A clinical trial assessing the risks and benefits of puberty-blocking drugs in children who question their gender has been paused after safety concerns were raised by the UK medicines watchdog.<\/p>\n
The Medicines and Healthcare Products Regulatory Agency (MHRA) is set to hold talks with King’s College London, whose researchers are leading the trial, next week to address concerns, the government said.<\/p>\n
Details of the trial, which would involve more than 220 children aged between about 11 and 15, were announced in November after getting approval from the MHRA and Health Research Authority.<\/p>\n
An MHRA spokesperson said the \u00ab\u00a0safety and wellbeing\u00a0\u00bb of participants – yet to be recruited – was \u00ab\u00a0paramount\u00a0\u00bb.<\/p>\n
Puberty blockers for people under-18 questioning their gender identity were banned in 2024. The drugs, also known as puberty suppressing hormones (PSH), are used to delay or prevent puberty happening.<\/p>\n
The clinical trial, called Pathways, was set to involve children who are distressed about their gender and currently accessing gender services. It would examine the impact of the drugs on their physical, social and emotional wellbeing.<\/p>\n
But the MHRA has suggested the minimum age limit of those taking part should be increased to 14, and that there should be more detailed monitoring of bone density and a more rigorous consent process for participants.<\/p>\n
In a letter published on the government website on Friday, the MHRA expressed concern over the current age limit for participants in the trial.<\/p>\n
\u00ab\u00a0Since 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,\u00a0\u00bb it reads.<\/p>\n
In a separate statement on Friday evening, an MHRA spokesperson said it was \u00ab\u00a0part of the usual process that clinical trials are kept continuously under review and for us to have active scientific dialogue with the trial sponsors\u00a0\u00bb.<\/p>\n
\u00ab\u00a0We have raised some concerns related to the wellbeing of participants and scientific dialogue will now follow with the trial sponsor,\u00a0\u00bb they added.<\/p>\n
The Department of Health & Social Care (DHSC) said participants would not be recruited until the issues raised had been resolved between the MHRA and the trial clinicians.<\/p>\n
\u00ab\u00a0We have always been clear about the red lines regarding this trial \u2013 ensuring the safety and wellbeing of the children and young people involved and always being led by the clinical evidence,\u00a0\u00bb a spokesperson said.<\/p>\n
They added that the trial would \u00ab\u00a0only be allowed to go ahead if the expert scientific and clinical evidence and advice conclude it is both safe and necessary\u00a0\u00bb.<\/p>\n
A spokesperson for King’s College London said the wellbeing and health of young people with gender incongruence and their families was its \u00ab\u00a0priority\u00a0\u00bb.<\/p>\n
It added that \u00ab\u00a0rigour and ongoing scientific discussion\u00a0\u00bb was important for a clinical trial, \u00ab\u00a0particularly one as complex as Pathways\u00a0\u00bb.<\/p>\n
Some doctors have questioned whether the trial is necessary. Campaigners are also taking legal action against the MHRA, the government and others involved in the trial. They claim it is unethical and that children cannot give fully informed consent to a treatment which might affect their future fertility.<\/p>\n
A 2024 review by Dr Hilary Cass found gender medicine had been operating on \u00ab\u00a0shaky foundations\u00a0\u00bb when it came to evidence for treatment, with the ban for puberty blockers for under-18s introduced after the review raised concerns about their safety.<\/p>\n
But Cass told the BBC last week it was \u00ab\u00a0vital\u00a0\u00bb that the trial for puberty blockers for under-16s went ahead, or \u00ab\u00a0we’re going to have ongoing charlatans just handing out inappropriate drugs\u00a0\u00bb, pointing to the private sale of the drugs – particularly online.<\/p>\n
Journalist Hannah Barnes, the investigations editor at The New Statesman, called the MHRA’s letter \u00ab\u00a0pretty significant\u00a0\u00bb.<\/p>\n
\u00ab\u00a0If you take it line by line, almost paragraph by paragraph, it pretty much throws out the current trial design,\u00a0\u00bb Barnes told BBC Radio 4’s Today programme.<\/p>\n
If doctors and clinicians want to reconfigure the trial, she said, they will need to so in a way that is \u00ab\u00a0safer\u00a0\u00bb and \u00ab\u00a0better monitors these vulnerable children\u00a0\u00bb.<\/p>\n
Barnes, who is author of Time to Think, a book examining the UK’s gender identity service, added: \u00ab\u00a0I think the trial in its current design is totally dead.\u00a0\u00bb<\/p>\n","protected":false},"excerpt":{"rendered":"
A clinical trial assessing the risks and benefits of puberty-blocking drugs in children who question their gender has been paused after safety concerns were raised by the UK medicines watchdog. The Medicines and Healthcare Products Regulatory Agency (MHRA) is set to hold talks with King’s College London, whose researchers are leading the trial, next week […]<\/p>\n","protected":false},"author":0,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":{"0":"post-9822","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-uncategorized"},"_links":{"self":[{"href":"https:\/\/placedesnations.org\/index.php\/wp-json\/wp\/v2\/posts\/9822","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/placedesnations.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/placedesnations.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/placedesnations.org\/index.php\/wp-json\/wp\/v2\/comments?post=9822"}],"version-history":[{"count":0,"href":"https:\/\/placedesnations.org\/index.php\/wp-json\/wp\/v2\/posts\/9822\/revisions"}],"wp:attachment":[{"href":"https:\/\/placedesnations.org\/index.php\/wp-json\/wp\/v2\/media?parent=9822"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/placedesnations.org\/index.php\/wp-json\/wp\/v2\/categories?post=9822"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/placedesnations.org\/index.php\/wp-json\/wp\/v2\/tags?post=9822"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}