Cass to blame for puberty blocker experiment

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Dr Tony Rukinski’s article about Cass does seem to ring true about the inherent weakness of Cass in accepting the category of’trans child’ hence giving credence to trans activists and setting up the groundwork for the puberty blocker trial which opens the door to their continuation.

The very drugs that ministers were finally persuaded must be banned ‘banned’ for use in gender clinics will now be given to vulnerable children inside government funded trials, complete with the blessing of senior medics and ethicists.
Worse still is that we have known this particular trial was going to happen for over six months while those doctors who’ve condemned it have been ignored.
For this is exactly what the Cass Review recommended and it is exactly why some of us could not join the chorus of conservatives and Christians hailing Cass as a decisive victory.
As TCW reported last April there was a ‘get-out clause’ included in Cass’s final report. It recommended that puberty-suppressing hormones should be prescribed only in the context of a clinical trial or under the guidance of the national multi-disciplinary team .The NHS in England and Scotland immediately took advantage of this.
Cass did say devastating things about the evidence base behind puberty blockers and cross sex hormones.
It found the research to be weak, biased and often incapable of showing whether these drugs actually improve mental health or reduce suicide risk.
For anyone who had watched Tavistock’s reckless approach for years, that official admission was welcome.
But instead of concluding that medical transition for children should be stopped as inherently unsafe, Cass accepted the category of the ‘trans child’ and recommended a ‘rigorous research programme’ to work out how best to treat them.

Cass to blame for puberty blocker trial

Blame Cass? Or blame standard medical procedure of including clinical experience in determining drug effectiveness which is what Cass stated justified the trial.

What is Dr Rukinski really saying here? Standard medical practice doesn't apply when ideologically inconvenient?

It's not "standard medical procedure" though: "PBs" are being tested against "PBs after one year", not against other treatments such as psychotherapy or watchful waiting.

Also, two years of treatment is nowhere near enough to know much: children whose gender dysphoria desists by the end of puberty wouldn't have desisted after one or even two years - the final result couldn't possibly be known before puberty is completed. For a 10 year-old that might be in 7 or 8 years. Not one or two!

I haven't read the protocol, but I used to work in clinical research, and I suppose the reason the time is so short is because they can only conceivably do a double-blind over a year or so: by the second year the children and parents, and even more so the staff applying the protocol will all have been able to work out who is getting the PBs and who a placebo.

But I suspect that is just not a sufficient time-scale.

And if it turns out that there isn't a double blind, then IMO the study is for the bin.

"It's not "standard medical procedure" though: "PBs" are being tested against "PBs after one year", not against other treatments such as psychotherapy or watchful waiting."

Testing mental health drugs doesn’t require a mandatory side by side comparison with psychotherapy; the comparison is typically against a placebo or a standard existing drug, not psychotherapy. Drug trials focus on the medication's efficacy and safety compared to a control group, while psychotherapy trials compare psychotherapy against a placebo or other treatments, like medication, to measure its effectiveness on its own.

"Also, two years of treatment is nowhere near enough to know much: children whose gender dysphoria desists by the end of puberty wouldn't have desisted after one or even two years - the final result couldn't possibly be known before puberty is completed. For a 10 year-old that might be in 7 or 8 years. Not one or two!

This isn't a desistance study though. It's a study to measure mental health stabilisation or improvement. That some people might eventually desist isn't relevant to that & you would expect that the candidates were individuals who had already demonstrated long term gender dysphoria & gender incongruence identification with the opposite sex.

Oh god, italics guy is back again.

As was noted at the time, Cass is a true believer in GI, unfortunately. But she did call for a follow up on previous patients, which is being ignored.

The Olson-Kennedy study results, which O-K tried to hide, are out. They show no improvement in mental health after 2 years on PBs. So why are we even doing this?
https://x.com/genspect/status/1930765095421841618

The Olsen Kennedy study is one of many so it can hardly be considered as the ultimate authority on PB efficacy particularly given standard practice is to consider all relevant studies. Reproducibility of studies is a fundamental principle that verifies scientific findings and distinguishes reliable work from less robust results.

I have been involved in animal studies (at the early drug discovery side of the process) and a clear negative result in other scientist's studies would always be a reason for a rethink if it's worth pursuing this approach/this kind of drug rather than thinking "gosh, lets repeat that just to make absolutely sure this isn't working". I'd think this would be even more the case when we are talking about children not mice.

The difference is there were already many studies refuting the Olsen Kennedy one. The problem with candidates suffering from gender dysphoria is they aren't a large cohort so that necessitates reproducibility.

And do these other studies show that puberty blockers improve the mental health of children or indeed have any measurable benefits for them?

ETA:
As far as I am aware, the O-K results are in line with other studies and the Dutch protocol results have never been replicated.

Cool, then you can give me some references to these.

It reminds me the Di Bella case in Italy. A medical doctor went rouge with an invented protocol to treat tumours. Despite the dubious claims, many patients fall for it, probably also because he is very charismatic. When the health authorities try to shut everything down, the media coverage is terrible: the visionary hero against the system. In the end, a small study is conducted to bring things to conclusion.
Was the study ethical? No. But the health authorities felt forced into it to disprove the method once for all.
I feel Dr. Cass might think the same. I partly blame her (or at least the way she communicated). The main responsibility, though, belongs to who designed and authorized the study.
They could have pushed for a longer follow up, for more stringent exclusion criteria (why include girls at all? What about children with an autism diagnosis?). It remains in my opinion deeply unethical and I struggle to find an acceptable design, but I'm sure something better could have been imagined. Hopefully this time it will give pause to most children and parents, as the information on the side effects is clearer. I hope they'll struggle with recruiting.

There are full references in WPATH SOC 8.

Or heres one link that refers to a few studies in the section on 'Puberty Blockers'.

https://headspace.org.au/assets/Uploads/Evidence-Summary-The-association-between-gender-affirming-care-and-youth-mental-health-and-wellbeing-outcomes.pdf

Yeah they do show improvement. Although some doctors like Helen Webberley have suggested a combination of puberty blockers & hormones is required to show significant improvement.

WPATH? Seriously?
That's like when homeopathy supporters refer you to Hahneman's tome of pseudoscience, or creationists to the Genesis.

No one has been able to replicate the Dutch study because they switched the questionnaires. They gave the girls a female questionnaire, transitioned them, then gave them the male questionnaire. Vice versa for the boys. The study is absolutely flawed. They could have given the children a lollipop between the 2 tests and it could have shown the same results. (See interview with Stella O'Malley, I think that's the one)

Cass is not entirely to blame for the trial. I think blame lies with the ethics committee. It's been pointed out that Cass also recommended the data linkage study which is not being completed. And I thought she had identified that the cohort who may benefit are the effeminate boys who have displayed a cross sex identity since toddlerhood. I thought Cass had identified that girls do not benefit from puberty blockers because they will likely need breast tissue removal anyway and taking the pill can stop periods and testosterone is very powerful even after puberty for girls. So I thought a trial would focus on identifying the little boys (with homophobic parents no doubt) and I thought the girls would be excluded. A trial on that basis would look very different to what we've got.

"Blame Cass" seems a bit harsh, given the intensely difficult challenges with ideologically intransigent actors throughout the NHS as she proceeded with her review.

She would probably have found herself even more blocked and undermined by colleagues if she had not made specific strategic concessions. Also, those very concessions may have made it easier for the wider public to experience the review as fair.

It was up to the ethics committee to determine whether it could ever be legit to implement the research she suggested.

In terms of Cass being a ‘true believer’, my take on her position was that she thinks there are a very small number of children who experience gender dysphoria and that there is a chance that they might benefit from puberty blockers. She highlighted that there were many ways in to experiencing gender distress and, in turn, many ways out. I took from this that the vast majority of children are understanding distress caused by other factors as being caused by distress and that this needs unpicking before any physical treatment is considered.

When the gender identity services at the Tavi opened, they saw 10-20 children/patients a year. I thought Cass had in mind very small numbers in mind regarding use of PBs.

I am not suggestion that my interpretation is correct, but I’m pretty sure she did suggest small numbers ‘might benefit’ and I wonder if the anticipated 2000+ sample in the trial aligns with her thinking.

I wish Cass had made a clinical trial conditional on the outcome of the linkage trial. But I'm not going to blame her for missing that and leaving this loophole. And I don't think she's a "true believer" more that she is open to the possibility.

It's on the ethics committee to close all the ethical loopholes and they are more worthy of blame for not doing that.

Well, not unless Dr Cass has said that this trial as currently proposed is a good'un. I would blame her for that.

Within minutes of the Cass Report being released, KJK strongly criticised Cass’ acceptance that there was such a thing as a trans child and that clinical trials were needed. KJK was shouted down as a spoilsport.

KJK, if you are reading this, you were so right.

She probably didn't want to be lynched in the street so had to make one concession which was that technically, yes a trial would be the way to prove effectiveness.

But we on FWR said at the time that this was a huge risk, and were told 'It will never get through ethics'...well we've seen that when it comes to 'trans', there are no ethics applied.

It was unfortunate that Cass left this window open. Given what she said, I was honestly surprised by the government response in blocking PBs. I felt they were reading between the lines to what she probably thought, rather than what she actually said.

There were many who pointed out at the time that the approach of trying to find a middle ground in a situation that was really quite clear cut (no benefits ever proven after several years of experimentation) was a risky strategy that might hand a weapon to those who want to continue to push these drugs on children. It was mooted at the time that she took this line to avoid accusations of extremism, but when you are dealing with extremists (as here) the middle ground is a dangerous place.

If this trial was conducted honestly with medics who had no agenda, it would probably demonstrate active harms with no real benefits, but those conducting it almost certainly want to prove benefits exist. That means the results will be skewed. I don’t think there is any way that this trial can ever be conducted ethically at this point. It could only have been done back when it wasn’t so embedded.

The most ethical experiment at the moment would be to take a step much further back. Clinicians don’t really know whether they are even able to select a group of children who would genuinely benefit (if such a group of children exists). It’s been noted that putting children on puberty blockers likely increases the chances of them transitioning. Clinicians would claim that the high rate of transitioning in this cohort means they selected the right group. So go back to supported watchful waiting, tell the clinicians to select a group they believe would go on to transition as adults, then see what percentage they get right. If they select a high percentage of those who do go on to transition as adults, then we would at least have proof there is an identifiable cohort of children who MIGHT benefit from transitioning early.

I suspect such a trial would clear these clinicians minds and a much smaller cohort, probably all male, would be selected. Even then, I have my doubts that they are capable of predicting which children will persist and transition and which will recover.

Until they can prove that they can properly identify a group of children with high efficiency, they should not be allowed to medically transition any children at all.

They wouldn't be able to find medics who could carry out this experiment who were not already captured, as it is wholly unethical from the point of 'diagnosis', as there isn't one.

I would love for Baroness Cass to come out and admit that the clinical trial had to in the report for the report to have any chance of being acted upon and not dismissed as bigotry.

She could somewhat save face as well as truthfully say that since the report has come out, there has been more and more evidence coming to light that no trial should be considered. If TRAs want PBs to make a comeback, they need to track down and study and report on the thousands of children who took PBs and disappeared into the ether. Which of course will never happen.

And it's easy to forget how much the issue has moved in public opinion since the review was published.

Concerns were raised on here about the language in the report and about the pb trial recommendation. But if Cass had made no concessions at all would it have been accepted? Dunno.

Listening to the Naomi Cunningham podcast on BBC yesterday and the interviewer repeatedly reassuring the listeners that he doesn't necessarily agree with her views (like... gasp! ... using sex based pronouns! The horror!), but the interview in itself would have been unthinkable a year ago

What I don't understand is why Cass is continuing to support the PB trials. That is unforgivable actually.

Thank you for making the point about what Cass noted about girls. I might have missed it, but haven't seen that raised yet in the challenges?