Why the NHS puberty blocker trial is appalling

[Soontobe60]

Stella O’Malley from Genspect telling it like it is - that a state endorsed trial of puberty blockers for gender dysphoric children should NOT go ahead.
the NHS are not walking into this nightmare blindly - there are enough experts out there telling them what will happen happen to these children if they’re given these life changing drugs.
https://x.com/genspect/status/1989896741358113127?s=61&t=gKvvk-rWmOlYFGMZN8QVvQ

Is it likely that the judicial review will result in the ethics committee decision being made public, after all that must be one of the key drivers behind the trial being given the going ahead? Surely it needs wider scrutiny!

Excellent article in the Critic

We must stop the puberty blocker trial | Annaig Birdy | The Critic Magazine https://share.google/lEiWKYkAh7mEEgQPT

There should definitely be a concerted effort to get it call the Streeting Trial, or the Streeting Trial on Children of Puberty Blockers.

Claire Coutinho, Shadow Minister for Equalities has been calling it the 'Streeting Trial' for a while now.

https://x.com/ClaireCoutinho/status/1999758348632404314?s=20

Have you got a copy of the documentation relating to the Ethics committee, who was on it and what they discussed? If not, and it hasn't been published, then it was done in secret.

Yes, I know what you mean.

There is a trope that being against the transing of children - through affirmation that they are not the sex they were born, through puberty blockers, then most likely through cross-sex hormones and even operations to follow - in order to prevent their almost certain suicides ( a common false assertion) is transphobia coming from the far right. No one would have even thought of opposing these practises ( apparently) were it not for the likes of Trump and Farage.

More MPs have signed Rosie’s letter

https://x.com/rosieduffield1/status/2000601975164145846?s=46&t=A2fpFNgDRyXF2d6ye97wEA

Interesting that, when applying for consent for research (in a completely unrelated subject), myself and one of our research governance experts said they cannot conceive why the puberty blockers research would receive ethical approval given what it entails! And yet, here we are...............

I've taken studies to Research Ethics Committees and this is how it works:

You write up / collate all the study documents. This will include at least the following:
Protocol

Participant information sheets (part of which is the consent form) - for this study there will need to be separate forms for parental consent & a child participant information sheet
Drug characteristics summary
Copies of all questionnaires used in the study
Letters from study sponsor (KCL), funder etc.

Using an online programme called IRAS you input required info about the study. That's everything from what the point of it is to your data management plans, lists of staff, locations - takes days to do. You select which REC you are applying to - someone has to attend in person (not sure if they are using Teams these days) but they get booked up in advance so it's a balance of choosing one you can attend but don't have to wait too long for.

Sponsor representative and study CI have to sign off the IRAS submission. Documents sent in electronically. REC reviews all documents, can request more info before the meeting
REC meets and discusses study - calls in study representative (would be Chief Investigator here I'd expect) and asks them questions.
No answer on the day. CI will receive REC outcome a little while after - often have to make changes and resubmit. I've only ever had to make minor changes and send in updated documents for approval, never had to attend a 2nd meeting. They could flatly refuse approval.

I've never been a REC member so I don't know what their record keeping is like. You'd hope their discussions were minuted but I've only ever seen the outcome letter.

I should add that the REC is not there to comment on the scientific rationale for the study. They are there purely to look at the ethics. That should include considering study design as it is unethical to put people in a badly designed study that cannot answer the research question - the Streeting puberty blockers study fails on these grounds alone, it's a rubbish design.

They are research or healthcare professionals and some lay people but will likely have no professional knowledge of the subject area. The REC that approved the Streeting Study will likely know less about puberty blockers than many people on this thread.

The most shocking thing about this study is that it's been approved by a REC & MHRA. Shows they are not fit for purpose in my opinion. I sincerely hope this is pulled and the ethics system reviewed.

Do the extra signatures to Rosie's letter include any more Labour MPs? Or is it still just Jonathan Hinder? I didn't recognise any names.

Excellent article - this quote stood out for me.

"We already ran this experiment already, just unlabelled and unsupervised. The results were damning: no reliable mental-health improvement, no reduction in dysphoria, no proven long-term benefits. And now we’re doing it again, but with a government stamp."

Wes, please note, we do have all the receipts!

I wondered that too; I’m really not sure

What is ironic, is that the Cass review, which suggested the trial, was commissioned by the tories.

this is surely an easy win for Labour MPs to say no

unless the trans choke hold is worse than we thought

It's a bizarre drug to use in children as a mental health treatment - a common side effect is depression!

The only half way decent comparator group they have planned is the Horizon observational study group - but they don't have the same panel of tests being done at all time points, will have a different standard of mental health care (as the observational group will with their local clinic anywhere in the UK), whereas the clinical trial groups will be getting psych input from the trial centres - inevitably with a lot more support being available to the trial group.

Fundamentally though the participants
will not be the same groups - the trial group (children & parents) must all WANT blockers. The observational group will be a mix where some do want them but they don't attend a clinic recruiting to the trial, some children who don't want them, some where the child wants them but the parent doesn't consent, or the child is not eligible for another reason. It's a ragtag poor quality comparator group.

Why else would Farage make the statement if not to make life difficult for Streeting & Labour? It's all he's ever done, snipe from the sidelines. Tice might want to win but like many Your Party members, opposition is where Farage is most comfortable.

Shuttering NHS England removes some of the drag & Brady's an NHSE employee, we can but hope he'll be on the receiving end of a P45.

I didn't make any real effort to find out who's on that REC, the first one I found so horrified me that I stopped there. These decisions should fall to people with a hell of a lot more by way of professional chops than a 20-something paralegal with a keen interest in human rights

I think this is very interesting.

I can imagine that most trials going to the Research Ethics Committee at least have a vaguely sensible research question and study design.

People on the REC will be looking at the detail - is the patient information form clear, have they got a range of outcome measures, etc.

But as you say, if they're not experts in the clinical area, and are broadly supportive of "trans rights" as many in academia are, they may never think to question "actually is there a good enough rationale for this study to be done at all?'. They probably assume there is (as there usually would be).

Also, if they do have any nagging doubts, it would take a brave person to voice them!

Is there a good clear layperson write up anywhere outlining the design of this study and the main problems with it?

As has been said, the comparison that is actually meaningful isn't randomised (so is a controlled cohort study rather than RCT) and the control group is not well matched.

Also, it's unclear to me how PBs fit into the treatment pathway. Surely they're not much use on their own - just as a precursor to hormones and surgery?

Also I still don't understand why they're useful to females who want to look more masculine, since they stunt growth.

I'm sure there are more major flaws!!

I see Himdia Willyboy is front and centre with his usual well reasoned and thoughtful take on the subject. 🙄

Sometimes I'm so glad I never signed up to Twitter.

One can apply to observe REC meetings; they're not conducted in secret.
We also know what was discussed: each application.

The meetings are confidential though (because many applications include potentially identifiable patient data), which is why only the outcome summaries are published.

There are also several trials besides this one which are controversial for one reason or another and this is why the volunteer participants are rightly shielded from "activists" stalking them or worse. To think a whole panel of these clinicians would deliberately target someone or something sounds paranoid.

Here are the governance arrangements for RECs: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/governance-arrangement-research-ethics-committees/

If you're really claiming to be unaware of the capture of the NHS by extreme transactivism, then I'm afraid you've not been paying attention.

From the shut down of GIDs, the reversal of so many NHS claims (puberty blockers are safe and reversible) and the evidence of the over involvement of adult trans lobby groups like Gendered Intelligence and Mermaids in GIDs and related child healthcare.

"Time to Think" by Hannah Barnes is a useful place to start if you're unaware of the extent of the problem.

Transgender Trend have commissioned a survey that shows two thirds of adults believe this NHS experiment on children should be stopped:

https://www.transgendertrend.com/opinion-poll-stop-nhs-puberty-blocker-trial/

No.

They are absolutely SHIT scared of Reform ATM.

They know that if Reform are loudly jumping on this one, the polls are saying something. (I refer to the YouGov survey from last year which had I think IIRC just 11% of all voters happy about medicalisation of under 16s for transition - and those numbers were LAST December).

This trial is a public relations disaster zone.

Streeting will be well aware of this.