Dutch Protocol

[TempestTost]

I was thinking this morning about what some of the pivot points were in the development of what we see now with gender. The Dutch Protocol came to mind as one such point, that so much of what came after depends upon.

It struck me though - without any research to back it up at the time, how was it ever approved? It was basically experimentation on children with completely unknown consequences, and was pretty unprecedented. I can't think of anything similar that's been allowed elsewhere, or that would be allowed.

Are the rules there about experimental drugs on children different? Did someone drop the ball? Something else?

I wonder that too. How ethics committees work in the Netherlands, (but the framework is the same across all countries), how the trial was allowed without previous animal work (but perhaps at the time the side effects of puberty blockers weren't known?), and how it was allowed without a randomised control group. That would have been the ideal time to conduct a serious, well constructed, randomised and as unbiased as possible trial - before social contagion, when we probably really thought that PBs were safe. Now it's a mess. I wonder whether there was any consideration about fertility, too, but perhaps that's in the methods of the paper(s), and I just need to search for them.

https://www.tandfonline.com/doi/full/10.1080/0092623X.2022.2121238#d1e146

According to this paper, there was no study done. It was just one professor and her team and clinic who started kids on puberty blockers because it seemed like a good idea to them.

I suppose if there was no official trial, there was no need for an ethics committee opinion?

Of note:

The Dutch protocol comprised not just a drug (GnRHa) and a treatment regime (from age 12 or Tanner stage 2) but also two discursive claims. The first was reversibility.

That would probably be a big reason why she was allowed to play around with puberty blockers: if they were reversible, then there would be literally no harm done in using them.

The second claim was that puberty suppression was a diagnostic tool. The case study of FG described GnRHa as an “aid in diagnosis and treatment”

I suppose that if it's not presented as a treatment, it doesn't need to be approved in the same way as a new treatment would be?

So basically, it looks to me like, "Oh hey, we're trying this in our clinic!" became "This is how it should be done everywhere," without being properly assessed and scrutinised. Pretty terrifying

This article came out a few days ago and explains some of the motivation of the originator of the Dutch protocol - in particular the fact that she was mentored by John Money:

https://genspect.substack.com/p/peggy-cohen-kettenis-the-dutch-architect

Off-label prescribing is not forbidden: it just transfers any liability for bad outcomes from the product licence holder to the treating physician.

That's a great article. It really shows that this was always about ideology rather than actual health care.
"she cleverly played the system: she presented the international consensus as an independent, unanimous truth — even though she herself was one of the main authors of those guidelines"

Remember that one of the original young men who was given puberty blockers and then surgery as part of this 'trial' died.