Puberty Blockers clinical trial.

[PlainJane999]

Simple question, do those here support the prescription of blockers as part of a clinical trial and why?

I have only got my phone on the moment sloe, is this the study where they gave the patients the opposite sex questionnaire after treatment vs what they received pre-treatment?

I think this is it for me. There is already a lot of evidence available which has been put away in a drawer, and which rapidly needs to come back out.

I’m absolutely not in favour of agreeing to “start again from a clean sheet” because that’s an abusers tactic to obliterate what we already know to be true.

I’d also like to know what it is you actually propose to trial and how you would differentiate between success and failure. What are your criteria for too many side-effects- because that’s always been part of the issue, the hostility to transparency.

Anyone that conscientiously believed that the long term effects were positive would welcome longer studies.

Anyone who wants to prevent unecessary harm to children would want to know the answer.

Cass appears to have set out with an open mind. This was the gender industry’s chance to prove they are genuinely convinced that their work is good, that they are willing to cooperate, and that they really do want the best outcome for any children entering the medical system.

The paranoia of this group would have to be off the scale if they truly believed in what they were doing, but blocked her anyway because of some kind of suspicion of outsiders.

I think Whittle, et al, know perfectly well that the medical approach is on very shaky ground, but they don’t want it to stop, so they are obsfucating for as long as possible.

Cass reflects the fact that this obsfucation is part and parcel of so-called “gender medicine”. You only have to watch the WPATH files video, and note (non-medic) Whittle’s past presidency of WPATH to suspect that these protocols have been politically led for a long time.

I think placing any more children on this pathway before following up thoroughly on earlier information would be criminal. Even collecting the information on the non-obfuscating group of children who used puberty blockers for precocious puberty would be a helpful start, but the drug companies presumably don’t want that done either as the ongoing, off-label use represents profit.

What will eventually happen is that lawsuits will end these practices in the US, where they are ignoring Cass and ploughing ahead as before. It’s very sad though, as Cass represented the perfect opportunity for an open-minded look at this. If there are really children who would benefit (doubtful, in my opinion, but not impossible) then a great chance to work for the good of these confused children has been missed.

Cracking job @Sloejelly - you've really gone to town on it while I was sleeping. My statement about participants getting psychosocial support was an inference from the way they talk about their model of treatment elsewhere in the paper, with all the psychosocial activity as well as hormones, and as participants were recruited from their clinic attendees I imagined they'd be getting something. Also, if they weren't getting anything, it's an even more tenuous comparison! That's another possible criticism of the paper - they haven't made it easy to visualise the exact package that each group is getting.

Even so, if this is representative of the best kind of evidence we have, it seems a rather flimsy basis on which to advocate carpet bombing the flower of the nation's youth with puberty blockers. And the rest of the world - they're not shy about it!

Aren't the clinical trials already in process? Truthfully measuring the outcomes and health conditions of those who have already been prescribed blockers and cross sex hormones? It can't be ethical to start afresh with 'new' children.

Evidence of harms must be recorded, but it appears that there has been precious little follow up so far, and where there has been, any unfavourable conclusions have been suppressed.

Having taken puberty blocker medication for a short time for endometriosis, I have direct personal experience of how dangerous and powerful these drugs are.

I'm not convinced they should even be prescribed for precocious puberty given how drastic the long term effects are.

I don't think a clinical trial for 'gender medicine' would be ethical because we won't understand the long term damage for decades. From the evidence we already have, it's clear that blockers lock confused young people onto a medical pathway that has devastating consequences.

It's like suggesting a clinical trial of oxycontin to see if it's addictive - we already know the answer to that.

Should families of children with GD and medical professionals have fentanyl on the table as an option? If not why not?

The participants and their families completed ‘several questionnaires’ though the paper only tells us about selected results from the ‘Youth Self-Report’ questionnaire. Which raises questions of data dredging.

Fortunately, the NHS has robust processes for accepting or rejecting proposals for trials.

Cass recommended that gender medicine should be brought in line with other medical fields within the NHS. She suggested that, like other forms of medicine, clinical trials should be used to determine efficacy of any drugs used for treating gender distress. Sitting within this recommendation is the assumption that ethical approval processes will be applied. It wasn't in her remit to delve into the issues arising with designing a trial that found meet criteria for ethical approval.

So yes, I do fully support the findings of the review. I am accept that 'being brought in line with other areas of medicine', does not include suggesting that clinical trials in this field should not proceed if they meet ethical criteria set for all other trials.

When Tavistock applied for ethical approval of their trial they were initially turned down by an ethics committee so rather than address their concerns they looked for a different ethics committee. If I remember correctly there were question marks over conflicts of interest of the committee that passed it. Tavistock also failed to follow their protocol or publish result timeously, neither of which were followed up by the MHRA as it should have been.

Sadly since Brexit, MHRA has been a shambles as so many staff left. The Clinical Trial Unit has had investment to get back to normal lead times for CTA approval but is still underesourced for other activities.

They’ve gone from world leading organisation to a shadow of their former selves rubber stamping EMA decisions. Its appalling.

One thing that's always puzzled me - why can't you have a control group of, for instance, a group of children who were treated at the Dutch clinic a couple of years before the puberty blocker trial?

Surely some of the children who would likely have been given PBs if they'd been available could be traced to see what happened to their lives.

Surely some of the children who would likely have been given PBs if they'd been available could be traced to see what happened to their lives.

We already know this. Prior to the availability of puberty blockers longitudinal studies that followed the natural history of cross sex identification in young children showed that the vast majority desists, and the vast majority have a homosexual orientation. And suicide wasn’t even a consideration. There was no epidemic of suicides in the cohort preceding the availability of puberty blockers that has been solved by puberty blockers.

Why are we being asked if we agree to a trial where 'successful' results create sterile adults with no sexual function, and possibly a reduced IQ?
If such a trial could pass an ethics committee it would already have taken place.

As for picking who should be on such a study. You cannot predict with 100% accuracy but that is the same for any medical reaserch.

For most studies you can't 100% predict which patients with the condition will benefit. That's why you're doing the trial. With this you have a less than 20% chance of predicting who has the condition you're treating. (Assuming persistent gender dysphoria is a genuine condition, which is in itself somewhat in doubt.)

Totally different.

Where I disagree with Cass is that if the reaserch participant numbers can be reached voluntarily, then forcing people to be on a study seems un-ethical.

Where does Cass say people.should be forced to parricipate in a trial? Page number and exact quote please. Because you can't do that for a prospective study. No trial would permit it. There are slightly fewer ethical barriers to enforcing opening medical records for a retropective study, but that is still difficult to impossible in most countries.

If you mean she said the treatment should only be available as part of a trial, that's a very different thing from forcing people to participate. And is a completely standard recommendation for all sorts of things.

Sorry just to go back to the posted study once more: it should be noted that 53 participants dropped out either because they did not complete the questionnaire or because their GD symptoms has ‘alternated’. We have no information about which of the clinic groups these belonged to. If they were in the PB group then that would represent 23% of that group - in other words it could be that nearly a quarter of those treated with PB suffered harms from them but were excluded from the results.

Going back to the study I also see that the pre-treatment group have not been diagnosed with GD. So some of the 53 could be those whose had ‘alternation’ of GD symptoms and (hopefully) never started on PB but there doesn’t seem to be any mention of referred patients otherwise NOT being put on PB and them CSH.

I suspect a fishing exercise.

Because why not follow the same cohort through, questionnaire at first contact and again 3 or 4 years after commencing affirmative treatment protocal?
It would make the quality of data so much higher.
Instead they've taken two entirely separate populations to make up their treatment arm - one "before" group and one "after" group. Completely unnecessarily.
I also baulk at the use of "cisgender" to desribe the control arm. Does that word mean anything other than, "hasn't sought gender medicine interventions" ?

Kathleen Stock had a good opinion piece a while back which explains why many people both welcome the Cass Report and think it (understandably) gives lip service to gender identity ideology in an unfortunate way.

https://unherd.com/2024/04/the-liberal-lessons-of-the-cass-report/

time and again in Cass’s report she is forced back into the conceit that the most pressing problem for contemporary gender medicine is the lack of good evidence for such interventions either way. It is as if a modern-day medic had been tasked with reviewing the efficacy of trepanning, and then ordered to defend her findings in front of fanatical fifth-century devotees. “It’s not that drilling a hole in a child’s skull to release demons is necessarily harmful, you understand — indeed, it may be the best outcome in some cases. The main issue is the lack of long-term follow up.”

The more I read that paper, the more extraordinary I find it that it was even accepted for publication.

That might also explain the complete inaction over the way PB have been advertised (within the definition of the legislation) to children and misrepresented in the press. Both of which are criminal offences.

I do not have time to respond to all the posts that appeared since I last contributed, but I hope this addresses most of the key points that people have responded with.

What are Risks of Talking Therapy ?
There is a significant lack of evidence that relying solely on talking therapy will address underlying issues, potentially worsening mental health problems such as depression, anxiety, and suicidal ideation. While many here argue these mental health risks do not outweigh the physical risks of medical transition, such trade-offs are best assessed individually by medical professionals in collaboration with families. I advocate for individualized healthcare where the benefits and risks are honestly recognised and assessed for each child based on their unique needs.

Study Quality ?
Assuming the 53 dropouts were harmed by puberty blockers is speculative. Dropouts can occur for various reasons, and there is no evidence linking these dropouts to puberty blocker-related harms. Furthermore, including non-diagnosed pre-treatment participants captures the natural variety of experiences at the point of entry. There may not be a large enough group of participants between diagnosis and prescription to conduct a cross-sectional study. Fundamentally, the study shows significant psychological improvements with puberty blocker use, contradicting claims of harm. These findings align with broader research supporting the benefits of gender-affirming care.

Why Cross-Sectional? (Not the Same Groups Before and After)
In the current political climate, any sincere effort to capture a snapshot of the care system should be welcomed. All data is relevant and useful. If the study were longitudinal, we might miss this data while awaiting results. The clinic may well be conducting or proposing a longitudinal study. Therefore, engaging in conspiracy-level speculation about the motivations behind a cross-sectional study is unhelpful conspiracy. We must remain evidence-led and avoid assuming malicious intent.

Agreed.

It seems MHRA and NICE will increasingly be expected to take their lead from FDA.

I can't quite accept that these organisations will be increasingly on a path that undermines their previous global reputations for excellence.

No I don't support it, because the underlying premise behind it is so flawed. Misleading children into thinking they can become the opposite sex is incorrect, cruel and abusive.

"There is a significant lack of evidence that relying solely on talking therapy will address underlying issues, potentially worsening mental health problems such as depression, anxiety, and suicidal ideation."

In relation to specifically this part, and excuse me as this will be anecdotal - but lack of evidence does not = potential worsening of mental health problems.
I'm also a bit hesitant to believe that there's a massive lack of evidence as suggested, all my life doctors have told me I've needed talking therapy but then gone on to fob me off with medication and not provide said therapy because the wait lists are so long.

I'm going to be going off topic here as I'm talking about my personal experiences and I am not trans, but I do have mental health issues - so kinda relevant.
Medications have NEVER helped me. Any medication that did help only helped temporarily.

I've been fobbed off and passed from pillar to post since the age of 16 despite begging for therapy and actual help the entire time.
I suffer from Depression, Generalised Anxiety Disorder, suicidal ideation (less so now as I've grown older) and severe Emotional Dysregulation.
I'm now 28 years old and have only started getting talking therapy in the last week.
12 years I've been pushing to get talking therapy.
12 years.
The only reason I've managed to recieve it now is because I told my GP that I refused to take any more medication as it doesn't help and I don't trust that I'll be given help. Lo and behold I'm all of a sudden on a referral list (that frankly I should've been on anyway), and although it took over a year to actually speak to someone, I'm speaking to someone finally.

Shortages of therapists and therefore shortages of evidence because of lack of therapists is not grounds enough to go "fuck it, let's just throw medication at them instead".
There needs to be some accountability for the fact that people can, will, and have been fobbed off with medication over talking therapy because of both shortages and the fact that some GP's literally just cannot be arsed.

Not sure if you're aware OP but the vast majority of mental health medications have side effects, warning specifically about the medications making mental health problems worse, not better. Many cite that they may increase feelings and chances of suicide.

Medication can help some people. It can be life changing for some people. but it is not a one size fits all and historically has always needed to be used in conjunction with talking therapies.

In the case of trans health care though, ANY talking therapy is seen as "conversion therapy" - So I'm not sure where we're supposed to go from there....

I think MHRA will stay aligned with EMA for a long time yet - MHRA did so much of the heavy lifting with EMA and they have grandfathered in most of the policies, probably because in many cases MHRA wrote the policies in the first place. But MHRA now accept decisions made on new medicines by EMA, FDA (USA), TGA (Australia), Health Canada, SwissMedic, PMDA (Japan) and HSA (Singapore). It was only a few years ago that many of those agencies were looking to the UK to take the lead. But MHRA no longer has the expertise and if they want UK citizens to have access to new medicines as soon as they are available, they had no choice.

Despite having similar roles, FDA and EMA are very different beasts with very different set ups, organisation, politics etc. i think the cooperation will increase on looking at the safety and efficacy of medicines, but in terms of policies, funding and treatment protocols, I don’t expect to see much influence from FDA in the UK because that is outside their scope.