Currently, under 18s who are experiencing gender-related distress can’t legally be given a new prescription for puberty blockers in the UK. A government ban, first introduced in May 2024, was made permanent in December. It followed the four-year independent Cass Review of young people’s gender identity services. Former President of the Royal College of Paediatrics and Child Health (RCPCH), Dr – now Baroness – Hilary Cass found that this was an area of healthcare for which there is “remarkably weak evidence”. She recommended that a puberty blocker trial be set-up as part of a “full programme of research”. Joining the NHS puberty blocker study will be the only way for a young person to get puberty blockers in the UK.
Now, we have finally got a glimpse of what the new NHS-funded research into puberty blockers might look like. The Pathways study, commissioned and paid for by the NHS with operational support from the National Institute for Health and Care Research (NIHR), aims to “build the evidence base on the care needs and development of children and young people with gender incongruence.” It will run until January 2031, and cost £10.7m.
The study is actually broken down into different parts, and the puberty blockers trial is just one element. No details are given about what eligibility criteria will be for joining the trial, but Dr Hilary Cass, whose four-year review of children’s gender services led to this research, has said that “a multi-disciplinary team approach will be taken to identify those children who, with the consent of their parents, may be deemed clinically suitable for consideration of puberty suppressing hormones through the study.” It will focus on the effects of puberty blockers on children’s physical, social and emotional well-being. Another aspect of the trial will look at how puberty blockers affect young people’s thinking and brain development. There is no further information on the design of the trial, but everyone taking part will also receive therapeutic, “psychosocial support” and be followed for two years.
But it is difficult to see, from the information we have, how this research will add to our current knowledge. Just like the existing low-quality studies that have been so roundly criticised, Pathways aims only to “Build the evidence base on the (short and medium-term) benefits and risks” of using puberty blockers. But the Cass Review identified how we do not know the long-term impact of the drugs: on neurocognitive development, psychosexual development or longer-term bone health. This is what led to NHS England ending the routine prescription of puberty blockers. It seems unlikely that any of these gaps in the evidence-base will be filled by the planned 2025 study. It seems to want to inform “any longer-term follow-up studies.” But why not do that work now?
It should be possible to answer some of the unknowns. But there have been unnecessary roadblocks. Research commissioned by the Cass Review tried to find out what had happened to around 9,000 children who had been seen at Gender Identity Development Service (Gids) – but the service itself failed to follow up any of its patients during its 35-year history. According to several freedom of information requests, up to 2,000 children may have been referred for puberty blockers during that time. The research would have helped “develop a stronger evidence base about the types of support and interventions received and longer-term outcomes”, Cass wrote, but it was “thwarted by a lack of cooperation from the adult gender services”.
To make matters worse, NHSE – having now taken on responsibility for doing this research – does not even have the required permission to even request the data from the adult clinics. In 2022, the Conservative government changed the law to make it possible for adult gender clinics to share all medical data with a small group of researchers working with the Cass Review. There seems to be a similar lack of any progress for a number of Cass’s recommendations: research does not appear to have begun on evaluating the outcomes of either talking therapy or masculinising and feminising hormones; services for 17-25 year olds have not been established, and nor has any new provision for those considering detransition.
The full study protocol for the proposed new trial will now be considered closely by an independent ethics panel. If approved, it will “follow stringent safeguards in scientific research”, said James Palmer, the NHS’s national medical director for specialised services. Health sources have confirmed to me that it is highly unlikely that the trial will begin recruiting participants in the spring, as originally hoped. It is worth pointing out, as well, that one of the co-investigators of the new NHS research, Dr Harriet Gunn, was also involved with another research team back in 2015, asking very similar questions.
While we have a glimpse of the research that the NHS plans to carry out, the limited information we have throws up more questions than answers. Who will be eligible to join the trial? Who will be excluded? How will different outcomes be weighed against each other to deduce whether the treatment is a success? What would a successful outcome even be? Most important of all: will this expose an unlimited number of children to unknown risks and benefits, and still – at a cost of close to £11m, tell us nothing we did not know already?
[See more: The BBC’s fumble leaves the stories of Gaza’s children untold]
Content from our partners
