More To Follow, Indeed

If his very close relationship with Peter Mandelson did not bar Wes Streeting from becoming Prime Minister or even from remaining in office, then this, from The Times, certainly should:

A clinical trial of puberty blockers for children has been paused after “new concerns” were raised by the medicines regulator.

Ethical concerns about the trial mounted as it emerged that children taking part would be asked if they wanted to freeze their sperm or eggs. About 250 girls and boys aged between 10 and 16 were to be recruited.

Puberty blockers are a type of medication called gonadotrophin-releasing hormone analogues (GnRHa), which pause the physical changes of puberty such as breasts, periods or facial hair.

The Medicines and Healthcare products Regulatory Agency said: “With all complex clinical trials, MHRA’s top priority is the safety and wellbeing of the trial participants. It is part of the usual process that clinical trials are kept continuously under review and for us to have active scientific dialogue with the trial sponsors.

“The safety and wellbeing of the participants to be recruited into the Pathways clinical trial is paramount, particularly in view of the age of the children and young people who may be involved. For this reason, the MHRA is applying the highest scrutiny and taking a cautious and measured approach.

“We have raised some concerns related to the wellbeing of participants and scientific dialogue will now follow with the trial sponsor. We rely on the best scientific evidence to ensure all trials are as safe as possible for those participating.”

The Pathways trial protocol says that all those participating must be advised about fertility preservation options before starting on the drugs, as the hormone blockers may affect their ability to have children in future.

The trial document says children taking part “will be encouraged to ask questions and explore fertility preservation options” before commencing the drugs.

It says: “The risks to long-term fertility will be discussed with each CYP [child or young person] considering GnRHa by a clinician in or attached to their gender service who has specific training and knowledge about fertility risks and options available to them … The information will include options around sperm donation and egg retrieval.”

More to follow