Puberty blockers - 'safe and fully reversible'🤔

[IcakethereforeIam]

An article in Unherd on the extraordinary reasons for refusing to publish a study that attempted to examine the basis for these claims.

https://unherd.com/2024/02/why-did-three-journals-reject-my-puberty-blocker-study/

How I wish all the 'be kind' fools who claim puberty blockers are safe would read this article. Her conclusion is spot on:

"Puberty blockers almost invariably set young people on a course of lifetime medicalisation with high personal, physical and social costs. At present we cannot guarantee that cognitive costs are not added to this burden. Any clinician claiming their treatments are “safe and reversible” without evidence to back it up is failing in their fundamental duty of candour to their patients. Such an approach is unacceptable in any branch of medicine, not least that dealing with highly complex and vulnerable young people."

Interesting piece. Baxendale might bring a helpful perspective to this board.

https://www.england.nhs.uk/commissioning/spec-services/npc-crg/gender-dysphoria-clinical-programme/implementing-advice-from-the-cass-review/cyp-gender-dysphoria-research-oversight-board/

There are rumours (impossible to pin down, far less validate) that there is a research proposal for puberty suppressing hormones (GnRH analogues)
for children and young people with gender identity | incongruence | dysphoria. It will be valuable to see what the design and protocol is, if that is true. Likewise, I'd be curious as to the informed consent.

This enormously worrying and almost incomprehensible.

If you think about the process that drugs normally have to go through before they reach market, it is lengthy, laborious and time-consuming. There have to be animal studies, then there have to be safety studies on a small sample of humans, then there has to be an RCT on a large number of patients. Then you have to go through approval by the FDA or similar authority. It takes a good couple of years.

None of this is happening with puberty blockers. The reason, it seems, is because puberty blockers are already approved for use for precocious puberty, therefore it is permissible to use them off-label for adolescents with gender dysphoria. But the cases are completely different - a child with precocious puberty will take the drug to halt puberty, but then resume it at a later date. Children with gender dysphoria who take puberty blockers may never go through puberty.

If this isn't a medical scandal in the making, I don't know what is.

RoyalCorgi - I agree. It's why, assuming there is a study, it would be very helpful to know

• the evidence base for any such study
• who the principal investigators are, the sponsoring organisations, and the research commissioners
• the range (diversity?) of stakeholders who might be involved in the scoping exercise for the design of such a study
• what informed consent involves for parents (presumably) who would be consenting to this on behalf of a child or young person (depending on the threshold for the latter).

it's all off label. i.e. it's not the pharma companies pushing it.
and I highly doubt that they would get authorisation for these indications if they tried.

Oh hey look, it's that single patient low IQ study again!

The world turns. Three journals refuse to publish a study by a well known anti-trans activist that contains no new findings or useful conclusions and admits that gender dysphoria has already been demonstrated to have a negative effect on cognitive reserves in unmedicated children who are experiencing it. (This pattern was already established enough a quarter of a century ago that it was discussed with me by Wren and then Brain & Viner at the time!)

Are there any studies showing that the effects of puberty blockers are completely reversible? Because I am not aware of any

I am always keen to look at both sides of any disagreement to better inform myself as to whether I need to alter my position.

But regrettably, this was a single case study, and while alarming, the conclusions we can draw from one person’s experience are limited.

I thought I recalled Baxendale making this acknowledgement about this case study. I considered the emphasis here added to her overall argument about the scant evidence base in this area.

It's not unusual for researchers to intend to conduct a systematic review with meta-analysis of a topic, only to discover that there are negligible publications in the area. I would agree with Baxendale's implicit point (wrt the peer review comments) that there are limits to just how grey grey literature can be and still merit inclusion within what becomes a narrative survey of the published literature rather than a systematic review.

I frequently have cause to be concerned about the level of competence on display from posters like BH when reading

• straightforward articles
• non-technical review pieces.

It makes me apprehensive about stakeholders with lived experience who might influence study protocols, designs, and informed consent or participant information documents.

Baxenden is very clear about the limitations of each of the studies.

If it's true that GD negatively affects the cognition of kids afflicted, then surely it's even more important to ensure that any treatment doesn't compound that.

You're so right! Best way to discount any historical patients able to attest to long-term outcomes if they disagree with you.

Sarcastic mansplaining isn't going to win anyone over, mister.

I thought misgendering was against Mumsnet's moderation policy?

Can't wait to see self interested adults being finally removed from influencing medical care for mentally vulnerable children. The final Cass report is desperately needed.

'Self interested' adults like the ones who once were one of these 'mentally vulnerable' children during a period where barely anyone in the country even knew treatment was available (thus discounting so-called 'social contagion') and who have a historical perspective on long-term outcomes?

By "historical perspective on long-term outcomes" you mean personal anecdote from someone with a vested interest in pushing a certain agenda.

That's not science.

Butterfly were you given off-label drugs? The risks associated with these drugs are well documented when being used as intended. Giving children harmful drugs without proper informed studies is scandalous.

Mentally vulnerable children experiencing confusion about their identity - be they young children or teenagers navigating puberty / adolescence are entitled to evidenced professionally qualified medical and therapeutic treatment. That's the standard that all other children receive from the NHS. No experimental medicine without prior clinical approval.
The removal of this group of children from these clinical standards is a national scandal. It appears to have happened because of the power of self interested groups - as cited in Cass, Time to Think and countless other sources.

This is a massive social and medical experiment on children with no historical precedent that needs to stop.

I don't blame commenters such as BH for the preferred engagement style. After all, it's modelled after the best known key opinion leaders like Stephen Whittle. Even today, Whittle has displayed bad faith at best or truly jaw-dropping ignorance when it comes to topics that touches on Whittle's lived experience and falls to some extent within Whittle's area of notional expertise (law).

Whittle tweeted Sam Fowler's New European article. The (now) notorious one that was mentioned at Rachel Meade's tribunal hearing today. Yes, the one that has now been removed in response to its numerous errors and, shall we say, misrepresentations of various individuals and organisations. Whittle is a lawyer and the errors should have been obvious. It's an embarrassing display and a very poor example.

x.com/stephenwhittle/status/1756989506031341916?s=20

Well, I have one of my Prostap SR (Leuprorelin Acetate depot injection 3.75mg) leaflets right here and it says:

4: CLINICAL PARTICULARS
4.1: Theraputic Indications
(i) Treatment of advanced prostatic cancer
(ii) Management of endometriosis, including pain, relief and reduction of endometriotic lesions
(iii) Endometrial preparation prior to intrauterine surgical procedures including endometrial ablation or resection.
(iv) Preoperative management of uterine fibroids to reduce their size and associated bleeding

and then further down

4.2 Posology and Method of Administration
Dosage:
Children: Safety and efficacy in children have not been established.

There isn't actually any mention of precocious puberty at all despite how much of the discussion-space around the suitability of GNRH agnonists invokes it.

Children: Safety and efficacy in children have not been established.

I wouldn't allow any child of mine to be administered a drug in which safety and efficacy in children wasn't established. What adults do to themselves is up to them.

You feel the same way about them being used to treat precocious puberty, then?

I would like to think that their use in precocious puberty was medically verified as safe. If it wasn't, I'd be looking to see if there were other medications that were established as safe for children.

But this is an irrelevance, as I'm sure you're aware. There is a huge difference between preventing puberty in an emotionally and physically inappropriate age for a child and preventing puberty at an age where it is essential for bone and brain future health. The effects are not irreversible as you should be well aware. https://www.iwf.org/2022/12/13/puberty-blockers-were-never-reversible-or-temporary/?utm_source=substack&utm_medium=email

Well, I have one of my Prostap SR (Leuprorelin Acetate depot injection 3.75mg) leaflets right here

You've kept that for a long time. Didn't you transition over 20 years ago?

None of the reviewers identified any studies that I had missed that demonstrated safe and reversible impacts of puberty blockers on cognitive development, or presented any evidence contrary to my conclusions that the work just hasn’t been done. However, one suggested the evidence may be out there, it just hadn’t been published. They suggested that I trawl through non-peer reviewed conference presentations to look for unpublished studies that might tell a more positive story.

So, they declined it on the basis that there might be a load of papers, which nobody knows about and she needs to clean the Augean Stables, in case she finds them. It seems unlikely to me.

The so called studies in favour, done ad nauseam on MN show very poor methodology, no blind trials, no meaningful follow-ups, if any. Just an woolly attitude of, "Child knows best, it's all lovely."

Sweden, the UK and other countries, looking into it, have now concluded that it's actually very shaky and needs to go on the back burner. Even the Dutch Protocol authors have admitted that they rushed in blind.

Just an woolly attitude of, "Child knows best, it's all lovely."

And according to Butters these children are cognitively compromised on account of gender dysphoria!