Puberty Blockers clinical trial.

[PlainJane999]

Simple question, do those here support the prescription of blockers as part of a clinical trial and why?

I am talking about recommendation 6 of the cass review.

Here's the actual paper
https://www.biorxiv.org/content/10.1101/2024.03.23.586441v1.abstract
@Sloejelly and @Callalllaaammma - everybody loves the original scientific ipsissima verba

Is it ethical to have clinical trials on healthy children, that's the problem.

Unethical

This is complex but I agree with Cass that a trial should be set up.

A proper trial should have a clear requirement that all participants, and for those under 16 (18) their parents, must give informed consent. As we know from the WPATH files there is significant doubt that anyone, child or parent, can give informed consent. That is a huge stumbling block.

Puberty blockers have historically been used more responsibly in the case of precocious puberty. The NHS defines this as where a girl under 8 or a boy under 9 shows signs of early puberty. The aim is not to stop puberty but to pause it for a short period.

I would want the first part of a trial to focus on children who have precocious puberty and received puberty blockers for a short time before going through puberty. This would need to be a long term trial with high quality data collection and follow up to assess the impact on adult health e.g. fertility, bone density etc. If there is evidence of an impact then a trial to prevent puberty would be unethical.

The trial could also follow up all the children who previously received puberty blockers long term and so did not go through puberty. Again this would need to be a long term study requiring high quality data collection and analysis. Sadly de-transitioners may be the most help.

There is also the question of delayed puberty as this can be the point children with undiagnosed DSD are identified. A trial may need to consider the right options for children with DSD. Again it would initially be about data collection and analysis rather than trialling puberty blockers. This is a particularly sensitive area as historically people with DSD have been subjected to horrifying treatment by medical professionals in the name of science.

A trial in my view does not start with prescribing puberty blockers rather taking a step back and looking for the evidence that already exists and following it up. First do no harm.

How many of the children presenting with dysphoria ended up actually being prescribed GnRH agonists? It was around 100 at the time of the ban, wasn't it?

I wholly support, as Cass recommended, research into improving treatment for gender incongruent youth so long as it does not compromise the welfare of those involved and does not disrupt existing well-established best practice pathways.

I do not agree with this. I am not GC but do not agree with testing on children.
I don’t think a child has the capacity to make a decision that will potentially impact the rest of their lives.

It is my belief that Cass made that caveat about trials in order to avoid her home being firebombed. No right-minded person would think there is anything ethical about it.

No one wants to do a long term study on the adults who are prescribed these drugs and how they affect them (the other groups being sexual offenders being chemically castrated, women undergoing treatment for hormone dependent cancers or endometriosis, and men with prostate cancer). There are anecdotal links in these groups to conditions like fybromyalgia and joint issues, as well as the known ones like bone density.

Before using children to conduct experiments, they could start with the adults.

One of the trials mentioned by Dr Baxendale in the video I shared measured IQ before the trial started but then didn't measure IQ at the end of the trial which is bizarre. Perhaps they could follow up with those trial participants to measure IQ. I don't particularly agree with animal experiments but I do think the only 'ethical' experiment could be on animals. It will show the problems with brain development and sexual organs atrophying at which point everyone will say bloody hell we're not giving this stuff to confused kids.

A clinical trial to what end though?
What are the ethics of it, are they being trialled on older teens or younger children?

My gut instincts were to vote no purely because I don't see how ethically a child can consent to all the side effects that we know already come from them as have been documented.

But that's not to say that if it can be proven to be done in an ethical way that I'd be against that.
Quite the opposite, I'd be in favour of that because frankly it'd give the hard line evidence and proof we need that it does more harm than good in a way that I'd hope wouldn't be ignored as other studies have been (though I don't realistically see how a trial could be done in any kind of ethical way).

That being said though, I'd imagine activists would find ways to call the trial & study "invalid" or "biased" for a myriad of different reasons, and therefore any evidence it comes out with will be ignored, and children will have gone through that trial for precisely nothing as any useful data will be discarded as "bigoted" or as "having an agenda".

Essentially, "yes" and "no" are simply too black and white to be adequate answers.

For me the importance of whether or not any trial or study is ethical, and is taken seriously and not shouted down as having an "agenda" one way or the other, therefore creating a scenario in which it is impossible for it to be ethical at all as regardless the participants will have gone through something only for the findings to have been ignored because of politics.
It becomes self defeating.

👆THIS!

👏👏👏
Well put @Lovelyview !

I was under the impression that Cass, grasping the febrile environment, was quite careful with her report. (And even then, activists managed to misrepresent it).

I don't for a minute think that a trial would be ethical, but as others have said, maybe going through the motions to hit that, in my opinion totally predictable, brick wall, is what's necessary.

Although, as places like WPATH begin to topple, and scientific evidence falls further and further off a cliff, even going through the motions of a trial might not be necessary.

Before designing a trial you would need a test to identify suitable candidates I.e. ensuring the child was not one of the majority who desist.

I think the participants would have to be clear what was meant by "reversible" for it to be ethical.

As a parallel example, hormonal birth control is reversible. As soon as you stop taking it, it no longer prevents you from becoming pregnant so its effects have ceased. However, if you take it from age 19 to age 34 and then stop, you don't then revert to having the fertility you had at age 19 because you haven't literally stopped time.

How can we ethically use up part or all of the normal window for a natural puberty - brain and body development - and risk the process not completing as it should?

I voted no for the reasons detailed in this analysis of the difficulties in carrying out an ethical clinical trial on children:

https://www.quackometer.net/blog/2024/07/what-would-an-ethical-clinical-trial-into-puberty-blockers-look-like.html

There is evidence suggesting that transgender adolescents show poorer psychological well-being before treatment but exhibit similar or better psychological functioning compared to cisgender peers from the general population after starting specialized transgender care involving puberty suppression. This conclusion is drawn from a research paper rated as high quality by Cass. Ignoring research like this and other supporting studies is unscientific. The main issue is that most research does not cover long-term outcomes. Given this context, I believe it is appropriate to move forward with long-term puberty blocker trials. The alternative is leaving many children to suffer and has a different set of risks.

I assume this is why Cass has not recommended an outright ban. She made many unpopular recommendations, and the comment about her "real" thoughts is pure conspiracy.

Best to only use blockers for a few years before moving to CSH then. Developmental windows still hit, patient welfare improved over blockers alone anyway.

The main issue is that most research does not cover long-term outcomes. Given this context, I believe it is appropriate to move forward with long-term puberty blocker trials. The alternative is leaving many children to suffer and has a different set of risks.

Or

Clinics could trace all the children who have been on blockers for a significant amount of time and see how they're doing.

And

The two clinics who refused to give up their results could be forced to do so

No. No. No. How can you get informed consent from pre-pubescent children such as trial.

Meant to say 'for such a trial' not 'such as trial'. Fat thumbs.

What age do you think children should be put on cross sex hormones ? If girls can start puberty at 8 do you think it would be fine for them to go on cross sex hormones before they're even a teenager?

Yes agreed. I am not suggesting people spend 15 years on blockers! Long term in my post above is about the follow up.

Why would anyone want to treat a psychological/psychiatric illness with a physical health treatment?

A UK clinical trial that has been through an ethics board, yes. A trial that only accepts severely dysphoric children who have had full MH reviews and assessments for ND and relevant comorbidities and who are deemed to be at risk from only continuing to get the currently available psychological treatment/ support.

I think we have to accept for a very small number of individuals including some under 18s, the distress and dysphoria they feel isn't able to be managed by any other means and once all other available options have been tried, for some this has to be an option, but the selection criteria and record keeping has to be immaculate so that outcomes and harms can be recorded and data collected.

We give kids drugs with limited safety data and with long lasting / not fully known long term side effects in other life saving/ life extending scenarios (cancer, severe neurological and MH conditions).

We shouldn't let our emotions on the topic make us treat one condition differently to another.