Inside job

Dodging the hard questions posed by youth gender medicine

Photo by Bernard Hermant on Unsplash

Analysis

“The research shows that these [puberty blocker] medications are safe and work well to delay puberty, and their effects can be reversed if stopped. Some studies also suggest that this treatment can help reduce the distress young people with gender dysphoria feel during puberty.”

So says the headline-grabbing summary for an “evidence check” of medicalised gender change for minors commissioned by government health authorities in NSW, Australia’s most populous state. The summary and full report were issued last Friday without promotion or explanation by the government.

How does the report itself characterise the evidence for puberty blockers, cross-sex hormones and transgender surgery, such as double mastectomy? In ways that repeatedly undermine the reassuring summary, for example—

“Weak due to poor study designs, low participant numbers and single-centre recruitment.” “[C]onsiderable flaws remain in the evidence”. “[T]he strength of the evidence remains poor.”

Even the summary gives the lie to its own over-confident endorsement of gender medicine—

“Overall, it is difficult to draw definitive conclusions about interventions for gender dysphoria in children and young people from the available research.” Plus, the revealing advice that, “Research teams could track existing groups of participants over time to learn about long-term outcomes, including checking for health risks, benefits and costs.”

Sydney’s Sax Institute—“Supporting smart decisions. Powered by research”—took charge of this check-the-evidence job for the government agency NSW Health. Sax says it is “independent” and its evidence checks “are ideal for informing the development or revision of policies or programs.” That policy link could be inconvenient.

NSW Health has been busy expanding the “gender-affirming” medicalisation of minors.¹ In its 2023 financial report Sax declares its “economic dependency” on NSW Health “for a significant contribution to fund corporate costs.” The latest annual report from Sax, dated November 2023, lists a senior NSW Health official, Dr Kerry Chant, as a member of its board.² NSW Health funds the lobby group ACON, which champions gender-affirming medicalisation.

Acting as a broker, Sax had the evidence check done by the BehaviourWorks unit of Monash University. That university has links with Monash Health, which runs a Melbourne gender clinic open to young people from age 16. Some of the authors of the Sax evidence check are affiliated with the University of Melbourne’s Medical School, which is home to a sizeable Trans Health Research group.

For the evidence check, NSW Health not only framed the questions to be answered but had a say in the “testing and refinement” of the literature search and “co-developed” the rules deciding which studies would be evaluated and which not.

The report, which declares no potential conflicts of interest, is dated February 2024. Why so many months of delay before releasing it?³

In the NSW Parliament on Tuesday, One Nation MP Tania Mihailuk put some pointed questions.

Asked about the publication delay, senior NSW Health official Deborah Willcox said Sax had indeed finished the report itself in February but apparently needed seven months to write the four-page summary—longer than the hard graft of the evidence check itself, which began with literature searches on 19 September 2023.

The NSW Health Minister, Ryan Park, told Ms Mihailuk he thought the February 2024 date on the report “might be a typographical error.”

Asked about England’s 2020-24 Cass review, the world’s most comprehensive study of how to respond to youth gender distress, Ms Willcox said a NSW Health analysis involving clinical advisers and officials had found “consistency” between Dr Cass’s recommendations issued in April and “our approach… to be person-centred, multidisciplinary…” NSW subscribes to the internationally contentious gender-affirming worldview.

“[British paediatrician Dr Hilary] Cass’s findings challenge key orthodoxies of gender-affirming care, especially where medical interventions are offered in isolation from other conditions, such as autism, which can go underexplored.”—Letter to the British Medical Journal with signatories including Oxford University’s professor of evidence-based medicine Dr Carl Heneghan, 10 September 2024

Policy-neutral evidence

The foreword to the Sax report says the evidence check “is not designed to support policy or clinical practice decision-making in isolation from other inputs and consultation activities.”

What other input or consultation might assure safe and beneficial outcomes for young people given medical interventions found, yet again, to rest on low-quality and uncertain evidence?

In 2020, Finland, a pioneer of paediatric gender medicine, adopted a new cautious treatment policy after a systematic review of the evidence. In 2022, Sweden did the same, in effect declaring puberty blockers experimental.

And earlier this year, England’s National Health Service (NHS) announced an end to routine use of puberty blockers as a result of the Cass review.

England’s decision to confine blockers to ethically controlled clinical trials was the expected result of an independent systematic review of the (lack of) evidence for these hormonal treatments of minors undertaken in 2020 by the UK National Institute for Health and Care Excellence (NICE).

The Sax evidence check, “a rapid review” inferior to a systematic review, managed to include work by NICE and yet imply that unlike England, NSW Health can continue its gender medicine rollout without interruption.

Sax’s outsourced researchers also had the benefit of Sweden’s systematic review, but they present it as a rather bland, ambiguous verdict on the internationally shared evidence base—“Some studies [in Sweden’s review] reported improved global function and quality of life; however, the long-term effects of hormone treatment on psychosocial health (i.e., global function, suicide ideation, gender dysphoria, depression, anxiety, cognition, quality of life) could not be evaluated.”

The conclusion of the Swedish researchers themselves is stark: “This systematic review of almost 10,000 screened abstracts suggests that long-term effects of hormone therapy on psychosocial and somatic health are unknown, except that GnRHa [puberty blocker] treatment seems to delay bone maturation and gain in bone mineral density.”

One of the Swedish review authors, Professor Mikael Landén, of the Karolinska Institute and University of Gothenburg, summed it up this way: “Against the background of almost non-existent long-term data, we conclude that GnRHa [puberty blocking] treatment in children with gender dysphoria should be considered experimental treatment rather than standard procedure. This is to say that treatment should only be administered in the context of a clinical trial under informed consent.”

Yet, handicapped with the same weak evidence base, it’s gender business as usual in NSW.

“The University of York systematic review [for England’s Cass review] found no evidence that puberty blockers improve body image or dysphoria, and very limited evidence for positive mental health outcomes, which without a control group could be caused by the placebo effect or concomitant psychological support. Indeed, given that hormonal surges are a normal part of puberty and are known to lead to mood fluctuations and depression, it is not unexpected that blocking these surges may dampen distress and improve psychological functioning in the short term for some young people.”—British paediatrician Dr Hilary Cass, article, British Journal of Psychiatry, 6 September 2024

Green light, with red flags

“The [Sax] report provides a green light for puberty suppression and gender-affirming hormonal therapy—this is despite serious concerns about the reversibility of puberty blockers and their ability to provide time for adolescents to think about their gender identity,” said Dr Philip Morris, president of Australia’s National Association of Practising Psychiatrists, which recommends non-invasive psychological therapies as first-line treatments.

Dr Morris also highlights “the lack of data on longer-term effectiveness of these hormonal treatments for gender distress and their significant adverse effects as noted in overseas reviews—for example, the Cass review.”

He notes that the Sax report, issued only last week but reportedly finalised in February, does not include recent, more up-to-date information.  

“The Sax report is limited because it hasn’t taken into account major systematic reviews commissioned by Dr Cass for her final review report [in April],” Dr Morris told GCN.

Child and adolescent psychiatrist Dr Jillian Spencer, who was stood down by the Queensland Children’s Hospital after she questioned the safety of the gender-affirming treatment model, said that in her opinion, the Sax report was a “shoddy” pretext to justify the ongoing expansion of paediatric gender medicine in NSW.

“[The report] warns about the very poor quality of evidence in this area, but nonetheless provides the [NSW] government with sufficient key statements that can be quoted to support the government’s plan for puberty blockers, cross-sex hormones and gender surgeries for minors with gender distress,” Dr Spencer said.

She says the Sax view that puberty blockers are effective simply means that, unsurprisingly, these drugs do suppress the normal development of secondary sex characteristics.

In this way, Dr Spencer says, the Sax report side-stepped any discussion of “the more clinically important questions of whether puberty blockers prevent children from recovering from gender dysphoria and whether children can consent to such an intervention, at such a young age, as the start of a [medical] pathway rather than a stand-alone intervention.”

The Sax report repeatedly cites positive outcomes from studies of gender medicalisation, with occasional low-key reminders that even as the volume of this feel-good research has increased, its quality remains poor. Will vulnerable young people and their families get the message that they should have little confidence in these promised mental health benefits?

Academic psychiatrist Dr Andrew Amos, who argues that the gender-affirming model is political rather than medical, said—

“In my opinion, any medical authority that chooses to rely upon the poor-quality Sax rapid review over the high-quality Cass review for the purposes of making decisions about gender medicine for Australian minors will have demonstrated such a fundamental lack of understanding of medical evidence that their competence should be questioned.

“Taken at face value, the Sax review attempts to summarise exactly the same research literature as the Cass review with a far less rigorous methodology. By the authors’ own admission, they used a low-quality ‘rapid review’ methodology that was ‘not designed to support policy or clinical practice decision-making in isolation from other inputs and consultation activities’.⁴

“In direct contrast, the Cass review was explicitly designed to make recommendations regarding health policy and clinical practice decision-making by combining a comprehensive and rigorous review of the literature, alongside extensive consultation with patients, families, advocacy groups, health professionals and international guidelines.”

Professor of paediatrics John Whitehall said he believes the Sax report minimises or ignores the full range of risks necessary to disclose for young patients to give informed consent to gender medicalisation.

He says the report’s language has a tone of “warm assurance that everything’s going to be all right—just trust us.”

And yet, he says, the report amounts to an acknowledgement that paediatric gender medicine is “an unregulated live experiment.”

“Throughout the whole report, they’re admitting their evidence base is low and we need to look at outcomes long term—they don’t know what’s going to happen to these children in the future,” Professor Whitehall said.

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Timing’s the thing

The Sax report claims that low bone density is “the primary concern” with puberty blockers. It does not highlight the potential interference with critically timed windows of cognitive and psychosexual development in adolescence dependent on natural sex hormones. The summary makes no mention of this cognitive uncertainty.

Professor Sallie Baxendale, who holds a chair in clinical neuropsychology at University College London, says it is correct to say that low bone density is “the risk we know most about.”

“However, when you suppress puberty you interfere with a fundamental stage of human development,” she said.

“Puberty triggers so many physical changes in the body and brain. It would only be possible to identify the ‘main risk’ of puberty blockers once the impacts of the medication on all of these changes have been identified, quantified and assessed.

“As the Cass review highlighted, this work has simply not been done, so we don’t know what the main risk is, or how serious it is, or how many people may be affected or what factors may modify these risks. That is why it is so difficult for [young] people to give informed consent for these treatments.”

She told GCN it was not right to claim that puberty blockers, which suppress natural sex hormones, are safe, effective and reversible without considering the risks to the still developing adolescent brain.

“Everything we know about cognitive development suggests it would be impacted by pubertal suppression,” she said.

Professor Whitehall said it was “biologically implausible” for the Sax report to recycle claims that puberty blockers give young people time “to explore their gender identity before embarking on irreversible, or partially irreversible, treatment [involving cross-sex hormones and surgery].”

Data from gender clinics in the UK and the Netherlands suggest that the vast majority of patients begun on puberty blockers go on to cross-sex hormones supposed to be taken lifelong.

Professor Whitehall says this one-way path is not a surprise.

He highlights the young age of the patients, as well as hormone suppression and its possible damage to executive function and the limbic system in the brain, making it more difficult for these minors to weigh the risks of lifelong medicalisation and inclining them to cling fearfully to an opposite-sex identity reinforced by peers, family and gender clinicians.

“In our professional practice, we are aware of parents and ex-patients who report unsatisfactory experiences of assessment at Australian gender clinics, including, for example, failure to identify and manage conditions such as trauma and autism. These reports suggest that practice in Australia’s gender services may share the problems reported at the [now closed UK Tavistock gender service], including that the focus on gender-related issues may overshadow other issues negatively impacting on a young person’s well-being.”—Melbourne psychiatrist Dr Alison Clayton and colleagues, article, Australasian Psychiatry, 31 August 2024

Video: “The biggest reason I transitioned was just running away from being a girl … I had a lot of sexual trauma when I was a kid, I felt none of that would have happened if I wasn’t a girl…”—detransitioner Heather

Detransition downgraded

There is an emerging group of detransitioners internationally who stop hormonal treatment and re-identify with their birth sex, often with the loss of friends and clinical help.

The Sax report acknowledges “an increased focus on gender detransition” in recent times and offers a short summary of five studies under the euphemistic heading of “care use.”

In the UK, the NHS has announced it will start work next month towards setting up the first service specifically for detransitioners.

Meanwhile, in NSW, the Sax report relegates detransition to an appendix, with the rationale that “care use was not a primary focus of this review, which focused on intervention effectiveness.”

More prominent, in the body of the Sax report, is a Dutch finding that “detransition was very rare.”

But there is support in the scientific literature for Dr Cass’s conclusion that the true rate of detransition for the chiefly female teenagers in today’s gender clinics is unknown or potentially rising.

Nor are readers of the Sax report told of the 2021 study by US physician and researcher Dr Lisa Littman in which only 24 per cent of 100 detransitioners told their former gender clinicians they had detransitioned. Gender clinician claims of regret below one per cent lack credibility.

The Sax report does cite an Australian paper on “desistance,” whereby a young person’s gender distress resolves or disappears. Elkadi et al reported that nine per cent of a group of young patients diagnosed with gender dysphoria at the NSW Health Children’s Hospital at Westmead, Sydney, had desisted.

The Elkadi authors, most of them affiliated with the Westmead hospital and the University of Sydney—appear to be relatively isolated in Australia as a source of expert opinion willing to scrutinise the dominant gender-affirming approach.

This 2023 paper is one of three internationally significant publications since 2021 written by Westmead’s child and adolescent psychiatrist Dr Kasia Kozlowska and her colleagues.

They have weighed the risks of gender-fixated medicalisation against the need for a more thoughtful examination of problems such as family trauma, sexual abuse, depression and autism affecting distressed young people. And they have been critical of the gender-affirming “Australian standards of care” treatment guidelines issued by the Royal Children’s Hospital (RCH) Melbourne.

This heterodoxy has riled gender clinicians and their lobby, the Australian Professional Association for Trans Health (AusPATH).

After the Elkadi study appeared, the then AusPATH president Dr Clara Tuck Meng Soo sent a report to members in which the study was described as “another damaging paper [containing] outrageous claims.”

“Hopefully, the passage of laws banning sexuality and gender-identity conversion in NSW championed by [independent MP] Alex Greenwich will clip their wings,” wrote Dr Soo, who did not offer any evidence that the Elkadi et al study was in some way advocating an unethical form of therapy.

Displeasure with the Westmead research, which can be seen as an internal obstacle to NSW Health’s embrace of the gender-affirming approach, also appears to have been a factor in the commissioning of the Sax report.

In 2023, after publication of Elkadi et al, the tragic suicide of a female patient at Westmead was used to press the claim that the children’s hospital—seen as offering more cautious mainstream mental healthcare than other state gender clinics—was not providing enough “life-saving” gender medicine.

The young patient had identified as a boy and had expressed interest in puberty blockers, but clinicians reportedly made the judgment that treatment of this patient’s eating disorder should be the priority.

This transition-or-suicide narrative was amplified on 10 July 2023 by the TV Four Corners current affairs program with the long reach of Australia’s publicly funded broadcaster the ABC. The next day, NSW’s newly appointed Health Minister Ryan Park announced a review by the Sax Institute.

“It will look at that [dissident Westmead] research, it will look at the concerns raised by some of the clinicians, but it will also be looking at the research and evidence across the board in relation to this treatment and care, and health services in this space, to make sure the hubs that we have are providing the best care, evidence-based care that’s up-to-date,” Mr Park told ABC radio.

Of the Westmead research, only Elkadi et al was cited by the Sax report, with little sense of the import of this 2021-23 challenge to the ideological gender-affirming model.

Also missing from Sax’s evaluation are the three contentious treatment guidelines driving the uncritical roll-out of more gender medicine for minors in NSW—the “Australian standards” from RCH Melbourne and the clinical guidelines from the Endocrine Society and the World Professional Association for Transgender Health (WPATH).

In a footnote, the Sax report says: “[T]he inclusion of the clinical practice guidelines was not within the scope of this [evidence check update] as the focus of the review was on the underlying evidence rather than clinical practice recommendations.”⁵

The 2024 Sax project is pitched as an update to a previous gender dysphoria evidence check, also at the behest of NSW Health.

Yet, to bump up the volume of the evidence in that 2020 report, Sax decided to include those three guidelines in its survey of the scientific literature. Such guidelines represent expert opinion—potentially groupthink—and are considered to be evidence of least value. Sax’s excuse—the “low number and quality” of empirical studies in paediatric gender medicine.

And so, on the strength of the low-quality 2018 RCH Melbourne guideline, the 2020 Sax report claimed a raft of benefits for puberty blockers—“Reversible, reduced distress, allows emotional/cognitive development prior to [cross-sex hormones or surgery]”. The only harm stated was reduced bone density.

In 2022, in a newsletter for gender clinic patients and families, RCH Melbourne (perhaps belatedly) acknowledged that the effects of puberty blockers on the brain are simply unknown. The clinic hoped to recruit patients as subjects for research into precisely this potentially serious risk.

Today, NSW Health still uses the RCH Melbourne guideline—and the Endocrine Society and WPATH documents—to justify medical interventions for vulnerable and distressed minors.

This year, a peer-reviewed evaluation of international guidelines was published in April—two months after the Sax report was finalised, it seems, and five months before it would be released—as part of the broad inquiry into paediatric gender medicine led by Dr Cass.

The three guidelines used by NSW Health—and by children’s hospital gender clinics across Australia—were rated poorly and not recommended for use. Cross-referencing between gender-affirming guidelines, with WPATH the key influencer, had created “an apparent consensus on key areas of practice despite the evidence being poor,” the Cass report said in April.

“Given the lack of evidence-based guidelines, it is imperative that staff working within NHS gender services are cognisant of the limitations in relation to the evidence base and fully understand the knowns and the unknowns.” Why would the same warning not apply to staff of NSW Health?

Only the 2020 Finnish and 2022 Swedish guidelines—which translated systematic reviews of the (very weak) evidence base into new, cautious treatment policies—were recommended by the Cass-commissioned researchers from the University of York.

This shouldn’t have come as a surprise for Sax or NSW Health, as they sat on their report.

In February 2023, an investigation by the British Medical Journal found serious shortcomings in the Endocrine Society and WPATH guidelines. A month later, a pioneer of the evidence-based movement in medicine, Canada’s Professor Gordon Guyatt, declared that the RCH Melbourne guideline was “untrustworthy.”

One of the stated reasons for the updated 2024 Sax check is to “inform” development of clinical guidance for NSW Health’s fast-expanding Trans and Gender-Diverse Health Service. “[Y]et to be announced” guidelines from NSW Health were mentioned in a Westmead paper by Kozlowska and her colleagues as long ago as 2021.

The weak evidence base remains a problem for any new clinical guidance, as it obviously has been for existing treatment guidelines.

Unless, of course, the Sax disclaimer is taken seriously. Remember, the report claims that, “Although knowledge of the state of the research evidence is an important input, policy decision-making and the development of clinical practice guidelines are separate activities requiring a range of other inputs and consultation activities that were not within the scope of this project.”

GCN put questions to NSW Health, the Sax Institute and BehaviourWorks

1. The Maple Leaf House gender clinic, opened in the regional city of Newcastle by NSW Health in 2021, tells young people that, “Some teenagers take puberty blockers to avoid the irreversible changes of puberty [starting as young as age eight].” As for cross-sex hormones: “Taking hormones can help you change your outside appearance to become the person you truly feel you are inside.” And surgery: “Usually chest surgery isn’t done until after you turn 16 years, and genital surgery until after 18 years.” A 2023 NSW Health document—The Framework for the Specialist Trans and Gender Diverse Health Service for People Under 25 Years—lists “referral for surgery” as part of the care offered by the public TGD Health Service.

2. Asked about this in the NSW Parliament on Tuesday, Dr Chant said she had recognised the perceived conflict of interest and sent a letter of withdrawal from the Sax board “many moons ago.”

3. The 2024 Sax report is presented as an update of a 2020 evidence check, also brokered by Sax for NSW Health and following media scrutiny of gender clinics in The Australian newspaper. During controversy about the safety of the Maple Leaf House clinic, the responsible NSW Health district issued a statement claiming that a Sax evidence check had “found strong evidence for a gender-affirming approach to health care.” This Sax report was not publicly available, but I obtained a copy. It did not find strong evidence for the gender-affirming approach. In fact, the report said the empirical evidence for the claimed psychological benefits of puberty blockers was “weak” and there was only “limited evidence” of improved psychological outcomes for minors on cross-sex hormones. I wrote about this in March 2023. The report now appears on the Sax website with an October 2023 publication date. This 2020 Sax report was not mentioned in the government’s “historic” LGBTIQ+ Health Strategy launched in March 2022. The ensuing Framework for the Specialist Trans and Gender Diverse Health Service for People Under 25 Years, dated July 2023, does cite the 2020 Sax report. The framework says nothing about the weakness of the 2020 evidence check but says that young people under age 25 can expect “High quality, safe, timely, affordable, accessible and evidence-based care.”

4. Both Drs Spencer and Amos were critical of the way the Sax report represented studies and scored their evidence quality using the NHMRC system. Dr Spencer said Sax had given a high-quality rating to “poor-quality narrative reviews of old, methodologically flawed and biased observational studies.” Dr Amos said a Sax footnote showed misrepresentation of low-quality case-control studies as high-quality evidence.

5. However, the Sax report does indirectly acknowledge that the RCH Melbourne guideline—promoted by the clinic as Version 1.4 of 2023—is out of date, having no studies on its reference list more recent than 2018, when it was issued.