17 May 2022: Ironside - C

Counsel began by clarifying a previous question about the iv50 measure. This appears to be an industry standard way that people in the world of Prof Ironside use across for all kinds of assessments when seeking to grade the probability of infectivity.

Most of the population of the UK has likely been exposed to some level of vCJD risk due to its expected residual prevalence in the country. The long asymptomatic incubation lead-time of vCJD has resulted in the possibility of an underlying, undetected passage of prions through the populace. With that, and the difficulties of being certain about diagnosis or testing, it leaves vCJD as being like a background phantom which most of us never meet, but occasionally it arrives to scare some poor soul by its enigmatic infamy.

The significant impetus to adopt an ”umbrella approach” to notifying all haemophilia patients of the possibility of exposure came from the UKHCDO with endorsement from the Haemophilia Society. Prof Ironside would have preferred a system of informing people in stages based on the increasing risk a person would be at depending on the greater or lesser use of the potentially infective material (factor concentrate). This would have allowed for targeted support, whereas the blanket approach did not allow for an individual assessment relative to the marker of a “1% threshold”. The ultimate decision-maker on the approach taken was the Health Protection Agency. His Panel did not make the initial suggestion of the umbrella approach but went forward with the clear direction these other bodies expressed as their preference for pursuing. This process was also another example of the length of time it sometimes took to progress work that had a certain level of urgency about it. But the Panel had no control over, for example, the speed with which the DH responded to communications or issued updates.

The Panel understood that in the first instance the umbrella notification would be communicated by letter with information included. They also understood that the opportunity for individual consultation and offering support would be available. The extent to which this happened in the envisaged way was not reported back to the Panel. As far as Prof Ironside was aware, the expertise of his team or others with specialist capacity to counsel people with CJD concerns were never accessed. So, it must have happened by local treating clinicians; if it happened at all. The witness was concerned, as were others, that after all the time it took to get to the point of deciding to inform this relatively large group (in public heath risk terms) altogether, it appeared there was no logistical planning to cover the likely demand for information and advice arising from the umbrella being put up. It appeared there was not even any thought given on whether to give individualised advice depending on the level of product use by a particular patient, or to give generic responses to questions.

When the Panel was dissolved, some of its role was passed to a local level, apart from “difficult” cases. Public Health England were not expected to maintain a CJD sub-group. The witnesses’ view is that it took a while for the local health authorities to get to a stage where they could respond. There were various support requests, and things eventually settled into the new way, but the feeling was that the changeover resulted in a general loss of expertise and specialism.

A holy grail objective was to discover a test with sufficient reliability to allow screening among “pre-mortem” patients, particularly asymptomatic persons. It turns out that there are some examples of techniques which could lead to screening assays, including Prof Collinge’s DDA test. A different approach comes from France. Having at least two tests is preferable since one can test and another can confirm. However, Prof Ironside was never able to have access to any tests in his work on CJD. A recommendation to develop a research study to assess the usefulness of those possible tests was presented to the authorising bodies but it was not taken forward. It was suggested the reason was down to available expertise. There was also a possible issue about certain commercial interests being protected. The witness spoke about the value of researching these potential solutions to discover assays, and it is with some regret to note that it has not happened.

On the issue of post-mortems, the witness explained how tissue samples of a recently dead person are stored for use as part of a network of research bodies (MRC tissue banks). These materials have been used across the world for a variety of studies, not just for prion disease research. Occasionally, the State can take control of a deceased person’s body if there is sufficient justification. The general process is for the person or their family to be asked to give consent for the retention of bodily materials, post-mortem. Some people give their consent while others do not, and people in Prof Ironside’s position just have to live with that.

The witness was one of only two pathologists who could perform autopsies on people with very infectious diseases. The other, who led the work in Edinburgh, was Dr Bell. Prof Ironside confirmed the establishment of the HIV brain tissue bank in Edinburgh. It was supported by DH and MRC. The MRC decided that collecting brain bank materials was a useful activity. The witness was once the lead of that network. He asserted that it is a valuable resource for research, far beyond any prion investigations. It still exists and is still being used to this day.

The image of Prof Ironside has shifted from the soft-spoken, academically-minded clinician. It underwent a major adjustment the more he spoke about his pathology and autopsy activities. In the imagination he became a more graphically represented character in blood-splattered “surgies” performing all kinds of very invasive tests on bodies and bits – both humans and animals. This raises some strongly-held views among animal-lovers who hold to the anti-vivisection philosophy more recently manifest by the rise of strident veganism. Contrary views express deep gratitude for his ilk due to the progress which has been achieved by this perhaps dirty job which someone has got to do. Extrapolating this moral or ethical contention stretches to the cases of scientific knowledge accrued from, for example, Nazi concentration camps, and this would not be the first time that very dark episode has bumped into the Contaminated Blood Scandal.

Counsel referred to studies involving pathological information which had been subject to D-Notice restriction. The witness mentioned that it only involved a small number of people.

When a final research paper was displayed, Counsel mentioned that unusually, Prof Ironside was not among the authors. Given his apparently prolific output, this brought a smile from the witness. It seems that despite having “retired” to “emeritus” status, Prof Ironside has nonetheless continued to author or contribute to new research papers. This witness is clearly highly motivated by his chosen line of work and studies. He is very comfortable when discussing his work or the work of his peers. His responses to questions from Counsel were measured and dispassionate.

With Counsel having exhausted her list of questions, all that remained was for questions from core participants, after a break.