The Clinical Advisory Network on Sex and Gender has submitted its response to NHS England’s consultation on its interim clinical policy for puberty suppressing hormones. We welcome the proposal to end the routine prescription of puberty suppressing hormones (PSH) to children and young people with gender dysphoria or gender incongruence and to focus on psychosocial and psychological support as the primary intervention.
However, we still have significant concerns, both about the proposal to offer PSH as part of research, and the exceptions to the policy which would allow the continued use of PSH outside research conditions.
The NICE systematic review found “very low certainty” evidence of benefit or harm, meaning that we do not know whether Puberty Suppressing Hormones are effective or safe when used to treat gender dysphoria. This underpins the proposed policy which is to no longer routinely offer PSH to children and young people with gender dysphoria, but it also underpins the proposal to do more research on PSH in this group. Information about the proposed research is contained in the health inequalities impact assessment section where it says that prospective research is being planned on use of PSH in “early onset” gender dysphoria.
We are concerned about this proposed research and think that if wider evidence of harm had been taken into account there would be more caution about proposing prospective research on PSH. We believe there are safer, more ethical and potentially more informative avenues of research.
Click here for the link to the consultation. It is open to all members of the public to contribute. The closing date is 1 November.
Click here to read CAN-SG’s contribution to the consultation.
This post contains a summary of the points in our consultation submission. The consultation submission has a list of references for the points we make.
There are three questions in the consultation:
Question 3 has all the relevant evidence been taken into account?
In response to Question 3 we listed several areas of evidence of harm from Puberty Suppressing Hormone (PSH) use that we think should have been taken into account, as well as weaknesses in the NICE systematic evidence review.
The NICE systematic review had limitations. It lacked a clear conceptual framework and did not evaluate the rationale and aims of treatment with Puberty Suppressing Hormones (PSH). The rationale and aims of treatment have never been clear and have changed significantly over time.
We believe the NICE evidence review should have reviewed the evidence for PSH from when they were first proposed as a treatment for gender dysphoria, in the process elucidating the nature and aetiology of the condition being treated, its natural history, the rationale for using PSH, and the expected outcomes.
We also think the NICE review should have looked at research on early onset gender dysphoria, adolescent onset gender dysphoria, and detransitioners in order to form a fuller understanding of the issues relating to PSH use.
Question 4 Does the equality and health inequalities impact assessment (EHIA) reflect the potential impact that might arise as a result of the proposed changes?
In response to Question 4 about the equality and health inequalities impact assessment we express the view that the EHIA lacks balance and over-emphasises risks of harm from the proposed PSH policy and under-emphasises the benefits of protecting children and young people from unevidenced and potentially harmful treatments, especially vulnerable or marginalised groups such as those with mental health problems, history of abuse or adverse childhood experiences, neurodiversity, emergent same sex orientation, adolescent girls, and looked after children.
We also questioned why the EHIA said the research overview group would prioritise researching use of puberty suppressing hormones in those with “early onset gender dysphoria”. This is the group which were the subject of the original Dutch research and it is already known that many if not most of this group are young boys who turn out, during puberty, to be same sex attracted. It was not explained why it is proposed to do a prospective trial with PSH on this group of children. We believe this proposal carries significant risk to children, especially boys who may grow up as same sex attracted.
Question 5 Are there any changes or additions you think need to be made to this policy?
Overall, CAN-SG members welcome the proposal that PSH will not be available for routine treatment due to a lack of evidence on safety and effectiveness, and that the primary intervention will focus on psychological and psychosocial support.
However, we have several concerns about the proposal to continue using PSH, either as part of research or as one of several exceptions within the policy.
Depending on various conditions, this could amount to continued substantial use of PSH in a context where there are serious concerns about safety and efficacy.
The situations where PSH will continue to be prescribed include:
- As part of research
- In exceptional cases
- Continuing prescriptions for those already taking PSH
- For those who have already been referred to an endocrinologist but not yet started PSH
- For those for whom PSH is a precursor to masculine/feminine hormones
- For those receiving PSH from private and unregulated sources
Prescribing PSH in research
Prescribing PSH in a research setting means that children and young people will be experimental subjects in an intervention with profound effects on physical, psychological, and developmental processes, about which little is known. Puberty involves sexual maturation, brain and cognitive development, social and personality development, as well as physical development.
CAN-SG believes that the grounds that might justify prospective research in which children and adolescents are given PSH have not been established, and we explain why. We outline other areas and types of research that could inform policy.
The fact that 96%–98% of children who undergo puberty suppression continue to cross-sex hormones and other interventions strongly suggests that puberty itself is important in bringing about the resolution of gender dysphoria for some (perhaps most) children who experience it. It is therefore possible that puberty suppression promotes persistence of gender dysphoria and increases the likelihood that children will go on to seek yet more invasive and risky medical and surgical interventions in adulthood.
In this context, it seems unlikely that it would ever be ethical to conduct a prospective trial. As we don’t know which children, if any, are likely to benefit, such a trial would knowingly expose many children to a potentially harmful intervention that would be of no benefit to them.
Prescribing PSH outside of research
We explain why we don’t think initiating or continuing PSH prescription in the other groups (2-6 listed above) is justified because these children and young people should be equal beneficiaries of the caution that has led to the decision to restrict PSH to research settings only. We don’t think children and young people in those groups should continue to be subject to potentially harmful treatments with no known benefit.
Exceptional cases
The draft PSH policy proposes prescribing PSH in exceptional cases. It is difficult to see what would qualify as an exceptional case of gender dysphoria sufficient to justify giving an unevidenced and potentially harmful drug. No examples of what would count as an exception have been given. Whatever the exception, it is likely it would act as a precedent for many others to claim that they too have exceptional status, and this could undermine the policy which is to protect children and young people from the harm of unevidenced treatment.
It is especially concerning that the interim policy proposal states that while there is no research planned on use of PSH in what it calls (without definition) “late onset gender dysphoria” such young people may still be prescribed PSH under “exceptional circumstances.” Given that the PSH policy endeavours to be evidence based we think it is contradictory to envisage any cirumstances where it may be appropriate to prescribe PSH to the group about which there is even less reliable research than there is for the “early onset” cohort. This is the group that includes the rapidly increasing cohort of adolescent girls presenting to gender clinics with puberty onset gender dysphoria, about whom almost nothing is known.
We think there should be no exceptions.
Other situations where PSH will continue to be used
The proposal to continue PSH prescriptions for those already on them, or to initiate PSH for those who have already been referred to endocrinology, is not consistent with the aims of the proposed policy. Use of PSH in these groups should be under the same conditions as for all other children with gender dysphoria, and the first line of treatment should be psychological and psychosocial support.
The policy proposes that PSH may still be used as a precursor or co-prescription with masculinising/feminising hormones (also known as gender affirming hormones). This would apply to 16 and 17 year olds and possibly 15 year olds. The NICE evidence review on gender affirming hormones found “limited evidence for the effectiveness and safety of gender affirming hormones in children and adolescents with gender dysphoria” and “Any potential benefits of treatment must be weighed against the largely unknown long-term safety profile of these treatments.”
It undermines the PSH policy consultation not to have also published the gender affirming hormone clinical policy so they can be considered together, given that their use is interconnected, and given the similar lack of evidence of safety and efficacy.
We believe PSH use in conjunction with masculinising/feminising hormones should be subject to the same constraints and caution as PSH used alone. The clinical policy on gender affirming hormones should be published and consulted on.
Private and unregulated prescribing of PSH
Although private and unregulated overseas prescribing of PSH is not explicitly part of this consultation, we don’t think it should be ignored by those with responsibility for the health and safety of children and young people, including NHSE. All NHSE commissioning policies should include child safeguarding concerns and we believe this policy is no exception. For that reason we believe NHSE should raise the issue of private and unregulated overseas prescribing with the appropriate authorities, with a view to measures to control this.