Tavistock puberty blocker study published

[PaleBlueMoonlight]

www.bbc.co.uk/news/uk-55282113

Finds 43/44 (98%) progress from PBS to cross sex hormones

Wrong study, but we're the results of this ever published?

www.rcpch.ac.uk/sites/default/files/Public_Info_Leaflet-GID-16-01-2012-FINAL.pdf (triggers download)

I also query how much influence the parent support group had on questionaires etc.

Well they actually write this:

There was considerable dissatisfaction by patients with the situation in the UK, with a number of parents electing to take their children overseas for treatment, particularly to the USA. This was documented at the time.[9] Service users linked with the Tavistock & Portman NHS Foundation Trust and charities supporting trans groups were strongly supportive of introducing early pubertal suppression.

We all know exactly who that is

@SophocIestheFox

I’m still not clear on what the benefits of the treatment were supposed to be, never mind if they were achieved or not...

Exactly what the judges said in Bell:

Firstly, there is real uncertainty over the short and long-term consequences of the treatment with very limited evidence as to its efficacy, or indeed quite what it is seeking to achieve.

Questions have already been asked about this study...

www.hra.nhs.uk/about-us/governance/feedback-raising-concerns/investigation-study-early-pubertal-suppression-carefully-selected-group-adolescents-gender-identity-disorders

It looks like they have just started a potentially more useful longitudinal study

njl-admin.nihr.ac.uk/document/download/2031909 (triggers download)

@ItsAllGoingToBeFine

It looks like they have just started a potentially more useful longitudinal study

njl-admin.nihr.ac.uk/document/download/2031909 (triggers download)

Although it's only for two years so not that useful...

That kidney comparison is so fatuous, I despair.

It would only work if you were getting dialysis because you felt deeply inside that your kidney function didn’t match other people’s. As opposed to actually, you know, having kidney failure. I should be used to the callousness, mendacity and sheer idiocy by now, but people still somehow manage to shock me.

Sophocles

Yes. The callousness is quite hard to miss.

@NeurotrashWarrior

*It looks as though at the start of the trial, 46.7% of the children were showing moderate to severe autism traits, and after 1 year on puberty blockers, that figure rose to 58.6%.

I hope I've got that wrong. Can someone familiar with the SRS test for autism make sense of this table?*

I can't comment on the table but one child I taught who was referred to the Tavi was only later referred for autism; this was over 10 years ago though. It's possible some children were diagnosed during the time there.

It's very concerning that it looks like for some their difficulties increased.

What that table seems to be saying is that around half the children recruited for this study showed moderate to severe autism traits. But didn't GIDS say in their evidence to the court that they had no data about autism in this group of children?

Thanks molesmokes

I’ve read the HRA report (into the study but also into itself)

I’ve focussed on their review of their own procedures rather than the study because I’m wondering how the hell this got ethics approval.

Investigators can submit their study for approval to any ethics committee in the country but it is common practice to submit to a local one.

The study investigators submitted to REC1 (a central London research ethics committee).

REC1 rejected it. A number of concerns but mainly that it was not a randomised controlled study. The investigator could not adequately address the issues raised in the meeting.

Guess what they did??

They made no changes to the study but wrote a cover letter explaining their choice for no control group and submitted to a different committee.
REC2.

Who had several members with undeclared conflicts of interest and close association with the investigators. They also didn’t have sufficient numbers. So REC2 co-opted a member from REC1 who was extremely closely involved with the investigators.
From the HRA report (my bold):

“ It was permissible within Standard Operating Procedures at the time for a researcher to choose to submit a study receiving an unfavourable ethics opinion to another REC, rather than appealing to the same REC. An appeal would normally be lodged when an applicant felt that the REC had issued an unfavourable opinion on a matter that the applicant felt had been adequately addressed, i.e. the applicant felt that the REC was making an error. The first REC in this instance did not feel that sufficient justification was provided by the research team for using an observational design instead of a controlled trial. As the applicant had not been able to fully address their points about alternative designs in the meeting, it was reasonable not to appeal.

I’m really confused about this and the wording is ambiguous.

I think they are saying the investigator shouldn’t have appealed because they were at fault. I.e the investigator had not fully addressed the question of REC1. Therefore it is highly unusual they could have gone to another REC??

There’s loads more to this, particularly about the lack of any interim report, which they say is OK but I think they are on very dodgy grounds.

I’ll have to come back to this later but I think there is a legal case to be brought against the HRA.

Service users linked with the Tavistock & Portman NHS Foundation Trust and charities supporting trans groups were strongly supportive of introducing early pubertal suppression.

And those charities mentioned, at the time, certainly stated that they follow WPATH, which, apparently, anyone can become a member of.

But didn't GIDS say in their evidence to the court that they had no data about autism in this group of children?

I believe they did.

@PronounssheRa

It seems like a poorly written paper with very odd inclusion of information about the pressures they were under

The inclusion of that statement sounds like a cry for help. The Tavistock are under hugh pressure from an unnamed parent support group, anything other than affirmation and they get accused of transphobia.

Is the Board still chaired by Paul Burstow? I imagine with his strong Lib Dem connections he’ll have been getting advice from well known quarters to be fully behind the affirmation model

GIDS have also said in the past that they did not liaise with the Specialist Autism Service that is also part of the Tavistock-Portman NHS Trust. I can’t remember now where I saw that but I was knocked off my feet by that. That and preventing staff from consulting the Trust Safeguarding Lead when they had concerns suggest some serious shortcomings that could amount to professional negligence and breach of duty of care.

Sonia Appleby! That’s the name! It Another whistleblower - Trust Safeguarding Lead:

Are whistleblowers being silenced at the NHS gender clinic?

www.spectator.com.au/2020/07/are-whistleblowers-being-silenced-at-the-nhs-gender-clinic/

Extract

Too many cases have seen systemic failures of care unaddressed because staff were not willing and able to raise concerns, leading to patients’ harm and sometimes death. Good whistleblowing policy and practice are fundamental to providing good, safe care.

Among the people at the Tavistock and Portman NHS Foundation Trust who are supposed to ensure such policy and practice are in place is Sonia Appleby, the ‘Named Professional for Safeguarding Children’. She describes her role in this way:

‘My primary task is to ensure that clinicians protect their patients/service users from avoidable harm and are also able to recognize and appropriately respond to situations where under 18s are in need of safeguarding. My secondary task is challenge practices which are either harmful or could lead to harm.’

In other words, Appleby is part of the system at the Tavistock and Portman NHS Foundation Trust that is supposed to identify and address concerns from NHS staff who want to ‘blow the whistle’ on things that could be causing harm to the children seen at the GIDS.

Appleby is now taking legal action against the Tavistock and Portman NHS Foundation Trust. She says that when she raised the concerns of GIDS staff about patient safety to senior management, she was effectively punished. She also says that the Trust management actively discouraged clinical staff from raising patient safety concerns with her.

• - -

There’s a fundraiser for her case on Crowd Justice (not linking in case that gets this post deleted but well worth searching for updates on her case and safeguarding issues at GIDS). There are earlier Mumsnet threads on this case too.

I do think the autism world isn't sure where to place gd. For example, the NAS is a mixed bag of advice.

They've also been waking up to the way more girls are being missed but at the same time referring to gender stereotypes (esp taken from Attwood) to help that diagnosis which seems conflicting. (Eg I've read descriptions they give and I honestly see a number of boys I've taught in them too and girls who don't fit that description. It's useful for picking up those who've been missed by teachers who rely on old fashioned autism stereotypes but not a useful blanket description.)

Most people who work with / teach children with autism would recognise how they often are just not interested in being conforming. However the NAS has been captured completely.

And a huge issue is that some who've written for the NAS have stated that to deny an autistic individual the ability to socially transition (and access gender neutral toilets at school for example) is transphobic.

@NeurotrashWarrior

But didn't GIDS say in their evidence to the court that they had no data about autism in this group of children?

I believe they did.

"The court asked for statistics on the number or proportion of young people referred by GIDS for PBs who had a diagnosis of ASD. Ms Morris said that such data was not available, although it would have been recorded on individual patient records. We therefore do not know the proportion of those who were found by GIDS to be Gillick competent who had ASD, or indeed a mental health diagnosis."

Did Ms Morris lie to the court?

@NancyDrawed

I've just started reading and already I am alarmed by the loss of data unless I have misunderstood?

44 patients had data at 12 months follow-up, 24 at 24 months and 14 at 36 months

So by 2 years they only have data from 24/44 (54% of participants) and at 3 years 14/44 (32%) Does this mean that when they refer to 'no change at 36 months' they are basing that comment on the 32% of participants? Will this paper even GET through peer review?

It is concerning that there appears to be no data re what happened to these patients that ‘dropped off’. Surely they didn’t just disappear? They were part of a very important study so you expect strong efforts to be made to contact them and establish their reasons for leaving.

I worked on an eating disorders study run by Oxford University (only in a data entry capacity) but the epidemiologists captured unbelievable amounts of detail on each subject and proper follow ups and a proper ‘exit interview’ or full write up if anyone left the study. There was no doubt that the focus of the study was to gather the best possible data to help make a difference- whereas the Tavistock...

Sorry if it's been asked but Keira was there during this time; is her case included? And the outcome?

Keira would’ve been on GIDs ‘Standard’ pathway whereas the study is on the ‘Early Intervention’ pathway (ie, the study is on kids who were referred for blockers between 12 and 15 and taken off them at 16. Keira was prescribed them at 16. Perhaps if she had been referred by GP to GIDs a year earlier she would’ve qualified for the early intervention study, dependent on other criteria).

It is concerning that there appears to be no data re what happened to these patients that ‘dropped off’. Surely they didn’t just disappear?

They didn’t disappear, they turned 16, came off GnRHa drugs and 43/44 started cross sex hormones. The study didn’t bother to follow the next bit of their clinical progress, because it was only ever intended to look at blockers in the short term.

Did Ms Morris lie to the court?

🤔

Plantman is there anything on what happened next?

I assume if they has ever assessed anyone as being appropriate to prescribe PBS to, but unable to give consent as not Gillick competent, they might have actually had a control group.

The study didn’t bother to follow the next bit of their clinical progress, because it was only ever intended to look at blockers in the short term.

For a treatment pathway which has implications for the remainder of a patient's life, this seems to be an incredibly blinkered view.

They all end at different times, with the final one exiting the study in 2019 (so spent approx 5 years on blockers?)
Seeing as it’s taken a lot of drama to get this bit published, the likelihood of follow up data seems pretty small.

I noticed a year or so ago that one of the parent-of-trans-kids activists was trying to find some of the study participants but I don’t think he was successful.

I will look through some of the board meeting minutes later to see if I can find anything relevant. Looks like loads of ‘audits’ of patient info have been promised. Wonder how many of them have been completed?