Tavistock puberty blocker study published

chattylion

Try

www.nihr.ac.uk/health-and-care-professionals/learning-and-support/good-clinical-practice.htm

www.hra.nhs.uk/planning-and-improving-research/

They would be the gold standard. they’re not designed for public but I think you would find the introduction sections very useful

This would be my understanding - the SRS is a screening tool for ASD, not a diagnostic tool. Children identified with high scores would often be referred for full assessment.

Is there any evidence that GIDS did this before starting them on puberty blockers?

May I ask a tangential question while we are talking about the published work. I’m not a scientist but I would like to understand research study design and process better so I can know what to trust. Is there anywhere non-scientists can read up on the type of questions we should be asking about published research? I’ve read various articles saying to look out for high quality or well designed research but I don’t know enough to know what that really means in practice.
Sorry if this is a ridiculous question, perhaps it’s like me asking a lawyer or doctor how I can understand their professional thinking better and you’ve all been studying this for years and done professional work for years in it. I hope it’s not an offensive question, its really not meant that way.

allmywhat and sultanasofa

Thank you very much for looking into the disparity between the recording suicide measures between the preliminary report and final report.

My questions:

1. this is a clinical trial. You are supposed to plan your outcome measures and how you will calculate them in advance in the statistical plan for the trial documents. if you change the plan part way through a trial you have to issue an amendment and rationale. All very normal... the purpose is To avoid data manipulation or questions about data manipulation. I wonder whether we can get these docs?

1. Do we have the raw data? Can we see if the mean scores for these two suicide questions were statistically significantly different at the later time points??

1. Why THE HELL didn’t they report an increase in their own suicide measures to the regulator as an Serious adverse event (SAE) at 12 months??

Eowynthewarrior

Also why was autism not properly explored before treatment given? It’s not as if a doctor is being faced with a choice of two harmless treatments for a common disease ( eg a skin infection where the only consequences of getting it wrong would be the rash doesn’t clear up and you switch treatment accordingly. How can a decision be made to give life changing potentially irreversible drugs without exhausting other avenues for diagnosis such as proper autism assessment first ? The risks snd stakes are so high surely it should have been throughly investigated? Did the children undergo any other tests to see if there were reasons for their distress ?

In terms of exploration of autism (or other diagnosis) before treatment started, the manuscript says that a full history was taken as part of the work up. Best medical practice would include an assessment for autism and other relevant history, would record this in the patient's medical notes, and take this into account when considering management. However this manuscript does not include any more details about whether this was done or not - we simply don't know.

At the first medical clinic, young people and families were seen by a senior paediatric endocrinology clinician together with a senior GIDS clinician........ A full medical history was elicited and the clinicians also reviewed a summary of the psychological history and assessment from the GIDS.

We know that a decision was taken not to record medical history in the study database. Therefore an important opportunity to quantify rates of autism and other relevant medical history in this GIDS cohort was missed.

I mean, if puberty is a maturation process which includes maturation of thought have we created people who are permanent juveniles?

I often wonder about this. Also if there could potentially be new "conditions" that arise if the use of PBs was to become more wide spread. I mean if you can go through the "wrong" puberty why not reject the idea of puberty altogether? I can imagine some sort of non-binary identity (just to make sure nobody would dare suggest it was a bonkers idea).

I wonder whether any of these children (or their parents) will go for the schools who have unthinkingly socially transitioned children, enabled children to access lobby groups without parental permission and ignored safeguarding standards?

I hope they do. It will focus school's minds on safeguarding and evidence very nicely.

MissLucyEyelesbarrow
That's very interesting when you say:
They are already in the pipeline. Solicitors have been touting for business from detransitioners for a year or so. This piss-poor paper from GIDS is Christmas come early for personal injury lawyers. It's so obvious that no proper steps were taken to monitor the effects of an experimental treatment that it will be impossible for GIDS to argue that it fulfilled its duty of care. And Keira's case has wiped out informed consent as a defence

I wonder whether any of these children (or their parents) will go for the schools who have unthinkingly socially transitioned children, enabled children to access lobby groups without parental permission and ignored safeguarding standards?

I do worry that many schools will be unaware of the implications of this judgement and will be carrying on with their 'Stonewall' policies and training.

Jo Bartosch wrote a great piece about her parents refusing growth hormones for her (not PBS, but a similar endocrine intervention that doesn’t have a clear clinical indication)

thecritic.co.uk/issues/july-august-2020/short-changed-by-society/?fbclid=IwAR2Ss5eb9HR_I5XVTvjtsTaeqOefizYpd1ZrH2C8uZIZesFvsBSsVQIFc1k

I'm pleased to hear that MissLucy.

Whilst many paediatricians prescribe ‘off-label’, halting natural puberty in gender dysphoria is entirely unrelated to previous indications. Prescribers, and psychologists who don’t prescribe, should not suggest that safety data can be transferred from triptorelin used for restoring correct timing in precocious puberty. Here, its use has many far reaching consequences so a more stringent research design was required. By gaining permission to study individuals without controls, and by not studying the whole pathway, we were never likely to learn much about the benefits or harms. Empiricism is simply not a good enough approach. Whilst RCTs might be difficult, they are not impossible, and simply have not been tried. Back in 2010, an opportunity for a UK pilot feasibility trial was missed when puberty blockers were not routine.

Quote from 21 October 2019
Richard Byng
GP and Professor in Primary Care Research
Susan Bewley, Emeritus Professor of Obstetrics and Women’s Health, Kings College London
University of Plymouth
John Bull Building, Tamar Science Park, Plymouth.

I'm trying to find an article I read once about a man who didn't take pbs for precocious puberty and the reasons given. Some of the reasons for taking them are that behaviour can be tumultuous for the child; his dad had the same condition and there was something about how his father felt that in the end it was ok (very vague memory.)

Anyway, obviously I'm wading through trans links. This rapid response debate in the BMJ about the study is fascinating and revealing.

www.bmj.com/content/366/bmj.l5647

So, if PBs aren't reversable and puberty has a window of opportunity and a person goes straight from PB to CSH for the rest of their life - are they an adult?

i mean, if puberty is a maturation process which includes maturation of thought have we created people who are permanent juveniles?

It can't be too long before the lawsuits start coming in.

How....

...unsurprising.

I'm wary of attaching meaning to any of the data given the bigger issues of no hypotheses, no primary endpoint, no control, no attempt to adjust for missing data, and no data collection beyond start of CSH.

So many experts on this thread! I believe we've got all the bases covered. Legal, medical, psychology, autism, safeguarding, statistics.... Thanks everyone for sharing your knowledge.

I remember TRA 'kilgoresprout', god knows what they call themselves now but most knew who they were years back..proper going down my neck when I was on twitter, when they were trying to convince me the goods of puberty blockers and how they were lifesaving, and reversible and so on. When they said it was just a pause button, and I pointed out how if puberty does not happen, the the huge brain development that goes on at that time would presumably also be paused. They went off it, and ended up blocking me too. But thats when I started thinking a lot about PB drugs, as it seemed totally nonsensical that everything else was blocked, but apparently brain develpment went on as usual and it was hugely bigoted to claim otherwise!

Clyme, that's my feeling about pbs. There must be some impact on the brain. There's lots of trimming and connecting going on. The other article I linked to suggested a huge turnover of cells in the hippocampus during prepubescence and puberty, part of the remodelling that goes on.

Meandering and all, and all posters, thanks for sharing all thoughts.

Yes I think we will hear from Biggs soon.

Allmywhat even in sheep they said that they needed to test with a cohort of female sheep to know if the impact was any different.

It is mind boggling.

or lumping the two self-harm statements together made the significant increase in one of them disappear (which strikes me as potentially dodgy.

Quoting myself. On further reflection, and to do them justice, if the increase in "I try to hurt or kill myself" was a real increase and not just a statistical fluke, then I think you would really expect it to be accompanied by an increase in "I have suicidal thoughts." I'm not a psychologist, but it seems to make good sense.

So while I do suspect them of creating this Self Harm index (lumping the two scores together) to disguise the increase that Michael Biggs highlighted - it still seems like a reasonable enough thing to do. I think I'm willing to absolve them of dodginess on this score, because I think lumping the two scores together would only work to disguise a statistical-fluke increase and wouldn't work to disguise a real effect.