Time is Running Out! Stop the NHS's Dangerously Incompetent Puberty Blocker Trial

New BBC Report Reveals Horrifying Details About NHS Puberty Blocker Trial

Genspect UK Needs Your Help!

Hot on the heels of Genspect UK’s letter to health secretary Wes Streeting, the BBC have published an article revealing new information about how the NHS puberty blocker trial is being designed. Readers, it is even worse than we feared.

Journalist Deborah Cohen does her best to uphold the BBC’s commitment to neutrality by giving both sides of the issue, but the article overlooks or ignores the most pressing implications of the study. We’ve outlined our concerns about what the article reveals in more depth below. But now we need to ask for your help.

Genspect UK wants to stop this dangerous and unnecessary trial once and for all. We hope that the health secretary will respond to the concerns in our letter, but we think that politicians across the spectrum need to understand that the British public opposes this trial.

We are asking Genspect supporters in the UK to send our template letter and report to their local MP, so that policy makers cannot pretend ignorance of these issues. We need your help to stop this trial and protect thousands of young people from undergoing unnecessary, experimental medical treatment.

You can look up your MP’s email address here and find Genspect UK’s template letter and report are downloadable here.

If you could use some support contacting your MP, or if you just want to get in touch and tell us you’re getting involved in this incredibly important campaign, you can email Genspect UK’s Director, Carrie Clark, on carriec@genspect.org

What does the BBC Report Reveal About the NHS Puberty Blocker Trial?

Redundant and Dangerous Study Designs

The BBC article outlines three designs for the puberty blocker trial that are apparently under consideration. These are introduced in the context of two key difficulties with conducting a blinded, randomised controlled study on puberty blockers.

The first is the difficulty of blinding a study where participants will easily be able to tell who has and has not received treatment: participants who have received the blockers will inevitably notice that their puberty is not progressing, while participants who have not received blockers will recognise that their secondary sex characteristics are continuing to develop.

The second difficulty is the risk that participants will drop out when they realise they are not receiving blockers, or surreptitiously obtain private treatment which invalidates the study results.

The proposed designs apparently aim to overcome these difficulties by prescribing puberty blockers to all participants, as though health authorities have not even considered treating gender related distress with the promising non-medicalised approaches identified by the Cass Review. Only one of the three designs includes a control group who would nominally receive no treatment. However, the NHS has pledged to provide psychological support to all trial participants so, as discussed further below, even the control group will actually be in receipt of treatment. Under the remaining two designs, all participants will ultimately be prescribed blockers in the course of the study.

Misconceptions About Puberty Blockers

Rather than confronting misconceptions about puberty blockers with a robust public health campaign highlighting their harms, these studies are designed to exploit those misconceptions by offering participants access to blockers as a kind of incentive. This speaks to cowardice on the part of health authorities, researchers and politicians. They lack the courage to confront the lies of so called ‘gender affirming care’ head on, by calmly and compassionately explaining to the public that the evidence simply doesn’t support the view that puberty blockers are a safe and effective treatment. Instead, they will medicalise thousands more healthy young people, putting off for another day the need to come clean with the public and admit that the medical profession has made a terrible error in popularising these dangerous interventions.

Ignoring all the established evidence that social transition is an active intervention, powerfully altering the trajectory of a young person’s identity development and fuelling the drive to further medicalise, Professor Gordon Guyatt of McMaster University Canada proposes a study design in which one group takes puberty blockers while the other socially transitions. This would not be a study comparing intervention with non-intervention and, in light of the established fact that gender related distress resolves after natural puberty for the vast majority of young people, this is surely the crucial distinction a definitive study would aim to scrutinise. Instead, under Guyatt’s proposal the trial would effectively be comparing two active interventions, one of which (social transition), is known to drive demand for the other.

Further, social transition is almost impossible to define or control for: has a young person ‘socially transitioned’ if they cut their hair and dress differently but don’t change their pronouns? What about if they change their name and pronouns but make no changes to their dress or presentation? Some adolescent males with symptoms of gender distress are adamant about not socially transitioning until they have undergone medical interventions that allow them to ‘pass’. Will such young people be excluded from the study because they refuse to socially transition? If a young person desists from a social transition will they be removed from the trial? If so, how will this outcome be recorded in the results?

The second study design proposed by Guyatt would see one group treated with puberty blockers immediately, a second treated with blockers only after they have undergone psychological interventions and a third control group that would ostensibly receive no treatment. But the control group will not in fact be a no treatment group, because the BBC article and the NHS itself report that all trial participants will continue to receive psychological support throughout, regardless of which group they are in.

Given that puberty blockers are known to impair psychological functioning and cause declining mental health in some patients, Genspect UK has already argued that it would be profoundly unethical to provide blockers without concomitant psychological support. But this renders the delay study redundant, because it makes it impossible to disentangle the impact of psychological support and endocrine intervention. Under the delay group model, all three groups would in fact be receiving psychological support. The most promising and least invasive model of treatment, psychotherapeutic intervention, is thereby rendered a mere common denominator across the trial, a baseline intervention that it is not possible to measure or delineate the impact of. It becomes impossible to understand the impact of psychological support discretely, in isolation from other treatments, because it is potentially influencing outcomes for participants in all three groups. The BBC article assures us that the results will be ‘balanced’ to account for co-occurring mental health conditions but it’s far from clear that striking this ‘balance’ will be possible.

Ethical and Practical Issues with Control Group

For example, how will the trial account for the fact that the attitudes and responses of the non-control groups in the delay study will be intrinsically shaped by the knowledge that they will ultimately receive puberty blockers? In light of the widespread misconception that puberty blockers are efficacious and ‘lifesaving’, the delay group will be strongly incentivised to emphasise their perceived need for treatment and treat psychological intervention as a frustrating hurdle they have to get over in order to obtain a prescription. The certainty that blockers will ultimately be prescribed invalidates findings about this group and any non-medical interventions they might be given during the delay.

The third proposed design would administer puberty blockers to two groups, one receiving the drugs early in puberty and one later. The BBC describes the purpose of this trial as being to “explore when the right time to give puberty blockers might be”. But this takes as a foregone conclusion the unevidenced view that puberty blocking treatment is beneficial, restricting enquiry merely to the precise time at which it should be administered and therefore failing to answer the critical question of whether patients could benefit more from less invasive treatments.

There is promising evidence that this is the case. The systematic reviews conducted by the University of York found that psychotherapeutic treatments were associated with improvements in wellbeing in a comfortable majority of available studies, including three out of four studies on suicidality that reported “significant improvements in suicidality scores”. By contrast, in relation to puberty blockers: “There was insufficient/inconsistent evidence about the effects of puberty suppression on psychological or psychosocial wellbeing, cognitive development, cardio-metabolic risk or fertility” and some evidence that puberty blockade was associated with declining mental health or no change in wellbeing in up to three quarters of patients treated.

None of these study designs are capable of contributing to our knowledge about how to safely and effectively care for young people experiencing gender related distress. None of them are capable of producing results that will definitively settle the central question of whether medical or non-medical interventions are the most efficacious treatment. Even a cursory reading of the proposed designs shows that the results will be hopelessly confounded by multiple, uncontrolled variables. Genspect UK believes that thousands of young people stand to be unnecessarily medicalised under any one of these study designs, and the irreversible changes caused to their bodies and developmental trajectories will not even contribute to solving the arguments over treatment.

Perpetuating the Myth that Puberty Blockers are ‘Lifesaving’

The comments from Professor Gordon Guyatt, mentioned earlier, presented entirely uncritically by the BBC, are perhaps the most disappointing part of the article.

Professor Guyatt has been extensively briefed on the troubling landscape of so called ‘gender affirming care’. He knows that puberty blockers do not reduce suicidality (as comprehensively proven earlier this year by the UK government’s expert adviser on suicide) and he is aware that the appalling lie that they do has been weaponised to coerce desperate parents into medicalising their children.

Yet in the BBC article, Professor Guyatt likens gender related distress to a ‘life-threatening’ condition, in order to argue that it would be ‘unethical’ not to conduct a further puberty blocker study. This further entrenches the dangerous myth that puberty blockers are ‘lifesaving’ and perpetuates the lie that young people experiencing gender related distress will commit suicide if they don’t receive puberty blockers. Professor Guyatt should not have made these unevidenced and dangerous claims and the BBC should not have repeated them at risk of further misleading the general public.

Failure to Account for Persistence to Cross Sex Hormones

The BBC article fleetingly mentions that: “the evidence suggests the vast majority who start on puberty blockers go on to take cross-sex hormones” but doesn’t even touch on the massive implications this has for the proposed trial.

When used to treat gender related distress, puberty blockers cannot be understood or studied as a discrete intervention. They are the first step on a pathway that results in sterilising cross sex hormone treatment for almost 100% of those who take them. Known persistence rates of this magnitude make it impossible to understand the effects of puberty blockers in isolation from the broader medical pathway they inevitably lead to, and this was specifically recognised as an essential feature of securing informed consent by the judge in Bell v Tavistock. The trial’s designers are therefore under an obligation to account for the ethical and medical risks associated with cross sex hormone treatment as a fundamental part of any study into puberty blockers.

Genspect UK has seen no evidence that persistence to cross sex hormones is being considered as part of the study design process. In responding to the Telegraph’s request for comment about Genspect UK’s letter to the health secretary, NHS England and the Department for Health and Social Care made no reference to how persistence would be accounted for in the puberty blocker study. The prospective study designs revealed in the BBC article make no mention of persistence to cross sex hormones and yet this is a guaranteed outcome for almost every young person who is prescribed puberty blockers. We believe it would be unconscionable for the study to proceed without fully accounting for this issue.

Radical and Unjustifiable Outcome Measures

The BBC article makes a huge ethical leap when it lists as a valid outcome measure for the puberty blocker trial: “the extent to which a young person’s mental health may be improved if they are happy with their body.” The radical logic underpinning this suggestion isn’t even glancingly touched on in the article or, it seems, accounted for in the proposed study designs.

If a young person told us that having liposuction, lip fillers, a face tattoo or breast implants would make them happier with their body, would the NHS launch a trial to test this proposition? Does it propose a similar study for young people with physical disabilities and deformities, to find out whether radical cosmetic treatments would improve their mental health? These young people have objective cause to feel dissatisfied with their bodies, whereas the young people the NHS proposes to medicalise with puberty blockers are entirely whole and healthy. In either case, would the BBC meekly report on such a study as though it were wholly unremarkable, rather than a radical, paradigm altering move that fundamentally changes the purpose of medicine?

Traditionally, we have tried to help young people love and care for the bodies they have. It cannot be overstated just how radical it would be for the NHS to change this baseline assumption and replace it with the view that it is appropriate to give children irreversible cosmetic treatments to resolve body image issues experienced during the turbulent period of adolescent development.

As outlined in our report to the health secretary, Genspect UK fundamentally disagrees that altering the cosmetic appearance of a healthy child’s body with risky, experimental treatments can ever be treated as a valid indication for the use of a medication with well documented adverse side effects. Were a study to proceed on this basis, it would require comprehensive ethical justification, thrashed out transparently in the public domain with ample opportunity for interested parties to raise concerns. We see no evidence that this careful process is taking place, or indeed that the NHS appreciates the magnitude of normalising radical body modification procedures for young people struggling with body image issues. Health authorities must be forced to address the radical implications of this indication for use and the accompanying view that it is appropriate to use dangerous medications to bring about purely cosmetic changes.

Still No Support for Detransitioners

Finally, while glancingly mentioning that the detransition rate is thought to be increasing, the BBC article suggests that the needs of detransitioners are still not being considered by those developing the puberty blocker trial.

Genspect has a very personal stake in this question. Our sister project, Beyond Trans, is currently the only service providing specialist counselling and support to detransitioners. The detransition pathway promised in the Cass Review has yet to materialise and the NHS has no specialist service to meet the unique needs of detransitioners. We know for a certainty that some of the young people who participate in the puberty blocker trial will regret medicalisation and detransition. We know because we meet such young people every week at our Beyond Trans support meetings.

Ultimately, the detransitioners created through participation in the puberty blocker trial will not be taken care of by the NHS. They will be supported by Genspect. It is supremely irresponsible for the NHS to proceed with the trial with no plan to care for those who will inevitably be harmed by it.

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