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Beryl Koener (1), Luc Vandecasteele (2), Caroline Eliacheff (3), Jacques Robert (4), Magali Pignard (5), Claudio Rubiliani (6), Patrick K. Hunter (7), Sophie F. Dechêne (8), Jean-Paul Leclercq (9), Jean-Pierre Lebrun (10), Céline Masson (11) Publié dans la revue de : Décembre 2024 Rubrique(s) : Psychiatrie infanto-juvénile
Summary of the article:
The last two decades have seen an exponential increase in the number of young people diagnosed with ‘gender dysphoria’. Specialised clinics in Ghent, Liège and then Antwerp are treating them, applying an approach described as ‘affirmative’ of the desired gender, the Dutch Protocol, based on the administration of GnRH agonists (‘puberty blockers’) followed by ‘cross-reactive’ hormones.
Many clinicians are unaware of this protocol's lack of evidence-based foundations, the many biases fostered by the WPATH (World Professional Association for Transgender Health) which promotes it, and the scandal that has erupted in various countries following its misuse. These have been brought to light by the NHS (National Health Service) in the UK through the Cass Review, and by the Report on the transidentification of minors by the Senate Republican group in France. They are all in agreement, including recently the European Society of Child and Adolescent Psychiatry (ESCAP), that the use of the Dutch Protocol should be discontinued in the case of gender-dysphoric minors.
The aim of this article is to outline the origins of the basis of this protocol, to provide evidence of the drifts and biases that have occurred worldwide, and finally to present the current recommendations.
What do we know about this?
Recently published systematic reviews of the literature analysing practices over the last few decades in relation to gender dysphoric minors have revealed the lack of evidence on which the guidelines established by the World Professional Association for Transgender Health (WPATH) are based. Yet gender clinics continue to defend these guidelines, and Belgium is seeing an increase in the number of centres dedicated to the management of gender dysphoria.
The systematic reviews recently published as part of the Cass Review in the UK, which was commissioned by the NHS, revealed a lack of benefits for gender dysphoria and mental health following the treatment of minors with GnRH agonists and ‘cross-reactive’ hormones. The European Society of Child and Adolescent Psychiatry has recently issued new recommendations for treatment practices, taking into account the conclusions of the systematic reviews.
What does this article tell us?
The aim of this article is to inform the Belgian medical world about the lack of evidence-based foundations for the current Dutch protocol for the treatment of minors suffering from gender dysphoria, promoted by the WPATH. Through an analysis of the societal reasons responsible for the increase in the number of minors diagnosed with gender dysphoria, the article describes the abuses that have occurred worldwide, and concludes with the new treatment recommendations that have just been published.
This is based on an analysis of all the systematic reviews used to draw up the Cass Review, which led the NHS to suspend the routine use of this protocol.
The article draws a parallel between the conclusions of the Cass Review and those of the French Senate Report on the transidentification of minors, which are echoed by the European Society of Child and Adolescent Psychiatry (ESCAP).
Key words
Gender dysphoria, Cass Review, Dutch Protocol, European Society of Child and Adolescent Psychiatry (ESCAP)
Full article:
Introduction
Over the last two decades, it has been clearly established in the literature that the number of minors presenting with distress related to their sex/gender and referred for specialist care in a ‘gender identity clinic’ has grown exponentially (1-7).
The international literature now agrees that the clinical pictures of children and adolescents seeking gender reassignment have nothing in common with those observed in the 1990s when Dutch pioneers developed an experimental protocol for the medical management of these minors (8): for the past 10 to 15 years, there has been an over-representation of psychiatric co-morbidities in these young people, particularly anxiety-depressive disorders, autism spectrum disorders, eating disorders, borderline personality disorders, suicidal ideation and a history of physical, psychological and sexual abuse (2, 8-13).
Indeed, many young people in distress over the physical and psychological issues inherent in puberty are looking for a solution to their suffering (14), for which the project of changing gender identity and/or sex often offers an illusory hope. In the general population, as well as in the medical and psychological worlds, there is currently a great deal of misinterpretation of young people's anxieties about puberty (12,15-17), under the influence of social networks, activism, political correctness and the market.
The Dutch Protocol, based on the blocking of puberty by gonadotropin-releasing hormone agonists (GnRHa), followed later by the administration of cross-reactive hormones, has spread internationally for the management of these minors who attribute their distress to their sex and/or gender, in accordance with the recommendations of the WPATH (World Professional Association for Transgender Health) and the Endocrine Society (ES) (8,18,19). However, the results of systematic reviews of the evidence1 - systematic reviews recently communicated by the Cass Review (20,21) and by a senatorial report in France (22) - confirm on the one hand the absence of rigorous foundations to justify the use of such a protocol for the management of minors, and on the other hand that the guidelines promoted by the WPATH and the ES themselves lack rigour and integrity (5, 7, 13, 23-28). Having developed these various points, we will conclude with the recommendations for the management of these young patients formulated by the NHS following the Cass Review and the French Senate report, and recently reiterated by the European Society of Child and Adolescent Psychiatry (ESCAP) (29).
A Systematic Evidence Review is ‘an examination of a clearly formulated question that uses systematic and reproducible methods to identify, select, synthesise and critically appraise all relevant research that meets predefined eligibility criteria to answer a given research question, and to collect and analyse the data from the studies that are included in the review. It should not be confused with a general review in which the bibliographic search is generally not exhaustive and which represents more the opinion of an expert or a group of experts’. [Nambiema et al, La revue systématique et autres types de revue de la littérature : qu'est-ce qu'c'est, quand, comment, pourquoi ? Archives des Maladies Professionnelles et de l'Environnement 82 (2021) 539-552. DOI : 10.1016/j.admp.2021.03.004]. For information on the methodology relating to systematic reviews of evidence, we refer to [Zaugg et al. Improving practices and the organisation of care: methodology of systematic reviews. Public Health 2014/5; 26: 655-67, DOI 10.3917/spub.145.0655].
Origins and lack of evidence of the Dutch Protocol
The medical treatment protocol for children and adolescents suffering from gender dysphoria - called the Dutch Protocol because of its origin - emerged from collaboration between the Utrecht psychology professor Peggy T. Cohen-Kettenis, in partnership with the paediatric endocrinologist Henriette A. Delamarre-van de Waal and the adult transsexual care centre at the Vrije Universiteit Amsterdam Center (8). The validity of the intervention and its subsequent international adoption are based on only two studies (30,31).
Few practitioners and patients are aware of this: the first study (30) refers to a cohort of 70 cases treated with puberty blockers and the second refers to a sub-group of these same cases after reassignment surgery (31). The Dutch team also failed to publish the fact that, in this cohort of 70 patients, one patient died as a result of surgical complications following vaginoplasty. This was because the blockage of puberty did not allow sufficient development of the external genitalia to perform a vaginoplasty, which had to be completed by a colonic tissue graft that became necrotic (8).
The protocol has been adopted by many countries, despite the very low sample size of the two studies that developed this medical management device. Subsequently, it was prescribed outside the eligibility criteria that had initially been defined, even by the pioneers of this protocol (8,18,19).
To date, the validity of this protocol has been invalidated because it is not reproducible (8, 18, 19). Indeed, when the Gender Identity Development Service (GIDS) of the Tavistock Clinic in London published the results relating to the cohort of its patients treated with puberty blockers, a comparison with the results of the Dutch showed a complete lack of reproducibility of the results between the two studies (8, 18, 19). In 2020, NICE (National Institute for Health and Care Excellence) carried out two systematic reviews for the NHS: one on puberty blockers (32) and the other on cross-referenced sex hormones (33). The overall quality of the evidence analysed using the GRADE system was classified as ‘very low certainty’, underlining the absence of any significant clinical benefit for gender dysphoria and mental health in general from the implementation of this treatment protocol.
German researchers carried out a systematic review of studies published between July 2020 and July 2023 (34), using the same procedure as NICE, and also concluded that there is currently no evidence of sufficient cost-effectiveness to support the use of puberty and cross-hormone blockers in minors with gender dysphoria compared with one or more psychosocial interventions, simple social transition to the preferred gender or no intervention (34).
The final report commissioned by the NHS and published in early April 2024, known as the Cass Review (20), which was drawn up after four years of systematic reviews of the evidence, ‘provides a scathing assessment of the gender affirming approach in general, and the gender clinic model of care, which has operationalised this approach to the management of sex reassignment procedures’ (21) in minors. The NHS has suspended the routine use of this protocol in the UK, following in the footsteps of other European countries such as Finland and Sweden.
Then it was the turn of the European Society of Child and Adolescent Psychiatry (ESCAP) (29,35) - which brings together 36 psychiatric societies, including the two Belgian societies, Flemish (VVK) and French-speaking (SBFPDAEA) 2 - to rule on the issue on 27 April 2024 (29). ESCAP stresses the importance of not promoting these experimental and invasive treatments with no proven psychosocial effects and of adhering to the ‘primum non nocere’ principle in view of ‘the low reliability and instability of the diagnosis of gender dysphoria in children over time’ (35). ESCAP does not rule out the possibility that a small number of children may benefit from gender reassignment, while acknowledging the current lack of high-quality long-term research to determine the risk/benefit ratio (29,35).
The systematic reviews of the Cass Review (5,7,13,20,23-28), the German study(34), the French senatorial report(22) and now ESCAP(29) all point to the fact that most of the studies carried out by specialised centres demonstrating the favourable effects of these treatments suffer from serious methodological shortcomings (poor sampling, absence of a control group, insufficient consideration of variables, presence of numerous biases, lack of validity of evaluation criteria, etc.).
Despite these recommendations, Belgium is seeing an increase in the number of specialist centres providing ‘gender affirming care’, while announcing the allocation of additional budgets to dedicated clinics3. At the same time, the use of GnRHa, previously restricted to university hospitals, can now be reimbursed by prescription. The figures for the increase in the prescription of GnRHa among minors are rising, and at a faster rate over the last five years, as confirmed by the inter-mutualistic agency (Appendix 1). How can we understand these paradoxes?
2 We refer you to the websites of these associations: https://www.escap.eu/members/belgium-flemish, and https://www.escap.eu/members/belgium-french.3 We refer you to the article in the Libre Belgique of 11 December 2023: https://www.lalibre.be/belgique/societe/2023/12/11/la-belgique-veut-depl...
The infiltration of activism and ‘political correctness’: treatment based on so-called ‘social justice’ rather than on evidence
Activism for the recognition of the rights of adult transsexuals has become confused with the right of access to treatment for minors. This led to the 7th revision of the WPATH's criteria for care, which no longer supported the introduction of a medical third party as a ‘gatekeeper’ deciding whether or not to administer such a treatment protocol. In effect, the assessment and guarantor function incumbent on mental health professionals has been downgraded (14). Gender specialists have adopted the affirmative response model, recognising the young person's ‘self-determination’ as valid.
Activist movements, in bringing out this notion of ‘self-determination’, have decided that only the patient knows what is good for him or her, even from the earliest age: not to administer the treatment that would enable him or her to fulfil his or her wishes would be discrimination, or even worse, transphobia. In London, long before the opening of the GIDS (Gender Identity Development Service) at the Tavistock Clinic, it was under pressure from groups of parents who had become activists, notably ‘Mermaids’ and ‘GIRES’ (Gender Identity Research and Education Society), that the concept of ‘transphobia’ emerged to describe the cautious clinicians who rejected the affirmative gender approach (8). As in the past, these clinicians favoured the ‘watch and wait approach’ (36), in other words an approach based on psychotherapy and holistic care, with no hormonal intervention before adulthood.
But the confusion caused by trans activism goes even further: those who take the time to explore and work with children and their families on the reasons for their request for a change of gender or sex risk being accused of practising ‘conversion therapy’. In fact, it was under their pressure that the GIDS opened at the Tavistock Clinic, under the direction of Polly Carmichael, initiating the ‘affirmative’ approach to young patients. It is the lack of sufficient assessment and care for these patients, and the co-occurrence of inadequately treated psychiatric pathologies(19), that has led to the current scandal.
This scandal did not only emerge at the Tavistock Clinic. Many countries have sounded the alarm, including the USA, Canada and even the Netherlands4.
This alarm has also reached WPATH (37). On 29 June 2024, at an international conference in Paris, the Society for Evidence-based Gender Medicine (SEGM) reported a major scientific fraud by WPATH: documents disclosed as part of an ongoing judicial investigation revealed that WPATH leaders interfered with the production of systematic reviews that they had commissioned from the Evidence-Based Practice Center (EPC) at Johns Hopkins University in 2018. WPATH demanded authority to influence the conclusions of the EPC team, with the power to reject publications that did not support their expected conclusions5.
4 We refer you to various articles and reports published in the international press: In the USA: https://www.thefp.com/p/i-thought-i-was-saving-trans-kids; In Canada: https://ici.radio-canada.ca/tele/enquete/site/episodes/864008/episode-du... In Quebec: https://ici.radio-canada.ca/recit-numerique/8610/transition-genre-testot... In the Netherlands: https://www.genderclinicnews.com/p/in-the-dark.5 Cf. SEGM's speech at this conference: https://www.youtube.com/watch?v=kJ_laTRcgdA, and the publication of the information referred to: https://segm.org/The-Economist-WPATH-Research-Trans-Medicine-Manipulated.
The Cass Review, through the systematic reviews it studied, indicates both the low quality and the lack of independence of the guidelines of the WPATH, the American Academy of Pediatrics (AAP) and the Endocrine Society (ES) (20,21). In fact, an independent team of methodologists assessed all the guidelines and treatment recommendations they provide using the internationally recognised AGREE II methodology. The study revealed a flagrant lack of independence in the drafting of guidelines, and circular references: one non-evidence-based guideline was used to justify the recommendation of another non-evidence-based guideline, and so on (20,21). Issuing strong guidelines and recommendations for the medical transition of young people on the basis of low-quality evidence was considered worrying and relayed in the British Medical Journal article devoted to this specific aspect of the Cass Review findings (38).
But that's not all. The activist movements have gone so far as to infiltrate the World Health Organisation (WHO). In December 2023, the WHO declared that it was setting up a working group to define guidelines for the health of trans people. SEGM and many other medical associations have made some important comments on the WHO's statements. On the one hand, they pointed to the biased composition of the ‘expert’ groups (composed solely of promoters of ‘gender affirmation’, some officially declared to be activists with no proper disclosure of their conflicts of interest, and no member defending a holistic approach), and on the other hand, the inadequate timeframe for public consultation and the inadequacy of the process in relation to the WHO's official practices (39).
Finally, the WHO retracted its position, announcing on 15 January 2024 (40) that the guidelines it would issue would relate exclusively to the treatment of adults and that no recommendations for children or adolescents would be issued because the scientific evidence for the affirmative approach was too uncertain. In addition, the composition of the group of experts has been modified and the timetable for the guidelines development process extended.
Understanding the explosion in the diagnosis of ‘gender dysphoria’ in minors: applying the Dutch Protocol to the wrong population?
Both the Cass Review (20) and the French Senate report (22) suggest that it should be recognised that the mental health problems of ‘generation Z’ (born after 1995) are probably at the root of the current phenomenon of ‘trans’ identification among young people. Furthermore, the invention and implementation of the Dutch Protocol has probably contributed to the rapid increase in the expression of pubertal sex anxiety (17) in young people through the diagnosis of ‘gender dysphoria’ (13, 20, 21). This is said to be a cultural idiom of distress, a ‘way of expressing distress that [...] proposes collective and shared ways of experiencing and talking about personal or social concerns’ (15,16,17).
The deterioration in the mental health of young people in Belgium, and elsewhere in the West, no longer needs to be demonstrated. It is linked to a number of factors, such as the major societal changes of the last fifty years, educational changes geared towards ‘positive’ education that no longer teach children to tolerate the frustration inherent in life in society, the inflation of individualism, over-consumption and excessive access to screens... All of this creates a context in which the younger generations are ‘sold’ the idea that they are entitled to everything, that anything is possible; a context that provides the breeding ground for numerous psychiatric decompensations in adolescence when these young people are confronted with the demands of reality and the intractability of the human condition.
These are the same young people who will find it all the more difficult to go through puberty and the uncertainty caused by the associated psychological and physical changes, looking to social networks - among others - for multiple attempts at explanations and solutions to their discomfort, including changing gender and/or sex.
Ambient activism, which has infiltrated even schools and hospitals, as was the case at the Tavistock clinic, and even some independent doctors and psychologists, has largely reinforced this phenomenon. These independent doctors are then referred to by militant associations as ‘LGBTQIA+ Friendly’ or ‘safe’, and are often quick to prescribe hormone treatments with little or no prior assessment.
However, child psychiatrists who defend a holistic approach, moving away from an ‘affirmative’ approach to gender, all too often find that these young people who claim to be ‘trans’ are trying to escape from what they cannot bear about their condition. In other words, a ‘creatively inappropriate’(14) solution to the distress caused by pubertal gender anxieties (17). It is in this context that American researcher Lisa Littman has observed Rapid Onset Gender Dysphoria (ROGD) in these adolescents (2, 6, 9, 10, 12, 16, 36, 41).
The fact that the Dutch Protocol is currently being applied to patients for whom it was not originally indicated is a global problem. The Cass Review highlights the very wide disparity in the management pathways in gender clinics in Europe, both in the composition of their teams and in their assessment methods, but also in their management of associated psychiatric comorbidities (5, 20).
Conclusions
The political and militant recuperation of gender dysphoria in minors still often generates anxiety, even muzzling or resignation among clinicians, even among those who question the ‘gender affirmation’ approach in their heart of hearts. This is tragic, because there is no denying the systematic evidence provided by the Cass Review (20), and consequently their recommendations relayed by ESCAP, of which Belgium is a member (29).
As the editor of the British Medical Journal (42) pointed out when the Cass Review was published: ‘current gender medicine rests on fragile foundations (43) [...] offering treatments without an adequate understanding of the benefits and dangers is unethical. [...] This is all the more important as the treatments are not innocuous; puberty blockers and hormone therapies are major life-changing interventions. Yet [inconclusive and unacceptable] evidence has been used to develop influential clinical guidelines, such as those of the WPATH, which have themselves been cascaded into the development of subsequent guidelines internationally [...]. A spiralling interventionist approach, in the context of a lack of evidence, amounts to over-medicalising the care of vulnerable young people. [...] According to the Cass report, too narrow a focus on gender dysphoria has neglected other characteristics and failed to provide a holistic model of care. Gender-based care became over-specialised when a more general and multidisciplinary approach was needed [...]. This failure is indicative of a societal failure in the field of child and adolescent health’ (42).
Below we discuss the conclusions reached by the European Society of Child and Adolescent Psychiatry (ESCAP) in the light of these updated scientific developments. These have been taken up by the Society for Evidence-based Gender Medicine (SEGM) (35), which summarises them, highlighting the main points:
- Firstly, a ‘principle of non-maleficence’: not to use, outside a research environment, experimental interventions with potentially irreversible effects or interventions whose long-term consequences are unknown; not to prematurely adopt new practices without sufficient evidence; not to continue outdated practices that may not be in the patient's best interest.
- Then a principle of beneficence: adopt medical interventions with a favourable benefit/disadvantage ratio; take into account the benefit/disadvantage ratio of the absence of medical interventions; ensure adequate diagnosis and treatment of co-existing psychiatric disorders; ensure a full diagnostic assessment of gender dysphoria rather than relying solely on the self-assessment of children and adolescents.
- Secondly, a principle of autonomy: involving minors in decision-making processes concerning their care in a way that is appropriate to their age and development, by assessing their capacity to consent; adopting an appropriate informed consent process for decisions that may be lifelong and irreversible, ensuring that children and adolescents are able to express their views and give their opinions.
- Finally, a principle of justice: guaranteeing access to reliable and up-to-date information, assessment and treatment of gender dysphoria, as well as during transition or detransition; adopting equal precautionary measures for all; and protecting the rights of children and young people as a group in a particularly vulnerable phase of development.
ESCAP insists that ‘new and experimental interventions related to gender dysphoria should be differentiated from routine clinical treatment and conducted exclusively in documented observational intervention protocols or research trials, safeguarding research standards on paediatric participants and vulnerable populations (e.g. meeting the minimal harm standard ; ensuring an informed consent process appropriate not only to the age of the subject, but also to their cognitive, emotional and social development; ensuring prior research on animal models and the adult population when using experimental interventions; respecting the precautionary principle when using experimental interventions)’ (29).
ESCAP calls on ‘the EU to establish a framework or registry of studies that should include patients currently receiving treatment, patients not receiving treatment and patients who have discontinued treatment, in order to better understand the outcomes of different treatment pathways, including cognitive, psychological and physiological effects’ (29).
ESCAP also stresses the need to ‘actively learn from any potential shortcomings of the past in the management of children and adolescents with gender dysphoria, in order to prevent violations of existing clinical, scientific and ethical standards’ (29).
ESCAP urges that ‘research findings should be published solely on the basis of quality criteria and not on the basis of their results’, as it is concerned about the publication bias whereby studies reporting favourable outcomes for young people's transition are frequently published and cited, even if they are deeply methodologically flawed (35).
Finally, we would like to quote the conclusions published at the beginning of May 2024 by the 128th German Medical Assembly (44), which adopted a resolution on ‘gender-affirming care’ for young people. This resolution, passed by a majority of the physician delegates (120 votes in favour, 47 against and 13 abstentions), states as follows: ‘The 128th German Medical Assembly 2024 calls on the Federal Government to authorise puberty blockers, sex reassignment hormone therapies or gender reassignment surgery for young people under the age of 18 suffering from gender incongruence (GI) or gender dysphoria (GD) only in the context of controlled scientific studies and with the involvement of a multidisciplinary team and a clinical ethics committee, and after a medical diagnosis, in particular a psychiatric one, and treatment of any mental disorder. The therapeutic results of these interventions must be the subject of sociological, medical, child and adolescent psychiatric, social and psychological monitoring over a period of at least ten years, and the results of the evaluation must be incorporated into the revision of the ‘Directive on gender incongruence and gender dysphoria in childhood and adolescence: diagnosis and treatment’ (44).
It therefore seems vital that the treatment of these young people in Belgium should be based on systematic evidence, as clinicians at the KUL (45) have already indicated, based on the recommendations drawn up by the Cass Review (20), confirmed by the French Senate report (22), and relayed by the European Society of Child and Adolescent Psychiatry (29).
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