Scrotum-neutral steroids

Lack of the male appendage is pleaded as a discriminatory obstacle to 'gender-affirming' testosterone for females

Photo by Robert Thiemann on Unsplash

The gist

A rule that requires a testosterone cream to be applied to the scrotum is discriminatory because females who identify as transgender “do not have a scrotum,” according to the Endocrine Society of Australia, the body that represents the medical experts on hormones.

Officials in Australia’s federal Department of Health have been working for some time on a change to this rule in order to remove what they describe in internal emails as “unintended barriers to some populations [trans-identifying females] where scrotal application is infeasible.”

The AndroForte five per cent testosterone cream intended for men deficient in this natural sex hormone is available under the taxpayer-funded Pharmaceutical Benefits Scheme (PBS), with the proviso that it be applied to the scrotum, not the torso, to deliver the right dose.

In a letter to the Pharmaceutical Benefits Advisory Committee (PBAC), which advises federal Health Minister Mark Butler on changes to the PBS, the Endocrine Society complained that, “Trans patients prescribed testosterone do not have a scrotum, so under current PBS criteria they are now excluded from using [the AndroForte] testosterone five per cent cream.”¹

The Department of Health has noted “several correspondences” from trans groups claiming that the rule—which stipulates that the cream “must be applied to the scrotum area”—“creates a barrier to transgender patients receiving therapy.” Testosterone cream and gel are popular with those who are needle shy.

There has been a dramatic increase in PBS-funded testosterone for female patients who, according to the paperwork, appear to suffer from male disorders involving unnaturally low levels of the sex hormone testosterone.

There is no PBS subsidy for testosterone if it is given to masculinise the body of a female with gender dysphoria who rejects her birth sex; the evidence base for off-label trans medicine is weak and uncertain.

The use of AndroForte has been rising in recent years.² The PBS spent $2.73 million on this drug from 2016-17 to 2022-23.

In many pages of health department documents obtained by GCN under Freedom of Information law, there is no explicit reference to the fact that what is being discussed is enabling girls and women, who identify as trans or non-binary, to take unnaturally high doses of taxpayer-funded testosterone to masculinise their female bodies.

Nor do the documents show any consideration of the health risks being debated internationally. “Gender-affirming care” is assumed to be mainstream medicine, while health officials focus on questions of cost and usage of the testosterone cream.

Information for health professionals, which is approved by the regulatory Therapeutic Goods Administration (TGA), says AndroForte “should not be used by women or children due to possible virilising effects.”

The scrotum rule for AndroForte application took effect on 1 July 2021, following a request from the drug supplier, Lawley Pharmaceuticals of Western Australia, for a price increase on the grounds that a shift to scrotal application would allow a lower dose than application to the torso and increase the number of treatments per tube, without a higher cost to the PBS.

Although the scrotum rule controversy has run on and off since 2021, the proposal for a change did not come up for consideration by the Pharmaceutical Benefits Advisory Committee (PBAC) until last month.

The agenda for the July PBAC meeting made no mention of it, and the result will not be known until publication of outcomes later this month. There appear to have been technical disagreements and lack of coordination between the PBAC executive, health department officials and Lawley Pharmaceuticals.

A spokesman for the department told GCN that the government relied on PBAC advice before any change to a PBS listing, “such as a change to the clinical criteria.”

He said the scrotum rule went before PBAC as a “non-submission item”—where the change was not one requested by a pharmaceutical company—and such items were “not routinely published on the agenda.”

“I went with the cream (AndroForte) cause I wanted to do low dose and I like the feeling of control it gives me rubbing it in every morning (and also needles are scary).”—trans-identifying female, social media post, Australia

“I’m going to Japan in a month with my parents who both don’t know I’m trans or have been on T [testosterone] for the last 7 months. I use the AndroForte cream (similar to the gels but more concentrated) which comes in a ‘toothpaste tube’ looking thing. If I just put it in my checked luggage will that be fine?”—trans-identifying female, social media post, Australia

The detail

The testosterone cream AndroForte 5 enjoys public subsidy under the PBS for the male conditions androgen deficiency, micropenis, (a need for) pubertal induction, and the constitutional delay of growth or puberty. Prescribing doctors are required to get an “authority”.

Emeritus professor of law Patrick Parkinson has questioned the practice of gender clinicians prescribing PBS-funded testosterone for trans-identifying females supposedly suffering from “androgen deficiency due to an established testicular disorder.”

British paediatrician Hilary Cass, who led the world’s most comprehensive review of youth gender medicine, has warned trans-identifying girls of the powerful, irreversible effects of testosterone, making it harder for them to pass as a woman in the future if they come to regret medicalised gender change.

“Although a diagnosis of gender dysphoria has been seen as necessary for initiating medical treatment, it is not reliably predictive of whether that young person will have longstanding gender incongruence in the future, or whether medical intervention will be the best option for them,” Dr Cass says in April’s final report from her four-year review.

The Cass report concludes that the true rate of detransition—whereby a person ceases gender medical interventions and reidentifies with her or his birth sex—is unknown.

Under the ruling centre-left Labor Party, Australia’s government promotes gender identity ideology and “gender-affirming care”, with the trans medical lobby well represented on the LGBTIQA+ Health and Wellbeing 10 Year National Action Plan Expert Advisory Group chaired by Assistant Health Minister Ged Kearney, a former nurse.

“The trans and gender-diverse community experience many obstacles in accessing and using the healthcare system—that includes accessing gender-affirming care and support,” Ms Kearney said in speech notes for the November 2022 launch of the documentary The Dreamlife of Georgie Stone.³

“We know that transgender children and adolescents have high rates of psychiatric comorbidities, self-harm and suicide attempts⁴ relative to the general population.”

In September 2023, Ms Kearney was briefed by departmental officials on the scrotum rule controversy and the associated discontent of “LGBTI organisations”. She was told that the bureaucracy was working on a solution with AndroForte’s supplier, Lawley Pharmaceuticals.⁵

The scrotum rule controversy appeared as an item in a seven-page memo for Ms Kearney on the extent to which “gender-affirming healthcare” ranging from “assessment, puberty blockers, hormones to surgical intervention” was funded under the PBS and the Medicare Benefits Schedule (MBS).

The handling of a yet-to-be-decided application from plastic surgeons for full MBS funding of a suite of gender-affirming surgeries suggests there is uncritical support for the contentious gender-affirming treatment approach among some officials in the federal Health Department.⁶

In an internal email from February 2023, an official whose name has been redacted says that—

“In addition to the policy/medical considerations for each [trans surgery funding] proposal, the request needs to be considered in the context of the potential for the adverse consequences of identifying, or targeting of individuals having any of these services, or the practitioners providing them, as is occurring in America and the UK by those with vehemently negative views on gender-affirmation interventions.”

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Scrotal exclusion

On 6 July 2022, the Endocrine Society of Australia wrote to the Pharmaceutical Benefits Advisory Committee, the independent expert body which makes recommendations to the federal Health Minister on changes to the PBS⁷.

The society bracketed trans-identifying female patients with disabled males⁸ who actually have a hormonal disorder but might need someone else to apply the cream to their scrotum. The society suggested an amended rule such as “where possible, the treatment [AndroForte] must be applied to the scrotum area.”

“This would ensure trans individuals and those with disabilities—where scrotal application is either not possible or inappropriate—are still able to use this preparation by application to the body,” the society’s letter says.

“Trans patients prescribed testosterone do not have a scrotum, so under current PBS criteria they are now excluded from using testosterone 5 per cent cream.

“Denying access to testosterone cream for these patient groups otherwise disadvantages many who often already come from marginalised communities where healthcare access and outcomes are not equitable.

“Almost 10 per of patients seen at the Monash Health Gender Endocrinology Clinic [which takes young people from age 16 in the state of Victoria] have autism spectrum disorder (ASD), and high rates of ASD are well described in trans patients.

“People with ASD often struggle with the texture of gel preparations and intramuscular testosterone undecanoate often cannot be used either due to significant needle phobia and/or raised haematocrit [with a risk of thromboembolism].

“By excluding the option of testosterone 5 per cent cream, they are finding a significant limitation on options for treatment.”

The letter, from the society’s medical affairs committee, makes no mention of females, girls or women—nor whether it is safe to give them testosterone well above normal female levels.

The society suggests that the “must be applied to the scrotum area” rule is in breach of the federal Sex Discrimination Act, which was amended in 2013 under Australia’s first female prime minister, Julia Gillard, to give protection to the nebulous concept of a self-defined “gender identity” untethered from biological sex.

In 2015, after complaints of discrimination from the group now known as LGBTIQ+ Health Australia, a rule restricting PBS testosterone to males was removed, so that trans-identifying females could get this subsidised hormone for “androgen deficiency”.

That “important and welcome” de-sexing of 2015 was effectively undone by the 2021 imposition of the scrotum rule, according to the society’s letter.

“Acute ischemic stroke may be an under-recognised complication of testosterone therapy in transgender males [i.e., females]... Further research is needed to establish a safety profile of testosterone therapy in this understudied population.”—Journal article reporting the case of an “otherwise healthy” 23-year-old female who, after a year on gender-affirming testosterone, suffered a stroke and developed locked-in syndrome, Neurology, 25 April 2023

Safety first

When putting its successful case for an increase in the price per packet of AndroForte, Lawley Pharmaceuticals argued that scrotal application was safer than rubbing the cream into the torso.

This was because less of it was needed and more was absorbed, thereby reducing the risk of bodily contact with others and the accidental masculinisation of a patient’s partner or children.

Information about AndroForte for health professionals, which is approved by the Therapeutic Goods Administration (TGA), says the cream is “for use as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.”

“Pregnant women must avoid any contact with AndroForte 5 application sites. In case of pregnancy of the partner, the patient must be particularly careful to avoid potential transfer,” the TGA product information says.

“Testosterone should not be used by breast-feeding women. In the event of accidental contact, women are advised to immediately wash with soap and water.

“The physician should inform the patient carefully about the risk of testosterone transfer [within the family, for example] and about safety instructions.”

“[AndroForte] should not be prescribed to patients with a major risk of non-compliance with safety instructions (e.g., severe alcoholism, drug abuse and severe psychiatric disorders).”

As a group, patients with gender dysphoria have an above average incidence of comorbid mental health problems.

Periodic tests are advised to monitor patients on AndroForte for thickening of the blood which might lead to thromboembolism.

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Screenshot: This guide from the website TransHub does not state that the 2 ml dose of testosterone cream is supposed to be applied to the scrotum; the guide is aimed at clinicians prescribing for females who seek to masculinise their bodies

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Hope and change

In 2021, Lawley Pharmaceuticals had formally accepted the outcome of its price-rise application—including the scrotum rule—following the March meeting of the Pharmaceutical Benefits Advisory Committee (PBAC), according to the Department of Health.

However, four days after the new rule took effect, Lawley informed PBAC that, “An unintended consequence of this restriction [to scrotal application] is that a proportion of patients (females) are now no longer eligible to receive PBS-funded AndroForte 5.”

The pharmaceutical company made its views known through a letter written on its behalf by the Melbourne health consultancy CommercialEyes.

“Lawley pharmaceuticals would like to work with the Department of Health to ensure that the treatment of these patients is managed appropriately on the PBS and would like to set up a meeting with the department later this week…,” says the letter dated 5 July 2021. There is no reference to patients with disabilities.

In a same-day reply, a health official said, “Any further changes to this restriction wording will require a PBAC submission [a process involving formal scrutiny] as changes to the wording will have clinical and financial implications that will require evaluation.”

Lawley’s application had requested that use of the cream on the torso remain available, and the PBS restriction to scrotum-only use was a surprise that the company had not picked up in the paperwork, according to the company’s chief executive and medical director Michael Buckley, who is a pharmacist.

“This was a problem of the department’s making, not of our making,” he told GCN.

He said he had been alerted to the problematic rule by clinicians who had been prescribing AndroForte for trans-identifying females. He said he had not been lobbied by groups representing people with disabilities.

Internal documents show that the PBAC executive agreed in principle to a relaxation of the scrotum rule.

However, on 2 January 2024, one Department of Health official emailed another, puzzling over the implications for cost to the PBS if the restriction were changed to, for example, “The treatment must be applied to the scrotum area, where appropriate.”

After seeing the data from before and after the scrotum rule, an official asked if it were “fair to assume that the trans and gender-diverse population [i.e., females]” which had been applying AndroForte to the torso before had kept using it the same way afterwards.⁹

On January 31 this year, Mr Buckley met health department officials, who claimed a price cut would be necessary if the scrotum-only rule went. He disputed the department’s analysis.

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GCN put questions to the signatory of the Endocrine Society’s letter to PBAC

1. A 2022 study, said to be the first of Androforte use among “trans and gender-diverse individuals” (i.e., females), found that the cream achieved serum testosterone levels within the range for males. The median age of the women in this retrospective study was 26; the youngest was 22. “A high proportion of individuals had a non-binary gender identity, with over 50 per cent commencing a lower dose than that administered to hypogonadal cisgender men [males with low levels of natural testosterone],” the authors said. “There are currently limited data evaluating testosterone prescription patterns in individuals with a non-binary gender identity, though a recent analysis from the Netherlands has noted a higher proportion of ‘partial’ hormone treatment amongst all individuals with a non-binary compared to binary gender identity.”

2. In 2019-20, before the scrotum rule took effect on 1 July 2021, there were 242 females begun on AndroForte, compared with 534 males. In 2020, there were 114 female patients registered, an increase of 356 per cent since 2017. In 2022-23, after the scrotum rule took effect, there were 132 females begun on the cream, as opposed to 957 males. However, it is not possible to be confident about the sex stated in PBS data because it comes from the Medicare health insurance system, in which for some years people have been able to overwrite their objective birth sex with a subjective “gender identity”. An unknown number of “males” recorded as AndroForte patients may in truth be females who identify as the opposite sex.

3. At age 10, Georgie Stone was the youngest person to be approved for puberty blockers by Australia’s Family Court. The 2018 gender-affirming treatment guideline issued by the Royal Children’s Hospital (RCH) Melbourne features a photo of Stone, who was appointed as gender service ambassador.

4. There is no good evidence to support the alarming “trans youth suicide narrative”. Robust research suggests the suicide risk in gender clinic patients is linked to comorbid psychiatric disorders and not to gender distress itself.

5. The reference to the scrotum rule in this ministerial brief itself led to complaints from the trans lobby.

6. The fully funded surgeries proposed by the Australian Society of Plastic Surgeons include procedures with high costs and potentially serious complications, such as facial feminisation for a trans-identifying male and the creation of a neo-phallus for a woman who identifies as a man.

7. This letter was among documents released to GCN under Freedom of Information law.

8. A 2019 trans advocacy manual, widely known as the Dentons report, advises activists to, “Tie your [trans rights] campaign to more popular reform” to “provide a veil of protection [when] gender identity remains a more difficult issue to win public support for.”

9. On a trans social media platform two years ago, one Australian user noted that AndroForte was “a little harder to have prescribed with recent changes to PBS” but “no harder” than testosterone by injection.