Health Secretary updates MPs on Government and NHS England’s work to improve gender identity services & implement recommendations of Dr Hilary Cass’s independent review. Includes extension of puberty blocker ban to Nov 26th & review of adult svcs

[TorghunKhan]

https://questions-statements.parliament.uk/written-statements/detail/2024-09-04/hcws70

I'm also struggling to see how a trial would get through ethics.

It's a good kick the can down the road strategy though. And as time goes on more evidence of harms will emerge making a clinical trial even less likely.

Exactly.

And every month that passes while blockers are banned helps to undermine the myth that blockers save lives, and that young people would feel suicidal without them.

The guy that is now CBE and head of pretty much most of children's services has 35 odd years of working out how a trial can get around ethics, bearing in mind he will likely be on the ethics panel and was the person that initially WENT AGAINST HIS OWN FUCKING AGREED ETHICS RESTRICTIONS IN THE FIRST PLACE.

He is the Sheriff who instigated the Wild West approach. He is not going to put a stop to it now.

Indeed.

Apologies if this was answered further up the thread and I missed it but does anyone know if ethics approval applications and results are exempt from FOI requests?

To Beowulfa's excellent points, the information in this document will be very revealing.

FOI exemptions:

https://ico.org.uk/for-organisations/foi/guide-to-managing-an-foi-request/exemptions/

Basically, I think you can ask and the organisation will tell you if they aren't obliged to provide.

https://ico.org.uk/for-organisations/foi/guide-to-managing-an-foi-request/exemptions/list-of-exemptions/

'Section 22A – research information
This exemption applies if, when you receive a request for information,

• you hold information on an ongoing programme of research;
• there is an intention by someone –whether an individual or organisation, private or public sector - to publish a report of the research; and
• disclosure of the information would or would be likely to prejudice the research programme, the interests of participants in the programme, or a public authority holding or intending to publish a report of the research.

So long as the research programme is continuing, the exemption may apply to a wide range of information relating to the research project. There does not have to be any intention to publish the particular information that has been requested, nor does there need to be an identified publication date. You do not have to confirm whether you hold the information requested if doing so would reveal the content of the information. This exemption is qualified by the public interest test. For further information, read our more detailed guidance:'

[link on page]

Or, you could ask the ICO.

Thank you @ArabellaScott

It looks like it could be exempt.

If the FOI was submitted prior to it commencing, they could say that "disclosure of the information would or would be likely to prejudice the research programme", while if it had already started they could say that it's an exemption because they "hold information on an ongoing programme of research".

Hopefully there would be some space to argue that the request doesn't relate to the research data, therefore the exemption doesn't apply. As you say, the ICO would be able to clarify this.

You can chat with them directly, they are very helpful and responsive.

In response to a query on whether Research Ethic Committee reviews are in the public domain - no, not usually. I would be very interested to see the study protocol which given the level of public interest it would be good practice to publish. I do struggle to see how this would get through ethical review - as previously suggested, the first point would be can you answer this question without doing a trial - possibly yes by looking at people who have already had puberty blockers and comparing them to a current matched untreated group. To respond and say that we couldn't do that because the clinics refused to cooperate (as they did with Cass) looks terrible and that's not a reason to do a trial. Plus raises serious concerns about safe trial management if the same clinics are involved in recruitment and study procedures.
Go use the existing data - you can justify it as an anonymised review of NHS patient data pretty easily and way, way cheaper and quicker. Could turn that around in 9 months, a trial would be minimum 3 years likely longer.

Seeing this thread again reminded me that in the Scottish Parliament today, the Health, Social Care & Sport Committee interviewed 3 doctors regarding the Cass Review recommendations. One of the doctors arrived late and didn’t speak for long but she did speak about an upcoming UK-wide clinical trial of puberty blockers very confidently and seemed to think it would be starting soon and that it wouldn’t be difficult to establish a research and ethical protocol and then get it authorised.

I was really surprised by that information. A few of the MSPs were glad to hear this because, I think, they feel that kids who have been taken off waiting lists for blockers can now access them via the clinical trial instead.

All in all, both the doctors and MSPs seemed very pleased that things were moving along quickly because an evidence base needed to be established.

Perhaps, another poster might have more knowledge or experience in this area and could interpret the discussion more expertly with regards to the difficulties in establishing this type of research.

All NHS REC approvals are managed through IRAS ( Integrated Research Approval System). I imagine most REC applications and decisions are FOIable.

The application forms detail the proposed research design, the justification for undertaking the research, the risks for participants, to what extent the risks can be mitigated, why these risks are justified etc.

There is a strong case for this information being in the public interest and, having been an assessor, can't think of many cases where applications or decisions would need much information redacted. The nature of research means that required information sheets and consent forms need to be transparent and accessible, and only in very limited circumstances would it be deemed ethical to withhold information from participants. E.g. In the case of RCTs, participants usually know the different conditions, just not the specific condition that they will be assigned to.

For once Natacha Kennedy seems to agree with us. Probably not what was intended… (Also, if you’re your own co-author, you have less than no standing to discuss ethics [in academia].

Amazing 😁🤦‍♀️ Yep, that's a beautiful demonstration of irony, lack of critical thinking and lack of self awareness. Although, to give Natacha some credit (albeit for a happy accident), it is helpful to call out that it's surely impossible to have informed consent given what's in the Cass Report.

I don't suppose you have the link on X by any chance please?
I'm not really using it any more except to read comments that are referenced here on MN - and boost the particularly good ones.

Every now and again one is worth commenting back on. This is very much in that category. Plus I'm intrigued about any other responses it might have attracted.

I don't really understand why informed consent would be such a difficult issue for this new piece of research. Puberty blockers are already used safely for precocious puberty, so surely giving them (for an appropriately brief time) to older children is not intrinsically dangerous?

The danger, as I understood it, was not to do with any inherent risk in the medication itself. It was to do with the appallingly lax way in which they were prescribed, without appropriate screening, without exploratory talk therapy, without ongoing intense further exploration so that they could be genuinely a "pause" rather than the first step towards further medicalisation.

If all those failings were corrected, and if other boundaries were in place (say, a maximum of six months on the blockers, or whatever other short period the study protocols deemed safe), why would that create difficulties with informed consent.

I mean, there may be other problems with the study, other reasons not to go ahead with it - I really don't know. But how would informed consent be an issue?

I understand that the bar for experimenting medically on children is high with trials having to meet very high standards? These drugs have the potential for negative impact on sterility, future sexual function, brain & body development. How can a child, one already so mentally vulnerable that they think their body is flawed and a mythical sex change will "cure them", possibly give informed consent to these potential negative impacts?

I think as a society we became so casual about the appalling brutal impacts on young bodies because of the "trans washing". What transactivists demanded they were given - even to the extent of causing harm to children. Society & the medical profession just turned away from the reality.

These drugs have the potential for negative impact on sterility, future sexual function, brain & body development.

I guess that's my question, really. As I had understood it (perhaps wrongly) those effects were a consequence of the fact that puberty blockers were, in effect, putting young people on a pathway that led to cross-sex hormones (and perhaps involved an unconscionably long period on the blockers ), not a result of the drugs themselves?
Im sure I have read in the past that the direct negative effects of blockers were more along the line of preventing young people from undergoing normal development alongside their peers, and were at least partly social and psychological in nature.

I mean, those effects in themselves are enough to make it wrong to prescribe them in most of the cases when they were in fact prescribed, but I am imagining that a properly designed study would only prescribe them to an exceptionally small number of people for whom there was a case to be made that those direct effects of blockers could be weighed against the distress that the blockers were meant to alleviate.
It may even be that the results of the study would include an evidence-based claim that no young person would in fact meet this threshold, which would be an extremely valuable result in itself.
I just don't see that the direct negative effects of blockers rule out the possibility that, in some cases, informed consent could be given (by someone with capacity for consent - which might entail parent/carer involvement)

Oh, and presumably there would also have to be a strict time limit on how long a young person could take them, so that they really were functioning as a "pause" during which adequate intensive exploration could be undertaken. God knows how long people stayed on them before

(though that exploration would have to be so intensive that it would create an enormous problem of social injustice, given that most people with mental health problems who do not have gender dysphoria are deprived of this intense and timely support.)

I think the research is showing that puberty blockers may have a significant impact on brain / body development alone. They're powerful drugs used in end stage prostate cancer and there are groups of women reporting dreadful impacts of lupron on their bodies. (see second link)

Maybe have a look at the analysis of PBs by Michael Biggs - he's looked at all the research and his conclusions are sobering:

https://www.transgendertrend.com/puberty-blockers/

www.statnews.com/2017/02/02/lupron-puberty-children-health-problems/

@BonfireLady

Sorry, no, I don’t follow them & didn’t note the link so it’d take me the same amount of Google-Duck-Binging to find it as it would anyone else minded to try.

PBs are very rarely used for precocious puberty due to the potential serious side effects.

These are controlled substances for a reason.

Let alone that interrupting puberty has potentially irreversible effects in itself, there have been many worrying cases of bone problems and other health issues, particularly in the US, and a massive lawsuit brought against Lupron, for example.

(All from when used for precocious puberty, not for 'gender incongruence ').

I'll find some links.

https://www.statnews.com/2017/02/02/lupron-puberty-children-health-problems/#:~:text=A%202003%20study%20in%20the,of%20growing%20a%20bit%20taller.

Article

Does anyone see a link between Lord Alli being an active Stonewall supported and this trial going ahead?

This is such a difficult question. I have started to wonder whether his evidently massive influence resulted in Starmer and so many Labour MPs sounding fools as they wibbled on about TWAW, unable to define a woman and other toddler level thinking and just who he's been introducing behind the scenes to influence labour policy?
As a lesbian I hate thinking that LGB groups are using children to pursue the trans agenda and are throwing women under the bus etc. Wes Streeting has been such a relief as he's firmly signed the government up to Cass and has apologised for some of the more extreme bullying of women.

But it is a fair question that needs to be asked given his evident closeness to those now in power.

Can someone provide some links on Alli's connections to Stonewall, please. I'd no prior awareness of him at all until the 'free clothing scandal'. He does seem very influential.