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6 December 2025

Will the new puberty blocker trial put children at risk?

It’s unclear whether the trial will be able to answer the many urgent questions surrounding gender care

By Hannah Barnes

A new trial looking at the impact of puberty-suppressing hormones on children with gender incongruence (a mismatch between birth sex and gender identity) will begin in the new year, having received all the necessary regulatory and ethical approvals. The research, led by a team from King’s College London (KCL), aims to determine whether these drugs are of benefit to often vulnerable and distressed gender-questioning children, or if they could be harmful. Or, perhaps, both. But will the way the trial has been set up allow it to achieve that? 

​​​​​ ​In March 2024, after a decade of routine clinical use, NHS​ ​England (NHSE) ended the prescription of puberty blockers for the treatment of gender-related distress, based on the findings of Dr Hilary Cass. Cass, a former president of the Royal College of Paediatrics and Child Health, led a four-year independent investigation into the care provided to gender-questioning young people on the NHS in England via the Gender Identity Development Service (Gids), part of the Tavistock and Portman NHS Foundation Trust. NHSE concluded that there was “​​not enough evidence to support the safety or clinical effectiveness of [puberty blockers] to make the treatment routinely available at this time​”.​     ​​ 

In her final report, published in April 2024, Cass was clear: “This is an area of remarkably weak evidence, and yet results of studies are exaggerated or misrepresented by people on all sides of the debate to support their viewpoint.” The reality, she wrote, is that there is “no good evidence on the long-term outcomes of interventions to manage gender-related distress”. The outgoing Conservative government outlawed new puberty blocker prescriptions the following month, and the ban was made permanent in December 2024 by the current Labour regime. Puberty blockers – which Cass has described as “powerful drugs with unproven benefits and significant risks for children” – remain illegal in the UK outside of an NHS trial context.  

​​This new trial – the “Pathways Trial” – is the second time such a study has been attempted in England. The first was carried out by staff at the now-closed Gids and their colleagues at University College London Hospitals (UCLH), with participants starting treatment with puberty blockers between June 2011 and April 2015 and final results published in 2021. This trial showed the drugs provided no clinical benefit in a group of 44 ​​“highly selected” children, chosen because of longstanding distress around their gender. The researchers “identified no changes in psychological function, quality of life or degree of gender dysphoria.” A later re-analysis of the study data showed outcomes for individual children varied widely: around a third saw their mental health deteriorate significantly, a third saw no change, while another third saw significant improvement. In 2014, just as the final participants were recruited to the study, NHS England allowed Gids to routinely refer children for puberty blockers. There was no robust data to support the decision​,​ and early signs in 2015 and​ ​2016 that the drugs were not providing the benefit the team had ​​expected ​they would​ were not acted upon.  A series of ​​Freedom of Information requests, ​including some ​from me, suggest around 2,000 children under the age of 16 were referred blockers before Gids closed in 2024.​​​ 

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​​There are a number of reasons this first study was poor – for one, it had no control group of any kind – yet it ultimately gained ​the ​​necessary​ ethical approval ​to go ahead​. (​The study was initially turned down ​​on methodological grounds: ​the​ proposed design meant ​​​“​​​​​​​there was no way to validate​​​”​​​​ the research​​, an ethics committee ​said.​ ​​But the study was eventually approved – unchanged – by a different committee​). As the study moved forward, the Health and Research Authority required the research team to submit annual updates, which it did not. But there was no sanction. NHS England was responsible for overseeing the clinical practice of Gids – as it is for the new children’s gender services. Both the HRA and NHS England are actively involved again this time​.​​​​​​​​​ The new Pathways trial has followed all the necessary rules and processes required to obtain ethical and regulatory approval, and ​​there are far more checks and balances built in, better data and safety monitoring, and attempts to control for bias. There is external monitoring of any adverse events, and additional​ oversight of ​clinical​ decisions​, to name two improvements. But the first study shows the systems designed to ensure safe and effective medical advancement are neither failproof nor a guarantee of robust research. ​​​ 

At a briefing on the new trial for ​p​​arliamentarians on 3 December, Labour MP Jonathan Hinder pointed out that one member of the presenting panel, NHS England’s James Palmer, had been responsible for overseeing and developing youth gender services for more than a decade; Palmer had spoken publicly about it being a “good thing” that so many young people were exploring their gender.  ​​“Why on earth is he anywhere near this trial?” Hinder asked, given Palmer had been in a senior position while the many problems at Gids unfolded, but did not act to stop it. Another MP present at the briefing told me how unpersuaded they were by the argument that a new NHS trial was necessary because so many children were accessing puberty blockers ​from unregulated private ​​providers​. R​isks and benefits ​had to​ be ​assessed ​in ​the safe ​environment​​ of a trial, it was argued,​ ​to safeguard these children as much as possible​. (This was an argument when the Tavistock study was seeking ethical approval in 2010, too: an “increasing number of UK families were accessing [puberty blockers] internationally.”​)​​     ​ 

For the Pathways trial, up to 226 children under 16 years old will be given puberty suppressing hormones as part of a wider suite of research projects aiming to identify how best to care for gender-questioning children. Participants will be randomised into two groups: half will receive the drugs immediately, half will have to wait a year before they receive them. Individual children in one group will be matched as closely as possible to those in the other – they will be the same sex, at the same stage of puberty (​​early or late), and those with​ “​​a diagnosis of a neurodevelopmental disorder or high levels of traits​” will be paired with someone with a similar condition. The trial will compare the outcomes of the two groups after two years, looking at ​​the​ ​children’s quality of life, mental health and body satisfaction, as well as the impact on cognition and brain development and ​the impact on​ bone mineral density.  

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The study has several entry criteria, but who is excluded is perhaps equally important, and highlights some of the difficulties the trial faces. Children unable to consent, ​or who have ​unstable mental or physical health or a “home situation affecting adherence to protocol”, will not be able to take part. Nor will anyone who has already taken either puberty blockers or hormones such as testosterone or oestrogen.  

But the New Statesman can reveal that this automatically rules out a sizeable proportion of the current youth gender services caseload. Close to one in eight young people being seen at the London-based NHS Children and Young People’s Gender Service at Great Ormond Street Hospital have disclosed self-medicating with irreversible masculinising or feminising hormones. In a Freedom of Information request the hospital trust acknowledged that this “may not be a true reflection of the number in receipt of hormone therapy without an NHS prescription as some patients under our care may not have disclosed this information to us”. 

​​​This data has widespread implications for the trial.​ ​Not only are a significant number of children who might potentially benefit ruled out,​ ​​potentially skewing ​​fair evaluation of the drugs​​, ​but ​it also raise​s a wider, deeper point. Puberty blockers are no​t what ​many in this group of young people want. Many​ do not wish to pause their development – they want to​​ ​change​ ​their bodies to match how they feel.​ ​​And ​​they are taking matters into their own hands to do that​​.​​ Yet, research into masculinising and feminising hormones thems​​elves​​, recommended by the Cass Review, has not begun.​ ​​​​A clinical review of these hormones – including an assessment of any potential harm caused by the continued use of unregulated hormones coming from private providers – ordered by the Health Secretary, Wes Streeting, has been completed and given to him and colleagues. But while I am told it will inform ongoing policy development, there is no plan for it to be published. Cass told me that the NHS was “trying to get the infrastructure to have long term follow up on hormones as well.” This is “absolutely just as important, if not more important than, the puberty blocker component”.  

​​​​​​​Meanwhile, the Pathways trial of puberty blockers goes ahead. There are several inclusion criteria children must meet to take part. 

  1. Prior engagement with non-medical interventions  

The trial team argue that the requirement for children to have already engaged with other non-medical care before entry to the trial reflects the Cass Review’s recommendation that puberty suppression should not be a first-line intervention. But what will that prior support look like, and how long would it have lasted? 

​​In response to ​a ​series of questions from the New Statesman, the trial team said participation was “contingent on completion of comprehensive psychosocial interventions”. But it has been difficult to obtain concrete information on how many times children might be seen or what psychological or other support is being provided. The team said that children and young people “typically attend multiple appointments over several months” but added there was “no rigid ‘same intervention for all’ model​​”​.​​ 

A young person might have individual sessions focused on “coping strategies, emotional regulation, and managing anxiety”, family sessions, or take part in group work. They might also receive educational or social support to ​help them feel less ​​isolated, and​​ encourage school attendance​​​. In most cases, these “other interventions may last for up to a year”, the KCL team said.  

Whether this represents a comprehensive attempt at non-medical support is an open question. But if there is no consistent non-medical intervention that children and young people receive, it makes it almost impossible to judge the success of this approach to care too. Having recommended in her review that research into non-medical interventions also be undertaken, Cass told me, “In a perfect world, yes, it would be better if one could look at psychological interventions first. But the reality of the environment that we’re working in means that the immediate pressure was to find some answers about puberty blockers. And if we didn’t do that, I don’t think we would be able to engage the young people to come into the service.”   

  1. ​​Diagnosis of gender incongruence
  2. A “reasonable prospect of benefit” 

​​All young people taking part in the new trial must have a diagnosis of adolescent  “gender incongruence”, as defined in the World Health Organization’s diagnostic manual. According to the definition, this is “a marked and persistent [at least two years] incongruence between an individual’s experienced gender and the assigned sex, which often leads to a desire to ‘transition’, in order to live and be accepted as a person of the experienced gender”. ​​​ 

A clinician must also believe there is “a reasonable prospect of benefit” for any given child in having their puberty suppressed. But what will this belief be based on?  

One major strength of the Pathways trial over former practice is a concerted attempt to overcome individual clinician bias. At Gids, a so-called “clinician lottery” developed, whereby, depending on a clinician’s personal views, a child would be more or less likely to be referred for medical interventions. In the new trial, all decisions by clinicians seeing the young people will require re-approval by a National Multidisciplinary Team (NMDT) to try to achieve consistency.​ ​ 

​​However, there are no objective criteria to help clinicians judge whether any given child is likely to benefit or not. That some children persist with lifelong gender incongruence​ is accepted. All ​​previous​ studies, whatever their quality, have shown that while most children’s gender-related distress​ will resolve​ (if ​they are not medicated​), for a small number it will not. ​The issue ​here ​is that ​​the trial proposes treating ​a broader group ​with a powerful ​medical intervention ​intended​​ for a small minority, without the ability to ​​identify​​ which children ​actually belong​ to that minority​. ​​​ 

The Cass Review pointed out that a formal diagnosis of gender incongruence or gender dysphoria (where a young person also experiences significant distress) was “not reliably predictive of whether that young person will have longstanding gender incongruence in the future, or whether medical intervention will be the best option for them”. Clinicians who have worked in this field for many years have also conceded that they are “unable to determine with any certainty which children and young people will go on to have an enduring trans identity.” The trial team did not address the issue in a response to the New Statesman and instead said there were “multiple strict eligibility criteria”. Decisions would “follow a structured, multi-step process” which would include assessment of psychological, social and physical health, safeguarding, and family context, they added.  

​​Cass told me that while we knew there was “not an exact art” in trying to identify the very small group of people who do seem to have long-standing, enduring trans identities,” she believed that clinicians would be “very cautious”. “I think the amount of caution with which these services have been set up, the fact there’s going to be no possibility of postcode lotteries, that is going to have to go through an NMDT, that people are going to have to justify it, that they’re going to have to have had a really comprehensive view of all the other issues that that may account for their gender distress, and that that will be fully documented. I think all of those are factors that just give this service a much, much better chance of achieving that.” If, she added, “you find you’ve done the right thing for some and for some you haven’t, I think the difference will be that there’s really, really robust data” which might help to create “more helpful predictors in the future”.​​​​​ 

Strange as it may sound, there is not one agreed view on what the primary purpose of puberty blockers is when used in gender medicine. Cass summarised in her interim review in 2022, that depending on who you ask, the answer to the question “what is the intended outcome of puberty suppression?” varies. Responses include: providing time/space for the young person to decide about continuing with transition; reducing or preventing worsening of distress; improving mental health, and stopping potentially irreversible pubertal changes which might later make it difficult for the young person to ‘pass’ in their intended gender role. The L​abour g​overnment summarised Cass’s final review as concluding that “the rationale for early puberty suppression remains unclear”. 

​​The team undertaking the Pathways trial told the New Statesman: “The primary function of puberty suppressing hormones is to pause pubertal progression, allowing continuing psychosocial interventions and exploration of identity without the distress of irreversible physical changes.” ​​​Yet this interpretation, which provides the foundation of the new trial, was rejected by the Cass Review. “Given that the vast majority of young people started on puberty blockers proceed from puberty blockers to masculinising ​[or]​​ feminising hormones, there is no evidence that puberty blockers buy time to think, and some concern that they may change the trajectory of psychosexual and gender identity development,” Cass wrote.  

​​One researcher, who is no longer part of the trial team​, tol​​​​d​​ me​, “the early planning meetings were unlike any other clinical trial I’ve encountered. We could easily list all the potential harms to monitor and how to test for them, but we didn’t have a clear rationale for giving the drug in the first place”. Normally, they said, “you start with a strong rationale for how and why a treatment might help someone, and then think carefully about the possible downsides. It’s very unusual to start planning a trial without a well-defined outcome, especially in children.​​​​​​​​​​​”

The 113-page study protocol setting out the details of the ​Pathways​​ t​​​rial and associated research​​ notes that systematic evidence reviews have shown “as few as 0-8​ per cent​​ (including 2​ per cent​​ of UK youth) receiving [puberty blockers] subsequently desisted from the treatment and a transitioning pathway”.  Yet, at no point does the study team consider puberty suppressants to be part of a wider pathway towards medical transition. They are seen solely as a standalone treatment. MPs and peers attending the parliamentary briefing with the trial team have told the New Statesman the team explained that families ​would​ be told that previously children “often” went on to masculinising/feminising​ hormones​. But several attendees were surprised to hear Cass say that, as puberty blockers in the P​athways​​ ​​trial would be provided in a new, ​​much more supportive context than the one provided ​by Gids (​where children would be seen less often ​by the service once on medication​​),​ t​​​​hey could not pre-empt that such a high proportion would ​maintain​ their desire to ​transition and​ proceed to treatment with hormones this time round. Explaining her reasoning to me, Cass said there had never been a chance at Gids to properly test the hypothesis of blockers buying time to think because the service was overwhelmed by referrals. Now, she said, “it’s a different world, it’s a different time, it’s a different setup. And so, I genuinely don’t know what will happen in this instance.”

​​During a briefing to health and science journalists, organised by the Science Media Centre, the trial’s chief investigator, Emily Simonoff, described concerns around long-term risks of puberty blocker use on fertility, sexual development and cognition as, “at this point in time, theoretical”. She added that “there isn’t a clinical signal for those specifically in relation to puberty suppression​​”​.​ ​​​ 

​​It is true that blocking puberty per se does not lead to infertility. But any young person who receives puberty suppression in the ​early stages of puberty who goes immediately on to hormones – as the vast majority in all previous studies have done – will be left infertile. Their eggs and sperm will never have had the opportunity to mature. It has also been acknowledged several times by the world’s leading advocates for child medical transitioning that these same children will not be able to experience orgasm as adults. The study’s FAQs note “there are some possible risks of puberty suppression that may not show up until later in life”. This included risks to bone health, memory and thinking skills and future fertility, “especially if young people go on to cross sex hormones.” However, the team said, “There currently isn’t any evidence about how common these are or whether these effects are directly related to puberty suppressing hormones.” The raft of research underway, at a cost of £10.7m ​to taxpayers​, will almost certainly fail to answer these questions.​​​​​​​

The primary outcome being measured by the trial is health-related quality of life, using the “Kidscreen-10” questionnaire. This is widely used in schools and medical settings to evaluate, monitor and screen for anxiety disorders, depression, and other mental health difficulties in those aged eight to 18. Children are asked ten questions about their previous week, including “Have you felt full of energy?”, “Have you felt sad?”, “Have you had enough time for yourself?” and must choose one of five responses.   

But the trial team will collect many secondary outcomes too, gathering a wide array of data on participants. Alongside mental and physical well-being, ​children will also be asked ​about sexual attraction, body image, ​and suicidal ideation​. These questionnaires will also be asked of all children attending NHS gender services as part of the wider Pathways research, encompassing around 3,000 children. But parents of varying views about whether their children should transition, are horrified at some of the measures. One of them, the Body Image Scale – Gender Spectrum (BIS-GS), has been branded “a horrific tool that asks children to assess how much they hate all their body parts”. It asks children how happy they are with more than ​30 body parts, and if they would like to change them. Another measure, the Utrecht Gender Dysphoria Scale – Gender Spectrum (UGDS-GS), is seen by some as promoting suicidal ideation. It asks children to respond to the statement, “It would be better not to live, than to live as my assigned sex.” 

And there are questions about how reliable any of these subjective measures are when assessing a serious medical intervention. “It’s concerning that the trial appears to primarily rely on a ten-item questionnaire to assess outcome,” the researcher involved in the early development of the trial told me. “Even standardised scales can be shaped by expectation, mood, or external pressures. Without any objective measures of improvement in the condition you are treating, this makes the study unusually fragile, given the magnitude of the intervention.” Earlier research had produced “frequent mismatches” between child and parent perceptions of well-being, they pointed out, too, illustrating “how complex and variable these subjective measures can be and how difficult they can be to interpret”. 

​​With so much data being gathered, a further issue arises. How will the researchers weigh up different findings against each other? How might positive answers to the Kidscreen-10 questionnaire, for example, be balanced against any adverse physical effects of the blockers? The trial team told me safety and adverse events will be separately monitored and reported, with independent oversight. How positive and negative findings will be balanced remains unclear.

The KCL team told the New Statesman that as the Pathways trial uses a randomised controlled trial design, it “can determine whether puberty suppressing hormones cause benefits and/or risks.”  Comparing the trial’s two groups will help them to “understand whether earlier intervention improves quality of life, mental health, or reduces distress, and what are the effects of longer versus shorter length of treatment​​”​.  

Yet a study of ​when it might be more beneficial to administer treatment (to children who desperately want it), is not a trial of the benefits and/or harms of the treatment itself. MPs who attended the briefing on 3 December, told me the research team had opted not to have a trial group who did not receive blockers because children would be “demoralised” if told they were not getting the drugs. It will be difficult to ​control​ for the almos​t-​​​​inevitable ​improvement in the group receiving the puberty blockers immediately – who want the intervention and believe it will be beneficial – ​as well as the disappointment felt by those ​who want the medication, but will have to wait a year to get it​.  

The two trial groups will also be compared with a third group of 300 “matched” children who are not receiving medical interventions. But how might young people’s personal wishes be controlled for, I asked the researchers? Those who are not part of the trial – by and large – don’t want puberty blockers, whereas those who are on it desperately do. The trial team did not answer.  

​​More fundamentally, it’s unclear how this trial design overcomes a core problem of previous observational studies: how to disentangle the impact of psychological and social interventions from those of the puberty blocker. In both the Tavistock/UCLH puberty blocker study and the pioneering Dutch study, children continued to receive therapeutic support alongside puberty blockers.  Any harms or benefits observed, therefore, may have been down to the blockers, the therapy, or something else altogether. The Pathways Trial has the same problem. All participants will continue to be supported therapeutically. It would be highly unethical not to do this, but the trial team did not explain how this confounding variable could be overcome. ​​​​​

While the new trial and the broader research programme it is part of will tell us more about the children seeking help from NHS gender services, and may help us to understand some of the gaps in the evidence base – the KCL team will undertake the first ever study comparing the brains and cognitive abilities of those taking puberty blockers with those who are not – what Cass was most concerned about in her review was the lack of long-term outcome data. Take just one example: bone density. Multiple studies have “found that bone density is compromised during puberty suppression”, she wrote, as puberty is the time where our bone mass increases at its fastest rate.  But what we don’t know is “whether there is full bone health recovery in adulthood, both in those who go on to masculinising/feminising hormones and those who do not.” And this new research will not ​provide​​ an​ answer either.  

The KCL research team rejects the suggestion that “a short-term clinical trial lasting for two years will not help to address the question of whether [puberty blockers are] beneficial​​”​.​ Long-term effects, they say, “can only be evaluated following research examining short- or medium-term effects​”​.​ And even though the trial will study children intensely for just two years, they will be monitored for a longer period – on an annual basis – for up to five and a half years while funding is available. (Those who join the trial earlier will be monitored for longer.) 

Both those taking part in the trial and those who are only receiving non-medical support will also be asked to give consent to be followed up into adulthood, via links with national health registries and routinely collected NHS digital datasets. The study protocol says this will allows “systematic capture of clinically relevant endpoints such as fracture incidence, fertility-related interventions, and major health events​”​. But this is not a separate piece of structured research. Children do not ​have​ to provide consent to be followed up, and there is currently no funding to carry out any of analyses of this data.​ ​The KCL team told the ​New Statesman​ that the National Institute for Health and Care Research (NIHR) has “recognised the importance of long-term follow-up and have agreed in principle funding for this purpose.”  

But what will happen while we wait for that data to emerge? Will the NHS wait for long-term data from the 226 trial participants before allowing any more children to be prescribed puberty blockers? 

​​“The intent has never been that this should be a short-term piece of work,” Cass told me. “The intent has always been that this is the first step in a longitudinal follow up of these children and young people. But if you want to determine whether there are immediate, short-term harms, you’ll find that out because this is the first study that’s actually looked at brain imaging and thorough neurocognitive assessments.” Assessing long-term benefits and harms would require a more “longitudinal approach”, she acknowledged, but pragmatism was needed. “Part of the problem is that we can’t get any long-term perspective on this group of young people without confidence and support from the trans community, because you can’t compel anyone to be followed up… So, it’s hugely dependent on goodwill.”​​​ 

Why carry out a new trial when we don’t know what happened to the children who received puberty blockers while under the care of Gids?​ ​This has been the question asked most often since the new trial was announced. Research commissioned by the Cass Review tried to find out what had happened to around 9,000 children who had been seen at the youth gender clinic – both those who been referred for medical treatments and those who had not. It had the necessary approvals and the funding required. The research was dubbed the “data linkage study”, as it aimed to link data on the individuals as children held by Gids, with data on those same individuals as grownups held by the NHS more generally, and, more specifically, by NHS adult gender clinics – for those who sought further medical treatment. This would, Cass concluded, “help to develop a stronger evidence base about the types of support and interventions received and longer-term outcomes.” ​​​ 

It might have shown, as Cass has argued, that a small subset benefited from puberty blockers or that some experienced significant harms – or both. With this information, further research could be developed that targeted only those children who might have the greatest chance of benefit, as well as providing us with crucial intelligence about the long-term health and happiness of those who have started a medical transition in childhood.  

Follow-up is standard practic​e in ​​​​​​healthcare,​ but the NHS adult gender services refused to cooperate with data sharing​ –​​ t​​​hey blocked the study​. In January 2024, NHSE wrote to Cass confirming that it would “take over responsibility for realising the ambitions of the study”. The letter acknowledged that failing to carry it out would be a “missed opportunity in gathering high quality evidence”.​​  

​​​​​​In her review, Cass described the data linkage study as representing “a unique opportunity to provide further evidence to assist young people, their parents/carers and the clinicians working with them to make informed decisions about the right pathway for them​​”. She also spoke about the difficulties of gaining informed consent for treatment with puberty blockers ​without​ this kind of follow-up data. ​​​​​​​​Yet, the Pathways trial protocol and public comments made by Simonoff, the trial’s chief investigator, have been dismissive of the utility of the data linkage study. The trial protocol flatly rejects that it would be a good place to start,  saying it would not “address important questions” about the long-term impact of puberty blockers for “several reasons​”​.​ ​​​ 

The document argues (correctly) that Gids’​s​ clinical records were not standardised, that some important data might be missing from them, and that “published reports” on this cohort of children suggest that the data that is available won’t be representative of the group as a whole. “We conclude that a retrospective study would not provide alternative evidence,” the KCL researchers write. But this is directly opposed to the assessments previously made by Cass (and NHSE), whose expert opinion is cited as ​the reason​ this new trial is going ahead. It’s true that retrospective research is never as robust as prospective research – following participants months or years afterwards to see what happens to them – but Cass pointed out that “a prospective study would take a minimum of 10-15 years to extract the necessary follow-up data”.   

NHS England declined to provide a formal response when asked for an update on the data linkage study. But there appears to have been little progress in the almost two years since it took responsibility ​for carrying it out​. NHSE still does not have all the approvals it needs to begin the study. I was told that further details will be published once independent research and ethical approvals have been secured. Assuming these are granted eventually (as they were to the team working alongside Cass), without the necessary appetite for conducting the study, its future looks very uncertain.  

Each child on the Pathways trial will have a full clinical review after they have been on puberty blockers for the two-year study period. At this point, a decision will be made about what happens next. If a child wants to stay on puberty blockers, they will be able to if it’s agreed by both the clinician responsible for them in the gender service and the NMDT of healthcare professionals. The decision will be reviewed every year they wish to remain on the ​drugs​.  

This arrangement throws up several questions. While children who continue on puberty blockers after the trial will receive “ongoing assessment” and “psychosocial care”, it does not appear that they will be subject to the same level of safety monitoring and data collection. The trial team anticipates that the youngest participants may be just ten or 11. This could mean their development is suppressed for five or six years, as masculinising or feminising hormones are only available at the age of 16. The trial team did not respond to a question about whether they were concerned about the potential impact of suppressing a young person’s mental, physical and identity development for so long. Nor did they confirm whether children would continue to have annual bone density scans, or whether the data collected from those on blockers for longer would be included in any formal analysis. ​​​ 

The trial team​ ​told me​,​ “It is not possible to know before starting puberty suppressing hormones what the treatment plan for any single young person will be at the end of the trial​.​” They could remain on the blockers, start treatment with hormones, or stop medical treatment altogether. “We also do not know whether safety monitoring from the trial more generally may be showing that there are significant risks from this treatment, which could mean it is not a good idea to stay on puberty suppressing hormones,” they added. 

​​While there is a strong system of data collection and analysis put in place for the two-year duration of the trial, as well as robust safety monitoring for any potential adverse outcomes, it is hard to know what will happen going forward. Simonoff told MPs and parliamentary peers that whatever came next would be a “policy decision”, based on “short-term data”.​​​​​​​​ ​​​​​In the past fortnight there has been an unravelling of the short period of broad consensus that followed Cass’s final report​ ​in April 2024. The briefing provided by Cass and the trial team to parliamentarians on 3 December ​​​shows how past divisions are quick to resurface ​​on this thorny topic​. While some MPs feared the trial was too restrictive – why were children with unstable mental health being excluded, when the blockers could help? – others branded the doctors a “frightening bunch”. Speaking to me afterwards, Labour’s Jonathan Hinder said the trial was “morally wrong” and would be “another massive scandal”. Former Labour MP, now Independent, Rosie Duffield described the meeting as “horrifying”.  

Asked whether she understood why there was concern about the trial and whether it would answer the questions she herself highlighted, Cass said: “Nobody is wrong on this. It’s a finely-honed decision, and, with justification, you could come down on either side of it.” She drew comparisons with the assisted dying debate taking place in the House of Lords: “Whether you are in support or against it, it’s an ethical decision about what you know, how many people you think you’re going to do something positive for against how many people might be harmed… and everyone makes their decision.” Cass explained that she had recommended a group of people should explore a trial, but that “I didn’t even necessarily anticipate whether or not such a trial would get through an ethics committee, or whether a group of academics would be able to even design a trial, given the circumstances that we’re in now. So, I didn’t prejudge whether it would happen… And if the ethics committee had said, despite everything, we don’t think this is an ethical approach, then I would have been content with that too.” 

​​Wes Streeting told the BBC on 3 December he too “recognised and respected” that MPs from all parties were concerned about the trial. The Health Secretary, who has spoken critically about the “scandal” that took place at Gids, has said the new trial will have “ethics and safety at its heart”. Streeting is, understandably, following the advice of doctors. But after this trial ends​,​ a decision must be made – a task that will likely fall on the Health Secretary. Whoever is in post at that time ​​will be ​forced to make a decision on the use of puberty blockers with ​​arguably​​ no clearer answers​ on their long-term impact​ than we have today​.​ ​​ 

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