NHS England has confirmed that the first clinical trial testing the effects of a puberty-blocking drug will not start recruiting patients until early next year, several months later than planned.
The trial, which will investigate “the potential benefits and harms of puberty-blocking hormones in children and adolescents”, was originally due to begin later this year.
Sources say the trial could potentially involve thousands of children and young people in England who are questioning their gender identity. trial The commission was set up to provide evidence on puberty blockers after a groundbreaking review into transgender medicine by Dr Hilary Cass in April found them to be an unproven treatment that could also harm those who take them.
The drug is used to suppress the development of the sex hormones testosterone and oestrogen, as well as the growth of breast and facial hair. Ms Cath’s highly regarded report said the NHS should exercise “extreme caution” before giving it to young people.
The previous Conservative government banned the vaccine and its successor Labour government has supported that stance, with Health Minister Wes Streeting warning there is a lack of evidence to show the vaccine is safe for use in such vulnerable patient groups.
NHS England’s willingness to enrol patients in the study recommended by Cath has sparked fresh debate over the use of the drug and how the health service should treat gender non-conforming patients under 18 years of age.
Naomi Cunningham, chief executive of gender campaigner Sex Matters, said: “We understand why the NHS and Dr Hilary Cass feel that clinical trials of puberty suppressants are necessary, but we urge them to reconsider.”
“Given the known risks of permanent damage to fertility, sexual function and overall health, such trials cannot be ethically justified.”
But when NHS England announced in March that it would stop prescribing the drug, trans rights charity Mermaids criticised the move, calling it “deeply disappointing and a disappointment for trans young people as it further limits the support available to trans children and young people through the NHS”.
The High Court recently ruled that the ban on puberty suppressants in England, Scotland and Wales is lawful, dismissing a legal challenge brought by advocacy group TransActual and a young person who cannot be named.
In his judgment, Judge Lang said: “The Cass inquiry’s findings of very significant risks and very limited benefits associated with the use of puberty suppressants, and its recommendation that puberty suppressants should future only be prescribed by the NHS in clinical trials and not routinely prescribed to children and young people, provide strong scientific evidence in support of restricting supply of puberty suppressants on the grounds that they are potentially harmful.”
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Critics, including the Good Law Project, have argued that recent NHS policies restricting access to puberty-suppressing drugs have led to a rise in suicides among young people with gender dysphoria – but a recent government-commissioned study rejected that claim.
Going forward, all children and young people referred to NHS England’s eight new local gender services for under-18s will be told about the trial and asked if they would like to take part.
The services will replace the Gender Identity Development Service, which was run by the Tavistock and Portman NHS Mental Health Trust in London until it was dissolved at the end of March. Two services are already in operation, run by Great Ormond Street Hospital for Children in London and Alder Hey Children’s Hospital in Liverpool.
