SimplyThick: A Tragedy No One Saw Coming (2013)(stlmag.com)
stlmag.com
SimplyThick: A Tragedy No One Saw Coming (2013)
https://www.stlmag.com/Simply-Thick-A-Tragedy-No-One-Saw-Coming/
44 comments
And if you read the article closely you would see that the FDA actually made that same connection, which is that while NEC was occurring in babies who were given SimplyThick it also occurred in babies who had not been given it, thus making it impossible to say that SimplyThick caused the NEC.
This article was from 6 years ago and a bit of research hasn't come up with any outcomes other than some sealed settlements with the families. The product labeling was changed to indicate a risk of NEC and the issues found at their packager (cold processing so incomplete sterilization of the product) have been rectified. And the product is still offered for sale suggesting that the company feels like they have put this behind them and the FDA has signed off on that.
This article was from 6 years ago and a bit of research hasn't come up with any outcomes other than some sealed settlements with the families. The product labeling was changed to indicate a risk of NEC and the issues found at their packager (cold processing so incomplete sterilization of the product) have been rectified. And the product is still offered for sale suggesting that the company feels like they have put this behind them and the FDA has signed off on that.
Yes but:
> Most of the babies who developed NEC were 2 or 3 months old, and had reached an age equivalence of full term. That’s very late to develop NEC. And half of them happened at home”—which was also unprecedented.
It sounds like there was enough abnormal presentation for drs and the FDA to assume these were more than just coincidence.
> Most of the babies who developed NEC were 2 or 3 months old, and had reached an age equivalence of full term. That’s very late to develop NEC. And half of them happened at home”—which was also unprecedented.
It sounds like there was enough abnormal presentation for drs and the FDA to assume these were more than just coincidence.
It’s not impossible that the base rate fallacy exaggerates the effect too:
https://en.m.wikipedia.org/wiki/Base_rate_fallacy
https://en.m.wikipedia.org/wiki/Base_rate_fallacy
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.
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.
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.
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.
The article even says that they went to all of the experts, followed FDA requirements to the letter and that they had no way of knowing that it may cause a danger to infants. The development process was sound.
I fault them for not doing do oversight during manufacturing.
I fault them for not doing do oversight during manufacturing.
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.
I’m not aware of any subsequent study but the result is not unreasonable.
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.
Bit of a content warning. This is horrifying stuff especially if you are a parent or expecting.
The surgeon's description was a bit gratuitous. I could have done without that.
Well, I guess be glad the surgeon is there, they have to live it, and we struggle just reading it.
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.
That's an interesting take. From my admittedly loose reading I had thought that they did sell it as a baby milk thickener / were aware of its use as such. Also I suspect more entrepreneurs would be concerned about being implicated in multiple child deaths than getting sued but I suppose you never know until you're the one on the spot.
Well, apparently if you outsource your production to Thermo Pac... yes.
The problem with this take is that the business knew there was interest in this use. As mentioned in the article, it was included on the patent. Once that happens, they can't claim ignorance. At the very least they could've warned the healthcare industry that xantham gum had never been properly tested on infants.
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.
- 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.
> 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.
For some people (at least in the US), the suing was presumably to be able to afford the doctors and therapists.
Is it even off-label?
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.
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.
> 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.
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.
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.
> "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."
That's horrifying... "Your baby's power source is gone. There is no replacement."
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.
Yeah... their website is full of broken links and there doesn't seem to be anything published about this in the last SEVEN years since the initial recall.
Edit: A 2017 "SDS" is lost in the source code of their website and it says nothing about infants:
https://web.archive.org/web/20191110194345/https://www.simpl...
Edit: A 2017 "SDS" is lost in the source code of their website and it says nothing about infants:
https://web.archive.org/web/20191110194345/https://www.simpl...
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.
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.
It's frustrating how light the article is on data while being so full of anecdotes.
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.
Pomax is already very well known for excellent technical writing, making arcane topics such as Bézier curves accessible to a wide audience.
> 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.
That's a reckless and misleading summary, to put it politely. For starters, here is something the article says:
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.
----
Yes, the article does spend some time up front on anecdotes for emotional response, but overall I felt it was quite well-written, trying to capture the nuances on different facets of the story -- quite unlike the above (aggravatingly shitty) "TL;DR" which presents a spurious simplification. Reality is NOT THAT SIMPLE; deal with it. For anyone who actually wants to understand, I recommend reading the full article.
That's a reckless and misleading summary, to put it politely. For starters, here is something the article says:
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.
----
Yes, the article does spend some time up front on anecdotes for emotional response, but overall I felt it was quite well-written, trying to capture the nuances on different facets of the story -- quite unlike the above (aggravatingly shitty) "TL;DR" which presents a spurious simplification. Reality is NOT THAT SIMPLE; deal with it. For anyone who actually wants to understand, I recommend reading the full article.
Move fast and break stuff.
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.
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.
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.
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.
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.
Xanthan gum is on the GRAS list so hard to blame the FadA’s oversight. Having presented before them for study approval they seemed anything but industry captured.
I agree that the GMP manufacturing OVERSIGHT could be stronger but I’d say Congress bears more responsibility for that course of affairs. At the time this was written the cause was unclear though.
I agree that the GMP manufacturing OVERSIGHT could be stronger but I’d say Congress bears more responsibility for that course of affairs. At the time this was written the cause was unclear though.
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"?
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"?
Usually this means they're using products that are already proven safe, that they contain nothing novel.
Of course, this case describes "nothing novel" since xantham gum was already an established-safe thickener.
Of course, this case describes "nothing novel" since xantham gum was already an established-safe thickener.
I agree with you. If you haven’t tested on animals, you are testing on your costumers.
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.)
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.)
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?
> 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?
The EU has banned the testing of cosmetics on animals for the last decade without the sky falling in.
Medical products typically are tested on animals. But it’s only so effective.
Medical products typically are tested on animals. But it’s only so effective.
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.