Gender dysphoria in children: puberty blockers study draws further criticism
BMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l5647 (Published 20 September 2019) Cite this as: BMJ 2019;366:l5647
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As journalists, reading some of the rapid responses to this article is depressing, highlighting a misunderstanding of “investigative journalism”.
Letters by Shaw and Scott et al fail to recognise why journalists have been drawn into reporting on interventions and research in transgender health and misrepresent what we have written. We will attempt to correct their false statements about the article; about us as reporters; and how the piece came about.
We did not set out to “investigate” the use of puberty blockers or an unpublished scientific study. We have a duty to examine claims that are brought to us that are of significant public interest – particularly when accompanied by primary documentation. Some people working in the field of gender identity are fearful of speaking about concerns they have about the evidence base. This is the very reason why journalism has a crucial role in scientific discourse, and we have no agenda other than to explore current debate.
We reject the assertion that we employed alarmist language. We looked at the evidence and primary source documents. We sought expert opinion from a wide variety of sources – from those who write clinical guidelines for NICE to statisticians involved in drug trials. Crucially, we also spoke with clinicians working in gender identity services and transgender people.
We interviewed Hannah Philips, a young transgender woman, on the record. Our quotes from this were an accurate reflection of what she told us, and what she has said publicly on her YouTube channel.
It seems an odd criticism that we referred to gonadotropin releasing hormone analogues as puberty blockers. This is how gender clinics around the world and academic researchers often refer to them.
Nor do we suggest that treatment with GnRHas may be responsible for persistence. We said that the limited existing studies show the majority - if not all - young people taking GnRHas at the onset of puberty – so-called ‘early intervention’ – progressed to cross-sex hormones. However, GnRHas are presented to young people and their families as providing time and space to think.
In their investigation into the early intervention study, the Health Research Authority warned against describing puberty blockers as “providing a ‘breathing space’”. Instead it described the treatment in the following way: “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”.
We reject any charge that we suggested that young trans-identifying people could ‘contaminate’ others. Moreover, comparing this feature to homophobic reporting some three decades ago is highly offensive, and we can see nothing in our reporting that could possibly warrant such an allegation. Indeed, we argued the opposite - that the transgender community should be entitled to the same standard of health research and care as anyone else.
In response to Scott et al, others are better placed to debate the merits of study design. We merely reported the fact the first research ethics committee had rejected the early intervention study because it didn’t have a control group. We made no judgement. Nor did we comment on clinical decision making or that researchers didn’t warn about harms. We reported that a Dutch study had showed all who take GnRHas at early stage puberty went on to take cross sex hormones and that this was not in the consent forms or in the study protocol.
We did not make any judgement that triptorelin is used “off label” in gender dysphoria. Nor did we prejudge the study’s results. We reported the researcher’s own analysis showing an increase in suicidal ideation whilst making public statements about how their results were positive. We were told this was based on a questionnaire – one that we haven’t seen nor has been published.
Contrary to what Scott et al say, we actually point out that we do not know if the observed suicidal ideation in some participants is a treatment effect because the study design does not allow that causal link to be made.
We strongly reject any accusation bias.
Competing interests: Deborah Cohen is former Investigations Editor of The BMJ. Hannah Barnes, no competing interests.
Gender dysphoria is not a diagnosis; it's a neurosis.
The Shorter Oxford English Dictionary defines dysphoria as ‘a state of unease or discomfort; esp. an unpleasant state of mind marked by malaise, depression, or anxiety.’
Thus, gender dysphoria means a person who is unhappy with his or her biological sex and wishes he or she, respectively, were of the opposite sex.
Perhaps it would be better for people who are unhappy about their bodies in this way to be offered psychotherapy to help them explore the reasons for, and come to terms with, their situation.
Significantly, in ‘A patient’s perspective’ in this article, a person who is being treated with a puberty blocker says, ‘It feels as if someone is finally listening to you.’
Maybe that is what he—as the person originally was—wanted: someone to listen to him. Instead, he got life-changing treatment with an experimental drug, triptorelin.
Competing interests: No competing interests
Following Cohen and Barnes’ investigative article,(1) it is positive that the BMJ is hosting an open medical debate about the effects of puberty blockers on young people with gender dysphoria. We agree that some of the problems identified were relatively minor misdemeanours that many researchers in constrained circumstances could commit,(2) but contend that the troubles of this GIDS service study(3) are symptomatic of a wider collective failure to ensure good science is applied to this important area. A more recent examination of the evidence has independently determined that it is still ‘experimental’.(4) Key institutions need to work together effectively in order to determine whether, and when, we should prescribe puberty blockers, or cross sex hormones, to children and young people identifying as transgender. Current patients cannot give fully informed consent in the absence of precise estimates of benefits and harms that could be life-long, except in research trials that admit the uncertainties.
The ethics of research conduct belongs to the Health Research Authority (HRA); the quality of science is primarily the responsibility of funders and sponsors (here UCL). However, the two are rarely completely unrelated. The HRA investigation concluded that although its oversight via annual reports is lax, other procedural issues were not serious.(5) We disagree with the conclusion that problems around the recording of declarations of interest were not important. More critically, the HRA report did not try to determine if its first committee (which ‘pushed back’ about the science) was right, preferring only to defend the applicants’ resubmission without addressing concerns, and its second committee’s decision to allow the small evaluation to proceed without considering, or testing feasibility for, a randomised trial. Effectively the HRA absolves itself from responsibility for judging the science in deliberations about ethics. Thus the avoidance of bad science (which is inherently unethical) relies entirely upon the sponsor’s usually ‘light-touch’ oversight (a problem also found with the AgeX trial).(6) In the absence of independent peer review during competitive funding, Universities must rely on the Principal Investigator. In the event of the inevitable occasional error, this weakness exposes individual employees to potential criticism.
Whilst many paediatricians prescribe ‘off-label’, halting natural puberty in gender dysphoria is entirely unrelated to previous indications. Prescribers, and psychologists who don’t prescribe, should not suggest that safety data can be transferred from triptorelin used for restoring correct timing in precocious puberty. Here, its use has many far reaching consequences so a more stringent research design was required. By gaining permission to study individuals without controls, and by not studying the whole pathway, we were never likely to learn much about the benefits or harms. Empiricism is simply not a good enough approach. Whilst RCTs might be difficult, they are not impossible, and simply have not been tried. Back in 2010, an opportunity for a UK pilot feasibility trial was missed when puberty blockers were not routine. It remains an option to only prescribe within the context of a trial, maybe robustly comparing an ‘earlier’ vs ‘later’ timing, with or without ‘earlier’ or ‘later’ cross-sex hormones or supportive psychological therapy. It is also important that the changing demographic of those identifying as transgender is taken into account. This new cohort of mainly natal females, often with more recent onset, and with high rates of trauma and developmental disorder may respond differently.
A further troubling aspect was the lack of justification for moving from a small, uncontrolled cohort with unpromising, unpublished results to the scaling up and widespread implementation of care which has not been evaluated. While GIDS has traditionally been more conservative about offering medical interventions than the US, Holland and Canada, following a trend is inadequate reason for the NHS to commission such expansion. The new, much larger NIHR funded study is again designed only to observe, not test, effects,(7) similar to a US study of different populations (i.e. comparing ‘apples’ with ‘pears’).(8) The absence of the development and evaluation of psycho-social therapy for the many individuals assessed by GIDS as suitable for hormonal therapy but with co-existing mental health and developmental problems is a further matter deserving investigation.
We agree it is troubling that clinicians are fearful about engaging in this area. (2) We need generalists and specialists, researchers, methodologists, public health experts, parents and individuals with lived experience (of desisting and detransitioning as well as those feeling the benefit) to work together in constructive disputation. We conclude that the real significance of the BMJ report(1) lies in illuminating part of the greater global issue of how commissioners, service providers and research institutions have failed to create a prospective framework with adequate controls to evaluate the impact of interventions in this vulnerable group who deserve equitable standards of research. The UK has the potential to create the best service for gender questioning young people in the world. To do so, key institutions and leaders will need both to embrace equipoise and to work together effectively - a modus operandi which has transformed the care of children with cancer.
References
1. Cohen D, Barnes H. Gender dysphoria in children: puberty blockers study draws further criticism. BMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l5647
2. Stott S, Ford T. Puberty blockers study: much ado about nothing? https://www.bmj.com/content/366/bmj.l5647/rr-1 (10 October 2019)
3. http://gids.nhs.uk/our-early-intervention-study [last accessed 20 October 2019]
4. Henegan C, Jefferson T. Gender-affirming hormone in children and adolescents
https://blogs.bmj.com/bmjebmspotlight/2019/02/25/gender-affirming-hormon...
5. https://www.hra.nhs.uk/about-us/governance/feedback-raising-concerns/inv... [last accessed 20 October 2019]
6. Bewley S, Payne M, Blennerhassett M. Analysis. Cost of extending the NHS breast screening age range in England. Br Med J 2019;364:l1293
7. Longitudinal outcomes of gender identity in children. ISRCTN98564473
https://doi.org/10.1186/ISRCTN98564473
8. Olson-Kennedy J, Chan YM, Garofalo R, Spack N, Chen D, Clark L, Ehrensaft D, Hidalgo M, Tishelman A, Rosenthal S. Impact of Early Medical Treatment for Transgender Youth: Protocol for the Longitudinal, Observational Trans Youth Care Study. JMIR Res Protoc. 2019 Jul 9;8(7):e14434. doi: 10.2196/14434.
Competing interests: No competing interests
We welcome the willingness of the BMJ to publish discussion around the treatment of children with gender dysphoria and in particular around the concerns that have been raised regarding the puberty blockers study (1). Although the outcome of the HRA investigation concluded that researchers did not veer from research norms we are left with significant questions over the appropriateness of the use of puberty blockers in children with gender dysphoria.
Gender dysphoric children and teens are experiencing a crisis of identity. All young people generally struggle to think about the long term consequences of life choices. It is no surprise therefore that questions are raised over the ability of these young people to make decisions with meaningful and informed consent. This is especially true of interventions that have unknown long-term outcomes (2)
Gonadotrophin Releasing Hormone Agonists (GnRHa) are generally given under the premise that they provide “breathing space” for a child or young person to explore their identity without the distress caused by pubertal changes (3). However it is becoming clear that once started on GnRHa to block puberty almost all children go on to receive cross-sex hormones (4). The information given to parents and children that puberty blockers are completely reversible and just give breathing space might therefore be construed as misleading.
Further concern around informed consent is highlighted by the increasing number of young adults coming forward to express their wish to “detransition” (5). These young adults have undergone varying degrees of social, medical and surgical transition before coming to a realisation that they do not want to identify as the opposite sex and want to accept and reconcile with their natal sex. These young people cite untreated mental health problems including depression and self harm as well as awareness of same sex attraction as reasons to transition initially. Studies show over-representation of major mental disorders, bullying and same sex attraction in adolescent gender clinic populations (6,7)
Children and Young People deserve detailed psycho-social assessment, treatment for other co-morbid conditions and the best evidence-based treatments. We need to be able to explore and debate these issues so that these vulnerable children can get the help and support that they need.
1. Cohen D, Barnes H. Gender dysphoria in children: puberty blockers study draws further criticism. BMJ. 2019 Sep 20;l5647.
2. Heneghan C. Evidence Spotlight: Gender-affirming hormones in children and adolescent [Internet]. BMJ; 2019. Available from: https://blogs.bmj.com/bmjebmspotlight/2019/02/25/gender-affirming-hormon...
3. World Professional Association for Transgender Health. Standards of Care for the Health of Transsexual, Transgender, and Gender- Nonconforming People Version 7 [Internet]. 2012. Available from: www.wpath.org/publications/soc
4. de Vries ALC, Steensma TD, Doreleijers TAH, Cohen‐Kettenis PT. Puberty Suppression in Adolescents With Gender Identity Disorder: A Prospective Follow‐Up Study. J Sex Med. 2011 Aug;8(8):2276–83.
5. Female detransition and reidentification: Survey results and interpretation [Internet]. 2016. Available from: 40. http://guideonragingstars.tumblr.com/post/149877706175/female-detransiti...
6. Kaltiala-Heino R, Sumia M, Työläjärvi M, Lindberg N. Two years of gender identity service for minors: over representation of natal girls with severe problems in adolescent development. Child Adolesc Psychiatry Ment Health. 2015 Dec;9(1):9.
7. Holt V, Skagerberg E, Dunsford M. Young people with features of gender dysphoria: Demographics and associated difficulties. Clin Child Psychol Psychiatry. 2016 Jan;21(1):108–18.
Competing interests: No competing interests
How-When-Where Does Common Sense Scream “The Transgenderism Emperor Has No Clothes!”?
Ghanaians worth their salt cannot possibly comment publicly on the British Medical Journal article by Deborah Cohen and Hannah Barnes [1] without using “Tafracher”, that valuable Ghanaian word I introduced to BMJ nearly 45 years ago [2] https://www.bmj.com/content/1/5953/329
DEFINITIONS
(a) In their article “Gender Dysphoria in children: puberty blockers study draws further criticism” Deborah Cohen and Hannah Barnes define Gender Dysphoria as “a conflict between a person’s biological sex (or ‘assigned’ gender) and the gender with which they identify”. [1]
(b) GIDS (Gender Identity Development Service) “based at London’s Tavistock Square and Portman NHS Foundation Trust, is England’s only provider of NHS specialist treatment for young people with gender dysphoria”. [1] Madeline Kearns says it used to be called Gender Identity Disorder. [3]
(c) TRANS CARE - the process by which doctors (physicians, surgeons, psychologists, and others) treat those wishing to alter their gender.
(d) Ethical Approval is when an Ethics Committee allows or disallows researchers and doctors to go ahead and do something as serious as (Tafracher!) turning a boy into a girl, or vice versa - Transgenderism.
(e) Common Sense is defined severally as “Native good judgment”, or “Good practical sense especially in everyday matters”, or “A set of general unexamined assumptions as distinguished from specially acquired concepts”, or “Sound and prudent judgment based on a simple perception of the situation or facts.”
THE SERIOUS CRITICISMS OF TRANS CARE
If the article of Deborah Cohen and Hannah Barnes which exposed certain goings-on is not a Wake-Up-Call I don’t know what is. Researchers have broken rules “when seeking ethical approval”. Negative data has been suppressed. Evidence about Puberty Blockers Outcomes, side-effects, and unintended consequences is lacking. Interim findings “that might suggest increased suicidality” have been downplayed. Full study findings remain unpublished. Some researchers were not “prepared to speak publicly for fear of reprisal” [1] and “protocol and information sheets were missing potentially significant information” [1]. One Ethics Committee turns down a procedure as unethical, only to be sanctioned by another Ethics Committee. Failure to submit regular progress reports. On … and … on were the concerns stated in the article of Cohen and Barnes and “GIDS declined to share (some) results ‘which could prejudice publication of the study’” [1].
I was disturbed reading the perspective of a girl, now 19, “who started taking puberty blockers when she was 16”. Equally unsettling was Researchers’ frequent use of “There is no evidence”, the phrase that we readers subliminally associate with “There is evidence” that the opposite is true! [4] Would we not be piling harm upon harm when, as stated by the authors, (Tafracher!) “Puberty blockers could now, also be considered for children under 12 in established puberty”? [1]
TWO PRIME MINISTERS AND ONE VICE-CHANCELLOR EXPRESS IN JUST 3 DAYS CONCERNS ABOUT OUR YOUNG
Monday 14 October 2019 during the Queen’s Speech Debate Prime Minister Mr Boris Johnson included this statement “looking after young people growing up in this country”. [5]
Tuesday 15 October 2019 during Queen’s Speech Debate Immediate Past Prime Minister Mrs Theresa May said “Young people can suffer harm on line” [6]
Wednesday 16 October 2019 in his Annual Lecture University of Hertfordshire Vice-Chancellor Professor Quintin McKellar CBE said “Clearly the number of students and other young people with mental health is a cause for deep concern”. [7]
Now, although these three very distinguished personages who are admirably concerned about our children, grand-children, and our great-grand-children were not referring in their comments quoted above to gender dysphoria and its complications including suicidality [1], which of us UK-trained doctors would be brave enough to forecast that the recommendation that children be given “time to explore their gender identity" [1] starting as early as (Tafracher!) the age of 4, as will become compulsory from 2020, could not possibly contribute to future human and societal catastrophic wreckage? Anyone, but anyone, who raises an objection to this state of affairs promptly invites what I call a “Perversion of language and thought” from almost all quarters. This is what I mean:
PERVERSION OF LANGUAGE AND THOUGHT
Imagine yourself driving on a very busy UK road. The vehicle just ahead of you indicates “Right” and you position yourself to overtake. But just as you accelerate to do that the driver turns left. And crash! You get out of your car, and so does the driver in front. You express your displeasure and ask to exchange papers. Before you finish speaking the driver vehemently accuses you of “dangerous-driver-phobia”. Sadly, others gathering round also agree with him/her. This, in my book, is Perversion of Language and Thought that produces wreckage; not just vehicle wreckage, but human and societal wreckage that lasts for generations. I’ve listed just a few examples of such human, and societal wreckage in Reference 8.
COMMON SENSE, I BEG YOU, SCREAM LOUDLY TO WAKE US UP!
Vice-Chancellor Professor Quintin McKellar CBE mentioned Common Sense at least twice in his masterly and informative Oration on Wednesday 16 October 2019. Sixty years ago, I qualified twice over as a doctor in England – (a) from The Royal College of Physicians London (LRCP) and Royal College of Surgeons England (MRCS) in January 1959 and (b) from University of London (MB BS) in April 1959. My teachers at Westminster Hospital School of Medicine in Horseferry Road, London SW1 who, being the very best in the entire world had a great deal of Common-Sense some of which rubbed off on me. After all, they included Clinicians of British Royalty – Sir Clement Price-Thomas operated on King George VI, and Sir Richard Bayliss was the superb Consultant Physician of Queen Elizabeth II. The British are known for reserving the very best for their Monarch. They chose Clinicians with Monumental Common Sense. I owe a great deal to them, as I spelt out openly in a speech on 5th September 2018 at St Albans City Cathedral [9]. Dare I say more?
Competing Interest: Imbibed a tiny bit of the Common Sense of my Illustrious Teachers who were Clinicians of the British Royalty.
felix@konotey-ahulu.com Twitter@profkonoteyahul
Professor F I D Konotey-Ahulu MRCS(Eng) LRCP(Lond) MB BS MD(Lond) FRCP(Lond) FRCP(Glasg) DTMH(L’pool) DSc(Hon UCC) DSc(Hon UH) FGA FGCP FWACP FTWAS, ORDER OF MERIT (OFFICER). Kwegyir Aggrey Distinguished Professor of Human Genetics, Faculty of Science, University of Cape Coast, Ghana, and Former Director Ghana Institute of Clinical Genetics Ghana and Consultant Physician Genetic Counsellor in Sickle Cell and Other Haemoglobinopathies Korle Bu Teaching Hospital Accra, and at Phoenix Hospital Group, 9 Harley Street, London W1G 9AL. [ www.sicklecell.md ]
1 Cohen Deborah, Barnes Hannah. Gender Dysphoria in children: puberty blockers study draws further criticism. BMJ 2019; 366: l5647
2 Konotey-Ahulu FID. PERSONAL VIEW – Tafracher (The Ghanaian devulgarizing prefix). BMJ Volume 1, page 329, February 8 1975. https://www.bmj.com/content/1/5953/329
3. Kearns Madeline. The origins of the Transgender Movement. [Gender Dysphoria used to be called Gender Identity Disorder, and “is still listed in the Diagnostic Statistical Manual of Mental disorders, so it’s still a disorder in the DSM, but that’ll likely change”. Causes “a massive cultural and political wave”] National Review.com 14 October 2019.
4. Konotey-Ahulu FID. Evidence – Do not forget the hidden human dimension. www.bmj.com/content/366/bmj.l4606/rr-11 “Evidence of Absence is not Absence of Evidence”. BMJ Aug 7 2019 Rapid Response.
5. Johnson Boris (Prime Minister): “looking after young people growing up in this country” – said in Queen’s Speech Debate House of Commons 14 October 2019.
6. May Theresa (Immediate Past Prime Minister): “Young people can suffer harm on line” - said in Queen’s Speech Debate House of Commons 15 October 2019.
7. McKellar Quintin CBE (Vice-Chancellor University of Hertfordshire): Dangerous Ideas – Will today’s students change the world? [“Clearly the number of students and other young people with mental health is a cause for deep concern”] Vice-Chancellor’s Annual Lecture 16 October 2019.
8. Examples of wreckage, not just of pupils, but doctors and parents too.
a. http://opr.news/2f33d35d191002en_ng Christian Doc Loses Job as UK Judge Rules ‘Biblical View of Male and Female’ Violates ‘Human Dignity’ opr.news
b. Schools pulled into row over helping transgender children ...https://www.theguardian.com/education/2018/may/15/transgender-row-teache... May 2018 ... As more teens come out as trans, experts clash over how schools should help. ...
It's still not easy being a trans child. This is what schools can ...
c. Virginia teacher sues after being fired for refusing to call trans ...
https://www.theguardian.com/us-news/2019/oct/01/virginia-teacher-sues-af... Oct 2019 ... A Virginia high school teacher who was fired for refusing to use a transgender ...
d. Smith Samuel. Texas Dad could lose custody of 6 -year-old son for not affirming transgender identity. The father has reportedly been legally prohibited from talking to his son about gender and sexuality. 29 Nov 2018 www.christianpost.com>news
9. Konotey-Ahulu FID. Hon DSc Acceptance Speech Sept. 5 2018 Univ. of Hertfordshire, naming all my Teachers https://youtu.be/41a1FZSpHd4
Competing interests: Imbibed a tiny bit of the Common Sense of my Illustrious Teachers who were Clinicians of the British Royalty.
The BMJ is to be commended for looking into the research on puberty blocking treatment for children with gender dysphoria. The views of academic CAMHS psychiatrists that don't work in the gender field, Professors Scott and Ford, are a welcome addition to the discussion. The more input to the debate from informed but 'impartial' psychiatrists, the better medicine will be equipped to avoid going astray.
However, it is surprising that they do not see at least the significant risk of over use of treatments with unknown long term outcomes. 100% of puberty blocked children going onto cross sex hormones is remarkable in that it suggests that either clinicians are able to predict outcomes with 100% accuracy (unheard of in any other area of psychiatry ) or that starting puberty blockers, in of itself, leads to cross sex hormones at the age of 16.
The fact that many medications used for minors are unlicensed, is a weak argument to defend the unlicensed use of puberty blockers. It could be argued that the rates of unlicensed psychotropic medication use for CAMHS patients, across the field, is excessive. No doubt that will also, in time, get the attention it needs, as is happening in learning disability and old age psychiatry currently.
Using common sense begs the question ; where are all the middle aged women wanting to transition to male? The ones that this research suggests would have been suffering in gender confused silence 20-30 years ago ?
Competing interests: No competing interests
The Health Research Authority (HRA) have responded to these concerns regarding the study. It appears there was indeed little to worry about. In fact the HRA went so far as to praise the researchers for being in some areas "ahead of normal practice at the time", as the authors themselves report elsewhere (1).
This article also does not acknowledge the basic principle of Gillick competence and the capacity of adolescents, and that it may be entirely appropriate for "puberty blockers" to be used for people who are going through puberty, as that is their function.
This article also ignores the advantages of GnRHa. For instance, one prospective follow up study of 70 gender dysphoric adolescents in Australia found that "behavioral and emotional problems and depressive symptoms decreased, while general functioning improved significantly during puberty suppression" (2). An assessment of 55 transgender adults who had gone through puberty suppression similarly found that well-being was "similar to or better than same-age young adults from the general population" (3). Another study of 201 gender dysphoric adolescents recorded their global functioning every 6 months and found that who underwent puberty suppression and psychological support had much better psychosocial functioning than those who only had psychological support (4) - surely this is the control group this article asks for!
I am also concerned by this article framing adolescents continuing to identify as transgender as a negative outcome. If the Dutch study showed that no adolescent withdrew from puberty suppression, this to me shows that we are correctly identifying the young people who are transgender and providing them with the appropriate treatment. To suggest that this is a flaw is to position transgender status as a failure. The fact that this article is intrinsically concerned with this worries me, as it only serves to further stigmatise transgender children and adolescents.
1. Cohen, Deborah, and Hannah Barnes. “Questions Remain over Puberty-Blockers, as Review Clears Study.” BBC News, BBC, 15 Oct. 2019, https://www.bbc.co.uk/news/health-50046579.
2. De Vries, Annelou LC, et al. "Puberty suppression in adolescents with gender identity disorder: A prospective follow‐up study." The journal of sexual medicine 8.8 (2011): 2276-2283.
3. De Vries, Annelou LC, et al. "Young adult psychological outcome after puberty suppression and gender reassignment." Pediatrics 134.4 (2014): 696-704.
4. Costa, Rosalia, et al. "Psychological support, puberty suppression, and psychosocial functioning in adolescents with gender dysphoria." The journal of sexual medicine 12.11 (2015): 2206-2214.
Competing interests: No competing interests
Investigative journalism has an inherent publication bias, it is difficult if not impossible to find a published piece of investigative journalism that did not purport to find what it went looking for. Furthermore, unlike scientific research the investigative journalist does not start with a null hypothesis. It is therefore highly questionable whether a piece of investigative journalism is the appropriate way to examine an unpublished scientific study and whether a scientific journal should blur the boundaries by publishing such a piece.
Cohen and Barnes view the complicated subject of the treatment of gender dysphoria in adolescence through a well-worn narrow media lens that fails to encompass the relevant socio-political, ethical and scientific issues.
Commentators from within the community such as Paris Lees have analysed the treatment of trans people by the media and the tropes that recur. These tend to be more overt within tabloid journalism. In relation to the treatment of young trans people, parallels have been drawn with the treatment of the gay community in the 1980s where fears were repeatedly expressed of non-heteronormative contagion. The suggestion that young people can be contaminated by non-heterocisnormative identities through social contagion can be used to challenge the legitimacy of providing education, support, advocacy and treatment. This is currently evident within the current objections and protest by certain groups in relation to LGBT+ education in schools.
Concern about the media portrayal of trans people led to Lees’ work with All About Trans (formerly Trans Media Watch) which aims to engage with and inform the media (allabouttrans.org.uk).
Characteristically the rhetoric in media headlines is inflammatory compared to the actual content of an article, emphasises age, and/or other perceived vulnerability (often using sexualised language such as “groom” in the example below) and focuses on interventions rather than identities:
“I’ve seen girls who change gender groom younger ones to so the same….and in nearly every case they are autistic says school teacher” Mail on Sunday (online content) 18th November 2018.
“Up to 150 autistic children could have been given sex-change drugs on NHS despite not being transgender” The Sun (online content) 22nd July 2018.
“Fury at BBC sex change show for 6 year olds” Mail on Sunday (print edition) 30th October 2016.
In the window containing “a patient’s perspective”, Cohen and Barnes choose the headline “We’re just so young that we just trust the doctors” (emphasis on age/vulnerability and influence by professionals) rather than choosing “it feels as if someone is finally listening to you” or “they have helping you as their best interest” (emphasis on therapeutic collaboration and a patient centred approach).
A US commentator, Cristan Williams (transadvocate.com) in October 2018 published an online critique of the media reporting of Rapid Onset Gender Dysphoria (ROGD) in relation to young transgender people. One of the assertions made by the media piece on ROGD was that “many cases resolve within a couple of years”. Williams could find no evidence to support this statement, even in the research undertaken by one of the advocates of ROGD. ROGD is a concept that has been heavily criticised by the World Professional Association for Transgender Care (WPATH), the international organisation that sets the standards of care for transgender people. The suggestion of a natural lack of persistence of trans identities over time is implicit in Cohen and Barnes piece with the added implication that professionals and/or treatment may be responsible for persistence occurring.
Cohen and Barnes repeatedly refer to gonadotropin releasing hormone analogues (usually abbreviated to “GnRH analogues”) as “puberty blockers” whilst only once acknowledging that these medicines would only be used for children “in established puberty”. They focus heavily on the chronological age of the patients and cite in positive terms the previous policy of only treating those 16 and over. They do not discuss that the age at which puberty becomes established may be well below 16, nor do they state that the cut off of 16 related to capacity legislation rather than developmental stage. Physiological age and chronological age often do not correspond, particularly when considering adolescents or the elderly. This is an important concept in medicine that the authors appear to have missed.
The authors place emphasis on the hazards of treatment whilst not considering the hazards of not treating. This is just as unbalanced as the directly inverse way that experimental treatments or potential treatments for other complex childhood conditions such as cancers are treated by the media where the benefits are often exaggerated ahead of the full findings from clinical trials.
In summary Cohen and Barnes by accident or design serve to frustrate the very openness of debate they profess to seek. It is difficult when faced with this type of reporting to expect to have a reasoned impartial scientific dialogue. My fear is that this piece will only serve to inhibit further attempts to advance scientific knowledge in this area.
Competing interests: No competing interests
The BMJ has a great tradition in exposing improper activities and unearthing scandals. So we read the four page article on the puberty blockers study avidly, yet were surprised when no substantive defects in the study or its conduct were revealed. We have no connection to the trial.
The criticisms raised in the article are minor but dressed up as major: this small cohort study correctly followed its protocol, and by definition there was no control group. A randomised trial is all but impossible in these young people who are highly reluctant not to take puberty blockers. The article implies that the study put participants at risk since subsequently most go on to further interventions, but this is confusing the decision by the clinical team to give treatment versus studying how participants fared. Likewise the authors imply that the study didn't warn of possible bone side-effects, yet the young person in the "patient’s perspective" says " the only certainties are….your bones go a bit weird, hence why you may have a few bone density tests…"
The article states the drug was "off label", but in fact 50% of drugs used in paediatrics are "off label", because few are formally tested on children. Many protocols for small cohort studies don't define serious adverse events precisely, and the article concedes that "similar concerns are common to many studies of puberty blockers". Failing to submit an annual progress report to a Research Ethics Committee (REC) is common. Submission is not a regulatory requirement and this does not indicate the study was unethical.
The authors seem to prejudge the study’s results. They imply that the researcher who said the interim results were positive was misleading, yet report that all the young people wished to continue puberty blockers. Some young people reported Self Harm (SH) ideation and acts, but contrary to what is suggested, we simply do not know whether this was related to the treatment - rates of SH increase dramatically between 12 and 15 years,1 and gender dysphoric young people have particularly high rates of SH. This was not pointed out by the authors. And while 4 young people showed an increased propensity to SH over time, 3 decreased – this is in no way an example of “bad science, where we’ve given treatments that have increased suicidality in teenagers” .
This is field that arouses strong passions, with patients who are often, understandably, very dissatisfied with their lot. It is therefore important for major scholarly journals to throw light and take a measured approach. This biased article does a disservice to progress in helping young people since it is not balanced - no editorial or counter view is offered. Such diatribes can make researchers leave contentious fields, as has already happened in chronic fatigue syndrome.
1. Stallard et al. BMC Psychiatry 2013, 13:328
Competing interests: No competing interests
"The HRA appears to be reluctant to enforce its rules"
As a former GIDS clinician, I am concerned about the issues that Barnes and Cohen [1] have raised, relating to the conduct of the GIDS puberty blockers blocker study led by current RCPCH President Russell Viner of UCL. I have spoken at length with the anonymous parent whose concerns about the study the Health Research Authority (HRA) investigated. We both believe that the HRA’s findings [3] present an unbalanced account of the study and miss an opportunity to learn from ethics shortcomings.
Last year the Science and Technology Select Committee concluded that ‘the HRA appears to be reluctant to enforce its rules.’ [2] The HRA's report into the puberty blocker study [3] amply justifies that finding. As Jacqui Wise reports, [4] not only did the researchers not follow HRA rules [5] but the HRA appears not to care. The researchers first defaulted on their requirement to submit an annual review in 2012, and the HRA gave up sending them reminders in 2015. In all, they failed to supply eight such updates, in contravention of the HRA’s rules. In its report the HRA is unconcerned as it is normal for researchers to ignore its rules, which the HRA itself considers to be ineffective and onerous. Professors Scott and Ford [6] also defend the failure to submit updates, by noting that it is a common failing in the research community. Is that meant to reassure? The HRA is thinking of changing the rules, but gives no timetable and hasn't changed them on any of the at least eight occasions it has revised its rule book since 2011. If I consider the taxation system onerous and inefficient, is it OK not to pay tax? If HM Treasury shares my view of the system's faults and is considering making improvements, is it OK not to bother paying tax in the meantime? Ultimately, public confidence in research depends on researchers' adherence to ethical rules.
The HRA report also swerves the issue of conflicts of interest reporting. UCL sponsored this research study and hosted the ethics committee meeting that approved the study. It employed three on the committee, plus a fourth co-opted member who was co-authoring papers with Viner, himself a UCL employee though, prudently, he stayed away from the meeting. Although the HRA report calls it ‘a requirement’ to record potential conflicts in the minutes, none were. Yet somehow the HRA is still ‘not clear whether the potential conflict of interest [regarding the co-opted member] was declared.’ [3]
This was the second ethics committee to consider Viner's study, for an earlier REC had already rejected it. The researchers considered that the earlier REC's decision was an error, and they were unwilling to amend their application to take account of the REC's objections. However, in this situation, the HRA's rules at that time unambiguously called for researchers to appeal to a fresh REC that is centrally-appointed, though they were told by the first REC that they could re-submit to them or to another REC 'within this domain'. Accordingly, what the researchers did was go directly to the UCL-based committee, because they felt it 'would better understand the issues’ [7] and ask it to overturn the first REC's decision. The HRA's justification of this is logically inconsistent, and it even suggests that the first REC 'extended beyond its remit in questioning the scientific design’ [3] of the application even though the HRA's own advice for RECs lists 'Social or scientific value; scientific design and conduct of the study’ [8] at the top of the things that RECs must always consider. Ultimately, if the researchers disagreed with the first REC they ought to have followed the HRA's rules and taken their chances with an appeal. But instead they went to another committee where they thought they would get the result they were seeking. The HRA did nothing to enforce its rules either then or since, so it is hardly surprising that the researchers behaved as they did.
The issue of oversight is a difficult one for the medical community, which prizes its freedoms; and the HRA may think it has done its job well, in giving itself and the researchers a clean bill of health. Yet beyond the laboratory and the clinic, society's expectations of accountability are growing. The public sector is strewn with regulators who failed to grasp that they serve the public not the profession. The latest is the Financial Reporting Council, until very recently the regulator of auditors and accountants and setting the UK’s corporate governance standards. ‘Chronically passive’ [9] and compromised by links with those it oversaw, the entire organisation has been scrapped, and in its place is a new body designed to be ‘respected by those who depend on its work, and where necessary feared by those whom it regulates.’ [10] Food for thought, one hopes, for the new HRA chair, past RCPCH President Sir Terence Stephenson of UCL.
The most important issues were not considered in the HRA's report: the safety and efficacy of the puberty blocker, and how this life-changing experimental treatment was adopted generally within NHS England. The researchers sometimes explain that the introduction of the puberty blocker was such a modest development that ethical review was merely their voluntary choice, and at other times they remind us that it was a decision of such extraordinary delicacy that it was preceded by ‘nearly a decade of consultation with international experts.’ [3, 4] Clearly, there is a gap in supervision here, and in fairness the report does conclude with a call for NHS England to ‘provide guidance to NHS organisations on appropriate and transparent oversight and governance of innovative practice undertaken outside research.’ [3] If it does not heed that advice, the NHS may instead be forced to listen to the High Court in London, where the mother of a GIDS patient is currently seeking to prevent her daughter being ‘subjected to an experimental treatment path that is not adequately regulated.’ [11] My own concerns have led me to join her in that action.
[1] https://doi.org/10.1136/bmj.l5647
[2] https://publications.parliament.uk/pa/cm201719/cmselect/cmsctech/1480/14...
[3] https://www.hra.nhs.uk/about-us/governance/feedback-raising-concerns/inv...
[4] https://doi.org/10.1136/bmj.l6034
[5] https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/res...
[6] https://www.bmj.com/content/366/bmj.l5647/rapid-responses
[7] Trust FOI 19-20011 at https://tavistockandportman.nhs.uk/about-us/contact-us/freedom-of-inform...
[8] https://www.hra.nhs.uk/documents/273/consistency-rec-review-2-may-2014.pdf
[9] https://publications.parliament.uk/pa/cm201719/cmselect/cmworpen/769/769...
[10] https://assets.publishing.service.gov.uk/government/uploads/system/uploa...
[11] https://www.crowdjustice.com/case/protect-children/
https://assets.publishing.service.gov.uk/government/uploads/system/uploa...
Competing interests: No competing interests