it's "news," he spend/gives millions to the press to
> ensure it.

No, it's news because the FDA is haulting COVID testing over utterly stupid
bureaucracy when we need massively ramped up COVID testing and SCAN/Seattle
Flu Study are actually providing quality home tests at scale.

This stands in stark contrast to the hundreds of poor quality home antibody
tests the FDA has approved with almost no oversight. It seems inconsistent
with the need to cut red tape to fight COVID.

~~~
SteveJS
It is fair to say this group is the reason we didn’t have an even worse
outbreak, and it was solely due to defying the Federal officials:

[https://marginalrevolution.com/marginalrevolution/2020/03/em...](https://marginalrevolution.com/marginalrevolution/2020/03/emergent-
ventures-prize-winners-for-coronavirus-work.html)

“By Feb. 25, Dr. Chu and her colleagues could not bear to wait any longer.
They began performing coronavirus tests, without government approval.

What came back confirmed their worst fear. They quickly had a positive test
from a local teenager with no recent travel history. The coronavirus had
already established itself on American soil without anybody realizing it.”

~~~
taeric
This story strikes me as off. It runs counter to every other aspect of the
virus we focus on. Specifically, if it was already spreading _in schools_ ,
then why don't we see scores of critical kids and parents? With how contagious
this is, I find it fairly unconvincing that it was just that student.

Combined with symptoms taking about a week to present, this was in community
spread for a while. Yet, here in WA, the deaths figure is still 92% over sixty
years old. I don't know the percent from long term care facilities. (I would
love that stat.)

Then the question is at what point did it break into long term care
facilities? And could we have done something to strengthen their protection?

With a further question of what, exactly, causes it to go severe.

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boulos
This is pretty similar to the 23andme shutdown years ago, and for the same
reason. The FDA regulates what kind of “medical advice” you are giving. From
the article:

> The two kinds of testing — surveillance and diagnostic — fall under
> different F.D.A. standards. In a pure surveillance study, the researchers
> may keep the results just for themselves. But coronavirus testing has
> largely revolved around getting results returned to doctors who can share
> the results with patients.

> “We had previously understood that SCAN was being conducted as a
> surveillance study,” the spokesperson said.

...

> Dr. Topol said it would not make sense to have people swab their noses and
> then not give them their test results.

> “To withhold that information from people is downright absurd,” Dr. Topol
> said.

While I agree with the sentiment, the 23andme situation provides a useful
counter balance: if you provide untrained people with _inaccurate_ results, is
that better or worse?

In the 23andme case there was a worry that people might commit suicide or make
massive life changes, if they discovered they had a potential terminal
illness. Here, the 2x2 matrix of positive vs negative and true vs false, seems
most dangerous on the false-positive side for people who believe it grants
them freedom to do whatever they like. False negatives are dangerous for those
who then feel certain they don’t have the disease currently and thus expose
others unwittingly (but this is already likely!).

So I dunno, I bet they’ll review this somewhat quickly (the group sent their
FDA materials in a few weeks ago according to the article) particularly once
they have a tighter estimate on the false positive and negative rates.

~~~
anewvillager
> In the 23andme case there was a worry that people might commit suicide or
> make massive life changes, if they discovered they had a potential terminal
> illness. Here, the 2x2 matrix of positive vs negative and true vs false,
> seems most dangerous on the false-positive side for people who believe it
> grants them freedom to do whatever they like. False negatives are dangerous
> for those who then feel certain they don’t have the disease currently and
> thus expose others unwittingly (but this is already likely!).

So you suggest it's better to not test people?

~~~
jmchuster
Isn't that the suggestion? That if there are groups of individuals who you
know are going to make wildly irresponsible choices because they don't have
the ability to interpret such information, you would prefer not to give it to
them?

~~~
greglindahl
It's entirely reasonable to assume that tests with high error rates cause
problems for everyone, not just "groups of individuals who you know are going
to make ..."

For example, a PhD biologist friend of mine agonized for months before she was
willing to look at her personal 23-and-me results, after the FDA certified
them as accurate enough to show to consumers.

It's a real problem for everyone.

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dehrmann
What would happen if the King County health department ignored the FDA? Would
the FDA have to sue? Could local official face federal charges?

~~~
loeg
What I've gleaned from the Theranos saga is that the FDA has an office of
criminal investigations and can refer cases to the DoJ for prosecution if
there is a crime. I don't know if there would be a crime in that hypothetical
scenario; Theranos was charged with wire fraud, and this is pretty clearly not
wire fraud. I don't know if there's any recent historical precedent (since
WWII) for researchers violating the FDA's notion of informed consent. It may
be a type of negligence crime although I think the FDA has a pretty weak case
for that.[1]

[1]: [https://www.encyclopedia.com/science/encyclopedias-
almanacs-...](https://www.encyclopedia.com/science/encyclopedias-almanacs-
transcripts-and-maps/informed-consent-i-history-informed-consent)

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mnm1
Stealing PPE. Stopping legitimate test programs. What else is the federal
government doing to actively hinder the pandemic response and kill people? Not
to mention everything they are not doing.

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dragonwriter
> Stealing PPE. Stopping legitimate test programs. What else is the federal
> government doing to actively hinder the pandemic response and kill people?

Using the Defense Production Act to order meat plants open (and thus prevent
states from taking action to close them or make them safer if they are to
remain open in the light of massive outbreaks at many of them.)

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ZitchDog
It’s become painfully obvious that the trump admin doesn’t want want testing
rolling out too quickly. It would appear as a new wave of infection and spook
the all important Stock Markets.

~~~
coredog64
The FDA has been a smelly dumpster fire for a long time, so I don’t think you
can lay this particular issue on his doorstep.

~~~
fzeroracer
The FDA, much like other departments which exist as the long arm of the
executive branch, depend on the president and whom the president appoints.

I think it's fair to lay it directly on his doorstep considering the person
running the FDA currently is someone he directly appointed.

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lumberingjack
They should shut that program down it's quite scary I'm fairly certain it's
for data collection and surveillance not healthcare

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yalogin
I don't get it. From what I can gather they are not testing a new medicine or
vaccine, this is purely testing. So there is no harm to patients at all. All
they are trying to do is understand the pandemic and the virus. Why stop it?
Correct me if I am missing something really obvious here, but I cannot help
but think it could be politically motivated given that its bringing out dozens
of previously undetected infected patients. I really hope its not the case but
cannot stop thinking about it.

~~~
greglindahl
There is harm to a patient if you tell them an incorrect test result.

~~~
loeg
There's also harm if you don't tell them a correct result. There's especially
harm if you stop testing their neighbors to monitor community spread during a
fucking global pandemic over this pointless red tape about providing results.

~~~
greglindahl
Thank you for elevating the discourse with phrases like "fucking global
pandemic over this pointless red tape". A global pandemic is exactly when we
should be thinking hard instead of trading insults.

~~~
loeg
> Thank you for elevating the discourse ...

> we should [not] be ... trading insults.

A backhanded compliment is a form of insult, friend. I don't think this kind
of ad hominem attack is substantially responsive to my remarks.

~~~
greglindahl
Pointing out that someone is using silly language with pointless effect is not
an "ad hominem attack": can you point out anyone who might be confused by what
I said?

Your use of "my friend" is similar to the thing you're complaining about. I
got what you mean. Bringing up "ad hominem" is dodging the real issue.

Another comment of yours: "utterly stupid bureaucracy"

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LordOfWolves
Beyond the reliability of the tests, which has also been questioned of those
by Abbot Labs (the same tests administered to the President), the FDA states
they simply need further inquiry.

Tests do not inject you with any form of matter or fluid. Why are we
completely halting testing, even if it is only 1/3 correct? Just disclose that
fact to the testee and/or use 3 tests for a statistically significant result.

Does this reek of backdoor capitalism (corruption)?

~~~
ZitchDog
It’s more likely they don’t want testing rolling out too quickly. It would
appear as a new wave of infection and spook the all important Stock Markets.

~~~
alistproducer2
Ding, ding, ding we have a winner. This is the same FDA that stopped ethanol
producers from making hand sanitizer, at the behest of the purell of
course[0]. The feds have done practically nothing for the States making them
compete each other for ppe and also confiscated shipments [1] while saying the
national stock pile isn't for the States [2]. At this point I hope they just
ignore the feds. We might be better off revisiting the articles of
confederation at this point.

Edit: adding sources 0: [https://www.reuters.com/article/us-health-
coronavirus-ethano...](https://www.reuters.com/article/us-health-coronavirus-
ethanol-sanitizer/u-s-calls-ingredients-in-some-ethanol-based-hand-sanitizers-
unsafe-idUSKBN22C0LG)

1: [https://www.snopes.com/fact-check/trump-admin-seizing-
ppe/](https://www.snopes.com/fact-check/trump-admin-seizing-ppe/)

2: [https://www.politico.com/news/2020/04/03/strategic-
national-...](https://www.politico.com/news/2020/04/03/strategic-national-
stockpile-description-altered-after-kushners-remarks-163181)

~~~
greglindahl
[0] includes text like:

> In one case, the FDA said it had found significant levels of the carcinogen
> acetaldehyde in ethanol supplied by a company for use in hand sanitizer,
> according to a recent email exchange seen by Reuters.

Is anyone surprised that using fuel ethanol might not be a good idea for hand
sanitizer?

~~~
loeg
> Acetaldehyde occurs naturally in coffee, bread, and ripe fruit,[10] and is
> produced by plants. It is also produced by the partial oxidation of ethanol
> by the liver enzyme alcohol dehydrogenase

Doesn't really sound like a problem in a topical solution like hand sanitizer
given people _ingest it_ regularly.

~~~
greglindahl
The quote said "significant levels" \-- before dismissing it as "doesn't
really sound like a problem", you might want to look a little harder.

~~~
loeg
I read the quote. Is significant some quantifiable term of art in this
context?

Edit: Here's the current guidance (may not be the same as from the time of
that article): [https://www.fda.gov/regulatory-information/search-fda-
guidan...](https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-temporary-policy-preparation-certain-alcohol-
based-hand-sanitizer-products-during)

I don't see any explicit guidance on Acetaldehyde. The requirements show 95%
ethanol for ethanol-based sanitizer, with a footnote saying actually, "Lower
ethanol content alcohol falls within this policy so long as it is labeled
accordingly, and the finished hand sanitizer meets the ethanol concentration
of 80%."

It goes on to add, "Ethanol produced in facilities normally producing fuel or
technical grade may be considered for use if the ethanol is produced from
fermentation and distillation as would be typically used for consumable goods,
and no other additives or other chemicals have been added to the ethanol. ...
Because of the potential for the presence of potentially harmful impurities
due to the processing approach, fuel or technical grade ethanol should only be
used if it meets USP or FCC grade requirements and the ethanol has been
screened for any other potentially harmful impurities not specified in the USP
or FCC requirements."

Edit2: Here's the USP guidance on hand sanitizer, which lists Not More Than
10uL/L Acetaldehyde / Ethanol:
[https://www.usp.org/sites/default/files/usp/document/health-...](https://www.usp.org/sites/default/files/usp/document/health-
quality-safety/usp-hand-sanitizer-ingredients.pdf) Again, it's an ordinary
metabolite of ethanol in the body, so this is probably pretty conservative.

Wikipedia notes, "After intravenous injection, the half-life in the blood is
approximately 90 seconds."
[https://en.wikipedia.org/wiki/Acetaldehyde#Exposure_limits](https://en.wikipedia.org/wiki/Acetaldehyde#Exposure_limits)
and "According to European Commission's Scientific Committee on Consumer
Safety's (SCCS) "Opinion on Acetaldehyde" (2012) the cosmetic products special
risk limit is 5 mg/l."

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aaomidi
Odd coincidence that Trump complains about testing too much and then a few
days later FDA steps in and starts stopping testing programs.

