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GENDER DYSPHORIA
Gender dysphoria: scientific oversight falling between
responsible institutions should worry us all
Richard Byng professor in primary care research and general practitioner 1, Susan Bewley emeritus
professor of obstetrics and women’s health 2
1Community and Primary Care Research Group, University of Plymouth, Plymouth Science Park, Plymouth PL6 8BX, UK; 2King’s College London,
London, UK
The troubles around the Gender Identity Development Service’s
study1 2 seem to be symptomatic of our wider collective failure
to determine whether, and when, we should prescribe puberty
blockers, or cross sex hormones, to children and young people
identifying as transgender.
The ethics of research conduct belongs to the Health Research
Authority (HRA), and the quality of science is an important
consideration when determining ethics. Some procedural issues
might not be serious, but the HRA did not try to determine if
its first research ethics committee (which advocated the need
for a trial) was right, and yet defended a resubmission without
tackling the first committee’s concerns.3 Effectively, the HRA
absolved itself from responsibility for judging the science in
deliberations about ethics, leaving it wholly to the academic
institution (as investigator and sponsor).
Although many paediatricians prescribe off-label drugs,4 halting
natural puberty in gender dysphoria could have far reaching
consequences, so a stringent research design is required. By
gaining permission to study individuals without controls or
piloting procedures for a (no doubt complex) randomised trial,
an opportunity to determine harms and benefits was missed.
The changing and growing demographic—mainly natal females
with high rates of trauma—make the need for proper studies
more urgent.
Instead, we have now moved from a small, uncontrolled study
with unpromising, unpublished results to the scaled up
commissioning by NHS England of interventions that are of
unproven benefit.5 The new study funded by the National
Institute for Health Research is again designed only to observe,
not test, effects.6 This illuminates the greater issue of how
commissioners, service providers, and research institutions have
failed this vulnerable group of people who deserve equitable
standards of research. The UK has the potential to create the
best service for young people questioning their gender. To do
so, key institutions will need to embrace equipoise and work
together effectively.
Competing interests: None declared.
Full response at: https://www.bmj.com/content/366/bmj.l5647/rr-7.
1 Cohen D, Barnes H. Gender dysphoria in children: puberty blockers study draws further
criticism. BMJ 2019;366:l5647. 10.1136/bmj.l5647 31540909
2 Gender Identity Development Service. An evaluation of early pubertal suppression in a
carefully selected group of adolescents with “gender identity disorder.” https://gids.nhs.
uk/our-early-intervention-study
3 Health Research Authority. Investigation into the study “Early pubertal suppression in a
carefully selected group of adolescents with gender identity disorders.” https://www.hra.
nhs.uk/about-us/governance/feedback-raising-concerns/investigation-study-early-pubertal-
suppression-carefully-selected-group-adolescents-gender-identity-disorders/
4 Scott S, Ford T. Puberty blockers study: much ado about nothing? [electronic response
to Cohen D, Barnes H. Gender dysphoria in children: puberty blockers study draws further
criticism]. BMJ 2019. https://www.bmj.com/content/366/bmj.l5647/rr-1
5 Heneghan C, Jefferson T. Gender-affirming hormone in children and adolescents. BMJ
Evidence Based Medicine Spotlight 2019. https://blogs.bmj.com/bmjebmspotlight/2019/
02/25/gender-affirming-hormone-in-children-and-adolescents-evidence-review/
6 Kennedy E. Longitudinal outcomes of gender identity in children. ISRCTN registry. http:/
/www.isrctn.com/ISRCTN98564473
Published by the BMJ Publishing Group Limited. For permission to use (where not already
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richard.byng@plymouth.ac.uk
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BMJ 2019;367:l6439 doi: 10.1136/bmj.l6439 (Published 4 December 2019) Page 1 of 1
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