Streeting says puberty blocker trial is ethical

[Apollo441]

https://www.thetimes.com/article/b7add3b3-dde5-441b-b6cd-72fc541f4dee?shareToken=3b33d5e67c9fc595192ba4d22fb4669a

They support 'trans' because it part of their 'community' and because of a mis-placed sense of victimhood.

Plus, most of the high profile activists are men, and it's men supporting men.

I'd like to know who was on the Ethic's committee that signed off on this, are the so called experts the same sort of experts they had Tavistock?

The whole world has been conducting these trials for nearly 3 decades. To say that the whole rotten lot of them have failed to make any notes about any of their patients is utter nonsense. They have the data. They would have shared it had it shown any successful outcomes.

And WS is the rock-solid backer that GC people have in the Cabinet? Doesn't look so solid now.

I don't understand why they can't run the trial for 10 years but report interim results as they come in.

No one is suggesting the kids take the drugs for 10 years, the difference would only be the amount of follow up of the same cohort.

It seems negligent to not only potentially sterilise another batch of kids, but to do that and not bother following up for long enough to say anything meaningful about long term effects seems positively criminal.

Cass specifically and repeatedly says that there is no solid evidence base, so either the trials weren't focused on the questions of concern to us now or they were of too poor quality to be relied upon. Or Cass is lying.

Not Cass' biggest fan but I am confident which is more likely.

I hope he's happy having his name on this.

'The Streeting sterilisations' has quite a ring to it.

If they applied and got 10y approval (say), the results in the interim could be absolutely dire but the discontinuance would be left to the conscience of the investigators. And perhaps we were thinking of different purposes of a longer period; I was thinking the PBs may be continued beyond the original period as part of the continued period not just follow-up of a limited period of PBs.

This way, they will have to apply as if new, citing the first set of results. This is an important safety break if continuing PBs is a purpose of extending the trial. Extended follow-up should be relatively easy to get approvals for and is important so we can all understand what happens.

Iswym.

I think the key point is extended follow up would be easy to get approval for, but there seems to be no will to carry it out (the cynic in me says because of what they'll likely find).

No child can be prescribed PBs for gender dysphoria except within a clinical trial so at the end of the two years of the trial they will need to come off the PBs or be enrolled into new trial.

The guy that started the original trial is very high up in the NHS so if he has conducted trials for 3 decades with zero follow up then he should be removed from his position.

She may have said that there is no solid evidence base but there HAVE BEEN thousands of kids given these drugs so there IS evidence they just choose to ignore it/not follow up on it/gave it to the dog for breakfast.

And we DO know what these drugs do, that's why those drugs were chosen in the first place.

This trial will have to run and run and that's what they are planning. It will never end. They will after 20 years realise they 'forgot' to ask something that is really important so they will have to restart another one.

Only if it shown that time limited use is at least "OK" (nothing effective in medicine is entirely without side effects). If it fails that hurdle, they shouldn't be able to take it any further.

For a moment I honestly thought that labour, under Wes Streeting, could become a party worthy of my vote.

As things stand I am tempted to say that if Wes Streeting is unable to back-track on the PB trial, and make some unambiguous statements that literally make him the most hated man in the UK as far as TRAs are concerned, then I can only assume that he is actually more devious and dishonest than, and therefore worse than, the absolute shitshow of a party he is part of.

Worked for many years in research/ethical approvals - couple of points of clarification:

• No trial will be approved to go ahead without the correct level of insurance/indemnity in place if anything goes wrong. This will be clearly explained in the Patient Information Leaflet but at no point will anyone be blocked from making a claim
• All Clinical Trials are required to provide periodical reporting - if it's shown that the anticipated results are not being seen or adverse effects are much higher than expected, ethical approval and/or funding can be withdrawn

It’s literally a trial. But yes, it’s a trial comparing PBs now vs later, not PBs vs no PBs. The sample size is stated as 226.

Sheep are still a good model because their neuroendocrine system is closer to our own than those of many other animals.
Streeting told the adult clinics to release the data ages ago so IDK what the excuse is for human trials when the DLS hasn't been done & the animal results are so utterly inadequate.

If I understand the summary of the evidence in the Cass report correctly, there have not been formal, rigorous trials on teenage children.

This lack of a clinical trial with children is common worldwide with many long established drugs and is not limited to PBs in the UK. This deficit is changing but the opening of https://pmc.ncbi.nlm.nih.gov/articles/PMC4345947/#:~:text=Abstract,evidence%2Dbased%20therapies%20in%20children from 2015 illustrates this issue:
Safety and efficacy data on many medicines used in children are surprisingly scarce. As a result children are sometimes given ineffective medicines or medicines with unknown harmful side effects.

This means we may only know what the main effects of PBs are for all ages and side effects just for adults (children may suffer the same ones to a greater or lesser extent and potentially others).

Because of the potential bias in the non-trial clinical notes (those who can't tolerate PBs may be less likely to return and disclose side effects), even if they were made available to Cass' team, a trial may still have been necessary.

Thanks for the correction

I think the follow-up period is deliberately chosen in order to avoid having to contend with all the potential long-term harms. 2 years means the cohort will still be kids & to a large extent still in the "transition" honeymoon period. At the most obvious, (along with the defiined age range) it's looks as thought the study designers are trying to avoid having to report on some of the trade-off issues between arresting chronologically normal puberty in boys & having sufficient penile material for inversion

having sufficient penile material for inversion

That phrase sends a chill down my spine, I can tell you!

Having ‘ethics at heart’ is a slippery way of saying ‘well-intentioned’. The former does not actually mean ethical just as ‘well-intentioned’ does not mean right.

Sorry. That procedure still doesn't have proper surgical standards & the surgeons who've been doing it for, what, 30-odd years now, still haven't managed to produce a single study worthy of Cochrane Review, but it's still less risky than peritoneal pull-throughs & all the other surgical busking on lads who've been subjected to GnRHas.

Absolutely agree!

I believe after the 2 years the cohort can continue on pbs or go onto cross sex hormones (instead of waiting until 18).

They have somehow fudged it so that this continued treatment after the trial still counts as a trial.

Is that what this means (from the trial protocol)?

24 months in randomised trial with potential for non randomised open extension according to clinical compassionate care.

Link at bottom of this page:
PATHWAYS: Puberty suppression And Transitional Healthcare with Adaptive Youth Services - NIHR Funding and Awards