31 March 2022: Perry - B

Round Two, ding ding. PFC vs BPL, the rumble in the jumble-sale. I think the first battleground is "my building is dirtier than your building". It's a close contest.

Prof Cash seems to have a fractious rapport with fractionators generally. Lane, like Watt, was an occasional sparring partner for the Cash-man. However, despite attempts to build closer working arrangements between the Angles and the Picts, their governmental masters were not so keen to see the marriage be consummated. So the lovers had to rely on informal trysts to carry on their developmental dalliances.

It appears to have been a missed opportunity by keeping England  and Scotland apart. They missed out on the synergies which could have been achieved by the free exchange of know-how, ideas, and results. But then, we know how Government likes to maintain control by methods such as discouraging communications and collaborations. Tactical tyranny.

Dr Perry confirmed the lack of sharing from and among the private pharmaceutical companies. State and voluntary sector bodies tended to me much more sharing.

There was a closer relationship with Edinburgh bods, not least due to the geographical nearness. This included the fact of Prof Ludlum's peer leadership role. Dr Perry said this potential favouritism was not to the detriment of other areas, however. The Northern Ireland setup did not include Dr Perry going to, for example, Belfast. However, there was a good relationship with Dr Mayne.

The lack of licence renewal was not welcomed by both Watt and Cash, but the negative inspection reports meant that this would not be granted anyway. NIBSC (the licensing body) received samples from PFC for testing, for example in relation to potency. This engagement was despite the Crown Immunity status. Senior staff felt it was still important to do. They wanted external confirmation of the safety and effectiveness of PFC outputs. So what was the rationale for Crown Immunity as a special designation? What was the positive intent, or was it just a way of not being subject to the rules which others had to follow? Could they not have given Crown Immunity to parties at Downing Street and just be honest and embrace the "one rule for us ... a different rule for them" accusation?

Internal communications, including from Dr Perry himself, highlighted the deficiencies of PFC. But the SHHD were in denial. Dr Perry and his colleagues felt exposed since they were not covered by limited liability insurance or the support of a body like the Medical Defense Union.

The licensing authority considered that PFC products should be licenced, however it appears that the level of detailed information required to achieve a license was far less than what would be expected from a commercial company. The process of reporting adverse events would only refer back to the PFC if the issue was not an already recognised side-effect.

The scenario of a significant adverse event during the period of the license - such as the inevitability of a patient getting virally infected after the very first use of the treatment - would expect to be a matter of notification to the authority. Similarly,  if the make-up of a product changed, this should be notified. Given that the commercial producers were using larger pool sizes, changes in pool sizes by PFC were not seen as a major issue. Reports to the licensing authority in these situations was normally standard so long as the event was unusual. The pharmaco-vigilant arrangements back in the 1980s was far more confusing and far less robust than they are nowadays.

The issue of donor selection was not seen as the main responsibility of the PFC in terms of licensing, but it was left at the door of the collection bodies. The licensing agency did not seek to know the donor selection procedures either of PFC or commercial producers. It wasn't seen as significant enough. Obviously, these days the donor selection details are of great interest.

The PFC didn't see itself as competent to judge the donor selection processes in place (or not) by plasma suppliers back in the 1970s and 80s. So long as there was reported to be some selection process in place, without looking at it in any detail, then that was seen as sufficient. I'm not sure if this illustrates an over-reliance on trust, simple buck-passing, or the assumption that a task was someone else's so the less said the better.

So if safety and purity of a blood product was to be ensured, what was actially being monitored back then? The facilities were sub-standard, the donors were insufficiently screened, the processes were too loosely defined, the experience of the patient was not sought, and more. So who was ultimately responsible for ensuring that blood and blood products were fit for human consumption (transfusion)? It sounds like everybody's job became nobody's job.