Letter to NHS England and Wes Streeting about puberty blockers trial

So we are now finally close to say that a mastectomy is a procedure that carries risks and is better avoided? Has a discussion developed weighting the risks of PBs against the ones of a mastectomy?

The justification in girls is puberty blockers will save them the need for a future mastectomy.

Also, if the objective is to pass more easily, it's difficult to justify the use of PBs for girls.

@LonginesPrime
Those questions are excellent.
Among the several absurd things of the trial design we've heard so far, the very short follow up, the lack of clear inclusion/exclusion criteria, and the lack of recognition of the cumulative risks of PB followed by cross sex hormones, stand out as totally mad.

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?

You don’t seem to understand Gillick competence.

What's going to happen if they do develop those symptoms?

their teeth start falling out, they keep breaking bones. All irreversible.

It's utterly mad. Because they want to be the opposite sex!!

I can't see how a PB trial in children can possibly be ethical in any way. There's a large, if disparate body of information on the side effects of PB drugs and that's for children who had short term treatment, for precocious puberty.

Kidney malfunction, heart valve and other cardiovascular problems, stunted mental abilities, crumbling joints and bones, for example. How can anyone possibly sign off on that?

I still fail to see how they are going to get consent. How can children consent?

Also, how are you going to test their psychological well-being? When you give them puberty blockers at ten and five years later they're still ten? With possibly a lower IQ.

It's absolutely bloody insane.

It seems far too early in the process of implementing the correct interpretation of the EA following the SC ruling to be able to know now whether or not medical transition will produce the best outcomes. Some trans people say their lives are ruined and they will be confined to their homes following the SC judgment, while many others have shrugged and told news outlets that the ruling won’t affect their daily lives at all.

Even if it turns out to be true that someone who passes as the opposite sex in everyday life will have an easier life, regardless of the sex-based restrictions arising from the EA, surely it’s still unethical to experiment on children to test which theory is true?

"Someone who passes is still going to have a much easier time in life than someone who doesn’t and will experience less discomfort."

That's just a baseless assertion on your part.

There's no evidence that transition has any positive impact in the long term. And that's before we even get to the fact that nobody can even agree on what is actually being treated.

Nobody can actually change sex. Nobody knows what it's like to be another sex. Nobody can demonstrate that negative feelings about one's body are any different than any other anxiety disorders/ body dysmorphia/ body integrity disorders.

And "happiness" with a deception is no evidence of a cure any more than someone who believes in a flat earth might be happier for other people to validate that delusion - it says nothing as to the truth underlying issue.

Gender dysphoria remains a deeply contested diagnosis among clinicians. They should probably sort that out before they destroy more kids' lives, eh?

If the risk of harm was so high there wouldn’t need to be a trial. My understanding of the trial was that it’s looking at outcomes of the child treated with PB.

Even though access to single sex spaces has been returned to birth sex, someone who passes is still going to have a much easier time in life than someone who doesn’t and will experience less discomfort. Having protection under the Equality Act, doesn’t mean discrimination still isn’t common.

PoisedRubyLion · Today 21:19

This doesn’t make any sense. You can’t advocate for no clinical trial and complain about unproven interventions at the same time.

What about various salts of arsenic for pulmonary tuberculosis? It used to be fairly standard in the 17th and 18th Centuries; Edward VI was famously treated with it.

Or mercury for syphilis? Used quickly enough, it's acknowledged that it was sometimes effective in preventing it spreading through the body and manifesting in secondary forms.

I applaud every word of the sentiment of the letter, but what will WS do, I wonder? If he were to put a stop to it, all hell would break loose, wouldn't it? Politically, that's a difficult decision.

They’re not saying that though - they’re saying that before SC ruling, they already argued that it was unethical to experiment on children when the potential benefits were unproven and the known risks of harm were high.

But now, following the SC ruling, the whole premise of puberty blockers (in enabling someone to prevent puberty and therefore better pass as the opposite sex) has fallen away anyway, because it has been confirmed that a child won’t be treated as the opposite sex for lots of important purposes anyway.

So it would be unethical to mislead children (and their parents) into taking experimental drugs under the false notion that it would allow them to change sex when that’s patently not how the world works.

We should try to find a way to force Johanna Olsen-Kennedy to release the longitudinal research she's currently hiding. That could save much anguish for many children, and do away with running new trials in this country.

Why can't we find out what ALREADY happened to the hundred of children we ALREADY experimented on?

Oh yeah that's right, we can't because it was felt that such a disclosure could be catastrophic to the well being of those, now young adults.

Because that screams 'substantial clinical proof of significant benefit' now doesn't it?!

I think it's a stretch to say that the SC ruling makes the puberty blocker trial untenable because of restrictions on same sex spaces.

I'm not convinced that not getting into the loo of choice is a bigger loss than fertility and sexual function and these children and parents are already willing to make those sacrifices.

I'm sure they're telling themselves that the 'passing rights' they'll achieve will open all those same sex spaces up anyway.

Thanks OP

I am watching to see what reaction this letter gets.

Do we know that the attempt to trace is definitely not part of the study? Again if there were a phased approach which looked at health outcomes in order to develop the risk sheet, the whole thing might self destruct? We can but hope…

They need to carry out follow-up studies on the children who've already taken puberty blockers before they even think about giving them to more children