Puberty Blocker Trial Paused

I would like to think the latter, but as these safeguarding mechanisms - the MHRA - totally overlooked all these concerns the first time round when they approved this study, I am feeling more like @Shedmistress. If an external noise and threat of legal action hadn’t happened, I feel like their original approval would have stood and no one would have been the wiser.

We also always said here it would be the court cases that would turn the tide

Given the context of how we got into this mess, which Hannah’s has diligently documented, one would hope that these mechanisms are only improving.

on this score, I’ve been following Dr Rachel Barr for a while. Her book appears to tackle the intersection between brains and environmental factors and how to navigate them to be healthier. Key points being that today’s society set up is really fucking tough. She’s a neuroscientist with autism and adhd. Good reads threw up Haidt as an associated author.

I do also want to highlight that there are some authors/ researchers who are balancing out the “it’s all phones and screens” narrative as I don’t think it’s that simple. i also think there’s a bigger, nuanced picture.

even very early things like the amount of daily support a new mother gets, especially when she’s already got older children. Western cultures do not have this. There’s countless posts on mn about this. R4 did a piece in early Jan about a Nordic country who basically have post partum doulas who visit several times weekly, even to just clean the house, for a long time on their nhs - but is now going to stop.

We could see it as a failure. We could see it as the safeguarding mechanisms of the legal system and compensation system kicking in and working.

This pausing of the trial is about self-preservation not about the kids.

It beats me. It feels like they did very poor research themselves.

How did MN FWR posters know all this years ago and yet the Brilliant Scientists at the MHRA hadn't got a clue?

Every doctor that prescribed them knew they were castration drugs.

I genuinely think it is the potential for all this to come out in court that did it.

It is really concerning when you look at the process to approve this trial. It did seem to have the ability to miss a great deal and to be ideologically biased.

It keeps coming back to that we already knew about the limitations the MHRA now mention. Yet those issues seemed to be dismissed.

The MHRA, who, according to Hannah Barnes’ article above, had already signed off on this study?

The MHRA that took zero interest in the off label dispensing of these drugs to children by the NHS for the last 20 years? That 'brilliant bunch of scientists'?

I note Hannah Barnes doesn't think there is a middle ground compromise on the puberty blockers trial. She basically thinks it's not possible and the only alternative is an unscientific unethical trial.

I wonder how long it's going to take for people to realise this across the board for gender identity. There is no middle ground because it's an ideology which is fundamentally sexist, homophobic and sometimes racist and harms vulnerable groups which means it's incompatible with equality if it's just blindly accepted. There is no compromise to be reached which doesn't harm vulnerable groups including transpeople themselves.

Thank you. That was a good read.

Found this horrifying

i was just thinking this yesterday.

Later diagnoses of autism and ADHD following difficulties at school are to a point subjective (I’m not talking about more profound autism, I’ve taught children in send for 20 years) as the context of the world the child is growing up in can make life more or less challenging.

At the same time, timely targeted support is vital. The younger a child receives correct interventions, the better they do.

What happens next after the MHRA halts puberty blockers trial? Hannah Barnes

www.thetimes.com/article/3f2d8165-2fce-422b-a496-aae118fc49b2?shareToken=be8dfeab33a2bbda3e2681baaa88e91c

I'm curious about the culture bound aspects of "gender distress". Particularly whether the 90-95% desistance rate for children who go through puberty is/would still be true today given how gender identity beliefs have spread and become so entrenched in the culture compared to the period of the original literature on desistance.

Pure speculation, but I wouldn't have been surprised if fewer children desist now after going through puberty simply because of the momentum and traction gender identity has gained in our culture. Possibly this is one reason non-binary identities have increased. Maybe medically transitioning seems less necessary when adopting a non-binary identity means a distressed young person can hold onto their trans identity without the physical toll of a medical transition (although I realise there are some with non-binary identities who do want hormones/surgeries to alter their bodies to be "neutral", although this usually seems to mean not female).

It's interesting that you're seeing just as many distressed children but fewer "gender distressed" children at your clinic.

I think it was Sarah Mittermaier who writes the Genderhacked substack who described gender identity as an idiom of distress. I wonder what new idioms or forms of distress will take its place.

There are some researchers/ medical academics whose whole career is based on publishing papers, becoming influential, well known in the right circles and so on. I have occasionally wondered if, for a tiny minority of these people, the outcomes for the trial subjects become less of a priority than they should.

The Other Phone. At the top of this page, for me at least.

Mumsnet do a kids phone. Or I dreamt they did

Thank goodness, the MHRA doing their job. There’s a great bunch of scientists working there.

For anyone who isn’t clear (the media doesn’t do a good job of reporting it) you need approval from two bodies to get Clinical Trial Authorisation. One is the ethics committee (REC) approval, and the other is authorisation from the MHRA. The MHRA is the ultimate body which decides whether a medicine can be licensed in the UK on the basis of safety, efficacy and quality (NICE decides whether the NHS will pay for it in an entirely different assessment). It is the U.K. equivalent of the FDA in the USA, but by contrast to FDA it is very hands off in terms of setting social policy - MHRA is purely focused on safety, efficacy and quality and whether the potential benefit of the drug (or trial) outweighs the risk.

it sounds like the MHRA have recently been reviewing the clinical trial application, which is the dossier that KCL will have submitted to them in order to get authorisation to run the trial. It is very normal for clinical trials to be paused while MHRA’s concerns are addressed. Less normal for the concerns to be so fundamental to the study design at this stage of the game.

In the normal scheme of things, if you’re going to be running a clinical trial that could be problematic, you would request a scientific advice meeting with MHRA before you finalised your protocol. All these points would be thrashed out well in advance of the expensive business of preparing dossiers for them and the ethics committee (who will have to reapprove any amended protocol).

Now, in recent years, MHRA clinical trial unit have had a backlog of meeting requests and many study sponsors have just said fuck it, submit the clinical trial application anyway and argue the toss during the review period. Higher risk though, as KCL is finding out.

Thank you @SingleSexSpacesInSchools

@Brainworm / others this is a good repository of the studies I believe https://www.anxiousgeneration.com/research/collaborative-review-docs

and this wider recent article by Cal Newport is well evidenced as well https://calnewport.com/whats-worrying-jonathan-haidt-now/

Some children / young people believe that they could navigate this complexity ‘as a boy’ or ‘as a girl’. This type of thinking is attractive because it provides a simple (one factor) solution that is readily at hand. They can find it very difficult letting go of this certainty, or entertaining letting go of it, and being open to exploring complexity…..when the complexity of life is what they are trying to get away from.