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Feminism: Sex and gender discussions

NICE Evidence Review for Use of Puberty Blockers for GD - Now Released

192 replies

IDontOnlyLikeJazzFunk · 31/03/2021 14:09

now released. NC. The full link is below, this is the summary. It's not looking good.

Discussion
A key limitation to identifying the effectiveness and safety of GnRH analogues for children and adolescents with gender dysphoria is the lack of reliable comparative studies. The lack of clear, expected outcomes from treatment with a GnRH analogue (the purpose of which is to suppress secondary sexual characteristics which may cause distress from unwanted pubertal changes) also makes interpreting the evidence difficult.

The studies included in this evidence review are all small, uncontrolled observational studies, which are subject to bias and confounding, and all the results are of very low certainty using modified GRADE. They all reported physical and mental health comorbidities and concomitant treatments very poorly. All the studies are from a limited number of, mainly European, care facilities. They are described as either tertiary referral or expert services but the low number of services providing such care and publishing evidence may bias the results towards the outcomes in these services only and limit extrapolation.

Many of the studies did not report statistical significance or confidence intervals. Changes in outcome scores for clinical effectiveness and bone density were assessed with regards to statistical significance. However, there is relatively little interpretation of whether the changes in outcomes are clinically meaningful.
In the observational, retrospective studies providing evidence on bone density, participants acted as their own controls and change in bone density was determined between starting GnRH analogues and follow up. Observational studies such as these can only show an association with GnRH analogues and bone density; they cannot show that GnRH analogues caused any differences in bone density seen. Because there was no comparator group and participants acted as their own controls, it is not known whether the findings are associated with GnRH analogues or due to changes over time.

Conclusion
The results of the studies that reported impact on the critical outcomes of gender dysphoria and mental health (depression, anger and anxiety), and the important outcomes of body image and psychosocial impact (global and psychosocial functioning), in children and adolescents with gender dysphoria are of very low certainty using modified GRADE. They suggest little change with GnRH analogues from baseline to follow-up.

Studies that found differences in outcomes could represent changes that are either of questionable clinical value, or the studies themselves are not reliable and changes could be due to confounding, bias or chance. It is plausible, however, that a lack of difference in scores from baseline to follow-up is the effect of GnRH analogues in children and adolescents with gender dysphoria, in whom the development of secondary sexual characteristics might be expected to be associated with an increased impact on gender dysphoria, depression, anxiety, anger and distress over time without treatment. The study by de Vries et al. 2011 reported statistically significant reductions in the Child Behaviour Checklist (CBCL) and Youth Self-Report (YSR) scores from baseline to follow up, which include measures of distress. As the aim of GnRH analogues is to reduce distress caused by the development of secondary sexual characteristics, this may be an important finding.

However, as the studies all lack appropriate controls who were not receiving GnRH analogues, any positive changes could be a regression to mean.

The results of the studies that reported bone density outcomes suggest that GnRH analogues may reduce the expected increase in bone density (which is expected during puberty). However, as the studies themselves are not reliable, the results could be due to confounding, bias or chance. While controlled trials may not be possible, comparative studies are needed to understand this association and whether the effects of GnRH analogues on bone density are seen after they are stopped. All the studies that reported safety outcomes provided very low certainty evidence.

No cost-effectiveness evidence was found to determine whether or not GnRH analogues are cost-effective for children and adolescents with gender dysphoria.

The results of the studies that reported outcomes for subgroups of children and adolescents with gender dysphoria, suggest there may be differences between sex assigned at birth males (transfemales) and sex assigned at birth females (transmales).

arms.nice.org.uk/resources/hub/1070905/attachment

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AfternoonToffee · 31/03/2021 23:50

@thinkingaboutLangCleg

there are big questions around why the UK’s supposed centres of excellence like the Tavistock have been unable to conduct rigorous research. Why is that?

I suspect they don’t want to know the answers to questions they’re scared to ask. But I have no idea why they’ve been continuing down a path they must know will ruin their reputations when the law suits start coming at them.

I wonder if there could be an element of by not doing any research they couldn't then be accused of acting against guidelines. Perhaps it is easier and quicker just to have everyone on the one pathway.
EmbarrassingAdmissions · 31/03/2021 23:21

there is no 'recommedation' section. Interesting.

afaik, if it were a NICE Guidelines committee they could comment on evidence gaps and make evidence recommendations. However, it looks like NICE was commissioned to do a specific evidence review, it's an NHS E working group that will conduct the full range review (IYSWIM) and it is up to the working group to make research recommendations etc.

Manderleyagain · 31/03/2021 23:17

So would there normally be a recommendations section in a NICE review document like this? Does anyone know how common it is for there not to be?

persistentwoman · 31/03/2021 23:13

This seems massive? How can these 'experimental' treatments continue given these findings that there is no evidence about their safety or long term negative impacts? The cynic in me says that the lobby groups are so powerful that their demands will continue to to be adhered to.
But for anyone having regrets, especially if they started treatment when a minor, this must be significant evidence for a claim via the courts?

RedToothBrush · 31/03/2021 23:08

@vivariumvivariumsvivaria

So the studies are not good enough to draw conclusions?

We couldn't do a Cochrane Review because the quality of data is so poor?

So, this is amateur science? Making life long patients of young people?

So....public enquiry into why we have this remarkable spike in prevalence of young people with gender related distress?

So are NICE recommending that we need more research on desistace and on side effects? You know those very studies that have been defunded and have been closed down after lobbying and hate campaigns?

Usually where there is lack of evidence this is what they recommend.

checks document

Nope there is no 'recommedation' section. Interesting.

In this case, given its children, can they make this recommendation for experimental treatment? Hmm....

If NICE pull support for something that usually ultimately gives excuses for individual Trusts and CCGs to refuse to fund it. Indeed the document states:
No cost-effectiveness evidence was found to determine whether or not GnRH analogues are cost-effective for children and adolescents with gender dysphoria.
Which will start to raise a few alarm bells with the NHS accountants.

Basically no one wants to fund treatment thats unproven and doesn't have the financials behind it.

So whilst looking at the safety / effectiveness side of things is hugely important and what most people will look at first, don't forget the financials. Its important....

....Especially if you start to see hints of litigation/liability/malpractice being a possibility.

MaudTheInvincible · 31/03/2021 23:05

I agree

vivariumvivariumsvivaria · 31/03/2021 23:02

I'd be interested to know whether there has been ANY medical ethics involvement at GIDs.

Rendering a specific group, like autistic people, infertile has certain challenging optics, you know?

What is it, 40% of the young female people at Tavi are autistic? It's eugenics.

IDontOnlyLikeJazzFunk · 31/03/2021 22:54

@thinkingaboutLangCleg

there are big questions around why the UK’s supposed centres of excellence like the Tavistock have been unable to conduct rigorous research. Why is that?

I suspect they don’t want to know the answers to questions they’re scared to ask. But I have no idea why they’ve been continuing down a path they must know will ruin their reputations when the law suits start coming at them.

I am wondering what their exit plan is here. Hmm

Those law suits are definitely on their way.

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thinkingaboutLangCleg · 31/03/2021 22:51

there are big questions around why the UK’s supposed centres of excellence like the Tavistock have been unable to conduct rigorous research. Why is that?

I suspect they don’t want to know the answers to questions they’re scared to ask. But I have no idea why they’ve been continuing down a path they must know will ruin their reputations when the law suits start coming at them.

ChattyLion · 31/03/2021 21:38

Tibtom I was just commenting on this post of yours, what a scandal:

‘There has been a recent issue with hedge funds buying up production of off-patent drugs which used to cost the nhs pennies each and putting the price up significantly. And because some of these drugs are so widely used this adds hugely to the nhs drugs bill.’

Manderleyagain · 31/03/2021 21:32

Thomost
I think you have it right, but I'm not a lawyer or medical either.

ChattyLion · 31/03/2021 21:31

Tibtom that’s awful. That feels like a market problem
www.gov.uk/guidance/tell-the-cma-about-a-competition-or-market-problem#what-to-tell-us-about-and-why

rogdmum · 31/03/2021 21:24

Tibtom They called it the “triple lock” yesterday- clinician recommendation, young person consent, parental assent”. While it is down to the endocrinologists, they seem to view it as a seamless operation between the Tavi and the endocrinologists.

AnyOldPrion · 31/03/2021 21:17

@rogdmum

Good Law Project JR: confirms existing law that where a child cannot consent to medical treatment, parents can. That really was all, and it was a waste of their time and money; that had never been in question anyway. This was not an important judgment (unless GIDS use it to change their processes, which would be outrageous and which they have not. Yet at least)

TheMost At the Tavi Board meeting yesterday they were discussing the impact of Friday’s judgement. While they stressed they were still working through the implications, they said that they had to date depended on child consent but now there was the possibility of parental consent with child agreement . IMO, agreement is rather different than informed consent so it’s something to be kept a close eye on.

If the Tavistock reverse their entirely clear statement made in court during the Bell case and move to parental consent, it will be a definitive demonstration of their absolute lack of ethics.
Tibtom · 31/03/2021 21:17

I did think the refusal to consider parent consent because Tavi said they never used it was the achilles heel of the Bell judgement. But when it comes to puberty blockers that isn't really Tavi's call anyway. They aren't doctors. Surely it is down to the endocrinologists who said they would blame the parents?

rogdmum · 31/03/2021 21:00

Good Law Project JR: confirms existing law that where a child cannot consent to medical treatment, parents can. That really was all, and it was a waste of their time and money; that had never been in question anyway. This was not an important judgment (unless GIDS use it to change their processes, which would be outrageous and which they have not. Yet at least)

TheMost At the Tavi Board meeting yesterday they were discussing the impact of Friday’s judgement. While they stressed they were still working through the implications, they said that they had to date depended on child consent but now there was the possibility of parental consent with child agreement . IMO, agreement is rather different than informed consent so it’s something to be kept a close eye on.

WarriorN · 31/03/2021 20:57

@mumwon

Its also the long (life time) unknowable/unforeseeable side effects - increases in cancers for instance? Or increases in diabetes anaemias? will this affect the thyroid glands brain liver? Dementia? Who knows? & that's the worry!

A few of these issues seem to be implicated in their other uses; eg precocious puberty especially in girls

IDontOnlyLikeJazzFunk · 31/03/2021 20:47

@TheMostBeautifulDogInTheWorld

Out of interest (and I read it entirely as a layperson, and fairly fast at that) the NICE document does not seem to have even considered effects on IQ. Is that right? I appreciate that studies on that are even more sparse than the studies they did study, but that seems to me to be something of an omission?
They did mention it but as with most of it the research wasn't adequate to enable them to draw any conclusions:

Cognitive development or functioning
The study by Staphorsius et al. 2015 in 40 adolescents with gender dysphoria (20 of whom were receiving GnRH analogues) measured cognitive development or functioning (using an IQ test, and reaction time and accuracy measured using the Tower of London task):
• The mean (±SD) IQ in transfemales receiving GnRH analogues was 94.0 (±10.3) and 109.4 (±21.2) in the control group. In transmales receiving GnRH analogues the mean (±SD) IQ was 95.8 (±15.6) and 98.5 (±15.9) in the control group.
• The mean (±SD) reaction time in transfemales receiving GnRH analogues was 10.9
(±4.1) and 9.9 (±3.1) in the control group. In transmales receiving GnRH analogue it
was 9.9 (±3.1) and 10.0 (±2.0) in the control group.
• The mean (±SD) accuracy score in transfemales receiving GnRH analogues was73.9 (±9.1) and 83.4 (±9.5) in the control group. In transmales receiving GnRH analogues it was 85.7 (±10.5) and 88.8 (±9.7) in the control group.
No statistical analyses or interpretation of the results was reported.

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mumwon · 31/03/2021 20:46

Its also the long (life time) unknowable/unforeseeable side effects - increases in cancers for instance? Or increases in diabetes anaemias? will this affect the thyroid glands brain liver? Dementia? Who knows? & that's the worry!

KatieAlcock · 31/03/2021 20:44

@TheMostBeautifulDogInTheWorld

Out of interest (and I read it entirely as a layperson, and fairly fast at that) the NICE document does not seem to have even considered effects on IQ. Is that right? I appreciate that studies on that are even more sparse than the studies they did study, but that seems to me to be something of an omission?
There's so little evidence of the effects on IQ/white matter/frontal lobe function it's really hard to call.
WarriorN · 31/03/2021 20:42

I'd say that's a good round up themost

Not sure about the IQ bit.

TheMostBeautifulDogInTheWorld · 31/03/2021 20:29

Out of interest (and I read it entirely as a layperson, and fairly fast at that) the NICE document does not seem to have even considered effects on IQ. Is that right? I appreciate that studies on that are even more sparse than the studies they did study, but that seems to me to be something of an omission?

TheMostBeautifulDogInTheWorld · 31/03/2021 20:25

Guessing this might have some significance to the Cass review as well.

The report draws itself to the Cass review's attention - so did the "parental consent" court ruling from last week.

I am neither a lawyer nor a medic or any kind of scientist and if any of what I say next is entirely wrong in those contexts I would outright welcome correction - these issues are so important and I want to learn, not least so that next time I write to my MP (or to a Select Committee or whatever) I don't make a fool of myself.

But I think what we are looking at with all this is a refining and repositioning of stuff, legally and medically - and that Good Law Project's touting of itself as achieving anything is mendacious entirely.

Keira Bell Judicial Review: confirms existing law that children cannot consent to what they cannot understand. "Introduces" (or rather, highlights) the concept that puberty blockers are an experiment not a treatment, based on the medical evidence presented (and more importantly not presented) to the court. This was an important judgment because the NHS had been acting as if children could consent; they can't.

Good Law Project JR: confirms existing law that where a child cannot consent to medical treatment, parents can. That really was all, and it was a waste of their time and money; that had never been in question anyway. This was not an important judgment (unless GIDS use it to change their processes, which would be outrageous and which they have not. Yet at least).

Situation so far: children whose parents do not want them to be will not be drugged by the NHS though of course the situation for the likes of GenderGP is basically not regulated; and parents like Susie Green will still be able to get their way via that route. As will children off their own bat, where the likes of GenderGP are prepared to overlook all ethics. (And there is of course as there should be a grey area for NHS patients already on the drugs).

NICE review: There is no good evidence of anything; what there is is not reliable or of any quality; what there is shows harms (to some extent, bone density, cardiovascular issues) and perhaps some goods (possibly psychological well-being, but there is certainly no good evidence). This - it seems to me - reinforces the "this an experiment, this is not a treatment" theme from Bell.

So after those three things surely what we have is a situation where a) only parents/carers can decide ultimately that their child should take these drugs b) any ethical doctor can only ask those parents "do you consent to this experiment" not "do you consent to this medical treatment".

You would of course also hope that a load of doctors are sitting up and going "Whoah, wait a minute" and no doubt many are - but at this point I doubt that the doctors that "matter" - the ones in the actual field, because they are often going to be the most "captured" - are thinking that. But, every little helps.

As I say I would really welcome correction from people that actually know what I'm talking about - as robust as you like.

But - I think - that is sort of the framework that the courts and NICE are telling the Cass Review to operate in.

EmbarrassingAdmissions · 31/03/2021 20:17

@ArabellaScott

Thanks, Embarrassing. 'later' - bit vague!
It's typically a bit less vague but, for a number of topics, a lot of clinicians have been redeployed for Covid or Covid-related cover reasons so the timetables have been a little blurrier than is the norm for the last year or so.
ArabellaScott · 31/03/2021 20:12

Thanks, Embarrassing. 'later' - bit vague!

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