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Scientists comment on reports that campaigners are beginning legal action to halt the Pathways trial of puberty blockers.
Prof Sir Jonathan Montgomery, Professor of Health Care Law, UCL, said:
“Campaigners are challenging the decisions of the Medicines and Health Care products Regulatory Agency and the Health Research Authority to authorise a trial that aims to address past failures of evidence-based medicine in the care of young people suffering with gender dysphoria or incongruence. Such a trial was recommended by Baroness Cass and presupposed by Parliament when it took the unusual step of banning the use of puberty suppressing hormones even when the patient, parents and treating clinician reached the conclusion it would be an appropriate treatment.
“The legislative ban on the use of puberty blockers itself contains the expectation that a trial will be set up. It is inconsistent to rely on the ban without acknowledging the legitimacy of a trial. In the absence of that ban, clinicians would be permitted to offer puberty suppressing hormones to those individual patients whom they think might benefit. Their reasons for believing this would need to be accepted as proper by professional standards, be logical and stand up to scrutiny, and should be driven by concern for the individual patient’s welfare not based on a prejudged ideological position.
“The Cass Review noted the poor quality of evidence both for the benefits of the puberty suppressing hormones and also the harms it might cause. Both those who seek them and those who oppose their use are able to point to published studies but the quality of the research studies is poor. Young people and their families have been let down by a collective failure to generate the science that would enable them to take informed decisions. Baroness Cass recognised that research is needed to remedy that failure. Blocking all such research would compound these past wrongs.
“The proposed research is consistent with the conclusions of the Committee on Safety of Medicines, on whose advice Ministers relied in proposing the ban. The Committee criticised the way in which the drugs had been used to treat gender incongruence or dysphoria, not the availability of the drugs themselves (which are used to treat children with problems unrelated to gender identity). The Committee advised that ‘the current prescribing and care pathway’, that is the one used at the Tavistock clinic and now closed, presented ‘an unacceptable safety risk without significant additional safeguards’. NHS England has now provided such safeguards. In accordance with the Cass Review’s recommendations, the new local services do not assume that puberty suppression is an appropriate option. Instead they offer children and families a range of options. Should they reach the conclusion that puberty suppression might bring benefits, that will be reviewed by a national multi-disciplinary team. Only if this additional safeguard confirms the view that puberty suppression is appropriate can a young person be considered for the Pathways Trial. The trial is not, therefore, a matter of gender-affirming care, but an option that arises from a holistic consideration of the individual child’s clinical needs.
“It is also important to take stock of the cluster court decisions that have considered the use of puberty suppressing hormones. The Court of Appeal has confirmed the validity of parental consent to the use of puberty suppressing hormones, noting that ‘parents routinely consent on their child’s behalf to experimental treatment, sometimes with considerable, including life changing, potential side effects.’ The Court of Appeal has also rejected the suggestion that age limits should be placed on children’s capacity to consent and instead that this was a matter of fact that must be assessed in relation to each child by their treating clinicians not prejudged by the court. The suggestion that courts must be involved before the puberty suppressing hormones were prescribed for children has been raise in a number of cases and has been rejected on every occasion. There is nothing in these decisions to suggest the proposed trial is inappropriate.
“The primary reference point for the ethics of clinical research is the World Medical Association’s Declaration of Helsinki, which was last revised in 2024. Article 37 explains what should have happened when the Tavistock Clinic began to use puberty suppressing hormones as an ‘unproven intervention’ that it believed might alleviate suffering. They should first ‘seek expert advice, weigh possible risks, burdens and benefits, and obtain informed consent’. This is exactly what the multi-disciplinary team review from NHS England puts into place. The use of unproven treatment is then ethical on the expectation that ‘it should subsequently be made the object of research designed to evaluate safety and efficacy’. This is what the Pathways trial provides. The Tavistock clinic, and also those treating adults, failed to meet the expectation in Article 37 that data on unproven treatment would be recorded and shared. Gathering that data now is an ethical imperative within the framework set out in Declaration of Helsinki.
“It is regrettable that the regulatory approval of the Pathways trial has become a party political issue. Legal matters should be settled by Parliament and the Courts. Evidence should be sought and robustly tested by scientists. The Cass review criticised past failures to follow the principles of evidence-based medicine. We should not continue to fail young people and their families be denying them the evidence they need to take informed decisions.”
Declared interests
Prof Sir Jonathan Montgomery: “Sir Jonathan Montgomery is Professor of Health Care Law at University College London and a former Chair of the Health Research Authority. He has been providing advice to the study team on how to ensure compliance with legal and ethical requirements on an unremunerated basis and is not one of the investigators in receipt of the grant.”