Would a Puberty Blocker trial be ethical?

This article by Dr Sinead Helyar and Dr David Bell examines concerns that the proposed clinical trial into puberty blockers for children who present with gender dysphoria will harm children and contravenes national and international codes of clinical trial ethics and regulations. 

Introduction

Puberty blockers (PBs) have been used to treat precocious puberty in children. In recent years they have been prescribed, off label, to delay or interrupt normal onset puberty in children who present with gender dysphoria. The rationale for this new use has been that stopping puberty would provide the distressed child with time and space to consider if their dysphoria might best be resolved by transition. As their use in this new group of children has grown, so has concern about their suitability and safety. For some they are seen as a direct pathway to medical transition and thus the claimed ‘space to think’ is not being provided. For others, their effectiveness and impact remain unclear. In her Final Report [1] on the United Kingdom (UK) Gender Identity Development Service (GIDS), Dr Hillary Cass noted the lack of evidence to support this new use and called for the cessation of prescription outside of clinical trials (Cass 2024).

In this paper we argue that while Cass has highlighted many of the concerns felt by those who are troubled by the medicalisation of gender non-conforming young people, the use of PBs in a clinical trial presents an unacceptable level of risk for children and runs contrary to national and international clinical trial ethics, regulation and legislation. Other avenues of clinical research into treating children with gender-related distress, which do not include medicating a child with PBs, and which are safe to the child, must be prioritised in the first instance. 

Background – Ethics and regulations in UK clinical trials

Medical clinical trials within the UK are governed by national and international codes of ethical conduct, regulation and quality standards, founded by the Nuremberg Code (1947) [2].  The International Declaration of Helsinki [3],  the International Conference on Harmonisation Good Clinical Practice (GCP) [4] and legislation, for example, Medicines for Human Use (Clinical Trials Regulations) (2004) [5], instruct and regulate the inception, conduct and governance of clinical trials to safeguard participants, and ensure they are not harmed in the pursuit and development of medical knowledge and treatments. They must be adhered to by all practitioners involved in clinical research. 

Principles and law regulating the conduct of clinical trials are far reaching but all centre on the prioritisation of the rights, safety and wellbeing of individual participants as the most important consideration. They include:

-to ensure voluntary participant consent, without coercion or overreaching (e.g. consent for one intervention is specific to what is clearly stated), and the ability to voluntarily withdraw from a clinical trial without detriment (e.g. to subsequent clinical care)

-to place significant focus on the protection of clinical trial participants, particularly vulnerable groups

-to be for the benefit of society and be unprocurable by other methods 

-to ensure research with human participants conform to scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and, as appropriate, animal experimentation

– to ensure the rights, safety, and wellbeing of participants, and that these take precedence over the interests of science, including the perceived benefit of the trial for society

-to ensure that before a trial is initiated, foreseeable risks are weighed against the anticipated benefit for participants and society (e.g. different risk/benefit calculation for an invasive treatment for the common cold compared to terminal cancer)

-that a trial should be initiated and continued only if the anticipated benefits justify the risks, and should not to be conducted where there is a preceding belief that death or disabling injury will occur

– instigation of proper preparations to protect participants against even the remotest possibility of injury or disability

– the clinician must evaluate safety and effectiveness throughout the trial and be prepared to terminate the trial if there is probable cause to believe, in good judgement, that continuation is likely to result in, for example, injury or disability to participants. 

The Declaration of Helsinki requires clinicians to work within national and international ethical, legal and regulatory norms and standards for research with human participants and no national or international ethical, legal or regulatory requirement can reduce or eliminate any of the protections provided in the Declaration. Specifically, UK legislation stipulates all clinical trials conducted must conform to the Declaration of Helsinki and GCP.  

Most studies relating to paediatric treatments and medicines are based on previous adult data and can include juvenile animal data. Most relevant safety data for medications for children come from adult studies/exposure and consider safety issues specifically related to children and suitability of alternative treatments for children. Children are classified as a vulnerable group, and as such, are specifically protected within the ethical and regulatory frameworks[6]. In particular, UK legislation states that a trial must be designed to minimise any foreseeable risk in relation to a child’s stage of development[5]. 

Prospective research pathway into puberty blockers 

The Cass Report was commissioned by NHS England to conduct a holistic and in-depth review of gender identity services for children and young people. There has been a rapid increase in child presentation, particularly girls [7]. The extended cohort of children who now present is over represented with children who are ‘looked after’ [8] (e.g. in foster care or children’s homes),  children with experience of loss, disturbances of attachment, autism and other mental health co-morbidities, physical and/or sexual co-traumas and serious family problems [9]. Substance misuse during treatment and mental health concerns during treatment are independently associated with accessing care [10]. Many of these children are also likely to be confused about their sexual orientation and many will emerge as same sex attracted in adulthood [7].

The Cass Review [1] has highlighted unsafe care due to institutional absence of norms of clinical practice for this group of children, for example, pressure to affirm a gender–related diagnosis without standard psychotherapeutic exploration into the many other potential and likely causes of presenting distress in children. Further, the report describes divergence from norms of governance, multi-disciplinary working, follow-up and documentation, all leading to grave concerns about the clinical practice. As a consequence of the Interim Report, NHS England has closed down the UK’s only child dedicated GIDS, at the Tavistock and Portman NHS Trust. 

There is concern about the use of gonadotropin-releasing hormone analogues (GnRH), colloquially known as ‘puberty blockers’ for this group of children. PBs act on the pituitary gland which is located in the brain and controls several hormone secreting glands within the human body, including thyroid, adrenals, ovaries and testes. PBs inhibit hormone secretion and suppress endogenous production of oestrogen in girls and testosterone in boys. This medication is used on licence to suppress early onset of puberty in cases of precocious puberty to then enable puberty to commence at a normal developmental phase/age.  Conversely, for gender dysphoria, PBs are prescribed to prevent normal pubertal development and human maturation.  As a consequence of the Cass Report, the UK Government [11] has banned the new use of PBs for gender dysphoria in under 18 olds, outside clinical trials.  

Given this background, NHS England  [12] has established an oversight board to embed research into the new children and young people’s gender dysphoria services developed post Cass. Its stated aim is to generate evidence in areas whether there are material gaps impacting treatment decision-making into the formation of national clinical policy. A study into the potential benefits and harms of PBs is currently being developed through the National Research Collaboration Programme, (NHS England and the National Institute for Health and Care Research). The trial will be shaped by existing research and engagement by stakeholders, including children and young people referred to NHS gender services, their families, parents and carers. Clinicians will identify eligible children and with the consent of their parents, enrol them into a clinical trial and prescribe PBs to determine their safety and effectiveness as a therapy for gender dysphoria. Reported clinical outcomes referenced by NHS England include levels of anxiety, depression and body image.  Other countries also concerned about the use of PBs for children presenting with gender dysphoria, have also discussed use of PBs within a clinical trial setting [13]. 

Prospective research programs have been welcomed by many who, for the above reasons, have concerns about the use of PBs particularly in the context of being outside normal clinical practice and governance.

It is important to note, however, that concerns have been raised about governance of a previous clinical trial into PBs at GIDS [14], particularly as regards to adequate regulatory oversight by the UK’s Health Research Authority. GIDS’s first scientific justification on its research application [15] stated that it was ‘unsatisfactory’ that early treatment with PBs was ‘offered in only some centres’ and that there was a ‘strong wish from service users’  for easier availability of PBs. The implication here seems to be that the trial was weighted heavily towards providing legitimacy for incorporating PBs into normal clinical practice, rather than a route to neutrally examine safety and effectiveness of a potential new treatment. Patient involvement in the thinking about clinical trials is of course unexceptionable but this is, we think, distinct from the situation here and indicates a strong built in bias towards the substantiation of PBs as the focus of treatment for this patient group; at the expense of other non-pharmaceutical treatment pathways.  In addition, justification for the study included that PBs had a ‘positive impact’ on ‘sex reassignment surgery for children in adulthood’, indicating that future surgical transition for children was part of the rationale for the use of PBs.

The application stated that there was no evidence or low/very low quality research to support PBs, and it detailed known potential risks on child bone development, cognitive functioning, mood and fertility. Nevertheless, GIDS was approved by the ethics committee and regulators to medicate these children, without first establishing a usual pharmacological safety profile / alternative treatment options. In addition, the trial was not required by regulators to be classified as a ‘Clinical Trial of an Investigative Medicinal Product’ (CTIMP) [16]. This classification has strict regulatory oversight, monitoring, reporting, assessment of adverse events, including an independent data monitoring committee and stopping rules, (agreed point in which the trial is stopped for safety reasons when potential harms are identified),- all of which would better safeguard children and is standard in pharmacological clinical trials. 

Concerns about a proposed clinical trial with children involving puberty blockers

The key aim of the Cass Review [1] is to determine effective and safe treatments for gender dysphoria in children. Cass’s Report is clear that norms of clinical practice to ensure safe and effective care will be at the heart of future services for this patient group. This is a very important step. It also means, in keeping with clinical trial requirements, the research and the evidence base produced to guide services must adhere to norms of clinical trial ethics and regulations and must not repeat previous mistakes. Children enrolled within any research program have legal and moral rights to the protections that they provide. 

Whilst PBs may or may not be effective in treating gender dysphoria, Cass is clear that the evidence base for the impact of PBs on gender incongruence, mental health and quality of life for children and young people is of low, or very low quality.  Reports of high rates of suicide in children and young people who present with gender dysphoria [17], as a key rationale for medical transition and PBs are undermined by other data, including a recent Finnish study [18], which highlights low overall incidence of suicide in youth (aged up to 23 years) presenting with gender dysphoria. This study covered 1996-2019 and identified suicide rates comparable to the general population, once other mental health co-morbidities were factored in. The authors emphasised diagnosis and treatment of mental health co-morbidities as the method to prevent suicide in young people who present with gender dysphoria. In addition, a report by Professor Appleby, Chair of the UK’s National Suicide Prevention Strategy Advisory Group [19] cautioned against the suggestions that suicide could be a likely outcome for children presenting with gender dysphoria.   There is thus no evidence base to support presumption of benefit- a standard and necessary rationale for commencement of a drug clinical trial for children administered outside the drug’s current licence, the absence of which would normally halt any presumption of a clinical trial, and where there are significant risks of harm.  

The first duty of any clinician inside or outside of a clinical trial is to ‘do no harm’. In contrast, the proposed research proposal to medicate selected children with PBs as part of clinical trial, we believe, goes against the ethical demands and normal regulatory practice of such trials. We believe there is evidence that it will cause harms to the children the Review has been set up to protect. 

The notion that the evidence base of the effectiveness of PBs could be determined in a carefully monitored clinical research trial is not congruent with ethical, regulatory and legislative frameworks. Whilst such trials have a pivotal role ensuring robust and high-quality data to provide answers to important clinical questions, they must first and foremost ensure the safety and wellbeing of the individual child participating – that is at the point of prescribing the child with PBs, we must be reasonably confident that the child will be safe and will not incur known injury, disability or death. Given the known harms, harms for which there is some evidence and harms that there is a reasonable argument for, the proposed research program is unlikely to provide reassurance regarding this crucial matter.  

UK legislation safeguards child development within clinical trials. A study on PBs for gender dysphoria, in direct contrast, proposes to interfere with child development as the key method of investigation.    

Prescription of PBs in the context of a trial would, in effect, introduce known and potential harms to a physically healthy child, and interfere with normal pubertal development, necessary for human development. There are strong grounds to believe that PBs will affect the child’s neuro-development as well as impacting physical development. 

This is a divergence from normal clinical trial practice and of the usual risk/benefit analysis of impacts on children who may participate in an NHS supported research program. 

Current known and potential harms of PBs are multi-fold and include reduced bone density and early-onset osteoporosis [20], brain swelling [21] and concerns around impairment of future sexual functioning and ability to form emotional relationships [22]. A recent review [23] of the impact of suppressing puberty on neurological function highlighted that adolescence is a critical window of neurodevelopment and puberty plays a critical role in this process. The author concluded that suppression of puberty impacts brain structure and the development of social and cognitive functions, in which the effects are complex and often sex specific. 

PBs may also ‘lock-in’ gender incongruence [1] to medical transition, including cross-sex hormones and gender reassignment surgery.  They also leave children sterile if administered before Tanner stage 2, if followed by cross-sex hormones [24]. Almost all  children started on PBs progress to cross sex hormones [25] and potentially to surgical intervention (number of the latter unknown). 

Given that the large majority of children started on PBs  progress to opposite sex hormone this prescription can no longer be regarded as an interregnum to think (the original rationale ) but as de facto, commencing  a child on a medical pathway that will proceed to cross sex hormones and potentially to surgical intervention. Thus starting any child on PBs is freighted with that knowledge, and of course the ethical implications of that knowledge.

Each of these factors would normally be sufficient in itself to call a stop to any clinical trial from commencement, particularly in otherwise healthy children. Alternatively, if they had been unknown pre-trial and then came to light during the trial, they would as part of a normal safety monitoring process be classified as serious adverse events, (i.e. as causing disability /incapacity), sufficient to shut down any trial. To commence such a trial with these known and potential harms and outcomes goes against clinical trial regulatory and ethical practice, which seeks to protect from harm.

All clinical trials require indemnity, but given these known and likely clinical outcomes, researchers and clinicians would need to be aware of the real possibility of future litigation by participants. 

In addition to the need that trials must be safe, the evidence sought must be unprocurable by other methods. This is particularly important with PBs in gender dysphoria given the lack of evidence, the known and potential harms and because usual processes of examining safety and effectiveness in adults before trials are carried out involving children cannot be implemented as adults have already completed puberty. 

Research should therefore initially focus on other methods of treatment before resorting to pharmaceutical interventions, to both protect children and generate an evidence base, particularly relating to potential harms. This includes juvenile medical animal experimentation on safety and impacts of PBs, (for example, data on sheep demonstrates long-term impact on spatial awareness post cessation of PBs), [26] intensive and long term research into standard psychotherapeutic interventions as treatments, long term follow up of children who have already undergone PB medication, qualitative studies of the experiences of detransitioners and full integration of current data, including safety profile of PBs when used as GnRH analogues for other clinical populations, (e.g. prostate cancer and precocious puberty). These avenues should be properly explored before any involvement of children to determine effectiveness and safety.   

In keeping with normal classifications of clinical trials, any trial into the safety and efficacy of GnRH in a new patient population and new clinical indication should be classified as a CTIMP [16].

In addition to the tighter regulations regarding safety and adverse event monitoring, reporting and assessment, children under the age of 16 years are not allowed to provide informed consent in a CTIMP [6]. Consent must always be provided by a parent or legal guardian. The NHS England announcement of a developing a clinical trial of PBs that will require parental consent [12] implies this study will be a CTIMP.  Parental consent in this context is a highly complex matter as such parents/ legal guardians will be required to consent to the known and potential harms and potential sterility of their own children. 

Informed consent is also at risk of being influenced by external political and cultural influences such as  Children’s Charities [27] and Human Right’s organisations [28]  who have publicly called for the active use of PBs for children who experience gender dysphoria. Organisations often cite high risks of suicide in those who do not rapidly transition[17], which, as we have said above  have no  foundation. Others have, unsuccessfully gone to the High Court to get the PB ban overruled [29].  In this context, it is difficult to see how assurances of valid informed consent and rights to withdraw, without coercion, can be achieved. In addition, within this context, differences in approaches to gender dysphoria between parents who consent versus those who do not consent to the study could itself be an unanticipated confounding variable- that is those who consent may represent a specific subgroup which may undermine the validity of the study. This is particularly relevant, if measurements of child distress, anxiety, depression and body image etc are reported outcomes. The politicised environment within which discussion of PBs for gender dysphoria sits indicates the need for even more caution. 

It should be noted that the NHS is already concerned about children accessing PBs through online and international sources. If trial participants did so, this would introduce participant bias and brings into question whether trial protocols will be adhered to and would jeopardise safety monitoring to accurately determine the efficacy and safety profile of PBs. To ensure that a clinical trial is valid, (e.g. it tests what it is supposed to test) and is reliable (e.g. can be reproduced using the same measurements etc), it is usual practice to use a control group and compare this to an experimental group (in a PB trial, a control group would be the group that would not receive PBs and the experimental group would be the group that would receive PBs). The highly complex background and heterogeneity of potential participants limits the scope for a control that is comparable to an experimental group. 

Implementing a control group in a PB trial is also problematic as participants allocated to a control group would know which group they are in and so there is a high likelihood of a nocebo effect (where a person experiences negative side effects/symptoms because they believe they will occur in the arm they are in) or may withdraw from the trial. Those in the experimental arm and prescribed PBs will be aware of this. This would create further complications as regard to a placebo effect in those in the experimental arm. Without a control group, a trial cannot be certain whether what is being treated produces the outcomes that are measured, distorting the premise of a trial. Heterogeneity of patients also limits the generalisability of the results of a trial to the clinical population. These factors undermine the feasibility of this clinical trial. It may well be concluded that because of these difficulties a control group is not feasible . The absence of a control group would further undermine the validity of the trial. 

Conclusion

Ethical and ordinary safety concerns and clinical trial regulations make clear the need for a complete moratorium on PBs, whether as part of treatment programme or in the context of a clinical research trial. 

Proposed research should instead focus on the effectiveness of standard psychotherapeutic treatment pathways for children in psychological distress; follow up previous patients; investigate the growing group of detransitioners; undertake further juvenile animal studies; and perform a systematic review into the safety and impact of PBs in other clinical populations. All of this needs to be undertaken before any consideration of administering PBs to children in a clinical trial. 

Dr Sinead Helyar is a clinical trial nurse

Dr David Bell is a retired Consultant Psychiatrist (Tavistock and Portman NHS Foundation Trust) and former member of the Trust’s Council of Governors

References

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