Blockers blocked

Wes Streeting's strictures; French trans activist triumph; Dr Olson-Kennedy sued for negligence; Kiwi ministers were warned; still waiting for Oz data; clinical trials and tribulations in the UK

Photo by Sue Hughes on Unsplash

GCN in brief

Medical scandal

United Kingdom | The UK Labour government has put an indefinite ban on any new routine prescribing of puberty blockers for gender-distressed young people.¹ On Wednesday, Health Secretary Wes Streeting, who had twice extended the emergency ban imposed by the former Conservative administration, said it was “a scandal that [puberty blocking] medicine was given to vulnerable young children without the proof that it is safe or effective or [without going] through the rigorous safeguards of a clinical trial.”

He said the ban would “restrict the sale or supply of puberty blockers to under-18s through a prescription issued by either a private UK prescriber or a prescriber registered outside the UK.” The ban is to be reviewed in 2027. (In March this year, England’s National Health Service announced an end to routine use of puberty blockers in the public system, apart from a possible clinical trial.)

Helen Joyce of the group Sex Matters welcomed Mr Streeting’s decision, and said: “It marks another step towards puberty blockers being relegated to a shameful chapter of history, in which parents and health professionals were emotionally blackmailed into harming children in the name of ‘progress’.”

Also on Twitter, Georgia Meadows, national trans officer for LGBT+Labour, said: “I cannot hope to describe the depth of depression this policy will cause. People will consider suicide, I already am. Many will attempt it.”²

Yesterday, Baroness Hilary Cass, who led the world’s most comprehensive review of care for gender-distressed youth, said those criticising the ban as “discrimination” misunderstood medical evidence. “What is worrying is when people say that if children don’t get these drugs, they will die, because clearly that’s not true,” she told The Times. She said it was “irresponsible for people to shroud-wave in that way.”

In the House of Commons, Mr Streeting cited advice from the Commission on Human Medicines that the supply of public blockers would represent “an unacceptable safety risk” at the moment. He said the commission had “found that children had received prescriptions after filling out online questionnaires and having one brief zoom call with prescribers from outside the UK.”

Earlier this month, the online clinic GenderGP, founded by British physician Dr Helen Webberley, was warned to stop the unlicensed provision of outpatient medical services to people in Singapore, where the business is based.

Video: Health Secretary Streeting addresses the UK House of Commons on puberty blockers

Experts in activism

France | In a draft good practice guideline, the French National Authority for Health (La Haute Autorité de Santé, HAS) has proposed that minors from the age of 16 be given the same swift access to fully subsidised gender medicine as adults, according to the newspaper Figaro.

“This includes surgical procedures, particularly thoracic surgery [mastectomy],” the newspaper reported. “Only genital surgery (which is not currently performed in France before the age of 18) is subject to a slight reservation, with the HAS recommending that healthcare professionals should not decide on their own to operate on a minor, but should take this decision during a multidisciplinary consultation meeting. Except that this meeting should also include—representatives of transgender associations.”

Figaro, which noted that the draft recommendations ran counter to the more cautious approach in some other European countries, said parents resisting gender medicalisation could lose authority over their children. The draft guideline states that “the absence of parental support can worsen mental health and endanger the person concerned.”

In such a case, the newspaper said, the proposal is that “mediation be set up with the parents to encourage them to accept their minor child’s decisions; but if the parents persist in refusing their child’s request, the HAS recommends “a report that may go as far as partial delegation of parental authority” or even “withdrawal of parental authority or emancipation.”

Figaro reported that the recommendations of the draft guideline “coincide in almost every respect with the demands made by the trans activist associations” and that the HAS expert panel responsible “includes almost exclusively activists from trans activist associations, healthcare professionals who have publicly supported the demands of these associations, and even trans people themselves.” The draft is under review and final recommendations are expected to be published “in the coming weeks,” Figaro said.

Watchdog group The Little Mermaid said the HAS expert panel had disregarded the principle “First, do no harm.”

“We urge the Ministry of Health to intervene as a matter of urgency if it does not want to become an accomplice to the medical, scientific and legal scandal that will occur in France, as in several other countries,” the group said.

In 2022, the French National Academy of Medicine warned physicians of the epidemic-like rise in minors seeking hormonal drug treatments, the risk of over-diagnosis and the possible role of social media immersion. “Great medical caution must be taken in children and adolescents, given the vulnerability, particularly psychological, of this population,” the academy said.

First stop, transition

America | Dr Johanna Olson-Kennedy, the brash director of the gender clinic at Children’s Hospital Los Angeles, faces a medical negligence lawsuit brought by former patient Clementine Breen. Now 20 years old, Ms Breen had puberty blockers at 12, testosterone at 13 and a double mastectomy at 14, according to The Economist magazine. Ms Breen said she had told a school counsellor when she turned 12 that she felt depressed, thought she might be trans or bisexual, but was generally unsure about her identity.

Looking back, “she believes that her unsettled feelings about going through puberty stemmed from a violent situation at home involving her older brother, who has severe autism, as well as sexual abuse she experienced at the hands of someone outside the family when she was six years old, which she did not disclose to anyone until much later,” The Economist reported.

Her first appointment at Dr Olson-Kennedy’s clinic was in December 2016. “Dr Olson-Kennedy’s notes from that first visit show that she immediately set Ms Breen down a path towards medical transition,” The Economist said. Ms Breen, who is unsure if testosterone has taken away her fertility and regrets her lost ability to breastfeed, said she had decided to take legal action partly out of frustration when hearing the familiar claim by trans rights activists that rushed medical transition of minors is rare. The Children’s Hospital Los Angeles said it could not comment on pending litigation.

Dr Olson-Kennedy is one of America’s most high-profile gender clinicians and also helped shape the “anti-gatekeeping” treatment guidelines that have made Planned Parenthood the biggest provider of cross-sex hormones to young adults in the country.

Video: Detransitioner Clementine Bree tells her story

Data, later

America | As leader of a $10 million multi-clinic research project into paediatric transition, Dr Olson-Kennedy is to come under scrutiny by US senators following an October report in The New York Times that she had withheld data showing no improvement in patients with puberty blockers because she feared this could be “weaponised” and used in litigation by opponents of “gender-affirming care.”³ Earlier this month, six Republican senators announced an inquiry into this research project in a letter to the National Institutes of Health, which is the funding source.

The letter accuses Dr Olson-Kennedy of suppressing the data because the outcomes likely “do not support her political agenda.” Minors were recruited to the study in 2016-18. The letter also notes the finding of England’s Cass review that the evidence for benefit with puberty blockers is weak, The Hill reported.

They were warned

New Zealand | In May, one month after the release of the final report from the Cass review, New Zealand’s Health Minister Dr Shane Reti and Mental Health Minister Matt Doocey⁴ were urged by a group of 34 doctors to immediately suspend the use of puberty blockers and cross-sex hormones with “gender-confused” minors, according to documents released under the Official Information Act.⁵

“We are deeply concerned about the ongoing use of off-label medications given to our children to deter the natural process of puberty, without a proper understanding of the long-term physical, psychosexual and cognitive consequences,” said the emailed letter to the ministers signed by 34 doctors including senior paediatricians.

“The response in New Zealand from the supposed experts in the area of gender medicine was to assess the Cass review as harmful and irrelevant to New Zealand. This happened within less than a day and a half of its publication.”

The letter protested that the NZ gender-affirming lobby, the Professional Association for Transgender Health Aotearoa (PATHA), had “published many still uncorrected misrepresentations about the review, including that it disregarded most of the available research.” The doctors, whose names have been redacted, noted PATHA’s “privileged relationship” with the government department Health NZ.

On April 11, an email to Dr Reti from a lone physician, whose name was redacted, deplored the “truly shocking response to Cass from PATHA, the group that advises [government] regarding transgender health in NZ.”

PATHA had dismissed the Cass review as “out of step with high-quality care provided” in NZ, where published data suggests puberty blocker use per-capita is higher than it was in England. PATHA also protested that the review did not involve “trans or non-binary experts,” but had relied on unnamed people who had “promoted non-affirming ‘gender exploratory therapy’, which is considered a conversion practice.”

In the email to Dr Reti, the physician said: “This [kind of response] is what happens when ideology infiltrates medicine. Absolute inability to think critically or accept responsibility. Full of denial and diversion. This group should have nothing to do with healthcare of young, vulnerable people. If doctors can’t accept criticism and change practice when evidence (or lack of evidence) is shown to them, that should be a matter for the [regulatory] Medical Council. First, do no harm.”

Last month, the NZ Ministry of Health published its evidence brief acknowledging the scarcity and poor quality of evidence for puberty blockers. These drugs remain available as routine treatment, although there is a suggestion the government may impose tighter regulation next year. Meanwhile, the ministry has issued a new position statement that appears to endorse the contentious gender-affirming treatment model. Health NZ has a 2023 contract with PATHA to update that lobby’s 2018 gender-affirming treatment guideline, which was rated 12/100 for the rigour of its development during an evaluation of international treatment guidelines commissioned as part of the Cass review.

Research tactics

Australia | Researchers are analysing data from the Trans20 study of patients at the gender clinic of the Royal Children’s Hospital (RCH) Melbourne and “are looking forward to publishing” their findings, according to the clinic’s head of research, Dr Ken Pang. Recruitment of patients at the clinic began in early 2017, and two years later, Dr Pang and colleagues declared “an urgent need for more evidence to ensure optimal medical and psychosocial interventions.”

The London-based Tavistock clinic delayed for several years the release of unpromising data from its trial of early puberty blocking.

Following the accusation that Dr Olson-Kennedy was withholding discouraging data for political reasons, 31 Australian doctors including one of the country’s most distinguished medical scientists—Dr T John Martin, emeritus professor of medicine at the University of Melbourne—signed an open letter calling on RCH Melbourne and its research partner, the Murdoch Children’s Research Institute, to publish interim results from the Trans20 project and make the data available to other researchers. “With four to seven years of data now collected, we believe it’s time for the Royal Children’s Hospital to publish their preliminary outcome findings,” the open letter says.

Earlier this month, in response to GCN’s application under freedom of information law for de-identified outcome data from Trans20, a senior legal counsel at RCH Melbourne said: “[Unfortunately,] the information you have requested cannot be readily extracted from the medical records of individual patients by use of a computer or other equipment that is ordinarily available to the RCH for retrieving or collating stored information.”

A recent journal article, with Dr Pang among the authors, suggests that puberty blockers and cross-sex hormones should not be judged primarily on whether or not they improve mental health. The authors said—

“For puberty blockers, the intended benefit is to prevent a misalignment of physical appearance with the young person’s gender identity and provide additional time for the young person to reflect upon and explore their gender identity without experiencing the distress of their body changing.”

“For gender-affirming hormones [testosterone or oestrogen,] the intended benefit is best understood as achieving greater appearance congruence,⁶ namely, to create better alignment of a young person’s physical appearance with their gender identity.”

The 2019 RCH Melbourne protocol paper describing the purpose of the Trans20 research study of puberty blockers and cross-sex hormones mentions the term “mental health” 20 times.

The $10m-NIH multi-clinic study led by Dr Johanna Olson-Kennedy in the US produced a 2023 paper in the New England Journal of Medicine (NEJM) reporting “psychosocial functioning” two years after patients aged 12-20 were given cross-sex hormones. “Hormone therapy improves mental health for transgender youths, a new study finds,” was the NBC News headline.⁷

Journalist Jesse Singal checked the 2021 protocol setting out the plan for the research. Of the eight key variables highlighted in the protocol—gender dysphoria, depression, anxiety, trauma symptoms, self-injury, suicidality, body esteem, and quality of life—only depression and anxiety were reported in the 2023 outcome paper. The study hypothesis had changed too. For example, Singal noted, in their outcome paper, “the researchers appear to be much more interested in the concept of ‘appearance congruence’⁸ than they were previously.”

Why the changes? Mr Singal wrote: “Overall, if I had to guess, I think the most likely explanation here is that the researchers did a lot of ‘exploratory analysis’ until they found reasonably impressive-seeming results, and then chose to refocus their efforts—and to rejigger their hypothesis—around those results, tossing some disappointing results in a file drawer.”

When RCH Melbourne publishes outcomes from its Trans20 study, it will be interesting to check the reported results against the research plan documented in the 2019 protocol.⁹

Meanwhile, the gender clinic recently qualified its previous confident claim that puberty blockers are “reversible.” The website for the RCH Melbourne clinic now says blockers are “largely reversible.” As recently as November, the assertion was that blockers were “reversible,” without any hedging. There were similar unannounced and unexplained retractions of over-confident online claims about puberty blockers by England’s National Health Service in 2020 and New Zealand’s Health Ministry in 2022.

Split verdict

United Kingdom | There is sharp disagreement about whether or not a post-Cass clinical trial of puberty blockers—scheduled to start recruiting participants next year—can be ethical and conclusive. In the House of Commons, Health Secretary Streeting said the trial would be a world first, elucidating “the effects of puberty suppressing hormones in young people, providing the robust evidence required.” His department has said any trial “will be subject to rigorous ethical oversight.”

However, the group Genspect UK, which is critical of the medicalised gender-affirming treatment model, has written to Mr Streeting advising him that essential safeguards are missing from the projected trial. Genspect’s open letter said—

“We believe the study faces significant practical and ethical challenges, particularly if it aims to be compliant with, and build on, the findings of the Cass review.

“The [National Health Service, NHS] have brought forward a risky puberty blocker study at speed when the evidence suggests that psychological interventions are the safest and most promising avenue for future research.

“To date, the NHS has not announced a complementary study into psychological interventions. Further, the NHS is proceeding with a puberty blocker study without awaiting the results of the Cass-recommended data linkage study, which may yet demonstrate adverse long-term outcomes from puberty blockade and mitigate against any further study.”

However, in a BBC news report, journalist Deborah Cohen quoted Professor Gordon Guyatt, a pioneer of evidence-based medicine, as arguing that randomised trials are undertaken in “life-threatening stuff all the time” where the long-term effects of treatment are uncertain. In Professor Guyatt’s view, it would “unethical” not to run a trial of blockers.

“With only low-quality evidence, people’s philosophies, their attitudes or their politics, will continue to dominate the discussion,” he said. “If we do not generate better evidence, the destructive, polarised debate will continue.” Genspect said. Ms Cohen’s reporting of trial designs under consideration only deepened its concerns.

GCN has sought comment from PATHA and RCH Melbourne

1. The National Health Service says: “If a young person has already taken these [puberty blocker] medicines or has been prescribed these medicines in the six months prior to 3 June 2024 in Great Britain (and 27 August in Northern Ireland), they can continue to do so, providing their prescription is now issued by a UK registered prescriber.”

2. Professor Louis Appleby, a British authority on suicide prevention, has debunked the “blockers or suicide” narrative and condemned irresponsible talk about gender-related suicide.

3. Dr Olson-Kennedy has claimed that The New York Times misrepresented what she said.

4. Mr Doocey has a background in mental health and once worked at the London-based Tavistock clinic, which before the rise of gender medicine had a reputation for therapy in the psychoanalytic tradition.

5. Thanks to Bob McCoskrie of Family First NZ for these documents.

6. My emphasis.

7. The study was hailed as a success in the media despite recording two suicides in a group of 315 young people. This seems a high rate of suicide, especially so because the protocol dictated that anyone with severe psychiatric problems, including suicidality, was not eligible for the study.

8. My emphasis.

9. GCN is not suggesting any impropriety in the management of the Trans20 study, only that clinicians and researchers believe publication of outcome data is overdue.