"A clinical trial into puberty blockers for children has been paused after the medicines regulator warned it should have a minimum age limit of 14 because of the unquantified risk of long-term biological harms. Discussions between the Medicines and Healthcare products Regulatory Agency (MHRA) and the trial sponsor, King's College London, will begin next week to discuss the wellbeing concerns, the Department of Health and Social Care (DHSC) said on Friday evening."
"We have always been clear about the red lines regarding this trial ensuring the safety and wellbeing of the children and young people involved and always being led by the clinical evidence. The MHRA has now raised new concerns directly related to the wellbeing of children and young people and scientific dialogue will now follow with the trial sponsor. As the evidence is now being interrogated by clinicians, preparations for the trial have been paused while the MHRA and clinical leaders work through these concerns."
The Pathways clinical trial of puberty blockers for children has been paused after the Medicines and Healthcare products Regulatory Agency warned that a minimum age limit of 14 should apply because of unquantified risks of long-term biological harms. The MHRA will begin discussions next week with the trial sponsor, King's College London, to address wellbeing concerns, and recruitment will not start until those issues are resolved. The trial followed a recommendation from the Cass review, which found weak research evidence for benefits of puberty blockers in young people with gender dysphoria. The Department of Health and Social Care said the trial will proceed only if expert clinical evidence deems it safe and necessary, with children's safety and wellbeing the primary consideration.
Read at www.theguardian.com
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