Professor who reportedly paused UK puberty blockers trial removed over bias claims

A health official who reportedly intervened to pause a clinical trial on the use of puberty blockers has been removed from any further involvement due to accusations of bias.Prof Jacob George, who was appointed chief medical and scientific officer at the Medicines and Healthcare products Regulatory Agency (MHRA) in January, raised concerns that led to the Pathways trial being put on hold by the government, according to the Sunday Times.But the regulator announced on Saturday that George would recuse himself from involvement in the trial after gender-critical social media posts made last year emerged.In one post he described the author JK Rowling, known for her gender-critical views, as being a “treasure of our time”. In another he said that “the denial of basic biological fact is concerning” in regards to questions about whether the Olympic boxer Imane Khelif was a woman.The MHRA said that although George’s posts were made before his appointment, he had been removed from involvement in the trial as a precaution.The Pathways trial, which was intended to assess the effect of puberty blockers on children questioning their gender identity, was due to begin recruiting participants in January. But it was paused in February after the medicines regulator raised concerns over the wellbeing of children and young people taking part.The youngest participants were expected to be 10 to 11 for biological females and 11 to 12 for biological males, although the team said at the time the rigorous selection process meant participants would probably be older.However, the regulator has now said the minimum age limit should be 14 because of the “unquantified risk” of “long-term biological harms”. The clinical trial had planned to recruit an estimated 226 young people over the next three years.The trial was announced after a recommendation by the Cass review into children’s gender care, which concluded that the quality of research claiming to show the benefits of such medication for youngsters with gender dysphoria was “poor”.Dr Hilary Cass, who led that review, has previously said her report “uncovered 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 believe passionately in the beneficial effects, a trial was the only way forward to make sense of this”.Dr Max Davie, a consultant paediatrician who previously worked at the NHS Children and Young People’s Gender Service, said there was no compelling scientific reason to pause the trial.“The tweets by Professor George give a clear indication of his personal views on the topic,” he said. “He is quite at liberty to hold whatever views on gender identity he may, but what he cannot do is allow these views to affect the fulfilment of his public duty.”He added: “To be clear, there is no compelling scientific reason to halt the Pathways trial. While Prof George’s personal convictions are not the only possible explanation for the MHRA’s abrupt volte-face, it is the only one for which we have evidence.”An MHRA spokesperson said: “With all clinical trials, the MHRA’s top priority is the safety and wellbeing of the trial participants. As part of that commitment, complex clinical trials are kept continuously under review and the MHRA maintains an active scientific dialogue with trial sponsors.“The MHRA has world-class medical, scientific and regulatory experts who work as a multidisciplinary team to provide evidence-based decisions on clinical trials. These experts will continue to meet with King’s College London to work through the next steps constructively.“Following the identification of social media posts made prior to his appointment, Prof Jacob George is recused from further involvement on the Pathways clinical trial as a precaution.”