Professor who reportedly paused UK puberty blockers trial removed over bias claims | Transgender
A health official who allegedly intervened to halt a clinical trial into the use of puberty blockers has been barred from further involvement due to accusations of bias.
Professor Jacob George, who was appointed medical and scientific director of the Medicines and Healthcare products Regulatory Agency (MHRA) in January, raised concerns which led to the Pathways trial being suspended by the government, according to the Sunday Times.
But the regulator announced on Saturday that George would recuse himself from taking part in the trial after making critical social media posts last year.
In one article, he described author JK Rowling, known for her critical views on gender, as a “treasure of our times.” In another, he said “the denial of basic biological facts is concerning” regarding whether Olympic boxer Imane Khelif was a woman.
The MHRA said that although George’s positions had been created before his appointment, he had been removed from any participation in the trial as a precaution.
The Pathways trial, which aimed to evaluate the effect of puberty blockers on children questioning their gender identity, was due to begin recruiting participants in January. But the project was suspended in February after the medicines regulator raised concerns about the welfare of children and young people taking part.
The youngest participants were expected to be between 10 and 11 years old for biological females and between 11 and 12 years old for biological males, although the team said at the time that the rigorous selection process meant participants would likely be older.
However, the regulator has now said the minimum age limit should be 14 years due to the “unquantified risk” of “long-term biological damage”. The clinical trial planned to recruit approximately 226 young people over the next three years.
The trial was announced after a recommendation from the Cass journal on gender protection in children, which concluded that the quality of research claiming to demonstrate the benefits of these drugs for young people with gender dysphoria was “poor”.
Dr Hilary Cass, who led this study, previously said her report “found a very weak evidence base” for the benefits of puberty blockers for children and young people with gender dysphoria, but “given that there are clinicians, children and families who passionately believe in the beneficial effects, a trial was the only way forward to make sense of this”.
Dr Max Davie, a consultant pediatrician who previously worked in the NHS children and young people’s gender service, said there was no compelling scientific reason to pause the trial.
“Professor George’s tweets give a clear indication of his personal views on the subject,” he said. “He is completely free to have his opinions on gender identity, but what he cannot do is allow those opinions to affect the discharge of his public duty. »
He added: “To be clear, there is no compelling scientific reason to stop the Pathways trial. Although Professor George’s personal beliefs are not the only possible explanation for the MHRA’s abrupt about-face, it is the only one for which we have evidence.”
An MHRA spokesperson said: “In all clinical trials, the MHRA’s top priority is the safety and wellbeing of trial participants. As part of this commitment, complex clinical trials are continually reviewed and the MHRA maintains an active scientific dialogue with trial sponsors.
“The MHRA has world-class medical, scientific and regulatory experts working as a multidisciplinary team to make evidence-based decisions on clinical trials. These experts will continue to meet with King’s College London to work constructively on the next steps.
“Following the identification of social media posts made prior to his appointment, Professor Jacob George is recused from any further participation in the Pathways clinical trial, as a precautionary measure.”
