NHS puberty blocker trial ‘not ethical', finds Trump-backed review
An NHS puberty blocker trial is 'not ethical', according to a Donald Trump-ordered review of children's gender medicine.
The US federal review goes even further than Britain's Cass Review by raising 'serious concerns about medical interventions' of any form in children and teenagers.
Its Department of Health and Human Services concluded that 'the overall quality of evidence is very low' to justify giving puberty blockers or cross-sex hormones to adolescents, including in trials such as the Pathways research planned by the NHS.
The highly critical review likens the trial of puberty blockers by the health service to trying to test the harms of jumping out of a plane without a parachute.
It was ordered by Mr Trump within days of taking office, having made gender ideology a central theme of his campaign in the run-up to the election.
Dr Jay Bhattacharya, the director of the National Institutes of Health, which is responsible for public health research in the US and contributed to the report, said: 'Our duty is to protect our nation's children – not expose them to unproven and irreversible medical interventions.
'We must follow the gold standard of science, not activist agendas.'
The findings echo the Cass Review, led by retired paediatrician Baroness Cass, who said gender medicine had been built on 'shaky foundations' and called for an end to the medical and 'affirmative' approach to treating children with gender dysphoria.
While the anonymous authors of the 409-page report agreed with Lady Cass that there was a lack of evidence to support the use of powerful puberty blockers in children, it went further by declaring that the potential for harms to children were known.
They said that for the use of drugs in children experiencing gender confusion, 'the evidence base does not support strong conclusions about their effectiveness'.
And that 'the evidence for harm is less uncertain', arguing that there is a clear biological basis for believing they carry significant risks, and that the lack of thorough studies into the harm caused does not mean it does not exist.
'We can be certain in the ordinary sense of 'certain' that these interventions cause harm, even if we do not have 'high certainty' evidence in the technical sense,' the report said, citing the 'experimental nature' of the interventions, including removing breasts or interfering with the reproductive system.
The authors also liken the trialling of the drugs to an 'unethical parachute test'.
It said: 'The likelihood of infertility when puberty blockers are provided at the early stage of puberty and followed by cross-sex hormones does not have to be demonstrated in a clinical trial. This is because the mechanism is well understood and conducting a trial would amount to an unethical 'parachute test'.'
The work builds on the work by Lady Cass and points to a 'a growing body of evidence pointing to significant risks – including irreversible harms such as infertility – while finding very weak evidence of benefit'.
The federal review also said attacks on Lady Cass by pro-trans US doctors were 'ridden with misrepresentations of the Cass review and contain multiple factual errors'.
But while Lady Cass recommended a trial of the treatment to establish both benefits and harms, those in the US argued it 'may conflict with well-established ethical standards for human subjects research'.
They cited recommendations from the World Medical Association that doctors must understand risks properly before beginning a trial, and point to the Nuremberg Code, which was drawn up in response to Nazi medical experiments and say trials should be designed so that 'the anticipated results will justify the performance of the experiment'.
They said: 'It is not ethical to subject adolescents to hormonal and surgical interventions used in [child transition], even in a research trial, until and unless the state of the evidence suggests a favourable risk-benefit profile.
'The state of the science does not support a favourable risk/benefit profile, nor does it give researchers a basis for confidence that the risks of [treatment] can be satisfactorily managed.'
The review was contributed to by medical doctors and ethical experts and made up of people across the political spectrum with underlying commitment to scientific principles.
It also criticised the use of phrases such as 'assigned sex at birth', which suggested an 'arbitrary decision' rather than 'the observation of a characteristic present long before birth, namely the child's sex'.
It claimed that activists 'go to extraordinary lengths to avoid the plain use of these [biological] words, and related words such as boy and girl'.
An NHS spokesman said: 'As is the case with any rigorous academic study, the Pathways proposal has been subject to independent academic peer review and a review by the National Institute of Health and Care Research committee – ahead of progressing to the usual strict ethical and regulatory approvals, which ensure stringent safeguards in scientific research.'
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