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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

OP posts:
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drspouse · 31/03/2021 20:01

@WarriorN

Where does this leave gender Gp et al?
Private clinics don't have to prescribe only effective meds -they can prescribe what they like as long as they don't mis-sell (a whole other argument). @lecanardnoir on Twitter is experienced at taking "alternative" medicine to task.
IDontOnlyLikeJazzFunk · 31/03/2021 19:54

@PosyP

OP, it looks like the review was completed in October 2020. Was it only posted online recently? Why would they not have made it available earlier given the active court cases?
I assume it has been going through a review process since then - it has only just been released - I've been keeping my eyes open Wink.

Maybe they've just been staring at it in horror, wondering what to do with it...

OP posts:
EmbarrassingAdmissions · 31/03/2021 19:49

@ArabellaScott

So ... apologies for my ignorance - is this this:

'NICE will also undertake a thorough review of the latest clinical evidence to help inform the working group’s review.'

from this:

www.england.nhs.uk/2020/01/update-on-gender-identity-development-service-for-children-and-young-people/

When is the working group to make its report or publish findings, etc?

Terms of reference:

It is expected that findings and any recommendations on this aspect of the review will be reported early in 2021 with the review’s wider findings and recommendations delivered later in 2021.

ArabellaScott · 31/03/2021 19:47

twitter.com/thecassreview

'more from us soon' - that was in feb

Manderleyagain · 31/03/2021 19:45

Will the NHS continue to appeal the court's ruling that children cannot consent themselves to use this drug, having seen this?

Manderleyagain · 31/03/2021 19:43

I get the impression that the cass review won't report for some time. They set up a twitter account to give updates back in January but it hasn't tweeted since 1st feb, and there is no sign of the promised Web site yet. That suggests to me it's at the very beginning of the work.

AnyOldPrion · 31/03/2021 19:40

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

ArabellaScott · 31/03/2021 19:29

So ... apologies for my ignorance - is this this:

'NICE will also undertake a thorough review of the latest clinical evidence to help inform the working group’s review.'

from this:

www.england.nhs.uk/2020/01/update-on-gender-identity-development-service-for-children-and-young-people/

When is the working group to make its report or publish findings, etc?

WarriorN · 31/03/2021 19:23

No change I presume but how on Earth can political parties be seen to support them?

WarriorN · 31/03/2021 19:22

Where does this leave gender Gp et al?

WarriorN · 31/03/2021 19:08

I bet the process is so much easier for puberty blockers.

I wonder why?!

happydappy2 · 31/03/2021 19:06

There is no such thing as a transexual child. A child presenting with body dysmorphia needs the same help as an anorexic-talking therapy to accept their body & live healthily.

EmbarrassingAdmissions · 31/03/2021 18:53

Not wanting to derail, that's interesting. There's the official BTF British thyroid foundation, which operates under the BTA (association) and wouldn't be able to do that.

I gave hypothyroidism as an example of a group of patients that had been badly affected by a price hike. They're not the patient group I meant which was a rare condition with an orphan drug iirc (and it was the rights to this drug that they purchased).

yourhairiswinterfire · 31/03/2021 18:47

@MrsToddsShortcut

‘The content of this evidence review was up to date on 21st October 2020’

I hope that when the Good Law Project appeal against the Bell vs Tavistock ruling takes place in June, that this is used to absolutely flatten their case.

I don't think anyone is allowed to submit new evidence, are they?
WarriorN · 31/03/2021 18:47

I don't which which patient group it was but one of them spotted the potential group for this to happen for them and they negotiated with the original company to buy the rights themselves. Very smart move that kept it an affordable treatment.

Not wanting to derail, that's interesting. There's the official BTF British thyroid foundation, which operates under the BTA (association) and wouldn't be able to do that.

There are a couple more groups/ charities eg thyroid U.K. and stop the thyroid madness.

There's been a lot of smearing of the btf on social media by the others.

PosyP · 31/03/2021 18:42

OP, it looks like the review was completed in October 2020. Was it only posted online recently? Why would they not have made it available earlier given the active court cases?

EmbarrassingAdmissions · 31/03/2021 18:21

Off-label but used for the indication.

Usually very, very cheap drugs that change ownership and suddenly have a substantial price increase.

And I recognise the scenario you outline - and yes, very expensive. It's one of the causes of conflict for hypothyroidism in the UK iirc because that happened a few years ago with T3. Didn't that increase x9 or something?

I don't which which patient group it was but one of them spotted the potential group for this to happen for them and they negotiated with the original company to buy the rights themselves. Very smart move that kept it an affordable treatment.

Tibtom · 31/03/2021 18:10

Puberty blockers are used for prostrate cancer.

Tibtom · 31/03/2021 18:09

EmbarassingAdmissions do you mean off-label or off-patent? 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.

MrsToddsShortcut · 31/03/2021 18:08

‘The content of this evidence review was up to date on 21st October 2020’

I hope that when the Good Law Project appeal against the Bell vs Tavistock ruling takes place in June, that this is used to absolutely flatten their case.

teawamutu · 31/03/2021 17:58

Will be very interested to see what coverage it gets.

Will the Guardian touch it? Will Jesse bloody Singal?

EmbarrassingAdmissions · 31/03/2021 17:58

Ahh, of course off licence, they probably started life with another purpose and have morphed into this.

Off-topic: but there have been some cases recently where pharma companies bought the rights/distribution for an off-label drug that has been used for a very long time. The company x8 - x10 the price so it had to go to NICE with its marketing authorisation for a specific indication (for which it had previously been off-label) so that it could become approved. Unfortunately - the price has been found prohibitive for the evidence base that does exist (which tends to be unimpressive) so the application has been rejected. The people who were already on the drug for that specific indication get to remain on it but it's no longer available for those who are newly diagnosed with that specific disease.

Belleende · 31/03/2021 17:54

I wonder do any of the royal colleges have anything to say on PBs?

R0wantrees · 31/03/2021 17:49

Yes R0, WPATH are not an official professional association; they are a lobby group of self interested people. I believe Susie Green is a member?

I'm more concerned that the NHS Service Specification for children and adolescents is so reliant on WPATH guidelines, especially as the GIDS then has responsibility for being the 'expert' service influencing Primary Care, schools, colleges, social work and voluntary sector.

Gender Identity Development Service (GIDS) for
Children and Adolescents
(extract)
The service will be delivered in line with:
ï‚· emerging evidence for best practice
 relevant national and international guidelines for the care of children and adolescents with GD such as the World Professional Association for Transgender Health Standards Of Care For the Health of Transsexual, Transgender and Gender Nonconforming people, (Version 7 2012) (referred to in this document as WPATH SOC v7) and the Endocrine Society’s Clinical Guidelines (2009);
ï‚· NICE guidelines specific to the treatment of mental and emotional health and wellbeing including for psychosis, anxiety and depression."
www.england.nhs.uk/wp-content/uploads/2017/04/gender-development-service-children-adolescents.pdf

Thingybob · 31/03/2021 17:44

It’s good NICE finally got round to looking at it.

Even now they wouldn't be looking at it if it were not for Keira, Transgender Trend, The Times, BBC Newsnight and many more brave lone voices. GIDS were certainly not calling for it

Swipe left for the next trending thread