We’re collecting signatures from clinicians for this open letter. Please add your name here: Sign the letter to Wes Streeting
Mr Wes Streeting
Secretary of State for Health and Social Care
Copied to Dr Hilary Cass
Dear Mr Streeting,
We are writing as a group of clinicians, academics and researchers, many of whom treat children and adults with gender-related distress, to express our grave disquiet about the PATHWAYS Trial[1], both from an ethical and a scientific point of view.
Gender-related distress in children and young people is a profound problem, and children and families need and deserve holistic support and care. Many children presenting to services have complex needs and are a particularly vulnerable group for a variety of reasons. We agree with you that the safety and wellbeing of children should be paramount, and for this reason we urge you to consider calling for the PATHWAYS Trial to be paused at least until the Data Linkage Study is completed and reported.
We appreciate that the trial has all the necessary approvals, and that you are following the advice of clinical experts. However, there is a lack of clinical and scientific consensus in this field, and professionals expressing concern about paediatric gender medicine have been marginalized, including during the development of the PATHWAYS research programme[2]. We ask that you take the time to listen to alternative views.
We think that PATHWAYS Trial is unsafe, doesn’t meet the requirements of UK clinical trial regulations[3], and should not proceed for the following reasons:
- The expected benefits do not outweigh the expected risks, jeopardising the safety and wellbeing of participants.
- Foreseeable risks to child development are not minimized.
- The trial is not scientifically sound.
- Important information from people who have already received gonadotrophin-releasing hormone analogues (GnRHa) (the Data Linkage Study) should be evaluated first.
We elaborate on these points in the annex below.
Baroness Cass called for a wide programme of research covering several aspects of gender-related distress in children and young people in her final report[4]. Other research priorities include further investigation into the causes of gender-related distress, links with co-occurring factors such as same-sex sexual orientation and autism-spectrum disorder, what kinds of psychosocial support are beneficial, what is the impact of social transition in childhood, and what are the risks and benefits of cross-sex hormone treatment in young adults. We note that research in this field is hampered by conceptual disagreements and political ‘toxicity’. The UK has the opportunity to lead the world in advancing a research programme that will start to address these disputes and forge consensus. We believe PATHWAYS in its current form will fail to grasp this opportunity.
We thank you for all the work you have done to tackle this important area of child health. We hope you will give this letter due consideration. We would be more than happy to answer any questions you might have, or to meet with you or your advisors.
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Annex
UK legislation governing the conduct of clinical trials (Medicines for Human Use – Clinical Trials Regulations 2004) specifies the following:
- A trial should prioritise the safety and wellbeing of participants and be initiated and continued only if the anticipated benefits justify the risks.
- A trial should not be conducted where there is a preceding belief that death or disabling injury will occur.
- A trial on children must be designed to minimise any foreseeable risk in relation to a child’s stage of development.
- The information sought must be unprocurable by other methods.
- Trials with human participants must conform to scientific principles.
Expected benefits do not outweigh the expected risks
PATHWAYS Trial is designed to address a narrow question regarding the timing of GnRHa treatment (immediate vs after 1 year) on quality of life as measured by the 10-point KIDSCREEN10 questionnaire at 2 years. This potential benefit in self-evaluated quality of life should be weighed against the substantial risks associated with GnRHa when administered during puberty: infertility (particularly when followed by cross-sex hormones), impaired development of the reproductive organs and sexual function, impaired bone development, metabolic abnormalities, and possible impairment of brain development[5]. We do not find it credible that even a substantial improvement in subjective quality of life at two years balances these risks, risks that would normally only be tolerable for potentially life-saving treatments such as chemotherapy for cancer. Furthermore, there is no evidence that links a gain in quality of life in mid-adolescence with better health and wellbeing in adulthood in this group of children, so even if this benefit is observed it gives no assurance of better long-term outcomes.
Foreseeable risks to child development are not minimized
As you are aware, GnRHa administered throughout adolescence will prevent puberty from taking place, preventing all sex steroid dependent physical and neurocognitive development from proceeding. There is no diagnostic framework for gender incongruence that has good predictive value for who will persist through adolescence into adulthood, and who will experience resolution of gender-related distress. The ICD 11 diagnostic criteria[6], used in PATHWAYS, are based around a set of highly subjective preferences linked to sex-role stereotypes. It is not therefore possible to reliably select only the children who might stand to benefit from GnRHa for the trial and exclude those who will not benefit. This means that inevitably children will be harmed in this trial who could not possibly derive any benefit from the treatment.
Furthermore, there is good reason to consider that puberty suppression is an important factor in preventing resolution of gender-related distress in some children: the high proportion of children progressing to cross-sex hormones after GnRHa in several cohorts suggests this[7]. The PATHWAYS Trial does not acknowledge this critical difficulty with selecting participants, nor will it investigate a possible causal link between GnRHa and persistence of gender-related distress. These considerations, we believe, add further weight to ethical concerns regarding this trial[8].
The trial is not scientifically sound
We understand the calls for evidence to help guide children, families, clinicians and policy makers in this very difficult field, but PATHWAYS Trial is not capable of delivering evidence that will help to resolve any of the disputes around the efficacy and safety of GnRHa. We are happy to provide a more detailed critique of the protocol, but in short:
- There is no clear research question grounded in a hypothesis about how puberty suppression might help children with gender-related distress.
- The comparison of immediate start of GnRHa versus delayed start at 12 months with follow up only to 24 months means that no reliable data on the benefit of GnRHa will be generated, and data about safety will be limited.
- There is no randomised control group to allow a reliable comparison. The planned comparison with a subgroup from PATHWAYS Horizon Intensive will not provide a reliable control, as this group will be too different from the group in Trial.
- Children from Tanner stage 2 to Tanner stage 5 will be included, but there is no acknowledgement that the use of GnRHa at these extremes of pubertal development constitutes a radically different intervention, with different potential benefits and a very different risk profile. This will hamper interpretation of the results.
Other important data should be analysed first
The Data Linkage Study was halted due to the non-cooperation of the adult gender clinics in the last phase of the Cass Review, and was subsequently passed over to NHSE for completion. This dataset will be the largest of its kind in the world, and while it cannot give us definitive information about whether or not GnRHa is beneficial, it can give us critical information about safety. While we understand the urgency to proceed with a research programme to meet the needs of this group of children, we think it is indefensible to proceed with a trial that exposes more children to the risks of GnRHa without first looking at what has happened to people who have already received this drug. The DLS will hopefully tell us about persistence and desistance rates, physical and mental health in the medium term, mortality, and could start to give us some indicators of important long-term outcomes like sexual function and fertility. If the DLS gives a strong safety signal, for example demonstrating excess mortality in people who have been given GnRHa, and PATHWAYS Trial has gone ahead, public trust in our medical research institutions could be undermined.
Although GnRHa is a well-studied class of drugs, in the treatment of certain pathological conditions, the effects of administration to physiologically healthy children, throughout adolescence, halting puberty into adulthood, are far from being well understood. We believe further pre-clinical (animal) testing could be helpful in characterising the safety profile, and is far preferable from an ethical perspective.
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Footnotes
[2] For links to relevant parts of legislation and the roles of the various regulators and oversight bodies see March 2025 Letter from Clinical Advisory Network on Sex and Gender to trial investigators, oversight board and regulators outlining ethical concerns.
[3] UK Policy Framework for Health and Social Care Research; Medicines for Human Use (Clinical Trials) Regulations 2004
[4] Recommendation 6, p 35, The Cass Review Final Report
[5] For up-to-date references in the published literature on GnRHa see US Dept of Health and Human Services (HHS) report Treatment for Pediatric Gender Dysphoria Review of Evidence and Best Practices, sections 5.3, 7.1, 7.2 and 7.3.
[6] ICD 11 Gender Incongruence
[7] Carmichael, P., Butler, G., Masic, U., Cole, T. J., De Stavola, B. L., Davidson, S., Skageberg, E. M., Khadr, S., & Viner, R. M. (2021). Short-term outcomes of pubertal suppression in a selected cohort of 12 to 15 year old young people with persistent gender dysphoria in the UK. PLOS ONE 16 (2).
Wiepjes, C.M., Nota, N.M., de Blok, C.J.M., Klaver, M., de Vries, A.L.C., Wensing-Kruger, S.A., de Jongh, R.T., Bouman, M.B., Steensma, T.D., Cohen-Kettenis, P., Gooren, L.J.G., Kreukels, B.P.C. & den Heijer, M. (2018). The Amsterdam Cohort of Gender Dysphoria Study (1972-2015): Trends in Prevalence, Treatment, and Regrets. Journal of Sexual Medicine 15 (4). de Vries, A.L.C., Steensma, T.D., Doreleijers, T.A. & Cohen-Kettenis, P.T. (2011). Puberty suppression in adolescents with gender identity disorder: a prospective follow-up study. J Sex Med 8 (8): 2276-83.
[8] For detailed discussion of ethics see Article by Dr David Bell and Dr Sinead Helyar Would a Puberty Blocker Trial be Ethical? See also HHS report section 13.4.1 on research ethics.
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Yours sincerely,
Dr Louise Irvine, MB ChB MRCGP DRCOG MSc retired GP
Dr Stella Kingett, MBBS MRCPsych DPMSA Consultant Psychiatrist
Professor David Curtis, MD PhD FRCPsych Honorary Professor and retired Consultant Psychiatrist
Dr David Bell, Retired Consultant Psychiatrist and Psychoanalyst
Dr Aileen O’Brien Consultant Psychiatrist and Reader in Psychiatry
Dr Juliet Singer MRCPsych Consultant Child and Adolescent Psychiatrist
Dr Lucy Grain MBChB FRCPCH Consultant Paediatrician
Dr Sinead Helyar PhD MSc PG Dip BSc Registered Nurse
Dr Az Hakeem, MBBS MSc FRCPsych Consultant Psychiatrist and Group Analyst, Honorary Clinical Professor, UCL Medical School
Dr Shahana Hussain MRCPsych Consultant Child & Adolescent Psychiatrist.
Dr Sarah Thurlbeck MBBS MRCP FRCPC Consultant Paediatrician (retired) and former Named Doctor for Child Safeguarding
Ms Sheila Stallard MD, FRCS retired Consultant Surgeon
Dr Pamela Yerassimou MB BS MRCPsych Consultant Psychiatrist
Dr Tessa Katz MRCGP General Practitioner
Robert Withers, Jungian analyst (training analyst Society of Analytical
Psychology member British Psychoanalytic Council) and former senior lecturer in the history and philosophy of medicine (University of Westminster)
Dr Jane Martin, MD MRCPsych retired Consultant Psychiatrist
Dr Ellen Wright MBBS MSc FRCGP GP Clinical Academic Fellow, King’s College London
Stella O’Malley, MA, Psychotherapist
Dr Seth Bhunnoo MBBS BSc MA MRCPsych PhD Consultant Psychiatrist
Professor David Pilgrim MSc MPsychol (Clin) PhD Clinical Psychologist
Dr Maria Atkins Retired Consultant Psychiatrist Former Lead for Wales and Vice President Royal College Psychiatrists
Dr Lenny Cornwall MD FRCPsych FFMLM Consultant Psychiatrist
Emma Gillard – Registered Nurse
Dr Gwenllian Boddington, Psychiatry Core Trainee
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Dr Rae Elizabeth Webster MBChB LLB(Hons) FRCA FFICM MBA Consultant in Intensive Care & Anaesthesia (rtd)
Dr Celia Sadie MA, MSc, MPhil, DClinPsy Consultant Clinical Psychologist
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Dr Josanne Holloway MB CHB FRCPsych Consultant Forensic Psychiatrist
Dr Kiran Sharma, MBBS, General Practitioner
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Dr Alice Hodkinson, MRCGP General Practitioner MA Medical Ethics and Law
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Professor Michael Biggs, Professor of Sociology
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