by Michael Biggs, Dept of Sociology, University of Oxford
(22 July 2019)
Tavistock and Portman NHS Trust started an experiment in 2011, using Gonadotropin-Releasing Hormone agonist (GnRHa) to block puberty in children suffering gender dysphoria. My original investigation for Transgender Trend (posted on 5 March 2019) raised serious questions about this experiment. The outcomes were never published in a scientific journal. And I discovered unpublished evidence that initial results, after the drugs had been administered for one year, were predominantly negative.
My research was reported by the Daily Telegraph. It is elaborated in a chapter in Inventing Transgender Children and Young People , edited by Michele Moore and Heather Brunskell-Evans. It has just featured on BBC Newsnight, broadcast on 22 July.
Following my original investigation, I wrote to Professor Russell Viner at University College London (UCL), the experiment’s principal investigator, and Dr Polly Carmichael, Director of the Tavistock’s Gender Identity Development Service (GIDS), asking why they failed to publish results. I also contacted the Research Ethics Committee which originally granted permission, pointing out that the researchers consistently failed to provide annual progress reports. Another researcher working with Transgender Trend submitted a Freedom of Information request for further details of the experiment, and this apparently prompted GIDS to post a webpage entitled ‘A statement and update on the Early Intervention Study by the Tavistock and Portman NHS Foundation Trust’ at the end of June. The statement first came to notice in the Sunday Times on 7 July.
The statement runs to more than 4,600 words. The first 3,600 detail the origins of the experiment, emphasizing two points. First, in the years before 2011, families and transgendering organizations like Mermaids lobbied vigorously to lower the age at which GnRHa drugs were administered to children, and the Tavistock could not resist this pressure. Second, the researchers could not employ the standard randomized trial to assess the effects of blocking puberty. Both points have some justification, but one wonders why such a lengthy apologia would be necessary if the experiment’s outcomes have been favourable.
The Tavistock now claims ‘The study concluded in February 2019 when the last cohort member began the next stage of therapy (cross-sex hormones) at age 17 years’. When the Daily Telegraph asked GIDS to respond to my questions (before publication on 6 March), its spokesman did not mention that the study had just concluded. Similarly, on 26 March, Viner replied to my letter, stating ‘The early intervention study cohort remain under study as some of the last recruited young people have still not completed the treatment pathway’ (italics added). Carmichael’s reply on the same date also said nothing about the study having been concluded in February. The webpage on GIDS’ research still describes it as ‘a study that is currently underway’.
When Lord Lucas kindly followed my suggestion to ask a parliamentary question, he was told on 22 May that the Tavistock ‘plans to publish the data once all of the young people in the study have reached the stage when a clinical decision is made about moving from pubertal suppressants to cross-sex hormones, which the Trust expects to occur in the next 12 months’. Did the Tavistock mislead the Parliamentary Under-Secretary for the Department of Health and Social Care, who answered the question? The earliest indication that the experiment had terminated came from the NHS Research Ethics Committee, which informed me on 25 June that a final report is now being drafted by the chief investigator, Viner. One suspects that this precipitous ending – which has apparently been backdated to February – was forced by Transgender Trend’s scrutiny.
Whenever the study formally ended, the researchers have been collecting data for eight years. The first subject consented to GnRHa drugs in June 2011. All 44 subjects enrolled in the experiment had completed one year on the drugs by mid 2015, two years by mid 2016, and three years by mid 2017. The results should have been closely monitored and the outcomes published in a scientific journal. After all, GnRHa has never been licensed for treating gender dysphoria, not just in the United Kingdom but anywhere in the world.
Five years ago, in 2014, Carmichael told the Mail on Sunday that the study demonstrated favourable outcomes: ‘Now we’ve done the study and the results thus far have been positive we’ve decided to continue with it’ (italics added). She even appeared in a BBC television programme – ‘I Am Leo’, aimed at audiences aged 6 to 12 – to promote the benefits of GnRHa drugs. (See our analysis of the programme here).
The Tavistock’s statement says remarkably little about the experiment’s outcomes. It cites Carmichael and Viner’s presentation to the 2014 World Professional Association for Transgender Health (WPATH) conference showing ‘there was no overall improvement in mood or psychological wellbeing using standardized psychological measures’ (italics added). This finding was presented in February 2014, but just four months later Carmichael claimed ‘the results thus far have been positive’. I cannot find slides from this 2014 presentation, but Carmichael’s presentation to the 2016 WPATH conference apparently recycles the same finding. It also acknowledges that ‘Natal girls showed an increase in internalising problems from t0 to t1 [after 12 months on GnRHa] as reported by their parents’ (italics added). This negative outcome is omitted from the Tavistock’s statement.
The statement also omits two other statistically significant negative outcomes that I discovered buried in an appendix submitted to the Tavistock’s Board of Directors in 2015. Most seriously, after a year on GnRHa, ‘a significant increase was found in the first item “I deliberately try to hurt or kill self”’’. Evidence that an experimental treatment raised the risk of self-harm should be a major concern, but GIDS have never addressed this finding. There is a backhanded admission in a presentation given by the GIDS endocrinologist, Professor Gary Butler, to the 2016 WPATH conference (only the abstract is available). ‘Partial suppression [of sex hormones by GnRHa] may produce more side effects due to hormone swings, and also a lowering in mood leading to clinical depression. Expectations of improvement in functioning and relief of the dysphoria are not as extensive as anticipated, and psychometric indices do not always improve nor does the prevalence of measures of disturbance such as deliberate self harm improve.’ Butler’s presentation is, curiously enough, not cited in the Tavistock’s statement.
The Tavistock’s statement also fails to mention an article coauthored by Carmichael (Costa et al. 2016), which includes data from some subjects in the Early Intervention Study. This article purported to show beneficial outcomes from GnRHa, but I have demonstrated that the authors made an elementary statistical error. The analysis actually failed to detect any difference between children who were administered GnRHa and those who were not.
Finally, the Tavistock’s statement cites a recent article on bone density, coauthored by Butler (Tobin, Ting, and Butler 2018). The article – a one-page abstract – emphasizes that bone density did not decline, in absolute terms, after GnRHa was administered. This is extremely misleading, as pointed out by Dr Michael Laidlaw and reiterated by Dr William J. Malone, both endocrinologists. Growing children need bone density to increase. The article admits that the children did experience a decline relative to the normal standard for their age group, and this decline was especially marked for girls. My graph shows the distributions implied by the article’s figures.
It is obvious that a substantial minority of the girls on GnRHa suffered from abnormally low bone density.
In sum, the Tavistock’s statement continues the sorry record of prevarication and obfuscation that has dogged the experiment for several years. GIDS is clearly incapable of undertaking rigorous scientific research, perhaps because it has been swamped by exponentially increasing caseloads. There is no such excuse for the failure of UCL’s Institute of Child Health, the experiment’s lead sponsor. Neither organization can be trusted to objectively analyze the 2011 experiment.
We demand that a team of independent researchers be given access to all the data from the experiment. They will need expertise in statistics, psychiatry, and endocrinology; most importantly, they must have no vested interests in the promotion of GnRHa drugs. Given that this experiment has been used since 2014 to justify the provision of these drugs to children under the NHS, the outcomes of this experiment – on all the physical, psychological, and behavioural measures that were collected – must be published urgently.
Our next post will examine in detail the process undertaken by GIDS to gain ethical approval for this study.