Pathways Study: Puberty Suppression

As Dr Cass has said, the vast majority of children and young people who question their gender will resolve it without needing any support other than that of their friends and family. For many young people, questioning their identity on many different fronts is a normal part of growing up, and we should simply let them be. For a small number of young people, though, greater support is needed because of the level and longevity of the discomfort that they feel. That can often involve counselling or therapy. For a very, very small number of young people, it is possible—I emphasise the word “possible”—that medical treatment would help to improve their quality of life and mental health, and reduce their gender-related distress.

That is why Dr Cass, whose approach until recently commanded cross-party consensus, recommended a trial to establish how best to support children and young people suffering gender incongruence. That is the Pathways study. It has four main parts, one of which is the clinical trial to study the effects of puberty-suppressing hormones on young people’s physical, social and emotional wellbeing. The Pathways trial, which is being led by King’s College London and the South London and Maudsley NHS foundation trust, was initially approved last November. The trial seeks to gain evidence on whether those potential benefits are real, alongside evidence on whether such treatment comes with the risk of harm.

It is right that this Government are guided by expert clinical advice and a clinical, evidence-led approach, but as this study involves children, and therefore comes with a particular responsibility, as Health Secretary I have sought the most detailed assurances possible from my clinical advisers about how children taking part in the trial will be protected. There are a number of important safeguards. Children can participate only with the consent of a parent or guardian, and the children themselves must consent or assent. They can participate only if they have had a diagnosis of gender incongruence for at least two years. They can participate only if they have received psychosocial support through the NHS. They can participate only if they are of stable physical and mental health. They can participate only if they are not subject to any safeguarding concerns. They can participate only if they and their parents demonstrate sufficient understanding of the nature of the treatment, including its potential advantages and disadvantages. They can participate only if they have been deemed clinically appropriate by both the NHS care team and the national multidisciplinary team, and they can participate only if they are already accessing NHS gender services. So, when it comes to eligibility, we are talking about a very small subset of a very small group. The number of young people who would expect to quality for the trial will be low, and the safeguards to ensure their safety and wellbeing are rigorous. I have sought and had reassurance that once participants are on the trial, they may be withdrawn at any point.

As hon. Members will know, the Medicines and Healthcare products Regulatory Agency raised new concerns at the beginning of this year, and the start of the trial was delayed so that they could be fully scrutinised. On Thursday last week, the regulators approved an updated protocol that significantly strengthened the objective criteria for withdrawing children from the trial. I welcome that change. Signs of greater risk to participants will now trigger increased monitoring, clinical review or automatic withdrawal from the trial. All participants will be monitored before, at the start of, every three months during and after the trial. Before and during the trial, information will be collected about mental health, quality of life, self-harm and suicidality, body image, cognition, puberty stage, physical health and side effects.

On bone health, puberty is normally a time of rapid bone gain, so if changes in bone density are identified, that will lead to a reassessment of whether the participant should continue in the trial, with set criteria for automatic withdrawal. On fertility, there is no published scientific evidence of irreversible changes, but that will be proactively addressed, with every participant offered repeated counselling and a range of options to preserve their fertility. On cognition, while there are no established scientific reports proving a cognitive effect, the new protocol sets out strict definitions for investigation and automatic withdrawal of young people from the trial.

The new criteria for increased monitoring or withdrawing children from the trial will mean that, at the first sign of negative impacts, action will be taken. These criteria will stop short-term harm, and the view of the National Institute for Health and Care Research is that that means any long-term harm should not occur or go unnoticed. Those reassurances about preventing harm to the children who take part in the trial, and taking clear action if any risks appear to increase, are critical. After considering the matter closely over the past few days, I have requested monthly updates on the progress of the trial, including on any emerging risks.

Pathways is rightly one of the most scrutinised UK clinical trials of recent times—we should expect nothing less when we are talking about the health and wellbeing of some of the most vulnerable children in our country. Yet, as Dr Cass has made clear, we have to build the evidence base to show whether the treatments are safe and whether they produce the positive outcomes that young people and their clinicians want from them. My view is that proceeding with the trial is, on balance, the most appropriate way forward.

This has not been easy—I am sure many hon. Members are also wrestling with this dilemma—and, as we debate this issue today, I hope that we will keep in mind Dr Cass’s ask to consider the issues sensitively and cautiously. As she said:

“Polarisation and stifling of debate do nothing to help the young people caught in the middle of a stormy social discourse, and in the long run will also hamper the research that is essential to finding the best way of supporting them to thrive.”

I will not pretend that I do not continue to feel discomfort and unease, but I believe that the only way for us all to come to a fair and settled conclusion on this matter—to move forward as a country on this difficult and sensitive issue—is on the basis of clinical evidence in which we trust. Thanks to the strengthened criteria now in place for monitoring children’s wellbeing and withdrawing them from the trial, there is now intense scrutiny, and there are robust mechanisms to prevent harm from coming to the young people who take part. It is on that basis that I believe we should follow the advice of clinical experts and seek the clinical evidence that will give us the confidence to know that where we settle on this matter in the future is right. I commend this statement to the House.

I understand that this trial has been approved, but time and again we have seen and heard how fear and hostility can distort priorities. We have seen tragedy occur when fears of accusations of racism limited mental health treatment. We have seen profound suffering when fear of accusations of Islamophobia limited inquiries into the grooming gangs. The healthcare of children distressed about their gender is another topic where there have been attempts to shut down debate with threats and accusations of transphobia.

Such attempts were reported in relation to the Tavistock.

When considering treatments for life, with lifelong implications, we have a duty to be careful and sensible, so I ask the Secretary of State: why are this Government funding a trial that will cause harm to physically healthy children? These children may be 11 years old, at Tanner stage 2. Some of them are primary school children with only minimal signs of puberty. This is far too young. The MHRA warned in February that the youngest patients are at greatest risk; they may end up on puberty blockers for a much longer period, and face a higher risk to fertility, because sperm and eggs have not yet fully developed at Tanner stage 2.

I am reminded of this point in the judgment in Bell v. Tavistock:

“There is no age appropriate way to explain to many of these children what losing their fertility or full sexual function may mean to them in later years.”

Yet as the Secretary of State confirmed, the children must consent or assent to being in the trial. Why did the Government not heed the MHRA’s recommendation of a minimum age of 14 years? This Labour Government think that 14 is too young to watch social media. Why do they think 11 is old enough for this trial?

What is the goal of the treatment? In the trial, the outcome is a short to medium-term effect on quality of life and body satisfaction. Does the Secretary of State believe this is proportionate to the risks of these medications? Is there any evidence suggesting that puberty blockers are safer than they were thought to be in 2024, when the Government banned them, following the expert advice from the Commission on Human Medicines? Some have suggested that the drugs help adults to pass as the opposite sex. Is the long-term damage really worth it for the cosmetic benefit of a few? And it is just a few, because we know that the vast majority will be better without any treatment.

The Secretary of State said that “when it comes to eligibility, we are talking about a very small subset of a very small group.” Even if we were to accept the premise that a very small number might benefit from treatment, how could the clinicians identify which those children might be? A study of clinical outcomes from kids treated at the Tavistock is due to be completed next year. That could help, so why is the Secretary of State not waiting until that report is completed before conducting an experiment on an unnecessarily broad group of children? Has evidence come to light since the Cass review that helps clinicians confidently work out which 11-year-olds will become adults with gender dysphoria and which will not?

The Secretary of State has said that the criteria will stop short-term harm, and that should mean that long-term harm will not occur or go unnoticed, but history is littered with examples of things that do not cause short-term harm but do cause long-term damage. He also suggested that the trial will resolve the dispute, but sadly, I do not think that will be the case, because, first, a single trial rarely resolves a dispute; and, secondly, the comparison group, who are not getting the puberty blockers, are not randomised and are an intrinsically different population. This is bound to be highlighted once the result is published. In medicine, we have a founding principle: primum non nocere—first, do no harm. I ask the Health Secretary to please cancel this trial before vulnerable children suffer unnecessary, irreversible harm on his watch.