Terrible news. I really can't grasp the details of the reasoning for the refusal; I don't understand enough of what's going on. Dusty, do you have any idea if there's grounds for appeal. You should probably get some rest.
My gut reaction is the central hope of any appeal is the balancing exercise between 'direct benefit' and risk. Trouble is I've only read the summary so far but I think the judge has just waved it all through because there was such a long drawn out process. As I have said elsewhere - never mind the quality, feel the width!
Any appeal will be very difficult.
I had a day off yesterday, thanks Winifred. Obviously that just put me further behind!!!!!!!
....continued re appeal prospects. It seems to me that our side is screaming, really clearly -don't do this, it will harm children and it is probably illegal too- What about the potential illegality of it which may draw litigation down the line. May only individuals impacted by harm litigate or may other interested parties have standing to do that since this is contentious issue and may have global impacts and further harms. But in the meantime can a new appeal draw that line around illegality in the sand. Obviously, I really don't know what I'm talking about .....but have thoughts? Any thoughts Dusty and anyone else?
My emphasis would be on the balancing act between potential benefit ( none found by Cass and the DHHS in the States and the report in Finland) and the known likely harms including osteoporosis, infertility, lack of sexual function and effects on cognitive development. I need to read the judgment still but my feeling is the judge felt: here are all these really sick children and they need some treatment. He kept on about an example of a child who is fatally ill but, obviously, in those circumstances you might give that child an experimental drug even though you didn't really know if it would work so that is a ridiculous example!
I'm not through with the judgement and surrounding legislation yet but just a point to consider here. The judge in deciding if there should be a Judicial Review is not concerned with the efficacy, structure or morality of the proposed trial. Only with the legitimacy of the proposed trial within the legislative frame work as it stands. That is what any appeal will need to be based upon.
An appellant must show that the judge erred in law or erred in his assumption of the facts when denying a review. "Think about the children" is not a factor.
My view is this judgement is not appealable on those submissions alone.
First of all the Department of Health and Kings Collage London have been very slippery to split this into a single 2 year trial on PSH and avoid the issues of continuing treatment and transfer on to MAF Hormones. In doing so the court can only deal with the trial as proposed.
The thing which leapt of the page to me was the September 2025 refusal by KCL to adopt the proposed trial declaration from the MHRA. That revised declaration does not to my mind meet the threshold of Principal 28 of the Declaration of Helsinki, following the amendments brought forth by the Medicines For Human Use (Clinical Trials) (Amendments) Regulations 2005. (see paragraphs 19-20 of the judgment). However, this did not form part of the Claimants Pleadings! Before I even got to the summations of Chamberlain J I picked up on that.
Angus McCullock covered it in his skeleton argument and the Judge sets out the argument at sections 123-128 of the judgement. but as it did not form part of the pleaded case it cannot be appealed. Chamberlain J states that as there had been considerable time since the directions he would not have given permission to amend pleadings in any event.
This is very unfortunate (understatement) because I believe his reasons for dismissing Mr McCullock's submission as set out at sections 130-135 of the judgment are wrong in fact and would have been appealable had they formed part of the Claimants Pleadings. His "high bar" for frustrating other clinical trials is not an absolute. In cases where a trial is sought where minimal benefit may only apply to a de minimis cohort in a life critical trial does not apply here. None of these patients will die as a result of this trial not going ahead.
The opportunity to halt this stage of the trial it seems has been missed. 😔
Thanks very much Amanda. I'm not going to read the judgement because it would suck my brain out of my head. So thank you and all who are in the process of reading it.
Stephanie Davies-Arai isn't quite correct when she stated that "Children as young as 11 will have their critical growth at puberty stopped for two years" . Under the Pathways Trial any patient given puberty blockers will be allowed to stay on them after the two years unless significant harm is evident. So theoretically an 11 year old could be on them almost 5 years before being prescribed hormones!
I'm going to have a read of the judgement today and see if there are any grounds for appeal.
And as predicted Bev Craig is installed as Mayor Manchester. 25% Electoral turnout, pathetic the UK is doomed!
Not content with the systemic decline in the city the good folks of Manchester decided to double down on DEI woke culture by electing a super woke queer woman as mayor.
I am sickened and heartbroken at this decision.
Hi Allison
Yes likewise. Let's hope they appeal.
Dusty
Terrible news. I really can't grasp the details of the reasoning for the refusal; I don't understand enough of what's going on. Dusty, do you have any idea if there's grounds for appeal. You should probably get some rest.
Hi Winifred
My gut reaction is the central hope of any appeal is the balancing exercise between 'direct benefit' and risk. Trouble is I've only read the summary so far but I think the judge has just waved it all through because there was such a long drawn out process. As I have said elsewhere - never mind the quality, feel the width!
Any appeal will be very difficult.
I had a day off yesterday, thanks Winifred. Obviously that just put me further behind!!!!!!!
Dusty
....continued re appeal prospects. It seems to me that our side is screaming, really clearly -don't do this, it will harm children and it is probably illegal too- What about the potential illegality of it which may draw litigation down the line. May only individuals impacted by harm litigate or may other interested parties have standing to do that since this is contentious issue and may have global impacts and further harms. But in the meantime can a new appeal draw that line around illegality in the sand. Obviously, I really don't know what I'm talking about .....but have thoughts? Any thoughts Dusty and anyone else?
Hi Winifred
My emphasis would be on the balancing act between potential benefit ( none found by Cass and the DHHS in the States and the report in Finland) and the known likely harms including osteoporosis, infertility, lack of sexual function and effects on cognitive development. I need to read the judgment still but my feeling is the judge felt: here are all these really sick children and they need some treatment. He kept on about an example of a child who is fatally ill but, obviously, in those circumstances you might give that child an experimental drug even though you didn't really know if it would work so that is a ridiculous example!
Anyone else?
Dusty
I'm not through with the judgement and surrounding legislation yet but just a point to consider here. The judge in deciding if there should be a Judicial Review is not concerned with the efficacy, structure or morality of the proposed trial. Only with the legitimacy of the proposed trial within the legislative frame work as it stands. That is what any appeal will need to be based upon.
An appellant must show that the judge erred in law or erred in his assumption of the facts when denying a review. "Think about the children" is not a factor.
Hi Amanda
Thanks for this
Well it is the sense of what is the benefit and what is the risk?
I also feel the judge was concerned that all hese children would be left with no treatment - which I do think was an irrelevant consideration
Dusty
Well that's 4 hours I'm not getting back!
My view is this judgement is not appealable on those submissions alone.
First of all the Department of Health and Kings Collage London have been very slippery to split this into a single 2 year trial on PSH and avoid the issues of continuing treatment and transfer on to MAF Hormones. In doing so the court can only deal with the trial as proposed.
The thing which leapt of the page to me was the September 2025 refusal by KCL to adopt the proposed trial declaration from the MHRA. That revised declaration does not to my mind meet the threshold of Principal 28 of the Declaration of Helsinki, following the amendments brought forth by the Medicines For Human Use (Clinical Trials) (Amendments) Regulations 2005. (see paragraphs 19-20 of the judgment). However, this did not form part of the Claimants Pleadings! Before I even got to the summations of Chamberlain J I picked up on that.
Angus McCullock covered it in his skeleton argument and the Judge sets out the argument at sections 123-128 of the judgement. but as it did not form part of the pleaded case it cannot be appealed. Chamberlain J states that as there had been considerable time since the directions he would not have given permission to amend pleadings in any event.
This is very unfortunate (understatement) because I believe his reasons for dismissing Mr McCullock's submission as set out at sections 130-135 of the judgment are wrong in fact and would have been appealable had they formed part of the Claimants Pleadings. His "high bar" for frustrating other clinical trials is not an absolute. In cases where a trial is sought where minimal benefit may only apply to a de minimis cohort in a life critical trial does not apply here. None of these patients will die as a result of this trial not going ahead.
The opportunity to halt this stage of the trial it seems has been missed. 😔
He too points out
Thanks very much Amanda. I'm not going to read the judgement because it would suck my brain out of my head. So thank you and all who are in the process of reading it.
Thanks Dusty.
You're welcome, Winifred 😊
Well , that’s shit but colour me surprised
Yes...let's hope they appeal, Petal!
I can usually have a slightly comedic comeback for most things but …..
Well the next update features Jason Momoa so that should cheer you up!!!!!!!
O my Lordy I can’t wait 😍
The b*stard still hasn’t phoned me 🤣
- never mind the quality, feel the width!
You knew that was going to make me snort !!! 🤣
I’m so juvenile
😀
🤣
Terrible but not unexpected news.
Stephanie Davies-Arai isn't quite correct when she stated that "Children as young as 11 will have their critical growth at puberty stopped for two years" . Under the Pathways Trial any patient given puberty blockers will be allowed to stay on them after the two years unless significant harm is evident. So theoretically an 11 year old could be on them almost 5 years before being prescribed hormones!
I'm going to have a read of the judgement today and see if there are any grounds for appeal.
Thanks, Amanda. Let jus know what yu think once you have read the judgment ( I haven't read it yet)
Dusty
And as predicted Bev Craig is installed as Mayor Manchester. 25% Electoral turnout, pathetic the UK is doomed!
Not content with the systemic decline in the city the good folks of Manchester decided to double down on DEI woke culture by electing a super woke queer woman as mayor.
Hi Amanda
A predictable disaster. The other problem is that 'What rape Gangs?' Burnham is having a bit of a (probably brief) honeymoon period!!
Dusty
Here's our Bev's stance on trans and the Supreme Court ruling in FWS
https://www.manchestereveningnews.co.uk/news/greater-manchester-news/labour-mayoral-candidate-bev-craig-34260431
https://www.telegraph.co.uk/politics/2026/08/01/unabashed-socialist-replacing-andy-burnham-mayor/
Aieeeeeeee!!!!!!!!!!!
Thanks, Amanda
I bet the Juster is in the doldrums!!!!!!!!!
I shouldn't imagine Barry is at all surprised.
Probably not. I look forward to his comments
Dusty