That this House calls on the Government to take steps to prevent the PATHWAYS clinical trial into the effect of puberty suppressing hormones on children with gender incongruence.
Before I start, I declare an interest as an NHS consultant paediatrician, a member of the Royal College of Paediatrics and Child Health, and a member of the British Medical Association. It is also important for us to recognise at the beginning of this debate that we are talking about the protection of children—vulnerable children who are troubled, and who need our care and compassion and the very best quality of healthcare.
The healthcare of children distressed about their gender is an area in which attempts have been made to shut down debate with threats and accusations of transphobia; we saw the way that the hon. Member for Canterbury (Rosie Duffield) was treated when she raised concerns. As adults and as elected Members of this House, we have a duty to safeguard children in our country. That means protecting them from adults who—with whatever motivation, good or bad—could do them harm.
As a children’s doctor, I have recruited patients for trials, and I have cared for children and babies participating in clinical trials. I recognise the value of a well-designed clinical trial in improving clinical care, but today the House is not being asked to consider the principle of performing clinical trials in general, or on children in particular—I hope we can all agree that a well-designed trial can improve care. Rather, we are being asked to consider the Pathways trial: whether it meets ethical tests, what it does, the cohort, the protocol and the consent. I will go through each of those points in turn.
The Pathways trial is part of a group of studies run by King’s College London and funded by the Government. So what does it do and why are we so concerned? The trial will take 226 children who are physically healthy—who are developing normally—and inject them with powerful drugs to delay that normal development in a way that may weaken their bones, affect their ability to think, damage their sexual function, and leave them unable to have children of their own.
As a consultant paediatrician, my hon. Friend will be able to give a definitive view on this matter. Some who campaign for this treatment and therapy argue that the effects of gene therapy are reversible. To what extent are they reversible? Should we be treating this as a reversible treatment? My hon. Friend has referred to permanent damage. Can we try to agree across the House at least on this matter: that gene therapy applied to children is not reversible?
This is not a form of gene therapy. It is a medication that is a GnRH analogue, and what it essentially does is delay puberty. It was designed as a drug to treat children who go into puberty much earlier than they would be expected to, and to delay it until, as it were, the right time. The effects of the use of puberty blockers in older children and for a much longer period, at an age when they ought to have started puberty, are not fully understood.
My hon. Friend says that we do not know the effects, but a number of children have been put through this process via the now discredited Tavistock process. Why does she think that the NHS will not refer to the data linkage study and use the data that would have been gained from the children who were put through that process, in order to find out what the effects are before deciding to put a whole new cohort of children through what is clearly a damaging procedure?
My hon. Friend raises a very good point, and I will come to the data linkage study shortly. What we do know from the Cass review is that the vast majority of children who went on to puberty blockers in adolescence went on to receive cross-sex hormones, which are known to have permanent effects.
One fact that is crucially important is that it is not possible for clinicians to confidently determine which children with gender incongruence will persist with the trans identity into adulthood, and which will not. How can the clinicians possibly know that they are not injecting potentially dangerous drugs into children whose incongruence will resolve itself? The answer is that they cannot. Will the Secretary of State tell us whether he is aware of new evidence allowing clinicians to work out confidently which children will persist with the trans identity at 11 and which will not? We need to think about the risk involved in the treatment, and whether it is worth the benefits that they will purportedly receive.
The trial researchers suggest that they will take a wide approach to looking at potential benefits, that they will look at quality of life and body satisfaction, and that there must be a reasonable prospect of benefit; but how can they know whether there is a reasonable prospect of benefit when they do not know whether or not the condition will persist? Some have suggested that giving puberty blockers will help the few adults who retain their trans identity into adulthood to pass as the opposite sex. Does the Secretary of State think that the long-term damage to many is worth it for the cosmetic benefit of a few? The Medicines for Human Use (Clinical Trials) Regulations 2004 specify that “anticipated benefits” must justify the risk. This is an ethical rather than a medical question. Does the Secretary of State think that the benefits justify the risk?
The hon. Lady knows that she is one of my favourite Tories—I think I have said that before. She has quoted Baroness Cass many times. Of course, Baroness Cass thinks this trial should go ahead, because the benefits outweigh the costs. Why is Baroness Cass wrong and the hon. Lady right?
Well, one of the things with doctors is that if you ask two doctors, you might get two different opinions. I completely respect Baroness Cass. She has been president of the Royal College of Paediatrics and Child Health, of which I am a member, and she has done great work on the report that we commissioned in the last Parliament. I know she is concerned that people may obtain these drugs illegally if they are not provided, but I do not share that concern. Personally, I think the important thing is whether the people obtaining such drugs legally are using them in a way that is safe, and I am not convinced that that is the case.
By giving way a second time, the hon. Lady shows why she is my favourite Tory. Does Baroness Cass not say that she has met young people who have been self-medicating with testosterone, which is irreversible? That is one of the problems that we are trying to address through this trial. It is about protecting young people so that they are not going down their own medical pathway, but are listening to medical advice and are well supported in a coherent framework.
I am sorry, but I just do not support that. We would not give children cocaine on the basis that they wanted it and would get it illegally otherwise. These are not sweeties; they are powerful drugs and need to be treated with respect.
Even if we accept the premise that a very small number of people might benefit from treatment, how could clinicians decide which children to treat? On what ethical or moral code would we want to inject powerful drugs into children who are likely to have a self-limiting illness and therefore do not need it? That is what the Government have chosen to do, and it is not necessary.
Following on from the point made by my hon. Friend the Member for Farnham and Bordon, they have this data already. The Tavistock was a travesty, but it means that the Government could analyse the data from the outcomes of those children. They could establish the outcomes as children went into adulthood, and Baroness Cass tried to do this using the data linkage study. Shockingly, six out of seven adult gender clinics refused to provide the Government with the data. Even when a specific piece of legislation was passed by the previous Government to clarify that it was legal to provide the information to this trial, the gender clinics still did not provide it.
I understand that NHS England is working on the data linkage study, but I ask the Secretary of State why it is taking so long. Is the abolition of NHS England causing delay? Why is he letting this trial, which he has expressed reservations about, go ahead in the knowledge that it is unnecessarily broad and in advance of the data linkage study?
Does the hon. Lady agree that unblocking the reasons why the data is not being made available should be the top priority, and that analysis of that data should be done before any further experiments on children are done?
The hon. Gentleman is exactly right, and he expresses my point succinctly. Why is the Secretary of State going ahead with a trial—experimenting on more children unnecessarily—when he has the data to analyse already? Why has he chosen to fund this trial? Is he worried about the children who will be put on a medical pathway that may lead to cross-sex hormones and a lifetime of medicalisation when they would have got better by themselves anyway?
I want to talk about the age of these young people. The Medicines and Healthcare products Regulatory Agency warned in February that the youngest patients are at the greatest risk, and may end up on puberty blockers for a much longer period. They have a higher risk to fertility because sperm and eggs have not yet fully developed at Tanner stage 2, but this Government have chosen to include children of 11 or 12. Some will wonder why it is 11 for girls and 12 for boys—indeed, I was asked that question yesterday—but as a paediatrician I am aware that puberty starts earlier in girls than in boys. It is somewhat ironic that a trial based on the premise that girls could be boys recognises this biology, but I am glad that in this respect it does. However, that means some of the participants will be primary school-aged children with the merest form of puberty. How can they possibly meet the eligibility criteria, which includes
I just say this to the hon. Lady and, perhaps more importantly, to the Secretary of State, who is very genuine, personable and easy to speak to. In Northern Ireland, the Assembly and the Minister there have taken a decision not to pursue this. Would the hon. Lady agree that, when the Government pursue something here that may set a precedent for somewhere that has not agreed to it at the time, there could be an influence, with an adverse impact on the regional Administrations—the Northern Ireland Assembly where we are, and elsewhere—and it is important that the Government here do not take a decision that could influence areas they do not control?
I thank the hon. Gentleman for his intervention on devolution, and I am sure the Secretary of State was listening and considering what he has said.
To go back to the age of the young people, I am reminded of the judgment in Bell v. Tavistock, which says:
“We do not think that the answer to this case is simply to give the child more, and more detailed, information. The issue in our view is that in many cases, however much information the child is given as to long-term consequences, s/he will not be able to weigh up the implications of the treatment to a sufficient degree.”
I draw right hon. and hon. Members’ attention to the next part of the quote:
“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 Secretary of State confirmed yesterday, the children must consent or assent to being in this trial. Another question that he did not answer yesterday is why the Government did not heed the MHRA recommendation for a minimum of 14 years. Having established that the Government are going to put a group of physically healthy children with a self-resolving condition at a risk they may not fully understand, the remaining question is why they would they want to do this.
I know what a sensitive, emotive and difficult issue this is. As I said in the House yesterday, I have myself struggled with the profound challenges this subject raises. We all, as adults, owe a duty of care to every child and young person in this country. That is a responsibility I bear, both as a citizen and as Health Secretary, with the utmost seriousness and sincerity. It is why, in all my deliberations on this matter, my consideration is to protect the safety and wellbeing of children and young people. Children’s healthcare must always be evidence-led, safe and effective. The way to ensure that is to follow expert clinical advice, which is what the Government are doing.
Dr Hilary Cass, the clinician who I think has more respect in this space than any other, has spoken about the importance of this trial in recent days. I remind the shadow Minister that it was her party that commissioned the Cass review and accepted its findings, which included the Pathways trial. I have been clear to the House that this is a challenging area. I accept and welcome the scrutiny of Members, but I encourage us to keep in mind Dr Cass’s request to consider the issues sensitively and cautiously. She says:
“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.”
There is a third option, which is to get NHS England to motor ahead with the data-linkage study, so that we can use the data that has already been collected to find out the answers to the questions that the Secretary of State is posing. Only then, if the information is not there, should the trial go ahead. Why is he not pushing that third way?
20 of 141 shown
We are told that the purpose of this is to treat a diagnosis of gender incongruence. So what is gender incongruence? The International Classification of Diseases states that it is
“characterised by a marked and persistent incongruence between an individual’s experienced gender and the assigned sex, which often leads to a desire to ‘transition’”.
We know that gender incongruence is a condition that is subjective. It is based on how someone tells us they feel. There are no blood tests and no lab markers that can be used to diagnose it. As a paediatrician myself, I understand that how patients feel, particularly in relation to their mental health, is very important. We know from the Cass review that the vast majority of children with gender incongruence will get better on their own. Again, as a paediatrician, I am used to providing supportive treatment for conditions such as respiratory viruses and gastroenteritis, which generally get better on their own, but I am not used to giving powerful drugs to children that can cause permanent long-term damage for subjective, self-resolving difficulties during adolescence.
I regret that we have ended up discussing the details of a clinical trial in the Chamber—the reality is that things should be done impartially by scientists in most cases—but with this topic we have seen the quashing of open debate, which is why we have ended up where we are.
I will move on to the point made by my hon. Friend the Member for Farnham and Bordon (Gregory Stafford). Even if the Secretary of State thinks the principle of the trial is right, he must surely agree that it is unnecessary and unethically broad. For example, if someone was designing a trial to treat children with a specific form of cancer, the children who would be entered into the trial would have that specific form of cancer. We would not include children with any disease, because that would make the results unreliable in terms of benefit to the target group and children would be unnecessarily put at risk of receiving experimental drugs that they did not need.
The same applies to this trial. The Cass report tells us that many of the children in the proposed trial will get better on their own. The Secretary of State said yesterday that
“we are talking about a very small subset of a very small group.”—[Official Report, 22 June 2026; Vol. 788, c. 56.]
“sufficient understanding of the treatment advantages and disadvantages, including discussion of fertility preservation”?
How can a child of 11 understand what it means to lose sexual function, to be unable to have children when they are older, to have difficulties in thinking and to have weak bones? Remember that this Government think that 14-year-olds are not old enough to watch social media, but they think 11-year-olds are capable of understanding this.
The trial itself has an interesting design. We are told that it is a randomised controlled trial—as a doctor, I am familiar with that term—but in this case it is a bit of a fudge. Yes, this Government-sponsored trial will randomise which children get the drugs now and which get them in a year’s time, but the comparison group that does not receive puberty blockers—300 children from the Horizon Intensive trial, with whom the trial will seek to compare—may not be considered a reliable comparison, because the group is a different group with different eligibility criteria. When the results of this trial are published, this fact is bound to be used by people who dispute or disagree with the findings. The Secretary of State said this trial will resolve the dispute over the issue, but that is one of the reasons why I think it will not.
I want to discuss sexual function, because yesterday the Secretary of State said that the trial would involve the completion of a number of questionnaires, and one of my hon. Friends raised the question about what happens to children’s sexual function in the long term. What is sexual function? It is desire, arousal and orgasm. The trial organisers are clearly concerned about this, because they put into the trial the ALSPAC—Avon longitudinal study of parents and children—romantic relationships questionnaire. I read the questionnaire on the Health Research Authority website, and children from the age of 12 and over will be asked these questions, one of which is:
“In the last year have you had oral sex with another person? (This is when they put their mouth or tongue on your penis/vagina or you put your mouth or tongue on their penis/vagina)”.
Let us be clear: if that is happening to a 12-year-old, that is sexual abuse and the police should be called. Is the Secretary of State content for the Government to be asking these questions of such young children? Can he believe that they will be paid £20 for completing their questionnaires, alongside £30 for completing the assessment of cognitive ability and £15 for completing physical and height assessments, in addition to travel expenses?
There will be lots of talk this week about the Prime Minister’s legacy. Putting children as young as 11 on puberty blockers, with irreversible life-changing consequences, would be the most disturbing final chapter in what has been a troubled book of leadership. Today, right hon. and hon. Members will be asked to vote to consider their approval or disapproval of the trial. I urge them to look at their conscience, read the trial protocol—it is online—and remember that these are vulnerable children who deserve the best care. One day, the children caught in the middle of this debate will be adults. It is our responsibility to ensure that when they look back on their one childhood, their one adolescence and their one chance to enjoy growing up, they must know that every decision was made with the utmost care, caution and respect for their future. The power to make that happen is in our hands today. I urge hon. Members to protect children’s futures.
I do not think that there is any question that a few years ago, children’s safety and wellbeing was not being protected when it came to gender incongruence. From around 2009, the number of children and young people being referred for NHS support around their gender identity increased rapidly. Stories subsequently emerged of young people struggling after undergoing radical and permanent transition surgery at an early age, of children rushed into taking medication without adequate therapy beforehand, and of clinicians disregarding conditions such as neurodiversity and mental health issues. As such, there was rightly deep concern about the vulnerability of these children and young people, the care and treatments they were receiving, and the surge in referrals. And so, in 2020, NHS England commissioned the leading paediatrician, Dr Hilary Cass, to carry out a review into NHS gender identity services for under-18s.
What Dr Cass uncovered was shocking and scandalous, and she made a series of recommendations for how children can be better protected and supported. It was, in my mind, unquestionably wrong for children and young people to be routinely prescribed puberty blockers for gender dysphoria without any clear evidence on their benefits or risks. The situation then was out of control and so I fully supported the indefinite ban introduced by my predecessor, my right hon. Friend the Member for Ilford North (Wes Streeting), which followed the temporary ban brought in by the previous Government.
In considering what to do next, Dr Cass identified that treatment for gender incongruence was
“an area of remarkably weak evidence”.
She found that even clinicians working in the field were divided on the best way to support, treat and care for young people suffering from gender dysphoria. Where there is strong divergence of medical opinion on treatment, the two possible responses are either to continue with uncertainty—and with that, conflicting opinions and advice—or to undertake a trial. It is only by doing that that we can ensure that children with gender-related distress get the same access to and standards of care as everyone in the NHS.