There was an interesting (albeit short) parliamentary debate on the proposed puberty blocker trial yesterday, which asked some interesting questions, including the following:
Can there ever be a situation where it is ethical to run such a trial when the harms could be significant? It is important to remember that the children who would participate in this trial are physically healthy children who stand to have worse health by the end of it. This trial is in no way similar to a clinical trial for a cancer drug, where the patient is seriously unwell at the beginning of the trial.
Secondly, approximately 9,000 children and young people were treated by GIDS over the years, which provides a plentiful supply of data about the long-term outcomes for those who took puberty blockers and those who did not. Would the Minister please clarify matters and explain why a new trial is needed, given this abundance of data? Will she please provide an update on the exercise that is currently under way to obtain more data?
Thirdly, the current trial only proposes to look at outcomes over a two-year period. To put that into context, a child who starts puberty blockers at the age of 13 will only have their outcomes followed and assessed until the age of 15. That is not long enough to understand medium and long-term outcomes. A positive result for a 15-year-old might look very different for a 25-year-old, when physical health, sexual function and fertility are likely to be more important and relevant to them than when they were 15. Does the Minister agree that two years is not a sufficient timeframe to properly evaluate the impact of puberty blockers on physical and mental health? If this trial goes ahead, will she commit to funding and ensuring that there is long-term follow-up of these children into adulthood?
Fourthly, how many children will the trial be limited to, and what criteria will be used to determine which children are eligible and which are not? Is it possible that all eligible children will be included and prescribed puberty blockers as part of the trial? How many children in total does the Minister expect to take part in the trial over its duration? How will the trial establish an appropriate control group?
Fifthly, given that gender nonconformity sometimes correlates with same-sex attraction in adulthood, how will the trial safeguard those children who may simply be uncomfortable with their sexuality rather than experiencing true gender distress?
Sixthly, given the high rates of progression to cross-sex hormones following puberty blockers, will only children who agree not to progress to cross-sex hormones be accepted on to the trial, so that the impact of the puberty blockers on outcomes can be seen in isolation? If the answer is no, given the corresponding likelihood of impaired sexual function and loss of fertility, which are monumental ramifications, how will the children taking part in the trial be able to give consent?
Finally, will the Minister please provide details of other trials that have been approved for paediatric medical interventions with equivalent or similar diagnostic uncertainty, to reassure the public that moving forward with a trial in this situation has precedent?