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

https://www.transgendertrend.com/children-change-minds/

“Gillick” will be used to assert informed consent, its use is well embedded in all areas of NHS, Social Care, Education and the 3rd sector on any wellbeing/health conversation.

Its use eliminates parental responsibility.

It functions by any individual in any of these institutions asserting any child they’re working with as “Gillick competent”. No record of a Gillick Assessment is required, only an ephemeral understanding that someone somewhere has carried one out on any topic at any point in the child’s lifetime. There are no limitations on any decision a member of these institutions can then make due to Autism, ADD, disruptive/abusive family environments etc etc.

Its practical existence is to indemnify any individual working for these institutions from any decision they may make about a child. Have a look at school policies ref Covid or any vaccines, topics around PHSE, drug misuse etc etc and even better if you can check out 3rd sector training guidelines on use of Gillick. See if you can spot any Gillick related policies that limit assessments and decisions to formal, medical professional roles and require the use of formal recording and monitoring systems for use specific assessments, most policies will reference generic non medical professional roles such as LEA approved keyworkers or nurse to do whatever they think is right.

The only people who cannot object/question/override a child’s state of “Gillick Competent” are parents. There are no non extreme legal routes to override a “Gillick Competent” decision.

This is my personal experience.

if Gillick is taken out, this trial cannot proceed.

It's the parents who give 'consent', the children are asked for 'assent'.

Relevant section:

3.5.1 Informed Consent for TRIAL
3.5.1.1 The process of determining clinical eligibility

The process of determining clinical eligibility is set out in the clinical service document titled “PATHWAYS TRIAL for Gonadotropin Releasing Hormone Analogues (GnRHa) – Guidance for CYPGS clinicians” A schematic of the interplay between providing research information, determining clinical eligibility and then research eligibility is shown in Figure 3. This will involve a series of clinical meetings with the CYP both on their own and with their parents/caregivers/legal guardians focussing on known and unknown possible benefits and risks of GnRHa including possible longer-term risks, alternative interventions that may alleviate their symptom/distress. Information will be provided in written formats, supplemented with visual material and audio-recordings (e.g., of clinical discussions) adapted to meet the cognitive style of the CYP and their parents/caregivers/legal guardians. NHS interpreter services will be used for those who are not confident in their use of English. CYP and their parent/caregivers/legal guardians will be asked to demonstrate their understanding of GnRHa and alternative treatment approaches by answering questions from clinicians using their own words or alternative preferred communication (e.g., typing, audio recording). As part of the submission documents to the national MDT, CYP and at least one parent/legal guardian will be asked to provide their reasons for requesting GnRHa.

Specific attempts will be made to meet with both parents/legal guardians to elicit their independent views. Where there is a disagreement between parents/legal guardians about GnRHa, this will be flagged to the national MDT to consider in their decision.

While caregivers with parental responsibility will be encouraged to attend sessions to give their perspective and to support the CYP, it will be ultimately the views of parents and legal guardians whose views are formally considered in the clinical eligibility decision.

Fertility: The risks to long-term fertility will be discussed with each CYP considering GnRHa by a clinician in or attached to their Gender Service who has specific training and knowledge about fertility risks and options available to them as well as training in working with CYP experiencing gender incongruence. The information will include options around sperm donation and egg retrieval. CYP will be encouraged to ask questions and explore fertility preservation options prior to commencing on GnRHa (if found clinically and research eligible). For those wishing to pursue fertility options at this time, a referral to specialist fertility preservation services will be facilitated by the Gender Service, noting that referrals are made either directly by paediatric endocrinologists or by the CYP’s GP. There will be no upper limit imposed by research consent on how long young people have to consider and then explore fertility preservation options, and potential participants will be reminded of other constraints, e.g., around the upper age limit of the study.

Where there is clinical uncertainty about a CYP’s suitability for GnRHa based on their physical health, e.g., low bone density, the relevant physical investigations will be undertaken prior to presentation at the NMDT, considered as screening investigations.

3.5.1.2 The process of informed consent to participate in TRIAL

CYP deemed clinically eligible for GnRHa and providing verbal consent to be contacted, will be contacted by the research team. The research team will confirm that the national MDT checklist was fully completed prior to the national MDT decision.

CYP and their parents/legal guardians will initially receive the standard paper PIS in clinic, but this may be supplemented by information in bespoke formats, to support the individual cognitive and learning styles of CYP and parents/legal guardians. CYP will be encouraged to read this information together with their parents/caregivers/legal guardians, prior to discussing it with a clinician in clinic. Specifically, researchers will check whether any bespoke sources of information were used to support the CYP’s discussions with their clinical team in preparation for the clinical eligibility review by the national MDT. These information supports can be re-used and extended as needed by the CYP and their parents/legal guardians.

Following receipt of the information sheets, CYP and their parents/ legal guardians will discuss their participation with the Principal Investigator (PI) or delegated sub investigator (SI) with GCP training. The PI/SI will further explain the purpose of the trial, the research procedures, and the potential benefits and harms associated with GnRHa, including possible long-term risks, and will establish the CYP and their parent/ legal guardian’s comprehension of the information. The uncertainty about impact on long-term health and the importance of signing up to the NHS Registry to provide health information into adult life will be explained. This will usually involve seeing the CYP on their own in part, i.e., without a parent/legal guardian present. The CYP may have their clinical keyworker from the CYPGS present for additional support if they wish. Both parents/legal guardians are encouraged to be involved in the consenting process, where appropriate, and with at least one parent/legal guardian accompanying the CYP to ensure a supportive environment. While caregivers without parental responsibility may attend the meetings with the medical investigator, it will be made clear that it is only parents/legal guardians with parental responsibility who are involved in the decision, alongside the CYP. When caregivers attend the consenting process, parents/legal guardians will also be seen on their own. Where only one parent/legal guardian attends, the reasons for this will be recorded.

The PI/SI will check again that the possibility of fertility preservation was discussed with each CYP and their wishes to access this prior to GnRHa treatment will be recorded. Fertility preservation options should be discussed at each appointment considering endocrine and other medical options.

Informed consent will be obtained in person on paper from parents/legal guardians and assent from CYP by a PI/SI, following Good Clinical Practice (GCP) guidelines. The CYP and their parents/legal guardians will be specifically encouraged to take as much time as they need to make a decision.

For children, informed assent will include demonstrating understanding, retention, and the ability to weigh up the potential benefits and risks of participation, and to communicate their decision freely and without coercion. Clinicians must document the young person’s and parent(s)’ understanding of the trial, including direct quotes where possible, and ensure that both individual and joint discussions have taken place.

A standardised checklist—modelled on that used in the national MDT process—will be employed to ensure that all key aspects of the trial, including the nature of the intervention, potential risks (including those not yet known), implications for fertility, and the right to withdraw, have been thoroughly discussed and understood. Any safeguarding concerns, communication barriers, or co-occurring difficulties that may affect the young person’s ability to assent or comply with trial procedures will be addressed and documented. Reasonable adjustments should be made where necessary. However, consent from a parent or legal guardian is required for the young person to participate in the research.'

The only people who cannot object/question/override a child’s state of “Gillick Competent” are parents. There are no non extreme legal routes to override a “Gillick Competent” decision.

That is insane in that a majority of the time it’s the parents who have the best of intentions, want the best for their child, and know their child the best rather than some unrelated person who has no skin in the game and if it all goes badly for the child can, what, shrug and go ‘it’s the 13 year old’s decision’?!

'3.2.1.3 Clinical Exclusion Criteria

1. Physical conditions where puberty will not commence or advance in a patient. This may include gonadal failure (e.g. due to genetic disorders such as Turner syndrome) or central hypogonadotropic hypogonadism.

1. Unstable physical health. The purpose of this criterion is to ensure that that the CYP is not undergoing concurrent high-intensity physical interventions which might affect their response to GnRHa or their ability to adhere to the trial protocol. These include but are not limited to:

a. Very low or very high BMI (or rapid changes in BMI), particularly if there is a concerning trajectory or associated nutritional or metabolic concerns. This could include eating disorders or body dysmorphic disorder.

b. Any poorly controlled medical disorder, such as uncontrolled epilepsy, inflammatory bowel disease, cystic fibrosis. This includes any other condition where participation may pose a risk to the individual’s health or compromise study integrity.

c. Concerns about bone health or significant risk of fractures (this may also include a low baseline bone density).

d. QTc interval above 470 milliseconds at screening, or concomitant high risk QT-prolonging drugs that cannot be ceased

1. Hypersensitivity to gonadotropin releasing hormone (GnRH), its analogues, or to any of its excipients

1. Known congenital long QT syndrome

1. Unstable mental health that may impair ability to provide informed assent/consent or lead to risk of serious harm to self or others. Many CYP with gender incongruence experience anxiety and/or depression which they relate to gender dysphoria or distress. It is not the intention to exclude those with mild to moderate levels of mental health symptoms. However, severe or unstable symptoms may affect the ability to engage in all aspects of the clinical protocol.

Examples would include (but are not limited to):

a. Severe or profound depression with significant effects on the ability to accurately evaluate choices and future outcomes;
b. Severe body dysmorphic disorder that is confounded with secondary sexual characteristics or physique not conforming to the desired gender;
c. Active psychotic symptoms;
d. Significant risk of harm to self or others as exemplified by consistent suicidal thoughts, repeated and ongoing acts of self-harm and/or the need for emergency plans with the child or young person and family;

1. Aspects of family/home situation that makes it likely the CYP will not be able to adhere to aspects of the protocol such as attending regular follow-up appointments. This last requirement will have been assessed in relation to the CYP’s ability to find ways of attending appointments in the CYPGS.
2. Clinical concerns about the young person’s capacity to consent.
3. Insufficient understanding of PATHWAYS TRIAL.
4. New or ongoing safeguarding concerns.

10. Birth-registered females with undiagnosed vaginal bleeding. 11. Birth-registered females who are pregnant or lactating. 12. Individuals of child-bearing potential (i.e. sexually active birth-registered female not using effective contraception as compatible with GnRHa**) who are at risk of pregnancy during the trial. Of note, whilst not an exclusion criterion, the clinical teams will strongly counsel against smoking or nicotine-containing vaping for GnRHa due to its contraindication with starting oestrogen or testosterone and its negative impact on bone health. '

Going through the questions asked. Another scale used is this one:

'ttps://pmc.ncbi.nlm.nih.gov/articles/PMC11602696/

'ALSPAC Romantic Relations'

'(question for 12 years+)
In the past 30 days:

• 1. Have you hugged anybody?
• 2. Have you held hands?
• 3. Have you spent time alone?
• 4. Have you kissed?
• 4a. Have you been kissed by anybody?
• 5. Have you cuddled?
• 6. Have you lain down together?
• 7. Has someone put their hands under your clothing?
• 8. Have you put your hands under someone else’s clothing?
• 9. Have you been undressed with your genitals showing?
• 10. Have you touched or fondled someone’s private parts?
• 11. Has someone touched or fondled your genitals?
• 12. Have you performed oral sex?
• 13. Has someone performed oral sex on you?
• 14. Have you had sex?'

And another:

Questions for Children/Young people on Body Image Scale – Gender Spectrum (BIS-GS)

'Each questions asks: a) How happy are you with [insert name of a particular body part]?: With answers i) very happy ii) happy iii) neutral iv) unhappy v) very unhappy vi) don’t have.
Each question is followed up with: Would you want to change that body part if it was possible through medical or surgical treatment? i) Yes ii) No

• 1) Nose:
• 2) Shoulders
• 3) Hips
• 4) Chin
• 5) Calves
• 6) Breasts
• 7) Chest
• 8) Hands
• 9) Adam’s Apple
• 10) penis
• 11) clitoris
• 12) testes
• 13) ovaries
• 14) scrotum
• 15) vagina
• 16) Height
• 17) Thighs
• 18) Arms
• 19) Eyebrows
• 20) Waist
• 21) Buttocks
• 22) Biceps
• 23) Hair
• 24) Feet
• 25) Muscles
• 26) Facial Hair
• 27) Face
• 28) Voice
• 29) Weight
• 30) Body figure/shape
• 31) stature
• 32) Body hair
• 33) Appearance'

These have been shared on the blog of a parent with a child who has a 'trans' identity.

I actually agree with much of what the parent says, despite, I imagine, having very different beliefs in this area:

'I do not believe [the trial] will add useful information to our academic understanding of trans young people, certainly not information that is worth the risks and harms inherent in the whole approach and service. '
...
'They are asking an excessive number of questions, which is itself abusive and unreasonable – over 314 questions are here listed.

A large number of these questions of more or less irrelevant or only tangentially relevant for trans kids – they are not clinically useful, necessary or meaningful

These questions will never demonstrate what healthcare benefits trans children.
The data collection shown here will be exhausting, time-consuming and expensive, a colossal waste of NHS and research resources whilst not delivering useful outcomes.

Many of the questions outlined below are deeply pathologising, invasive, trauma-inducing and inappropriate.'

archive.ph/Dskqe

Not sure that there's an excess of Qs, incuriosity is what got the NHS into this mess. The researchers need to know as much as possible about these kids, especially if they've been affirmed. Presumably however, the kids will have a parent with them when these questions are asked. In normal research contexts I'd be glad of them having that support but when your parents have gone to bat to force the world to pretend that little Tabitha is in fact Josh, it's hard not to answer in ways that will please them, just as it's hard not to answer some of the other Qs with a mind to protecting them - we know that disclosure of CSA often comes in adulthood precisely because the victim tried to protect their family from the fallout of disclosure.
How best could these questionnaires be applied?

Thank you

Personally it looks very impressive, however (quick/first reaction):

• There are no clinical roles defined in who makes the assent/consent record/decision and where that will be recorded (so anyone can, and “some notes” will probably do)
• There is no requirement for validation of any decision/record of a decision (2nd Doctor etc)
• This is a clinical trial, not a life saving proven safe vaccine, it’s written so that no adult can just say no - what’s the rush?
• There’s no limitation that one or two parents/carers’ consent must formally exist and be recorded, nor is there any requirement or test that their “informed” state is of a good and necessary standard. Similar for the child.
• A social worker can be a carer, a temporary carer for a child in care (looking at Blackpool and Brighton here), see points on coercion below - social worker training continues to be “affirmation only” typically provided as a monopoly by activist organisations such as Allsorts Youth Group etc
• There’s no restrictions on existing conditions such as Authism ADD etc
• There’s no restrictions on coercion (any involvement from Mermaids, Allsorts Youth Group, Gendered Intelligence, Transaction, Good Law Project, Jackson Bird/Jammi Dodger on YouTube/Tiktok etc etc)

In summary it’s largely a rewrite of the GMC guidelines on Gillick which operate like they do as I’ve outlined from experience, unlimited indemnity of the individuals involved underwritten by the government, elimination of parental authority, and enabling secrets with children and child consent.

Any contract or policy that has lots of impressive, technical words is intended to blind and impress, to distract and avoid scrutiny. To be furtive. It feels in practical terms very like Ryan Air’s general terms and conditions of carriage, and that’s written so there’s only ever one winner, and it’s not the passenger.

If I had been asked some of those questions at any age between 9 and 15 with one or both of my parents present, I would have have almost died of embarrassment. And some are entirely inappropriate to ask most children and young adolescents whether or not a parent is present. I am fairly sure my Dad would have been apoplectic.

Yes it really is insane, and it’s a core social contract underpinning parental trust that’s been deconstructed, and more recently overtly being abused by activists.

Parents simply cannot say “no” anymore, individuals working loco-parentis can have secrets with our children and operate with child consent. This trial will do the same, because the institutions seem to have elected themselves as the “good side”.

Just take a look at this thread and see the behaviour of the secondary school head teacher towards a dad objecting to teenage boys being allowed to change with the girls at swimming. The head of the school is dismissing and now openly bullying a parent for a very reasonable request, to just follow statutory safeguarding law.

I understand that reaction but we know that many children & adolescents who've sought transition had previously endured trauma, including CSA. The original Dutch Protocol study sought to exclude those children, they should be excluded from a research perspective because they present confounding variables, & from an ethical perspective because they need very different help. However, to exclude them you have to try to identify them.

For clarity's sake - I don't think this trial should be happening at all.

I think there are some children who should be asked probing questions, even if they may be embarrassed, but I have heard of gender questioning children being asked questions that appeared to be inappropriate or even prurient (about masturbation). I hope that some sensitivity would be used, and that professionals would stop short of asking every child every question.

What would be the point of giving PB to a 15y 11m old girl for two years. I would have thought most girls would have completed puberty by age 16. So you are just medicating someone with drugs that can’t possibly achieve their goal.

I've been spending the weekend reading up on this trial.
It's no surprise we knew it was coming, they've been setting up the clinics and advertising for clinicians who will follow a PB protocol for a while.
It's been clear the new clinics are going to be for medical pathways, with some therapy now as well, and will be staffed by clinicians who believe this is ethical and needed.

A question I have which I can't get answered is what is the desired outcome of the trial? Or what is the hypothesis or research question?

In giving children experimental drugs you'd presume it would be to cure them of a disease or condition. A very serious one to allow experimental drugs.

Is the aim here to resolve gender dysphoria and make them happy with their body?

That should be the aim for all children but while the notion of some children being truly trans persists, that won't be said, so the aim seems to be to reveal through PB which children are truly trans.

So treating an issue with children's 'souls' (which seems to be being implicitly accepted) with medication to alter their bodies...which is really WTF???

But I can't make sense of the hypothesis otherwise.

Surely the time to think hypothesis cannot be used again?

So what is the rationale? To find out if PB do....what???

Also:

What are they going to do if, as happened before, all the children after 2 years want to continue on to cross sex hormones?

Surely the trial would have to be abandoned as it would be demonstrating (what we already know) that PB lead to the embedding and prolonging a trans identity and therfore risk of permanent sterilisation loss of sexual function etc.

Which Surely is just the same bloody scandal playing out again, but worse because they know what happened last time.

Doing the same experiment again which led to harmful outcomes last time, just to collect most robust data, is insane. And EVIL.

@MalagaNights, the rationale seems to be to find out if PBs make children happy and less depressed. And, as far as I can tell, feel more congruent with their inner “soul” sex - which clearly isn’t going to happen on just PBs, which just halt development, they don’t do anything about the whole “wrong body” problem.

What is the current situation in prescribing Cross sex hormones to under 18s?

If after 2 years on PB many of these children are going to want them will they get them?

They can't keep children in a pubescent state until they're 18?

I dont understand how/why children signed up for this would continue with it if they know they're in the control.group.

Is anyone (Sex Matters with the help of lawyers?) writing to all staff involved in this?

Every single one should have a letter clearly spelling out what we do know and putting them on notice that they cannot claim not to have been informed when they are sued by the people harmed by their barbaric experiments on kids.

Even if this was a rationale hypothesis which it's not, how would PB do this?

They would still be a child with the sexed body different to their identity, albeit a prepubescent one, why would the incongruence resolve?

Unless the hypothesis is that given time it will naturally resolve for those who aren't truly trans, in which case it's the time to think hypothesis again.

But if it naturally resolves, as there is evidence for, why not let them proceed into puberty and see who it resolves for that way?

The ones that persist with a trans identity are the tru trans. It's the same design without unnecessary risky drugs.

As you try to understand it you realise it's really about the few boys who will persist into adulthood being able to pass and sod all the confused, abused, gay autistic kids who are caught up in it. They're just collateral damage.

@WhyThatsDelightful it is the rise of the authoritarian left deciding they know best. Seeing parents as the problem and some activist teachers and healthcare professionals thinking they know the child better that the parents. Then, convincing themselves that actively working towards separating the child from the parents is in the best interests of the child.

Questions for Children/Young people on Body Image Scale – Gender Spectrum (BIS-GS)
'Each questions asks: a) How happy are you with [insert name of a particular body part]?: With answers i) very happy ii) happy iii) neutral iv) unhappy v) very unhappy vi) don’t have.
Each question is followed up with: Would you want to change that body part if it was possible through medical or surgical treatment? i) Yes ii) No

As it happens, I have many concerns with such questionnaires, their content, who uses them, how they’re used, and the wider implications of using them.

Far too often healthcare professionals are focusing on the task of asking questions and filling in the forms without anything like near enough skill and knowledge on child development let alone more subtle skills and understanding in working with ASD/ADHD children.

Asking a question is a powerful activity and very easily inserts thoughts or ideas into a child’s mind that was not present before being asked the question. An idea that takes root and expands with potentially disastrous consequences. It works on all children, but more poignantly and deeply on suggestible and susceptible children and teens.

None of this gives me any reassurance about this trial.

All excellent questions.

I assume the desired outcome is to get the “evidence” they need to continue to prescribe puberty blockers to anyone who asks for them. They already know the results will be positive. Imagine the pressure on those poor children to report an improved mental state. The experiment is short enough that none of the longterm consequences will be seen. Children will still be in the grasp of the trans cult by the end of the process. It’s so massively flawed. Even Wes’ X post gives the game away. He has no doubt that the result will give them the “evidence” they need. The whole thing is fake.

“We're now setting up clinical trials to build the evidence base we need to support vulnerable children properly.”

@DrBlackbird:

Asking a question is a powerful activity and very easily inserts thoughts or ideas into a child’s mind that was not present before being asked the question.

At my final orthodontic appointment as a young teenager, the orthodontist said in passing, to my father, “At some point she may say she wants a nose job. In her case I would recommend a chin enhancement.”

Reader, I had never considered up to that point that I might want to alter my face in any way. But you had better believe that I started thinking about it daily at that point. Never did have any sort of surgery, but that man’s words drilled into me and stay with me 40 years later.