Puberty blocker trial UK

[RoamingGnome]

I was looking for official updates on the puberty blocker trial - which has been presented as 'recruiting early in 2025' which was always unrealistic.
Weirdly in the Commission on Human Medicines report it says:

'As of Jan 2025, the study team's application for funding is going through all the usual review and approval stages, including peer review and NIHR funding committee consideration'

is there even definite funding for the trial? The rest reads as if the trial is a done deal, but if in reality they are at the stage of applying for NIHR funds it may not be funded and no way will they be recruiting this year.

https://www.gov.uk/government/publications/chm-report-into-the-safety-implications-of-proposed-puberty-blockers-legislation-factsheet/commission-on-human-medicines-report-into-the-safety-implications-of-proposed-puberty-blockers-legislation-factsheet

I hope it never happens. Enough damage has been done to children already.

I don’t see how this could ever pass an ethics review which makes me think that it will never happen.

I'm not sure anyone even wants this trial now to go ahead, specifically not in the UK. It would be under very heavy scrutiny, and there is no guarantee that, if correct methodology would be applied, it would lead to the "desired" results (approving the treatment)

The NHS England CYP Gender Dysphoria Research Oversight Board is currently interviewing for a member who is young and has lived experience. There are no changes from last time that I looked. They expect the trial to go ahead with Siminoff as the Principal Investigator.

The full version of the report (linked from the first para of the page in the OP) says it's currently being considered for funding by NIHR. Searching here: https://fundingawards.nihr.ac.uk/ finds several other grants with Emily Simonoff as PI, but not this one. So I think funding for it has not yet been announced, anyway. In passing, I notice that they say the trial would be expected to report in 2031, and that (apart from the "off ramp" that allows discretion in keeping participants on puberty blockers after they've been on them in the trial, if appropriate, for ethical reasons) puberty blockers won't be prescribed other than in the trial before then. That seems a good amount of breathing space, at least.

Passage from the report: CHM heard that NHS England does not plan to provide NHS access to GnRH agonists for puberty suppression until the results of the National Institute for Health and Care Research (NIHR) puberty suppressing hormone study are available (estimated 2031). As currently planned, the study will require, from a safety perspective, an ability to continue GnRH agonists for puberty suppression as children and young people exit the trial (as children and young people may not have reached 16 years of age and therefore be eligible for gender affirming hormones). Any gap in planning should be addressed rapidly as it is likely to reduce children’s and young people’s confidence in the study and may cause delays to final approvals from an ethical perspective and therefore in study start up

Given that the NHS has such limited resources, it's massively unethical for any trial of blockers to go ahead until the data that we already have has been properly analysed.
And that's even before you look at the ethics of exposing vulnerable children to such risky drugs when there's no diagnostic framework for dysphoria and no clear measurable outcome.
One useful thing Trump could do is force Olson Kennedy to publish the results of the US trial before any more children are experimented on.

The NHS should scrap this unethical trial and put the saved money towards the staggering costs it will soon be paying in compensation to detransitioners, as they grow up and understand what’s been done to them.

Re-thinking life has posted this on another tread

https://fundingawards.nihr.ac.uk/award/NIHR167530

That document seems to start off with a foundational acceptance of the concepts of gender incongruence. and gender identity..using language such as " the sex given at birth". That surely does not bode well for academic impartiality?

"The PATHWAYS study aims to find out how the NHS can best support children and young people with gender incongruence. Gender incongruence is when a person feels their gender identity differs from the sex that they were given at birth. Some people with gender incongruence want their bodies to be more like their gender identity"

There seems to be minimal gatekeeping as to which children are accepted onto the trial. Their parents basically have to agree to it.

The trial has been awarded about £10.5 million of funding.

Puberty blockers are already prescribed to children who experience early puberty, and have been for decades. The safety of the drugs has already been assessed. The rationale of this trial is (as ive understood it) to try and ascertain the risks, benefits and efficacy in use for gender dysphoria.
Seeing as most arguments against the use of puberty blockers reference the lack of evidence for this use I would think a trial would be welcome?

No. Given the evidence that we already have regarding these drugs - including issues that people have who have taken these drugs for precocious puberty - I think that saying that 'The safety of the drugs has already been assessed' is dismissive and naive. This is a different cohort of children, at an older age, who will take the drugs for far longer and then move onto cross-sex hormones in most cases. It needs a whole new safety assessment and frankly, giving drugs like this to physically healthy children is a huge ethical problem. This new cohort does not have precocious puberty, they are having a nornal puberty at the normal age.

'First do no harm' has been truly memory-holed by the faithful, the Doctors willing to experiment on healthy children and those who stand to earn money from this.

Interesting podcast on the trial with Stella O'Malley and Mia Hughes and Carrie Clark...

1

Article today in the Times:
https://www.thetimes.com/article/eaa9ed7f-b693-4025-8255-232d48b08db7?shareToken=ff190b57d6f348b2cbe932ae36abf9e7

Archive version

https://archive.is/lN2NJ

Nuanced in presenting different perspectives on the value of a trial.

It’s MIND BLOWING that we’re back in this position so soon. TERF island? I don’t think so

Quote from article:

”But rather than recommending an outright ban on the drugs, Cass became persuaded during her investigation that a small group of patients might possibly benefit from puberty blockers. A re-analysis of the early Tavistock data found that 9 to 29 per cent of those given the drugs saw a reliable improvement in distress levels, 15 to 34 per cent saw a deterioration and 37 to 70 per cent saw no change.

Determining whether some children might benefit, and identifying which children fell into that category, was Cass’s main argument for carrying out a trial. Without this certainty, some families with children convinced of their gender dysphoria would continue to seek out the drugs from overseas or on the black market.”

This is the thinking that worries me when it comes to the Cass Review and the new clinical trial:

• It’s treating self-reports from children (who have been inculcated in Genderism and believe transition will solve all their problems) that PBs improved their levels of distress as being reliable data. It ignores the ideological elements that influenced the children and the gender clinics.
• The doctors/researchers are discussing and treating gender identity as if it’s an innate thing that some people possess, and that medics can learn to diagnose 100% accurately, rather than a mental health and ideological issue affecting vulnerable children.
• Doctors/researchers are willing to cause medical harm to a large group of children in order to find this theoretical small group of children that PBs might help and they are claiming that improving their knowledge base/diagnostic skills regarding the use of PBs for gender distress is worth this trade off.
• Doctors/politicians are giving in to blackmail/pressure from parents threatening to seek PBs online rather than firmly closing down those options so that any parents who break the law are punished.