Protesters have marched against the ban on puberty blockers for young people (Image: Getty)
Children will be given puberty blockers in two-year clinical trial from this spring, after researchers were awarded £10.7million for a gender care study.
The , which suppress hormones linked to puberty, have been banned indefinitely in the UK for under 18s after experts raised concerns they posed an “unethical safety risk”.
Health Secretary announced in December that a clinical trial would be launched to “establish a clear evidence base for the use of this medicine”.
However, some experts have warned that the commissioned study is “unethical” as it will only monitor young people for two years, which may not be enough to prove benefits or identify risks.
Dr Louise Irvine, co-chairman of the Clinical Advisory Network on Sex and Gender, said it would “add nothing to the research already done”.
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She added: “The Cass Review said there was a lack of long-term outcome studies and this is just more of the same. I am shocked they are putting children through the known risks of puberty blockers for no gain in knowledge, and I consider it totally unethical.”
Puberty blockers were prescribed to thousands of children through the Tavistock clinic, also known as the Gender and Identity Development Service (GIDS).
The 2024 Cass Review, launched after reports from whistleblowers, identified serious concerns about the service which suggested some children were rushed into taking hormones.
It concluded the quality of studies claiming to show beneficial effects of such medication for children and young people with gender dysphoria was “poor”.
Baroness Hilary Cass, who led the report, said the research aims to “fill some of the gaps in our knowledge about the outcomes of different interventions and address some of the uncertainty about the impacts and efficacy of puberty suppressing hormones”.
She added: “Access to the study will be through the new NHS children and young people’s gender services where a multi-disciplinary team approach will be taken to identify those children who, with the consent of their parents, may be deemed clinically suitable for consideration of puberty suppressing hormones through the study.
“The children participating in the study will also continue to receive comprehensive psychosocial support.”
But Dr David Bell, a psychiatrist who was a whistleblower at the Tavistock trust, suggested the NHS-backed trial amounted to “an experiment” being carried out on children.
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He added: “If we accept that puberty blockers were an experiment that failed many many children, how can we justify conducting a trial when we know that a significant number of children will be harmed?
“There are a number of reasons why it is unethical. Once children are started on puberty blockers it’s extremely hard for them to come off them. By starting puberty blockers children are in effect being put on a medical pathway to gender transition which will include, for many, progression to surgery.
“The prescribing of puberty blockers introduces physical harms to a physically healthy child. There is significant evidence that puberty blockers seriously impact on bone density.”
Led by King’s College , the puberty blocker trial will form part of the four-part wider Pathways study.
It will see young people, who have the agreement of their parents and NHS gender services, given puberty suppressing hormones (gonadotropin releasing hormone analogues or GnRHa) while having their physical, social and emotional well-being monitored across two years.
Other parts of the overall study will involve tracking the well-being of children, including those not on the puberty blocker trial, attending NHS gender clinics.
The research will also monitor whether puberty blockers affect young people’s thinking and brain development, using various activities and brain scans.
Researchers will speak to young people about their experiences of living with gender incongruence and of the care they get, as well as obtaining the views of parents and staff.
The first patients had been expected to be recruited to the puberty blocker trial this spring but the NHS has noted this will be subject to strict ethical and regulatory approval.
Professor James Palmer, NHS national medical director for specialised services, said: “This suite of research will examine the evidence for a range of clinical care, including the use of puberty suppressing hormones, following advice from the Cass Review.
“Independent researchers led by King’s College London will now progress this joint NHS and NIHR project, which will be subject to strict ethical and regulatory approval and follow stringent safeguards in scientific research.
“In the meantime, the NHS continues to expand and improve services for children and young people with gender dysphoria and incongruence, in line with recommendations from the Cass Review.”