Would we treat eating disorders with Ozempic?

Gender distress in children and young people may have been the subject of a raging social polemic, but it is undeniably psychological phenomenon arising within diverse developmental, family and social contexts.  The proposed Pathways clinical trial [see here]  is laden with methodological and ethical concerns. Its publication has been in the pipeline for some time. Yet again the British Psychological Society fails members and the general public – it has neither produced a timely response the this highly controversial project, nor is there any sign of the guidelines for psychological interventions with gender distressed children that was promised many months ago. The BPS has fundamentally abdicated on this important issue of psychological theory, research and practice. We republish here, with permission and in full, a highly pertinent blog post [see original here].

As well as concerns about risks vs benefits, and the ethics of irreversible interventions  with children, the UK’s puberty blocker trial raises fundamental questions about how we respond to distress.

So the UK’s puberty blocker (PB) trial has ethical approval, and thus the green light to proceed. The details of the trial are extensively covered elsewhere. Suffice to say that drugs which suppress the hormonal changes which come with puberty are currently banned from being prescribed to minors. This  follows concerns raised by the Cass Review. Clearly this is not a perfect ban, both inside the NHS and outside it (I won’t provide any link to recent publicity surrounding dodgy private providers). However, the Cass Review also pointed to the limited evidence for the effectiveness of such drugs and called for more research. So, the UK is now running a trial to consider the effects of these medications on the mental and physical wellbeing of under 16s with gender incongruence “when a person’s gender identity does not match the sex they were assigned at birth” (a quote from the trial summary). The evidence to date has been of poor quality and, charitably put, not hugely suggestive of benefits.

While this trial has been long-anticipated, reactions have been, perhaps predictably, mixed. Here though I want to focus on some of the risks. There have been a number of prescriptions of such drugs in the UK in the last fifteen years (estimates suggest at least 2000) and, as Cass pointed out, follow up of those people has been poor. Also significant health concerns about the wider effects have been raised (and have been known for some time). Indeed the original “Dutch Protocol” for young teens assumed to be transgender, relied on the effects of such drugs stunting male genital growth to facilitate later “passing” as female. And while that sounds really very creepy indeed, it’s fairly remarkable the degree to which this was overlooked as the protocol influenced the development of services in other countries. There was simply an assumption that we were sure, even at very early stages, that we know what gender ‘is’, that we would know who would have a settled transgender identification, and that the risks of treatment were worth the benefits. The first assumption has been thoroughly debunked by the Cass process, and worries about the second (harm vs benefit) are really at the heart of objections to the current research.

In relation to harms, as well as effects on sexual development, concerns have also been raised in relation to irreversible consequences for bone health and brain development. Given this I don’t think it’s hugely insightful to point out that proper follow-up of those given such drugs is a logical first step. Not to mention the possibility of further animal trials before opening up more experimentation on children. While proper follow-up has been an aspiration for a while (and there is a current review into adult gender services which might provide some of this information), finding the data for that basic first step has been more difficult than you might imagine. But still lot of this information is out there already. On the basis of what was effectively a huge unregulated trial conducted by the UK’s Gender Identity Development Service (GIDS). The concerns about brain development are clearly present for the investigators, and there will be a parallel study looking at brain changes over time. However, this study is also with live ammo (i.e. actual human children), something which surely should be ethically questionable given the, at best, inconclusive results from previous animal trials (linked above).

These worries about the general mental and physical health effects of PBs are also highly relevant when considering the quality of the study protocol itself. This piece, by Hannah Barnes (the author of Time to Think, award-winning account the UK’s national gender service), outlines many of the issues. Methodology will, I think, be a significant area of coverage over the next few weeks. Initial concerns include the degree to which the questions about any changes to mental wellbeing will be answered at all, given that the study compares the PB group to a group receiving other support and interventions. The risks (and apparent irreversibility) of the effects of such drugs also raises ethical questions which it is perhaps surprising that the ethics committee has not taken more seriously. As Dr David Bell (a clinician who investigated practices at GIDS) said the other day, not only is the trial unable to reliably answer its own questions, but also,

“UK law, derived from European law and the Declaration of Helsinki, says that research on children should not disrupt their normal stages of development without good reason,”

Part of the reasoning behind such prohibitions is that we do not consider children able to meaningfully consent to potentially permanent changes of the sort puberty blockers may produce. All of which is to say there is more to this than simply a poor study design. We’re asking children to consent to something permanently life altering. We may do this with medical trials where lives are at stake but, again a significant finding of Cass, was that suicide risk in the cases of children presenting in GIDS services was not discernibly different from those presenting in other mental health services. The myth which terrified so many parents (“would you rather have a live son or a dead daughter”) was just that.

All of these concerns are being raised and documented elsewhere, and there will doubtless be more critique emerging. But, however we gauge the risk vs benefits, there is still something that is somewhat odd with the PB trial. Are we looking to treat mood and wellbeing issues? But we seem to be doing so by accepting that someone simply is what they say they are. And by enacting that belief with them. This is dramatically different from the way we would proceed in most other areas. We don’t, for example, respond to bodily dysmorphia by instead decide to amputate limbs. Indeed reactions to such things have generally been very negative. Maybe we just haven’t become open minded enough yet, but I’d be surprised if we ever even consider broad acceptance of this to be a sign of progressive liberality. Imagine, for a moment, that the proposed trial was about mastectomies for thirteen-year-olds with gender discomfort. Would that seem shocking? I imagine it would. What though is, fundamentally, the difference between that and permanently impeding the effects of puberty? Other than that it is less visible.

Another parallel might be if we decided we’d trial treating eating disorders with Ozempic. If we actually decided the treatment was to encourage children to become as thin as the want? At a key moment in their physical development. Would that be OK? It seems that in the case of eating disorders we enter treatment with an idea that living in your body and minimising dangerous changes is our preferred stance. With gender issues however, sometimes that stance seems to be dismissed as cis-hetronomative or as conversion therapy.

Of course all such calculations of cost vs benefit fall away if one other factor holds: that we treat the idea of being trapped in the wrong body as real. That we decide that an experience or feeling is some kind of metaphysical identity. As Helen Joyce puts it, a “gendered soul”. After all, you perhaps need to believe in something pretty strongly if you are, for example, going to castrate a child on TV. Risks/side effects/long term outcomes, comorbidities and complexities will be of little concern as the belief is so fundamental. Given that, it is worth revisiting the quote at the beginning of this piece, about “when a person’s gender identity does not match the sex they were assigned at birth”. The reference is to “gender identity” rather than, for example, to bodily, or role, discomfort. An experience is being interpreted as an identity which is potentially fixed. But one which really has no scientific validity. And this is happening in reference not even to a real case, but when considering hypothetical children who might enter the study. As an encore we get sex “assigned” at birth, something which may have some relevance to very rare circumstances of unusual genital development, but for the rest of us create the false impression that sex is somehow a chancy guess. This kind of language is something we might expect from gender identity activists, but I at least was surprised to see it from the oversight committee of a high profile medical trial. Perhaps it’s less surprising though when you consider that the host institution has a long record of an affirmative position around what is routinely framed as LGBTQ+ rights. Which now, evidently, include the right of adults to deny children normal development.

Kathleen Stock recently compared PBs to trepanning, a process that presumably also felt less morally complex in a time when we believed we needed to release tormenting demons. Maybe, if you believed hard enough, you might allow a shaman with a dubious skull-slicing protocol near your head? I had rather hoped medical researchers today might not ground their judgement in such notions of souls and spirits. After the announcement of the puberty blocker trial though I am left wondering.