Why the NHS puberty blocker trial is appalling

[Soontobe60]

Stella O’Malley from Genspect telling it like it is - that a state endorsed trial of puberty blockers for gender dysphoric children should NOT go ahead.
the NHS are not walking into this nightmare blindly - there are enough experts out there telling them what will happen happen to these children if they’re given these life changing drugs.
https://x.com/genspect/status/1989896741358113127?s=61&t=gKvvk-rWmOlYFGMZN8QVvQ

This is so disturbing.

PATHWAYS: Puberty suppression And Transitional Healthcare with Adaptive Youth Services - NIHR Funding and Awards

Award:
£10,694,902.24

'APPENDIX D - Side-effects of alternative GnRHa’s

Leuprorelin Acetate IM

Common: In under 18’s: Depression, emotional lability, gastrointestinal discomfort, haemorrhage, headache, metrorrhagia, nausea, skin reactions, vaginal discharge, vomiting.

In adults: decreased appetite, arthralgia, bone pain, breast abnormalities, depression, dizziness, fatigue, gynaecomastia, headache, hepatic disorders, hot flush, hyperhidrosis, insomnia, altered mood, muscle weakness, nausea, paraesthesia, peripheral oedema, sexual dysfunction, testicular atrophy, vulvovaginal dryness, weight change.

Uncommon or Rare: In under 18’s: Myalgia In adults: alopecia, diarrhoea, fever, myalgia, palpitations, visual impairment, vomiting, haemorrhage

Unknown frequency: In under 18’s: Idiopathic intracranial hypertension, interstitial lung disease, seizure, severe cutaneous adverse reactions.

In adults: Anaemia, dyslipidaemia, impaired glucose tolerance, hypertension, hypotension, idiopathic intracranial hypertension, insulin resistance, interstitial lung disease, leucopenia, metabolic syndrome, osteoporosis, paralysis, pulmonary embolism, QT prolongation, seizure, severe cutaneous adverse reactions (SCARs), skin reactions, spinal fracture, thrombocytopenia, urinary tract obstruction.'

If a young person wants to stay on puberty suppressing hormones and their doctor in the NHS Children and Young People’s Gender Service agrees that they may continue to benefit from it, their care will be reviewed again by the NMDT, who will need to agree that they should stay on puberty suppressing hormones. If the NMDT don’t agree, they will give the young person reasons why they think this is not the right ongoing care for them. If they make that decision and the young person’s circumstances change so the reasons they gave no longer apply, the young person’s doctor can ask for another review of your care. If a young person stays on puberty suppressing hormones their care will need to be reviewed by the NMDT every year while they are on it, to check it is still the right treatment for them.'

How is this randomised?

We’re though the looking glass here, where simple things are complicated and complicated things are simple 🪞

Great digging @ArabellaSaurus thank you!

https://pmc.ncbi.nlm.nih.gov/articles/PMC7430422/

Children will be assessed using this Utrecht questionnaire (among several), They are asked how much they agree with the following leading questions:

I prefer to behave like my affirmed gender
Every time someone treats me like my assigned sex I feel hurt.
It feels good to live as my affirmed gender.
I always want to be treated like my affirmed gender.
A life in my affirmed gender is more attractive for me than a life in my assigned sex.
I feel unhappy when I have to behave like my assigned sex.
It is uncomfortable to be sexual in my assigned sex.
Puberty felt like a betrayal.
Physical sexual development was stressful.
I wish I had been born as my affirmed gender.
The bodily functions of my assigned sex are distressing for me (i.e. erection, menstruation).
My life would be meaningless if I would have to live as my assigned sex.
I feel hopeless if I have to stay in my assigned sex.
I feel unhappy when someone misgenders me.
I feel unhappy because I have the physical characteristics of my assigned sex.
I hate my birth assigned sex.
I feel uncomfortable behaving like my assigned sex.
It would be better not to live, than to live as my assigned sex.

Also the PAGES-Y questionnaire:

1. My parents are proud of me
2. My parents are ashamed of me
3. My parents try to hide me
4. I can be myself around my parents
5. My parents advocate for my rights as a gender-expansive/trans* child
6. My parents protect me and defend me against others prejudice against gender-expansive/trans* people
7. My parents have problems with my gender expression
8. My parents use rewards or treats to pressure me to live as my sex assigned at birth
9. I can talk to my parents about romantic relationships and dating

10. My parents worry about how my gender identity will affect our family's image 11. My parents probably believe they are bad parents because I am gender-expansive/trans* 12. My parents probably believe that I am gender-expansive/trans* because of something they did wrong 13. My parents are supportive of my gender transition 14. My parents are worried that my gender identity is a bad influence on other kids in my family

The trouble is that the entire field is rigged already.

It's not possible to do research with an open mind when everything is set up according to a belief in 'gender identity' that doesn't even make any sense. The parameters are cooked.

Tooth fairy science.

Yes this is my view on it too so far.

Why has the ethics committee said yes?

Thanks for the various posts @ArabellaSaurus

But how - unless the ban on use of PBs changes - would the young person be able to receive the treatment after the end of the trial (or experiment)?

'6.2 Randomisation implementation
Allocation sequence generation

The randomisation sequence will be generated dynamically by the KCTU team via the KCTU web-based randomisation system, in accordance with the specification agreed with the CI and Senior Statistician. The Chief Investigator, Senior Statistician and TMG will be blinded to the sequence generation.

Enrolment of participants
Participants will be enrolled in the study for the purpose of CONSORT reporting at the point of signing a consent form to being screened for eligibility and will be part of the target N=226 at the point of randomisation.

Assignment of participants to interventions

Recruiting sites will assign participants to interventions by logging into the ‘KCTU randomisation system’ at www.ctu.co.uk (click ‘randomisation’ and select
‘PATHWAYS study) and entering the participant’s year of birth and age and
stratifiers. The system will randomise the participants to active immediate or delayed in a ratio of 1:1.

Randomisation procedure

The Randomisation procedure will be provided in the site set up documentation.

6.3 Blinding status of researchers

[I can't copy-paste this table - Arabella]

Table 3 - blinding status of PATHWAYS researchers X

The blinding status of the research team is detailed in Table 3 above. Trial statistician will be initially blinded to complete the Statistical Analysis Plan, then will be unblinded to complete DMC reports. '

I'm sure I'm missing it, and this is very much not my area of knowledge, but I can't find any info on the ethics approval at all.

12 Ethics Approval This protocol and related documents will be submitted for review to Health Research Authority (HRA), REC and MHRA. PATHWAYS TRIAL, HORIZON INTENSIVE and CONNECT will be conducted in compliance with the principles of the Declaration of Helsinki (1996), the principles of GCP and all of the applicable regulatory requirements (specify current legislation). 12.1 Protocol amendments and version control of study documents The Trial Manager will be responsible for preparing and submitting protocol amendments to the ethics committee. The Trial Manager will be responsible for updating the ISRCTN register following relevant protocol amendments. Subsequent protocol amendments will be submitted to the REC and Regulatory Authorities for approval, and will comply with regulations, particularly specifying, Pharmacovigilance reporting and providing the REC & MHRA with progress reports, and a copy of the Final Study Report.

Just that, in future tense. I'd have expected some kind of rubber stamp somewhere to say that it had been approved. Given that it's the NHS, I'd have expected it in triplicate, tbh.

That is almost unbelievable,
Asking a child if they feel they
‘I prefer to behave like my affirmed gender’
What is ‘like a gender’?

‘Every time someone treats me like my assigned sex I feel hurt.’

What is ‘like my sex’?

Why is the questionnaire saying ‘assigned’?

Why is it whispering that the parents may be harming them by not agreeing with their gender? ( Surely parents could be at odds with their children about other aspects anyway.)

This is a skewed questionnaire.

I understand how they randomise which participants receive puberty blockers immediately and which participants receive puberty blockers after a year, but then if after perhaps just a year the participant can decide whether they want to continue, it seems that that would interfere with long term analysis.

If one participant joins the trial at 11 and starts PBS a year later and another starts at 12 and starts PBs immediately; and then they both continue on blockers for the same number of years, what is being studied?

Sorry that was in reply to
@ArabellaSaurus · Today 15:15

https://pmc.ncbi.nlm.nih.gov/articles/PMC7430422/

They mention it being individualised because it is dependent on individual pubertal deveopment.

Interesting thanks. I wonder what it means, perhaps approval yet

I hope it doesn’t get it if so.

We think this group of young people are likely to be more diverse in terms of their personal characteristics and previous experiences and could have different support needs to those who have attended NHS gender services in the past. So, it’s important to study the needs and experiences of this specific, current group of young people over time.

This might explain the psychological impacts of treatment but the done density question could be explored. Did you take PBs? Yes/No. For how long? Prescribing records could be used. What age/Tanner stage were you at when treatment started? Moving on to cross sex hormones may be a confounder but they could do some work around that.

Has there been any effort to recruit detransitioners for studies? I know they are distrustful of gender clinics but they might be willing to participate in research on eg bone density to help answer questions around potential risks. To me that feels like a more ethical intervention because there are treatments available to bolster depleted bone density which would support them in later life.

https://pmc.ncbi.nlm.nih.gov/articles/PMC5685204/

'...a parent may be somewhat accepting of their child's disclosure of transgender identity, but prohibit (or not fully support) their child from initiating a social gender transition (e.g., using an affirmed name or gender pronouns) in or outside the home. In other cases, parents viewed as otherwise supportive of an adolescent's gender identity, and expression may be perceived as rejecting if they refuse to support an adolescent's desire to pursue gender-affirming hormone therapy and consent for treatment. Parental rejection may result from a parent's doubts about the validity of their child's self-identified gender or due to deficits in parenting ability or capacities'

I'd assume they needed approval before recruiting, though? The BMJ says it got approval in June, and it's recruiting now.

I posted the webinar above but here is CAN-SG's page (from Aug) on trial ethics, including email addresses of who to write to with concerns.
https://can-sg.org/2025/09/20/can-a-clinical-trial-of-puberty-blockers-in-children-experiencing-gender-distress-be-carried-out-ethically/

includes the Dr Hannah Ryan's view that there is no clinical equipoise and “For a good clinical trial, you need to have a good research question, and the design of your trial flows from your research question,” she said. “You need to have a clear and coherent hypothesis about a condition and an intervention, and how that intervention helps that condition, and how you might measure how that intervention helps the condition.
“But we don’t really know with any clarity what this condition is, if it indeed is one coherent condition; we don’t really have a clear hypothesis as to how the intervention works and over what time period; and we don’t know how to measure any kind of benefit. We don’t know what measures reflect medium or long term benefit.”

According to this, the approval process consists of the REC, going to to the MHRA for approval. Looks like the REC opinion (favourable) was 6/11/25. I can't tell from this website whether there is MHRA approval? But if they have already announced recruitment, then I assume that this hurdle must have been jumped too. https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/pathways-trial/

Yep 🤬🤬🤬

I haven't read the whole thread yet so this point might already have been made. Hilary Cass was interviewed by Cathy Newman on The Ladder section of her Friday evening show on Times Radio on the 14th of November. She still seemed to be firmly of the view that some children would benefit from puberty blockers and, therefore, that a trial should go ahead. It was very disappointing to hear. Unfortunately, the catch-up facility on Times Radio seems to only be available for a week so I can't post a link.

Thank you for this. It has a list of people to email. Does anyone have an idea which would be the best bet?