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Why the long wait for research into puberty blockers and the brain?
It is hard to understand why research into the effect of puberty blockers on the brain was not begun earlier in the history of this off-label drug use with minors, according to Australian barrister Belle Lane.
In her 135-page dossier for family law judges and lawyers, Ms Lane cites the 2020 international study by Chen et al, which identifies many yet-to-be-answered research questions about puberty blockers and the still developing adolescent brain.
Pioneered in the Netherlands in the late 1990s to early 2000s, off-label use of these hormone suppression drugs to interrupt the natural puberty of gender-distressed children has driven the international surge in gender clinic caseloads.
The drugs, which suppress natural sex hormones, have regulatory approval for conditions such as prostate cancer and precocious puberty, but not for gender dysphoria.
Puberty blockers have been promoted as a safe, reversible pause in development, easing the distress of transgender-identifying children as they consider whether or not to go on to lifelong cross-sex hormone drugs. These claims face increasing challenge internationally.
In Ms Lane’s dossier, which became public last month, she noted that Australia’s most influential gender clinic, at the Royal Children’s Hospital (RCH) in Melbourne, Victoria, had launched a study on blockers and brain only last year. In a newsletter to patients and parents, the clinic acknowledged that the effects of these drugs on the brain are unknown.
“This is in the context of the [RCH] gender service presumably having referred children for puberty blockade for at least the last 10 years,” Ms Lane said.
“It is difficult to understand why [the] potential impact on the brain is only being investigated now.
“The process of physical, mental, and emotional maturation in puberty is recognised in every culture and in our legal system. It is not difficult to imagine that blocking puberty would have an impact on the whole human system, including the brain.”
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Video: Psychiatrist Dr Philip Morris on the case for caution
Guidance in absence of data
A former chief justice of Australia’s Family Court, Diana Bryant, told GCN that she regards Ms Lane’s dossier as “a valuable contribution to an area in which there has been a paucity of long-term statistics.”
Ms Bryant presided over the appeal court that liberalised access to puberty blockers in the 2013 test case re Jamie, involving a 10-year-old biological male who identified as a girl. The parents, the RCH gender clinic and the Australian Human Rights Commission all argued for less judicial oversight of treatment decisions.
The trial judge in the case was told by the treating endocrinologist, “Dr G”, that puberty blockers were “fully reversible” and had “no side effects.”
The human rights commission claimed there were no alternative treatments for gender dysphoria. It argued that withholding blockers might lead to self-harm by patients, and that the consequences of a mistaken decision to give these drugs were “not grave (particularly because the treatment is reversible).”
The thrust of Ms Lane’s dossier, based on a presentation she gave to family law judges in April, is that in a series of gender dysphoria cases, the Family Court has been presented with one-sided arguments in favour of life-altering medical interventions not supported by good evidence.
Bum steer: Science journalist Jennifer Block calls out the spinning of the Tavistock yarn
Last week, England’s National Health Service (NHS) confirmed plans to confine puberty blockers to clinical trials, “as there is not enough evidence to support their safety or clinical effectiveness as a routinely available treatment”.
Systematic reviews of the evidence base led to a decision last July to replace the London-based Tavistock clinic with a network of gender services anchored in mainstream mental health care. Poor assessment and hasty medicalisation of vulnerable young people were among the concerns about the Tavistock.
(Note: An earlier version of this article stated that blockers would still be available outside research in exceptional cases; that was a proposal in the draft interim specification.)
A new national Children and Young People’s Gender Dysphoria Research Oversight Board, chaired by psychiatrist Professor Sir Simon Wessely, has approved work towards the 2024 launch of a clinical trial of blockers as a gender dysphoria treatment.
“The role of the board is to maintain an overview of emerging national and international clinical evidence and ensure it informs front-line clinical practice [in England],” the NHS said.
Among the members of the board is paediatrician Dr Hilary Cass, whose February 2022 interim report on youth gender care singled out uncertainties about puberty blockers. Her adverse report was followed by the NHS decision to shut down the national Tavistock clinic; the closure is now expected in March next year.
“The most difficult question is whether puberty blockers do indeed provide valuable time for children and young people to consider their options, or whether they effectively ‘lock in’ children and young people to a treatment pathway which culminates in progression to feminising/ masculinising hormones by impeding the usual process of sexual orientation and gender identity development,” Dr Cass said in her report.
“A closely linked concern is the unknown impacts on development, maturation and cognition if a child or young person is not exposed to the physical, psychological, physiological, neurochemical and sexual changes that accompany adolescent hormone surges. It is known that adolescence is a period of significant changes in brain structure, function and connectivity.”
Reportage: The New York Times connects the dots between England’s new cautious policy and similar shifts elsewhere in Europe
“These European countries are reversing course not because they have experienced some religious revival or have been subjected to conservative culture-war politics. Rather, their more publicly rationed form of health-care provision, severely constricted by public budgets, puts a premium on showing good results and thereby limits the reach of ideological fantasy disguised in medical language”—editorial, National Review, 13 June 2023
New Zealand’s high-stakes “evidence brief” on the safety and reversibility of puberty blockers will not be made public for two to three months, that country’s Ministry of Health says.
The brief was to be released in May, then June, and now the ministry says more time is needed to cover recent international developments and to familiarise clinicians with the findings of the brief before they are made public.
A spokesperson for the ministry told GCN:
“With an increasing number of international jurisdictions changing their legislation in this space, and emerging evidence, we have had to ensure that [the] most up-to-date evidence has been reviewed and included in the brief. This has meant adding several more studies to the original brief.
“The increased level of public interest has meant we have taken extra care to ensure that our findings will be communicated clearly.
“From a clinical perspective, there is no immediate urgency to release these findings. The process by which people can consider gender affirming care remains the same.”
Asked the purpose of the evidence brief if it were to have no effect on this gender-affirming process, the spokesperson said: “The findings [of the brief] will help us provide clearer information to the public, patients and their families, as well as relevant clinicians, about whether or not puberty blockers can be considered safe and reversible.”
“On April 4, stories covering the National Press Club speech by [Australian] trans activist and actor Georgie Stone stated puberty blockers were ‘completely reversible’. When the medication is ceased puberty resumes, some other long-term effects are currently unclear”—Correction, Australia’s public broadcaster, the ABC, 8 May 2023
“Puberty blockers are reversible. The only risk is that it can affect your bone density”—RCH gender clinic director Dr Michelle Telfer, Australian Story, ABC, 20 May 2021
Nothing Down Under?
Meanwhile, the Cass review and Ms Lane’s dossier led an Australian Senator, Matt Canavan of the Nationals party, to ask senior health officials in parliamentary committee hearings earlier this month whether there had been any Australian investigation of “the latest evidence on the long-term impacts of the use of puberty blockers”.
The head of the federal health department, Professor Brendan Murphy, said there had been “no specific work” done, and the department had to rely on clinical advice from “expert, multidisciplinary clinic services, such as [RCH]”.
Pressed by Senator Canavan, who cited the “remarkable growth” in case numbers at the RCH clinic, Professor Murphy said there had been “very significant governance reviews” of the gender clinic by Victoria’s health department and the hospital itself.
“I think we all share the concerns about the capacity of children to make decisions in this matter,” Professor Murphy said.
“We [in the federal health department] have sought assurances from [RCH] that they have a very robust process where there are psychiatrists and psychologists and social workers—their assessments go over many months.”
He also cited a 2019-20 review of gender dysphoria care by the Royal Australasian College of Physicians (RACP) undertaken at the request of the former federal health minister Greg Hunt. (The review followed my news reporting in The Australian.)
The RACP’s four-page letter to Mr Hunt did not discuss the nature or risks of the hormonal interventions under scrutiny, but claimed that a national inquiry into youth gender medicine “would further harm vulnerable patients and their families through increased media and public attention.” It gave no evidence for this claim.
It emerged that the RACP in 2014-15 had lobbied—on one occasion with the RCH clinic director, paediatrician Dr Michelle Telfer—for faster, easier access to the medical interventions that the college was asked to review.
Along with a trans activist group and the college of psychiatry, the RACP was also involved in a 2016 project seeking $8 million in public funding to set up a gender clinic network for Australia’s most populous state, New South Wales. The project drew on the RCH model from the state of Victoria and cited “close consultation” with Dr Telfer.
Treatment that blocks recovery
Earlier this month, an anonymous Australian child and adolescent psychiatrist uploaded to YouTube a presentation of her concerns about the now dominant “gender-affirming” treatment of children with gender dysphoria.
“Social transition [whereby adults enable a child to live out an opposite-sex role] and puberty blockers prevent children from recovering from gender dysphoria,” the psychiatrist says.
Without these interventions, she says that “between 60-90 per cent of children with gender dysphoria become comfortable with their own body [this called ‘desisting’] by the time they reach adulthood, [according to the scientific literature].
“There is no evidence that children with gender dysphoria in Tanner stage 2 [of puberty]—that is, age 10 to 12—are more likely to persist in their gender dysphoria.
“It is the whole course of puberty that can heal gender dysphoria, through the formation of friendships, the sexual awakening, a broadening of activities, falling in love and experiences of physical intimacy.
“There is no way of knowing which children will persist or desist.
“The evidence underpinning the affirmation model is of very low quality and does not provide convincing evidence of psychosocial gains to justify the harms.”
Harming healthy bodies
Also this month, The Australian newspaper reported the call of a consultant paediatrician, Dr Dylan Wilson, for an independent inquiry into the youth gender clinic in his home state of Queensland.
In a letter earlier this year to the head of Children’s Health Queensland, Dr Wilson said that early puberty blocking followed by cross-sex hormones exposed children to sterilisation and sexual dysfunction as adults.
“These children have healthy bodies at the start of this process [at the Queensland gender clinic]. They have no endocrine disease that needs correcting,” Dr Wilson said.
“But by the time they leave [the clinic], they have had endocrine disease iatrogenically induced by your service. This comes with a number of harms, short-term, long-term and unknown.
“Assessment and exploration of children’s mental state is poor. For example, I have direct evidence of a child being recommended for puberty blockers after two appointments [at the clinic].
“Puberty blockers are not a pause. Nearly every child who commences puberty blockers progresses to cross-sex hormones [according to international data]. Puberty blockers are the start of a lifetime of medicalisation.
“It is evident to most that children cannot consent. Children cannot, at the age of 11, for example, understand the loss of their future fertility and sex life. They cannot understand the impact that may have on relationships.
“I have direct evidence of children treated at [the Queensland clinic] who have reported that they genuinely believed they would become the opposite sex. The lack of genuine consent for this is likely to form the basis of future legal action.
“The commonly repeated trope that these children will kill themselves without this [hormonal] treatment pathway is poorly evidenced, hyperbolic and dangerous in itself.”
In defence of its clinical practice, the hospital said it followed the 2018 RCH treatment guideline for youth gender dysphoria.
Dr Wilson said the RCH guideline was “just one opinion on how children should be treated. It is not definitive. It is not evidence-based.”
“It is hard to understand how Finland, Sweden and the U.K. can conclude there is no evidence, but clinics in Australia can continue to pronounce they are operating an evidence-based practice,” he said.
“What evidence exists here that isn’t available in Stockholm?”
In a comment supplied to The Australian, Children’s Health Queensland said it was “committed to providing the best, safest, evidence-based care and acknowledges that the treatment of trans and gender-diverse children and young people is an emerging field which raises important clinical and ethical questions.”
“It seems that ideology and feelings have been allowed to trump traditional medical evidence in the work [of the Tavistock clinic]. And where ideology impacted [the clinic] so strongly was in the service’s inability to keep an appropriate distance from charities and support groups like Gendered Intelligence and Mermaids. That the bosses of both organisations saw themselves as entitled to write to [Tavistock] director Polly Carmichael directly and demand clinicians be reprimanded, or switched, or that the service go further and faster with physical interventions, is telling”—author Hannah Barnes, “Time to Think: The Inside Story of the Collapse of the Tavistock’s Gender Service for Children”, 2023
In her gender law dossier, Ms Lane noted the influence of the RCH treatment guideline, which is badged as “Australian Standards of Care”, despite there being no government-commissioned or official national standards.
She also posed a question about the line between trans advocacy and medical recommendations.
She noted the overlapping roles of Dr Telfer as lead author of the 2018 treatment guideline; as head of the country’s largest youth gender clinic (2012-22); and as vice-president (2014-18), then president (2018-20), of the gender-affirming lobby the Australian Professional Association for Trans Health (AusPATH), which gave its imprimatur to the guideline.
Ms Lane said critics internationally had raised concerns about the same clinicians being involved in the development of the Dutch protocol, which pioneered the use of puberty blockers, in the standards of care of the World Professional Association for Transgender Health and the Endocrine Society’s guideline.
“The concern is that each group’s development of their clinical recommendations and affirmation of the other’s approach is not truly independent,” she said.
“Arguably, these concerns are relevant to Australia with the connections between the authors of the [RCH] Australian Standards, [the RCH gender clinic] and AusPATH.
“AusPATH states that it has a majority of trans directors on its board and all sub-committees have trans health professionals.
“While it may be admirable for clinical practice to be informed by lived experience, there are concerns about the mix of advocacy and medical recommendations.
“A significant criticism of [the Tavistock clinic] in the U.K. was its close association with advocacy group Mermaids [which lobbies for “trans children”] and the extent of Mermaids’ influence on the decision-making in the service.”
Note: GCN put questions to RCH, the four authors of its treatment guideline, and to AusPATH’s president. RCH has defended its gender service here. GCN does not dispute that gender-affirming clinicians believe their interventions bring benefit to vulnerable patients.