Tavistock puberty blocker study published

[PaleBlueMoonlight]

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

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

sultana fair point on criteria for SAE.

What about it being reported as an adverse event?

It gets worse. From strengths and limitations section of the paper:

“ Scoring of psychological questionnaire data was rechecked at the completion of the study however this was not possible in very small numbers of participants in whom only scale scores rather than individual item data were preserved during data migration in hospital clinical information systems.”

Years ago, back in the mid-1990s when I was a teenager, I remember reading an article about a child who had been born female but who had severe gender dysphoria and wanted to be a boy called Fredd. The article would have probably been in either Sugar or J17 (neither of which exist anymore, afaik). I remember reading the article at the time and I'm sure the child interviewed mentioned the prospect of going on puberty blockers. I remember Fredd saying something like "I want to go on them because the last thing I want is for my body to start developing into that of a woman." It was the first time I had ever heard about puberty blockers.

I've since tried to trace the article online but have been unable to. However, I did find a brief reference to a TV documentary featuring a transgender child called Fredd that was aired around 1995 or 1996. I suspect the article I read followed the TV show. I haven't been able to find anything else about Fredd since then.

Anyway, my point is that clearly PBs have been used for cases of gender dysphoria for some time (unless my memory of the article is playing massive tricks on me). If kids like Fredd were put on these blockers back in the mid-90s, surely we must have some long term data by now?

Of course, since I can't find any follow-up information on Fredd, it is possible that Fredd desisted and never medically transitioned at all.

They mention the statistical plan but have not included it.

This is really not helping with the transparency of such a high profile piece of research which has already come in for so much criticism and controversy. And is so delayed in its reporting.

I think some very hardworking clinicians were pressured into doing a clinical trial they didn’t want to run. It was unfunded, underpowered and uncontrolled.

Ultimately, due to the poor quality of data, it is unusable.

I agree that it reads like a cry for help at times.

But, someone went to the trouble of getting it through an alternative ethics committee, when the first one rejected it.

And that ethics committee approved it.

They should never have approved it and I think there is a legal case against the HRA.

Yes, (re hardworking clinicians being pushed into things that they didn't want to do) and I imagine that the huge staff turnover will have had an effect as well. And the ongoing pressure from external agencies to find certain outcomes maybe? Or at least a reluctance to publish something that would bring more pressure?

I think some very hardworking clinicians were pressured into doing a clinical trial they didn’t want to run. It was unfunded, underpowered and uncontrolled.

I hope I am wrong in thinking that this was the trial that a Gender clinic was paid £1.3m to run?

Not sure what you’re referring to gardenbird but apparently this was an unfunded study.

I've just been looking again at the table about autistic traits in the trial participants from the board meeting in 2015 (this isn't covered in the newly-published paper). I was wondering exactly how many children moved into the 'mild to moderate' or 'severe' categories after a year on puberty blockers, since these numbers were higher than at the start of the trial.

16.7% scored as 'severe' on the SRS test at the start of the trial. 16.7% of 44 is 7.3. I would expect this to be a whole number representing the number of children in that category.

After a bit of number crunching, it looks as though only 30 of the children took this test at T0 (the start of the trial) and 29 at T1 (after a year on puberty blockers), since this is the only way to get whole numbers of children for all the percentages they state.

They clearly state on that page that the number of children is 44, so I assumed all of them would have been tested. Why didn't they test the other 14 (15 after 1 year)? Is it because they already had an autism diagnosis, so they felt it was unnecessary? What else could be the reason? They don't even mention that not all the children were tested (or not all their scores were recorded).

It's on page 50 of the board meeting document (Appendix 7) if anyone else wants to have a look. It's possible that I've misinterpreted something.

tavistockandportman.nhs.uk/documents/142/board-papers-2015-06.pdf

They should never have approved it and I think there is a legal case against the HRA.

Isn’t it the research team and sponsor’s job to make the research fair, capable of finding out about its proposed subject etc? I thought the people and organisations listed on the published paper are responsible. I notice this paper hasn’t been peer reviewed so hopefully those ‘peers’ will highlight all the research design or analysis problems when that is done?

@everythingthelighttouches

They mention the statistical plan but have not included it.

This is really not helping with the transparency of such a high profile piece of research which has already come in for so much criticism and controversy. And is so delayed in its reporting.

I think some very hardworking clinicians were pressured into doing a clinical trial they didn’t want to run. It was unfunded, underpowered and uncontrolled.

Ultimately, due to the poor quality of data, it is unusable.

I agree that it reads like a cry for help at times.

But, someone went to the trouble of getting it through an alternative ethics committee, when the first one rejected it.

And that ethics committee approved it.

They should never have approved it and I think there is a legal case against the HRA.

Difficult to say. The standard of a lot of medical papers is remarkably poor, because - even for non-academic doctors - there is huge pressure to have publications on your CV. It's a question of 'Never mind the quality, feel the quantity'.

If they realised it was rubbish, I doubt Russell Viner would have put his name to it. I think they thought of themselves as brave medical pioneers and expected to get a pat on the back for their ground-breaking work. They probably weren't too bothered about statistical integrity.

OldCrone

I was wondering exactly how many children moved into the 'mild to moderate' or 'severe' categories after a year on puberty blockers, since these numbers were higher than at the start of the trial.

I don't think that children moved into the more severe category. What's happened is that children age out of the study at different rates, because they are not followed up beyond age 16.

All the participants are scored in after 12 months, but only those who are still under 16 are re-scored at 24 and 36 months.

What this suggests is that children who started PBs at a younger age (14 year-olds and younger) scored higher on the SRS than older adolescents (age 15). Which doesn't strike me as particularly encouraging.

MissLucy

I think they thought of themselves as brave medical pioneers and expected to get a pat on the back for their ground-breaking work. They probably weren't too bothered about statistical integrity.

This is exactly why we have a regulatory system.

It may not be the clinicians’ (main) day job to design clinical trials and write scientific papers but it is what the regulatory system and those who work or volunteer within it specialise in.

From a v good thread by MF.

twitter.com/mforstater/status/1338096822947024899?s=21

That’s a good Maya thread.

@InvisibleDragon

OldCrone

I was wondering exactly how many children moved into the 'mild to moderate' or 'severe' categories after a year on puberty blockers, since these numbers were higher than at the start of the trial.

I don't think that children moved into the more severe category. What's happened is that children age out of the study at different rates, because they are not followed up beyond age 16.

All the participants are scored in after 12 months, but only those who are still under 16 are re-scored at 24 and 36 months.

What this suggests is that children who started PBs at a younger age (14 year-olds and younger) scored higher on the SRS than older adolescents (age 15). Which doesn't strike me as particularly encouraging.

Your post made me look more closely at the data in this document. For the 'psychological functioning' test (on the next page) they say that they only have results for 30 out of the 44 trial participants, which correlates with my calculations for the number of participants for whom SRS scores were quoted.

I'm thinking now that this is because at the time of this report in 2015, it's possible that the other 14 hadn't yet had a full year on puberty blockers, so their results wouldn't have appeared here, neither for the SRS test nor for the 'psychological functioning' test. I don't think it's because some of them have 'aged out' of the study before they had had a year on puberty blockers, because if that were the case, their T0 values would still appear.

I think that the comment from my earlier post is still true, that of the children whose SRS scores were given for both T0 (start of trial) and T1 (after a year on puberty blockers), the number (as well as the percentage) of children who showed autistic traits has risen:

Normal:
T0: 53.3% (representing 16 children out of 30)
T1: 41.4% (12 out of 29)

Mild to moderate:
T0: 30.0% (9 out of 30)
T1: 37.9% (11 out of 29)

Severe:
T0: 16.7% (5 out of 30)
T1: 20.7% (6 out of 29)

This must be the same cohort of children, since it would be nonsensical to state the percentage of one group of children with autistic traits at the start of the trial, and the percentage of a different group of children with autistic traits after a year on puberty blockers.

@Signalbox

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).

Oh don’t worry, they’ve already gone there! This was discussed as a “theoretical” ethical case study where they weighed up the pros and cons of just keeping PBs going without progressing to CSH. You probably won’t be able to read the article as it’s behind a login but the conclusion is that they think it’s perfectly fine to keep a female’s body as what they call “non-binary”. It’s actually keeping a female as a permanent prepubertal child.

pediatrics.aappublications.org/content/145/2/e20191606

I don’t for one minute believe this is theoretical, I think they’re prospectively protecting themselves for a case they have who is probably 15-16 and doesn’t want CSH.

It’s grotesque.

Thanks for that link NotBadConsidering. I knew I'd seen something about this on here before. This is another paper about this case - this one is open access.

jme.bmj.com/content/medethics/46/11/743.full.pdf

OldCrone

In the end section of the paper they said they lost some patients’ data. Could that be the reason ?

Thanks OldCrone that’s the other one, I was probably mixing up the two.

It was likely inevitable. You have a girl who is terrified of puberty, what the changes to her body might bring and takes the opportunity to put it off with two hands.

Then she gets to 16. Doctors say “ok, time to start testosterone”

“No, I don’t want that with a hairy face and voice change”.

“Ok, let’s stop PBs then and go through (hopefully, if we haven’t ruined it) normal female puberty.”

“Oh no, I don’t want that either.”

So now they’re stuck. Do they withdraw PBs or keep going? They’ve decided it’s more ethical to keep going.

Just shocking really.

Like so many of us, I was relieved at the decision in Keira's case. But it doesn't stop there, as we all know; and the backlash wasn't slow.

My thanks to everyone who's involved in helping us to understand the details of the Tavi's documents.

This bit, quoted by PlantMam [Sat 12-Dec-20 12:15:06]: "an inspiration for our own international ambitions" really is quite chilling. I had to sit and think about that for quite a long while.

It reminded me of cases of "diagnosis" of CSA (Cleveland?), and the possible elements of fame playing a role.

Is there anywhere non-scientists can read up on the type of questions we should be asking about published research?

Ben Goldacre's books are very good! Though they are quite old by now, , they're sadly still very relevant. Bad Pharma is a good one to read about dodgy clinical trials.

capx.co/the-keira-bell-case-was-not-a-defeat-for-trans-people-but-a-victory-for-restraint/

This is helpful at explaining how judicial review works and the links to potential later negligence claims

Ok so paragraph 138 of the judgment is the actual statement of the law as it now is
drive.google.com/file/d/1KDvSdXmjFfTlyPooIkEDHKzRsKluSpyN/view

A reminder of paragraph 138. So this is what Tavistock needs to overturn based on its 10 grounds of Appeal

“138. It follows that to achieve Gillick competence the child or young person would have to understand not simply the implications of taking PBs but those of progressing to cross- sex hormones. The relevant information therefore that a child would have to understand, retain and weigh up in order to have the requisite competence in relation to PBs, would be as follows: (i) the immediate consequences of the treatment in physical and psychological terms; (ii) the fact that the vast majority of patients taking PBs go on to CSH and therefore that s/he is on a pathway to much greater medical interventions; (iii) the relationship between taking CSH and subsequent surgery, with the implications of such surgery; (iv) the fact that CSH may well lead to a loss of fertility; (v) the impact of CSH on sexual function; (vi) the impact that taking this step on this treatment pathway may have on future and life-long relationships; (vii) the unknown physical consequences of taking PBs; and (viii) the fact that the evidence base for this treatment is as yet highly uncertain.”

@allmywhat

Is there anywhere non-scientists can read up on the type of questions we should be asking about published research?

Ben Goldacre's books are very good! Though they are quite old by now, , they're sadly still very relevant. Bad Pharma is a good one to read about dodgy clinical trials.

Margaret McCartney's - The Patient Paradox: Why Sexed Up Medicine is Bad for Your Health is second to none on the time of question that both professionals and laymen should be asking about medical research and bias.

It will make you seriously rethink a lot about lobbying in other areas of medicine which are not necessarily helping patients as much as you think.

Exceptional book.