The minimum age for children to participate in a trial of puberty blockers is now being set to 11, contradicting advice from the Medicines and Healthcare products Regulatory Agency (MHRA).
The Pathways trial, which seeks to assess the use of puberty-blocking drugs on children, was paused in February after the MHRA raised concerns and warned that the age limit should be raised from 10 to 14.
In a letter to King’s College London, which is leading the research, the MHRA said that the trial should “at the very least” be limited to children age 14 or over due to “potentially significant and, as yet, unquantified risk of long-term biological harms.”
Now, researchers say the new age limits are 11 for female participants and 12 for males.
“The decision to lower the minimum age for the Pathways trial to 11 is wrong,” Andrea Williams, Chief Executive of Christian Concern, told en. “Eleven-year-old children are still developing physically, emotionally and intellectually. They cannot possibly be expected to weigh the profound and potentially lifelong consequences of medical interventions affecting their healthy bodies, fertility, sexual development and identity.
