13 May 2022: Collinge - B

The risks to blood transfusion recipients had been the focus of the earlier evidence. Prof Collinge was not able to say much about the risks to people who received pooled blood products. Again, the risk was considered to be low, but the small numbers of people involved made it difficult to come up with a robust assessment. The witness was aware of a person with haemophilia who died and was discovered as having CJD prions in his spleen. This case raises different questions about the investigations being performed on bleeding disorder patients when they die. Were they looking for something they already suspected might be there, or worse, was it a continuation of the covert research such that the post-mortem investigations were nothing more than cadaver and bereaved family abuse?

The Health Minister for some of the time being considered was Frank Dobson, who was the witnesses’ constituency MP. Dobson was very interested in and valued Prof Collinge’s advice. He was able to go to Tony Blair and get things approved swiftly. It’s not what you know …

Moving on to the potential contamination of surgical instruments, the witness mentioned the case from Switzerland where a surgical instrument had been used on a patient who was CJD positive, asymptomatically, then sterilised in the normal way. Two subsequent patients were infected with CJD after the same instruments were used on them. A chimpanzee exposed to the instrument died as a result. It turns out that CJD prions are very good as “sticking” to mental instruments despite the cleaning regimes at the time. Significant research was carried out by Prof Collinge and others to discover new ways to sterilise instruments, and eventually a solution was found. However, the NHS has not yet adopted the new method. As academics, they could not impose their findings on the Government. The witness and his colleagues were able to get a deal with DuPont, who did produce a commercially available product which applied the techniques from the research, but the NHS has not yet adopted it. Counsel mentioned examples of patients being denied NHS procedures due to the risk of making instruments unusable (they had to be destroyed or quarantined). Using the DuPont product would have solved the problem. It was mentioned how occasionally there are no records in place to say what instrument was used so a whole theatre full or those of a certain type had to be put out of use. Also, the awareness of possible CJD contamination after someone had had an operation using an instrument which was subsequently discovered to have been used on another potential CJD infected person, led to more people being advised that they may have been exposed to vCJD, with all the anxiety that causes.

The prion decontamination process the witness and his colleagues had developed was relatively simple and inexpensive. The witness expressed his concern that the Government would not change its mind and start to use the prion decontamination product until someone was found to have died as a result. He felt he had been “banging his head against the wall” for so long, he needed to express himself in the “someone has to die before they take notice” terms. It seems like it was a decision related to cost, even though the DuPont product was not expensive. Surprised?

The process involved pre-washing since it was much harder to remove a prion once it had dried on to a surface. In time, DuPont lost interest since the NHS was showing no motivation to adopt the technology. Interestingly, a review of general practices related to surgical instrument sterilisation actually turned up a whole load of red-light warnings about common practices. How reassuring.

An assay test designated as “DDA” (Direct Detection Assay) was developed for CJD, but there have not been any cases for years so while it is still available, it is not currently used in specific cases, and certainly not across the board as a public health precaution. A detailed consideration of the development of the tests threw up some further information. The sample of blood used in the test is very small. There is not much material available for testing. Not everyone with vCJD has prions in the blood. So, while the test was usefully sensitive, the nature of some patients meant that the test did produce about 30% false negatives. Those without prions in the blood might be thought to be less likely to pass on vCJD if they donated blood, but that could not be stated with complete confidence. The DDA test was developed in the way it was because there are no known whole blood samples available to use in trials. There have been a lot of animal tests, but it is not right to infer automatic results from animals to humans. The US was a useful control group because vCJD is not prevalent in that population, whereas there is a high prevalence in the UK population. The introductory work of Prof Collinge and his colleagues was never picked up by commercial diagnostic producers. The funders from MRC diagnostics had previously worked in the commercial sector. The witness later gave evidence to a Government Committee and the phrase “the value of death” was recorded due to the challenges of turning clearly useful academic results into a product that commercial companies considered as worth developing and Government then purchasing. So, as with the prion decontamination efforts that have not been picked up, Prof Collinge’s work on a vCJD test was also not progressed, even though both of these worked well. Is the reluctance to invest simply down to money, or is there another reason for not wanting to progress knowledge and public health safety in these areas?

Attempts to secure funding from the MRC for prevalence studies were unsuccessful. The reasons for not allowing the funding caused the witness concern. More recently (2016), there has been some renewed interest. Again, the records of more recent discussions which did not recommend progressing this work do not adequately explain the reasoning behind the decisions, and may even be suggesting ways forward that would be illogical, despite the attendees being senior medics and scientists. It could be said that Prof Collinge is simply expressing sour grapes at not getting the money he and his colleagues wanted to progress their work, but the reasoned arguments and contextual information being explored by the line of questioning suggest he is giving his evidence in good faith. It would be bad enough if it was only money restrictions that were hindering this area of public health interest being progressed, but it would be far worse if other, non-financial factors, were at play. Are they?

Those who were advised that they may have been exposed to vCJD still feel like they have the Sword of Damocles hanging over them (if Lord Penrose will now allow that phrase – actually, who cares if he doesn’t). People still feel obliged to disclose the information as a public health requirement. What a wonderful legacy that is still being experienced.