25 March 2022: Foster - B

The pharmaceutical companies did not have direct links to PFC's R&D activity, according to Dr Foster. Apart from attending conferences, there were not direct communications. Even then, the pharma reps were tight-lipped about detail for reasons of commercial confidentiality. So viral inactivation developments were a no-share commodity.

Pasteurisation was considered not suitable for blood products (other than albumin). Factor VIII was too fragile to heating attempts. First reports from a Bonn conference attended by Prof Cash of Behring apparently achieving this were considered to be errors or anomalies. This was the subject of a chat during an informal lunch discussion, not an actual meeting. It must not have been considered important enough.

The next relevant conference was in Budapest. There, Hyland/Baxter were next to announce their progress in this area. However, detail was again missing, and it later turned out to be a dry heat method that was being used. Steadily, heat treatment became the preferred option for further research and development activity.

The subsequent documents illustrate the extent of the research activity which involved using patients in the studies seeking to develop these products. It is as if NHS patients were automatically seen as fair game as research subjects. After all, they would ultimately benefit, so why would they (we) be concerned. Eh?

I grew up aspiring to be a research scientist for a while. I remember being interviewed for a university place. It was noted that I had certain religious interests. The wiley tutor leading the interview warned me of the potential conflict between my interests. He explained how in scientific studies people were subjects, and their human nature was a secondary consideration. People were, in effect, the "useful material" which we have heard applied to virally infected people (sorry, not people, PUPS/subjects/case studies/a dehumanised number/etc).

The production of factor concentrates was becoming an ever more complex set of processes. While whole blood was too raw to be used without some safety and categorisation interventions, the drive to derive maximised batches, yields, and cost minimisation led inevitably to increasingly interventionist adjustment of the original material. When it comes to foodstuffs, the general rule is that the closer to the raw item we consume, the better it was going to be for you. Concomitantly, the more processed the food, with all the additives and activities it had been subject to, the less healthy and good for you it would be. It is perhaps a clumsy analogy, but the principle is useful. Additives are often the source of side effects, both in foods and in biological products; think carcinogens, various toxins, mood altering substances, absorption restrictors, addictive behaviour inducers, etc.

Factor VIII was not actually understood as "a thing" until the 1980s, says Dr Foster. That lack of clarification and categorisation of the nature or typology of the stuff affected the ability of those seeking to research factor concentrates in their efforts to progress product development.

The possibility of starting earlier to produce safer products, say by trying the application of heat treatment processes, was according to Dr Foster, not due to a lack of imagination or will, since some actors in the field had tried various processes, but all had failed.

Dr Foster reported how the achievement of using heat treatment on factor concentrates was due to an accident during research experimentation. Only then, and with some accomplished investigator work, did it lead on to the development of what had initially been stumbled upon.

Z8 was a PFC attempt to advance product development in parallel to the 8Y activity of BPL. But there's more to come on this after the break. Yet another sandwich lunch awaits.