Why would the FDA approve any drug for any treatment, then? You're not making sense.
The FDA doesn't initiate the process, the drug makers do. The reason the FDA hasn't approved the use of blockers for the treatment of gender dysphoria, is because the drug makers haven't taken the steps required to receive approval. These steps are costly, and in the end involve monitoring the safety of the drug. No one promoting the Dutch protocol really wants FDA monitoring.
Hormone blockers are described as a pause on puberty, so the kid has time to grow up before making permanent changes. According to research about 98% of kids on blockers go on to cross sex hormones, according to research 80% of dysphoric kids who do not take blockers will desist. IMO, putting kids on blockers locks them in, because it's not only the obvious physical changes being blocked, but also cognitive development that occurs during puberty.
I'm a little light on the facts:
- Docs can prescribe blockers even if the FDA hasn't directly been asked and approved for an alternate use?
- How long have we've been using blockers specifically for gender dysphoria? Is this kinda a new-ish thing?
- How old can the kids be to receive such a treatment? I assume parents need to approve?
And yeah, I can totally see the slippery slope of whether messing around with cognitive developments cloud or clear the decision making capabilities going forward. The whole thing seems messy at best.
It is extremely common for drugs to be used off label in the US. If a drug is being prescribed for its intended use, and a particular side effect is noticed, and it is one that is seen as beneficial in treating something else, then doctors will start prescribing it. New drugs need FDA approval, once they have that approval for an intended treatment, then using them for other things is legal. It's also considered off label for medication to be prescribed in dosages not part of the original FDA trials. I think it is illegal for drug manufacturers to promote the usage of approved drugs in an off label manner, though. Probably why you don't see commercials for "puberty blockers".
An example of a drug commonly prescribed off label - Gabapentin is FDA approved to treat seizures, but is often prescribed to treat hot flashes, anxiety, and restless leg syndrome.
The idea of pubertal suppression has been kicking around since the 1990s. The FDA approved GnRH agonists for the treatment of precocious puberty in 1993. They became widely used to block puberty in dysphoric teens around 2015 or so.
Blockers are usually prescribed at Tanner stage 2, so it's not an age it's when certain sex characteristics begin to develop. I think, at the moment, you still need parental approval in every state in the US, but I know Washington state is working on a bill that would make it legal to offer treatment without parental consent. Also, I think there are several states where you only need the consent of one parent, and the dissenting parent has a great chance of losing access to their kid altogether if they try to stop the treatment. (bunch of legal stuff I don't feel like looking up at the moment)
The entire notion of informed consent needs to be examined in this line of treatment. Can an 11 or 12 yr old really understand the consequences? Are the clinics being sure to tell them in ways they can understand about what they will lose? Most of the kids I read online think they will have the puberty of the opposite sex once they start taking hormones, but that just isn't the case. Everyone thinks the only thing going on in puberty is getting hair, boobs, balls, etc. Just the stuff we can see. So much more happens!
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