Transgender Trend’s full submission to the NHS Interim Clinical Policy for puberty supressing hormones (puberty blockers). Read our shorter guide to the consultation here. Please submit your own response here:
https://www.engage.england.nhs.uk/consultation/puberty-suppressing-hormones/
*Deadline November 1st 2023*
Question 3:
• Has all of the relevant evidence been taken into account?
No
The proposition of the NHS interim clinical policy on the use of puberty blockers is that puberty suppressing hormones (PSH) are not recommended to be available as a routine commissioning option for treatment of children and adolescents who have gender incongruence or dysphoria, because
“the quality of evidence for all these outcomes was assessed as very low certainty. There remains limited short-term and long-term safety data for PSH, however, PSH may reduce the expected increase in lumbar or femoral bone density during puberty.”
We welcome the proposal to stop the routine prescription of puberty suppressing hormones to children with gender-related distress and to offer psychological approaches as an alternative.
However, we consider the risks of PSH used off-label for children too great to justify a clinical trial. We believe it is unethical to prevent a child’s natural pubertal development into adulthood, unless there are exceptional reasons for doing so, for example if the child’s condition is life-threatening. There is no evidence that medically preventing a child’s puberty is “lifesaving care.”
The NICE systematic review covers the most reliable studies specifically relating to outcomes for certain measures, excluding studies that have little or no value. The research is conclusive that there is insufficient evidence to show the safety or benefit of this intervention.
However, the scope of the research was too limited, and we would like to see a systematic research review into the use of PSH for other indications, such as precocious puberty and prostate cancer. There are also limited animal studies for PSH used during natural puberty and it is not clear why the results of these studies were not considered.
The NICE evidence review focused on the impact of PSH on gender dysphoria, mental health, quality of life, and body image. These are subjective outcomes. Animal studies, and studies for precocious puberty, prostate cancer, endometriosis and sex offender research has demonstrated potential harmful physical and cognitive outcomes such as drop in IQ points[1], memory loss[2], cognitive function[3], depression, diabetes,[4] osteoporosis[5] and cardiovascular risk.[6] All of these additional harms should be considered, especially in the case of minors. Even without these risks we consider that supressing the sex hormones necessary for a child’s healthy growth and development is unjustifiable as a treatment for a psychological condition.
Given the high rate of progression to cross-sex hormones (98% in the case of the Tavistock GIDS Early Intervention trial) it makes no sense to separate the two interventions and exclude the NICE review of hormones[7] as part of the consultation on PSH. Comparative studies of desistance/persistence would be useful, between children previously treated with a ‘watchful waiting’ approach who did not have access to blockers until age 16, and those set on a ‘gender affirmative’ pathway leading to puberty blockers at Tanner stage 2 of puberty.
Cultural context is also missing from the evidence picture. Very few children now will be referred to the clinic from a truly neutral background and environment. Assessment of a child’s persistence in historical cases can no longer apply when persistence may now be encouraged through a ‘gender affirmative’ approach in a child’s early environment, at home, at school and within wider society.
Historic persistence/desistance studies would provide a baseline for evidence of the natural trajectory for young children who profess a cross-sex identity in early childhood, which can no longer be reliably measured. This is because the reason for persistence of a cross-sex identity is now confounded by adult encouragement and social transition. It would be difficult for a child to desist under these conditions.
Although limited, studies do exist of detransitioners and those who regret medical intervention, which give some information about longer-term physical and psychological outcomes of puberty blockers followed by cross-sex hormones. For a complete picture of whether these interventions are harmful for children, we consider a broader evidence review is necessary.
Question 4:
• Does the equality and health inequality impact assessment reflect the potential impact that might arise as a result of the proposed changes?
No
The overall interim service specification reduces health inequalities across all of the protected characteristics by bringing the service into line with normal standards of paediatric medicine. For the interim clinical policy the answer to this question depends on the research outcomes of the clinical trial.
It is not possible to say whether being enrolled in the clinical trial will disproportionately harm/benefit one protected characteristic group, but from existing evidence it is possible to speculate. The weak evidence base for puberty blockers, coupled with the invasiveness of the treatment, means that the risk/benefit calculation for this intervention is heavily weighted towards risk of harm.
We consider that not going through puberty is an adverse outcome for a child. Given that the Tavistock Early Intervention study showed that 98% of children administered blockers progressed to cross-sex hormones, this is a given result for the majority of children who begin blockers at Tanner stage 2 of puberty, as is the outcome of infertility and impaired adult sexual function.
As the potential risk is so high and it is not possible to reliably determine which children will improve and which will deteriorate short-term, nor the children who will experience long-term regret and health consequences, the question for children covered by the different protected characteristics can only be based on whether they are receiving the same standards of care and safeguarding as other children.
The equality and health inequality impact assessment does not give enough weight to the impact on children protected by the protected characteristics sex and sexual orientation, nor the group looked after children, all of whom are overrepresented in Tavistock GIDS data and are especially vulnerable, along with autistic children.
The Sexual Orientation section includes a study by a number of trans lobby groups that includes BDSM/Kink and Polyamorous as sexual orientations and uses data collected on the basis of ‘gender identity’, not sex. It is therefore of no value in determining the number of same-sex attracted people as defined in the Equality Act and it is concerning that NHSE includes it. A 2012 study of referrals to the Tavistock showed that of the girls, 67.6% were lesbian and 21.1% were bisexual. Of the boys, 42.3% were gay and 38.5% were bisexual.[8]
To offer puberty blockers at Tanner Stage 2, before a child has started the process towards full sexual maturity, would foreclose any opportunity for the child to grow into their sexual orientation and discover who they are. This is the case for every child, but is more of a concern for pre-gay and lesbian children who are more likely to be gender non-conforming and confused about their sex.
While it is good that ‘late onset’ children will not be considered for enrolment onto the trial, historic data shows that in early-onset cases, under a watchful waiting approach, the majority will grow up to be gay. There are currently no evidence-based means to predict whether a child will grow up to be transgender or gay.
For children with ‘early onset’ gender distress who are enrolled in the trial at Tanner stage 2, we consider the protected characteristic groups most at risk are:
Gender Reassignment
The protected characteristic Gender Reassignment does not give patients the right to the treatment they demand. It means that they must be given the same standard of clinical care as those who do not have this protected characteristic, according to the same principles of medicine. In the case of children specifically, it does not mean they should be treated as adults, with the same level of understanding as adults in relation to this protected characteristic.
Are they being protected from harm to the same degree as other children with different mental/psychological health conditions? Would a clinical trial be considered ethical for children with a different psychological presentation with a drug treatment that prevents growth?
We are waiting for the definition of ‘late onset’ but would expect this to eliminate the ‘rapid onset gender dysphoria’ cohort (the group we know least about) who develop gender distress once puberty has started. This would protect adolescents, in particular girls who make up the majority.
Age
- Research indicates that nearly all children on blockers subsequently progress to cross-sex hormones. Children have a right to go through puberty and grow up with their fertility intact.
- Young children have not reached full sexual maturity and are developmentally incapable of making choices that affect their future adult lives. They are not at a life stage where they are able to fully understand what it means to be a man or a woman or how they will feel as adults.
- Adolescents are not yet at an age where they can fully weigh benefit and risk or understand what will be important to them as adults.
- Blockers rob children of the opportunity to explore and develop different coping mechanisms and management strategies to deal with their discomfort with their sex, which would be less likely to lead to lifelong medical intervention with all the associated risks.
- Use of blockers sets a higher value on avoiding unwanted physical development that would make it harder to ‘pass’ as the opposite sex and a lower value on avoiding known and unknown harms; a higher value on the cosmetic and a lower value on biological function that will have significant consequences for a child’s future adult life and relationships.
Sex/Sexual Orientation
The policy will have a disproportionate impact on young pre-gay boys for the following reasons:
- They are more likely than girls to be encouraged to believe they are the opposite sex at this age, due to homophobia and greater societal acceptance of ‘tomboy’ girls.
- Early pubertal suppression leads to lack of genital development in boys so that any future surgery would be more risky and complicated. If a boy later desists it is not known at what age the suppression of growth becomes irreversible.
- It is more likely that the early onset group will begin blockers at an earlier age than the late onset group.
The Tavistock GIDS Early Intervention trial results were not disaggregated by sex, which should be a key data measure, as the preliminary results for the GIDS trial and the Dutch study both showed worse results for girls than for boys.[9]
Disability
Children with autism or other neurodevelopmental conditions are more at risk of developing set thinking at any age, and more at risk of bullying, social isolation and mental health issues associated with the development of gender dysphoria.
Looked after children
These are the most vulnerable children who are likely to have suffered early-life trauma and have the most complex needs as young children.
Question 5:
• Are there any changes or additions you think need to be made to this policy?
There should be no exceptional cases outside the trial – these cases would be lost to the research and there is no justifiable reason to exclude some children from the study.
Prior to 2011 children were offered puberty blockers at age 16, and cross-sex hormones only at adult clinics. Given the results of the Early Intervention trial, we would like to see the rationale for why the puberty blockers clinical trial does not revert to a minimum age of 16, when even at that time (pre 2011) concerns were being raised within the GIDS about lack of adequate assessment. The one outcome of puberty blockers that has been reliably replicated across studies is persistence. Given this knowledge it is unclear why NHSE would consider the use of PSH before a child has reached the stage of fertility development or had any experience of sexual maturation which may influence resolution of gender dysphoria.
The interim clinical policy states that the use of PSH as a precursor to a moving onto gender affirming hormones is covered by a separate clinical policy.
“If the proposal is adopted by NHS England following stakeholder testing and public consultation, it would be appropriate to make a consequential change to the related clinical policy for prescribing cross-sex hormones for young people with gender dysphoria by removing the requirement for a young person to have been receiving puberty supressing hormones for a defined period of time.”
We would like to see a more detailed explanation of this possibility and whether this will be a public consultation.
We would like clarity on whether, in the case of a child who is not Gillick competent, parental consent for enrolment onto the trial will be sufficient. What safeguards will be in place to protect the child?
Although studies are few, it is important to factor in the possibility of regret and subsequent detransition, in which case medical intervention will lead to a deteriorating quality of life and health. We would like to see evidence that NHSE has considered detransition studies in development of this policy.
We would like to see evidence that cultural factors have been recognised in the drafting of this policy; that the cultural landscape has completely changed for children growing up now, along with the influence on parents. It is much more likely now that a child with persistent gender dysphoria has been affirmed and socially transitioned to a greater or lesser extent, at home and at school. A boy, for example, accepted into the clinic at age 7 may have been told he is a girl every day by the significant adults in his life for a number of years.
We would like to see evidence of alternative, less risky routes NHSE has considered as alternatives to a puberty blockers study, for example randomised control trials, further animal research, feasibility trials.
The old service specification (2016) states: ‘Outcomes research with children who completed early social transitions would greatly inform future clinical recommendations’ (WPATH SOC v7).’ Previous studies have shown that childhood social transition is an important predictor of persistence, especially among natal boys (Steensma 2013). A 2022 study found that 94% of socially transitioned children persisted.[10] This can be compared with a persitence rate of only around 20% in historic studies where children were not socially transitioned.
The recent study of social gender transition among referrals to the Tavistock GIDS aged 4 – 17 found no mental health benefits for social transition or name change.[11]
We would like to see more evidence of outcomes and more caution about the risks of social transition and that this is taken into account as a factor for those children who persist long enough to be eligible for the puberty blockers research trial. There is no evidence that NHS has considered social gender affirmation and social role transition as a factor in influencing a child’s certainty and persistence of belief.
There is no clear rationale for treatment with puberty blockers explained in this consultation. The Health Research Authority, in its report on the way in which the Early Intervention trial gained ethical approval, stated that
“It would have reduced confusion if the purpose of the treatment had been described as being offered specifically to children demonstrating a strong and persistent gender identity dysphoria at an early stage in puberty, such that the suppression of puberty would allow subsequent cross-sex hormone treatment without the need to surgically reverse or otherwise mask the unwanted physical effects of puberty in the birth gender.”[12]
It is concerning if this is the rationale for the proposed clinical trial.
There is no indication or estimate of the numbers of children who will be eligible for the trial. The authors of the GIDS study conceded that the sample was too small to detect significant changes. Achieving a large sample size for the purposes of research cannot be a reason for enrolling children onto the trial. This presents a conflict between best case for children (low numbers) and best case for research (high numbers). If it is to be a ‘last resort’ treatment for very few children it is critical to know what the criteria are for those judged eligible.
We would like more information on how NHS considers a clinical trial of puberty blockers would adhere to international regulations. The founding principles are set out in the 1947 Nuremberg Code[13] an ethical code established as a direct response to Nazi medical experimentations by clinicians.
The subsequent international Declaration of Helsinki[14] requires clinicians to safeguard participants and ensure they are not harmed in the pursuit and development of medical knowledge and treatments. They must be adhered to by all practitioners involved in clinical research.
The 8th principle of the Helsinki declaration says “While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.” To adhere to this principle, the Service Specifications must state a clear rationale for using children as research subjects, beyond advancing medical knowledge.
In addition, children are classified as a vulnerable group, and are protected under the Health Research Authority framework.[15] If research is to go ahead it must be classified as a CTIMP,[16] a Clinical Trial of an Investigational Medicinal Product. This is important, as this classification of study is standard in testing the efficacy and safety of medications in a new patient population, which children with gender dysphoria clearly are, and for a different indication, as is the case in using puberty blockers for gender incongruence rather than precocious puberty.
A CTIMP has strict regulatory oversight, monitoring, reporting and assessment of adverse events, and stopping rules, which would best safeguard participants, in this case children under 16.
Submit your own response here by November 1st 2023.
[1] https://www.frontiersin.org/articles/10.3389/fpsyg.2017.00044/full
[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5333793/
[3] https://pubmed.ncbi.nlm.nih.gov/28188757/
[4]https://www.researchgate.net/publication/322138557_Treatment_of_Paraphilic_Disorders_in_Sexual_Offenders_or_Men_With_a_Risk_of_Sexual_Offending_With_Luteinizing_Hormone-Releasing_Hormone_Agonists_An_Updated_Systematic_Review
[5]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3195423/#:~:text=Current%20literature%20suggests%20that%20GnRH,months%20of%20GnRH%20agonist%20therapy
[6] https://pubmed.ncbi.nlm.nih.gov/16983113/
[7] https://cass.independent-review.uk/nice-evidence-reviews/
[8]https://www.researchgate.net/publication/268879198_Young_people_with_features_of_gender_dysphoria_Demographics_and_associated_difficulties
[9] https://link.springer.com/article/10.1007/s10508-020-01764-1
[10] https://publications.aap.org/pediatrics/article/150/2/e2021056082/186992/Gender-Identity-5-Years-After-Social-Transition
[11] https://link.springer.com/article/10.1007/s10508-023-02588-5
[12] https://www.hra.nhs.uk/about-us/governance/feedback-raising-concerns/investigation-study-early-pubertal-suppression-carefully-selected-group-adolescents-gender-identity-disorders/
[13] https://history.nih.gov/display/history/Nuremberg+Code
[14] https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
[15] https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/research-involving-children/
[16] “There is no statute in England, Wales or Northern Ireland governing a child’s right to consent to take part in research other than a Clinical Trial of an Investigational Medicinal Product (CTIMP), i.e. consent for non-CTIMPs.” https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/research-involving-children/