What’s the difference between Factor VIII and a Blood Transfusion?

The information below outlines the vast difference between “Blood” (Whole-Blood) and Factor VIII / Factor IX Concentrate Products. Factor VIII is not a Blood Transfusion. This is often confused in the press, creating a cycle of misinformation and preventing the full truth from being known. Here are the facts.

1.     FACTOR VIII IS NOT BLOOD. FACTOR VIII IS NOT A BLOOD TRANSFUSION… A blood transfusion is simply the transfer of 1 person’s blood to another and does not involve any kind of manufacturing or mixing process.

Factor VIII

2.     Factor VIII & IX Concentrate Products were extremely different, part of the line of processes involved in their creation was “pooling” (mixing together) the plasma (NOT BLOOD) of up to 60,000 people during manufacturing, monstrously amplifying infection risk.

3.     A unit of blood for Transfusion comes from 1 donor.

4.     An infusion of Factor product came from up to 60,000 donors.

a.     “these products, known as factor VIII and factor IX concentrate, were produced from pooled plasma from as many as 60,000 donors Encyclopedia of AIDS (1998).

b.     “concentrates were made from pools containing tens of thousands of units Hemophilia Federation of America (2014)

c.      “Plasma products are manufactured from large pools of donations, the haemophilia products are highly processedPaul-Ehrlich-Institut Federal Agency for Biological Medicinal Products (2006).

5.     Factor Concentrate Products were largely imported into this country from commercial sources overseas (e.g. USA).

6.     Whole-blood was not imported.

a.      Blood is not imported into this country” – David Owen, Minister of State for Health (28th April 1976) http://hansard.millbanksystems.com/written_answers/1976/apr/28/blood-transfusion-service#S5CV0910P0_19760428_CWA_72

b.      “My Lords, we are not importing blood. We are self-sufficient in whole blood, but we need to import blood products such as Factor VIII, to which I think the noble Lord was referring.” Simon Glenarthur, Parliamentary Under Secretary of State DHSS (5th December 1983) http://hansard.millbanksystems.com/lords/1983/dec/05/blood-licensing-requirements#S5LV0445P0_19831205_HOL_30

c.       Supplies of whole blood are not imported since the United Kingdom is self-sufficient; only certain blood products such as factor VIII are imported.” – Tony Newton, Minister of State for Health (20th November 1986) http://hansard.millbanksystems.com/written_answers/1986/nov/20/aids#S6CV0105P0_19861120_CWA_459

7.      Factor Concentrate Products were commercial in nature and were bought and sold by companies for profit, Factor products had financial value.

8.      Whole-blood was not bought or sold, it was not commercial in nature.

9.      Whole-blood was and still is managed by the NHS “volunteer donor” system and has in itself no financial value.

a.      “In the year ending 1978, which is the latest year for which figures are available, the amount of expenditure for the purchase of commercial Factor VIII for England and Wales was approximately £1,180,000; although the product is imported by the suppliers no information is available on the foreign exchange content of the purchase price.” – Roland Moyle, Minister of Health (26th June 1978)  http://hansard.millbanksystems.com/written_answers/1978/jun/26/haemophilia#S5CV0952P0_19780626_CWA_271

b.      “The voluntary donation of blood is the principle upon which the National Transfusion Service has been based, and it is a principle that we would not wish to change.” John Brynmor, Minister of State (31st March 1977) http://hansard.millbanksystems.com/commons/1977/mar/31/offenders-blood-donorship#S5CV0929P0_19770331_HOC_122

c.       No blood is sold by the National Health Service to other organisations, whether in this country or abroad.” Roland Moyle, Minister of Health (22nd May 1978) http://hansard.millbanksystems.com/written_answers/1978/may/22/blood-supplies#S5CV0950P0_19780522_CWA_151

10.   Even before specific tests for Hepatitis or HIV were available, Factor Concentrates were able to be made free of these viruses via “Heat Treatment” (a form of pasteurisation to kill the viruses which was eventually introduced).

11.   Heat Treatment cannot be used with whole-blood.

a.      Heat-treatment can be applied only to certain blood products, of which factor VIII is one of the most important.” Kenneth Clarke, Minister of State DHSS (5th February 1985) http://hansard.millbanksystems.com/written_answers/1985/feb/05/blood-products-1#S6CV0072P0_19850205_CWA_433

b.      “All factor VIII and IX produced from screened and tested donations are heat treated to inactivate HIV and other viruses. Blood itself cannot be heat treated.” Stephen Dorrell, Parliamentary Under-Secretary Department of Health (21st May 1991) http://hansard.millbanksystems.com/written_answers/1991/may/21/medical-products-contamination#S6CV0191P0_19910521_CWA_255

c.       “supplies of Factor 8—which is the blood clotting agent needed by haemophiliacs—are heat treated, which therefore makes them safe Baroness Trumpington, Parliamentary Under-Secretary of State for Health & Social Security (23rd October 1985) http://hansard.millbanksystems.com/lords/1985/oct/23/aids-disease-containment#S5LV0467P0_19851023_HOL_45

12.   The risk of exposure to Hepatitis C via the use of untreated Factor Concentrate Products was approximately 100%.

13.   The extremely small risk in comparison of exposure to Hepatitis C via a whole-blood transfusion was simply equitable to the prevalence of the virus in the overall population which was far less (approximately 0.1% - 0.4%).

a.      “The risk of post-infusion non-A, non-B hepatitis (NANBH) in patients receiving a first exposure to unheated or conventionally 'dry heated' factor VIII concentrates approaches 100%.” Department of Haematology, Royal Free Hospital, London (1987) https://www.ncbi.nlm.nih.gov/pubmed/3118932

b.      All of those who received commercial concentrates developed hepatitis British Medical Journal (10th December 1983).

c.       “The prevalence of Hepatitis C in the UK is estimated to be between 0.1 % and 1 %” Chief Medical Officer (3rd April 1995).

d.      “the prevalence in the population is 0.1%” “then a single treatment from a single donor will reflect that prevalence”. Dr Myrtle Peterkin, Consultant Haematologist (9th March 2011) http://www.penroseinquiry.org.uk/downloads/transcripts/090311.PDF

14.   On average 50% of whole-blood transfusion recipients would die from the original cause of requiring a blood transfusion, a blood transfusion is often given in life-threatening circumstances.

15.   In contrast, only 0.1% of Factor is given in life-threatening circumstances. 99.9% of Haemophilia episodes are not life-threatening, this was documented in the 2013/2014 United Kingdom Haemophilia Centre Doctors Organisation report which surveyed 10,000 Haemophilia bleeding episodes.

a.      “50% of recipients of blood die of the primary disease within 12 months of transfusion.” Notes of a meeting held at DHSS (30th January 1987)

b.      “Recipients of 50% of donations die within 1 year of their primary disease” Dr Rejman, Department of Health – Paper for Executive Board (2nd September 1996)

c.       However, in the case of Factor, only 0.1% of Haemophilia Bleeds are “life-threatening”, the vast majority (83.3%) are classified as “minor”. UKHCDO Annual Report 2013/2014 Page 76 http://www.ukhcdo.org/docs/AnnualReports/2014/Bleeding_Disorder_Statistics_For_Website_2013-2014.pdf

16.   UK Whole-blood donors were never paid cash to donate.

17.   The National Blood Transfusion Service in this country operates on a volunteer-only basis.

a.      “The National Health Service does not use imported blood obtained from paid donors. In this country we have an entirely voluntary system of blood collection. There is no financial or other incentive for our voluntary donors to put others at risk.” Kenneth Clarke, Minister of State DHSS http://hansard.millbanksystems.com/written_answers/1985/feb/25/aids-2#S6CV0074P0_19850225_CWA_387

b.      “This country is self-sufficient in blood obtained from our voluntary, unpaid donors and we do not obtain supplies from other sources.” Tom Sackville, Parliamentary Under-Secretary (Department of Health) (18th October 1994) http://hansard.millbanksystems.com/written_answers/1994/oct/18/blood-donations#S6CV0248P0_19941018_CWA_49

18.   In contrast, the blood-plasma donations used overseas to create Factor were usually from donors who were paid cash including IV Drug Users, Prisoners and Prostitutes. This increased the risk of infection as donors were given a motive to lie about their health status or lifestyle.

a.      “Factor VIII is generally prepared from large pools of plasma…” “most of them paid donors.” NY Times (18th November 1984) http://www.nytimes.com/1984/11/18/magazine/donated-blood.html?pagewanted=all

b.      “Lots of Factor VIII concentrate are prepared from plasma…” “Most material is pooled from paid donors in plasmapheresis centers.” Institute of Medicine (US Inquiry - 1995) https://www.ncbi.nlm.nih.gov/books/NBK232403/

c.       “The U.S. fractionators used both source and recovered plasma in the manufacture of commercial blood products, including factor VIII and factor IX concentrates. Almost all the source plasma came from persons who were paid for their plasma” Justice Krever (Canadian Inquiry – 1997) http://publications.gc.ca/collections/Collection/CP32-62-3-1997-2E.pdf

19.   Factor VIII & IX Concentrate products were usually used to treat bleeding-disorders, mostly Haemophilia (the condition is characterised by a deficiency of Factor VIII or Factor IX) and so provide a consistent use basis.

20.   Conversely, whole-blood was used across a great multitude of people and situations including severe road traffic accidents, major surgery, child birth complications, anaemia, malaria and many others. There is no consistent use basis of whole-blood.