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The NHS England PATHWAYS puberty blockers trial protocol was published last week. We believe the trial will put the most vulnerable children at risk of long-term harms, including autistic children, children in the care system, those with trauma histories and adolescents with emerging same-sex attraction.

Team member Janey Galloway wrote to Lady Cass to voice her particular concerns about autistic children. Lady Cass redirected her to the trial leaders and a slightly amended version of the following letter has now been sent to Chief Investigator for the trial Professor Emily Simonoff and Joint Co-Lead Dr Michael Absoud, along with Secretary of State Wes Streeting.

Janey Galloway is the Director of Evidence Based Autism, an autistic led organisation advocating for the safeguarding of autistic children and young people identifying away from their sex. You can read her essential report on Autism & Gender Identity for Transgender Trend here.

Dear Lady Cass

I hope this e-mail finds you well. 

I had the pleasure of meeting with you, alongside my colleague Heather Finlay and the children’s poet Rachel Rooney, when we gave evidence to the Cass Review regarding autistic children and gender identity. You had previously read my report on Autism & Gender Identity, which was published by Transgender Trend.

I wonder if it would be possible to meet with you again, either in person or via Zoom/Teams regarding the trial? Having read through the protocol for the Pathways Trial, Pathways Connect and Pathways Horizon-Intensive, we are unclear how the anticipated – and significant – autistic cohort will be adequately safeguarded, given the numerous differences in functioning, processing and understanding between them and any neurotypical children taking part.

The exploratory objectives contain the following statement: ‘Do risk benefit profiles vary according to presence or not of neurodevelopmental disorders or high levels of neurodevelopmental trait levels?’. It appears to us to be self-evident that this will be the case, and that the potential side-effects of blocking puberty will have a greater deleterious effect on the long-term functioning of autistic children and unnecessarily impact on their adulthood.

Our particular concerns are as follows:

Consent

To the best of our knowledge, there is no consent protocol within the NHS that is specifically designed to be used by autistic children and adults. Autistic patients are given consent protocols written and designed for neurotypical people, and are expected to  give consent to procedures in a way that they may not fully understand. This is an issue that we are planning to address separately and more widely as an organisation, however, there is no acknowledgement of this difference within the protocol. We are unclear how autistic children, whose understanding and processing of this information will lie within a complex constellation, can be supported to give informed consent to experimental medication with potential side effects that they are unlikely to fully understand.

The consent process naturally involves parents; however, with an anticipated significant cohort of autistic children, it is very likely that many of these parents will be autistic themselves. Many of them will be unaware that they are autistic. We are concerned that where informed consent is concerned, this is an area that may not have been anticipated or controlled for, or indeed, have safeguards in place for those parents.

Brain Function

We know how important the role of GnRH analogues are in pubertal brain development and plasticity, as well as in increasing cognition. We also know that the 2024 literature review by Professor Sallie Baxendale suggests that the impact of suppressing puberty has a potentially harmful effect on cognitive development.

‘There is no evidence that cognitive effects are fully reversible following discontinuation of treatment. No human studies have systematically explored the impact of these treatments on neuropsychological function with an adequate baseline and follow-up. There is some evidence of a detrimental impact of pubertal suppression on IQ in children’ (Baxendale 2024).

We are aware that assessing the impact of blocking puberty on cognition and brain development has been written into the design of the trial, however, there is no acknowledgement that we can see, of the differences in brain development of autistic or otherwise neurodevelopmentally disabled children. We would posit that there is simply not enough known about the differences in brain development between the autistic and neurotypical child to be able to make a valid assessment about how brain processing and development may or may not be affected.

Autistic children and adolescents already develop emotional understanding and risk assessment at a slower rate than their peers, are less able to attach value to outcomes, are less able to recognise danger, and are  unable to manage emotional as well as sensory input in the same way as other children. 

They are already held back psychologically, emotionally, socially and educationally by their cognitive differences. We can see the impact this has had in on SEND children within the education system due to a lack of understanding of how to properly support autistic children. This failure is further reflected in the fact that only 30% of autistic adults in the UK are in employment. 

We have serious concerns about any medical intervention that might impact on their brain function, how this will be safeguarded during the trial, how this can realistically be consented to, and how the affect on their later life chances can be protected.

Social Functioning

As you are aware, autistic children struggle with social functioning, finding peer groups and making and maintaining friendships. We have previously expressed concern that autistic children are finding instant peer acceptance through identification with LGBT+ groups, and by adopting a ‘gender identity’ that give them access to these groups. 

Acceptance shouldn’t be underestimated as a powerful driver for autistic children to adopt a particular way of being, or identity. We are aware of autistic girls who, without in any way deviating from wanting to be girls, have recognised and tried to access puberty blockers and requested mastectomies, as they see them as a means to an end – to prevent the bodily changes that they find so hard to manage during puberty. However, their cognitive functioning prevents them from understanding the long-term impact of these decisions. 

The inner worlds of autistic children are complex and unpredictable and their differences in processing and understanding of the outer world can lead to harmful decision making. Our concern is that autistic adolescent girls are so adept at masking and adapting their performance in order to please others and gain acceptance, that they will appear to be more cognizant of risk and more credible in their presentation than they actually are.

Communication

The information regarding informed consent for the Pathways trial states: 

‘For children, informed assent will include demonstrating understanding, retention, and the ability to weigh up the potential benefits and risks of participation, and to communicate their decision freely and without coercion. Clinicians must document the young person’s and parent(s)’ understanding of the trial, including direct quotes where possible, and ensure that both individual and joint discussions have taken place.’

As you know, communication with autistic children is far more complex than simply adapting to their preferred communication style. It can be a complex process, with many autistic children receiving interventions via speech & language specialists or educational psychologists which may impact significantly on the way that communication is approached. 

Autistic children and adolescents also learn by mimicking, absorbing and repeating information relevant to whichever situation they find themselves in. Polly Carmichael, former head of The Tavistock GIDS, has acknowledged that children have come having learned a script from the internet. It shouldn’t be underestimated how adept autistic children are at doing this – often entirely subconsciously, and unaware that this is what they are doing. 

Are there safeguards in place to ensure that autistic communication is approached sensitively but with an awareness that many autistic adolescents are adapting to the situation they find themselves in, and simply supplying the ‘correct’ information to the trial team while appearing (and believing themselves to be) entirely credible?

When we met previously, we were impressed by your excellent legacy of work with disabled children and your genuine concern for the welfare of autistic children. We would welcome the opportunity to meet with you and/or with your colleagues to discuss these concerns. No matter how well meaning the process, we often find that the widespread differences inherent in autism are not fully taken into account and we have genuine safeguarding concerns about the trial that we are keen to see addressed.

We very much look forward to  meeting with you again, at your convenience,

Yours Sincerely

Janey Galloway