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The explanations and justifications for the puberty blockers trial from the trial team and Hilary Cass herself seem to have moved far from the Cass Review and in some respects are in direct contradiction to it. The Cass-commissioned data linkage study is just one area where information and opinion has drastically changed.

The trial protocol states:

It has been suggested that UK research on GnRHa for puberty suppression in gender incongruence might start with a retrospective study of the young people previously seen at the Tavistock Service who are now young adults. It would not be possible to address important questions about GnRHa for several reasons. First, clinically recorded information on this patient cohort was not standardised or recorded at specific timepoints. Second, published reports from this cohort suggest high levels of attrition which are likely to be biased in relation to clinical outcomes. Third, some important classes of data, including cognition, childhood adverse experiences and neurodiversity, were not recorded at all. Hence, we conclude that a retrospective study would not provide alternative evidence.

However, Cass was fully aware when her research team commissioned the data linkage study that important data was missing and recorded information was not standardised at the Tavistock GIDS: it was her review that identified this failing (among the many others) at the clinic. Cass, having worked on her review for four years, and despite being thwarted by the adult gender clinics, nevertheless persisted, making completion of the study one of her recommendations in the final report:

Recommendation 5: NHS England, working with DHSC should direct the gender clinics to participate in the data linkage study within the lifetime of the current statutory instrument. NHS England’s Research Oversight Board should take responsibility for interpreting the findings of the research.

The Cass Review’s stated reason for commissioning the study was to ‘improve the level and quality of evidence’:

The data linkage study, using data held by the NHS, was commissioned to improve the level and quality of evidence for their treatment and care by using existing data held by the NHS [p 59]

And that this is standard NHS practice:

15.60 This type of research is usual practice in the NHS when looking to improve health services and care received. [p 190]

In fact the Cass Review suggests, crucially, that this evidence is important to help children/parents give informed consent:

15.64 This research represents a unique opportunity to provide further evidence to assist young people, their parents/carers and the clinicians working with them to make informed decisions about the right pathway for them.

Cass expands on this in her final report:

90. When clinicians talk to patients about what interventions may be best for them, they usually refer to the longer-term benefits and risks of different options, based on outcome data from other people who have been through a similar care pathway. This information is not currently available for interventions in children and young people with gender incongruence or gender dysphoria, so young people and their families have to make decisions without an adequate picture of the potential impacts and outcomes. [P 33]

Cass describes following up 9,000 patients from a single service as a ‘world leading opportunity’:

15.66 NHS England in its letter has committed to realising the ambitions of this study beyond the life of the Review. As a single integrated health service, which for the period in question had one provider of specialist gender care for children and young people, the NHS offers a world leading opportunity to look at outcomes for around 9,000 patients and add to the evidence base.

Cass initially identified the need for long-term data in her Interim Report (2022):

Secondly, there is very limited follow up of the subset of children and young people who receive hormone treatment, which limits our understanding about the long-term outcomes of these treatments and this lack of follow up data should be corrected. [p 39]

The York research team had gone to great lengths to obtain the research data, as set out in Annex A of the Review, even to the extent of getting a new law passed through Parliament:

1.11. The Gender Recognition Act (GRA) creates an offence of unlawfully disclosing information about individuals who have obtained a GRC. To ensure an offence could not be inadvertently committed, a ‘statutory instrument’ was passed through Parliament, permitting the handling of information about people with GRC for the very limited purpose of this research. This was required before REC and CAG would consider the research protocol, and before NHS England and the NHS Data and Analytics team would support the research.

It is interesting to see how much care the Research Ethics Committee (REC), the Confidentiality Advisory Group (CAG), NHS England and NHS Data and Analytics (rightly) took, prior to achieving full Health Research Authority (HRA) approval, in order to protect adult trans people from being identified. We can’t help but compare this attention to data protection with the lack of care in protection of children’s bodies in the approvals granted for the puberty blockers trial.

Following an outcry on social media the research team did their best to reassure service users:

1.14. The PPI sessions found that, while some participants were initially sceptical about the research based on what they had heard in the press or on social media, when the study was explained the majority understood the approach, the reason for the research and how their data would be used. Some participants were surprised that outcomes were not routinely collected and measured, and there was generally a high level of support for the research.

While support was generally high among the service users, the research team also worked hard to gain the trust and cooperation of the clinics:

1.18. Additionally, prior to final REC and CAG approval, a workshop was held with the adult gender clinics to talk through the study, data requirements and technical aspects and to identify any logistical challenges, where some concerns were highlighted. Following the workshop, the University of York met with the clinics to discuss the issues raised.

The research team took extra care to reassure stakeholders about the protection of their data, giving them an opt-out option. It was at this point, just as it looked like the study would finally be able to go ahead, that the adult clinics pulled out and refused to cooperate further. The Cass Review reports:  

15.62 The University of York undertook stakeholder engagement and developed the patient notifications and communications resources to explain the research and provide information about how to opt-out of the study should an individual choose to do so. It was at the point of trying to launch the 3-month opt-out period that the NHS gender clinics indicated their unwillingness to participate. [p 190]

The University of York team expresses the frustration of the researchers:

1.16. Despite the rigor applied in meeting HRA requirements, the University of York received significant opposition from all but one of the adult GDCs including refusal to facilitate the initial opt out stage of the study.

Even NHS England could not get the adult clinics to cooperate, which indicates the extent to which these clinics are operating as a law unto themselves:

1.21. In January 2024, NHS England wrote to inform the Review that it had written to the Chief Executives and Medical Directors of the NHS trusts that host adult GDCs and GIDS to ask them to fully cooperate with the University of York in support of the research. Despite this, the necessary cooperation from the services has not been forthcoming and as a consequence, the University of York advised that it was not appropriate to begin the next stage of the study.

The research team is clearly frustrated and now has to trust NHS England to take the study forward as promised:

1.22. The Review is disappointed that the study has not progressed to even the first stage during its lifetime. Despite this setback, it is pleasing that NHS England has stated a clear commitment to realising the ambitions of this study beyond the life of the Review.

1.23. The statutory instrument is in place until 2027, and oversight of the study will transfer to the NHS National Research Oversight Board for Children and Young People’s Gender Services.

This study was clearly of great importance for the Cass Review; the research team worked hard to find solutions to setbacks and did not give up until the adult clinics forced an end to it, and the Cass Review final report had to go out incomplete.

In a letter to John Stewart in March 2024, just before the final report was published, Cass expresses her clear frustration that such ‘vital evidence’ had been withheld:

I am frustrated on behalf of the young people and their families that the opportunity to reduce some of the uncertainties around care options has not been taken.

Ultimately, the NHS is an evidence-based service with a responsibility to maintain the safety of those in its care. Understanding more about what support people who attended the Gender Identity Development Service (GIDS) received, and whether this helped them, will provide vital evidence to assist young people, their families, and the clinicians working with them to make informed decisions about the right pathway for them. As a single integrated health service, which for the period in question had one provider of care for children and young people, this was a world leading opportunity to look at outcomes for c.9000 young adults and add to the evidence base.

I look forward to submitting my final report and recommendations in the coming weeks. In the meantime, my recommendations on this specific issue are that NHS England:

1. Work with the University of York to take forward phase one of the data linkage study without delay.

2. Work with Department of Health and Social Care to mandate the data exchange from the clinics to facilitate this.

3. Undertake a case note audit of record keeping in the adult clinics to assess the feasibility of phase 2 of the data linkage study.

[Cass letter to John Stewart 20 March 2024 p 383]

Would the final report have gone ahead with the recommendation for a puberty blockers trial if the long-term data had shown poor outcomes? We will never know, but what we do know is that it is a common strategy of activist clinicians and organisations to bury data that shows bad results, from WPATH hiding systematic reviews they had commissioned from Johns Hopkins University to Johanna Olson-Kennedy’s reluctance to publish research which did not show children’s mental health improved on blockers, to the Tavistock’s inability to publish results of their 2011 puberty blockers study until 2021.

Reasons given by the adult clinics to block the study were the usual justification for burying bad results: that the data could be weaponised for political reasons. This is not a justification for the NHS to be offering any treatment that is risky with poor outcomes:

The unintended outcome of the study is likely to be a high profile national report that will be misinterpreted, misrepresented or actively used to harm patients and disrupt the work of practitioners across the gender dysphoria pathway.

The study may not be fully independent, and may suffer from interference by NHS England, the Cass Review Team and Government ministers whose interests do not align with those of providers and users of gender identity services. [York research p 9]

We can make an educated guess that the adult clinics either did not want to expose poor data collection or poor outcomes. If patients were doing well, why would they block the research?

The King’s College protocol and FAQs are revealing about priorities:

There are also questions about the balance of longer-term effects between those that are helpful (for example better psychological adjustment, better alignment of body shape with gender) and those that are harmful (bone health, possible effects on brain development and sexual health). These are important questions, but we don’t know the answers yet. We first need to examine short-term effects and then follow young people up into adult life.

The assumption here indicates influence from older cross-dressing men who profess regret about the unavailability of blockers when they were children because they think they would be happier in adulthood if they could ‘pass’ as women. It is certainly a routinely expressed, desired ‘trans’ outcome. The other side of the equation is brittle bones, diminished brain function, infertility and lack of sexual function.

You could only support these specific ‘benefits’ if you believe these children are ‘trans’ and will grow up to have a trans identity. If not, the ‘better alignment of body shape with gender’ (which is only a presumed benefit for a tiny number. The Cass Review stated that ‘even after masculinising/feminising hormones, dysphoria may still persist’) moves across into the harmful category. This is clearly not a positive risk/benefit profile.

We would have a better idea of longer-term outcomes if we had the data linkage study evidence. The trial team admit that this is the area where evidence is most lacking:

However, there is less knowledge about their safety when used for gender incongruence, particularly regarding longer-term possible adverse effects.

They also admit the need for long-term evidence about the short-term risks that we already know about:

There are also some less common but important risks. These medicines may affect bone health by slowing down bone strength development. We do not know whether this persists after stopping puberty suppressing hormones.

And they admit:

Some possible risks may not show up until later in life. These include possible effects on:

– Future fertility, especially if young people go on to cross sex hormones like testosterone or oestrogen

– Bone health – increased risk of fractures

– Sexual development and function

– Memory and thinking skills

These are physical results of blockers and hormones the long-term data could show which do not depend on rigorous baseline data on such things as mental health and social circumstances. If there turns out to be a large percentage of young adults with brittle bones in comparison with population controls, for example, that would provide us with more certain evidence to inform parents.

The FAQs justify the trial through using the discredited idea promoted by activists that blockers are a ‘pause button’:

Puberty suppression is used to allow young people with gender incongruence to explore their gender identity without worrying about their bodies developing further changes.

But the Cass Review was clear about the function of blockers as a first step on the medical pathway:

83. Moreover, given that the vast majority of young people started on puberty blockers proceed from puberty blockers to masculinising/ feminising hormones, there is no evidence that puberty blockers buy time to think, and some concern that they may change the trajectory of psychosexual and gender identity development. [P 32]

For this very reason, it is hard to understand why a study on blockers as a standalone treatment is of any real value and why it has been prioritised by NHS England.

And it is even harder to understand why Cass, speaking to Hannah Barnes, is now saying that previous strong evidence is suddenly no longer relevant:

Explaining her reasoning to me, Cass said there had never been a chance at Gids to properly test the hypothesis of blockers buying time to think because the service was overwhelmed by referrals. Now, she said, “it’s a different world, it’s a different time, it’s a different setup. And so, I genuinely don’t know what will happen in this instance.”

And despite the claims that it is short-term evidence for puberty blockers that is needed, Cass is justifying the trial on the basis that it is the beginning of a longitudinal study:

“The intent has never been that this should be a short-term piece of work,” Cass told me. “The intent has always been that this is the first step in a longitudinal follow up of these children and young people.”

The Cass Review states the trade-off clearly:

15.65 Although retrospective research is never as robust as prospective research, a prospective study would take a minimum of 10-15 years to extract the necessary follow-up data. [P 190]

In other words, do we gather the imperfect data linkage study evidence now, or do we wait 10 – 15 years for the supposedly much better evidence, in the meantime putting more children at risk? Cass now seems to come down on the side of the latter.

So, either the data linkage study would “provide vital evidence to assist young people, their families, and the clinicians working with them to make informed decisions about the right pathway” or it “would not provide alternative evidence.” Which is it?

And what has happened to the data linkage study and where are we now? We know that oversight of the study was transferred to the NHS National Research Oversight Board for Children and Young People’s Gender Services, chaired by Professor Sir Simon Wessely. In a letter, Hilary Cass was told:

I am sure you will agree that the NHS should not lose the opportunity to make further use of the statutory instrument that was passed by Parliament, which enables the collection of the data for use in an approved research study until 2027. [Letter to Hilary Cass from John Stewart, January 2024]

In March this year we heard from Baroness Merron:

This work is being undertaken with oversight from the NHS England National Research Oversight Board and is progressing as intended.

This month Karin Smyth, Minister of State, DHSS, said:

NHS England has taken time to undertake due diligence work on the data sources critical to the study, and to work with organisations to refine the planned approach to data sharing. Study approvals are currently in progress.

And two days later, Zubir Ahmed, Under Secretary for Health and Social Care said:

NHS England, in conjunction with the National Institute for Health and Care Research, is commissioning a data linkage study, which will provide different and separately valuable evidence to both understand the experience and outcomes of former patients of the Gender Identity Development Service and inform future National Health Service gender care.

So it’s still not clear. What is clear, however, is that time is running out to collect the data. And that in the meantime, NHS England has put in the work to gain the necessary approvals and funding for a puberty blockers trial to go ahead, without the long-term evidence necessary to justify it.