High-risk meds

Gender medicalisation of teenagers is beset by legal uncertainty

Photo by Tim Mossholder on Unsplash

The Gist

The prospect of gender clinicians having a legal defence against medical negligence actions will be influenced by Australia-wide treatment guidelines now being drafted, according to a report to the state government of Queensland.

The independent review’s report, published on December 19, confirms that the evidence for the use of puberty blockers and cross-sex hormones with gender-distressed minors is of low quality.

Queensland’s centre-right Liberal National Party government, which commissioned the review earlier this year, has extended a pause on new hormonal treatment in the public sector until there are results from the controversial UK clinical trial of puberty blockers.

“We believe that it’s in the safety and interests of children that these drugs not be made available through the public system until such time as there is better evidence available,” Queensland Health Minister Tim Nicholls said.

New Zealand’s ban on new under-18 treatment with blockers and hormones, itself paused pending court review, is also to be revisited after the UK clinical trial, which is scheduled to start in January with results not expected before mid-2032.¹

The remote, sparsely populated Northern Territory is to join Queensland as the second Australian jurisdiction to ban these hormonal treatments in public health, The Sunday Territorian newspaper reported on December 21.

Steve Edgington, health minister for the centre-right Country Liberal Party administration in the territory, said minors had to be protected from the “dangerous ideologically driven practices” of paediatric gender medicine.

He said the government’s ban was “consistent with approaches taken in other jurisdictions including Queensland, New Zealand and several European countries”.

In a statement, he said only “a handful of young teenagers” had been getting these hormonal drugs through NT public health. Earlier this year, in response to a request that Edgington release basic treatment data, it was claimed that the NT Department of Health “does not maintain data collection or a register for patients experiencing gender dysphoria”.

Meanwhile, in the US, the Trump administration has announced measures seeking to enact an effective national ban on hospitals offering puberty blockers, cross-sex hormones or transgender surgery, such as double mastectomy, to gender-distressed minors.

US Health Secretary Robert F Kennedy Jr has foreshadowed rules that would deny federal payments under Medicaid, Medicare and the Children’s Health Insurance Program to any hospitals offering “sex-rejecting procedures”, as he termed them. Hospitals are heavily reliant on these federal insurance schemes.

At a Washington, DC, event on December 18, Kennedy said the key inspiration for the new restrictions was the recently reissued scientific report on youth gender dysphoria commissioned by his Department of Health and Human Services.

“I don’t think anybody can read that science without saying we made a huge mistake here [by allowing paediatric medical transition],” Kennedy said. “It’s a disgrace to the medical establishment that they let this go on for so long, based upon so little positive data.”

The detail

High-risk meds

The report of the Queensland review panel led by psychiatrist Professor Ruth Vine noted the concern of some health practitioners that hormonal treatment of gender-distressed minors was “experimental” and carried the risk of medical negligence actions. As well, the panel said, government health services would be “vicariously liable” for negligence by staff gender clinicians.

However, under the law, clinicians would have a defence if they were following a practice widely accepted by peer professional opinion, and it did not matter if some practitioners disagreed with this opinion.

The panel said it had “heard from a significant range of medical practitioners who supported the provision of [puberty blockers] and [cross-sex hormones] in line with existing standards and guidelines”, and therefore the panel did not think this practice “would be deemed negligent”.

But what was judged a reasonable standard of care by the courts would probably be influenced by the new Australian treatment guidelines being drafted by the National Health and Medical Research Council, the panel said. Interim advice on puberty blockers is expected in mid-2026, with the full guideline to be issued in 2028.

The NHMRC-endorsed guideline will supplant the low-quality “Australian standards of care” gender dysphoria guideline issued in 2018 by the Royal Children’s Hospital (RCH) Melbourne and used across the country, including in Queensland.

The new NHMRC guideline is charged with evaluating the quality of evidence using the international GRADE system, whereas the RCH authors failed to rate the quality of the evidence for their treatment recommendations.

Multiple systematic reviews—undertaken independently in countries including Finland, Sweden, the UK, Canada and Germany—have concluded that the evidence base for paediatric medical transition is very weak and uncertain.

Given the freeze on new hormonal treatment in Queensland’s public sector, the Vine panel’s legal warnings take on more immediate relevance for gender clinicians in private health who pick up unmet demand for blockers and hormones.

Despite its reassuring take on the negligence issue in general, the panel stressed that the success of any legal claim would turn on the facts of the given case, with key vulnerabilities being any departure from guidelines, failure to undertake a proper assessment in diagnosing gender dysphoria, or not documenting properly the clinical decisions in the patient record.

“The provision of medications which are accompanied by a range of reversible and/or irreversible physical and psychological outcomes, where clinical evidence ranges from unknown to weak or moderate, to a cohort of children and adolescents whose capacity to consent is variable, can reasonably be described as a high-risk area of medicine,” the panel said.

In this wider ethical context, the Vine panel also said that “medicating otherwise physiologically healthy children and adolescents to help in managing their internal distress in the face of wider societal misunderstandings of gender diversity may create a disproportionate and indefensible burden on them”.

“This consideration may become particularly problematic where the long-term physical and mental health and social impacts of prescribing [blockers] and [hormones] are not settled.”

Into the unknown

Another legal risk raised during the review panel’s talks with health practitioners related to any failure by gender clinicians to disclose “material risks” before minors undergo hormonal treatment.

The concern was “that there are either unknown risks and consequences of the use of [blockers] and [hormones] in young people, or uncertainty surrounding some risks, some of which may potentially carry very serious consequences,” the panel said.

“Where there are unknown and uncertain risks, there is an obligation to disclose that fact. It is important the patient and/or their decision-maker are made aware of the fact that there are unknown risks and long-term consequences associated with treatment, and/or there is a lack of evidence or understanding about some risks/consequences.”

On the adequacy of the informed consent process at the Queensland Children’s Gender Service (QCGS), a government facility based in Brisbane, the panel heard conflicting accounts, with some “young people and their families [stating] there was not a full appreciation of the risks, consequences and uncertainties” of blockers or hormones.

“To discharge the duty to disclose material information, it is imperative that full, detailed and genuine discussions surrounding the risks, consequences and long-term impacts of the treatment occur and are appropriately documented in the patient record,” the panel said.

“There should also be adequate documentation of the disclosure and discussion of the fact that there are potentially unknown risks and consequences of the treatment, and that this is understood by the patient/decision-maker before proceeding with treatment.

“In relation to the disclosure of material information, the risks, side effects, long-term consequences and the fact that there are likely unknown risks or consequences, are all types of ‘material information’ that must be disclosed to and understood by patients and their decision-makers.

“Reasonable alternatives to [blockers or hormones] should also be discussed and explained. Thorough documentation of discussions around the informed consent process is required, demonstrating the extent of the discussions about these issues, in addition to signed consent from the patient.”

The panel also flagged the shift in gender dysphoria law as laid down by Australia’s federal Family Court, citing the landmark ruling in re Devin’s case, where Justice Andrew Strum ordered that a 12-year-old gender non-conforming boy be protected from puberty blockers, which interfere with normal sexual development.

“Some judicial decisions have questioned whether minors will ever reach a threshold of understanding to validly consent to [blockers or hormones] based on unknown risks and long-term consequences and based on the potential for such treatment to impact the minor’s future reproductive capacity and sexual functioning,” the Vine panel said.

“Relevant issues include that the young person is still developing, and their views on deeply personal areas such as parenthood, sexuality, sexual function and identity, may be in flux.”

Referring to the tension between Justice Strum’s ruling and other more permissive court decisions, the panel listed a series of legal risks for gender clinicians, including the provision of blockers or hormones under the “depathologised” diagnosis of “gender incongruence”, which unlike gender dysphoria requires no distress and would undermine the legal claim that these interventions are “therapeutic”.

The panel said it “understood” that at the QCGS, a diagnosis of gender dysphoria, not mere gender incongruence, would “always” be made before consideration of blockers or hormones.

However, the panel was told, variously, during its consultation process that “a diagnosis may be changed to justify access to “blockers or hormones; that “a diagnosis is pathologising and a source of oppression”; and that “diagnosis does not help to predict which adolescents will desist or detransition and [that] the stability of diagnosis from adolescence to adulthood is unclear”.

Comments by US Commissioner of Food and Drugs Dr Marty Makary, speaking at December 18’s Washington DC announcement of measures against “sex-rejecting procedures”—

“One of the most barbaric features of a society is the genital mutilation of its children. It’s based on a medical dogma, sadly, that the normal, sometimes stressful experiences of boys and girls growing up is a pathology that requires medical intervention.

“Parents are told, if they don’t agree to these disfiguring and permanently sterilizing procedures, they’re putting their child at increased risk of suicide, a baseless claim that has never been supported with good data.

“Pushing transgender ideology in children is predatory. It’s wrong, and it needs to stop. This ideology is a belief system that some teachers, some pediatricians and others are selling to children without their parents knowing sometimes, or with a deliberate attempt to remove parents from the decision making.

“Puberty can be stressful, and for all of history, being a kid and interacting with kids from the opposite gender can be awkward, even confusing at times. But to see a society putting kids on a path of chest binders, drugs, castration, mastectomies and other procedures is a path that now many kids regret.

“Let me be clear about something, and this is an important distinction. We’re not talking about medically treating kids with a biological basis for ‘differences in sexual development’, what used to be called ‘intersex’. We’re not talking about children with 5-alpha reductase deficiency, Klinefelter syndrome, Turner syndrome or other sex chromosome abnormalities.

“We’re talking about an ideology that is supported by flawed science, that every child as young as four years of age should pick from an array of genders. We’ve got high schools now where half the kids don’t identify as a boy or girl. What’s going on?

“To American hospitals and clinics, do not ask parents to leave the room in order to sell your transgender ideology to America’s children.”

Video: At Genspect’s Albuquerque conference Dr Patrick Lappert details the “fraud and misrepresentations” of gender surgery

Data vacuum

Queensland’s Vine panel noted defects in data collection, analysis and reporting by the Queensland Children’s Gender Service (QCGS), which was still operating without a “finalised written model of care”, relying on a 2023 draft.

It also used an out-of-date “gender-affirming” work instruction which did not reflect the QCGS adoption of the latest, eighth standard of care from the World Professional Association for Transgender Health, which abruptly abandoned minimum ages for medical interventions following pressure from the US Biden Administration.

The QCGS work instruction states that “chest reconstructive surgery”—double mastectomy for girls who identify as male or non-binary—is “an integral part of the transition process” for many.

Staff at the QCGS are instructed that girls as young as 15 may be competent to consent to the removal of their healthy breasts.

The document claims this surgery, which the Queensland Children’s Hospital itself does not perform, “may be in the best interest of an older adolescent under 18 years” in unexplained “exceptional circumstances”.

Presumably this can continue, because the government treatment pause is limited to blockers and hormones, and does not prohibit the QCGS referring its female patients to private surgeons.

Asked by GCN if he would review or stop such referrals, the office of Queensland Health Minister Tim Nicholls said the government was “not looking at areas outside of the scope” of the job entrusted to Professor Vine.

The Vine panel advised that if blockers and hormones were to resume in the public sector, a “finalised QCGS model of care should outline the routine collection of outcome measures,” implying that this has not been happening.

“While we were able to consider some data from QCGS, this was limited in extent and analysis,” the panel said.

“We note the absence of QCGS annual reporting on service activity, outcomes and safety and quality data. The impact of this absence is that the service does not know at any given time what its patient cohort looks like in detail.

“The limited capacity of QCGS to record, search and collate information and the absence of a finalised written model of care also adds to the difficulty of understanding what occurs and has occurred in practice.”

The QCGS, the panel said, lacked “the capacity to capture in an accessible/searchable way (other than individual entry into each patient’s clinical notes)” information such as—

the diagnoses of gender dysphoria;

the medication or dosage prescribed or administered;

observed or reported side effects and/or effectiveness of medications;

the number of patients who undergo fertility preservation procedures;

the reason for discharge;

and presence or absence of co-occurring conditions.

Nine-year-olds on blockers

The panel did manage to get some basic treatment data from QCGS, which showed that, measured by median age, younger children were being given puberty blockers as time went by.

In 2019, 117 patients were started on blockers, with the youngest aged nine and a median age of 15. In 2022, 81 patients began on blockers (minimum age nine and median age of 13). And last year, there were 24 patients initiated on blockers (minimum age 10 and median age of 12).

In 2019, 88 patients began cross-sex hormones, meant to be taken lifelong, with a minimum age of 14 and a median age of 16. In 2022, 103 patients began hormones. In 2024, there were 85 new patients on hormones. For each of these three years, the median age for starting hormones was 16, with the youngest aged 14.

“In each year for which the panel was provided data, some patients who commenced [hormones] had previously received [blockers] and others had not,” the panel said. No clarifying percentages are given.

“Without more detailed data, we are unable to comment further on the proportion of those who are referred that do meet criteria for a diagnosis of gender dysphoria or the extent or detail of assessment and information provision,” the panel said, suggesting that the QCGS claim of always requiring such a diagnosis could not be verified.

The Vine panel’s report does not mention international data suggesting that the vast majority of children begun on puberty blockers will proceed to cross-sex hormones, a combination with potential harms such as sterilisation, sexual dysfunction, cardiovascular disorders and as yet unknown long-term disorders during a lifetime of medicalisation.

Notwithstanding this omission, the panel says “it appears from the available research that the effects of [puberty blockers] are reversible”. Elsewhere, the panel says blockers are “largely reversible if used for a limited time”, without explaining in what way they might not be fully reversible.

On the possible cognitive harm of puberty blockers interfering with critical windows in development of the adolescent brain, the panel said no conclusions can be drawn because of the limited evidence.

Yet the limited evidence did not prevent the panel talking up the “potential psychosocial benefit” of puberty blockers, while hedging that cause and effect in these low-quality studies are unclear and “long-term outcomes are uncertain”.

The report also talks up a recent gender-affirming treatment guideline from Germany, without making clear that this project had abandoned a necessary but inconvenient systematic review of the (weak) scientific literature, and was downgraded from its intended “evidence-based” status to a mere consensus-based document.²

Even so, Queensland’s Vine review did suggest some caution before medicalisation.

“Our view is that a person/child-centred approach warrants the full assessment and early management of any co-occurring conditions before initiation of [blockers or hormones],” the panel said.

“This in no way diminishes the importance of respect, acceptance and engagement. Young people and their families expressed appreciation for a gender-affirming approach, but for some parents, this was also viewed as a barrier to having co-occurring problems, conditions or issues that may be contributing to their child’s distress addressed.”

Scarce psychological support

The panel said that in 2022-23, the QCGS responded to its growing waitlist of patients by cutting back mental health support.

This was characterised as “refocusing QCGS clinicians on delivering mental health support through assessment only and redirecting consumers to external practitioners for ongoing mental health treatment and monitoring”.

And the panel was told that “children currently on the QCGS waitlist do not receive psychological support from QCGS and struggle to receive support from private or other clinicians due to them being on the waitlist”.

Also, the panel heard of “the challenges experienced by individuals that were referred from QCGS for mental health support in the context where general local [child and youth mental health services] are already operating at full capacity and private providers, particularly relevant specialists, are scarce and costly”.

The panel highlighted the lack of co-ordinated data on—and oversight of—paediatric gender treatment not just in Queensland, but nationally.

“While services in all Australian jurisdictions are generally making [an] effort to collect and analyse data on who is accessing the service, what treatment is provided and with what outcome, overall, we noted a lack of integration across services, and between the public, primary and private sectors,” the panel said.

“We noted limited information on numbers of young people prescribed [blockers or hormones] for gender dysphoria, how such treatment is monitored and assessed and how long-term outcomes are tracked.

“There is currently no statewide line of sight of the provision of [blockers] and [hormones] for children and adolescents with gender dysphoria in Queensland.

“We were informed of various avenues of obtaining [blockers and hormones], including through QCGS and certain local [public hospital and health services], in the private sector, through moving interstate, obtaining access internationally and through illegal means. We were also informed of significant variation in practice including safety and quality processes and clinical oversight and accountability.

“The panel is not aware of any requirement of private providers in specialist or primary care to provide data on the numbers or outcomes of young people to whom they prescribe or administer [blockers or hormones].”

Hormone misinformation

As if to reassure, the panel declared that the use of synthetic testosterone drugs to masculinise a female minor’s body “is quite tightly regulated”.

“Testosterone deficiency is a requirement for [publicly funded] prescription of testosterone therapy,” the panel said. “We were advised by QCGS that such prescriptions are written on the basis that the individual concerned is considered testosterone deficient.”

In fact, trans-identifying girls have no hormonal disorder until they are given testosterone drugs in male-level doses.

Under the taxpayer-funded Pharmaceutical Benefits Scheme (PBS), testosterone is available to treat the male disorder of androgen deficiency/testicular disorder. To secure access to PBS-subsidised testosterone, gender clinicians purport to apply this diagnosis to females who identify as male or non-binary.

In a 2019 Medical Journal of Australia podcast, gender clinician and endocrinologist Dr Ada Cheung explained the prescribing rationale for biological females who identify as transgender men on the basis that they lack testicles. (Endocrinologists specialise in hormones.)

Dr Cheung acknowledged there was no PBS listing for testosterone to treat gender dysphoria, but said females who identify as “transgender men are males, and they have a low testosterone level, so they have androgen deficiency, and they don’t have testicles.”

“So, we’ve been able to use the [PBS] indication ‘androgen deficiency due to an established testicular disorder.’ And when I’ve checked this with the PBS, they … have said that this is okay.”

Earlier this month, the British father of a 15-year-old autistic girl who was prescribed a potentially fatal dose of testosterone by the online clinic GenderGP spoke publicly for the first time about the resulting case heard by England’s High Court last year.

“I was foolishly under the belief that being under 16, she couldn’t access this stuff. There’d be due process,” the father, identified as “John”, told The Times.

“He describes how—in his view—his ex-wife weaponised gender medicine to cut him out of his daughter’s life, how his daughter went from being sectioned for anorexia to being affirmed in her trans identity by all the adults in her life except him, how she was given a prescription for testosterone after one online session with a counsellor, and how this was injected by her local NHS GP with no blood tests or clinical evaluation,” The Times reported.

The High Court heard expert evidence from an Australian paediatric endocrinologist that the double “loading” dose of adult-level testosterone prescribed for the girl put her at risk of sudden death.

A comparable “loading” dose of testosterone is suggested as a starting dose for female adolescents in RCH Melbourne’s “Australian standards of care” used by clinics across Australia, including the QCGS.

Children’s Health Queensland, the government entity responsible for the QCGS, did not reply when GCN asked last year if it used this dangerous dose of testosterone.

There is no accurate public data on how many girls nationwide have been exposed to synthetic testosterone at male-level doses far in excess of the naturally low levels of this powerful hormone in a female body.

In passing, the Vine report remarked that the RCH guideline “may be interpreted as lessening the requirement for psychiatric sign off in every case compared with other guidance that requires or strongly recommends psychiatric involvement for all patients”.

GCN does not dispute that gender-affirming clinicians believe their interventions benefit vulnerable minors.

1. The official FAQs for the UK PATHWAYS clinical trial state: “Currently, the trial is due to run for 5.5 years. We aim to publish the main results, including primary and secondary outcomes, in a peer-reviewed, open-access medical journal within 12 months of the trial’s completion”.

2. Prominent child and adolescent psychiatrist Professor Florian Zepf, who with his Munich-based colleague Alexander Korte was among the experts who left the German guideline development group out of professional and ethical concerns, was lead author of an independent 2024 systematic review confirming the weak evidence for puberty blockers and cross-sex hormones.

The review concluded: “Current evidence does not clearly suggest that [gender dysphoria] symptoms and mental health significantly improve when [blockers or hormones] are given to minors with [gender dysphoria]. Children and adolescents with [gender dysphoria] should therefore primarily receive psychotherapeutic interventions that address and reduce their experienced burden.”

In response to a draft of the gender-affirming German guideline, the 126th German Medical Assembly in 2024 passed a resolution in which the German Medical Association called on the country’s federal government to restrict puberty blockers, cross-sex hormones and trans surgery for minors to ethically controlled clinical trials with at least ten years’ follow-up.