Why the NHS puberty blocker trial is appalling

[Soontobe60]

Stella O’Malley from Genspect telling it like it is - that a state endorsed trial of puberty blockers for gender dysphoric children should NOT go ahead.
the NHS are not walking into this nightmare blindly - there are enough experts out there telling them what will happen happen to these children if they’re given these life changing drugs.
https://x.com/genspect/status/1989896741358113127?s=61&t=gKvvk-rWmOlYFGMZN8QVvQ

Fucking hell. So a “successful” outcome will be measured in terms of height and weight, not fertility, ability to participate in sexual relationships, depressive symptoms or cognitive development?

When I read the Times article and the requirement for parental or legal guardian’s consent to participate I immediately thought that a significant proportion of the trial cohort could end up being looked after children in local authority care. It’s much easier to sign a child’s fertility away when you won’t have an enduring long-term relationship and accountability to them. 😔

Edited to correct hasty posting and typos.

IIRC, a large portion of Tavistock kids were in care.

I think this is what’s happened in Canada isn’t it? Children in care are way over-represented and many have been “treated” by just one doctor. Edit to include link.

gendercriticalwoman.blog/2021/05/03/looked-after-children-gender-dysphoria-2/

What the fuck is the BBC thinking? How can they even think of presenting the information like this!

How much does the NHS pay out in a clinical negligence claim for fertility loss or impairment? That should have been built into the trial costs - 250 x £££ - and then maybe they might have paused to question whether this is right. God, I’m angry about this today. Experimenting on children is just evil. This is preventable harm in the face of a global roll back on affirmative approaches.

226 participants

Exclusion criteria:

1. Physical conditions preventing puberty commencement or advancement.
2. Unstable physical health requiring active intervention.
3. Hypersensitivity to GnRH, its analogues, or any of its excipients.

4. Known congenital long QT syndrome

1. Unstable mental health impairing ability to provide informed assent/consent. 6. Family/home situation affecting adherence to protocol.
2. Clinical concerns about capacity to consent.
3. Insufficient understanding of PATHWAYS TRIAL
4. New or ongoing safeguarding concerns.

10. Birth-registered females with undiagnosed vaginal bleeding. 11. Birth-registered females who are pregnant or lactating 12. Individuals of child-bearing potential who are at risk of pregnancy during the trial

Inclusion criteria:
3. Confirmed Tanner stage 2-5.
4. Younger than 15 years and 11 months at the time of consent.

Inclusion criteria

1. Clinician in CYPGS believes GnRHa treatment for 2 or more years may be helpful to the CYP. No current plan to initiate cross-sex hormone treatment in the next two years.
2. Written informed assent and consent from CYP and parent/legal guardian respectively.
3. The CYP and their parent have reviewed the suite of measures, including physical health investigations, cognitive assessments and questionnaires, and understand that their completion is required for the clinical trial.

4. Participants who are sexually active agree to use contraception throughout the trial.

Pre-pubescent children who are sexually active should be a safeguarding referral, not questioned about their willingness to use contraception.

Wow - are there specific safeguarding plans in the protocol? If they are asking 10 year olds if they are sexually active they need a concrete plan about what they will do if a 10 year old child says 'yes I'm having sex'

I think emailing Streeting is a good start. Inboxes need to see backlash to this.

From
www.kcl.ac.uk/ioppn/assets/pathways/trial/pathways-trial-protocol.pdf

1. At least one parent or legal guardian has demonstrated sufficient understanding of the possible advantages and disadvantages of treatment; demonstrated they can retain key information to provide informed consent

So only one insane parent needed.
That's outrageous.
Parental dispute over this matter should mean no taking part in the trial.

Outrageous.

1. Leading clinician considers there is a reasonable prospect of benefit from GnRHa for puberty suppression

So one clinician has to be in favour of a benefit. Is this what normally goes on in trials? Pre-empting outcomes?

'12 Ethics Approval

This protocol and related documents will be submitted for review to Health Research Authority (HRA), REC and MHRA. PATHWAYS TRIAL, HORIZON INTENSIVE and CONNECT will be conducted in compliance with the principles of the Declaration of Helsinki (1996), the principles of GCP and all of the applicable regulatory requirements (specify current legislation).

12.1 Protocol amendments and version control of study documents The Trial Manager will be responsible for preparing and submitting protocol amendments to the ethics committee. The Trial Manager will be responsible for updating the ISRCTN register following relevant protocol amendments. Subsequent protocol amendments will be submitted to the REC and Regulatory Authorities for approval, and will comply with regulations, particularly specifying, Pharmacovigilance reporting and providing the REC & MHRA with progress reports, and a copy of the Final Study Report.'

page 82. So it hasn't yet had approval?

If parents disagree there is no way they can be entered into the trial. The trial protocol in no way supersedes parental decision making in family law.

The more you read the more concerned we should be

Primary Objective: To map trajectories of brain development in CYP with gender incongruence, comparing those receiving GnRHa immediately (two years) vs delayed start (one year) with a non-randomised comparison group from HORIZON INTENSIVE not receiving GnRHa Secondary Objective(s): To link trajectories of brain development to cognitive measures, including general intelligence, memory and executive function.

What?

Are they allowed to do this in animals - testing drugs that they think will affect the intelligence, memory and executive function?

Cant see anything on HRA website. Although there is this, from 2023:

https://www.hra.nhs.uk/about-us/news-updates/pride-month-2023-sheroes-heroes-and-queeroes/

https://www.hra.nhs.uk/about-us/news-updates/pride-month-2023/

So about that consent
Unstable mental health impairing ability to provide informed assent/consent. Family/home situation affecting adherence to protocol.
Clinical concerns about capacity to consent.
Insufficient understanding of PATHWAYS TRIAL
Surely the whole point of seeking treatment is unstable mental health?

It looks as though the BBC transactivist veto/promotion desk is still controlling them. They really must be arrogant, complacent and ignorant to let this continue.

Professor Simonoff who is heading the trial said they are not expecting a “one size fits all” result. On the one hand that is what one would expect, simply as common sense. But on the other hand, it could rule out a decision that any results showing harm are reason enough for an outright ban.

This could mean there will be a large wedge for gender doctors to use to overturn all findings of harm. Each gender questioning child patient accessing one of the doctors would be found to be the special size X that puberty blockers fit.

www.bbc.com/news/articles/c2k4jg0wkj4o

Also isn’t the trial pool too small for accuracy?

In my opinion the trial is not long enough either. The subjects will be children under 16 who have reached puberty, and the trial will finish in 2030 meaning some will only be 21 or younger. They will not have reached full maturity or even had experience of the realities of the adult world.

One massive elephant in the room, which isn't being said often or loudly enough, is that 'trans' is not a physical illness therefore this is about giving hormone suppressants to physically healthy children.

There is nothing wrong with these children. Their bodies are absolutely fine. Their development is normal. The medication is strictly for cosmetic purposes (and therefore the myth that the alternative is suicide has been pushed hard because otherwise there is no ethical justification for the use of these drugs in this cohort.)

The short and long term side effects of this type of hormone suppressant is well documented because they have been studied in other cohorts - not just precocious puberty, but in women with severe endometriosis and men with prostate cancer. There is no reason to believe that the downsides will be any different in healthy children who are anxious about puberty.

The argument seems to be, AFAIK, that it's not good enough to say we can't use this medication with this cohort because we believe that the harms will outweigh the benefits based on what we know from their use in other groups. We need actual tangible evidence of the harm and we can only get that by harming children from this cohort. Because the children who have already been harmed weren't studied properly and therefore don't count.

Is anyone here in Wes Streeting's constituency?

In terms of consent - think about how this might have to be worded for children as young as 9 or 10:
Are you OK about having your sexual feelings limited in the future? Do you know what that means?
Are you sure you don't want children in the future? Definitely?
Will you mind if your ability to think, understand and analyse things is not as good as it is now?

Or asking parents to consent all this on behalf of their young child (which should raise every safeguarding red flag in the world about the parent)

Unbelievable that this is going ahead.

Making me feel ill. So true.

I think anyone can write to Streeting re pp about constituency

I was thinking a few could visit and try and explain to him face to face the issues.

Such an extraordinary question to think is viable in the first place. How on earth could a ten year old know if they will want to have children in the future?

There is no language in the world that would make that clear to them.

Good idea