On 1 May the US Department of Health and Human Services published Treatment for Pediatric Gender Dysphoria: Review of Evidence and Best Practices.
The Review of evidence and best practices was commissioned pursuant to an Executive Order of the US Trump administration.
This is a magisterial piece of work: comprehensive, scientific, informative and thought provoking. It has been called the US “Cass Review” but while there is much in common with Cass, in particular examining the evidence for paediatric medical intervention, the HHS Review is methodologically distinct from the Cass Review and goes further and deeper than Cass in important ways.
Aims
The Review aims to answer the question about how best to help the growing number of young people with gender dysphoria. It seeks to provide the most accurate and current information available regarding the evidence base for the treatment of gender dysphoria in children and adolescents, the state of the relevant medical field in the United States, and the ethical considerations associated with the treatments offered.
The Review acknowledges the suffering of many of these young people and their families and therefore when they seek professional help, they and their families should receive compassionate, evidence-based care tailored to their specific needs. In addition, society has a special responsibility to safeguard the well-being of children.
The Review is intended for policymakers, clinicians, therapists, medical organizations and, importantly, patients and their families. It summarises, synthesizes, and critically evaluates the existing literature on best practices for promoting the health and well- being of children and adolescents with distress related to their sex or to social expectations associated with their sex.
Summary
At the core of the HHS Review, as in the Cass Reviews is a systematic examination of the evidence for medical interventions for children and adolescents who are experiencing gender related distress, but the HHS Review goes further than Cass in also considering the systematic review of the evidence for surgical interventions and evidence from basic science to inform our understanding of the risks of medical and surgical interventions.
The Review confirmed the Cass Review’s observation that “this is an area of remarkably weak evidence.”
It concluded that the risks of harm were less uncertain than the evidence of benefit and include infertility/sterility, sexual dysfunction, impaired bone density accrual, adverse cognitive impacts, cardiovascular disease and metabolic disorders, psychiatric disorders, surgical complications, and regret.
Important related issues such as ethics, including research ethics, are explored in detail, as well as comprehensive review of the history and current practice of paediatric medical transition in the US and across the world, the discredited role of WPATH, problems with the diagnostic frameworks of gender dysphoria and gender incongruence, the collapse of clinical safeguarding for this group of young people in the US, the role of US medical and psychological institutions in blocking change, the reasons for the shift away from the “gender affirming” model of care in parts of Europe towards a psychotherapeutic approach, and the challenges to current US practice this brings, together with the impact of whistleblowers within the US..
The final chapter on psychotherapy explores this as an alternative approach to helping children and adolescents with gender related issues.
Background
The Review was published against the backdrop of growing international concern about paediatric medical transition.
In the past decade, the number of children and adolescents who question their sex and identify as transgender or nonbinary has grown significantly. Many have been diagnosed with a condition known as “gender dysphoria” and offered a treatment approach known as “gender-affirming care.” This approach emphasizes social affirmation of a child’s self-reported identity; puberty suppressing drugs to prevent the onset of puberty; cross-sex hormones to spur the secondary sex characteristics of the opposite sex; and surgeries including mastectomy and (in rare cases) vaginoplasty. Thousands of American children and adolescents have received these interventions.
As the Review was commissioned by the Trump government, not known for its respect for medical science, it would be easy to dismiss the HHS Review without reading it. But that would be a mistake. The Review is of a high methodological and scientific standard, thoughtful and well evidenced, and in keeping with standards for evidence reviews honestly discusses its strengths, weaknesses and areas of uncertainty. It should be judged on its merits.
Readers should not be put off by the length. It is written in a style that is accessible to a lay person and each chapter can be read and appreciated independently. The sweeping history of how we got to the current situation whereby paediatric medical transition became established in the US and worldwide – without any good evidence supporting it – is fascinating; the results of the review of the evidence are clearly explained; and the chapter on ethics is profound and thought provoking, breaking new ground in this important area.
Language
The Review refers throughout to “paediatric medical transition” instead of “gender affirming care” as it considers the latter to be a misleading euphemism that makes a process that carries significant risk sound harmless and beneficial. The Review rejects the use of ideological terminology pointing out that paediatric gender medicine has developed “a vocabulary and a mode of communicating that is scientifically ungrounded, that presupposes answers to ethical controversies, and that is in other ways misleading.”
Evidence Review
The core of the Review is a methodologically rigorous assessment of the evidence underpinning paediatric gender medicine, consistent with the principles of Evidence Based Medicine (EBM). There is a detailed and useful explanation of EBM, the role of systematic reviews within that, and the methodological approach the Review took.
The Review conducted an overview of systematic reviews—also known as an “umbrella review”—to evaluate the direct evidence regarding the benefits and harms of treatment for children and adolescents with gender dysphoria. It evaluated the evidence for social transition, puberty blockers, cross sex hormones, gender surgery and psychotherapy. The Review found that the overall quality of evidence concerning the effects of any intervention on psychological outcomes, quality of life, regret, or long-term health, is very low.
Systematic reviews gave sparse information about evidence of harm. This was supplemented by identification of risks based on knowledge of basic science, physiology (in particular of puberty) and effects of drugs and surgery:
International reversal of gender affirmative approach
The reversal of the “gender affirmative” approach began in Finland and Sweden, followed by UK, and now several other European countries (and at least one state in Australia) are reviewing their policies. According to the Review the global reversals away from paediatric medical transition can be attributed to six main factors: a significant change in the patient population to predominantly adolescent girls with complex problems; uncertainty surrounding the natural history and prognosis of gender dysphoria; increasing recognition of the risks associated with medical interventions; a more accurate understanding of the suicide risk; the collapse of the original treatment rationale; and a weak underlying evidence base.
Ethics
The ethics chapter is deep and wide-ranging. An interesting aspect is the shift by advocates of paediatric medical transition from justifying it ethically as a beneficent “medically necessary” and even “lifesaving” treatment to an ethical justification based on patient autonomy, specifically the patient’s right to get treatment to meet their “embodiment goals” regardless of any benefits or risks. This is attributed to the failure, despite three decades of practice, to come up with any good evidence to support paediatric medical transition.
The “gender-affirming” model of care, as practiced in U.S. clinics, is characterized by a child-led process in which comprehensive mental health assessments are often minimized or omitted, and the patient’s “embodiment goals” serve as the primary guide for treatment decisions.
The ethical discussion acknowledges the importance of patient autonomy and patient choice but points out this does not extend to an obligation on the part of the clinician to provide treatments that are not medically justified and that the clinician believes are more risky than beneficial. It criticises the use of these interventions to satisfy adolescents’ embodiment goals as veering from clinical error into clinical recklessness.
The principle of respect for patient autonomy does not justify subjecting patients to interventions that pose medically unnecessary risks of harm, or which are otherwise non-beneficial, even when patients prefer, request, or demand those interventions.
Research ethics
Concerns about the risk benefit balance of paediatric medical intervention extend to the ethics of clinical research in that field. The Review recognises that a natural response among researchers to the absence of higher quality evidence is to conduct more and better research but explains why it is doubtful that hormonal or surgical interventions for gender dysphoria can ethically be offered in a trial, irrespective of trial design. Several reasons are given such as poor understanding of aetiology, lack of clinical rationale, lack of clarity of goals of treatment, lack of utility of diagnostic criteria to predict persistence – but overarching all these is the absence of clinical equipoise: the possible benefits do not outweigh the significant risks. This would make such research unethical according to international and national research ethics regulations.
A further important ethical point is that an intervention must be favourable relative not only to doing nothing but also to other known alternatives. In the field of paediatric gender medicine this would include psychological treatments.
Psychotherapy
Psychotherapy for gender dysphoria is a relatively under-researched area but the Review states that there is every reason to believe that psychotherapy can be an effective intervention as there is good evidence of benefit of psychotherapy for related comorbidities such as anxiety and depression. Importantly, the systematic reviews of psychotherapeutic interventions showed no evidence of negative or adverse effects in any of the studies examined.
This is the approach that is increasingly being taken in several countries in Europe, including the UK, and the authors of the Review are advocating that the US should follow suit. If the matter were one that could simply be settled by evidence and argument this would have happened already. Unfortunately the intransigence of US medical and psychological associations mean that it will take a groundswell of public opinion and the collective voices of members who disagree with the leadership to effect change. This Review provides a wealth of information for those advocating for change both in the USA and other countries so that children and young people with gender related distress receive safe evidence based care and are protected from harm.