
SimplyThick: A Tragedy No One Saw Coming (2013) - myth_drannon
https://www.stlmag.com/Simply-Thick-A-Tragedy-No-One-Saw-Coming/
======
nneonneo
Per
[https://www.nichd.nih.gov/health/topics/nec/conditioninfo/ri...](https://www.nichd.nih.gov/health/topics/nec/conditioninfo/risk),
NEC occurs in about 9000 preterm babies a year in the US. The mortality rate
is about 25%, so that’s roughly 2300 deaths from NEC a year.

What the article doesn’t mention is how many babies a year are fed
SimplyThick. That’s necessary to assess whether SimplyThick is really causing
deaths significantly above the expected rate.

Infant deaths are all tragedies, and when they happen it’s tempting to try and
find a reason. Certainly, it’s in everyone’s interests to exercise caution,
but I would like to know what the state of the statistical evidence is like
before pinning the blame on one factor.

~~~
JacksonGariety
It is true that we cannot know if the product causes NEC without statistics.

But the point is that _even if no one had died_, SimplyThick had not been
developed and manufactured with health and safety in mind.

The incident illustrates the dangers of reckless innovation and
experimentation.

~~~
dmix
Did you miss the part where it dramatically improved the quality of life of
tens of thousands of people who were in the intended consumers of the product
(post-stroke and old age)? There's a significant long term cost to killing off
innovation in the name of some idealized pursuit of perfection.

The fact poor factory production quality hurt a small subset of children it
wasn't originally 'invented' for is not a failure of 'reckless innovation and
experimentation' (whatever that means). Xanthan gum was tested by the FDA and
continues to be consumed in countless other products today, that process will
always be imperfect.

It's very questionable any sort of hyper-safe approach to regulation and a
general hostility towards innovation/experimentation would have even caught
the risks of poor factory conditions... or whether they would have even tested
it on a subset of premature babies at risk for NEC.

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gumby
FWIW, the long term result (post this article) was to recommend that no such
thickeners be administered to anyone under 12 months of age (it was not only
neonates who suffered). This was was an observational response pending any
actual study of the cause (whether manufacturing or inherent to the source
material)

I’m not aware of any subsequent study but the result is not unreasonable.

~~~
myth_drannon
Also the current recommendation is to consult the doctor if the child is under
12 years old, but doctors still continue to prescribe thickeners based on
xanthan gum or any other gums.

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afandian
Bit of a content warning. This is horrifying stuff especially if you are a
parent or expecting.

~~~
oftenwrong
The surgeon's description was a bit gratuitous. I could have done without
that.

~~~
tudorw
Well, I guess be glad the surgeon is there, they have to live it, and we
struggle just reading it.

------
dnautics
This is terrifying as an entrepreneur. You build a product, someone starts
using it in an off-label fashion, people get hurt, you issue guidance, and
then you still get sued.

~~~
scarface74
There is a lot more nuance and a lot you missed.

\- if I as an entrepreneur, create a product in good faith, work with the
experts, honestly go through all of the FDA approvals, get approved and follow
all of the regulations, then if later on my product is at fault, I don’t think
I should be sued [1]. Sometimes things happen even if no one was being
negligent and everyone was acting in good faith.

\- on the other hand there seemed to have been abnormalities in how the
product was produced by the company they outsourced to. Yes you can outsource
manufacturing, but you can’t outsource responsibility. It was the company’s
selling SimplyThick responsibility to ensure that all of its partners were
doing things in compliance. So yes, SimplyThick should have been held liable.

\- Even when they found that their might be problems, they buried the lede and
put the warning down 9th on the list.

[1] I am on the other side of this argument. I have relatively mild cerebral
palsy. I’ve lived an active life - run half marathons, was part time fitness
instructor and today I have a decently well outfitted home gym - when I
research information on CP, the first few links and all of the ads are for
lawyers looking to get people to sue doctors. I find it appalling. My parents
didn’t spend time in the 70s looking for people to sue - they were looking for
doctors, therapists, etc.

~~~
rsynnott
> My parents didn’t spend time in the 70s looking for people to sue - they
> were looking for doctors, therapists, etc.

For some people (at least in the US), the suing was presumably to be able to
afford the doctors and therapists.

------
hinkley
I know an adult with wheat sensitivity that swears up one side and down the
other that xanthan gum causes issues. And it shows up in a lot of GF food to
help bind things together without gluten.

Used to be we used guar gum for these things. But fracking companies are
buying it up by the truckload, raising the prices. Maybe we could get them to
switch to xanthan.

------
nabdab
> It is mind-boggling how you can market a product and sell it to a patient
> population knowing absolutely nothing about how it will affect them

Seems the problem is that the product got classified essentially as “just a
new baker baking bread”. And in that case you wouldn’t do clinical trials to
see how people react to eating your exact loves of bread.

Then people realized that his exact brand of bread could be given to infants,
and still you wouldn’t do a clinical trial because it’s just bread.

Then it seems that the production process might have been flawed in a way that
doesn’t quite harm adults, but is dangerous to infants and here we are.

So what really was the major flaw? Should we start doing clinical trials on
all foodstuff given to infants? It likely wouldn’t have shown anything if the
root cause is manufacturing process problems, because those problems would not
have been present in the batches used for the clinical trial anyway. But we
would end up having to test every single brand and procedure of mashed carrots
to see if it caused problems in infants.

That seems to be the pitch because it fits the trope of “big bad company never
thought of the potential consequences of their money making scheme!”

But really this might just be a straight forward case of manufacturing
practices not being held to the needed standards, because a plant got thrown
around between a couple of companies and the people on the ground didn’t know
any better.

Also, you have to now wonder if Heinz ketchup produced with the same process
given to infants might cause NEC. I’m sure that even if there where such cases
no-one would have been able to connect the dots.

------
rthomas6
With all the research coming out about gut bacteria's ties to pretty much
everything, this makes me wonder if other supposedly innocuous ingredients
could have an effect we didn't notice before, and in adults too.

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p1mrx
> "Some of these kids, when you operate on them, everything is dead, from the
> stomach to the rectum. It’s called a peek-and-shriek. You have to close and
> hand the child to her parents."

That's horrifying... "Your baby's power source is gone. There is no
replacement."

------
oftenwrong
What did the Food and Drug Administration's investigation reveal? It seems
like the agency failed to do its job in multiple ways. I cannot find any
current information on this case.

~~~
h2odragon
TFA says 'still investigating' ... I hadn't heard of any of this that i
recall, my wife says she's heard of at least one of the case stories.

~~~
LukeShu
But TFA was written 6 years ago.

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TheRealPomax
tl;dr: someone came up with the idea of a xanthan-based thickener for adding
to liquids for post-stroke adults, xantham is made using bacteria, and they
outsourced the production to an established manufacturer or such products.
Turns out hat manufacturer didn't actually ensure that there were no live
bacteria in the final product, people started marking the substance as
suitable for premature infants, and babies have died from the worst possible
bacterial infections imaginable as a result.

For those who don't want to spend 20 minutes reading an article that's written
by someone 1/4th journalist, 3/4th aspiring novelist.

~~~
stallmanite
Thank you for the summary. If this is indicative of your style I wish you a
long and prolific career in journalism. We need more writing like this.

~~~
raphlinus
Pomax is already very well known for excellent technical writing, making
arcane topics such as Bézier curves accessible to a wide audience.

------
vincent-toups
Move fast and break stuff.

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thrwy88
Had to create a throwaway to touch this, and I am _not_ an anti-vaxxer but...

One of the primary arguments of the anti-vax movement is not that "vaccines
cause autism" but that the FDA is a poor, industry-captured steward of public
health WRT the shit that they give the thumbs up to be fed or injected into
kids. This story is a case in point for that argument.

~~~
rsynnott
The problem claimed in the article was with manufacture, not with the product
as a concept. You could definitely argue that the FDA needs a greater
supervisory role for manufacture, but this wasn't an issue with the approval.

~~~
rileymat2
The article left that in doubt. They did not rule out the thickener.

FTA

> Did the cold processing method and the failures in sanitation cause NEC?

> Nobody’s sure. The FDA’s current theory is that the problem is the xanthan-
> gum thickeners themselves, because of the way they interact with an immature
> gut.

------
ars
This is why I try to avoid products labeled "cruelty free", or "not tested on
animals". If you don't test your product, how do you know it's safe?

There are so many cosmetics and food additives put on the market with no, or
barely any testing. Why would you advertise "we don't know if it's safe, we
never tested it"?

~~~
jmull
Well, here's an outside perspective with no particular axe to grind:

Your position to avoid "cruelty free" products may or may not be valid. But
this case does not support it.

I think in this case you've fallen victim of the natural human tendency to
confirmation bias ("the tendency to interpret new evidence as confirmation of
one's existing beliefs or theories")

Sorry... you may not be receptive to this info, in which case I'm sorry to
bring it up since it's only going to annoy you. (Also, sorry if I'm wrong.)

~~~
ars
I don't mind a discussion, if I'm wrong, I'm wrong.

> But this case does not support it.

Seems to me it supports it. This was a product that seemed safe, no testing
needed, just like "not tested on animals" products - the ingredients are
probably safe, no need to test.

Except that in the particular way it was used here, it wasn't safe.

To lead back to cosmetics: What if a particular mixture of two otherwise
harmless ingredients is toxic? What if an ingredient is thought safe, but next
to the eye is actually not safe?

Or for food additives, thought safe - except if used in an acidic food, or
heated, or mixed with some other additive?

