The United Kingdom will move forward with a new medical research trial into the use of puberty blocker medication in the treatment of youth experiencing gender incongruence.
Researchers at King’s College London said the two year Pathways trial would analyse the physical, social and emotional wellbeing of about 226 young teenagers.
The announcement and details of the project has drawn criticism from both sides of the debate over the treatment of transgender youth.
The research will cover two projects.
The Pathways Trial is described by researchers as a carefully designed clinical trial of puberty suppression. It is open only to those accessing specialist NHS care and support for gender incongruence and co-occurring conditions, who meet the clinical criteria, and after approval by an independent expert panel. Consent from the young person’s parent or legal guardian will also be needed.
While Pathways Connect is a study of brain health comparing those receiving puberty suppression together with psychosocial and other non-medical care with those receiving psychosocial and other non-medical care alone.
Both studies are part of the larger Puberty Suppression and Transitional Healthcare with Adaptive Youth Services (PATHWAYS) study, which aims to find out how the NHS can best support children and young people attending gender services.
Professor Emily Simonoff, Professor of Child and Adolescent Psychiatry at the Institute of Psychiatry, Psychology & Neuroscience and Chief Investigator of the study, explained the project.
“All young people attending NHS Children and Young People’s Gender Services receive a comprehensive package of assessment and support which can include a mix of paediatrics, psychological therapies, occupational therapy, communication interventions, family and school support.
“We are already evaluating young people’s experiences of these services in the world’s largest observational study of its kind, called Pathways Horizon.”
“We expect that a much smaller number of young people attending the services may also want to consider puberty suppression after accessing extensive gender incongruence support.
“They will receive comprehensive information about what taking part in the trial would involve, and would also need the consent of their parent or legal guardian, and the agreement of their lead clinician and a multidisciplinary team that they have a reasonable prospect of benefiting from taking part.” Professor Simonoff said.
The trial will begin recuiting subjects in January and is expected to induct five to six patients each month. THere is no minimum age for participation but researchers have noted that puberty usually begins for girls around the age of 11 and boys experience puberty a year later.
The new research follows on from the release of the Cass Review, which questioned the treatment of transgender youth in the United Kingdom, and the research that treatment approaches were based on. The review has been criticised by international experts in the field, but also welcomed by advocates who argue against the affirmation model of care.
Dr Hillary Cass, who authored the review, has welcomed the commissioning of the new trial.
“My review uncovered a very weak evidence base for benefits from the use of puberty blockers for children and young people with gender dysphoria. In fact, some children had more negative than positive effects.
“However, given that there are clinicians, children and families who believe passionately in the beneficial effects, a trial was the only way forward to make sense of this.” she told the BBC.
“Although a lot of media attention has focused on the trial, they have a much broader research programme. Following the outcomes for young people who do not elect for a medical pathway will be just as important as following those who do.” Dr Cass Said.
Following the release of the report the UK government stopped all new prescriptions of puberty blockers for patients under the age of eighteen outside of a clinical trial.
The trial will cost the equivalent of AUD$20.3 million and see half of the patients gain access to puberty blocker medication, while the second half of the cohort would have to wait a year before accessing the medication, given only psychological support for that period.
It’s been suggested that those undertaking the trial will have to fill out around 50 different forms to be considered and questions will delve into their past trauma experiences and history suicide ideation.
Parents in the United Kingdom who are eager for their children to be treated have criticised the approach describing it as a return to the ‘wait and watch’ approach.
Chay Brown, the director of operations at advocacy group TransActual, told Pink News that the approach being taken was disappointing.
“It breaks my heart when I think of the young people affected. This research is not about the safety of these medications which have been used for this very purpose since 1989. It is the result of an ideological view at the top of the NHS that being trans is a ‘less desirable outcome’.
“This goes against every assurance made previously. I am surprised that this trial received ethical approval. Hard questions will one day be asked of those who have given this trial the fig leaf of ethical approval.”
Keira Bell, who took the Tavistock gender clinic to court in 2020 after she was given puberty blockers and cross-sex hormones as a teenager, said the trial should be halted immediately. If it is not, she says she and another campaigner will start judicial review proceedings at the High Court.
She said it was “disgusting” that children were being put on the drugs when they had already been banned because they were “unsafe”.
In Australia Rachael Wong, CEO of Women’s Forum Australia, said the plans for the UK trial were disturbing.
Appearing on the Sky News program Danica and James Wong said there was no need for the trial to proceed.
“I would say the the entire youth gender medicine industry has been a trial or an experiment on young people and on children To actually now have the NHS formalising this experiment, I just think its disgusting.”
Wong said there plans for the trial lacked “logical rational thinking”.
“There is already plenty of evidence out there to show the harms of puberty blockers to young people.” Wong said, listing loss of sexual function, infertility and bone density loss as potential side effects.
“What are they doing to find out that hasn’t already been found out?” Wong asked.
Earlier the interview Wong criticised Australian Health Minister for describing the science around the treatment of youth experiencing gender incongruence as “evolving”.
“i would debate it contested or evolving.” Wong said. “I think the evidence is there right now to say there is no evidence of benefit and plenty of evidence of harm.”
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