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Comment by nneonneo | Hacker News Reader

Per https://www.nichd.nih.gov/health/topics/nec/conditioninfo/ri..., 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.

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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.

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.

It’s not impossible that the base rate fallacy exaggerates the effect too:

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.

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 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.

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