Health Secretary updates MPs on Government and NHS England’s work to improve gender identity services & implement recommendations of Dr Hilary Cass’s independent review. Includes extension of puberty blocker ban to Nov 26th & review of adult svcs

[TorghunKhan]

https://questions-statements.parliament.uk/written-statements/detail/2024-09-04/hcws70

This is worrying. They are talking about the trial as if it’s a certainty. Presumably that means they have ethical approval…

“In partnership with the National Institute for Health and Care Research (NIHR), NHS England is launching a clinical trial to assess the potential benefits and harms of puberty suppressing hormones.

“Within this trial, the effects of puberty blockers can be safely monitored, and the research will give government and the NHS the evidence we need to decide whether they can be used as a safe and effective treatment. The trial aims to begin recruiting participants early in the new year.”

Hmm. I wonder how they'll overcome the consent issues in relation to consenting to future sterility, loss of sexual function, impairment of brain / bone development etc?

I can't see any trial (except in relation to life limiting illness) accepting that a pre pubertal child can consent to all of the above and more? But presumably the trans extremists have such a hold on this aspect of child medicine, they need to go through the motions to demonstrate this rather than expect medics to practise ethical medical care?

'Within this trial, the effects of puberty blockers can be safely monitored'

Fucking how?!

If blockers are unsafe, they're not rendered magically safe by the fact of being part of a trial.

I'd be very interested in the answers.

I think we need to see how (or if) they have approved the ethics and if they have asked the right questions and if not why not? I think this can be stopped if they are made to face up to the reality and not just try and gloss over it.

Came here to say exactly this!

"Safely" by what standard?!?!

When the impacts on brain development are unknown, it's a terrible choice of adverb.

Unless they simply mean that the monitoring itself will be safe... e.g. children can have brain scans done in a safe environment.

FFS.

I read this and thought it represented a nuanced and balanced approach to the issue.

There is as yet no convincing evidence on the risks/ benefits of puberty blockers so they are going to collect it via a properly constructed, ethical trial. When they say they are recruiting candidates, it will not be a case of taking anyone who rocks up. There will be some children/young people for whom puberty blockers in a controlled trial represent a valid approach when risk/ benefit is taken into a account eg the 5 year old with precocious puberty or the suicidal 12 year old with long standing gender dysphoria for whom other interventions have been ineffective. Parents will be part of the consent process alonside clinicians and psychiatrists - as they are now in other potentially dangerous drug trials involving young people.

I assume that the trial will be lengthy as in most cases risk/benefit will only become clear once the young person has reached their late 20s early 30s at the earliest.

It will be rejected at the ethics stage I am certain don't worry.

To add:

NHS England previously used to talk about the impact of puberty blockers on the developing teenage brain being unknown. See first screenshot and link below to 2021 archive:

https://archive.ph/LwIm3

This wording about the uncertainty re puberty blockers has now disappeared completely. See second screenshot and link to current page:

https://www.nhs.uk/conditions/gender-dysphoria/treatment/

It is impossible to have a safe, ethical trial where the risk of permanent brain damage is unknown.

It wasn’t rejected last time.

I feel rather a lot has changed since "last time"

I'd wonder if they could use the data on children which have already been experimented on, but then I remembered the Tavistock didn't actually collect any data, so they can't.

I think this should be the first stage of any future study. Cass was refused access to the previous data. This should be collected and analysed before any more children are experimented on.

A lot has changed. We will find out very shortly if the change is heading in the right direction.

There is evidence on the risks. These drugs are used in end-of-life care for men with prostate cancer. They've also been used for precocious puberty.

The side effects are quite well known, although granted for men with advanced prostate cancer they aren't likely to be long term, and for precocious puberty they are used on a more short term basis than might be suggested for 'gender incongruence' - I think in the UK at least they are only prescribed for precocious puberty in extreme cases because of the side effects.

https://www.statnews.com/2017/02/02/lupron-puberty-children-health-problems/

'In 1999, the FDA examined 6,000 adverse-event reports about Lupron filed by doctors, patients, and researchers. Although the FDA couldn’t locate its 1999 report on the matter, a court document that summarized the findings of the report said it found “high prevalence rates for serious side effects” including depression, joint pain, and weakness, and noted similar effects in men and women with very different ailments suggested the drug was causing the problems rather than underlying medical conditions.'

Lawsuit from 2001:

'The settlement resulted in a corporate guilty plea for conspiracy to violate prescribing laws and one of the largest fines at the time — $875 million.'

https://www.justice.gov/archive/opa/pr/2001/October/513civ.htm

All of this.

I remember the horror in the 80s(?) about the 'doping' of Eastern bloc gymnasts with what were basically puberty-blocking drugs of some sort.
We really are going backwards.

@ArabellaScott

Quote from Health Secretary Statement

“The Cass Review made it clear that there is not enough evidence about the long-term effects of using puberty blockers to treat gender dysphoria and incongruence to know whether they are safe or beneficial”…

..hence the need for a properly constructed ethical trial

I am not underestimating the difficulties associated with framing that trial.
But I do not think we should be arguing with the intention of systematically collecting evidence (not just anecdote).

I am all for evidence collection which is why I think that the data from the last 10 or so years should be collected and analysed before any new children are experimented on. We know this evidence exists because Cass was denied access to it. This missing data could potentially tell us everything we need to know without subjecting a whole new cohort of children to treatment that they know has harmful side-effects and may lead to loss of sexual function and infertility.

I can't find anything online about who will be running the trial, where it will take place and who will be eligible. They will definitely need Research Ethic Committee (REC) approval - and they are very hawkish generally. Any trial must be appropriately registered on a public trial register - likely ClinicalTrials.gov.
I wonder if this is too much of a poisoned chalice for any centre or senior investigator to want to get involved. Ethics would be a total nightmare.

Quodraceratops do you know if the decision for a study like this by an ethics committee is available for the public to view? I don’t know very much about the process. And not getting very far with google!

What are they treating exactly in this trial?

or the suicidal 12 year old with long standing gender dysphoria for whom other interventions have been ineffective.

But other interventions have not been taking place. I’m completely against a PB trial, but if this is an argument for who should be included, we need these children to have undergone long term therapy (as in years, not months) to look at the underlying causes of distress and help to resolve them, bearing in mind that puberty itself is the “cure” in many cases- ie even assuming you assume there will be this cohort, we’re years away from identifying who might be part of it.

I don’t see any way this trial could be done in an ethical or safe manner.