The NHS is created and Crown Immunity is applied to all NHS bodies and premises.

In 1958, Dr J. Garrott Allen conducts a survey in the Chicago area where he discovers what he refers to as the “prison effect”. He finds that there is 10 times more hepatitis in patients who had received blood transfusions from ‘professional’ paid-for blood than in patients who received transfusions from volunteer-donated blood. Dr Allen, warns that plasma centres and blood banks would have to quickly change their methods of operation.

Dr. Judith Graham Pool discovers that Factor VIII can be precipitated by cold from normal human plasma, produced a simple and low-cost method of preparing the Factor VIII protein which could then be easily administered to hemophiliacs.

Dr. Pool later goes on to develop a method for determining the concentration of Factor VIII in human plasma.

The Medical Research Council runs a growth hormone programme as a clinical trial which commences in 1959 and runs until 1 July 1977. Between 1959 and 1985, nearly 2000 children are treated with the growth hormone, which is extracted from the pituitaries of cadavers (dead bodies).

As early as May 1961, a patient is infected with Hepatitis C virus (formally Non-A Non-B Hepatitis (NANBH) from non-virally inactivated factor IX concentrate administered in Oxford.

Dr. Thelin, a hemophiliac working as a scientist at Baxter, begins to develop the first factor VIII concentrate, which he initially tests by injecting himself.

He discovers that the freezing and thawing of blood plasma enables him to obtain a layer rich in factor VIII, resulting in the first highly purified dried concentrate of factor VIII.

Cryoprecipitate is discovered in 1964 by a team of scientists led by Judith Pool, who was a student of Dr. J. Garrott Allen.

The Labour Party gains power with Harold Wilson as Prime Minister.

In the Haemophilia Society's 'Submission to the Archer Inquiry' of 2007, we learn of how many countries used surrogate tests to determine the presence of Non-A Non-B hepatitis (now Hepatitis C):

"The UK was one of the last countries in the western world to introduce a test for hepatitis C. Prior to the discovery of a specific test in 1989, many countries used surrogate tests. These tested people for raised ALT (liver enzyme) levels or hepatitis B. Although surrogate tests were crude and showed a high number of false positives, many countries thought it best to err on the side of caution."

"West Germany introduced a surrogate test in 1965."

"Other European countries such as Italy and France followed suit. The USA introduced surrogate tests in September 1986."

Note: Whilst the main thrust of this entry is to draw attention to the fact that West Germany introduced a surrogate test in 1965, we dispute the reference in the submission that a specific test for HCV was discovered in 1989. We firmly believe that the Chiron Corporation discovered, cloned and sequenced the Hepatitis C virus - the causative agent of Non-A Non-B Hepatitis (NANBH) two years earlier, in 1987. (see related entries link below.)

The first blood clotting products for haemophiliacs are produced.

The first commercial Factor VIII concentrate is produced by Baxter's Hyland division in 1966 to treat hemophilia.

There is now a Labour Government and Harold Wilson is in power. Kenneth Robinson is currently Minister of Health. He remains so until October 1968.

In 1968, a direct test for the presence of Hepatitis B (HBsAg), (Hepatitis B Surface Antigen) is developed and used to identify persons with the disease.

Richard Crossman becomes Secretary of State for Health and Social Services.

In a study published in 1969, Dr. J. Garrott Allen states that the laboratories of Hyland and Courtland in Los Angeles manufacture from large pools of blood taken from paid "skid row" donors – and because of the increased chance of viral agents being within the pooled blood, that it has to be heated for longer.

Allen also claims that he has been told that neither the National Research Council nor the Government Regulators have inspected the labs, and that there is evidence there that they are not performing within industry standards.

In the early 1970s it becomes clear that the world-renowned Lister Institute is not holding its own financially.

A study published in 1970 states that it only takes 1 unit of blood contaminated with hepatitis to infect the donor pool - even when diluted to 10 millionths, the hepatitis-tainted blood would still be infectious.

Four US-based pharmaceutical companies to distribute Factor VIII and Factor IX around the world.

The use of factor concentrates becomes more widespread.

Britain is importing huge quantities of Factor VIII from the USA.

In the early 1970’s, a test is not yet available for the Non-A Non-B Hepatitis virus, so the only means to prevent the virus from contaminating the US plasma supply is to exclude donors with lifestyles that were inconsistent with good health - precisely the populations from which US Pharmaceuticals companies allegedly recruit paid donors.

UK Clinicians are aware that there is a risk of Hepatitis being spread.

The Conservatives are now in power with Edward Heath as Prime minister. Keith Joseph becomes Secretary of State for Health and Social Services.

A letter from G. M. Bebb to Mr. K. A. Sidford shows that the government had knowledge of the viral risk of blood and blood products as well as the virulence of the HAA agent:

“An Advisory Group has recently been set up by the Department of Health under Dr Maycock’s chairmanship to make recommendations on the testing of blood donations for the presence of Hepatitis Associated Antigen (HAA) and it’s antibody.”

The agent is associated with widely reported deaths in renal failure units.

Screening for Hepatitis B becomes available.

Note: The screening of donated plasma for hepatitis B, (HBV) is introduced by BPL in November 1971.

In 1972, commercial factor VIII is imported from the USA into the United Kingdom for the first time.

The paper, entitled "Haemophilia Treatment in the United Kingdom from 1969 to 1974" by Rosemary Biggs, goes on to state that:

"It has been shown that such commercial blood has been 10 times more likely to transmit hepatitis than blood collected from unpaid donors by National Transfusions services." (Maycock 1972).

It becomes apparent that the production of factor VIII in the UK is insufficient to meet the stated needs of clinicians.

The UK starts to import Factor VIII products as early as 1973

Defendants, Bayer, Baxter, Armour & Alpha Therapeutic, (allegedly) purposefully seek out paid donors despite knowing that the risk of diseases transmissible by blood is far greater among paid donors than among volunteers.

In a DHSS letter from the Chief Medical Officer to all Senior Administrative Medical Officials, the impending availability of foreign human factor VIII concentrate is discussed:

"Product licences have very recently been granted to two firms which enable them to market foreign human AHG concentrate to hospitals and haemophilia centres in the UK. It has come to the notice of the Department that one of the firms is already engaged in active promotion of the very expensive product." (paragraph 3)

In a DHSS letter of 6 March 1973 from the Chief Medical Officer to all Senior Administrative Medical Officers, it is clear that the availability of American and Austrian commercially-produced Factor VIII concentrate is causing cost concerns for the Department:

"Product licences have very recently been granted to two firms which enable them to market foreign human AHG concentrate to hospitals and haemophilia centres in the UK." (page, paragraph 2)

"It has come to the notice of the Department that one of the firms is already engaged in active promotion of this expensive product. The firm has indicated that they can supply large quantities of human AHG concentrate and this could result in very significant expenditure if amounts were bought in excess of immediate needs." (page 2, paragraph 2)

"The Department hope to let you have a further statement soon. Meanwhile, in view of the impending availability of foreign human AHG concentrate and its very high cost, you may like to let all concerned with the treatment of haemophilia in your region know what is happening." (page 2, paragraph 6)

Note: There is no mention of safety concerns, only the usual emphasis on cost.

DHSS Haemophilia Expert Committee recommends 400,000 blood donations be used for Factor VIII, 275,000 donations as concentrate for the production of 12m iu Factor VIII.

DHSS Expert Group on the Treatment of Haemophilia recommends that the NHS should be self-sufficient in blood products as soon as possible.

In the recommendations of the DHSS Haemophilia Expert Committee on the Treatment of Haemophilia, under point 3, the following recommendation is made:

"At the same time the U.K. should aim to become self-sufficient as soon as possible by increasing home production of freeze-dried AHG concentrate." (page 4, point 3)

US National Blood Policy is adopted by the Federal Government in July 1973. It advocates conversion to an all-volunteer blood supply. The pharmaceuticals, however, not only continued to use paid donors, but also focus their recruiting efforts on the highest risk populations (allegedly).

Dr David Owen decides that if enough money is invested, the UK can become self-sufficient and blood would then come only from British sources and would be much more likely to not be contaminated.

David Owen announces in the House of Commons that several million pounds has been allocated - but the initiative does not follow through as there is considerable resistance in the Department of Health against putting in the money.

The World Health Organisation warns Britain in 1974 not to import blood from areas with a high prevalence of Hepatitis - areas such as the United States.

In a study from Dr. J. Garrott Allen of Stanford University Medical Centre, it states that "Cutter sources blood solely from Skid Row derelicts."

Commercial Factor VIII (introduced in 1972) has now grown to account for 13 per cent (13%) of the available clotting factors for persons with Haemophilia A.

Commercial Factor IX is currently available for purchase in the United Kingdom, but there is enough NHS Factor IX, and only small amounts of commercial Factor IX are required.

An alanine aminotransferase (“ALT”) test is available to test for elevated levels of liver enzymes called SGOT that indicate the presence of hepatitis.

US prisoners are associated with SGOT levels of over 60 IUs per ml, a level that increases the risk of non-A non-B hepatitis (later known as hepatitis C transmission) by a factor of 6.

Despite knowledge of this risk, the US Pharmaceuticals (allegedly) actively recruit PRISONERS for plasma to be used to manufacture Factor VIII and IX, whilst concealing or failing to disclose the risk to hemophiliacs (plaintiffs), their physicians, or the FDA.

Haemophilia Centre Doctors are reluctant to stop commercial import of products.

Centre Directors (consultants) sign up to receive products for trials.

Haemophilia Centre Directors meeting (with DHSS representative) endorses the Biggs MRC Working Party report recommending UK self-sufficiency on the grounds of cost. A need is recognised for a minimum of 38m to 53m iu products (550,000 to 750,000 donations) per annum, including 500,000 donations solely for concentrate.

Harold Wilson becomes Prime Minister for the Labour Party.

Barbara Castle is appointed Secretary of State for Health and Social Services.

David Owen is appointed Minister for Health. He is Minister for Health for some 26 months - until September 1976.

NANBH strain of hepatitis is first predicted by Prince et al.

The Minister of State earmarks central funds of £0.5m (half of which is to be recurring). This is to be used to increase the output of plasma from Regional Transfusion Centres (RTCs) to 275,000 blood donations annually for the preparation of factor VIII and 100,000 donations for cryoprecipitate.

DHSS letter to Regional Transfusion Directors explains that £0.5m has been allocated to make the UK self-sufficient in blood products aiming at using 275,000 donations for concentrate.

Dr J. Garrott Allen, of Stanford University California, writes to the head of the Transfusion Service in the United Kingdom to warn him of the dangers of using United States pooled plasma from high-risk paid donors.

Expert Group on the Treatment of Haemophilia estimates that 275,000 donations of blood will be required to achieve self-sufficiency in factor VIII.

While working in a laboratory in London in 1975, Australian virologist Yvonne Cossart discovers, quite by chance, the human Parvovirus B19. The virus can manifest in the following ways:

Fifth Disease (Erythema Infectiosum)
Fifth disease is a mild rash illness with a red, patchy, "slapped cheek" rash on the face. The rash may appear on other parts of the body, such as arms, torso, buttocks, and thighs. Other symptoms such as fever, headache, body ache, sore throat, congestion, runny nose, cough, nausea, or diarrhoea may come before the rash.

Arthritis
Parvovirus B19 can lead to a seronegative arthritis and joint pains in adults and possibly in children.

Foetal Anaemia in Pregnancy
"Parvovirus infection in pregnant women is associated with hydrops fetalis due to severe foetal anaemia, sometimes leading to miscarriage or stillbirth. The risk of foetal loss is about 10% if infection occurs before week 20 of pregnancy and especially between weeks 14-20, but is minimal after then. This risk may be reduced with correct diagnosis of the anaemia (by ultrasound scans) and treatment (by blood transfusions). Once the baby is born, there is evidence to suggest no developmental abnormalities due to B19 infection during pregnancy."

Chronic Anaemia in the Immunocompromised
In people with a compromised immune system, the B19 parvovirus can manifest clinically as chronic anaemia or pure red cell aplasia.

When commercial factor concentrates are introduced more widely between 1974-1975, there is a sudden exceptional spike of 5.2% in the yearly incidence of hepatitis. The yearly incidence otherwise remains roughly the same for 11 years between 1969 and 1980.

The Lister Institute of Preventative Medicine Chelsea laboratories are forced to close due to repeated annual deficits and failure to secure adequate government support.

Astonishingly, the government stopped funding the only research facility that could have developed heat-treatment and a screening test for Non-A Non-B hepatitis by as early as 1978.

Dr J Garrott Allen, (former Professor Of Surgery, Stanford University, USA), writes a letter to Dr William Maycock, Head of Blood Transfusion Service, warning of the risks of commercial blood, particularly with regard to non-A non-B hepatitis and that as far back as 1975, that paying blood donors tempts them to lie about their circumstances and that this can compromise safety.

"As you know, Cutter's product Konye, for Factor deficiency, has proved extraordinarily hazardous, a 50-90 percent rate of icteric hepatitis developing from it. About half of these cases prove fatal."

"Cutter's source of blood is 100 percent from Skid-Row derelicts (Transfusion: May/June, 1974)."

Note: It is sad to read of the detrimental consequences of the UK purchasing commercial Factor VIII and IX upon the USA's attempts to form their own volunteer donor programs.

Money that is apportioned off for the protection of haemophiliacs is “diverted to other purposes”. (Former Health Minister, Lord Owen speaking with reference to 1975, on the BBC's "Face the Facts" programme in August 2001).

On 22 January 1975, Dr David Owen as a Minister in the Department of Health and Social Security, announces to the House a programme to make the UK self-sufficient in blood products, particularly Factor VIII.

The DOH gives Regions provisional targets of increased production of plasma and invites estimates of the additional expenditure that will be incurred.

In a government Written Answer from 6 March, 1975, it clearly shows David Owen’s intention for the pledged £500,000 to increase production, not to increase donations; which is where it eventually ended up:

Dr David Owen: "As I told my hon Friend the Member for Sowerby on 17 February, I have authorised the allocation of special finance of up to £0.5m (about half of which would be recurring) to increase the existing production of AHG concentrate within the National Health Service with the aim of the NHS becoming self-sufficient as soon as possible" (final paragraph)

Note: This demonstrates government maladministration as the £500,000 was in fact used by the RTC, leaving BPL Elstree short-changed. The DHSS should have insisted on the extra money being allocated to its intended purpose - which was to fight this threat to public safety.

David Owen repeats that pledge of making the UK self-sufficient; when he said it, he had hoped that it would be done in 2 to 3 years.

World Health Organisation (WHO) issues a resolution stating that each country should be able to supply sufficient quantities of its own blood and blood products to meet clinical needs.

According to correspondence between J Walker SHHD and Health Board Secretaries, "In England and Wales the view is taken that in law the activities of health authorities attract Crown exemption so that the provisions of the Medicines Act are not binding on them. … arrangements are being made whereby health authorities will be brought within the licensing provisions of the Act in a manner analogous to that which applies to commercial pharmaceutical manufacture…"

Mannucci et al. report that 45% of patients with Non-A Non-B Hepatitis (NANBH) had raised ALT Levels.

In August 1975, Travenol withdraws Hemofil after the product is associated with an outbreak of Hepatitis B. It is recognised that commercial factor concentrates are associated with these outbreaks.

Dr Craske, et al, report in Lancet an outbreak of hepatitis in England that shows that commercial concentrate is more risky than NHS concentrate.

At a haemophilia centre in Bournemouth, there is an outbreak of hepatitis which is associated with 3 out of 4 batches of a commercial brand of freeze-dried factor VIII concentrate between the months of April and June 1974.

• 18 out of 20 patients receive commercial factor VIII
• 9 patients become ill out of a total of 18
• there are 4 cases of hepatitis B within 6 months of product use
• there are 7 cases of non-B hepatitis
• 2 of the patients contract both types of hepatitis

In the Autumn of 1975, there is an outbreak of hepatitis B infections among haemophiliac pupils at the Lord Mayor Treloar College in Alton, Hampshire.

We know from the witness testimony of a former pupil who was in his second year at the school in 1975, that the epidemic down in Alton concerned hepatitis B infections and the outbreak involved around ten boys from the school. One of them was in his dormitory and, by coincidence, the morning the outbreak was registered was the same morning of the school medical, and he woke up looking yellow-faced. The boys involved were informed that it would take around 6 months for them to fully recover.

Note: It is disconcerting to learn that all of the infected boys were forced to endure the stigma of having small red spots (as markers) put on their meal plates and were required to specifically hand their marked plates in to canteen staff, in person, in order for them to be sterilised.

A retrospective survey of cases of hepatitis associated with a commercial brand of factor VIII is carried out in 24 Haemophilia Centres in the UK from January 1974 until December 1975. Four of the suspect batches of concentrate are found to be positive for HBsAg.

• 371 patients are transfused with the commercial product
• There are 78 cases of hepatitis affecting 66 patients (17.7%)
• 1 patient dies after contracting Hepatitis B
• 12 patients contract 2 types of hepatitis: Non-B hepatitis, then HBV later on

BPL decides to increase donations. The pool size increases from 830 donations to 2,000 donations.

In 1976, only a few years after the factor concentrate products of Bayer, Baxter, Armour & Alpha Therapeutic go on the market, the United States Food and Drug Administration (“FDA”) Bureau of Biologics holds a Conference entitled 'Unsolved Therapeutic Problems in Hemophilia.'

The research articles compiled from the Conference discuss the high incidence in patients using these products of disorders such as liver dysfunction, enlarged spleen, Hepatitis B, and Non-A Non-B Hepatitis. The articles conclude that these disorders were tied to the patients’ use of factor concentrates, and emphasized the risks entailed in producing such concentrates using plasma from paid donors.

The Blood Transfusion Service Board manufactures "Anti-D" agent (from human blood) using blood products that originated from a donor who had jaundice.

Dr. McDonald, in a meeting of the HCDO, states that "commercial factor VIII was at present used in the West of Scotland. In 1976, 14% of all factor VIII was commercial." The supply of NHS factor VIII was increasing and in 1976, 46% of all factor VIII used was freeze dried NHS intermediate potency concentrate.

In a transcript of a Witness Seminar held at the Wellcome Institute for the History of Medicine which took place in London on 10 February 1998, Dr Helen Dodsworth refers (retrospectively) to her time in 1976 when she sat on a committee convened to advise the Department of Health on how much factor VIII concentrate was needed to treat patients in the UK:

Dr Dodsworth speaking in 1998 with reference to 1976: "Our spokesman, Dr Tovey, the Director of the Bristol Transfusion Centre, had been through a similar exercise for the World Health Organization in Geneva. He persuaded us that if we wanted to treat our patients adequately, it would be necessary to fractionate at least 80 per cent of the blood that was donated. At this point the Government decided that money was available for neither extending the fractionation unit at Elstree nor for equipping the transfusion centres to separate yet more plasma from donor units."

Dr Dodsworth speaking in 1998: "So this is really why we found ourselves buying large quantities of factor VIII concentrate from America, and why we infected so many of our patients with HIV."

In a DHSS memorandum of 20th February, 1976, the following is discussed with reference to Factor VIII concentrate:

"The line of reply from Oxford does not surprise me. They are correct in stating that they are a major producer of AHG without which the programme will founder, something we cannot possibly contemplate as the Minister of State has only recently reaffirmed his aim of NHS self-sufficiency in this substance. Quite apart from this, the alternative of buying the commercial product (with its higher hepatitis risk) is more costly than producing our own." (paragraph 1)

The MHRA grants a product licence for Factor VIII (PL 00231/0038 FACTORATE INJECTION - HEAT) to Armour Pharmaceutical Company Limited.

Note: The granting of this licence is one of the earliest Factor VIII product licences that we know of.

The licence documentation for this product clearly states the word "HEAT" in the description of the licence name. The word is in brackets but it appears that some text is missing, as the brackets are not closed. It is interesting to note the use of the word HEAT as early as March 1976.

DOH issues a press release re-affirming the aim of the UK to become self-sufficient in the supply of blood products by mid-1977.

James Callaghan becomes Prime Minister for Labour on 5th April 1976.

David Ennals becomes Secretary of State for Health and Social Services on 8 April, 1976 and remains so until 4th May,1979.

In a speech to the World Federation Haemophilia Congress, David Owen repeats the self-sufficiency pledge again, where he states that we hoped to be self-sufficient in blood products by mid-1977, he was not speaking in the House, so that statement did not bind successive Governments.

Note: The Government is, however, responsible for the two earlier pledges that were given in the House. The targets are not achieved and the UK is still not self-sufficient in blood products.

In a DHSS memo entitled "UK Aims to be Self-Sufficient in Supply of Blood Products", the following is stated by Dr. David Owen:

"Following a special allocation of £500,000 last year substantial progress was now being made in building up production capacity in the NHS, and self-sufficiency in home-produced Factor VIII was expected to be reached in mid-1977." (paragraph 3)

Note: The half million, (intended for building up capacity within the NHS) was, in fact, NOT used for building-up production capacity for self-sufficiency and instead ended up being paid out to increase the amount of people donating blood in the UK.

Expert Group on Haemophilia meets. The old target of 31m-34m iu is believed to be out-of-date. They agree to wait until the old target is achieved before reviewing the situation.

In the minutes of a meeting at the DHSS of the Expert Group on the Treatment of Haemophilia and Allied Conditions on 4th May, 1976, it was accepted that:

"There was no shortage of concentrate in the UK. Commercial producers could meet all the requirements likely to be made on them, on demand, but at considerable cost." (page 3, paragraph 1)

"It was suggested that the money at present being spent on commercial concentrate might be better spent if it was used to increase still further the output of NHS concentrate but it was generally agreed that money was not the only limiting factor. The Chairman drew attention to the fact that expenditure on commercial concentrate was continuing to rise even though more NHS concentrate was becoming available." (page 3, paragraph 2, lines 1-6)

The Department agreed to bear in mind the following:

"Of the English and Welsh Blood Transfusion Centres only Manchester RTC distributed commercial concentrate at present." (page 6, paragraph 2)

"The view was expressed that the purchase of commercial concentrate should be a Regional rather than an Area responsibility." (page, 6, paragraph 3)

DHSS realises need for comprehensive review of future needs of blood products and fractionation capacity.

In a document called "Blood Products and Plasma Fractionation Laboratories", it states on page 4 that there is an active collaboration between Elstree and Oxford in 3 clinical investigations (TRIALS):

"Trial of factor VIII concentrate in prophylaxis BPL Elstree, Lord Mayor Treloar College, Alton." (page 4, paragraph 4)

Note: We have to wonder whether the pupils' or parents' consent was gained prior to a trial being conducted in a school? Using a new medicine for the sake of improved health, or improved yield of Factor VIII is one thing, but using the new concentrates as part of trials connected to a collaborative study is quite another.

In a document entitled "Blood Products and Plasma Fractionation Laboratories" there is clear knowledge of the shortcomings of both BPL and the PF Laboratory in July 1976:

"PF Laboratory has been inspected. BPL will be visited in October." (page 7, paragraph 2, line 1)

"It is not unlikely that the accommodation of both laboratories will be criticised and, in certain respects, found inadequate. Both were designed before the Medicines Act was passed and therefore several years before those responsible for applying this Act had formulated the criteria to be met." (page 7, paragraph 3)

Note: It is quite disgusting that these failings at BPL Elstree coincide with the use of their factor VIII concentrates in trials involving children at the Treloar boarding school.

In a letter dated 12 August 1976, the target of factor VIII production from all sources was a usage of over 40 million international units per annum. Plans had been agreed to produce 35 million i.u. per annum. It was pointed out that in theory this level of production had already been achieved in England and Wales, assuming a yield of 60 i.u. of factor VIII activity per donation of plasma processed to cryoprecipitate.

"We know that in addition clinicians are buying and using or accumulating commercially produced factor VIII concentrate at the rate of 10 million i.u. per annum." (paragraph 3)

"There is some highly potent cryoprecipitate about. I understand that the Edgware product contains levels of 100 i.u. factor VIII or more consistently." (paragraph 4, lines 1 and 2)

The MHRA grants Porton Speywood Ltd a product licence for Factor VIII (PL 03070/0004 HUMANATE AHF CONCENTRATE).

Roland Moyle is appointed Minister for Health on 10 September 1976 and remains so until 4th April, 1979.

In October 1976, Dr Alan Dickinson, a veterinary scientist of the Agricultural Research Council, who is working on scrapie, telephones the MRC to alert officials to the risk of transmission of CJD through human growth hormone.

The MHRA grants a product licence to Baxter Healthcare Limited for Factor IX (PL 00116/0049 PROPLEX FACTOR IX COMPLEX.

In the minutes of the Central Committee for the National Blood Transfusion Service, under point 3.5 (item 10), testing for hepatitis B surface antigen and its antibody is discussed:

"With the agreement of the Advisory Group, the Department had decided that the recommendation to readmit to donor panels persons with a history of jaundice would be permissive; Regional Transfusion Directors could exercise their individual clinical judgement in the matter." (page 2, line 2)

Note: It is appalling to see that in 1976, the Department allowed the readmission of people with a history of jaundice to return to donor panels. We strongly disapprove of a decision which helped expose persons with haemophilia to hepatitis B.

6 women develop jaundice (later identified as Hepatitis C) shortly after giving birth, after having been treated with contaminated "Anti-D" which is derived from blood products.

The MRC human growth hormone programme is taken over by the Department of Health in 1977.

A report in 1977 by NHLBI (US) notes that albumin, another plasma product, is “heat treated to remove almost all danger of hepatitis.”

Several articles from a US Conference raise alarm over the unprecedented convergence of immune disorders in the US hemophiliac community, and there’s a call for close medical monitoring of the situation:

Dr. Peter Levine states, “One wonders whether our patients are suffering a sort of immune complex disease as a result of intensive bombardment with foreign antigens....”

Some consultants are in receipt of payments from companies producing Factor VIII products.

Dr Jones is a paid consultant to Hyland Laboratories in 1977.

Professor Blackburn reports that there is a hold-up in the expansion of fractionation in the UK. Prof. Blackburn is planning to organise a meeting to look into ways of expanding the facilities for fractionating.

Dr Waiter of DHSS tells Haemophilia Centre Directors’ meeting of a commitment to use the facilities at Liberton, Scotland.

In a meeting of the HCDO in 1977, Prof. Stewart of Middlesex Hospital Medical School, states that there is still a problem in finding distilled water to dissolve the NHS concentrate.

Prof. Stewart: "The commercial concentrates were supplied with water for solution which was an advantage." Dr. Ellis said that Elstree was looking into this problem and might in the future supply the water with the concentrate.

In a meeting of the HCDO in 1977, Prof. Blackburn states that it seems as if the PFC at Liberton Scotland has the capacity to supply factor VIII for the whole U.K.

Dr. Waiter states that plans have been made to divert plasma from South of the Border to Liberton when Mr. Watt is ready to receive it. The Factor VIII made from this plasma would return to Centres south of the Border. Agreement in principle has already been reached between the DHSS in London and the Scottish Home and Health Department.

Dr. Rainsford (of the Lord Mayor Treloar College, Hants), asks "if England and Wales would be charged for the use of the fractionation facilities in Scotland? If so, might it be as well to continue to buy commercial concentrates?"

In the minutes of a meeting of the HCDO on 13th January 1977, Dr Rainsford, of the Lord Mayor Treloar College, drew attention to the fact that the number of haemophilic boys applying for admission to the college had decreased and that there were only 4 applications that year compared with 7 the year before.

He wished to know if Haemophilia Centre Directors were changing their policy with regard to sending boys to the College. The comment was made that the decrease in haemophiliacs applying for admission was in all likelihood a reflection of the improvement in haemophilia treatment throughout the United Kingdom both at Centres and by home therapy.

Note: We would like to pose the question as to whether there some sort of agreement between Haemophilia Centre Directors that they would 'channel' their patients toward the school each year on behalf of Dr Rainsford?

Who, then, decided to send the haemophiliac boys to the school? Was it the Local Authorities, school headmasters, GPs or local haemophilia centre Consultants, or did the school approach families direct?

Background: Unfortunately, we have reason to believe that in some cases children were actually 'forced' to go to the school by their Local Education Authorities on the supposed grounds that it was the only way the LEA felt able to fulfil their legal obligation to provide an adequate education... and parents would have been 'forced' into it as well. Also, we would like to point out that some children with haemophilia came from unstable family backgrounds and were encouraged to be just dumped at the school.

In a letter in February 1977, Dr Alan Dickinson, veterinary scientist, makes 4 suggestions to improve the safety of the human growth hormone. Two suggestions are never acted upon, a third is only partly implemented, and the fourth - which is to exclude the use of pituitaries from cases with dementia - is not put into force until 1980.

In a DHSS letter of 2nd February 1977, a viability study of the world-renowned Lister Institute is discussed. The letter states that a conclusion has been reached:

"the Department should not on financial grounds make a loan or grant to [Lister?] and that the possible consequences of [Lister?] ceasing to produce sera and vaccines should be accepted". (Paragraph 1, lines 3-5)

"Nevertheless we should be faced with very real difficulties if [Lister?] were to be wound up" (Line 4 of paragraph 3)

"Any disruption in production during this interim period, which could well arise if we were forced to act too quickly, would probably cause clinicians to fall back on commercial suppliers of blood products, thus adding to the total cost of the NHS as well as inducing a setback for Ministers' policy of UK self-sufficiency in blood products production" (Last 6 lines of paragraph 3)

Note: This situation ended up with the Lister Institute's Elstree Lab closing in 1978 due to repeated annual deficits coupled with the need for major expenditure in order to modernise the production facilities. The Lister Institute was well-poised to possibly go on to develop heat-treatment or even a test for NANBH by as early as 1978 - if only the Government had made that loan or grant.

The MHRA grants Lister Institute of Preventative Medicine a product licence for Factor VIII (PL 00134/0007 HUMAN ANTIHAEMOPHILIC FRACTION).

The MHRA grants Lister Institute of Preventative Medicine a product licence for Dried Factor VIII Fraction (PL 00134/0008 OCTOCOG ALFA).

The Factor VIII production target that was set in the beginning of 1975 is attained; however demand has increased.

In a letter of June 1977 from the DHSS, entitled "The Distribution of Factor VIII", it states that:

"Biggs in her recent paper (B.Journ.Haemat. 1977,35,487) estimates the clinical demand for factor VIII at 50 million I.U. per annum in the UK of which at least half, and preferably all should be in the form of the concentrate." (Page 1, point 3.)