Off-label drug alert

South Africa's health professions regulator issues a warning to doctors medicating minors for gender distress

Photo by Aleksei Zhivilov on Unsplash

The health professions regulator in South Africa has issued a warning about the off-label use of drugs for minors with gender dysphoria and says it may develop some form of guidance for practitioners.

On August 12, the Health Professions Council of South Africa (HPCSA) published a statement on its website that one of its regulatory boards had “noted a concern … on the off-label use of drugs on children with gender dysphoria.”

It said the executive committee of the Medical and Dental Professions Board, which has the power to protect the public by de-registering doctors, had “issued an advisory to practitioners that the [use of off-label] drugs needs to be done with care, consent and be based on scientific evidence. Practitioners are advised to adhere to the above-mentioned advisory.”

In many countries, puberty blockers and cross-sex hormones, approved by regulators for other conditions, are prescribed off-label for gender-distressed minors, meaning without regulatory approval or clinical trials testifying to the safety and efficacy of that use.

Earlier this month, in response to questions put by GCN, the HPCSA said “it can be expected that a policy, guide or even a position statement will shortly follow to embellish on the [August 12] statement previously made.”

Mr Mpho Mbodi, head of division for professional practice at the HPCSA, told GCN that the August 12 statement was “not a direct response to a particular complaint, but it was [the medical board’s] general reaction to several enquiries received on the matter.”

The HPCSA had also given some clarification of the August 12 statement to the health professional watchdog group First Do No Harm South Africa (FDNHSA), which has kickstarted debate in the country about the weak evidence base for medicalised gender change of minors.

The group, whose members are predominantly doctors, was told by email that the August 12 advice was “meant as a holding measure whilst the [medical] board consults with practitioners who may be implicated in this practice. A definitive board position is yet to be developed and communicated to all interested parties.”

“Until recently, it has been very difficult to have open debate in South Africa. Some doctors who have expressed concern about the lack of evidence for ‘gender-affirming care’ have been reported to professional bodies and employers, forced to undergo hearings, had their concerns misrepresented and their character attacked in public.

“This has resulted in a climate of fear and extreme reluctance to discuss or debate or speak out in public—whether in the media, the healthcare environment, in academia or in schools.”—Drs Allan Donkin, Reitze Rodseth and Janet Giddy of FDNHSA, opinion article, Mail & Guardian, 21 July 2024

We knew it was coming

Although data is lacking, South Africa’s gender clinicians appear to be operating on a smaller scale than in Western nations, although they have been campaigning for a few years to increase the uptake of puberty blockers, cross-sex hormones and transgender surgery.

South Africa is not the only place where the gender-affirming treatment model has landed as an import from a more affluent world, but the stakes are high for this black-majority nation of 60-plus million people. The health system is already under strain with inadequate budgets and the heavy burden of HIV/AIDS, tuberculosis, diabetes, kidney disease and injuries from chronic violence.

If costly puberty blockers are mostly limited to middle-class families with doctors in South Africa’s private health sector, there is a push in public and rural healthcare to promote cheaper cross-sex hormones for adolescents and young adults, including black and mixed-race patients thought to be gay or lesbian.

But Dr Allan Donkin, a general practitioner¹ and one of the founding members of FDNHSA, believes South Africa has a chance to avoid some of the damage being done in the developed world because his country tends to be a late adopter of medical novelties.

“Usually, things in America follow on to South Africa a few years down the line. So, we get a heads up and a warning,” Dr Donkin told GCN.

In 2021, he felt “grave concern” after watching an interview with the US journalist Abigail Shrier, author of the book Irreversible Damage: the Transgender Craze Seducing our Daughters.

“I predicted that this would come our way, and later that year, I saw a patient with adolescent-onset gender dysphoria in my own practice for the first time,” Dr Donkin said.

“I knew that we were going to be looking at an exponential increase.”

Even so, he hopes his country may be able to stem or slow the growth of socially driven gender medicalisation, if health authorities are prudent and take advantage of the now considerable body of international reviews adverse to the “gender-affirming” treatment approach.

The affirmative worldview has for some years been making itself felt in rural health, even in the field of drug-resistant tuberculosis, and threatens to divert scarce time and resources once dedicated to HIV/AIDS, according to public health specialist and physician Dr Janet Giddy, another founding member of FDNHSA.

“We have huge problems with poverty and diseases,” she says. “They talk about the ‘quaternary burden of disease’—it’s chronic diseases, it’s infectious diseases, it’s maternal-child health, and it’s violence and its effects.”

The national government, she says, is overstretched and although it wants to appear “quite woke and progressive,” it has not yet engaged with the gender medicine lobby. This makes it hard to assess how many South Africans are being medicalised in the name of gender.

“I think it’s much more common [than might be suspected] because it’s been going on for a few years,” Dr Giddy says.

“Baragwanath [Hospital in impoverished Soweto] is a war zone. People come in with gunshot wounds every day and have to sit in casualty, waiting, because there’s not enough doctors. The idea that you walk past them to go get your double mastectomy, because you paid $20 to someone you know [in the hospital] and have a fake letter [stating the requisite time spent on hormones], is obscene.

“The perception is that the [South African] government doesn’t do anything well, but the problem is, they do bad things well, so you underestimate the power of corruption. I’m afraid that South Africa is ripe for the picking for this [gender] ideology.”—Sweden-based, South African counsellor Angelo Vincent Deboni

Medicating tomboys

A South African offshoot of the London-based Our Duty network for parents emerged in May. It is too early to pick a trend, but those joining so far typically have trans-identifying children in their 20s and only half those young adults are female—a patient profile different from the chiefly teenage female caseloads in Western nations.

“This really seems to have hit a slightly different age, maybe because of Covid, maybe because we’re always a bit behind the rest of the world,” says the spokesperson for Our Duty South Africa.

“I think it’s fair to say the pandemic, for us, was a massive accelerant.

“We do know that general practitioners are giving out puberty blockers in the private sector to 12-year-olds, mostly tomboys.”

She says the early members of the local Our Duty group have been mostly English-speaking middle-class people, who are perhaps more likely to be alerted to international scepticism about gender medicine. As for their gender-distressed children, some have pre-existing mental health issues or trauma.

There are “sensitive kids, maybe a little bit arty, a little bit nerdy [who] stumbled across [trans] either online or though clubs at university,” the spokesperson says.

Some of these young adults seem “spectrumy,” not especially troublesome, but “kids taking their pain inside.”

By the time the doctors associated with FDNHSA broke cover in January this year with an opinion article in the liberal-minded Daily Maverick newspaper, they were able to alert readers to new critiques of the puberty blocker-driven “Dutch protocol,” as well as the adoption of more cautious, less medicalised treatment policy overseas led by progressive Nordic countries since 2019.

This first opinion article was signed by 22 South African health professionals. Like Dr Donkin, a doctor in the province of Western Cape, most are medically trained but the group included two psychologists.

Their article described the concerns and crosscurrents of the international debate—much of which would have come as a surprise to a local readership—and noted the precept of South Africa’s constitution that, “A child’s best interests are of paramount importance in every matter concerning the child.”

“Absolutely, gender-affirming care is colonialism from America. There is USAID [overseas development] money pushing this. There’s definitely a big question about the financial implications [of gender medicalisation for South Africa’s] public health sector.

“Not just in terms of the surgery hours, but the cost [of the hormonal] drugs over a lifetime, and then, when the iatrogenic diseases start to develop, we’re looking at a whole other chronic health problem. And that’s aside from the fact that, I think, this is Aversion Project 2.0—we’re ‘transing away the gay’ in effeminate gay men and lesbians. It can still be dangerous to be either in many parts of South Africa, but we need to change that, not LGB bodies.

“This medicalisation does seem to be affecting all South African population groups, although young minors going to the gender clinic of Cape Town’s Red Cross War Memorial Children’s Hospital seem to be predominantly white. From age 18 up, however, anecdotal reports suggest that patients in the public health system prescribed cross-sex hormones are predominantly black or mixed-race adolescents and young adults.”—Spokesperson, parents’ group Our Duty South Africa

Contradicted by Cass

A month after FDNHSA initiated debate, Daily Maverick published a reply from the Professional Association for Transgender Health South Africa (PATHSA is the local counterpart of the World Professional Association for Transgender Health) and the Southern African HIV Clinicians Society (SAHCS issued a gender-affirming treatment guideline in 2021).

In their reply article, these two organisations offered familiar, gender-affirming reasons for reassurance: not all gender-distressed minors seek medical interventions; social transition to an opposite-sex identity does not always lead to medical transition; the increase in the number of gender dysphoria diagnoses is a good thing because it signifies more acceptance of “diverse-gender identities.”

They claimed that concerns about the effect of puberty blockers on “fertility and bone health, while noted, are often overstated, and the benefits far outweigh potential risks.”

Many of the claims and arguments of their article would be undermined a few months later when UK paediatrician Dr Hilary Cass published the final report flowing from the world’s most comprehensive review of gender dysphoria care for minors.

The historic Cass report has not been big news in South Africa,² where mainstream media has spent some years platforming the double act of over-confident gender clinicians and biddable parents fed the “transition-or-suicide” narrative. Readers are given the impression that the only problem is the long waiting list that stands between a distressed child and salvation in chemical and surgical form.

“Their mental health improves dramatically to within normal health levels as for their same-aged peers and under one per cent ever choose to stop taking the hormones or have a change in gender identity,” child and adolescent psychiatrist Dr Simon Pickstone-Taylor told the University of Cape Town News last year.

“For pre-adolescent gender-diverse children, all their associated psychopathology disappears overnight when they are supported and allowed to socially transition. It’s like pulling out a thorn.”

No evidence is cited in the article to support these sweeping claims.

In the news24 media outlet in March 2022, Dr Pickstone-Taylor boasted of “over 40 schools (both private and public) in the Western Cape where children have socially transitioned with professional support.”

There is also as yet unresolved litigation, backed by trans lobbies, against two schools in the Western Cape—Stellenbosch High and Beaumont Primary—over their alleged resistance to “gender-affirming care” and its enthusiasm for child-led social transition.

Dr Pickstone-Taylor runs the Gender Identity Development Service at Cape Town’s Red Cross War Memorial Children’s Hospital. This hospital, with its publicly funded paediatric endocrinology service, appears to be a key centre for under-18 hormonal treatment. It collaborates with Groote Schuur Hospital—also in Cape Town—where older children are referred. The reach of these gender services is thought likely to extend beyond the middle class.

Apart from his WPATH and PATHSA affiliations, Dr Pickstone-Taylor has an honorary post at the University of Cape Town. Universities and well-resourced non-government organisations, both local and international, help to spread the gospel of gender medicalisation in South Africa.

“Actresses Thishiwe Ziqubu [famous from the 2015 romantic comedy Tell Me Sweet Something] and Mandisa Nduna have quickly become one of the hottest couples in [South Africa] and flag-bearers for the LGBTIQ community, but claim that they never wanted to make their ‘coming out’ as lesbian into a statement.”—TimesLIVE, news report, 2017

“Actor Thishiwe Ziqubu has opened up about his gender transition journey. He asked people to stop calling him Tish, her, or an actress. He also said that he gets misgendered a lot, and needed to correct that.”—The Citizen, news report, 2023

Surgery for survival?

In a 2021 Spotlight article, the mother of a trans-identifying 17-year-old lamented the lack of surgery for minors in South Africa’s public health system “other than a few cases through Red Cross Children’s Hospital.”

“What is often the case is that trans boys [females] may need top surgery [mastectomy] as soon as possible and this is the sort of initial surgery that a trans young person may need to remain alive,” this mother said.

Dr Pickstone-Taylor was quoted, in paraphrase, as saying “the waiting list for surgery in the public health sector is so long that none of those under 18 would be still under 18 when offered surgery.”

“Very few transgender male youth are lucky enough to have parents who can afford to pay for top surgery before 18 years old.”

Spotlight, which promises “public interest health journalism,” has Dr Pickstone-Taylor making the claim, again in paraphrase, that “50 per cent of transgender children will try to kill themselves if they do not get appropriate support.” No study is cited.

The article reported a similarly alarming claim by Chris McLachlan, chairperson of gender medicine lobby PATHSA, that “trans and gender-diverse people [unable] to access gender-affirming care have a 42-45 per cent suicidality³ rate, meaning they would have attempted suicide in their lifetime.”

This time, Spotlight provided a link to research undertaken in South Africa and eight other African countries. This 2019 study does not appear to support the claim attributed to McLachlan. It reported a high level of suicidality—the percentages do not quite match with the Spotlight article—but the results did not compare the relative suicidality of those people with or without access to “gender-affirming care.”

And, in any event, this was a low-quality self-report survey with a sample of people recruited via activist lobbies and therefore unlikely to represent the “trans and gender-diverse” population as a whole. It was funded by a former gay rights lobby from the former colonial power, COC Netherlands.

If Dr Pickstone-Taylor turns up repeatedly in soft media coverage of gender medicine, McLachlan personifies the small network that is busily reaffirming the affirmative model.

A clinical psychologist and non-binary cleric, the Reverend “Chris/tine” McLachlan co-chaired the development group for South Africa’s 2021 SAHCS guideline, was a member of the team that wrote gender-diverse practice guidelines for the Psychological Society of South Africa; helped to write WPATH’s 2022 eunuch-enriched standards of care and also serves on the World Health Organisation’s panel developing its trans health guideline.

In a 2018 journal article, McLachlan argued that the international project to “depathologise” trans-adjacent diagnoses might not be right for South Africa.

“The African context may be more sympathetic towards a person who has a diagnosis [such as gender dysphoria] and is identified as having a mental condition than a person who diverges from what is seen and/or constructed as the norm,” McLachlan said.

“This would grant ‘the patient’ access to gender-affirmative healthcare in order for the person to be ‘healed’ and become part of the ‘normative discourse’.”

“I’m currently counselling two trans-ideating [black] adolescents. What they want is status. They want access to resources. They want privileges. When you grow up in a country surrounded by serious poverty and deprivation, well, that’s a lifeline. 

“And if you grow up with this idea that there was a system that oppressed you because of your skin colour, then you’re going to find any way to avoid being oppressed ever in future. And what they notice is that, if you just say you’re trans, then people kind of make way. Keep in mind, you can’t openly be gay in most parts of South Africa.”—Sweden-based, South African counsellor Angelo Vincent Deboni

“[We are mindful] of global and local anti-gender movements which create a hostile climate for gender work… [and we recognise] the legacies of colonialism and apartheid which erased pre-colonial identities and practices around gender diversity and created profound health inequalities.”—South African gender-affirming position statement, endorsed by American queer theory academic Judith Butler, 18 August 2024

Ubuntu

The expanded version of the 2021 gender-affirming treatment guideline from SAHCS, an organisation held in high regard for its work on HIV/AIDS, invokes the African idea of Ubuntu as if to give Western identity affirmation some indigenous heft—

“Umuntu ngumuntu ngabantu: a person is a person through other people. The African concept of Ubuntu is central to South Africa’s democracy. It calls on us to see the inherent humanity in all people and helps us to understand human interdependence within the indigenous context. All persons need to be seen, recognised and affirmed as who they are, in order to live fulfilling human lives.”

The SAHCS guideline says: “Access to [gender-affirming healthcare] has been geographically restricted in ways that prejudice clients in rural, remote and under-resourced areas.

“Due to South Africa’s colonial and apartheid past, the divide between those who have access to resources and those who do not, continues to fall along racial lines.”

The guideline claims that the psychosocial and medical interventions of “gender-affirming healthcare [are] safe and effective, and the risks and benefits of the various treatment options are well understood.”

That comforting statement would surprise the authors of multiple systematic reviews declaring the evidence cupboard all but empty.

The South African guideline, which is not endorsed by the national government, cites legal advice that at age 12, children with sufficient maturity “may independently give [informed consent] to both psychosocial and medical assessment/s and intervention for [gender-affirming healthcare] without legally requiring the support or consent of their parents/legal guardians.”

“We have this very well organised, very militant [trans activist] elite—NGOs who in the social media domain can really cause a ruckus, and they can try to destroy lives. They’re not medical people. They don’t really understand the detail. They’re just activists. People are afraid to stand up and say something. [Gender medicine has been promoted] as a human rights issue.

“The apartheid legacy gives a particular charge to lefty, middle-class intellectual tribe membership. In this respect, there is a real fear of being labelled or perceived to be allying with anything that isn’t part of the Left-wing package of correct causes for white middle-class lefties. People are afraid of being called ‘transphobic’ because there are hate speech laws here.”—Spokesperson, Our Duty South Africa

Dismissing Cass

Using arguments similar to those deployed in other countries, South Africa’s gender clinicians have argued that the Cass report has little relevance outside the UK.

And yet South Africa’s SAHCS treatment guideline was among 23 such documents from around the world subjected to independent scrutiny in research commissioned by Dr Cass.

For the rigour of its development, South Africa’s guideline scored only 21/100 in the Cass evaluation project. For overall quality, the guideline’s score was 3/7. None of the three reviewers in the evaluation recommended that the South African guideline be used with gender-distressed children.

“Most national and regional guidance has been influenced by the World Professional Association for Transgender Health and Endocrine Society guidelines, which themselves lack developmental rigour and are linked through co-sponsorship,” said the York University authors who ran the project.

GCN sought comment from Dr Pickstone-Taylor and Chris/tine McLachlan

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1. A general practitioner or GP is a family doctor in primary care.

2. In July 2024, the Mail & Guardian newspaper published a commentary on the Cass report by Drs Donkin, Rodseth and Giddy of FDNHSA. The Cass review was covered by the South African specialist media outlet, Juta Medical Brief, which has also reported on England’s Tavistock clinic controversy and recent US news that discouraging data on puberty blockers had been withheld.

3. Suicidality refers to suicidal ideas or intentions.