What went wrong?

Internal documents suggest that radically new gender treatment was approved at a children's hospital without proper evidence or oversight

Photo by Sigmund on Unsplash

Alison Clayton

How is it that the untrustworthy treatment guidelines of the Royal Children’s Hospital (RCH) Melbourne were approved by the hospital’s governance processes, endorsed by health departments and medical bodies across the nation and are still to this day used to guide clinical practice at virtually all of Australia’s public youth gender clinics?

Those clinics practise the “gender-affirming treatment” model of care, which is underpinned by the Australian Standards of Care and Treatment Guidelines for Trans and Gender-Diverse Children and Adolescents, first published by RCH Melbourne in 2018. Australia’s gender clinics also cite the 2022 standards of care issued by the World Professional Association for Transgender Health (WPATH).

Key interventions for minors, as outlined in these documents, include the affirmation of a child’s stated “gender identity”, social transition, puberty blockers, cross-sex hormones and in some cases, surgery.

Internationally, the gender-affirming treatment approach is coming under increased scrutiny because of a lack of reliable evidence for the mental health benefits it is claimed to confer on minors. There are also increasing concerns about harm, and ethical doubts. In recent months, serious questions about the integrity of the WPATH standards have come to light. These include suppression of research, violation of conflict-of-interest rules, and political interference.¹

Another red flag is the unexplained change in the number, demographics and clinical profile of young people referred to gender clinics. For example, at the RCH Melbourne clinic, there were only 0-2 referrals a year up until 2009, whereas in 2021 there were 821 referrals. Previously, most referrals were natal-sex boys yet to enter puberty; in recent years, 70 per cent have been natal females, chiefly adolescents.

Many of these young people have co-existing mental health and neuro-developmental disorders. RCH clinicians have reported that almost half of their patients showed elevated autistic traits, and a quarter had symptoms of eating disorders. In 2023, some 30 per cent of referrals were “non-binary”, whereas this identity accounted for only seven per cent of patients between 2009-2017.

Such changes in caseloads and the weak evidence base for gender-affirming treatment have led a number of jurisdictions to restrict or ban the use of puberty blockers, cross-sex hormones and surgeries in minors, instead prioritising psychosocial interventions as first-line treatment. Finland, Sweden and the UK have in effect designated blockers and/or hormones as experimental treatments to be confined to research settings.²

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Start again

Earlier this year in Australia, the Queensland state government announced an independent review, and paused new treatment of minors with blockers or hormones. Shortly afterwards, Australia’s federal Health Minister Mark Butler declared that he had asked the National Health and Medical Research Council (NHMRC) to review the RCH treatment guidelines and develop new national, evidence-based guidelines for youth gender care.

His deputy, Assistant Minister Ged Kearney, stated that this NHMRC project was “not a national inquiry” but rather an update of what she described as the “excellent” RCH guidelines.

The RCH guidelines are not excellent. They fall far below international and national standards for trustworthy medical guidelines. In a recent review, the RCH document was rated at only 19 per cent on the rigour of its development; it was not recommended for use. Untrustworthy guidelines are likely to offer clinical guidance that does not serve the best interests of patients. It is incumbent on clinicians and policy makers to recognise untrustworthy guidelines and not to endorse them.

What went wrong in the case of the RCH guidelines?

Drawing on documents obtained under Freedom of Information law, I will focus on the RCH approval processes. (The endorsement of the RCH guidelines by agencies external to the hospital is worth a separate article.)

I first corresponded with the Research Ethics and Governance office of RCH Melbourne in December 2020. I raised my concern that the gender-affirming protocol of the 2018 guidelines had been introduced as standard treatment. In my view, it was experimental, and its adoption as routine treatment was in breach of NHMRC guidelines for ethical research.

In response, the chair of the Human Research Ethics Committee (HREC) at the hospital stated that the treatment protocol did not constitute research and thus was covered not by her committee but by other approval processes. I was referred to the hospital’s executive director of clinical governance, who told me in March 2021 that under standard procedures, the gender clinic’s treatment model had been approved a few years earlier by the New Technology and Clinical Practice (NTCP) Committee.

Not so, according to the FOI documents I recently obtained.³ The only application to the NTCP committee shown by these documents was made in September 2019. That is at least 18 months after publication of the RCH guideline, and well after its treatment protocol was being offered as routine treatment at the gender clinic.

The cover letter for the application stated that the “evolution” of the clinic’s treatment protocol pre-dated the formation of the NTCP committee, and this was why it had not previously gone before the committee. The clinic also noted the controversial nature of the treatment approach and the associated media debate.

At the October 2019 meeting of the NTCP committee, the majority voted not to approve the treatment protocol. There is only a brief reference to the reasons in the FOI documents. The minutes state that the gender clinic’s treatment protocol was already an established clinical service and the committee “felt that it did not have the authority to review and endorse” it.

The next point to highlight is that the application to the NTCP committee claimed that the new treatment protocol outlined in the RCH guidelines introduced only “minor” changes from the treatment approach that began in 2004.

This seems incorrect. The new protocol at the RCH gender clinic involved several major changes from preexisting practice. This is clear from a study of a group of patients referred from 2003 to 2011.

The resulting 2012 paper by Hewitt et al sets out the following features of clinical practice at RCH over that period—

There was an emphasis on engaging all patients in psychotherapy, with the result that for about 20 per cent of the adolescents, gender dysphoria was resolved without medicalisation.

Before any start to puberty blockers, two independent child and adolescent psychiatrists had to assess the patient.

Cross-sex hormone treatment could only begin at age 16 or older.

For each patient, clinical ethics review and Family Court authorisation were required.

No surgery under the age of 18 was available.

In contrast, the 2018 RCH guidelines did not require an assessment by even one psychiatrist; assessment by a “mental health clinician” sufficed. Psychotherapy as a treatment for gender dysphoria was given scant mention (and other commentary from Australian gender clinicians implies that psychotherapy is an unethical “conversion practice”).

Minimum age requirements were removed by the new 2018 guidelines; obligatory clinical ethics review and Family Court authorisation requirements were also removed. Mastectomy was introduced as a recommended treatment for some minors.

The 2012 paper by Hewitt made no mention of the “social transition” of children before puberty. The Dutch model and existing international guidelines urged great caution about the full social transition of pre-pubertal children. It was noted that most children, if not socially transitioned, did not remain gender dysphoric and were far more likely to become homosexual rather than transgender adults.

The new RCH guidelines stated that if the pre-pubertal child desired to socially transition, the clinician should facilitate this. (There is no mention of homosexuality in the new guidelines, nor the risk that transition for some children might be a result of internalised or external homophobia.) Other RCH publications indicate that full social transition is promoted at the gender clinic’s first assessment triage service—that is, prior to any comprehensive and multidisciplinary assessment.

All these changes would appear to constitute major departures from the RCH gender clinic’s previous treatment protocol and international guidelines. This was implied by Associate Professor Michelle Telfer, the lead author of the RCH guidelines and then director of the gender clinic, in a 2019 interview with the Lancet, where she said—

“I knew that it might be controversial because of the changes we made from the previous guidelines … but that was the whole point—to make changes so that the guidelines were clinically relevant.”

A 2018 editorial in the same journal also highlighted the radical changes represented by the RCH guidelines—

“The guidelines stand apart from existing recommendations by suggesting that social transition … should be led by the child. They also move away from the idea that access to hormone treatment should be based on chronological age …”

The gender clinic’s 2019 application to the NTCP committee invoked the authority of the Family Court as overseeing and supporting the changes to the treatment protocol at the clinic in the preceding years. But the court is not a medical authority and, in any event, the judges appear to have relied only on the medical information presented by advocates for gender-affirming treatment in the absence of independent expert witnesses. This does not appear to be adequate medical oversight.

It is also important to note that the gender clinic did in fact have an opportunity to submit its radical new treatment protocol to the hospital’s NTCP committee before the 2018 publication of the guidelines. Although I cannot pinpoint the exact date of the establishment of that committee, available documents indicate it existed at least as far back as March 2017.

So, why was there no application to the committee until September 2019? Was this an attempt to retrospectively correct an error?

According to minutes from the October 2019 meeting, the gender clinic’s new treatment protocol was referred to the RCH executive after its rejection by the NTCP committee. The FOI documents I have obtained do not say whether the executive gave its approval. However, we can presume so because, in December 2019, the hospital’s chief executive officer John Stanway and chairman Rob Knowles published a strident defence of the gender clinic, stating that it followed “strict clinical governance standards”.

But the available FOI documents appear to contradict this claim, and suggest that the RCH guidelines and new treatment protocol did not go through the usual strict governance processes before these interventions were implemented as routine treatment at the gender clinic. Instead, there was an unsuccessful retrospective application for approval by the NTCP committee.

Importantly, the application form stated that, “evidence of efficacy and clinical effectiveness must exist for the proposed Technology/Practice”.

The form continued—

“Please summarise the best available evidence (including literature search, research trials done previously and documents from other organisations using this technology), outlining key aspects, for clinical effectiveness of the Technology/Practice for the defined clinical problem(s).”

In response, the gender clinic stated that, “There is a paucity of published data on the clinical effectiveness of treatment for Gender Dysphoria”.

The clinic’s application went on to cite one study of 55 participants, incorrectly identifying this Dutch research as American. The applicants also noted there was a large US study underway, but no results were yet available.⁴ In the section of the form where the level of evidence had to be stated, the applicants wrote “XX”.

It is worth repeating that where the NTCP application stipulated “evidence of efficacy and effectiveness must exist”, the gender clinic acknowledged the “paucity of published data” for gender-affirming treatment and could cite only one Dutch study, not mentioning it was low-quality research with a high risk of bias.

Nor is that study applicable to the RCH treatment protocol because the Dutch imposed strict eligibility requirements before any medical intervention. For example, gender dysphoria had to be present from early childhood and patients had to be free of significant mental health issues. Neither of these safeguards was included in the RCH guidelines, which stressed that mental health and neuro-developmental conditions should not preclude medical transition.

The 2019 application form for the NTCP committee also requested a review of the scientific literature, but the gender clinic did not provide one. This is surprising because the clinic’s own head of research, Associate Professor Ken Pang, was among the authors of a study presented the year before as “the first systematic review of the effects of hormonal treatment in transgender youth”.

This 2018 systematic review by Chew et al found a lack of evidence and noted that the key Dutch studies (including the study cited in the clinic’s application to the NTCP committee) were at a high risk of bias. The Chew paper made the specific point that there was no research evaluating the psychosocial outcomes of gender-affirming hormones in trans youth.

The RCH clinic’s guidelines also failed to cite the Chew paper—their own systematic review funded by the hospital foundation—which further undermines the trustworthiness of that document.

Against this troubling background, the RCH executive appears to have approved the gender clinic’s new treatment protocol in 2019, giving rise to serious questions.

How was that approval justified, given the requirement that “evidence of efficacy and clinical effectiveness must exist” for a new clinical practice?

Was the hospital executive given accurate information? For example, were they told about the findings of the gender clinic’s own systematic review? Were they appraised of all the major changes to pre-existing clinical practice being introduced in the RCH guidelines treatment protocol?

And did the executive at any point consider that the lack of evidence for gender-affirming treatment might require the new protocol to be classified as experimental and to be referred to the HREC?

In the NTCP application, improvements in mental health and quality of life were listed as the key patient health outcomes. However, there was a lack of evidence that puberty blockers or cross-sex hormones resulted in those outcomes, as the clinic’s systematic review showed.

Blockers and hormones pose serious risks to patients. The patient consent forms presented to the NTCP committee cited potential increased risks of stroke, heart attacks, liver disease, diabetes, heart disease, blood clots and pulmonary embolism, impaired fertility (potentially irreversible), impaired bone health, and adverse mental health impact.

Surely, given the lack of evidence of benefits and the potential risks, the new treatment protocol at the RCH gender clinic should have been regarded as experimental and subject to HREC review and approval. This is the exact point I had raised in my original letter to the hospital’s Research Ethics and Governance office in 2020.

The NHMRC’s Statement on Ethical Conduct in Human Research explains—

“This guidance applies to research, but sometimes the distinction between research and innovative clinical practice is unclear. For example, innovative clinical practice occurs on a spectrum from minor changes at the border of established practice that pose little change in risk to patient safety, to novel interventions that should only be introduced as part of an ethically approved research protocol”

If in doubt, it is recommended that advice be sought from the HREC (see also the discussion in my 2022 article on informed consent and a recent editorial published by Archives of Disease in Childhood).

Instead, the gender-affirming protocol—outlined in the RCH guidelines and involving major changes to previous clinical practice—appears to have been introduced at the RCH as standard treatment. It was not even subject to approval and oversight by the NTCP committee, let alone by the HREC.

The treatment protocol of the 2018 RCH guidelines was—and still is—a series of poorly evidenced, novel interventions that pose numerous serious health risks to patients for a poorly understood condition. Now, in 2025, there are multiple systematic reviews confirming a lack of reliable evidence to support the claim that gender-affirming treatment has mental health and quality of life benefits.

In my opinion, in accordance with NHMRC stipulations, the new RCH treatment protocol should have only been introduced as part of an HREC-approved clinical trial. Following their own systematic reviews, this has been the position adopted by health authorities in England and Sweden, where puberty blockers and/or cross-sex hormones for gender dysphoria in minors are now regarded as experimental treatments.

The history of the RCH guidelines, as well as the findings of England’s Cass report and other international reviews, add to the argument for the development of new, trustworthy Australian guidelines. The NHMRC has been commissioned to do this.

In addition, the information I have presented here indicates the need for a rigorous, independent inquiry into the RCH guidelines—their development, clinical governance processes, and ongoing endorsement by RCH and by external health organisations.

In the meantime, vulnerable Australian children and adolescents are still being recommended to undertake social transition and be given puberty blockers, cross-sex hormones, and surgery. In the interests of their health and well-being, it would be prudent for all Australian jurisdictions to do as Queensland has done—and pause gender-affirming treatment of minors pending a proper inquiry and the new national guidelines from the NHMRC.

Dr Alison Clayton is a Melbourne psychiatrist and researcher who has published peer-reviewed papers on the gender dysphoria debate. It is not disputed that gender-affirming clinicians believe their interventions benefit vulnerable young people.

1. See also the Gender Dysphoria Report issued on 1 May 2025 by the US Department of Health and Human Services (HHS), PP160-178.

2. See HHS report, PP146-149.

3. Under FOI law, RCH Melbourne was asked for documents, as far back as 2002, relating to any approval process for the treatment model of the gender service. The hospital was also sent detailed questions about this uncertainty in clinical governance before recent news coverage in The Weekend Australian.

4. Five years later, the results for puberty blockers in that US study were still unavailable. In October 2024, the lead investigator of this multi-centre research project, Johanna Olson-Kennedy, reportedly told The New York Times that results showing no improvement after puberty suppression had not been released because such a discouraging outcome might be “weaponised” by opponents of the gender-affirming treatment approach. Dr Olson-Kennedy has disputed the reporting of her interview.