Drug alert

A disturbing court case on the other side of the world sounds the alarm for Australia's teenage girls on high doses of testosterone drugs

Photo by 🇸🇮 Janko Ferlič on Unsplash

The safety of an unknown number of teenage girls given testosterone by Australian gender clinics is in question following an extraordinary UK court case involving a 15-year-old girl thought to be at risk of sudden death because of a “dangerously high” dose of this cross-sex hormone drug.

England’s High Court heard expert evidence that the teenager, known as J, whose history included autism, self-harm and anorexia, had identified as a boy and was prescribed online a double (“loading”) dose of adult-level testosterone to initiate masculinisation of her body.

A comparable “loading” dose of adult testosterone is suggested as a starting dose for female adolescents in the 2018 “Australian standards of care” treatment guideline issued by the Royal Children’s Hospital (RCH) Melbourne and used by clinics following the “gender-affirming” model across Australia. There is no public data on how many girls nationwide have been exposed to this high-dose testosterone treatment.

Setting out the issues in the UK case of J earlier this month, Judge Sir Andrew McFarlane noted the evidence of an Australian paediatric endocrinologist¹, Dr Jacky Hewitt, that the testosterone level in J’s blood was “dangerously high” in October 2023 after treatment running from January to August that year.

He said Dr Hewitt had advised the court that, “apart from the potential for adverse long-term consequences of such a level, J was ‘presently at risk of sudden death due to thromboembolic disease’, meaning the potential for the hormone to cause thickening of the blood [polycythaemia].”

She explained that the dosage of 1000mg of long-acting testosterone undecanoate “was at the level that one would administer to an adult only after a course of treatment that would have started at a much lower dose but built up to 1000mg/4ml over the course of two or three years,” the judge said.

“Not only did [the online clinic] GenderGP prescribe this top-end dosage to a testosterone-naïve child, but they did so by directing a ‘loading’ (double) dose² at the commencement of the treatment.”

“Dr Hewitt advised ‘with confidence’ that ‘there is no professional society of paediatric endocrinologists internationally who would consider this anything other than a highly abnormal and frankly negligent approach’. She stated that ‘in Australia, the treatment provided by GenderGP would be unlawful³’.” 

She had “never before (in her 20 years in the field) seen such a ‘massive dose’ of testosterone administered to a young person,” said Judge McFarlane.

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Screenshot: GenderGP promotes the “Australian standards of care” issued by the Royal Children’s Hospital Melbourne

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Rogue dispensary

GenderGP, which rejected the verdict of last month’s Cass report that the evidence for hormonal treatment of transgender-identified youth is “remarkably weak”, has said it follows the 2018 “Australian standards of care” treatment guideline issued by RCH Melbourne⁴.

In the particular case of J, it is unclear whether GenderGP was using the RCH guideline. The online clinic, originally a British entity but now operated out of Spain, was not a party in the High Court proceedings. The RCH guideline was not mentioned in the judge’s decision.

The guideline advises that trans-identifying female adolescents in later puberty (at Tanner stage 4-5) who, like J, have not been on puberty blockers to suppress their natural sex hormones, can be started on a loading dose of 1000mg testosterone undecanoate involving a second adult-level dose at six weeks and thereafter every 12 weeks⁵.

Apart from the RCH document, the international treatment guidelines invoked as guarantors of quality care by Australia’s children’s hospital gender clinics are the 2017 guideline from the Endocrine Society and the (2012, then 2022) standards of care from the World Professional Association for Transgender Health (WPATH). These documents advise starting adolescent females gradually on lower doses of short-acting testosterone esters. Both the Endocrine Society and WPATH stipulate 1000mg of testosterone undecanoate every 12 weeks as an adult dose.

The RCH guideline also offers clinicians the option of starting late-puberty patients gradually on the shorter-acting testosterone enanthate recommended for those earlier in puberty and currently on puberty blocker drugs.

GCN put questions about this safety issue to public health authorities responsible for youth gender clinics across Australia.

The only reply was from SA Health, which has oversight of the clinic at the Women’s and Children’s Hospital in Adelaide. Although this clinic follows the RCH treatment guideline, it does not use a loading dose of testosterone, according to an SA Health spokeswoman. “All youth undergo initial assessment and care as indicated from the mental health team prior to medical assessment or care,” she said.

In a 2021 US podcast interview, Australia’s most influential gender clinician, paediatrician Dr Michelle Telfer, said her RCH Melbourne gender clinic team created their own 2018 treatment guideline because international guidelines had fallen “out of date.⁶”

Researchers commissioned by England’s Cass review recently evaluated gender dysphoria guidelines internationally and the RCH guideline scored only 19/100 for the rigour of its development, compared with 71/100 for the more cautious and up-to-date Swedish guideline.

“When a child enters the clinic of a paediatric gender endocrinologist for their first injection of a puberty blocker, they have zero endocrine disease. That child’s hormone levels are all exactly where they should be. Yet when they leave, the paediatric gender endocrinologist has induced abnormal hormone levels. When that child turns 16, that iatrogenic hormone suppression has continued. The paediatric gender endocrinologist then goes one step further, and deliberately introduces exogenous sex hormones. They deliberately raise a female’s testosterone to levels that can only be described as pathological. They are inducing iatrogenic disease. On purpose. Not as a side effect, but deliberately.”—Paediatrician Dr Dylan Wilson, Substack post, May 2022

Missing data

Australia’s taxpayer-funded gender clinics do not publish regular, basic treatment statistics, but patchy data obtained under Freedom of Information law suggests that at least several hundred minors began taking cross-sex hormones from 2016 to 2023 at the three large children’s hospital gender clinics in Melbourne, Perth and Brisbane.

Hormone usage data is unavailable for the large gender clinic at the Queensland Children’s Hospital and the fast-growing Maple Leaf House clinic in regional New South Wales. There are also smaller clinics in Tasmania and South Australia. And there is a push for general practitioners to initiate 16- and 17-year-olds on hormones without specialist backup. The RCH treatment guideline is used across the country.

The number of Australian girls started on an adult dose of testosterone is unknown but in a 2022 follow-up study on pelvic pain among 158 trans-identifying female minors at the RCH gender clinic in Melbourne, 84 (53.2 per cent) of the group had been given a high dose of testosterone at the outset.

Apart from pelvic pain, the effects of testosterone include vaginal atrophy potentially requiring hysterectomy, sexual dysfunction, clitoral growth and discomfort, mood changes, aggression, infertility, and an increase in red blood cells with the risk of blood clots, heart attack or stroke.

Dr Telfer, who directed the RCH gender clinic from 2012-2022 and is first author on the RCH treatment guideline, has said that “a level of oversight” is required with testosterone drugs “to keep things safe”.

“We do measure testosterone levels in the blood to make sure those levels aren’t too high,” she said on the 2021 podcast⁷.

“We know there are risks of having too much testosterone in your system—for example, your haemoglobin [and] haematocrit can increase, and that can increase the risk of clots in your blood… which can lead to heart attacks and strokes.”

Dr Telfer compared this to the risk for athletes who take “testosterone-like” drugs to enhance performance.

In 2017, Dr Telfer’s clinic ran test litigation to persuade Australia’s Family Court that the science of gender medicine had advanced such that the judges could safely wind back their supervision of the decision to start a minor on cross-sex hormones with irreversible effects, including possible sterilisation. A draft form of the 2018 RCH treatment guideline was admitted into evidence as proof of this scientific progress.

The legal reform campaign succeeded but the court’s 2017 test-case decision approving testosterone for a 16-year-old trans-identified female known as “Kelvin” did not state the safe dosage for adolescents⁸.

In their reasons, the judges did refer to the claim that minors could avoid the delay and cost of a requirement for court approval by “cheaply and freely” getting hormones online and end up taking “inappropriate dosages of hormones which can be life threatening.” This seemed to be offered as another reason to wind back judicial oversight, except in cases where parents or doctors were at loggerheads.

It’s experimental

GCN sought comment on the case of J from an endocrinologist independent of gender clinics—Dr William Malone is an American endocrinologist and advisor with the Society for Evidence-based Gender Medicine, which scrutinises the evidentiary standards, ethics and safety of these medical interventions.

“I think it’s safe to say the whole thing [the hormonal treatment of minors with gender distress] is experimental, and based off of ‘expert opinion’,” Dr Malone said.

He noted that the goal was to attain male testosterone levels in a female body.

“I agree that rapid initiation [with testosterone drugs] would carry increased psychological risks, but I’m not sure about clotting/myocardial infarction [heart attack],” Dr Malone said.

“The main risks of blood clots, hypertension and liver damage should be proportionate to the maximum testosterone level achieved, if one can even use that word.

“I think the main point is that these protocols [set out in treatment guidelines] look official because they’re on medical society paper, but they’re absolutely experimental⁹ in every sense of the word.

“If we return to basic principles of ethical medicine, we shouldn’t experiment on young people outside of ethically designed clinical trials designed to determine if the interventions actually improve mental health.”

“In 2022, almost 500 females aged 14-18 started Australian government-funded testosterone as if they were being treated for the male malady of ‘androgen deficiency due to an established testicular disorder’.”—Gender Clinic News, November 2023

Frictionless hormones

In the UK case of J, her only live interaction with GenderGP was with a counsellor, according to Judge McFarlane’s decision. There was no direct communication with a doctor, no medical examination, no blood testing or other clinical evaluation.

The prescription was signed by a Barcelona-registered doctor with a postal address in Bucharest. The doctor’s accompanying letter said J “has undergone a full gender appraisal by our team, and we are confident that they fulfil the criteria for medical intervention as per [National Health Service] specifications.” J’s NHS primary care doctor gave the testosterone injections.

The RCH treatment guideline sets out prerequisites for starting testosterone, including blood tests and medical assessment with counselling about fertility; it also advises monitoring of testosterone levels.

In J’s case, her father had argued that she was “not competent to consent to [testosterone drug intervention], having regard to the serious, lifelong and irreversible nature of the treatment and J’s underlying and co-existing diagnoses of autism and anorexia.”

J’s mother supported the girl’s wish for testosterone. The separated parents nonetheless agreed that J could undergo assessment at Gender Plus, a new private clinic in London, meaning it was premature for the judge to rule on disputed issues in the case.

Dr Hewitt’s alarm at J’s testosterone level was countered in the proceedings by the opinion of a paediatric haematologist, Dr Russell Keenan, “who advised that the results were effectively normal when compared to reference points relevant to an adult male (which Dr Keenan considered was the appropriate comparison in this case)¹⁰.”

In gender medicine, there is a trend to adopt opposite-sex reference points for health and medical indicators, as if hormonal intervention has changed the sex of the body.

The drug cited in the RCH Melbourne guideline—Reandron 1000mg testosterone undecanoate—is used off-label, meaning it does not have regulatory approval for use with youth gender dysphoria.

Product information published by Australia’s Therapeutic Goods Administration warns that, “Cases of benign and malignant liver tumours have been reported in users of hormonal substances, such as androgen compounds.” For women, the drug is “contraindicated”—not to be used.

“Clinical trials with Reandron 1000 have not been conducted in children or adolescents under the age of 18 and use in this population is not recommended,” the product information says.

GCN sought comment from the Royal Australasian College of Physicians, the Endocrine Society of Australia, the Australia and New Zealand Society for Paediatric Endocrinology and Diabetes, GenderGP, RCH and Dr Telfer, as well as health authorities responsible for youth gender clinics in Western Australia, Queensland, Tasmania, and New South Wales. GCN also approached prominent endocrinologists. In the case of J, no endocrinologist could be found in the UK willing to give expert evidence to the court. GCN does not dispute that gender-affirming clinicians believe their medical interventions benefit vulnerable young patients.

1. Dr Hewitt was first author on a 2003-11 follow-up study of 39 patients at the Royal Children’s Hospital (RCH) in Melbourne. The 2012 journal article says “very close collaboration is required between psychiatrists, endocrinologists and gynaecologists, with regular case conferencing and clinical group meetings to discuss management, establish [an] audit process, and review new literature.”

2. At the start of his decision in J’s case, the judge refers to dosages “every 3 months” but elsewhere he says “every 6 weeks”. It’s possible he meant a loading dose to begin treatment—two 1000mg doses 6 weeks apart—followed by 1000mg doses every 12 weeks. This would be consistent with the dosage allowed under the RCH guideline. GCN sought clarification from UK lawyers in the case and Dr Hewitt.

3. The UK court decision does not state how this treatment would be unlawful in Australia. GCN sought comment from Dr Hewitt. In Australia, court approval is needed to start a minor on cross-sex hormones if there is disagreement between the parents or doctors. Australian family law also requires a formal diagnosis and multidisciplinary assessment, according to emeritus professor of law Patrick Parkinson.

4. In a 2020 podcast interview with RCH gender clinic director Dr Michelle Telfer, GenderGP’s co-founder Dr Helen Webberley described the RCH guideline as “beautiful”. The guideline broke with international counterparts by doing away with minimum ages for hormonal interventions. Dr Webberley said the RCH document gave “backup” and “permission” to clinicians “who have that gut feeling that this is the right thing to do, but nothing to back it up with—and that’s what was missing, wasn’t it?”

5. The RCH Melbourne document, elsewhere drawing on pre-existing guidelines, does not cite any specific evidence or authority to support its advice that adolescents can safely be started on a loading adult dose of testosterone, rather than a gradual increase in dosage. A 2021 paper, with RCH staff among its authors, notes that international guidelines recommend the use of short-acting testosterone preparations with adolescents. However, the paper says that if these preparations are “unavailable or unacceptable (eg, because of frequent injections), alternative regimens and routes may also be used. Longer-acting injectable testosterone preparations are more typically reserved for use in those with well-established pubertal hormone exposure.” The paper also cautions that, “Endocrine practice in this area remains relatively new with sparse medium- and long-term outcome data.”

6. The RCH authors of the 2018 guideline version published in the Medical Journal of Australia claimed they could not rate the strength of the evidence said to support their treatment advice because of the “scarcity of high-quality published evidence”. This claim led a pioneer of evidence-based medicine, Professor Gordon Guyatt of Canada’s McMaster University, to declare the RCH guideline “untrustworthy”.

7. On the 2021 podcast, Dr Telfer explained that with a younger female patient already on puberty blockers, “we would start the dose [of testosterone] at a much lower level and very slowly increase that dose in increments so that we’re mimicking an endogenous puberty.” However, she said, the dose would be increased more quickly for a minor at age 16-17 who had gone through puberty. “We do in all cases grade up the dose until we’re at a level [where] that person is getting the effect that they need physically and also the effect that they need from a mental health perspective.”

8. Some Australian Family Court decisions approving trans testosterone simply state that the drug is to be administered “in such dose, in such manner and with such frequency as determined in consultation with the treating medical practitioners to achieve male puberty.” Others are more specific. In the 2015 case re Martin, the judge notes that, “It is likely that the child will be given low shorter-acting doses to begin with and, if he tolerates those well, the doses will be increased and administered in a longer-acting form.” In another case the same year, the court warns of “the possibility that Christopher’s mood may be affected and that Christopher [a 15-year-old girl who identified as a boy] could become aggressive if the testosterone dose is increased too rapidly.” The court also paraphrases a paediatrician in the case stating that “the effect of testosterone on the ovaries and other female organs over time is not well understood and there is a danger of inducing abnormalities, such as ovarian cancer, although this has not yet been extensively studied.”

9. US detransitioner Helena Kerschner has recounted how, just 18, she got testosterone at Planned Parenthood with one appointment and no blood tests: “When the nurse practitioner suggested a lower dose to start, I objected, saying I believed I had ‘higher estrogen than most [girls],’ citing the size of my thighs and breasts as evidence. [The nurse] asked me what dose I would like to start at. Nervously, I said something along the lines of, ‘well, what’s the highest we can go?’”

10. A 2019 Australian position statement on trans hormone interventions for adults advises that, “Standard replacement doses of testosterone are recommended to initiate masculinisation” for trans-identified females, as if treating a male lacking natural testosterone. On the risk of polycythaemia, or an abnormal increase in levels of haemoglobin, the position statement suggests the male reference level should be used for safety monitoring. The position statement gives treatment options including “testosterone undecanoate 1000 mg, intramuscularly administered 12-weekly (with the first two doses 6 weeks apart)”—the same as in the RCH guideline for minors.