The taintedblood Timeline  -  what really happened...

In a 1981 report of the NBTS Protein Fractionation Technology Working Party, we read of scientific advances in the manipulation of genetic material that led to technological developments introducing the possibility of large-scale production of proteins [of which Factor VIII is one] for therapeutic use from bacteria or from animal cells cultured in vitro [in the test tube or Petri dish].

There have been two major lines of work toward this end: "One has drawn on recombinant DNA techniques to construct bacteria capable of producing "human proteins". The alternative has been to change the characteristics of animal, including human, cells to make them more amenable to large-scale cultivation in vitro.

We are not surprised to see what criteria the NBTS PFT Working Party use to decide whether or not to implement genetic manipulation techniques:

"It is necessary to decide whether the principal plasma proteins could be generally available at a competitive cost and of proven safety in a time-scale which bears upon the development of BPL. If so it is important to decide whether the technology arising from genetic manipulation is one which BPL would logically become engaged in." (page 27, para 3)

"Given prompt action on the redevelopment of conventional fractionation facilities, the return on investment will have been achieved before genetically engineered products can have a major impact. Nevertheless failure to take account of them may lead to a crisis shortly after the new plant has commenced operation." (page 30, final para)

Note: From 1981, it took 13 years for recombinant clotting factors to be licensed for use within the UK (i.e. in 1994). We believe that this could have been done in far less time, like Hyland, who were running human clinical trials of their recombinant in 1987. We would also like to point out that it took Government until 2006 to fully 'roll-out' recombinant factor concentrate to all adult haemophiliacs across the UK.

From 1981, that's a grand total of 25 years of deferment.

In a letter of 27 October 1983 from the Association of Scientific Technical and Managerial Staffs, it is clear that the ASTMS holds the belief that the Scottish Fractionation plant is substantially under-used and that this appeared to them to be being ignored by the Department.

"...I am advised by my members that PSC could increase its capacity to a level where we could manufacture over two-thirds of the Factor VIII currently purchased from the USA." (page 2, point 5)

Note: We assert that Scotland had the capacity to attain the 1974 'self-sufficiency' target of 40 million units. By 1983, they could have reached the required self-sufficiency target. All the two governments needed to agree on was that Scotland would supply the factor concentrate requirements for the UK until the development of the new English facility came through with genetic 'recombinant' factor products.

The whole of the UK could and should have been using plasma-free products by 1988.

Hyland begins the first human clinical trials of a recombinant FVIII concentrate.