Video: Puberty blockers for gender dysphoria: The Dutch protocol
Dr. Michael Biggs
In the UK on December 1st 2020 the High Court handed down judgment on the use of puberty blockers for the treatment of children under the age of eighteen.
The judicial review was brought by former Tavistock psychiatrist Susan Evans against the Tavistock & Portman NHS Trust. The claimants were Keira Bell, a 23 year-old lesbian who regretted the medical intervention she underwent at the Tavistock Gender Identity Development Service, and Mrs A, the mother of an autistic 15 year-old girl who was waiting for treatment. The claim brought before the court was that a child under the age of eighteen cannot give informed consent to treatment with puberty blockers.
This was the court’s conclusion.
The full court judgment can be read here.
Puberty blockers are a class of synthetic gonadotrophin-releasing hormone (GnRH) analogues. By acting on the pituitary gland, these drugs prevent the release of chemical signals which stimulate the production of estrogen and testosterone, halting the changes of puberty caused by these sex hormones.
The Tavistock GIDS began an ‘Early Intervention study’ in 2011. Previous to this, puberty blockers were offered as a treatment only to children from the age of sixteen. The trial lowered the age to twelve, and subsequently, by 2014, to any child who had reached Tanner Stage 2 of puberty. This meant that now children as young as ten could be given blockers. No final results of this trial have as yet been published. To date GIDS has treated over a thousand children with puberty blockers, with about 230 of these children under the age of 14, the youngest child being 10 years old.
The claimed therapeutic benefit is to allow more time for children to consider whether they want to continue transitioning via cross-sex hormones and surgery, without the stress of ongoing unwanted pubertal development. Those who choose not to transition can stop taking blockers, and it is claimed that their original puberty will resume and progress normally. It was claimed that the drugs are effective, safe and fully reversible.
Is there any evidence to back up this claim?
The NHS changed their guidance on puberty blockers this year. From previously claiming that blockers “are considered to be fully reversible” the NHS webpage now states:
“Little is known about the long-term side effects of hormone or puberty blockers in children with gender dysphoria.
Although the Gender Identity Development Service (GIDS) advises this is a physically reversible treatment if stopped, it is not known what the psychological effects may be.
It’s also not known whether hormone blockers affect the development of the teenage brain or children’s bones. Side effects may also include hot flushes, fatigue and mood alterations.”
All the available evidence to support their defence was presented to the court by the Tavistock. This is what the court found:
Side effects of puberty blockers
GnRH analogues were first licensed for use as end-stage prostate cancer drugs in 1985 and are still in widespread use today. They are also prescribed to chemically castrate sex offenders in Broadmoor. They have since been used in other indications and are most recently being used ‘off-label’ to delay puberty in children with gender dysphoria. They are also used by transgender adults on cross-sex hormone therapy to suppress the production of their natural sex hormones.
In the US, a GnRH analogue drug with the tradename Lupron was licensed in 1993 for use in children with precocious puberty. It was also commonly used off-label to help children who needed to grow taller. There is now a growing number of women who used Lupron in childhood who are reporting serious issues with bone and blood disorders and joint problems in adulthood. This information is reviewed here.
It has long been known that mechanistically GnRH analogues can cause bone thinning. The reduction of estrogen levels in girls can induce a temporary osteopenia (similar to what’s seen in menopause when estrogen levels naturally fall). A 2009 study showed that Lupron caused bone thinning in girls treated although bone density was seen to return to normal levels within 10 years after treatment. There is also a large 2005 study in men treated for prostate cancer in which a significantly increased risk of bone fractures was observed. The bone thinning effects are also mentioned in the ‘Important safety information’ leaflets that accompany Lupron and extended use is not recommended in people with pre-existing bone thinning conditions.
The FDA considers the drug’s impact on children’s bones an unanswered question, according to a statement: “The effects of bone density in children whose central precocious puberty is arrested with a GnRH agonist are considered ‘unknown’ as they have not been studied”
The UK endocrinologists at GIDS used the GnRH analog called Triptorelin. Although slightly different to Lupron all these drugs are in the same class of GnRH analogs and all have the same mechanism of action. The mechanistic safety issues will most likely apply to the whole class of drugs.
Triprorelin is manufactured by two different companies under the tradenames Gonapeptyl Depot and Decapeptyl SR. This drug has been approved by NICE for use in children with precocious puberty, although it should be noted that it is being used ‘off label’ for children with gender dysphoria. This means its use by the NHS does not come with regulatory approval because the appropriate safety studies are not available.
Leuprorelin (Lupron) has not been approved by NICE for use in children. This is only prescribed if adverse reactions are observed with Triptorelin. GIDS prescribing information was made available under a freedom of information request here.
What is the longer term impact on gender identity?
Although blocking the progression of puberty can in some cases relieve the immediate distressing symptoms suffered by children with gender dysphoria, the evidence is mixed. The long term effects are unknown. There have been no long term studies on the effectiveness of puberty blockers and it is unknown whether interrupting natural puberty alters the natural trajectory and perhaps resolution of gender dysphoria in children.
Gender identity is shaped during puberty and adolescence as young people’s bodies become more sexually differentiated and mature. Given how little we understand about gender identity and how it is formed and consolidated, we should be cautious about interfering with the normal process of sexual maturation.
What we do know however is that virtually all the children who start on puberty blockers eventually go onto cross-sex hormones suggesting that changing their minds is rare once natural puberty is interrupted.
The Health Research Authority, in its investigation into the Tavistock’s Early Intervention study, questioned the stated purpose of puberty suppression as providing children with ‘space to decide’. The HRA report suggested that blockers were in fact used as a first step towards further medical intervention in the form of cross-sex hormones:
It would have reduced confusion if the purpose of the treatment had been described as being offered specifically to children demonstrating a strong and persistent gender identity dysphoria at an early stage in puberty, such that the suppression of puberty would allow subsequent cross-sex hormone treatment without the need to surgically reverse or otherwise mask the unwanted physical effects of puberty in the birth gender.
Cross-sex hormones have serious lifelong effects which cannot be ‘reversed’ if treatment is discontinued. If a child takes puberty blockers at Tanner stage 2 of puberty followed by cross-sex hormones at age 16 they will be sterilised as gametes have not developed.
The court found:
Are the effects on puberty really reversible?
Since its rare for children with gender issues to stop taking puberty blockers this also means there have been no long term studies to show that normal puberty will resume in these children. The evidence of ‘reversibility’ is from studies in a different set of children; namely children with precocious puberty (a puberty disorder in which puberty commences very early. Technically this is before the age of 8 in girls but could be as young as pre-school age). In these children puberty blocking drugs are normally withdrawn around the age of 12 and menstruation in girls commences about 1 year later. In this respect the resumption of puberty occurs around the ‘expected age’ in children and will be in line with other aspects of physiological and psychological adolescent development.
This is very different from the approach in children with gender dysphoria. Normal puberty is postponed while the normal ageing process proceeds. Restarting natural puberty (or inducing cross-sex puberty artificially at 16) would therefore be out of step with other development processes. It should also be noted that virtually all cases of precocious puberty occur in girls so there is extremely little evidence of the restarting of puberty in boys. For these reasons the true reversibility of blocking puberty in children with gender issues is currently unknown.
The court found:
What are the implications of preventing a natural puberty?
Proponents of the use of puberty blockers say that not only do these drugs relieve the distressing symptoms of ‘the wrong puberty’ in childhood but also prevent the body from undergoing irreversible changes which then have to be modified surgically during adulthood. For example, permanent growth of breasts in females which may necessitate a double mastectomy in the future. Alternatively, permanent facial hair growth in males which may necessitate its removal in the future. However, what is rarely discussed is the effect on the reproductive and sexual development of the child.
Puberty blockers followed by opposite sex hormones cannot create ‘opposite sex puberty’, only secondary sex characteristics of the opposite sex. However, normal sexual or reproductive development will not occur. Girls will not begin menstruation and so will be infertile. Boys testes will not grow and develop and will impact on fertility. The change therefore is only cosmetic. A boy’s penis will remain immature and remain the size of a child’s into adulthood. This will cause problems sexually if the penis is retained, both functionally and in terms of sexual arousal. It is also problematic if gender reassignment surgery is later chosen since there is too little material to use from the penis and testicles.
When a child’s natural puberty is blocked we can expect to see effects not only on the body but on the developing brain. It is the surge of sex hormones at puberty which triggers the important changes in the adolescent brain which only reach completion in the mid-twenties. Hormonal changes at puberty are thought to influence the development of both brain structure and function.
Recent research indicates that there is a window of development for some cognitive functions, and if this window is missed, cognitive development does not resume later even if blockers are discontinued. A reduction in long-term spatial memory was found to persist after discontinuation of blockers in a recent study on sheep, which concluded:
This result suggests that the time at which puberty normally occurs may represent a critical period of hippocampal plasticity. Perturbing normal hippocampal formation in this peripubertal period may also have long lasting effects on other brain areas and aspects of cognitive function.
Two previous studies which analysed IQ performance in girls taking puberty blockers for central precocious puberty also suggest the possibility that GnRHa treatment may have an adverse impact on cognitive functioning in children. The first study of 25 children in 2001 found a drop of 7 IQ points after two years on blockers. The second study in 2016 found a drop of 8 IQ points in 15 girls compared to a matched control group. An analysis of these studies is here.
A study in 2017 of men with late stage prostate cancer found that treatment with GnRH analogs affects cognitive functions such as language ability, short-term memory capacity, mental flexibility, and inhibitory control.
The court found:
A recent analysis of evidence by Professor Michael Biggs, who researched the Tavistock GIDS ongoing Early Intervention study, indicated some significant and worrying emotional/behavioural effects reported after children had taken puberty blockers for a year:
‘Natal girls showed a significant increase in behavioural and emotional problems’, according to their parents (also from the Child Behavior Checklist, contradicting the only positive result). One dimension of the Health Related Quality of Life scale, completed by parents, ‘showed a significant decrease in Physical well-being of their child’. What is most disturbing is that after a year on blockers, ‘a significant increase was found in the first item “I deliberately try to hurt or kill self”’ (in the Youth Self Report questionnaire).
In a review of all recent published research studies, Professor Carl Heneghan highlighted the very low quality of evidence for the benefits of blockers:
Problems within these studies, however, make it difficult to assess whether early pubertal changes regress under GnRHa treatment and whether prolonged puberty suppression is safe. For example, there is a lack of controls, and in one study that included controls, these were inadequate as relatives and friends of the participants were asked to participate, serving as age-matched controls. A lack of blinding was also problematic.
The conclusion on the evidence for all ‘gender affirming’ treatment for children and young people was this:
Treatments for under 18 gender dysphoric children and adolescents remain largely experimental. There are a large number of unanswered questions that include the age at start, reversibility; adverse events, long term effects on mental health, quality of life, bone mineral density, osteoporosis in later life and cognition.
It is often said that the use of puberty blockers in children is completely safe and irreversible. This claim however has never been tested in long term studies and its use for gender dysphoria is experimental. What the evidence does show is that blockers may simply lock children into a medical pathway resulting in sterility and potential loss of sexual function.
Now the evidence has been examined in a court of law. All the evidence presented in support of the use of blockers by the one provider of this treatment in England, the Tavistock GIDS, was read by three High Court judges, and the Tavistock’s lawyer presented their case over a two day hearing. On the basis of all the evidence the court has judged that children under the age of eighteen in most cases are not able to give informed consent to take puberty blockers without application to the court.
The long-awaited study results of the Tavistock’s puberty blockers trial were finally published the day after the court judgment. The results of the study serve to reinforce the judgment and the court’s reasons for the ruling. The full study can be read here.
For the full story of the Tavistock’s Experimentation with Puberty Blockers, download our free pdf of all five of Michael Biggs’ articles written for Transgender Trend. From the scandal of unpublished negative results to the Keira Bell victory in court and the finally published study, read the full shocking story here.