NHS England to review cross-sex hormones policy

hormones

In a letter to Dr Cass, published on their website, NHS England has committed to conducting a proper review of cross-sex hormones:

NHS England will review the use of gender affirming hormones through a process of updated evidence review and public consultation, similar to the rigorous process that was followed to review the use of puberty suppressing hormones. In the meantime, you have made clear that the new providers should be ‘extremely cautious’ when considering whether to refer young people under 18 years for consideration of hormone intervention.

While we welcome the promise from NHSE to conduct a rigorous review, we think this should have been done as a matter of urgency after the publication of the Interim Report in 2022.

We have written about our concern that the clinical commissioning policy for cross-sex hormones had not undergone the same revision and public consultation as for puberty suppressing hormones (PSH) and raised this in our responses to the NHSE consultations on the new service specification.

The Cass Interim Report, although conceding that “The administration of puberty blockers is arguably more controversial than administration of the feminising/ masculinising hormones, because there are more uncertainties associated with their use” (3.24) made no distinction between the two treatments in her recommendations.

The Interim Report says

1.5. The Review is not able to provide definitive advice on the use of puberty blockers and feminising/masculinising hormones at this stage, due to gaps in the evidence base; however, recommendations will be developed as our research programme progresses.

However the distinction was acknowledged in separate sections: essentially that risks for CSH are known:

3.18. Sex hormones have been prescribed for transgender adults for several decades, and the long-term risks and side effects are well understood. These include increased cardiovascular risk, osteoporosis, and hormone-dependent cancers. 

But the risks for blockers are still largely unknown:

3.24. The administration of puberty blockers is arguably more controversial than administration of the feminising/ masculinising hormones, because there are more uncertainties associated with their use.

In Section 5 of the Interim Report, Principles of Evidence Based Service Development, Cass acknowledges the inconclusive evidence of the NICE reviews for both blockers and CSH:

5.21. The lack of available high-level evidence was reflected in the recent NICE review into the use of puberty blockers and feminising/masculinising hormones commissioned by NHS England, with the evidence being too inconclusive to form the basis of a policy position.

The Interim Report makes no distinction between blockers and CSH in both the following paragraph and Recommendation 7:

5.22. It is still common that drugs are not specifically licensed for children because the trials have only taken place on adults. This does not preclude their use or make their use inherently unsafe, particularly if they are used very commonly in children. However, where their use is innovative, patients receiving the drug should ideally do so under trial conditions.

Recommendation 7: Prospective consent of children and young people should be sought for their data to be used for continuous service development, to track outcomes, and for research purposes. Within this model, children and young people put on hormone treatment should be formally followed up into adult services, ideally as part of an agreed research protocol, to improve outcome data.

The response by NHSE was to conduct a review and public consultation for blockers, which resulted in the end of their routine prescription, while failing to do the same for cross-sex hormones.

The result is that children may now be offered hormones at “around age 16” without a preceding year of taking puberty blockers as was previously required.

We are concerned about where this leaves the current cohort of adolescents until the policy is updated fully and we set out our reasons below.

The cross-sex hormones policy is so bad it should have been a priority for change

Within the new service specification, the CSH policy alone remains unchanged from the 2016 policy, (except for a few tweaks to bring it in line with the new policy for puberty blockers.) To compare, you can read the 2016 policy here and the 2024 policy here.

As it stands, the policy is inconsistent with both Cass recommendations and the rest of the NHSE updated service spec. For example, the policy says even very troubled teenagers may still be considered for hormones as long as:

Associated difficulties such as a psychotic episode, drug addiction or self-harming are not escalating.

NHS England states that the policy is informed by the same guidelines as in 2016:

  • Advice for Doctors Treating Transgender Patients, General Medical Council, 2016
  • Good Practice Guidelines for the Assessment and Treatment of Adults with Gender Dysphoria; Royal College of Psychiatrists, 2013
  • Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline, Endocrine Society, 2018.

The first two are guidelines for adult patients. The GMC guide specifically states:

“This advice applies to doctors treating adults. It does not apply to the treatment of children and young people in this area of care.”

The RCP adult guideline was informed by WPATH Standards of Care 2011. It is worth looking in detail at what the Cass Review Final Report says about WPATH and the Endocrine Society:

9.16 Most guidelines scored well on the scope and purpose domain, but poorly on the rigour of development, applicability and editorial independence domains. Only the Finnish guideline (Council for Choices in Healthcare in Finland, 2020) and Swedish guideline (Swedish National Board of Health and Welfare, 2022) scored above 50% for rigour of development.

9.20 Alternatively, they referred to other guidelines that recommend medical treatments as their basis for making the same recommendations. Early versions of two international guidelines, the Endocrine Society 2009 and World Professional Association for Transgender Healthcare (WPATH) 7 guidelines influenced nearly all the other guidelines.

9.21 These two guidelines are also closely interlinked, with WPATH adopting Endocrine Society recommendations, and acting as a co-sponsor and providing input to drafts of the Endocrine Society guideline. WPATH 8 cited many of the other national and regional guidelines to support some of its recommendations, despite these guidelines having been considerably influenced by WPATH 7.

9.22 The circularity of this approach may explain why there has been an apparent consensus on key areas of practice despite the evidence being poor.

There is more detail about WPATH methods on page 131 of the report.

The Endocrine Society gives a strong recommendation to commence hormones on the basis of low evidence:

2.4. In adolescents who request sex hormone treatment (given this is a partly irreversible treatment), we recommend initiating treatment using a gradually increasing dose schedule after a multidisciplinary team of medical and MHPs has confirmed the persistence of GD/gender incongruence and sufficient mental capacity to give informed consent, which most adolescents have by age 16 years. 1|⊕⊕OO

The Endocrine Society’s grade classification is as follows:

1 = Strong: “We recommend…” Benefits clearly outweigh harms and burdens, or vice versa

But this strong recommendation is based on low quality evidence:

⊕⊕OO = Low Quality: RCTs with serious flaws • Some evidence from observational studies

This is not normal practice. Although strong recommendations may be given on the basis of low evidence in extreme, rare cases – for example, a new drug is available for a condition where no other drug is available and the only other outcome is death – this is not applicable in this case.

This is the evidence base upon which teenagers have been given cross-sex hormones up to now. This in itself is a scandal.

Keira Bell was given blockers at the Tavistock at age 16 and cross-sex hormones a year later. She was too young to make this decision about treatment which is known and openly acknowledged to be irreversible. Teenagers have the right to keep options open- the right to an ‘open future’ – and whereas it has taken time to establish that blockers close down options, we have always known this about cross-sex hormones.

The Cass Final Report references this critical ethical principle:

101. Although young people often express a sense of urgency in their wish to access medical treatments, based on personal experience some young adults have suggested that taking time to explore options is preferable. The option to provide masculinising/feminising hormones from the age of 16 is available, but the Review would recommend an extremely cautious clinical approach and a strong clinical rationale for providing hormones before the age of 18. This would keep options open during this important developmental window, allowing time for management of any co-occurring conditions, building of resilience, and fertility preservation, if required.

102. The overarching conclusion from the evidence presented in this Review is that the puberty blocker research protocol, which is already in development, needs to be one part of a much broader research programme that seeks to build the evidence on all potential interventions and determine the most effective way of supporting these children and young people.

The recommendation in the final report is clear:

Recommendation 6: The evidence base underpinning medical and non-medical interventions in this clinical area must be improved. Following our earlier recommendation to establish a puberty blocker trial, which has been taken forward by NHS England, we further recommend a full programme of research be established. This should look at the characteristics, interventions and outcomes of every young person presenting to the NHS gender services.

The puberty blocker trial should be part of a programme of research which also evaluates outcomes of psychosocial interventions and masculinising/ feminising hormones.

Consent should routinely be sought for all children and young people for enrolment in a research study with follow-up into adulthood.

The systematic review of studies into CSH conducted by the Cass Review team at the University of York reinforce the findings of the NICE systematic review, concluding:

These findings add to other systematic reviews in concluding there is insufficient and/or inconsistent evidence about the risks and benefits of hormone interventions in this population.

NHS England has failed children up to this point by adopting WPATH and Endocrine Society guidelines without having assessed their merit or examined the evidence. It is critical now that NHSE amends the clinical commissioning policy for cross-sex hormones to bring it into line with the policy for blockers, by ending the routine prescription of hormones.

We do not understand why NHS England did not address this after the Interim Report; it is incumbent on them now to instigate the promised review of CSH as a matter of urgency.

The recommendation in the report to adopt an “extremely cautious clinical approach” is inadequate protection for the current cohort of adolescents as long as the actual policy remains the same, leaving teenagers at risk until the clinical commissioning policy itself is changed.  

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