Astral Codex Ten

Omegaven

5 min read

Omegaven

Article

Omegaven is a recurring brand in the Astral Codex Ten archive, appearing 2 times across 2 issues between August 06, 2021 and August 08, 2021. The archive places it in contexts such as “a fish-oil-based infant nutritional fluid called Omegaven”; “Europe had a fish-oil based fluid, Omegaven”; “Fresenius, who held the rights to Omegaven”. It most often appears alongside Dr. Gura, Europe, FDA.

Metadata

  • Category: Brands
  • Mention count: 2
  • Issue count: 2
  • First seen: August 06, 2021
  • Last seen: August 08, 2021

Appears In

Source Context

Recovered passages from the original issue text. When the raw archive preserved outbound links inside the source passage, they are listed directly under the quote.

Details Of The Infant Fish Oil Story
August 06, 2021 · Original source
In my recent post on the FDA, I mentioned a story about a fish-oil-based infant nutritional fluid called Omegaven. The FDA took too long to approve it, and lots of infants died.
Inline links: my recent post on the
After more research, I’ve concluded that the story I told is basically true, although I got a few details wrong. I want to go over it at more length here to set the record straight and see what we can learn from it. My main source will be Dr. Kathleen Gura, the pharmacist most responsible for getting Omegaven approved. She won an award for her work, she gave a very long acceptance speech describing her adventure, and the transcript of her speech is where I’m getting most of this information.
Inline links: the transcript of her speech
Omegaven is a fluid for parenteral nutrition. If your digestive tract doesn’t work (a problem frequently associated with newborn babies), then you risk starving to death. Doctors can avert this by pumping nutrients directly into your veins through an IV. This is notoriously hard, because food has lots of nutrients, and if you try to put together a complete replacement for food you will probably miss something. The US standard is a nutrient fluid called Intralipid, which uses soybean oil as its main fat. Because of the usual random cross-national differences in medicine, Europe used a formulation with fish oil as the main fat (though I’m not sure whether they used it along with soybean or on its own). In the early 2000s, nobody thought there was any interesting difference between these.
Inline links: the usual random cross-national differences in medicine
Contra Drum On The Fish Oil Story
August 08, 2021 · Original source
That story would be wrong. In 2013, NBC ran an article called Drug Treatment Omegaven That Could Save Infant Lives Not Yet Approved By FDA. In 2014, libertarian blogs were using it as an example of excessive FDA delay - here’s one of them (search for “Bureaucratic Delay Endangers Lives”). Also in 2014, I personally learned about this for the first time, when writing my review of The Perfect Health Diet (I thought the book was generally bad, but it did alert me to this issue and the evidence supporting Omegaven). In 2016, my friend Eliezer Yudkowsky started writing a book about bureaucratic inefficiency that used the FDA failure to approve Omegaven as one of its central cases; in 2017, he published it as Inadequate Equilibria and I reviewed it here, including a mention of the Omegaven story. In January 2018, my friend Kelsey Piper also blogged about the FDA’s failure to approve Omegaven. Finally, in July 2018, the FDA finally approved the drug. I’ve been hearing about this story for so long that I thought I could recite it from memory (I was wrong, which is why I screwed up so many details in the original).
Inline links: Drug Treatment Omegaven That Could Save Infant Lives Not Yet Approved By FDA, here’s one of them, my review of, here, also blogged about
I think this history might be one of the reasons Drum and I interpret this story so differently. Drum hears about Omegaven, checks and sees that it’s FDA approved, and thinks “well, things worked out well in the end, what’s he complaining about?” I heard about it years ago, saw it wasn’t FDA approved, was able to confirm that it was revolutionary and life-saving, thought “well, I guess a lot of people are going to die from not being able to get this”, and read a gradual stream of articles over the next few years confirming that babies were still dying. Then, long afterwards, the FDA approved it. I guarantee you this is less fun and more enraging than hearing about it after the fact.
I got this from a book and haven’t been able to figure out exactly what it’s referring to - there doesn’t seem to be a corresponding entry in Dr. Gura’s notes. I suspect it’s true, since I find a lot of “compassionate use of Omegaven” studies from around this time, but I can’t find the actual FDA document involved. In any case, if true it slightly exonerates the FDA, so it’s probably not one of my points of contention with Drum.