New children's gender identity clinic, clinical trials and Cass

Just had another look, as of this evening, the NHS England CYP Gender Dysphoria Research Oversight Board hasn't been updated with information about the trial:

https://www.england.nhs.uk/commissioning/spec-services/npc-crg/gender-dysphoria-clinical-programme/implementing-advice-from-the-cass-review/cyp-gender-dysphoria-research-oversight-board/

Updated the archive version in case it's relevant in the future:

https://archive.is/wip/O9AbI

For completeness, this report was published 24 Jan 2025: Commission on Human Medicines report on proposed permanent order to restrict the sale and supply of GnRH agonists in children and young people under 18 years of age for the purpose of puberty suppression in gender incongruence and/or gender dysphoria

I'm quoting this recommendation because it's relevant to the trial:
Recommendation 7
The planned puberty suppressing hormone trial will recruit children and young people under 18 years who have not had previous exposure to GnRH agonists. A clear exit strategy needs to be put into place for continuation of GnRH agonists when exiting the trial if this is the pathway agreed with the patient and/or parents or carers. This should be accompanied by data collection on the efficacy and safety of the GnRH agonists.

https://www.gov.uk/government/publications/chms-report-on-proposed-changes-to-the-availability-of-puberty-blockers/commission-on-human-medicines-report-on-proposed-permanent-order-to-restrict-the-sale-and-supply-of-gnrh-agonists-in-children-and-young-people-under-1

Discussion with Michael Biggs Louise Irvine and Susan Evans:

The NHS Puberty Blocker Study – Necessary evil or medical scandal in the making?

https://www.youtube.com/live/tAiOUhs_FEM?si=FGbgrZgDF8qJ29Ao&t=1

This clinical trial is a terrible idea. We don’t need more evidence
https://genspect.org/call-to-action-help-genspect-uk-stop-the-nhs-puberty-blocker-study/

Its just like the sports issue. Assume its all fine and let the change happen, THEN start testing.

I think @Cerialkiller is right and it’s that kind of psychological intervention trial, perhaps with more analysis of existing data, that they’ll set up to kick this into the long grass. Whoever said early in the thread that this BBC piece may well be a sign of the wind turning in that direction, I reckon that’s likely. There’s got to be a search for ways out now.

Yes I thought the same. It's impossible to both produce valid results and be ethical.

By their very nature there will be differences between any group that has physical interventions and those who don't (unless randomly allocated/controlled) which would be deem unethical regardless of you are within the ideology or not.

Which means the medical pathway group will have higher rates of distress, more parental pushing or something which makes them more likely to be chosen for that group. There's no way that group will be equivalent to the less motivated group.

In some ways if the above happens and there is still a high degree of desistance or lack of improvement in mental health markers then that would be pretty conclusive as a result. If those children undergoing the most treatment seemed the most certain then you can draw conclusions about the subjects that were less motivated. Same is true if the unmedicated group do better then the medicated group long term.

Overall though it all seems very difficult to justify unless you believe in the base (impossible) premise of the ideology.

I don't understand why they don't start with more basic studies or meta studies e.h. observational studies where they gather all the tavistock patients from the past or something and use that to work out a hypothesis/informed model for any trials going forward.

I don't understand how medical personal can be aware of previous studies showing harm or lack of improvement from medical interventions but still think that a study into medical interventions can be ethical.

Why not do a trial just on psychological intervention first rather then set yourself up for liability. Do they think we are in some kind of golden age where medical scandals like Dr money, thalidomide, the tainted donated blood issue, just can't happen anymore?

What sort of person is going to take that job? We aren't even halfway through the woods yet.

😢

I should imagine most are firmly clinging on to the fact that their child must be truly trans and that this must be life-saving. They won't be listening to any of this until it gets deafeningly loud.

Seeing the pain in Elon Musk's face when he spoke about this was heartbreaking. It's hard to know if it's kinder that his eyes have been opened to it or he remained in the dark. It's impressive that he's channelled his pain into helping get the message to the world about how dangerous it all is.

I can't imagine how the poor parents who've been gaslit, manipulated and coerced into sterilising their children by the absolute ghouls pushing that narrative must feel.

And it's not borne out by evidence.

Those poor families.

Some parents are so frightened / bullied / confused / unable to practice firm parenting that they'll sign anything if their child has got caught up with any of the toxic organisations. Groups who will threaten any parent with "better a son than a dead daughter" and attempt to alienate the child from the family, so desperate are these adults to transition other people's children.

I suppose what it does do in the long run is set these parents up as legally culpable in the if they failed to protect their child's long term health, their brain & bone development along with their fertility because they felt threatened by transactivists and their groups? But by the time the child matures and finally understands the damage, it will be too late. Not sure that suing their parents would give them much satisfaction.

As ever, I applaud Deborah Cohen's courage while acknowledging that this shouldn't need courage:

https://www.mumsnet.com/talk/womens_rights/5226742-puberty-blockers-can-a-drug-trial-solve-one-of-medicines-most-controversial-debates

I can believe setting up the trial is plausible, what I cannot believe is that any parent can or will give informed consent when all the risks are fully explained.

I’ve no doubt it will be done. The point is it can’t be ethically done.

I just can’t see how this could get ethical approval.

Just maybe, they could gather kids who are already taking the drugs and give them trial-like follow up.

But giving out new prescriptions to children for drugs which have huge adverse effects and no benefits? One of Cass’ key points is that there’s not even a consistent explanation for WHY the drugs were being prescribed. For a clinical trial, you’d need to be able to say exactly what effect was intended and why you think it outweighs known problems.

The drugs have become an article of faith for gender loons, but there are no medical grounds for prescribing them, only ideological ones.

(I wrote this on a different thread but copying it here too. Apologies if the Sallie Baxendale link is already on this thread. I can't remember which one I got it from)

There has already been a 9 year trial... in the US. It used US taxpayers' money (it had a huge grant) yet nobody knows the results:

https://www.nytimes.com/2024/10/23/science/puberty-blockers-olson-kennedy.html

Thinking about this a bit more,
given it's of international interest, could Wes Streeting put pressure on the next US government to force its publication? From a UK perspective, I would like the NHS to have access to the methodology and results of this US trial before deciding whether it's ethical to start our own**. Ideally, the Cass Review would have had access to this US trial. Had it done so, we might not be in the position where we "need" to run one here.

**I can't imagine a situation where it's deemed ethical to run a puberty blocker trial in the UK. Fertility and bone density aside (both of which are red flags anyway), the impact on the developing teenage brain is unknown and highly likely permanent in every case.

Sallie Baxendale's explanation of what we already know about brain development tells us all we need to know about whether preventing puberty completely is ethical:

How on earth could it ever be ethical to run a trial where the outcome would be highly like to be permanent brain damage?

A trial will be done. And kidding ourselves it can’t be done is naive.

A couple of recent tweets from Jamie Reed (the American gender clinic whistleblower) on the proposed clinical trial:

https://x.com/JamieWhistle/status/1864711772600467724

"The nytimes needs to make a correction. Emilty Bazelon & Adam Liptak wrote this sentence: “In Britain, young people can get prescriptions for puberty blockers in clinical trials.”

This is not correct.
Transgender Care for Minors Faces Supreme Court Test

There is no clinical trial that is currently enrolling patients. There is no published or public protocol. There is no published or public inclusion/exclusion criteria. Any clinical trial (FYI my Masters of Science is in Clinical Research Management) will need to be approved. There are serious clinical researchers and ethicists that doubt that this trial will be approved.
Medical Ethics Declaration of Helsinki"

Ethics approval is supposed to be due this month with recruitment ready to start in Feb. 2025.

They never say "subject to ethics approval" do they? It's almost as if they think ethics approval is in the bag. I wonder why that might be?

Is there any detailed info in the public domain on the proposed trial?

Beyond what I posted above, I haven't seen any.

It's not on clinicaltrials.gov

Not listed on Be Part of Research
https://bepartofresearch.nihr.ac.uk/results/search-results?query=Gender%20dysphoria&location=

or ISRCTN

https://www.isrctn.com/search?q=&filters=condition%3Agender+dysphoria

Although it looks like it will be an 'invitation' trial, I'd still expect to be able to see the protocol on relevant sites with an elaboration of the inclusion and exclusion criteria and the treatment protocol(s).

Maybe it will eventually appear on KCL's or a related site as Simonoff is the Principal Investigator?

www.kcl.ac.uk/research/pears-maudsley-centre

Is there any detailed info in the public domain on the proposed trial? I know the team and site have been announced but any sign of a protocol or which ethics committee it's going to? If they haven't got their ethics yet I'd be amazed if recruitment started in Jan or Feb - there will definitely be changes requested by the ethics committee (I've had multiple for tiny studies) and just setting up the admin and contracts for a multisite study takes months.

Okey dokes.

Some food for thought on ethics:

If the NHS does fully tracked trials when administering medication that has an unknown (likely permanent) impact on children's brain development, does that make them more or less ethical than Mengele when he did his fully tracked trials on twins (where the outcomes were also unknown and likely permanent) in the second world war?

Thanks for that X thread.

I watched this "GC infighting" unfolding at the time but didn't see this particular thread.

TBH I'm looking forward to the day when we can all look back on this and wonder how on earth it all happened. Obviously that will also come with a lot of heartache regarding all the children and young people who have been physically and mentally harmed forever. I don't think I'll ever get my head around that part 😢

The safeguarding failures relating to all of it will be wide open for everyone to see at that point, just like all historical safeguarding failures. Sadly, we'll never learn fast enough at a societal level. We'll just be on to the next one.

To add: re the wondering, obviously once you know about the Denton's document, your wondering takes on a new direction. It's so massively messed up. Both the scale and nature of it.

Re shouting about safeguarding. This kind of framing - sorry to say - comes off as a silencing technique and I regard it as one. But you hear it a lot because lots of groups and people say it and I'm not sure it's always said with an intent in mind but like I say, that's how I take it.

There are women who've been pushed to the sidelines. It takes some finding and that's presumably the point of pushing them out. Especially if they are helping us understand why you CAN repeal the GRA.

Example here in a thread: x.com/alessandraaster/status/1863574019812798958?s=46&t=WHoOZ_3Kv5G6-FyQuvE0LQ

What do you mean @@mumda

Tell me about Ethics.