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 consider the risks of this drug 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” for gender dysphoria.
The public consultation does not ask for views on the ethics of a clinical trial. In this guide we have responded to the actual questions asked within the parameters of the draft and supporting documents, but added our concerns. Please use any information that is useful here to submit your own response, adding your own points.
Deadline November 1st
• Has all of the relevant evidence been taken into account?
The NICE systematic review covers the most reliable studies specifically relating to puberty blockers and excludes studies that have little or no value. We think the research is conclusive that there is insufficient evidence to show the safety or benefit of this intervention.
However, the scope was 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.
• Does the equality and health inequality impact assessment reflect the potential impact that might arise as a result of the proposed changes?
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 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 who do not share a protected characteristic.
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 to test 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.
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 Age, Sex, Sexual Orientation, Disability and the group Looked After Children.
- 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.
The policy will have a disproportionate impact on young pre-gay boys for the following reasons:
- Boys may still be 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.
- In addition to potential sterilisation, there is extra risk for boys as early pubertal suppression leads to lack of genital development 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 of both height and sexual organs becomes irreversible.
- It is more likely that the early onset group will begin blockers at an earlier age than the late onset group.
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 be the most susceptible to promises of being included and accepted into the ‘rainbow family.’
• 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.
The interim clinical policy states that the use of PSH as a precursor to moving onto cross-sex 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 there will be a public consultation for this related policy.
We would like clarity on whether, in the case of a child who is not Gillick competent, parental consent will be sufficient for a child to be enrolled on the trial. 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 the NHS 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 would be a rare case now that a child arrives at the clinic from a neutral environment; it is more likely 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 three years.
We would like to see evidence of alternative, less risky routes the NHS may have considered as alternatives to a puberty blockers study, for example randomised control trials, further animal research, feasibility trials.
We would like more information on how NHS England considers a clinical trial of puberty blockers would adhere to international regulations. The founding principles are set out in the 1947 Nuremberg Code an ethical code established as a direct response to Nazi medical experimentations by clinicians.
The subsequent international Declaration of Helsinki 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. If research is to go ahead it must be classified as a CTIMP, 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.
Deadline November 1st.
 “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/