PATHWAYS Puberty Blocker Trial

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PATHWAYS Puberty Blocker Trial

Summary: Gender distress in children and young people – many of whom are autistic or grappling with same-sex attraction – is overwhelmingly likely to be temporary and resolve naturally in the majority of cases. Despite this fact, the proposed PATHWAYS trial - which involves giving children as young as 11 drugs with potentially permanent, harmful life-long effects – is being pursued and prioritised over other less intrusive options available which would actually build the evidence base about the use of puberty blockers for gender incongruence.

The trial goes against public opinion: the most recent polling shows that the majority of Britons are opposed to allowing children under the age of 16 transgender treatments, with 75% saying puberty blockers should not be allowed for this cohort.

The legal challenge brought jointly by detransitioner Keira Bell, therapist James Esses and Bayswater Parents was unsuccessful and so PATHWAYS has been allowed to start recruiting child participants. However, the pressure to halt it will continue, as the risks mount of future legal challenges from participants and a potential medical scandal to rival the infected blood outrage.

The proposed PATHWAYS trial of puberty blockers (GnRHa) for gender incongruence in children will not help policymakers or improve care. Put simply, PATHWAYS is a human experiment, not a clinical trial.

It does not follow established medical research ethics. No other subjective or psychological experience is treated using drugs with the explicit purpose of disrupting normal human development in growing children.
It lacks the basic prerequisites expected for ethical research: i.e. a clear understanding of the condition being treated, a clear rationale for the relevant intervention, and a research question against which to judge success.
It involves giving children a drug with potentially permanent, harmful long-term effects:
- Irreversible interruption to healthy development during a critical phase (risk: certain).
- Future infertility & sexual dysfunction when puberty blockers are followed by cross-sex hormones, which is what happens in practice (risk: near certain).
- Damage to developing bones; harms to cardiovascular and metabolic health; impaired cognitive development (risk: likely).
- ‘Locking in’ of gender identity in adolescence (a ‘critically important’ unanswered question as per Cass), psychosocial & physical limbo as the child’s peers continue developing (risk: likely).
- Menopause symptoms in females if administered later in puberty (risk: likely).

This clinical intervention is being explored in preference to less invasive (and considerably less costly) options, i.e. the data linkage study, that could achieve similar self-reported improvements in well-being.
It relies on clinicians to select which children might benefit from puberty suppression even though it is not possible to predict how a child’s feelings about their gender identity will evolve over time. The trial will not show whether puberty suppression is better than no drug. Certain aspects of the trial design suggest that this is actually an uncontrolled experiment presented as a trial.
The trial authors themselves recognise the placebo effect of being given the drugs: “Knowledge of the intervention is part of the effect”. Giving a drug with established adverse effects to induce a placebo response is unethical.
The broad range of secondary outcome measures risks post-hoc cherry picking to highlight particular findings. There is concern that the trial is a Trojan Horse designed to remove the ban on proscribing of puberty blockers.
PATHWAYS sends mixed messages: Why if puberty blockers are banned from clinical practice due to safety concerns is it safe to give them to children in a trial?
The argument that the trial is necessary because children are accessing the drugs by other means (i.e.privately, from abroad or online) makes no sense. Those willing to self-medicate would not be attracted to the 9 month assessment and chance of randomisation to wait another 12 months. PATHWAYS is not designed to address the risks of self-medication or to deliver harm reduction and it includes no measures to evaluate whether this has been achieved. The drop in referrals to gender clinics often cited as evidence for this argument is more likely to be an indication that the social contagion of transgender identity has peaked.
Aesthetic results in adulthood must be weighed against risks of early intervention and setting children on a lifelong medical pathway. While some adult cosmetic procedures might be avoided (e.g. facial feminisation surgeries for males), others become riskier and more invasive (e.g. vaginoplasty in males). Even if improved cosmetic adult outcomes were assured (they are not), the fact that we cannot predict which children will persist means we cannot proceed safely.

Alternatives: what should we be doing to help gender distressed children?

PRIORITY: a follow-up of GIDS patients via the Data Linkage Study is the essential foundation for future research with a focus on clear outcomes, pre-specified protocols and transparency. The DLS will include critical safety data on deaths, hospitalisations, and chronic illness. A new SI enables the adult clinics to provide this data. If as previously, the clinics fail to cooperate in supplying this data, this will be a huge red flag and prevent the clinical trial recruiting a new cohort of children.
Robust evaluation of psychosocial support - this is the acknowledged primary pathway in NHS services, yet no research is being conducted to evaluate or compare therapeutic interventions.
A prospective cohort study to follow-up GIDS patients and screening for long-term adverse effects e.g. bone, metabolic, cardiovascular, and neurocognitive effects over time.
Observational research designed in line with best practice early-stage research principles; to better understand the aetiology and natural course, to identify any subgroups, and to generate future research questions.
Animal studies e.g. follow-up on early signals of cognitive impairment/physical harm.
Public health campaigns to counter misinformation about medicalised pathways, while reinforcing that trans-identified youth deserve safe, effective, and evidence-based care.
Criminal sanctions for any person or organisation supplying young people with puberty blockers or cross sex hormones via online, private or overseas routes.

Evidence shows the general public are opposed to the trial with polling finding that ‘nearly three-quarters of adults (74%) agree that services for under-16s with gender dysphoria should focus on psychological and mental health support rather than medical interventions’. Public opposition to the original trial was widespread and the new trial design with the lowered minimum age for participation of 11 for girls and 12 for boys will be strongly opposed. It contradicts all government messaging about protecting children - questions are rightly being asked as to why a child this young can consent to risks of lifelong medical harm including loss of sexual function and fertility, but not be allowed a social media account.

A petition calling for the trial to be stopped was signed by over 150,000 people, and hundreds of members of the public attended a Parliamentary Lobby Day against the trial

On July 27th psychotherapist James Esses, detransitioner Keira Bell and parents from the Bayswater Support Group brought judicial review proceedings seeking an emergency injunction to prevent the commencement of the trial. Despite the high court hearing strong evidence that the study is unlawful and fails to adequately protect participating children, the JR was rejected. This was a deeply disappointing decision and means that recruitment for the trial has now begun. However, the campaign to raise awareness of the harms and risks of the trial continues and Labour Women’s Declaration are working hard to flag these concerns.

The Case of ‘Jo’

On 25 th June Dr Hilary Cass spoke in the House concerning the case of ‘Jo’,

“I ask noble Lords to consider the case of a child I will call Jo, who was a biological male socially transitioned at two and a half by his parents. At 11, she—I say this advisedly, because the chances of her reverting to her biological gender are vanishingly remote—has been in stealth and will not go to secondary school because she is so afraid of being outed in that environment. She is now refusing to come out of her room except very rarely and has weak bones, not as a result of puberty blockers but through inactivity. Should her subsequent treatment be decided by politicians or by the clinicians looking after her?”

Baroness Cass has since clarified that ‘Jo’ is an amalgam of several cases, which is, in many ways, more troubling. ‘Jo’s’ story is an utterly shocking account of failures in safeguarding and child protection, and the fact that it is not an isolated case makes it even more alarming. Such failure cannot be used to justify the puberty blocker trial or any other irreversible medical intervention that will cause further harm and distress to Jo and other vulnerable children like him.

Looked after children who are recruited to the trial are also at heightened risk of harm due to the ideological capture of the social work establishment.

Since the publication of the Cass Review in 2024 new evidence continues to be published on the harms and non benefits of puberty blockers. In the US lawyers have predicted a “flood of lawsuits” from adults who were put on medical interventions when they were children.

The PATHWAYS clinical trial is not inevitable - it is the more risky, less favourable option that the public don’t want. Moving resources over to a swift completion of the Data Linkage Study so that this is completed ahead of time and definitely before any clinical recruitment begins should be the action pursued by this Labour government. Dr Cass’s Review made a huge contribution to the exposure of policy capture at GIDS. However, in backing a drugs trial in advance of the Data Linkage Study’s outcomes, she is herself contradicting her own review, as Dr Zoe Hollowood explains here.

The government should also establish an independent inquiry to examine the factors contributing the unprecedented surge in the number of children and young people seeking treatment for gender-related distress, and to fully investigate what led to the scandals at the WellBN Clinic in Brighton and other similar private providers.

“If the puberty blockers trial can tell us nothing meaningful, its commissioning seems like a political decision – a seemingly neutral avoidance tactic to delay the inevitable conclusion that the benefits of adolescent gender medicine do not and cannot outweigh its considerable harms. We know this already. The precious political benefits come at a heavy price, to be paid not by politicians, researchers or clinicians, but by a new cohort of distressed adolescents.” Mathilda Gosling, social scientist and author Evidence Based Parenting.