FOI release
Pathways trial
Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.
Case reference FOI2026/00419
Received 19 April 2026
Published 3 June 2026
Request
Before proceeding any further, I should make it quite clear that I do not have any doubts about the integrity of Professor George or anyone else at the MHRA. However, I know that when humans act, they are not necessarily guided by conscious rational reasoning; hence the occurrence of the current and previous recusals to which the CEO refers. If humans were always consciously rational, life would be a lot simpler – and a lot less interesting! Given all that it seems obvious to me to ask "what changed", between the original approval and the discovery of the "new concerns". At one point, the MHRA agreed the KCL Pathways trial in the form in which it was recruiting. Then at a later point, the MHRA felt the need to question some aspect of this. Between those two points something occurred. Either the original team who gave approval thought further and identified new concerns, or the team changed by the arrival of Professor George or possibly others(I don’t know your rate of staff turnover). Now, I cannot see that the new contact with KCL arose in a vacuum, and that one MHRA person took it upon themselves to make that contact. There must have been some prior discussion at the MHRA, and on an issue as important as a clinical trial, there must have been a note made of the participants in that discussion and what was said in the process in which the "new concerns" arose. Question 3. You ask for some clarification about this. I was, and am, trying to find the details of what occurred before KCL was newly contacted about the PATHWAYS trial. Question 3: So, if I may now modify my question 3: please send me details of who discussed what with whom in the process that led to KCL being contacted about the Pathways Trial after the trial was initially approved. I assume that these details may be in the form of emails, memoranda, minutes (informal or formal) or anything other form that has not occurred to me. Question 4: I would also like to clarify my question 4. The CEO says in the internal email “scientific dialogue that is going on...is not so unusual. It is not uncommon for complex clinical trials to go through stages of iteration.” What the email does not say is how common it is for this dialogue and iteration to occur after the trial was approved. Therefore, I am interested in other such cases of dialogue after the trial was approved. I will redraft my Q4: Question 4 Please may I have the following details for the last three trials in which the MHRA intervened after the trial was approved. a) the name of the trial and the nature of the intervention, bearing in mind that for the PATHWAYS trial we were told that the “MHRA has now raised new concerns”, b) how long after each trial was approved did the intervention take place, and c) what press releases were published about the intervention. Question 5. My original Question 5 has now been subsumed into Qn 4. I have a final comment on the internal email sent by the CEO. In it the CEO says “Jacob is an ethical man…”, rather than an "ethical person" As I said at the start I have no doubts about the integrity of anyone at the MHRA. But I am quite unable to see what Prof George’s gender has to do with his integrity or character or role. The use of the phrase ‘an ethical man’ shows how naturally our culture still weaves the irrelevance of gender into our linguistic framework, so long after most of us have given up on the ‘chairman/woman’ usage, and more than a century, I believe, after 'doctress' was proposed and abandoned.
Response
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