Puberty Blocker Trial Paused

But what is the research justification?

By which I mean, why do we think that stopping puberty will improve the quality of life of prepubescent kids with gender incongruence? What are the previous studies that suggest that this specific thing might be worth examining as a treatment with this specific outcome?

Like, do we have previous studies that show that stopping puberty was effective in treating some other mental health issue? Or do we have studies that show that something chemically similar to puberty blockers, but not the same drug, had a positive effect on the mental health of kids with gender incongruence? Like, how are we getting to “I know, let’s stop their puberty?” rather than any other flipping thing? Why not, as I’ve said before, prescribe eating ground up glass for breakfast? It seems to have the same level of justification.

You don’t just pull these things out of a hat unless you want to retroactively justify their use when they have already been prescribed for totally different reasons.

This is what I cannot, as a researcher, get my head around.

“Being happy and living a happy life” is the central message behind transitioning.

This is the other issue; some MH and wellness books are known to have created more MH issues because they sell and idea that everyone is happy and happy is the goal. The reality is that everyone has days where they don’t feel content or even pretty unhappy. The trick in life is to learn to accept feeling emotional discomfort and find ways to re frame situations.

Gender incongruence is an entirely made up subjective “diagnosis.”

the fact they’ve got no way of predicting, testing or diagnosing in any way shape or form which children might end up ’happy,’ when transitioned as adults, for their whole lives, proves this.

What could possibly do wrong?

Gender incongruence.

The implication of that phrase is that anyone who doesn’t happily confirm to the social stereotypes around their sex needs drugs and surgery. It sounds like something out of a dystopian novel.

And then people talk about how their DD thought she was a boy but later got keen on long hair, dresses & makeup & now has 2 kids, so there’s a happy ending, wasn’t it a good thing she didn’t go on blockers.

If DDs grow up to have buzz cuts, live in trousers & play rugby & never decide to have kids, it’s still a happy ending if they don’t go on blockers because they’re still just as much women as the ones who develop ‘girly’ tastes, and even if they don’t want to get pregnant they shouldn’t be going through early menopause, having their healthy breasts cut off or taking dangerous drugs that they don’t need.

This isn’t directed at any particular poster because I haven’t read back through the thread lately & my memory is increasingly bad (cheers peri). I just think it doesn’t get said often enough.

They are intending to treat an undefined malady, of which they don't know the cause, with drugs that they know harm people, have no evidence they will help, giving them to people who cannot consent, with no measure of what success would be.

I really wonder how these some of the people involved aren't yet going...err maybe this is a bit risky, I'm out.

Or maybe they are that's why we've got the pause, some people are finally worries about their own skin even if they weren't worried about the children's.

💯

There should be a clearly articulated problem that PBs can be positioned as a probable solution (or part solution) with clearly defined desired outcomes, from good to poor against which the impact of PBs are measured.

It’s not my understanding that the focus of the trial is on the unwanted side effects. I think the primary focus is exploring the impact on quality of life and mental health measures linked to ‘gender incongruence’.

I'm happy to have this pulled apart, but I would have thought that if a clinical trial is ethical, it should be possible to explain its purpose to a lay person, and I don't think e.g. Wes Streeting can explain 'gender incongruence' in terms that explain why you wouldn't be treating this like any other mental health condition.

Can anyone suggest a clinical trial that is ethical but that can't be easily explained to a lay person?

Perhaps she could explain what it is they are treating and why sterilisation is the cure? Go on Dame Hilary, give it your best shot.

It’s pretty shoddy to suggest the MRHA is bowing to external pressure when their objections are clearly articulated and reasoned.

I get the point about the pointlessness of a study for 14+ but Cass should be challenging the underpinning reasons for specifying a minimum age of 14 if she disagrees. A range of concerns have been raised, Cass should highlight which she agrees or disagrees with and why- to substantiate her claims.

suggesting a trial that blocks puberty post Tanner stage 3/4 isn’t worth doing is not unreasonable.

the trials are of the drugs’ effects. They can have other effects than blocking puberty, which continues beyond a fixed point in time. Subtle but important distinction.

I agree.

This being ‘just one of many contradictions’ rings true and I think the multiplicity often leads to getting stuck in the weeds.

Medical trials, a bit like court cases, should provide opportunities for clarity to be established.

I was dismayed that the trial was granted NHS ethical approval despite being opaque. I wondered how closely KCL had been working with MRHA in the development work for the trial. If they had, it would have meant almost certain MRHA approval, but it appears not and the adults may have entered the room! Fingers crossed.

Well may you ask!

She does seem to be challenging the concerns raised by the MHRA. From the Observer article:

Cass told The Observer she was “disappointed” by the MHRA’s intervention. “There are no new research findings and the MHRA hasn’t presented any new evidence,” she said. “It feels to me like they are responding to political pressure rather than to science.”

So, the MHRA have effectively changed their mind - there is, as Cass said, no new evidence, despite the fact that the MHRA have said there is. BUT, the MHRA should have spotted these issues the first time round. The fact that they have done so now is a good thing. If it only came after “political pressure rather than science,” that’s only because they got the science wrong the first time, and pressure was required to make them see this.

If Cass can’t get her head around that, I have no respect for her.

This is, in my view, the overriding flaw in the trial.

What is the desired outcome for any of the participants in relation to the condition, as opposed to its constituent parts/ symptoms.

From a medical perspective, it’s a no-brainer. The goal of symptoms desisting and for patients to be discharged without need for physical interventions that carry harms and risks is blindingly obvious. This doesn’t involve any positioning on gender non conformity or living your life in any way, yet TRAs position it as wanting to eradicate trans people and conversion therapy.

If we are to have a medical trial, using the scientific method, it needs to be presented as such, with clearly defined terms and good and poor outcomes defined in advance.

The overarching problem is that of trying to reconcile a position that being trans is natural and a normal part of human variation whilst also seeking medical intervention.

This is just one of the contradictions in the trans narrative. If trans is a natural and normal part of human variation (like being gay), it doesn't need medical intervention.

By framing it as something needing medical intervention it's stating that being trans is not normal or natural, but something which needs to be treated with medication.

If it needs medical intervention, a cure which would reconcile the brain with the sexed body should be seen as the best solution, since this would leave the body in a fully healthy state.

The demands of the trans lobby, by framing such a cure as conversion therapy, means that we can't even consider or investigate such a cure as a solution for people who believe they are 'trans'. As a result, what we should be doing is completely at odds with what is actually being done.

We're even forced into a position where people are 'celebrated' for having a medical condition leading to demands that doctors cause harm to their healthy bodies. It's insane.

There are 3 broad questions that drive decision making of ethics committees, under which other key matters sit:

Is the knowledge worth having?
Is it acceptable to involve participants in this way?
Do potential benefits outweigh potential harm?

High risk trials happen in the context of these questions - Early bone marrow transplants had mortality rates of around 50% but trials were conducted. It’s not difficult to see why.

There are widely differing perspectives when it comes to the 3 broad questions as applied to the Pathways trial. I believe that they are significantly influenced by whether or not the ‘condition’ being ‘treated’ is understood as primarily a medical or a social one.

I meant in terms of clinical outcomes. Why would anyone prescribe harmful drugs to physically healthy girls because those girls don't want periods or breasts?

That would have been me. Puberty was so awful, both physically and mentally, that I would have done anything to escape it. I did attempt suicide, but as I didn’t have the Internet to inform me, my attempt was unsuccessful.

That given the choice they would rather not have periods or breasts, even if only for a few years and regardless of the consequences.

Isn’t her position simply that we don’t yet know which treatments work best and more research is needed?

I don’t think there is an issue with her saying her position hadn’t changed, if the above is understood to be her position. She found there was insufficient evidence and she still thinks this to be the case.

In terms of her position on the Pathways trial, I am aware that she has said that it would be unethical to run the trial if it is conducted with only those over the age of 14. I don’t think anyone is disagreeing with this statement.

Has she challenged the concerns raised by the MRHA? I would likely take issue with her if she has, but suggesting a trial that blocks puberty post Tanner stage 3/4 isn’t worth doing is not unreasonable.

In the field of high quality research, stating ‘we know’ needs to be supported by empirical evidence. It shouldn’t be based on opinion, logic, anecdotes or common sense.

When you are assessing whether it is ethical to carry out a trial at all, opinion and logic are the only resources you have.

Here, the fundamental question is whether it is ever ethical to prevent a child from going through puberty.

What is the desired outcome for girls?