Blocked and promoted
Spanish talks; irregular regulation in the US; woke doctors against Cass; that pseudo-Yale report; anti-conversion export; judging GenderGP; smarter in Europe; Japan's sperm bank; gender capitalism
GCN in brief
Risky, but necessary
America | The US regulatory Food and Drug Administration (FDA) found โan increased risk of depression and suicidality, as well as seizure riskโ after running a safety review of puberty blockers known as GnRH agonists, according to an internal email from January 2022 recently released in court proceedings. Most of the โadverse eventโ notifications under review involved cases of central precocious (or premature) puberty, a condition for which these hormone suppression drugs are approved. However, the review also took in โa handfulโ of gender medicine cases, where these drugs are used off-label to block the normally timed puberty of children who identify as transgender or non-binary.
Despite the results of the safety review, the FDAโs clinical team leader in general endocrinology, Dr Shannon Sullivan, argued that โa patient listening sessionโ with โtrans kids and separately with trans adultsโ showed there was โdefinitely a need for these [GnRH agonist] drugs to be approved for gender transition, as they are typically not covered by insurance and are expensive out of pocket.โ However, in her 2022 email, Dr Sullivan said no drug supplier had yet approached the FDA seeking approval for puberty blockers to be used in children with gender dysphoria, a regulatory process that would draw attention to the weak evidence base and lack of long-term safety data for this usage. The Sullivan email came to light after the conservative group America First Legal took the FDA to court over access to internal documents about blockers.
Screenshot: Two women from the Spanish parent group AMANDA petitioned Equality Minister Ana Redondo (at centre) for a thorough study of gender dysphoria spread online and through peer groups
Cass in castellano
Spain | The Spanish parentsโ group AMANDA has secured a meeting with the countryโs Equality Minister, Ana Redondo, and came away with a commitment that the minister and her team would โstudy in depthโ the phenomenon of rapid-onset gender dysphoria (ROGD). The group presented a copy of Englandโs Cass report to Ms Redondo, whose centre-left government pushed through a Queer theory-style national Trans Law and opposed a cautious reform in the Community of Madrid intended to strengthen safeguards around paediatric gender transition.
After the long-awaited July 29 meeting, AMANDA said: โWe have asked for an independent, scientific and exhaustive study to be carried out, such as the Cass report, on the increase in cases of gender incongruence, by sex and age, the health care and educational protocols in the different autonomous communities [of Spain], and we hope that this will be the first step towards the development of regulations and compulsory guidelines at national level, adjusted to the highest quality scientific evidence.โ
According to the newspaper ABC, AMANDA presented the minister with data profiling the young people caught up in socially-driven ROGD as โadolescent (eight out of ten cases), between 11 and 17 years of age, and with special social vulnerability and difficulties in relationships with peers, either due to their personal characteristics (autism, high abilities, previous mental health pathology) or traumatic background (sexual abuse, gender violence in their family context or bullying at school).โ ABC noted that the minister had not committed herself to any action beyond looking at the concerns put to her. In the first year since Spainโs Trans Law was passed, more than 5,100 people changed their registered sex.
Casstigated
United Kingdom | The British Medical Association (BMA), which represents doctors, says it will carry out an evaluation of the Cass report, and argues that pending its outcome in January 2025, restrictions on puberty blockers for minors should be lifted. The July 31 media statement follows some weeks of speculation about trans-affirmative discontent with Cass among some members of the BMA council. A motion recently passed by the council calls on the BMA to, โPublicly critique the Cass reviewโ and to lobby the UK government and National Health Service โto ensure continuity in provision of transgender healthcare for patients younger than 18 years old.โ
There came a swift, but polite rebuke from the Academy of Medical Royal Colleges, which represents 24 colleges and faculties in the UK and Ireland. Noting that โsome members of the medical profession are questioningโ the Cass review, the academy says that โfurther speculative work risks greater polarisation on this matter which is not helpful and our focus should be on implementing the recommendations of the Cass review by providing the most appropriate treatment for children and young people with gender dysphoria or gender related distress.โ
The BMAโs media statement cites concerns about โweaknesses in the methodologies used in the [Cass] review and problems arising from the implementation of some of the recommendations.โ It cites a 39-page document issued on July 1 by prominent clinician-advocates for the gender-affirming treatment approach, including paediatrician Meredithe McNamara of Yale University, gender clinician Johanna Olson-Kennedy, psychiatrist Jack Turban and researcher Ken Pang. A key complaint of the documentโmisleadingly promoted as the โYale reportโ when in fact it has no such university imprimaturโis that, โThe systematic reviews relied upon by the Cass Review have serious methodological flaws, including the omission of key findings in the extant body of literature.โ
In concluding that the evidence-base for the use of puberty blockers and cross-sex hormones with gender-distressed minors is weak and uncertain, the two relevant systematic reviews commissioned by the Cass review note that their findings are consistent with those of previous, independently undertaken systematic reviewsโincluding the very first such review in this hot-button field.
Prefiguring the 2024 Cass findings, this pioneering 2018 review concluded: โLow-quality evidence suggests that hormonal treatments for transgender adolescents can achieve their intended physical effects, but evidence regarding their psychosocial and cognitive impact [is] generally lacking.โ Among the authors of this 2018 review published in Pediatrics is the same Dr Pang who has put his name to the 2024 โYale reportโ that supposedly demolishes the systematic reviews of Cass. No mention of this awkward 2018 review appears in the Yale-adjacent document.
The โYale report,โ which is not a peer-reviewed paper, has a polemical tone and is peppered with words of special pleading or emotive charge such as โnuancedโ (seven occurrences, suggesting the field of gender medicine is bristling with good quality evidence, if one only squints), โdeeplyโ (7), โdebunkedโ (3) and โpseudoscientificโ (2). At one point, the authors of the document rebuke the Cass review for having โsolicited invalid professional viewpoints.โ In one Cass focus group, it seems, 32 per cent of health workers agreed with the taboo statement, โThere is no such thing as a trans child.โ The pseudo-Yale report says: โA guideline that solicits opinions from those who will not acknowledge the condition for which care is sought should not be used.โ Are these critics of Cass really suggesting that trans identity is a condition in need of treatment?
Conversion contagion
Ireland | The controversy attending the UK Memorandum of Understanding on Conversion Therapyโseen as influenced by trans-affirmative activists and hazardous for ethical, exploratory therapyโis being exported to Ireland. Peter Jenkins, of Thoughtful Therapists, notes that the UK policy has been adopted by the College of Psychiatrists of Ireland, the Psychological Society of Ireland, and the Irish Association for Counselling and Psychotherapy. โA fierce row is brewing over the all-Ireland adoptionโ of the UK policy, Mr Jenkins says.
Non-affirming
United Kingdom | A legal challenge to the UKโs emergency ban on puberty blockers has failed. In the High Court, lawyers for a trans health service and the mother of a 15-year-old boy who identifies as a girl attacked the lawfulness of a legislative ban imposed by the outgoing Conservative Secretary for Health, Victoria Atkins, and taking effect on June 3. The complainants argued that the minister did not undertake the right consultation and that the Cass report did not amount to a charter for prohibition.
However, in her July 29 ruling Mrs Justice Lang held that the Atkins decision survived judicial review. She said the minister was โentitled to conclude that the Cass review was the best and most up-to-date scientific evidence available, and further research on the effects and safety of puberty blockers for children and young people was not required.โ The judge highlighted cross-party support for Ms Atkinsโ approach from her shadow, Labourโs Wes Streeting, who is now the portfolio minister; Mr Streeting defended the ban in this High Court case.
In her reasons Mrs Justice Lang also noted Health Department anxiety about the rogue online clinic GenderGP and its dismissal of the Cass report as an obstacle to the provision of puberty blockers. A health official gave evidence recounting the concern of the National Pharmacy Association โabout a sample prescription issued by GenderGP where the electronic signature was simply a QR Code linking to a statement saying โthis confirms that the prescription QR Code scanned today on [date] is authenticโ. It gave no further details about the prescription. The statement occurred each time the QR Code was scanned and so could be accessed from multiple pharmacy sites.โ
Mrs Justice Lang said the Health Department believed that, โGenderGP uses a prescriber who is a Spanish national who is registered in Romania. GenderGP provides prescriptions for puberty blockers to patients in the UK.โ (GenderGP claims to follow the โAustralian standards of careโ treatment guideline issued in 2018 by the gender clinic of the Royal Childrenโs Hospital Melbourne.)
Mrs Justice Lang highlighted an interview in The Times with GenderGP co-founder Helen Webberley confirming that โthe company now uses AI algorithms in place of the healthcare advisers who had previously been employed, stating it is โrun like self-service nowโ with no phone or email service. [Ms Webberley] claimed that GenderGP had facilitated treatment for thousands of children, from different countries. She also claimed that since the UK Governmentโs ban on [European Economic Area] prescriptions, parents were travelling abroad to get puberty blockers for their children.โ And the judge noted that Ms Webberley had rejected expert evidence in a separate UK court case that GenderGP had prescribed a potentially lethal dose of testosterone to a 15-year-old girl with autism who identified as a boy.
Video: The risk to children of gender medicalisation varies by jurisdiction
Europeโs attraction
International | A survey of gender medicine rules in North America and Europe has compared the ease of access to puberty blockers, cross-sex hormones and transgender surgery for minors. โIn Canada and the US, patients are eligible for invasive surgeries and/or potentially irreversible and medically harmful dispensation of puberty blockers and cross-sex hormones at a much younger age than is the case in Europe,โ says a report of the survey findings from the Aristotle Foundation for Public Policy and the medical watchdog group Do No Harm.
โGiven the growing body of evidence and the emerging European consensus [turning away from gender medicalisation], which is grounded in medical science and common sense, Canada and the US should protect our youngest and most vulnerable patients by reconsidering the gender-affirming model of care.โ
Custody win
America | A California father, Harrison Tinsley, has won full custody of his four-year-old son, Sawyer, following court proceedings in which it was said that the mother wanted to raise the child as โnon-binary,โ The Daily Signal reports. The boyโs paediatrician gave evidence favouring the motherโs approach. Journalist Virginia Allenโs podcast interview with Mr Tinsley is here.
Japan | Japanโs first fertility preservation clinic for transgender-identifying people has opened as a result of a Supreme Court ruling in June that recognised a trans-identifying male as the father of a child who was conceived with his sperm frozen before medical transition. โSo far, eight individuals ranging from their teens to their 30s have preserved their sperm at the centre,โ The Asahi Shimbun reports. โTeenagers and people in their 20s may not think about whether they want to have a family in the future, but I recommend that they come here to learn that they can keep their options open,โ said a staffer at the new clinic. Gender medicalisation of minors carries the risk of permanent infertility.
Trans currency
America | Online gender clinic Plume, which describes itself as โthe first health technology company fully dedicated to the trans community,โ has raised $US38 million in venture capital since its 2019 launch, the magazine Slate reports. โThough TERFs, right-wingers, and liberals who are โjust asking questionsโ might argue that gender-affirming care is too easily accessible, especially for trans youth, trans telehealth has clued venture capitalists in to the fact that obstacles do indeed abound, and that these barriers represent an enormous opportunity for profit.โ
It has only taken all the years from 2017 to have the documented email evidence revealing the FDA in the U.S. was then ( and presumably remains) ideologically captured from within , when the senior endocrinologist within the statutory bodyโs policy determinations can advise support for puberty blockers in minors, after being informed by an empathetic โ listening โ by others. To not be wanting to pursue official blessing from the current โ off labelโ status of the use of GnR agonists might be in the knowledge that there would be predictable difficulties in obtaining evidence for benefit, over potential harm. Our own TGA is likely, for the same reasons, to not be approached by the activists to obtain approval for use by the same gender affirming clinicians. Best not to test the regulatory bodies in both countries! . Bernard , I remain curious about any role which might have been played in the NHS Englandโs challenge and closure of Tavistock. I donโt recall any such discussion during the recent NAPP hosted webinar with Hillary Cass. We know our AHPRA is but an agency of government and only able to respond to complaints ( rather than act as an independent investigatory body) , perhaps a more proactive response might be expected from our TGA? Just a , likely naive, thought ?
Just yesterday (8/2/24; https://www.city-journal.org/article/the-deposition-of-meredithe-mcnamara) Leon Sapir wrote of "Yale report" co-author Dr. Meredith McNamara: "The transcript of that deposition [in the case brought against an Alabama age-restriction law] reveals that McNamaraโs many public and under-oath statements about her clinical experience are fundamentally misleading, if not outright falseโand even perjurious."