Open Letter to Health Secretary: Concerns About NHS Puberty Blocker Study

Dear Health Secretary,

We are writing to you as organisations and individuals concerned with issues of sex and transgender identity to raise our concerns about the NHS’s forthcoming puberty blocker study.

At present, there is limited information in the public domain about how the trial will be conducted. The NHS have advised that a study protocol will be published in December and that recruitment is scheduled to begin in January 2025, leaving little time for affected parties to register potential objections. This is important, because we believe the study faces significant practical and ethical challenges, particularly if it aims to be compliant with, and build on, the findings of the Cass Review.

These challenges are outlined in depth in the attached report, ‘Ethical and Practical Challenges for the NHS Puberty Blocker Study‘. Briefly:

• The puberty blocker study is at odds with the principles of the Cass Review, which emphasised the disservice done to gender distressed young people by excessive focus on risky medical interventions. The systematic reviews conducted by the University of York show that less invasive, psychotherapeutic interventions are associated with no negative side effects and with improvements in mental health in a comfortable majority of gender distressed patients. By contrast, puberty blockers are associated with multiple adverse outcomes and unknowns. The NHS have brought forward a risky puberty blocker study at speed when the evidence suggests that psychological interventions are the safest and most promising avenue for future research. To date, the NHS has not announced a complementary study into psychological interventions. Further, the NHS is proceeding with a puberty blocker study without awaiting the results of the Cass recommended data linkage study, which may yet demonstrate adverse long-term outcomes from puberty blockade and mitigate against any further study.
• The Cass Review struggled to identify a clear rationale for the prescription of puberty blockers to gender distressed youth. The rationales commonly given are either directly contraindicated by evidence cited in the Review or else ethically insurmountable.
• The established evidence suggest that a strict set of inclusion and exclusion criteria would be required to avoid causing unnecessary harm to young people. In order to be compliant with the findings of the Cass Review, the study would have to be restricted to male patients at Tanner Stage 3 or below, with a documented history of early-childhood-onset gender dysphoria, and who are capable of giving informed consent to the possibility of future surgical complications. We do not believe minor children are capable of giving this manner of consent. Further, young people from this cohort who have comorbid mental health or neurodevelopmental conditions, unstable family relationships, poor psychosocial functioning or a history of trauma should be excluded from the puberty blocker study.
• Based on the demographics of the current gender distressed patient cohort (who are predominantly females with adolescent-onset of symptoms and multiple comorbid conditions) our report shows that only a very small number of patients should be eligible to participate. This has consequences for the study’s ability to recruit an adequate number of participants in order to generate valid results.
• The study must address the near 100% rate of persistence to cross sex hormones following puberty blocking treatment, in both practical and ethical terms. Practically, it must show how it will gather data on puberty blockade as a discrete treatment when further medicalisation is a near inevitability. Ethically, it must account for the decision to provide risky, experimental treatment to minors when a majority of patients presenting with gender related distress experience resolution of symptoms after puberty if treated with less invasive approaches. It must also show how it will prevent the unnecessary medicalisation of youth with a nascent same sex sexual orientation, who would otherwise grow up to be happy same attracted adults without invasive medical intervention.
• The existing research on puberty blockers is confounded by the concomitant provision of psychosocial support. The Cass Review found that it is not possible to distinguish whether treatment outcomes are attributable to either endocrine or psychosocial interventions. Puberty blockers are known to cause declines in psychological functioning and declining mental health in some patients. It would therefore be unethical to provide puberty blocking treatment without concomitant psychosocial support. However, this means that the results of the study will be confounded and risk simply contributing further weak and ungeneralisable findings to an already weak evidence base.
• Finally, the NHS does not currently provide a service to support those who have been harmed by gender related medical interventions and who have chosen to detransition. Although little is known about detransition rates, emerging research suggests that transition regret may take up to ten years to manifest. Before proceeding with a puberty blocker study, the NHS must have services in place to support those patients who are harmed by their participation and a system to collect data in the long term so that adverse outcomes are not overlooked.

In our work, we support gender distressed people, parents, professionals and detransitioners, many of whom have direct experience of puberty blockers and NHS gender identity services more broadly. As you will be aware, gender medicine is the subject of unhelpfully polarised public debate. Part of our work involves public education and trying to cut through some of this polarisation to clearly communicate the facts to our audience.

Given the historic failings identified by the Cass Review in the way research has been conducted in this area, we believe there is a strong public interest in transparency and openness. It is easier to combat polarisation when equipped with the facts. Engaging in open and constructive dialogue is central to our work. We are asking you to pause the puberty blocker study so that this dialogue can take place and hope this correspondence is a starting point for such discussion.

Yours Sincerely,