UK Launches Puberty Blocker Trial on 226 Children After Ban Over Safety Concerns

A controversial trial of puberty blockers (PBs) in children under 16 years old is moving forward in the United Kingdom after getting approval, despite concerns that it cannot be conducted ethically. Researchers will recruit 226 children for two groups, and the study is expected to begin in January. One group will receive PBs at the beginning of the trial. The second group will start receiving the drugs after 12 months. Children will be evaluated at 12 months and 24 months against a control group of 300 children who have a diagnosis of gender incongruence but will not be taking PBs.

Researchers will evaluate the children’s quality of life, emotional well-being, and cognitive, physical, and social development. Children must have a diagnosis of gender incongruence, be under 16 years of age, and have started puberty. There is no minimum age for participants as long as they have begun puberty. The American Academy of Pediatrics (AAP) estimates that puberty for girls begins between the ages of 8 and 13, while boys are a little bit later, but starting as early as 9 years old.

The UK currently has banned PBs for minors after the results of the Cass Report, which found there is no long-term evidence to support the use of PBs and cross-sex hormones (CSH) in children with gender dysphoria or gender incongruence. Author Hilary Cass suggested at the time that children should not be given these treatments unless they are part of a clinical trial. She said she is pleased the trial is proceeding to learn more about the potential harms and benefits of this treatment.

Last week, the Department of Health and Human Services (HHS) released a 400+ page peer-reviewed report about gender affirming care treatments, including the use of PBs for children. The report said there is a high certainty of evidence that PBs “exert physiological effects (such as sex hormone suppression) and often cause infertility when followed by CSH, depending on the patient’s pubertal stage and sex.” Low-certainty evidence also suggests that PBs may compromise bone health.

WPATH has said PBs are “fully reversible,” a claim that the HHS report said is “largely untested.” The authors of the HHS report also say there is little data available on outcomes of children who use PBs but do not proceed to CSH. The report also says there is an absence of long-term high certainty evidence on critical outcomes, including suicides, fractures, fertility, growth, and neurocognitive development.

Dr. Aidan Kelly, a London-based clinical psychologist who specializes in gender services, said the results of the study will likely not provide a “conclusive answer” to the benefits of puberty blockers. Kelly said the treatment is not meant to be a “stand-alone intervention” and the real benefits of the treatment only come after the patient utilizes CSH to “bring them into alignment with their gender identity.” Dr. Kelly is a former staffer of the Tavistock clinic that shut down after an independent review by Dr. Cass found that the clinic was putting young patients at “considerable risk” of poor mental health and distress.

Dr. Kelly is also a member of WPATH, which caved to the Biden Administration pressure to remove age minimums despite concerns about “sloppy” assessments and “opportunism by inexperienced and sometimes dangerous providers.”

Dr. Johanna Olson-Kennedy is an American physician who specializes in gender affirming care treatments for children and was also the leading author on a puberty blocker study that showed no change in patient well-being after two years on puberty blockers. The study, notably, had 31 out of 94 patients who initiated CSH, referred to as Gender Affirming Hormone Treatments (GAHT) in the paper. Dr. Olson-Kennedy initially refused to release the study that was funded by US taxpayers to the tune of $9.7 million out of fear that the results would be weaponized.

Dr. Olson-Kennedy was also the defendant in a lawsuit alleging she misdiagnosed a 12-year-old girl as having gender dysphoria rather than the more likely explanation of unresolved trauma from sexual abuse that resulted in depression, anxiety, and PTSD. The lawsuit has since been dismissed due to the California statute of limitations. The girl received a double mastectomy at 14 years old, allegedly under pressure from the doctor, without being told about the potential long-term effects. The lawyers allege Dr. Olson-Kennedy failed to obtain informed consent.

The recent HHS report, an update to an earlier version released in May, has been criticized for being ideological and having come to a predetermined conclusion by authors who have been critical of medical and surgical interventions to treat gender dysphoria. While organizations that advocate for gender affirming care state the research should be done by individuals treating minors with gender dysphoria, there also exists a conflict of interest for researchers like Dr. Olson-Kennedy, who earn income from costly gender affirming care procedures.

The Daily Caller reported in February 2023 about the lucrative industry that was expected to grow from $1.9 billion in 2019 to $5 billion in the US in 2023. Market Research Future estimates that the global market is valued at $11.96 in 2024, with projected growth of $13.93 billion in 2025 to $63.53 billion.

New Zealand is the latest country to block puberty blockers for children with gender dysphoria after a review of the literature found there is not enough evidence proving safety regarding bone density, fertility, and organ systems, including renal or liver function. The review also found that studies suggesting an improvement in depression, anxiety, and suicidality are based upon poor-quality evidence. New Zealand joins the UK, Sweden, Norway, Finland, Italy, and France in heavily restricting or outright banning minor access to these treatments. 

“The American Medical Association and the American Academy of Pediatrics peddled the lie that chemical and surgical sex-rejecting procedures could be good for children,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “They betrayed their oath to first do no harm, and their so-called ‘gender-affirming care’ has inflicted lasting physical and psychological damage on vulnerable young people. That is not medicine — it’s malpractice.”

The puberty blocker study conducted in the UK will occur alongside another comprehensive study that will follow 3,000 children with gender incongruence over 5.5 years to track their quality of life, including mental and physical health as it relates to their gender identity. The study may be extended at a later point in time to track participants into adulthood, but that is yet to be determined.