Child puberty blocker trial paused after watchdog concerns
Scheme open to those as young as eight faces growing backlash
A trial of puberty blockers for children will be paused following concerns from the healthcare regulator.
The Medicines and Healthcare products Regulatory Agency (MHRA) has stepped in amid a growing backlash over the experiment, which was open to those as young as eight.
In a letter to those running the trial, the MHRA said it wanted to discuss introducing a minimum age of 14 for participants.
The letter said “potentially significant and, as yet, unquantified risk of long-term biological harms is present to participants”.
Earlier this week, The Telegraph revealed that children would be paid to take part in the controversial experiment.
Discussions between the MHRA and the trial’s sponsor King’s College London will begin next week to address the new concerns.
A statement from the Department of Health and Social Care (DHSC) said that the medical regulator had raised concerns about the “wellbeing of children and young people”.
Regulators also raised concerns that giving drugs at the early stage of puberty, followed by cross-sex hormones, is very likely to render participants infertile.
And it warns that using some puberty blockers for more than a year can “cause persistent and potentially permanent bone structural change”.
Other concerns raised include the potential impact of the drugs on the functioning of the brain, with a recommendation that the advice of independent clinical experts be sought.
The regulator also expressed concern about the ability of “very young children” to cope with vaginal bleeding that can be caused by the drugs.
‘Unacceptable safety risk’
The trial was due to involve some 226 children who believe they are transgender, in a study of the side effects. It was set to start in April.
The drugs, which stop the body’s natural development, were indefinitely banned by the Health Secretary after the Commission on Human Medicines said they posed “an unacceptable safety risk” to children.
Claire Coutinho, the shadow equalities minister said that the pause was a “huge win” and that Wes Streeting “must now end this trial for good”.
She added: “Wes Streeting has ignored warnings from the Conservatives, campaigners and health experts for months. It should never have taken the regulator to step in and tell him that putting 200 children at risk of sterilisation was wrong.”
Maya Forstater, the chief executive of the charity Sex Matters, said she hoped that “all organisations involved will heed the MHRA’s warning and that the trial will ultimately be cancelled”.
She added: “We are delighted and immensely relieved that the MHRA has pressed pause on the puberty blockers trial. This badly designed experiment would have harmed vulnerable children in the misguided effort to ‘research’ a treatment already known to offer no benefits and carry serious risk.”
The Telegraph: continue reading
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