Irish campaigners have welcomed the UK’s pause on a clinical trial assessing the risks and benefits of puberty-blocking drugs for children after concerns were raised by the UK medicines watchdog.
The planned trial set up by the NHS and run by Kings College London into the long-term impacts of puberty blocking medicines on children with gender incongruence, as recommended in the Cass Report, was halted after intervention by the UK Medicines and Healthcare productions Regulatory Agency.
The Cass Review, carried out in the UK, found that children had been let down by a lack of research and that there was not “good evidence” that puberty blockers, drugs used to delay or prevent puberty from happening, were safe or effective.
The author of the report, Baroness Cass, is a consultant in paediatric disability and a former president of the Royal College of Paediatrics and Child Health.
The trial, which had been due to start in April, caused controversy after it emerged that participants, aged under 16, would receive £30 vouchers for each of the 15 cognitive assessments they complete, as well as £15 vouchers for each of the three MRI scans they undertake, over the two years of the trial.
Northern Ireland announced it was joining a trial of the drugs earlier this month amid Health Minister Mike Nesbitt appointing Baroness Cass to review Northern Ireland’s gender services. It has also suspended participation.
In the MRHA statement and letter to King’s College London, concerns were raised about the age range included in the study design, the risks to future fertility and bone health in participants, and risk of excessive vaginal bleeding in girls. The MRHA recommended raising the minimum age of eligible participants to 14 and addressing medical concerns.
Details of the trial in England, which would involve more than 220 children aged between about 11 and 15, were announced in November. An MHRA spokesperson stressed that the “safety and wellbeing” of participants – yet to be recruited – was “paramount”.
In the North, First Minister Michelle O’Neill last week hit out at Health Minister Mike Nesbitt after he announced a decision to suspend Northern Ireland’s participation in a clinical trial to assess the risks and benefits of puberty-blocking drugs in children. The Sinn Fein politician said it was “disgraceful.”
“That’s disgraceful, that’s actually to turn their head against those people out there in the trans community that are really, really anxious right now,” she told reporters at Stormont.
Participation in the trial had been reported earlier this month in a review of Northern Ireland’s gender identity services carried out by Dr Hilary Cass. Mr Nesbitt said he had suspended Northern Ireland’s participation in the trial in light of ongoing legal action in the courts in England.
‘IT’S TIME TO STOP THE USE OF THESE DRUGS’
Sorcha Nic Lochlainn, Director of The Countess, commenting on the pausing of the trials in both the UK and Ireland, said: “While the intervention by MRHA is welcome, within the Cass Report and within the broader gender services, there is an underlying assumption that somewhere there exists a child who would benefit from interference with their natural development to the extent that they never experience puberty and instead develop the secondary sex attributes of the opposite sex.
“But this synthetic ‘puberty’ cannot replace the normal development that would happen if they were left alone. The full impact on body and mind is not understood. And the question remains, who is this mythical cohort? And how many children should be harmed in order to find them?
“We say there is no such thing as a trans child. It’s time to stop all use of these drugs and start trying to help those who have already been harmed.”
Nic Lochlainn went on to say: “The pausing of the trial comes after Mike Nesbitt had withdrawn Northern Ireland from the trial because of legal action being taken. It is imperative that the trial be scrapped and the data on those children who received these drugs in GIDS Tavistock be obtained to measure the long-term impacts. The use of drugs to disrupt a vital developmental step should not be considered without clear clinical need.
“That need has never been demonstrated. The original Dutch protocol from which all this flows was designed because adult men were unhappy with being unable to completely disguise themselves as women because of their male secondary sex characteristics like deep voice and prominent Adam’s apple.
“The Dutch team postulated that if they stopped these pubertal developments in children experiencing gender dysphoria, the trans-identified adults would have less mental anguish.
“This is no basis for any kind of radical intervention. Any further experimentation is deeply unethical.”
Nic Lochlainn finished by saying: “We are calling on the Irish government to ensure no Irish children are harmed by these drugs and instead promote a therapeutic exploratory model of care that would allow children to grow up whole and healthy.”
‘CHILDREN IN THE UK ARE SAFER THIS MONDAY MORNING’
The DUP’s Diane Dodds said last week that the government’s suspension of the trial means “children in the United Kingdom are safer” – while hitting out at Michelle O’Neill.
The DUP health spokesperson accused the First Minister of having “no thought for the safety of children” white accusing the Alliance Party of caring about nothing but “the woke agenda”.
Speaking in the Assembly yesterday, Ms Dodds welcomed the government’s decision to put the trial on hold.
“Children in the United Kingdom are safer this Monday morning since the UK medicine authority has expressed concern about the long term impact of puberty blockers and paused the King’s College trial.
“So let us remind ourselves who these children are in Northern Ireland. Hilary Cass describes them as vulnerable young people who have experienced bullying and trauma in their lives. Interestingly, she also says that they often present as clusters from the same schools,” said Dodds.