Work on NHS England’s planned puberty blocker trial has been paused after the medicines regulator raised concerns over its safety and efficacy.
The Department of Health announced that the trial will not start to recruit children until issues raised by the Medicines and Healthcare products Regulatory Agency (MHRA) have been resolved. Discussions between trial sponsor King’s College London (KCL) and the regulator are due to take place this week.
KCL has been given £10.7 million in funding for the Pathways project, which includes the controversial trial. Puberty-blocking drugs are due to be given to children with “gender incongruence”, who will be monitored for two years with brain scans and tests.
‘Unquantified risk’
The MHRA stated: “Since potentially significant and, as yet, unquantified risk of long-term biological harms is present to participants and biological safety has not been definitively demonstrated in this proposed cohort, at the very least, there should be a graded/stepwise approach starting with those aged 14 as the lower limit of eligibility.”
It called for improved safety monitoring and specified withdrawal criteria to be included in the protocol, including a “much more detailed physiological safety assessment” of gender-confused children displaying “normal biological hormonal and sexual development”.
The regulator pointed to data that suggests taking certain puberty blockers beyond twelve months “will result in persistent and potentially permanent bone structural changes” and called on KCL to “clarify whether participants with any reduction in bone density” after this period would be removed from the trial.
It also raised the risk of unreported vaginal bleeding and the need for haematological monitoring, the likelihood of infertility, whether the trial’s “consent process” was sufficiently robust, and urged closer monitoring of the effect of puberty blockers on cognition.
‘Outbreak of common sense’
Announcing the pause, the Department of Health said: “This trial will only be allowed to go ahead if the expert scientific and clinical evidence and advice conclude it is both safe and necessary.”
Institute Deputy Director Simon Calvert Simon Calvert commented: “It is dangerous and immoral to use children as guinea pigs for drugs that we already know are harmful for them and useless at treating gender dysphoria.”
“In the overwhelming majority of cases, childhood confusion about gender typically resolves during puberty. So these drugs block the very process which relieves that confusion.
“We must hope and pray this outbreak of common sense is permanent and that the trial never goes ahead.”
Northern Ireland
Last week, Stormont Health Minister Mike Nesbitt suspended Northern Ireland’s involvement in the trial.
At the time, the Ulster Unionist Party (UUP) Executive member said he would only revisit his decision if legal proceedings launched in London by campaigners to stop it from going ahead fail.
However, UUP leader Jon Burrows has since confirmed to the Belfast News Letter that his party “would not support the resumption of NI’s participation in the trial, regardless of the judicial review’s outcome”.
Bayswater Support Group, psychotherapist James Esses, and detransitioner Keira Bell recently lodged papers with the High Court seeking judicial review of what they called “government-funded experimentation on young children”.
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