Puberty Blockers Trial

[Cismyfatarse]

NHS to launch £10.7 million trial of puberty blockers

www.thetimes.com/article/1a43ff7e-3929-4d78-9ac4-7490b5cc2e2e?shareToken=14e04db1b508819178c480124574cb9b

I really, really hope they are not going ahead with this. I have only skim read the article. But can you trial something where there is evidence of harm?

But the context is totally different - it is highly challenging to evidence base how we resuscitate people, for obvious reasons. That means that we don't actually have good evidence for using adrenaline - so the baseline is that we don't know if it helps. We also know that most out of hospital resuscitation scenarios are unsuccessful- less than 10% survive. So actually it is justifiable to ask if we are using the right drugs/ techniques, and the level of harm for those in the study isn't high as over 90% die currently.

For gender dysphoria we know that 80% of kids will self resolve after normal puberty. We know that puberty blockers have serious side effects, many of which are irreversible- impact on sex organ development, bone density, voice and so on. Unknown impact on fertility but likely to be bad. So doing a trial has a high risk of harm and low risk of benefit. It's totally unethical in my view and I will gladly contribute to any organisation legally challenging the trial.

I've been involved in obtaining ethical approval for studies and the Research Ethics Committee (REC) absolutely will turn applications down or request amendments - it's very common not to get approval first time, often for minor reasons. Looking online if this was approved I believe the route to object would be complaints to the Health Research Authority (HRA) or funding a legal challenge. Not sure that's ever happened in the UK.

Honestly I think the best parallel here is the US Tuskegee scandal where racist medics left African American men with syphilis untreated to observe the natural history of syphilis in black people. It started in 1932 when treatments were limited (but there were some treatments that worked somewhat) and continued when penicillin was available and they could have been cured very easily. Clinton formally apologised - not that it was during his era, but took decades for the government to apologise.

So the question for Starmer is - will you allow a new Tuskegee to happen on your watch?

I completely agree.

The point I was trying to make is that whatever reason TRAs come up with to do the trial they don’t hold water.

And whatever reason TRAs come up with to do the trial ethically don’t hold water either.

While I appreciate the nuance in your points, doesn't it give you a shock to realise that this would negatively impact on yet another group of children? Stopping their brain and body development, effectively sterilising them, rendering them inorgasmic while expecting them to give informed consent to these likely outcomes?

I can't see a way of making this an ethical choice for these individual children.

We know enough @RethinkingLife . We know that they plan to follow these kids for two year - that's right there a 'close the idea down, it won't work' problem. Secondly, we know they do not plan to exclude children with other comorbidities such as ASD, ADHD, eating disorders etc - that's utterly unethical. We also know that the language used is ideological. There is literally no reason to support this trial. it's badly designed. We have 9000 kids to work with already. They had puberty blockers through the NHS. This £10 million should be focused on obtaining the outcomes of these children who are now adults.

I am in a car park on my phone so can't access anything but can we please remember that the guy that did the original 'study' not only ignored his own age limits but is also very high up in the NHS and has OBE type awards for his work?

I can't remember his name, Russell or something.

Agreed it is the very definition of Hobson's choice. I do fear that without some quality studies this debate will rage on for ever. Is it worth risking the health and safety of some kids, (some of whom would go private for this treatment) to answer once and for all whether PBs in kids can ever be justified? How many studies and how many participants would be needed to really answer this question? Will activists just ignore the answer if they don't like it anyway? This will always be a very nuanced debate, with no clear cut right or wrong answer.

Sunlight and data are the antidotes to activism gone wrong. We have thankfully been getting lots of sunlight, but we have precious little data. Without data I get worried that activists will just get smarter at creating arguments. Good data are hard to argue against.

On balance, I think generating the data, even if this means some kids will be harmed, will be the most effective way to minimize harm over the longer term.

So some gay boys are best off castrated?

There are no children who need this treatment. All of these children have normal, healthy bodies. What they need is support with accepting their bodies. There's so little conversation around encouraging adolescents who have distress about their body to focus on the positive things it can do, on feeling positive about having a body that is well and functions as it should.

But it's not 'this study now or no study ever'.

As well as the past Tavistock cohort there is the precocious puberty cohort - easier to track, less likely to have skewed dropout problem, plenty of long term info available. And prospective, properly blinded studies can be done on animals.

Proper reviews and crossreferencing of these data would give robust details of harms.

Then we can weigh up whether the known harms might be worth testing against an undefined, unconfirmed, undiagnosable condition that has an 80% recovery rate with watchful.waiting.

Going ahead with human trials at this point means we can't weigh A against B for ethics approval because we don't know A.

I think the entire concept of using body modification to treat dysphoria is false and should be abandoned.

A lot of people with bulimia are overweight but we don't treat them with weight loss drugs and surgery.

We shouldn't be jumping to a clinical trial in humans without preliminary work - what does the animal data say? What happens if you block puberty in primates? If that hasn't been done it should be prior to experimenting on human children.

The majority of the world still believes in trans, gender, and “trans kids”.

Do you think that's true? I don't think it's true at all. I first came across the idea of 'trans kids' only about 10 years ago when I saw the Louis Theroux documentary about Americans transing kids, and I mentally filed it under "Batshit stuff the Americans do", alongside things like child beauty pageants. It was a year or two later when I realised how widespread this was and that it had spread outside America. It's a very new ideology.

I think that lots of (particularly older) people haven't got a clue that there are now child transsexuals.

In 2019 someone who worked in a school told me that there was a girl in the school who wanted to be a boy and the staff were all supposed to pretend that she'd turned into a boy (it was a girls' school). She said that she, along with many other staff, were baffled by this, as they'd never come across the idea of 'trans kids'. This is all very new to many people and I don't think in such a short space of time it would be right to say that most people accept this nonsense ideology.

I'm sure there's more awareness of this now, but I don't think that there has ever been a majority of people believing in children being born in the wrong body.

As I explained earlier, any retrospective study is likely to generate poor quality evidence.

Precocious puberty is a red Herring. These kids are treated for the minimum period and then go through puberty once the blockers are stopped. They won't tell us anything about kids that take the blockers, go on the cross sex hormones and never go through puberty.

Animals also don't have gender dysphoria and can't express things like happiness and satisfaction. Animal studies may show some of the harms but they will never be able to ask questions about the potential benefits. They just aren't a substitute here. I don't think there is a substitute to doing the trials in people.

If I look at this from a rational pov, I suspect that doing the prospective studies and doing them well will, in the long run, be the best way to keep more kids safe from these unproven treatments.

If I was on the ethics committee being asked to green light one of these studies. I don't think I would, as my job is to look at the study, not the bigger picture...

You're missing the incremental nature of this.

Retrospective studies have a lot of faults - but they give us some answers to the long term effects question now rather than waiting 20 or 30 years.

Precocious puberty use shows minimum harm levels. If people taking them for 18 months have X amount of bone loss, people taking them for 5 years are very likely to have have at least that much. If puberty doesn't resume normally when blockers are stopped at 10 or 11, it's reasonable to assume the 'totally reversible pause button' claim is bollocks and it won't resume normally at 17 or 18.

Animal studies give us data on the physical harms - including brain development. What the animal feels about its gender doesn't matter for this side of it.

It's a jigsaw. And the potential for harm is so great that it would be utterly irresponsible to start prospective human trials before gathering the pieces we already have or can easily fill in without using children as test subjects.

Trust me, I am not missing this at all. I see huge parallels between this and the clamour for prostate cancer screening. The current tests for Prostate cancer may very well do more harm than good, but activists and some researchers, have been clamouring for a national screening programme.

The activists wanted the screening programme introduced, even with clear evidence it could do more harm than good. There has been lots and lots and lots of research, but nothing of the scale and quality needed to introduce screening on a national level. The national screening committee said no. Finally a proper trial has been funded. This should have been done years ago, lots of time money and effort has been spent on arguments that have not moved the decision any further forward.

Sometimes, particularly when clinical equipoise is in question and when there are activists involved, it is the only way to settle these types of questions. The incremental research just doesn't get you anywhere. It creates conflicting conclusions and the argument just keeps circling back, and the activists get louder each time. I don't want to be having the same discussion in 20 years time

The ethics committee absolutely have to consider the bigger picture. Does this research need to be done? Is this the right group to do it in? Could the question be answered in a different way? Doing research that is unnecessary is unethical - it wastes people's time and public resources. If I was on that REC I would want to see detailed data from people already treated with puberty blockers. If there is sufficient evidence from that group to justify blockers or show they are too unsafe to use the trial is not ethically justified.

I honestly believe that in 20 years we'll be back to where we were in the 1990s - before child gender dysphoria had been invented. I can't see how a 2 year long trial will answer any of the activists' questions adequately. It's pointless.

Totally agree, a 2 year trial is worse than no trial at all. There needs to be 20 year plus follow up, so we can see the impact when these kids start realizing they can't have kids.

Some of your questions wouldn't be addressed ordinarily by an ethics committee. Questions like, is this the right group of people to test this question in would normally be addressed by peer review at the funding stage. RECs won't have the expertise to critique this. They focus on the trial participants and the study team. They will ask to see evidence of risk and benefits to participants, but we know the evidence to date is not compelling either way, largely because the research has been so poor. RECs can and do approve studies in these circumstances. They will have a real challenge in their hands when it comes to informed consent.

I am not so optimistic that gender mania will dissipate. See you here in 2045.

I agree that this needs a longitudinal study design.

I have just seen thread about post-vaginoplasty regret with the belated realisation that the ‘cavity’ doesn’t deliver the orgasmic experience of the previous, functional sex organ.

I have so many questions about the standard of informed consent and how to assess someone’s level of understanding.

https://x.com/hazelappleyard_/status/1896531898442371276?

Do you think that's true?

I think it’s true in the sense that most people haven’t given it any deep thought or been challenged/challenged themselves on what that means. It’s just been blind acceptance of all the other TRA tropes they’ve been told, like pronouns, “most oppressed”, “just like being gay” etc. People see trans identifying adults and just assume they were kids once, ergo, “trans kids”. I agree that if challenged, no one thinks kids are actually born in the wrong body, but people don’t think about it. They just parrot the TRA mantras. But what people need convincing of is that “trans” as a concept itself is a vague ill-defined concept of circular definitions.

Yeah, it's as ethically questionable as it gets, but we are in too deep already. It's unlikely that things can just be stopped.

RCTs can be useful without that. If it were possible to get patients to cooperate, we could look at, for example, the percentage that naturally recovered from gender dysphoria without social transitioning and puberty blockers.

The "random" aspect would mean you probably couldn't question that the cases were equivalent.

IMO the fact that the Tavistock deliberately didn't keep records is very telling. In every other area of medicine, the need for accurate record keeping and retention is drummed into everyone.
In midwifery, for example, records must be preserved for at least 21 years. It may be more now (I am going back to what I was taught in the 70s).
Cancer trial records have to be retained and accessible for minimum 25 years.
Every medical professional in the UK knows about record keeping, which makes the whole thing worse.

Spot on. The medics involved know that what they're doing is unethical and likely to cause harm to numerous children and young people. They're hoping to take the money, make a "name" for themselves while avoiding all consequences.

I don't believe that the Tavistock 'don't have records' - medical information is retained for a set period (varies between organisations) - the data is all there, they just haven't organised it or followed people up. You absolutely could go back and trawl through all the records of children seen at GIDS and then contact them and ask if they would participate in an outcome study (some will be hard to trace, but not all).

It'd be difficult but so are clinical trials!

I can't imagine recruiting children to this trial will be easy now there has been so much negative publicity about blockers. I imagine the parent or responsible adult would have to agree with their participation- even if legally the child could consent without them it'd be difficult to arrange the multiple study visits without parental cooperation. And any parent who refused is safe in the knowledge that blockers aren't available via other routes in the UK.

They told Dr Cass there were no records. So either there weren't any/ they destroyed them/ they didn't want to give them to her because they contained evidence of malpractice and harm.
Whichever it was, it is damning.

Records? What records?

The general rule for hospitals is to consider them for deletion after 6 years. Some types - for example childbirth, or if the person is still receiving ongoing treatment - will be kept longer.

So the Tavistock may not have complete records but should have at least 5 years worth.

Tracking down former patients is harder than it should be because they were given new NHS numbers.