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

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.

"West Germany introduced a surrogate test in 1965."

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 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).

"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)

"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.

"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)

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.

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.

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.

• 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

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.

• 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

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."

"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)

"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.

"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)

"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.

"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.

"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)

"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.

"The case against the Government hinges upon the time it took to build a huge blood products laboratory at Elstree, Hertfordshire, which could have provided safe supplies of Factor VIII for British sufferers."

"The Labour Government announced in 1977 that the plant would be finished by 1979, and that Britain would be self-sufficient in blood products, and would no longer have to import any from the United States."

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.

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.

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?"

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.

"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.

"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.)

It is stated in the report, that this new type of hepatitis virus appears to be the most common form occurring after blood transfusion - in some areas. (Page 3, paragraph 4)

"...In view of these facts which, I am sure are well known to everyone, I am surprised that we are exercising our minds towards the improvement of a product which is destined for obsolescence..."

"Failure to do this is just delaying the inevitable. Probably, time and money would be better used in convincing the health departments to enlarge production facilities to obviate the use of foreign currency for purchase of commercial factor VIII."

"A final possibility is that, since the blood products would be emanating from the U.K. they would carry the cache of our good manufacturing practice. No product licence is required for the export of blood (unlike immunological products) but this subtle distinction between the holding of a manufacturers licence and the holding of a product licence would doubtless be missed by the purchaser overseas." (point C, line 3)

"It is my own view that assuming the company elect to go for the manufacture of blood products within the UK followed by export one should make it clear that inspection of the premises established in the UK would be very likely combined with inspection of the premises from which blood was obtained since these are part and parcel of the whole operation. This would certainly be so if product licenses were involved since blood as a raw material is caught under S.I. 1971 No. 1200." (page 2, lines 6-12)

"If this produces alarm and despondency in the hearts of Cutter Laboratories then it would appear that my suspicions are not unfounded and that the firm are trying to dodge tighter requirements in the interests of making a PROFIT disregarding safety." (page 2, from line 12)

Note: What on earth were Medicines Division doing even considering the exportation of blood products overseas when the UK hadn't got anywhere near enough for their own haemophiliacs? This is hard to comprehend in light of the DOH press release of April 1976 where they re-affirmed the aim of the UK to become self-sufficient in the supply of blood products by mid-1977. (see related entries link below)

It's a great shame the DHSS couldn't have concentrated on getting the UK self-sufficient before looking into the idea of exporting blood products.

"The Working Party has been informed of 3 cases of hepatitis in haemophiliacs who had previously received treatment with concentrates which included (amongst others) Armour "Factorate" Batch R8212."

"The non-A non-B agent has not yet been purified from the livers of infected individuals or animals, or from the stool."

"Most recently it has been reported that the non-A non-B agent has been transmitted to chimpanzees. There is a preliminary report that the non-A, non-B agent has been visualized by electron microscopy in the livers of chimpanzees. This, however, needs further documentation. While the chimpanzee is a clumsy experimental animal, this will provide new opportunities for characterization of the agent."

Note: It is disconcerting to read of such a lack of respect for research animals that would eventually give their lives to such experiments. Also, in such a context, it is worrying to see mention of the livers of ‘individuals’ ploughed straight into in the same sentence as ‘animals’ or ‘the stool’.

"He felt that, at present, chimpanzees were the only possible source of reliable antigens and antisera. These animals were, however, expensive, their supply was limited, and maintenance costs were high." (Page 2, Paragraph 5)

"[Deleted Name] pointed out that it remained uncertain whether non-A non-B hepatitis virus was present in the British population and asked whether blood products of British origin were causing non-A, non-B hepatitis." (Page 3, paragraph 3)

Note: On the last page, reference is made to how few infections British Blood was causing. This clearly shows why self-sufficiency should have been achieved. The bottom line is that we all know how research is the only way to progress with any Public Health safety issue, but if the will and money had been made available, we could have achieved the same information via British donations and reduced total infections by at least 80%.

Dr Aronstam strongly disagrees with the PHLS suggestion:

"We have not had any cases of hepatitis following N.H.S. Factor VIII. As far as your suggestion about transfusing mild haemophiliacs with this material is concerned, I totally disagree with this concept. I do not wish any of my mild haemophiliacs to develop hepatitis in any form and therefore adopt the policy of either using D.D.A.V.P. or Cryoprecipitate."

Note: It should be pointed out that the Lord Mayor Treloar College was in fact a boarding school for children. It is disturbing to read that the PHLS were trying to persuade the school to adopt some other type of Factor VIII material which would have caused the pupils to develop hepatitis.

What on earth was the PHLS doing contacting a school to 'promote' hazardous medicines?

"Some patients who have received commercial factor VIII since 1.1.80 will already have contracted HTLV-3 infection from other infected batches."

Here's a quick summary of the main aspects of our concerns about Cryosan:

• Cryosan Ltd., a blood-broker, obtained blood from Russian cadavers [1]
• They re-labelled the blood as having originated from Swedish donors [1,12]
• Cryosan Ltd. repackaged out-of-date blood & exported it to Europe [13,16]
• They ran a 'vampire operation' in Bogata & sourced from Haitian slums [12,13]
• Cryosan Ltd. also shipped contaminated Arkansas prison blood [12,19,21]
• Cryosan pleaded guilty to false re-labelling and was fined in 1980 [1,13]
• Cryosan shipped huge quantities of plasma to Travenol in Belgium [14,15,17]
• Over 11 million i.u. of Travenol’s Hemofil and Interhem Factor VIII were imported into the United Kingdom between 1980 and 1981 [18]

NOTE: Taintedblood would like to know the exact origin of the source-plasma for this factor VIII...

Numbered sources listed above are available from the SSCM Website: www.slowlyslowlycatchymonkey.com

"There was a problem of non-A, non-B hepatitis related to freeze-dried factor VIII and IX, both of NHS and commercial types imported from Austria and the USA. ...[Deleted name] described a recent study at the Royal Free Hospital of 11 selected patients of whom 8 received commercial concentrate, 2 NHS concentrate, and 1 cryoprecipitate." (page 2, paragraph 4, lines 1-6)

"Experiments so far showed that there were probably 2 types of non-A, non-B hepatitis associated with factor VIII. The second type had been produced by the same batch of 'HEMOFIL' which was associated with the Bournemouth outbreak in 1974." (Page 3, point 4)

Note: These minutes also show that Factor IX was being made by Immuno Ltd. in Austria; which would therefore constitute a commercial import with regards to Factor IX. (Page 3, point 3.4)

Note: We would like to draw attention to the fact that the Immuno is listed here as manufacturing a Factor VIII product under the trade name Kryobulin. As we are aware that Immuno Ltd. was a commercial company, we can safely describe 'Kryobulin' as a commercial product. (See the additional source and the related entries link below).

"It is vital to recognise that these products carry an inherent risk for the recipient which is quite independent of any system of quality control of the manufacturing process. The acceptability of this risk is the basis of modern, life-support therapy, which enables doctors to treat previously fatal conditions."

In the case of the use of imported commercial blood products the source plasma was not given freely, but paid for, so physicians and the Blood Transfusion Service could not enjoy their usual exclusion from any liability. Also, consultants who were using the commercial Factor VIII concentrates were able to by-pass the public bodies set up to protect the patient.

Note: In trials involving infrequently treated patients, doctors could loose their protection under the rules of "Life-support therapy" if the majority of the patients included were not severe haemophiliacs.

Background: When a doctor treats a patient (without consultation) on the basis that they meet the criteria of research such as previously untreated patients "PUPs", we would suggest that they contradict, or even compromise their Hippocratic Oath by letting the research dictate clinical need.

"On the question of the use of foreign plasma members agreed that because of the risk of contamination, imported plasma from paid donors should not be processed in [the] same plant as UK plasma. However, if industry were to function at ECONOMICAL capacity there might be no alternative but to allow it to fractionate imported plasma from overseas unpaid donors such as that which might be provided by voluntary transfusion services."

"The two types of plasma and finished product would have to be kept separate at all stages and there might have to be separate quality control arrangements. It was thought that monitoring such an arrangement would not be easy." (page 3, paragraph 5)

Note: These comments make it abundantly clear exactly how much the DHSS knew about the risk of contamination from imported plasma from paid donors. They knew about the risks in 1980. In fact, we know that they were warned in January 1975 about the dangers of sourcing commercial blood from paid donors. Now we have it documented, complete with names of attendees, that they knew for sure in 1980 - so there should be no more denials and pathetic statements about 'no wrongful practices' and no more excuses about being caught unawares by the ensuing AIDS crisis.

Under the heading 'Technology' on page 2, we learn of further evidence of an early awareness of the possibility of genetic engineering: "The method of fractionation should be negotiable; (in 5-8 years' time, fractionation by genetic engineering could be the more effective technology.)"

Note: It never ceases to amaze us as to exactly how far back in time the awareness within industry and the DHSS of the process of genetic engineering of synthetic factor concentrates actually goes. We are now able to trace this knowledge right back to March 1980.

"The alternative will then be to import NHS requirements if such supplies are indeed available, and there are also grave doubts whether quality of overseas production will be acceptable. My experience of overseas plants generally leads me to believe that quality standards will be no better than those at BPL. Some of the Elstree staff told us that on recent visits to the USA they had visited fractionation plants in which the manufacturing conditions were worse than those at BPL." (pages 2, paragraph 1)

"The cleaning specifications which we agreed was the best that could be achieved in an unsatisfactory building. It is false and dangerous to imply that the revised cleaning programme has produced a safe system." (page 2, final paragraph)

The following was recorded in writing by Dr Walford in 1980: "I must emphasise that 90% of all post-transfusion (and blood-product infusion) hepatitis in the USA and elsewhere is caused by non-A, non-B hepatitis viruses which (unlike Hepatitis B) cannot, at present, be detected by testing donor blood."

Campaigner and researcher Carol Grayson (who sourced this letter), identifies in her MA dissertation the anomaly of why the DOH Self-Sufficiency Report into Blood Products of 2006 insists that the prevailing medical opinion in the 1970s and the early 1980s was that NANBH was "mild and often asymptomatic", when it is quite clear that Dr Diana Walford was fully aware in 1980 that 90% of hepatitis was caused by NANBH and could be rapidly fatal.

NOTE: We would like to draw attention to the level of knowledge that the DHSS possessed in 1980. This is the knowledge they had then; the very same information that the haemophiliac community are only discovering now. However, this is not a question of government only having the ability to understand the situation with regard to fatalities from viral hepatitis after they had happened, this letter of 1980 demonstrates full comprehension by the DHSS of the gravamen of such infections from commercial imports. Therefore, we must ask why any preventative action wasn't taken by the DOH and why was it that a complete myth was somehow propagated that NANBH was "mild and often asymptomatic"?

Dr Peter Jones: "What should have been put in is something more in the region of £25 million..." (page 4, paragraph 2)

Reporter [with reference to hepatitis]: "Research has shown that haemophiliacs are TEN times more likely to contract the disease if they use commercial imports, rather than National Health Service material." (page 11, paragraph 6)

Reporter's Closing Comment: "The Department says there's no money available. That means hospitals will spend millions more on imports, patients will risk the consequences of skid row blood and Britain will become increasingly dependent on the world blood market." (page 16)

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.

"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.

Sir George Young's warning was reported the following month in the Sunday Telegraph (on 01.02.81) in an article entitled: "10 Sick After Factor 8 Doses". The article goes on to say:

"Imports worth an estimated £10 million of Factor 8, the missing factor in a haemophiliac's blood, come from America, Germany and Austria in powdered form to supplement the limited amount made in Britain."

Dr Charles Rizza: "There might be a greater degree of risk from commercial products."

"The National Institute for Biological Standards and Control, [NIBSC] which tests all foreign blood products imported by Britain, rejects a "small amount," believed to be about 5%, of the millions of bottles of Factor 8 brought in each year."

They were only children, aged between 9 and 14.

In February 1981, 10 children at the Treloar specialist school in Alton, Hampshire are infected with hepatitis from contaminated Factor VIII in what we believe to be a second outbreak of hepatitis B. There then follows a warning regarding infected Factor VIII supplies being imported from the USA.

The Department of Health admitted at the time that they knew there was a risk of infection and the then Health Minister, Dr Gerard Vaughan, claimed that the £1.29m being invested in the BPL Elstree would resolve the problem.

Note: We have to wonder if this second outbreak of hepatitis was as a direct consequence of an approach made by the Public Health Laboratory Service (PHLS) two years earlier on 14th May 1979? We can determine from documentation that there was the intention from the PHLS of transfusing mild haemophiliacs with a Factor VIII 'material' which would have caused mild haemophiliac children to go on to develop hepatitis.

In a reply letter of May 1979 to the PHLS from Dr A. Aronstam of the Lord Mayor Treloar Hospital, we read that Dr Aronstam totally disagreed with the PHLS suggested 'concept' and he adamantly stated that he did not wish any of his mild haemophiliacs to develop hepatitis in any form.

Factor VIII: "It has been decided to make special arrangements for one unit only - the Lord Mayor Treloar Hospital in Wessex whose residential 'school' caters for 40 severe haemophiliac pupils drawn from all over the country. The Hospital will receive an allocation of 300,000 international units of Factor VIII per annum calculated on the basis that the Blood Products Laboratory (BPL) currently produces approximately 7,500 units per severe haemophiliac." (point 2.)

BPL aims initially to return to Regions 80% of the notional gross yield. This equates roughly with the present production levels. The remaining Factor VIII will be used to build up a necessary reserve stock and to meet the allocation for the Lord Mayor Treloar Hospital. (point 3.)

Factor IX: "Treasurers will wish to note that since we are currently self-sufficient in Factor IX and production is expected to keep pace with demand for the foreseeable future, it has been decided to exclude this product from the pro rata system." (point 5.)

Note: This is a useful document for several reasons. Here we have written proof that the Lord Mayor Treloar School was indeed catering for severe haemophiliac pupils, therefore confirming the age-range and we are also given a figure for how many - 40 haemophiliac pupils in 1981.

We are also interested to read that BPL will supply RTCs with certain blood products, such as Factor VIII, by proportional distribution to their input of plasma and that this system excludes Factor IX.

Mr. Race Oral Question, May 1983: "As the House of Commons' favourite own-goal merchant, the Minister for Consumer Affairs, was warned two years ago by his own Department of the danger of contaminated blood supplies coming from the United States, will the Prime Minister rectify that deplorable and disgraceful mistake by immediately authorizing the necessary expenditure within the National Health Service to make Britain independent in its blood supplies?" (see first column, para 9.)

Manufacture of Products by Genetic Engineering

"At the last meeting of the PSG it was asked whether the redevelopment of BPL would be permitted to produce genetically engineered material in direct competition with Industry."

"As a general principle Ministers are not in favour of NHS facilities engaging in activities which Industry is competent to perform. This does not preclude involvement in product development but, with certain exceptions (eg products derived from human substances) manufacture of products which are or will be available commercially is difficult to justify."

Dr Gerard Vaughan: "I appreciate your Society's concern about the extent to which the NHS relies upon commercial blood products. As I told you, the upgrading programme being carried out at the Blood Products Laboratory at Elstree will, at present yields, enable the Laboratory to double its output of Factor VIII to 30 million international units by the end of 1982."

Dr Gerard Vaughan: "While this will not eliminate the need for commercial products, it represents a major step forward in NHS production of the vital material."

"The use of animal models for infectivity study purposes was discussed. Chimpanzees would cost £10,000 per animal test per 6 months. If humans were used it would not be possible to have a "known positive" control. The methods of inactivation available were heat treatment; irradiation or absorption." (Page 5, paragraph 1, line 4)

"It was agreed that infectivity was the crucial question and the dilemma over the use of chimps (an endangered species), owl monkeys (information to be supplied by Dr Sommerville when available) and humans formed the basis of a long discussion." (Page 5, paragraph 2, line 7)

Note: It is disconcerting to read of infectivity study models involving human beings. We would have said that the crucial question should have been over the use of humans in infectivity studies. Did they carry this out, or was it just a discussion of what these doctors thought their options were?

"It is clear that chimpanzees can be used at a much younger age than was previously mentioned (2 yrs vs. 3 years). It is also rumoured that NIH costs (contracted to a colony in U.S.) are lower than those in Liberia." (Page 4, point b)

On page 5, under the heading "Procurement of Infective Material" we read that:

"Various people were contacted in the U.K., but none had much to offer. C. Rizza in conjunction with J. Craske are running a prospective trial of "first time" haemophiliacs receiving NHS and commercial concentrates." (Page 5, point 3.)

Note: We have to ask what the reference to "first time" haemophiliacs really means in practice? We would suggest that in order to meet the criteria for trials such as this, the haemophiliac subjects should not have been exposed to large pool concentrates - which would almost certainly mean that they were either a young child PUPs (Previously Untreated Patients), or moderate to mild haemophiliacs, who were again likely to be children, but might also have been adults.

Note:
Perhaps the question should be posed as to whether the medical profession knew that haemophiliacs already had antibodies to Hepatitis B? Yet, the profession’s desire to amass research through trials on PUPs (Previously Untreated Patients) prevailed.

"Doubts have been raised now about the project, triggered by difficulties with the inactivation process necessary to render any such vaccine non-infective from free virus and by recent concern over the possibility of transmission of AIDS (Acquired Immune Deficiency Syndrome) via the human plasma from which the vaccine is derived."

We can date the source document for this information, since on page 4, under the paragraph with the heading: "Present Situation" we learn that the circular was written sometime in June 1982, and that Dr. Harris, then DCMO, was considering the importation of a US vaccine.

Note: The DHSS seemed more concerned with commercial interests - like whether to continue with the financial contribution they had been making towards the development of a plasma-derived Hepatitis B vaccine which they could exploit commercially - than the safety of products made from source-plasma obtained in questionable circumstances:

"...This is due to concern which has arisen about the possible transmission of AIDS in plasma-derived products, in circumstances where the blood donors likely to be the most productive sources of hepatitis B surface antigen happen often to be individuals at risk of developing AIDS."

"....plasma taken from homosexual drug-takers contains a sort of virus which goes undetected when the plasma is tested because it is suppressed by the drugs. However, when used for Factor VIII, it becomes active again."

The DHSS letter states that information has been received from the American Bureau of Biologics (via NIBSC) indicating there may be considerable publicity in the next couple of weeks concerning the safety of American Factor VIII.

From the following comment, it appears the DHSS are complacent at this stage:

"In any case with our voluntary unpaid donor system we do not have the same problems as in the States where drug addicts are tempted to give blood simply for the money. However, about half of the Factor VIII bought from commercial companies is imported from the USA.”

Note: In terms of knowledge in the United Kingdom, this is one of the earlier dates (16 July 1982) which demonstrates that the DHSS had advance ‘private’ knowledge of the safety risks from US commercial factor VIII almost 10 months earlier than we previously thought. This DHSS letter went out 1 year prior to the infamous July 1983 CSM meeting (reported in the Guardian by Sarah Hall on Friday May 25, 2007).

A trial is to be conducted at Oxford involving Haemophilia A patients, whereby the vaccine is to be administered by subcutaneous route.

Note: The requirement of an autopsy is applied to ALL persons with haemophilia who have died. There is nothing in the minutes which indicates that the cause of death is taken into account.

Dr Craske is tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States. HCDO minutes state that: "It appeared that there was a remote possibility that commercial blood products had been involved."

Note: Despite Dr. Edward Shanbrom patenting and proposing the process to US industry in 1980, solvent detergents are not widely taken up by the leading pharmaceutical companies until 1987.

"Since there are as yet no confirmed laboratory tests available for non-A, non-B hepatitis the only sure way of assessing the risk of transfusion hepatitis associated with new brands of concentrate where attempts have been made to inactivate hepatitis viruses by heat, ultra-violet light and propiolactone or other methods, is by use of chimpanzee inoculation experiments, or TRIALS of each product compared with an UNTREATED product in a group subjects where the susceptibility to hepatitis is known to be high. We have demonstrated such a group in the patients with mild coagulation defects already studied at Oxford. (Page 1, paragraph 4)

"Some children with cirrhosis have received concentrate for 6-7 years. (Page 2, under "Complications", 16 lines from the bottom of the page.)

Note: The worst thing we are seeing here is that it is seems to be acceptable to these physicians that CHILDREN should have cirrhosis. It should be noted that this is coming from the very people who said that they weren't aware or didn't think that hepatitis was a serious problem.

On reading the circular, we discover that highly purified genetically-engineered Factor VIIIc was already being produced by a team at the Royal Free Hospital and that Genentech owned the RF method. We also read that Speywood signed a collaboration agreement with Genentech in relation to genetic engineering of FVIII.

At the end of the circular, under 'STOP PRESS', we read an alarming statement by the DHSS that they thought there could be valuable spin-off from a story in The Times. The DHSS state that they thought it should prompt the CBLA into examining its proposed investment in light of current developments in genetic engineering:

The DHSS in 1982: "I feel that the sooner this exercise is done the better in order to reassure our financial colleagues and the Treasury - otherwise each new reported 'break-through' will have them rushing to cancel the cheques!"

Note: Rather disgracefully, it took another 12 years for recombinant clotting factors (made synthetically) to be licensed for use within the UK in 1994. Compare this with Hyland running human clinical trials of their recombinant Factor VIII as early as 1987, just over 4 years from the date of this DHSS circular.

From the point of being licensed, why did Government take another 12 years (right up to 2006) to make the safe product available to all adult haemophiliacs across the UK?

From 1982, that's a grand total of 24 years of delays.

"Manufacturers entering the trial should undertake to make positive contributions of data and financial support in return for a properly conducted trial in a well-documented community of haemophiliacs."

"It is realised that overseas producers do not have access to trial facilities of equivalent quality and veracity elsewhere." (Page 2)

Note: Again, not enough emphasis on product safety, moreover, we see only cost concerns and world market trends being placed over and above patient safety. Clearly, trials were not being conducted in the product manufacturer's country of origin, for example, the United States, because they knew all too well that such trials would not have been permitted within their law.

His inadequate solution reads as follows: "The problem related to the investigation of factor VIII related Acquired Immune Deficiency Syndrome (AIDS) has been satisfactorily resolved. We will report any patient detected in the U.K. who has received U.K. commercial factor VIII direct to the C.D.C. and will at the same time notify C.D.S.C. at Colindale."

Background: On 13 September 1982, Dr Craske was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States. The HCDO minutes stated that: "It appeared that there was a remote possibility that commercial blood products had been involved." We hardly think that putting in place a simple detection and reporting protocol could be considered a satisfactory resolution to the problems surrounding AIDS and commercial factor VIII. We are appalled that more wasn't done.

Note: The reference on the letter from the PHLS of 10th January 1982, shows the letters "JC", which we believe are the initials for Dr John Craske.

• failure to provide adequate details on the manufacturing process
• failure to provide adequate evidence of the product's efficacy
• failure to provide evidence that the cryoprecipitate was at least equivalent in quality to that used for the manufacture of Alpha's factor VIII
• there should be an undertaking offered that a donor list will be available to the manufacturer.

"The object of the study will be explained to them, and their consent or that of their parents obtained, if under 16 years of age."

"You will see that the class of patients to be given these products are those who have had no previous treatment with factor VIII concentrate."

"It is likely that there are only a limited number of these patients in the U.K. who will require factor VIII therapy in any one year. We will be grateful if you notify Dr. J. Craske of any approaches from commercial firms with a proposal to evaluate their product."

Note: This is really damning evidence. It is monstrous that the PHLS are still actively looking for both Previously Untreated Patients (PUPs) and inviting approaches from commercial firms as late as March 1983 in order to expose previously untreated patients to hepatitis for the sake of their trials, especially whilst Dr Craske categorically had knowledge of AIDS from 13th September 1982; at which point, he was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States where there was the 'remote' possibility that commercial blood products had been involved.

The following is stated: "Attached are letters recently released by FDA, on or about the 17th March 1983. You will see that the US are taking steps to avoid the use of blood from high risk groups in the preparation of certain blood products."

It is reported by all Directors present that sessions were held in penal institutions in all regions.

"These observations are consistent with the hypothesis that AIDS is caused by a transmissible agent, presumably a virus, that can be included in blood products, and that some recipients of the agent have not (at least not yet) developed the complete clinical syndrome with its devastating complications."

"These alternative hypotheses might be distinguished through a study of T-lymphocyte subpopulations among similarly treated haemophiliacs in a geographical area to which AIDS has not yet been introduced. The resolution of this question by a timely investigation in some country, where cases of AIDS have not yet been reported would be an immense help to public health workers worldwide. In this situation "negative results" would be of great significance."

NOTE: Please click the 'Find Related Entries' link below to see how this Timeline entry relates to the one for 10th October 1983 regarding the Medical Research Council. It appears that Dr Gordon's letter somehow managed to engender a controlled AIDS study of UK Haemophiliacs; the Edinburgh Haemophiliac Cohort; a study which we believe to have been entirely unethical. TaintedBlood has members who have testified at the Archer Inquiry where they expressed belief that their infections where acquired as a result of this study. (see 2nd link below)

Mr. Race: "As the House of Commons' favourite own-goal merchant, the Minister for Consumer Affairs, was warned two years ago by his own Department of the danger of contaminated blood supplies coming from the United States, will the Prime Minister rectify that deplorable and disgraceful mistake by immediately authorizing the necessary expenditure within the National Health Service to make Britain independent in its blood supplies?" (see first column, para 9.)

Note: This Oral Question reveals that Dr Gerard Vaughan, then Minister for Health, knew sometime in 1981, possibly from as early as May, of the threat of contaminated blood supplies which were being imported from the United States. This is one of the earliest warnings that we are aware of so far and we are astonished to learn of how early this awareness was, and that so little was done. Clearly, we are not being told everything.

We would like to comment in turn on the following statements made by Professor Bloom:

Bloom: "Haemophiliacs, their parents and doctors have always balanced the quality of life and the dangers from bleeding against the risks of treatment."

Note: TRUE regarding the balancing act. But we would have to state that we were not always informed of the risks, in fact, hardly ever, if at all. We know that trials of 'Hepatitis Reduced' Factor VIII were still being planned as late as 22nd March 1983 (after the UKHCDO suspected the link between AIDS and Factor VIII) and that the PHLS were still actively looking for Previously Untreated Patients (PUPs) and courting approaches from commercial firms in order to expose previously untreated patients to hepatitis for the sake of trials.

Bloom: "The cause of AIDS is quite unknown and it has not been proven to result from transmission of a specific infective agent in blood products."

Note: We must take exception with this based upon documented evidence regarding exactly what Professor Bloom knew or strongly suspected at that time. Professor Bloom was Chairman of the UKHCDO at the 13th September 1982 meeting; which was 8 months earlier. It is minuted on page 10, paragraph 3, that Dr Craske was tasked with looking into reports of the syndrome in 3 haemophiliacs from the USA and that it appeared that there was a remote possibility that commercial blood products had been involved.

Bloom: "In addition the importation of licensed blood products has always been strictly monitored and controlled."

Note: We find this shocking statement to be both inaccurate and misleading. We know from the 11 January 1982 Oxford Letter that Professor Bloom had an excellent understanding of the 'named patient' basis and had discussed plans to request exemption from a Clinical Trials Certificate in respect of individual products in order to expedite trials.

This man had been infused with American Factor VIII.

"... I have reviewed the literature and come to the conclusion that all blood products made from blood donated in the USA after 1978 should be withdrawn from use until the risk of AIDS transmission by these products has been clarified. Appended is a paper in which I set out my reasons for making this proposal. Perhaps the subject could be discussed at an early meeting with haematologists, virologists and others concerned so that a decision may be made as soon as possible."

"In conclusion, I say that I am most surprised that the USA manufacturers of the implicated blood products have not informed their customers of this new hazard. I assume no critical warning has been received in the United Kingdom?"

Note: Why did the DHSS not agree with PHLS (CDSC)? After all, the PHLS were the people who should have had the last word.

IMPORT OF BLOOD PRODUCTS

"Imports of blood products into the United Kingdom for medicinal purposes have to be licensed under the Medicines Act 1958. Licensed products must satisfy the requirements of the Act for safety quality and efficacy."

"It is made a condition of product licences in this field that the licence holder exercises proper quality control, which involves accounting for the source and quality of the blood, its processing and final product examination. On all blood products the licensing authority imposes a "batch release" condition under which samples must be supplied for testing by the National Institute for Biological Standards and Control." [NIBSC]

"Although all medicinal products require a product licence if they are to be promoted for medicinal use, a doctor may prescribe an unlicensed product provided this is on what is known as a "named patient" basis."

Nevertheless, the DHSS appear to take little notice:

"In my view this suggestion is premature in relation to the evidence and unbalanced in that it does not take into account the risks to haemophiliacs of withdrawing a major source of their FVIII supplies".

Note: Where were the DHSS obtaining their medical advice? The HCDO had already had 9 months to consider the problem of imported Factor VIII as Dr Craske had been specifically tasked by the HCDO with looking into reports of AIDS in 3 haemophiliacs from the United States - this was in September 1982. Dr Craske, at that time, had suspected a link to commercial Factor VIII and this was minuted.

"It was agreed that there was insufficient information available from the U.S. experience to warrant changing the type of concentrate used in any particular patient. Moreover once the condition is fully developed it seems to be irreversible so that there would seem to be no clinical benefit to be gained by changing to another type of factor VIII." (page 2, paragraph 2)

"With regard to general policy to be followed in the use of factor VIII concentrates, it was noted that many directors have up until now reserved a supply of National Health Service concentrates for children and mildly affected haemophiliacs and it was considered that it would be circumspect to continue with that policy. It was also agreed that there was, as yet, insufficient evidence to warrant restriction of the use of imported concentrate in other patients in view of the immense benefits of therapy." (page 2, paragraph 3)

Prior to this meeting, physicians should reasonably have known the following:

• As early as 13th September 1982, Dr J. Craske was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States, and he suspected a remote possibility that commercial blood products were involved.
• On 15th January 1983, there had been an article in the Lancet by Dr Jones (a member of the UKHCDO) where AIDS had been linked to common cell immunity in haemophiliacs.
• By March 1983, the Directors of Haemophilia Centres were requested to report any cases of AIDS in haemophilia patients to the Oxford centre, to then be relayed to the Communicable Disease Surveillance Centre.
• On 23rd March 1983, in the USA, FDA regulations for the collection of plasma excluding donors from high-risk groups were introduced. However, use of pre-March 1983 stock was unfortunately NOT banned due to supply concerns.
• On 6th May 1983, the UK's CDSC telephoned the DHSS to inform them that a 23 year old haemophiliac patient from Cardiff was now showing symptoms of an AIDS diagnosis after having been infused with US Factor VIII.
• On 9th May 1983, the CDSC had written a crucial letter recommending that American FVIII should be withdrawn from use due to the risk of transmitting AIDS.

The only exception the Directors made was to continue with their policy of only using NHS material for children under the age of 4 and for mild haemophiliacs.

Background: Why didn’t the Directors of Haemophilia Centres try and do more to ban imported Factor VIII concentrate? They appear to have ignored the following warnings:

• Dr Craske had been tasked by the HCDO with looking into reports of the syndrome in 3 haemophiliacs from the United States a whole 9 months before (in September 1982) and he suspected a link to commercial Factor VIII.
• 5 months earlier, (January 1983) there had been an article in the Lancet by Dr Jones (also HCDO), where AIDS was linked to common cell immunity in haemophiliacs.
• The FDA requirements on blood donations had already been introduced on 23rd March 1983 – this was 2 months before this decision.
• On 6th May, (1 week earlier) the CDSC telephoned the DHSS to inform them that a 23 year old haemophiliac patient in Cardiff was now showing symptoms of an AIDS diagnosis after having been infused with US Factor VIII.
• On 9th May 1983, (4 days earlier), the CDSC had written a letter recommending that American FVIII should be withdrawn from use due to the risk of transmitting AIDS. The DHSS definitely had sight of this CDSC letter by 13th May 1983.

"Products manufactured from plasma taken before the new regulations were introduced have to be labelled to indicate this." "However, the UK product licenses do not contain this requirement and there are fears among haemophilia centre directors that the more "dangerous" material may be dumped in the UK."

• To take all necessary steps and measures in respect of AIDS.
• To avoid the use of coagulation factor products from large plasma pools, except when such a product is specifically indicated for medical reasons; this is especially important for those countries where self-sufficiency in the production of such products has not been achieved.
• To inform attending physicians and selected recipients, such as haemophiliacs, of the potential health hazards of haemotherapy and the possibility of minimising these risks.
• To provide all donors with information on AIDS, so that those in high risk groups will refrain from donating.
• To pursue rapid and full implementation of recommendations of R(80)5 and R(81)14.

• The significance of AIDS to the Committee was in relation to the effects with respect to the transfusion of blood and blood products, particularly with coagulation factor concentrates given to patients suffering from haemophilia. Absolute proof that AIDS is cause by a transmissible infectious agent is not yet available, but the consensus in the Committee was that it should be regarded as such that a recommendation should be made to the Council of Ministers at the meeting in June to take necessary steps to minimize the transmission of AIDS by the transfusion of blood products. (page 1, paragraph 4)
• With respect to the importation of plasma products, particularly from the USA, I find it difficult to believe that these can be phased out in the near future, since the Haemophilia Directors have always maintained that they require up to 100 per cent more Factor VIII for the treatment of haemophilia than can be produced from BPL. No doubt the opinion of the CBLA will be sought on these aspects. (page 2, point 4)
• It is important, I think to avoid "emotive over-reaction" amongst recipients, a phrase which will also appear in the recommendations. (page 2, final paragraph.)
• As will be evident from the above, the implications of AIDS in various aspects of blood transfusion practice kept appearing. Undoubtedly it is an important disease with a high mortality rate which has attracted considerable press publicity. Whilst it has not yet reached proportions in Europe as it has in the USA many members of the Committee considered that we may be seeing the beginnings of a problem which could escalate if appropriate steps are not taken now. (page 3, final paragraph)

"I do not think that anyone is complacent about the situation but I think that we all agree that it would be counter-productive to ban the importation of blood products at this moment." (Line 6)

Prof. Bloom: "We are however taking steps to recommend that imported products from the U.S.A. at least meet with the new F.D.A. regulations." (Line 8)

"Your comments about the use of cryoprecipitate and N.H.S. factor VIII concentrate have been incorporated into our advice although at the moment we are not rigidly differentiating between cryoprecipitate and N.H.S. concentrate as far as severely affected patients are concerned at any rate." (end of line 9)

Note: It seems that this recommendation, that imported blood products from the US meet the new post-March 1983 FDA Regulations, was not adhered to. WHY did Physicians decide to keep using the 'pre-March 83' high-risk concentrates?

"MB4 advise that all FVIII concentrates are subject to full "Stop Orders", which require the manufacturers to submit protocols and samples from every batch they propose to sell in the UK, to Dr Duncan Thomas's department at NIBSC." (Page 1, point 2).

"The content of an individual manufacturer's protocol is very much a matter for agreement between Dr Thomas and the company. Date of plasma collection is thought not to be a requirement at present, but probably could become so if it were thought desirable." (Page 1, point 2).

Note: We are completely dismayed to discover that people knew that stock-piled imported Factor VIII almost certainly included material made from pre-24th March '83 plasma.

"However, such a trial could pose ethical problems at the present time."

Note: We would like to point out that these clinical trials were being considered at a time that we would describe as the heart of the AIDS crisis. Only 3 months earlier, the PHLS were actively looking for Previously Untreated Patients (PUPs) and inviting approaches from commercial firms (March 1983). We know from documented evidence that the PHLS were strongly considering exposing previously untreated patients to hepatitis for the sake of 'meaningful' trials. This is especially unethical, since Dr Craske (PHLS) had knowledge of AIDS in relation to clotting factors from as early as 13th September 1982.

"In earlier discussions on a protocol for such a clinical trial, Haemophilia Centre Directors had been of the opinion that a meaningful trial could only be conducted in patients who had not previously been treated with Factor VIII ie newly diagnosed mild haemophiliacs. However, this is a particular group of patients for whom the Directors have recommended that only NHS material should be used."

Note: It should be pointed out that only 1 month later, we learn in a DHSS letter to Manchester Regional Transfusion Centre, (July 1983), that 3 chimpanzees went on to develop hepatitis after having been injected with Hyland Factor VIII - which had supposedly been heat-treated.

The DHSS circular continues:

"From these figures it can be seen that there is no option but to treat the majority of our haemophiliacs with large-pool products and thus it could be argued that the use of such products is specifically indicated for medical reasons since the risks of non-treatment are greater than the risks of treatment. However, this is a rather dubious 'let-out' and I think we should prefer to see the recommendation re-worded viz:"

• To avoid wherever possible [practicable] the use of coagulation factor products prepared from large plasma pools: this is especially important for those countries where self-sufficiency in the production of such products has not been achieved.

It is clear from these comments that there were attempts within the DHSS at 'skin-saving' and possibly cost-cutting apparently designed to mitigate or even circumnavigate the draft recommendations of the Council of Europe.

(See Related Entries link below for an astounding Kenneth Clarke comment made only 5 months later.)

1. "For mildly affected patients with haemophilia A or von Willebrand’s disease or minor lesions, treatment with DDAVP should be considered. Because of the increased risk of transmitting hepatitis by means of large pool concentrates in such patients, this is in any case the usual practice of many Directors."

2. "For treatment of children and mildly affected patients or patients unexposed to imported concentrates many Directors already reserve supplies of NHS concentrates (cryoprecipitate or freeze-dried) and it would be circumspect to continue this policy."

"It was agreed that there is as yet insufficient evidence to warrant restriction of the use of imported concentrates in other patients in view of the immense benefits of therapy but the situation will be constantly reviewed."

Paragraph 3: "Also, I expect we will find this material will be double the cost of the unheated Factor VIII and if demands are made for its use by either Haemophilia Directors or possibly the patients themselves, if they hear or read about it, it will play havoc with the R.H.A.'s finances."

The DHSS, in reply to the RTC states:

"...However, your comments about the potentially major financial consequences for health authorities, in the event of unjustified demands for this material being made, could be used to support the argument for the need for properly controlled clinical trials before such material is introduced into this country."

It is understood that ARVI have recommended that the PHLS undertake surveillance of recipients of Hepatitis B vaccine.

”The group considered this practice to be highly questionable because of the incidence of homosexuals and homosexual activity in prisons and the present unease about the incidence of AIDS among this group of people. The Group asked to be advised of Departmental policy on the practice of collecting and using blood from borstals and prisons.”

Note: We have now found definite proof that prison blood was being used by Scottish and English Transfusion Centres. We are concerned to learn that Blood Transfusions Centres in Scotland were taking blood from borstal and prison sources and at least some of the English Blood Transfusions Centres were also receiving blood from these sources.

Background: We should point out that serious concerns were raised in the UK in 1980 over the safety of using blood from Scottish prisoners in NHS transfusions - and this was hardly the first warning. There were international warnings from as early as 1958, from Dr. J. Garrott Allen, who after having conducted a survey in the Chicago area, discovered what he referred to as the “prison effect”.

We are dismayed to learn that blood was taken from UK prisons and borstal institutions right up until March 1984 - well after prisoners were considered to be high-risk donors. WHY did the Authorities persist with taking blood from prisons?

The following is a quote from a document released under FOI: "Furthermore it is socially and psychologically undesirable to exclude prisoners and volunteers from tropical areas from the donor population. Acceptance of prisoners as donors helps to rehabilitate, and some of these volunteers become regular donors after their release."

"Although future supplies of FVIII both for export and for use in America will of course be manufactured from plasma collected in accordance with these regulations, there is still a quantity of stock, some already in this country and more in America awaiting shipment here, which has been made from 'pre-March' plasma…" (Paragraph 4, line 3)

"We have to balance the risk of AIDS against the severe risks to haemophiliacs of withdrawing a major source of supply of Factor VIII which cannot be made good from elsewhere in sufficient volume." (Paragraph 4, line 9)

"Haemophilia Society is aware of the situation and has in fact made known to me its opposition to any move to ban American FVIII." (Paragraph 4, last 2 lines.)

Background: The mention of 'pre-March' plasma is a reference to the point in March 1983 where the FDA introduced new regulations for the collection of plasma that excluded donors from high-risk groups. It should be remembered that any plasma intended for FVIII products was likely to have been collected up to 2 years previously. Therefore, even as the FDA restriction came in around March 1983, the products available then could have been made from high-risk 1981-2 plasma.

Note: It is also worth noting that it should have been possible for cryoprecipitate to have been used instead of high-risk Factor VIII - at least until alternative arrangements could have been made, except the production facilities for cryo in the UK were no longer adequate. Just 1 month earlier, in a July meeting of the CSM, the possibility was considered of withdrawing clotting factors from the market and replacing them with cryoprecipitate, except it was concluded that this was not feasible in the UK on grounds of supply. (CSM Minutes Agenda Point 5.3, see additional source below)

Two of those present told the BBC of furious exchanges over what to do with leftover non-heat-treated factor VIII. There was talk of certain countries agreeing to take-on those leftover stocks and even talk of money available from 'grateful' commercial companies to support research. Some of those present were shocked and objected, others were more sympathetic.

"Only a few penitentiaries are still being licensed. They are exclusively in the Southern States, including Florida, Louisiana, Mississippi and Arkansas. The respective States' Department of Correctional Services requests the licensing to continue as a moral booster for the inmates."

"Since these centres are licensed and inspected as any other plasmapheresis centre, it is NOT ILLEGAL to use this plasma for the production of fractionation products for HUMAN USE. It is, however, considered MOST IMPRUDENT."

On page 2, under "A.I.D.S. Risk:" the memo states "The Coagulation Factors present a definitive risk."

Note: Surprisingly, under the risk for hepatitis B, they state that in the case of Factor VIII and IX that these should not be released if the plasma pool contains a hepatitis B positive unit or an untested unit.

Rather alarmingly, the memorandum mentions a definitive risk from AIDS, but it does not state that the coagulation factors should be discarded if the plasma pool contains material from a donor subsequently implicated with AIDS.

Note: Travenol are strongly criticised by the Sub-Committee for writing promotional letters making unjustified claims on improved safety margins in respect of AIDS infection.

Under point 6, it states: "I discussed genetically engineered FVIII - still about 10 years off, is the guess." (Page 2, point 6.)

Note: This estimate of genetically engineered factor VIII being 10 years off was too generous. Somehow, within just 4 years, Hyland (Baxter) had managed to begin human clinical trials of a recombinant Factor VIII concentrate. (See additional source below).

"I refer to your minute of 7 October to Dr [Name]. I note you will be considering with Dr [Name] how best to approach other countries about the availability of "AIDS-Free" Factor VIII. I would myself have thought it ill-advised to tackle this through the WHO since we are taking a very independent line which may in fact not necessarily be approved of by the WHO. What if all countries adopted our approach? In fact I do not think we need go too far in exploring the availability of suitable products from elsewhere. Surely it would be sufficient to approach two or three of the "respectable" large countries who have volunteer donor panels to see what they say. If we suspect the answer was negative our approach need go no further." (Transcript of Letter 10 October, 1983)

In an earlier letter of 7 October 1983, the DHSS states: "We are all aware, I think, that this global approach is purely cosmetic (as, indeed, is the letter to the Swiss Red Cross, but this is a rather special case)."

Note: Was the Government only going through the motions in October 1983 by appearing to look for AIDS-free factor VIII from other countries? Britain had its own voluntary donors. The Government had already been told by WHO and the PHLS not to import blood products; and without a test for Aids available, how could any country in the world know that their donors were safe?

"The special features arising in relation to haemophilia were discussed and the possibility of identifying the role of imported Factor VIII concentrate used for UK patients was outlined. There followed discussion on the varying and considerable period of incubation (1 to 4 years) and the possible relationship between the size of inoculum of the PROPOSED AGENT and the length of latency." (page 2, point 3a, line 14)

"It was noted that blood product associated cases could enable some of these alternative hypotheses to be tested." (page 3, end of paragraph 4)

Opportunities Special to the United Kingdom:
"The Working Party sought to identify particular opportunities for research unique or special to the United Kingdom. The fact that the epidemic was lagging some three years behind that in the USA was considered an important factor in enabling the background against which AIDS develops to be delineated. This could enhance our ability to detect the emergence of AIDS and virological status of the high risk groups. The underlying immunological and virological status of the high risk groups BEFORE they encountered the "AIDS agent" could thus be defined." (page 4, point 4)

"The UK system for haemophilia treatment and for blood product organisation would allow detailed study of haemophilia associated cases which has not been possible in the USA due to their system of record keeping and organisation." (page 4, end of paragraph 3)

"The organisation of epidemiology in the United Kingdom was well suited to studying this problem. The importance of establishing such studies early in the emergence of disease was again stressed." (page 4, final paragraph, line 5)

"It was noted that in addition the UK offered particular opportunities to pursue carefully controlled and monitored therapeutic trials." (page 5, paragraph 2)

"It was thought that suspect blood products could provide valuable raw materials for work of this type. Indeed, the possibility of fractionating blood from patients with "pre-AIDS" in order to concentrate the agent was a notable suggestion.” (page 5, paragraph 4, line 10).

Under the heading "AIDS UK Situation" the following is stated:

"Spouses of patients who received FVIII will also be followed. Choice of control group for the above study not decided as yet but is considered critical to the study." (Page 1, circa line 21)

On page 4, under the heading "U.K. Situation", the minutes state:
"Twenty-two patients have N.I.H diagnostic criteria for AIDS - many through contact in USA. 10 patients have so far died. Details of haemophiliac cases (A1 and A4) are contained in Appendix B and the follow-up protocol is to be circulated in due course."

The following comment, made during the AIDS crisis also doesn't bode well:
"...Neither Dr Boulton, Dr Ludlam or myself considered it appropriate to discuss publicly the details of our current 'clinical trial' on heat treated FVIII" (Page 1)

Note: Rather than focussing on control groups and studies, it would have been prudent and more ethically sound to commence an immediate notification exercise with the imparting of advice to the spouses of patients with haemophilia.

"Dr. Chisholm raised the problem of patients refusing to take up commercial factor VIII concentrate because of the AIDS scare. She wondered in view of the worry of the patients whether the Directors could revert to using cryoprecipitate for home therapy."

"Other Directors reported that they had the same problems. After discussion it was agreed that patients should not be encouraged to go over to cryoprecipitate for home therapy but should continue to receive the NHS or commercial concentrates in their usual way."

Background: This mention of an 'unlimited' availability of cryoprecipitate, right in the middle of the AIDS crisis in October 1983, demonstrates that there were viable, much safer alternatives for haemophiliacs in the UK.

Note: This statement regarding unlimited availability of cryoprecipitate directly contradicts what was stated in the 13th July 1983 meeting of the Biologicals Sub-Committee of the CSM. During that meeting, those present considered the possibility of withdrawing US clotting factor concentrates from the market and replacing them with cryoprecipitate, but they hastily concluded that this was not feasible in the UK on grounds of supply. (CSM Minutes, Agenda Point 5.3, 13th July, 1983.)

"The question of the production of an artificial source of factor VIII in the near future (that is within the next two to three years) was raised and discussed. Professor Bloom said that he thought that there was still a lot of work to be done on this type of product before any material would be available for use in patients and it was not likely to be available in the near future." (Page 7, final paragraph)

"You say that there is no conclusive evidence that AIDS is transmitted through blood products. I would argue that the evidence is very strong. There are now about 20 American haemophiliacs with AIDS, and this figure is likely to underestimate the risk because of the apparently long incubation period." (page 1, point 2)

"I also draw your attention to a paper prepared jointly by DHSS staff and the HSE which was submitted to a recent meeting of the Advisory Committee on Dangerous Pathogens (ACDP/83/P9). This paper states quite specifically that "there is now strong circumstantial evidence that AIDS may be transmitted by blood products." I am tempted to ask you what you would consider to be conclusive evidence, particularly in the circumstances where the agent or agents for AIDS are as yet unidentified?" (page 1, point 2)

"I think you are placing undue reliance on the Regulations introduced by the U.S. Food and Drug Administration. These Regulations rely on the use of interviews and questionnaires to identify donors from high risk groups; ...."

"The companies also do not intend to recall contaminated lots after manufactures." (point 3)

"I do not regard the situation concerning "pre-March" plasma to be satisfactory because, in effect, it means that despite the introduction of the above Regulations we are essentially carrying on as before. In such circumstance there must be a real danger that the UK will become a dumping ground for USA companies to get rid of their non-regulated products. I think for this reason your Department should reconsider its rather passive response to the need for Regulations." (Page 3, point 4.)

"...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.

• Question: "When and why did it end and what were the circumstances?"

• Answer: "The last collections in penal institutions were in January 1984 in prisons and in March 1984 in Young Offender Institutions. This followed comments made by the Medicines Inspectorate as well as discussions by the Transfusion Directors."

Note: What he fails to mention in the above is that the Medicines Inspectors commented adversely on the collection of prison blood as far back as 1982. These concerns were then reiterated after further SNBTS inspections, also stating the reasons as to why it was not a good idea. The problem was mentioned again in BBC's Frontline Scotland: "Blood and Tears" in June 2005 when a certain Professor, working for the Scottish National Blood Transfusion Service, was asked if it was a good idea to take blood from prisoners, and he circumnavigated the issue by repeating to Eleanor Bradford that they "phased it out". It should be noted that this 'phasing out' rather astonishingly took 2 years to do.

He also fails to mention that the Home Office was warned of the dangers of AIDS in prisons in December 1983 and again in January 1984 by the Assistant Secretary for the Prison Officers Association - we know this from another document released under FOI.

Background: According to documentation released under FOI, it appears that discontinuing the collection of blood from prisons was going to cause considerable problems for the English and Welsh Health Authorities; as they would not be able to meet their annual blood quotas. (Source: FOI document).
It seems, therefore, that collecting blood from prisons was not just to help the prisoners feel good, the Authorities needed the blood for the repeated attempts at achieving the much-promised self-sufficiency.

Alpha Therapeutic fails to present adequate product information and are unable to confirm that the bulk cryoprecipitate would be prepared only from human source plasma derived from Alpha’s own licensed plasmapheresis centres. They fail to provide satisfactory evidence that the product is at least equivalent in quality to Alpha’s US Licensed factor VIII products.

Dr Cash: "We are particularly keen to see part of this product is put into "virgin haemophiliacs" and would much appreciate the assistance of the U.K. Haemophilia Centre Director's Working Party on Hepatitis."

Note: This letter makes very upsetting reading. At the time this letter was written, February 1984, they were several years into the AIDS crisis. There had been numerous warnings (from the CDSC to the 1983 FDA regulations) yet, we still find trials being conducted on PUPs or as this letter so horrifyingly words it 'virgin haemophiliacs'.

These Doctors knew that there was no cure for AIDS.

• Obtaining a clone
• Development of the clone
• Fermentation of the clone material
• Purification of protein
• Toxicity trials
• Clinical trials

"It was noted however that the Genetics Institute, Boston, USA, had reached the stage of obtaining a clone for Factor VIII."

Note: The future role of BPL with regard to genetically engineered products was questioned and the view was expressed that in the long term, the Laboratory would not purely be involved in human products, but rather in the late 1980's or early 1990's it would have the potential for downstream purification of cloned material.

Here is a list of just some of the ignored warnings regarding UK prison blood:

• In 1958, there was an early warning from a respected international source. Dr. J. Garrott Allen discovered what he referred to as the “prison effect” after conducting a survey in the Chicago area.

• In 1980 we know that blood from Scottish prisoners was used in NHS transfusions despite serious concerns being raised.

• Then in 1983, the Medicines Inspector commented adversely on the practice of collecting blood from prisons and borstal institutions.

• By July 1983, the Medicines Division's Inspection Action Group had expressed serious concerns about the collection and use of blood from borstal institutions and prisons.

Note: We are appalled to learn that the practice of blood collection from UK prisons and borstal institutions continued right up until March 1984 - well after prisoners were considered to be high-risk donors.

Certain conditions are imposed by the Sub-Committee in the granting of the licence. The product particulars are to be amended to include a statement that the material is heat-treated, that no claims are made regarding the transmission of HBV and NANBH and that there are to be no claims with reference to AIDS other than in the form of a warning that the blood product may contain the syndrome.

The memorandum states that the products currently available are:-

• Heated products from Armour, Cutter, Travenol and Alpha Therapeutics
• NHS Factor VIII prepared from a specially selected donor panel
• Heated NHS Factor VIII (one brand from PFC Edinburgh, one from Elstree available later in 1984)
• A heated preparation from Behringwerke, Germany

"All products except those derived from NHS factor VIII are made from plasma imported from the U.S.A., and, therefore, they carry a putative risk of transmission of AIDS." (Final paragraph of page 1)

Note: They conducted these trials whilst knowing that there was no cure for AIDS.

Margaret M. Heckler: "We now have a blood test for AIDS which we hope can be widely available within six months" (Paragraph 1)

Heckler: "With the Blood test, we can now identify AIDS victims with essentially 100 per cent certainty." (paragraph 2)

Note: Rather astonishingly, the article also mentions that it was thought by Federal Officials that an AIDS vaccine might well be available within 2 to 3 years. (Paragraph 3)

A patent was pending for the AIDS test, and the US government was said to be interested in either making the test or farming-out it's manufacture to industry. (Final paragraph)

"The occurrence of acquired immunodeficiency syndrome (AIDS) in haemophiliac patients has strongly suggested transmission of the disorder by blood products and epidemiological studies have suggested it may be related to a transmissible agent."

"In Great Britain the number of haemophiliacs who have been reported with AIDS remain at 2. Thus the incidence is less than 1 in 1,000 patients at risk."

Note: We are concerned to read that the incidence of AIDS in haemophiliacs was only described at 0.1%. Surely this was a gross misrepresentation of the risk from blood products? Christine A. Lee's comments on the risk suggests a misleading mindset as she seemed to think the total haemophilia community totalled 2,000. This could not possibly have been right - it should've been nearer 5,000. We have to wonder what statistical information this population figure was based on?

Background: The following list of developments detail what we believe Christine A. Lee should have considered before making the statement; (after all, the clues were there as to the real scale of the risk):

• In January 1983, Desforges published an article in the NEJM on Hemophiliacs and AIDS, recommending that cryoprecipitate rather than concentrate be used.
• In August 1983, the first UK haemophiliac dies of AIDS from US Factor VIII administered in December 1981.
• Whilst in October 1983, in the UK, there were only 2 haemophiliac cases of AIDS, in the USA, however, there were 22 patients with N.I.H diagnostic criteria for AIDS and 10 patients had by that time died.
• In January 1984, a summary was published in the NEJM of 18 US cases of AIDS where blood components were involved.
• By April 1984, the National Hemophilia Foundation learned that the CDC had received reports of 9 new cases of AIDS among US haemophiliacs.

Note: We would like to point out that only 10 months later, (March 1985), the DHSS Finance Division (FA1), expresses fears that the haemophiliac population (around 5,000) could be very seriously affected indeed, with two-thirds possibly already sero-positive, and 240 haemophiliacs possibly manifesting AIDS within one year, and as many as 1,200 eventually developing AIDS.

Note: Clinical State of the Art was established about here. All efforts should have been made at this stage to secure heat-treated products for haemophilia A and B patients.

Armour fails to present adequate evidence of safety and efficacy in clinical use, and fails to present adequate biological evidence of the effect of heat-treatment on infectivity and on the transmission of hepatitis.

"Since my minute of 6 July there have been further developments regarding the radio immunoassay for antibody to HTLV III. Some 2,000 tests have been carried out on AIDS patients..."

Note: It is clear that in order for some 2,000 tests to have been carried out on Aids patients by the time the DHSS minute was written on 6th July 1984, the early diagnostic tests must have been available some months prior to this time...

Background: We know that by the Summer of 1984, the PHLS had access to 'in house' anti-HTLV-3 assays which were being developed in UK research laboratories.

Production, Evaluation & Introduction of Screening Tests

Summer 1984: "In house" anti-HTLV3/LAV assays developed in a few foreign and UK research laboratories. PHLS Virus Reference Laboratory (VRL) and the Middlesex Hospital available as primary testing centres.

NOTE: The discovery of this new information within the latest DOH FOI release (20.05.09) is very important because we are now learning just how early on in time the diagnostic assay for Aids antibodies was available - but only to certain bodies, such as the PHLS. For the actual screening of the UK's blood donors, we had to wait another year and 3 months - i.e. until 14th October 1985, when the UK implemented Donor Screening. This is very disturbing.

"The note might also need to deal with the question of publicising the research in such a way as both to take credit for Government support for development of the test and to make it clear that the arrangements at the North West London RTC were experimental, ie to forestall pressure for the immediate availability of the test throughout the blood transfusion service and more generally through GPs and STD clinics." (Paragraph 3)

Note: It is not altogether clear what is being implied by this letter. However, it can be said that in a DHSS letter dated 4 days early (27 July 1984), that the radio immunoassay for antibody to HTLV III had already been used to test some 2,000 AIDS patients. (see additional source link below).

"Dr [Deleted Name] referred to a batch of Factor VIII in Scotland, fractionated in November, 1983, which was discovered to contain anti-HTLV3 in August, 1984. It was noted that a virus attack rate on this product could be as high as 80%. The remainder of the product had been withdrawn, but the incident served to highlight the difficulties that lay ahead in this context." (Page 2, point 8.2, paragraph 3)

"[Deleted Name] confirmed that he would be able to test the Scottish material whilst continuing to test that supplied by the Director BPL. [Deleted name] considered that some assistance towards such trials could be forthcoming from the S.W. Region..." (Page 3, point 9/84, paragraph 1)

"It was noted that there was not sufficient suitable patients in Scotland to test its heat treated Factor VIII whilst [Deleted Name] explained that the trials might have to be re-thought in view of the HTLV3 virus" (Page 3, point 9/84, final paragraph.)

"You will be aware of the recent development by [deleted name] of a radioimmunoassay for HTLV III antibody and the findings that the limited use of this test has revealed…" (Page 1, point 2.)

"…it is hoped to extend the screening test to at least two other Regional Transfusion Centres. This, of course, depends on our ability to scale-up productions of reagents for the test using either the virus isolate from Dr Gallo’s laboratory or a UK isolate (yet to be achieve)." (Page 1, point 2, lines 7-11)

"The information collected from the use of a screening test in three centres will provide a basis on which to base policy decisions about extending the test more widely to the whole of the NBTS. We would therefore be in a strong position to make decisions about the need to buy from one of the five US pharmaceutical companies who have licensed to produce a screening test and are likely to wish to start marketing these tests in the UK in the next few months." (Page 1, point 2, from line 8.)

Note: Five US pharmaceuticals were poised to start marketing HTLV tests in late 1984. Yet, there seemed to be some reluctance in the NBTS to buy in the test from abroad; perhaps due to cost or the availability of the isolates. Nevertheless, there appeared to be a 'race' on for Britain to find it's own test – an action which may have served to delay the wider release of these urgently needed tests.

"The test is based on isolates of HTLV III obtained from [Deleted name, probably Dr Gallo’s?] laboratory at the National Institutes of Health, Bethesda, USA who made them available to research workers in the UK on the basis of exchange of material resorted to by such people. The test appears to be sensitive and specific and is possibly more reliable than other tests currently available in the USA and elsewhere." (Pg 2)

The batch numbers in question are detailed in the following table:

Note: This shows that Haemophilia Centres had a good enough system of record-keeping so as to be able to identify and trace which patients had received which batch. We have to ask whether patients were warned so that they could inform and protect their partners?

The letter outlines the previous donations of the male donor, who had donated blood in November 1982 in Leeds, and three more times at Bournemouth in September 1983, March 1984 and September 1984. "There is also the possibility of a donation before November 1982 in this region, which we are attempting to trace." It appears that the September 1983 and March 1984 donations were already used.

Note: We cannot help but wonder why there aren't any recommendations here to alert patients?

In another WRTC letter from the Deputy Medical Director to various Consultant Haematologists in the South, including the Lord Mayor Treloar school, the author explains the reason for the recall. The Deputy Medical Director makes the following unethical request of the centre directors: "In order to prevent undue worry to your patients, may I ask for your discretion here and, for the time being at least, to keep this news to yourself."

Note: We are perturbed to read that Doctors are specifically told not to tell patients, thereby putting partners at risk.

In fact, a total of 885 units were supplied as follows:

• 485 vials were sent to Wessex RBTS on 10th August 1984

• 400 vials were supplied to Cardiff RBTS on 17th August 1984

The notes go on to say that: "They were passed down to Haemophilia Centres for supply to patients. Thus it is known by the Centres precisely which patients received supplies from this batch. BPL are recalling the batch and this is under control."

• This clearly leaves 390 contaminated vials unaccounted for.

Note: We are extremely concerned to read that 167 vials of this contaminated batch were used up at the Lord Mayor Treloar College, Alton - a well-known specialist school, catering for boys with haemophilia. Only 33 vials out of a total of 200 were returned from the Treloar school.

Note: We believe that there was a good chance that the WRTC were aware that most, if not all, of the 390 unreturned vials had already been transfused into patients. Presumably these patients could have been easily traced and informed?

Note: It is disgusting to read that despite the donor having a confirmed AIDS diagnosis, the official line of the Deputy Medical Director and the WRTC is still not to inform patients.

Then in a letter from WRTC dated the same day, a Consultant Pathologist is notified at the Royal Naval Hospital, Gosport, Hants. This correspondence is obviously the first the RN Hospital has heard of the contaminated batch - and for some reason 12 days later than anyone else.

In a third letter of 16th October 1984, the WRTC write to the Queen Alexander Hospital, Portsmouth, where we learn of another hospital where this notification is the first they've been told about receiving the contaminated batch.

Note: As with the Naval hospital, why weren't these hospitals informed earlier?

Dr. Craske: "An alternative strategy would be not to tell the patient of the risks involved but to observe him at regular clinical review four monthly, to collect serum specimens for HTLV-3 antibody examination and send them to me at Manchester." (page 3, section ii)

“There is evidence that HTLV-3 infection can be transmitted by sexual contact. Therefore some sexual partners of recipients of factor VIII contaminated with HTLV-3 may be at risk.” (page 2, point 5)

Investigation of spouses: “This will be at the discretion of the Haemophilia Centre Director, and will depend upon whether it is decided to inform the index patient of the possibility that the batch of factor VIII was contaminated with HTLV-3 virus.” (page 3, section d)

Note: Even after Dr Craske knew that HTLV-III infection could be transmitted by sexual contact, he was still deliberating the option of not informing patients. In an Appendix on page 5, Dr Craske does eventually state that the option of informing the patient is "the only one tenable on moral and ethical grounds." However, this conclusion should not even have required discussion, never mind arriving at it almost as an afterthought.

"The Chairman confirmed that following [Deleted Name’s] attendance at the Committee’s last meeting, he and the Director of BPL had recently visited the USA to discuss possible research and development collaboration for the preparation of Factor VIII through genetic engineering". (Page 1, point 8.1)

"Two firms, namely [Deleted Company Names], had now made significant progress in cloning Factor VIII…" (Page 1, point 8.1, line 5.)

"The Government is already committed to self-sufficiency in blood products by trebling the manufactured output from British donors."

"On 23 March this year Norman Fowler, Secretary of State for Social Services laid the foundation stone for the re-building of the Elstree Blood Products Laboratory - part of the NHS - and increased production should begin in January 1986."

Mr Patten said: "Our multi-million pound development project at the Blood Products Laboratory, Elstree, is on target for completion early in 1986 and this should enable us to become self-sufficient in blood products, such as Factor VIII which is the clotting agent required by haemophiliacs, by the end of that year..."

"...This will mean we no longer have to import factor VIII from abroad."

Note: So what went wrong? ...

Dr John Seale: "I wrote to both Mrs Thatcher and the Public Health Laboratory Services to suggest blood transfusion policy changes then." (paragraph 4)

Note: This article shows that both Margaret Thatcher and the PHLS were notified circa November 1982 and could reasonably have been expected to know about the threat of AIDS to the Blood Transfusion Service and thus to haemophiliacs.

Note: This is an example of COST concerns overriding Physicians' urgency to inform patients of their status. The emphasis, here, is on the cost of the commercial isolates for the AIDS test, which is overriding the importance of CLINICAL NEED.

"that in order to determine the effectiveness of the heat-treatment, spiking of Factor VIII with antigen was required prior to heating. The present methods used by the NHS and commercial companies may still leave an active antigen. BPL would therefore be looking for follow-up studies during 1985 with Haemophilia Centre Support". (page 8, paragraph 4)

Note: We have seen documents that state that physicians felt it had never been appropriate to test the final factor VIII concentrate in an attempt to demonstrate its safety from viral infection - because the available techniques were not adequately sensitive to identify infectivity, i.e. concentrates which test negative on virological investigation can still transmit viral infection.

So are we to assume that after the Factor VIII concentrates are deliberately spiked with whichever potentially fatal virus, that there is no way to know for sure if the heat-treatment has killed-off the pathogen, until haemophiliac patients receive the “spiked” factors and either do or do not go on to contract the virus?

NON-CONSENSUAL RESEARCH?

"Patients who asked their HTLV-III antibody test results should be informed of them otherwise it is up to individual Directors to decide whether or not they wish to tell patients their results." (Page 1, final paragraph)

"...Moreover the virologists considered that there was no evidence that haemophiliacs already HTLV III antibody positive would suffer if they received further doses of antigen (this view is based entirely on theoretical consideration)." (Page 2, paragraph 1, line 8)

December 1984: "Most agreed that untreated BPL Factor VIII could continue to be used until heat treated Factor VIII was available from Elstree." (Page 2, paragraph 1, line 14.)

Note: These minutes demonstrate that doctors were testing haemophilia patients' blood for HTLV III without consultation. This practice denied the patient's rights concerning pre- and post-test counselling.

Dr Tedder: "the Gallo cell line was available for investigation although the USA had made the isolates difficult to obtain." (Page 1, item 2, point i)

Dr Craske: Under the subject heading "Availability of Tests", Dr Craske advised that currently, the reagents were only available on a research basis, and that substantial resources would be required to enable the proposed workload to be undertaken. (Page 2, point ii)

"Inconsistencies in the results of the tests reveal that a study of the haemophiliac population would provide the invaluable material to increase our knowledge of the disease. [Deleted Name] has developed the same test as [Deleted Name] using the Gallo isolate obtained with his permission through Professor Weiss."
"I believe a study of haemophiliac patients could be regarded as a research project now and Dr Mortimer could provide facilities for doing these tests." (Point a. Paragraph 2.)

Note: Firstly, the choice of wording used here is disgraceful. Secondly, it is clear from this, that the Physicians' main priority was studying haemophiliacs as a 'research project' - whilst people were dying.
Again, we are seeing RESEARCH dictating and overriding CLINICAL NEED.

• Dr Jones: "A long discussion took place on whether persons found to be +ve were to be informed. Several differing views were expressed. It was agreed that each clinician would decide for each case depending on the facts of the case but in general to provide information if asked for." (page 4)

• Dr P. Kernoff commented that as some 70% of haemophiliacs are now +ve it may be considered irrelevant if one tells or doesn't tell the results of testing. (page 5)

"Certain heat-treated products are not being subjected to sufficient inactivation. There is considerable variation between the methods used by commercial firms and in particular the Protein Fractionation Laboratory in Liberton in Scotland introduced on a short term basis a very quick method which they thought might inactivate the virus, at the beginning of the year. I believe that it is this latter which may be implicated in the information I have received."

"And although the press has been dramatizing the AIDS problem and the risk of imported blood coming into this country, I think it is very important not to forget that without the imported product the quality of life of those who need Factor VIII and Factor IX would have been much poorer."

Background: What was known: In August 1983, the UK's CDSC reported the first case of AIDS in a UK haemophiliac, a patient from Wales, who had received factor VIII concentrate imported from the United States.

By October 1983, the USA had seen 15 AIDS cases in haemophiliacs and the UKHCD (Haemophilia Centre Doctors) were privy to this information and could reasonably have been expected to be able to work out that the risk from US commercial products was much higher. With reference to the U.K. Situation, 2 haemophiliac cases of AIDS (A1 and A4) were also known about in October 1983.

Note: The Bulletin statement speaks for itself. However, it should be noted that cryoprecipitate could have been used. [Edgware made highly potent cryoprecipitate that had levels of 100 i.u. of factor VIII or more - consistently.] Moreover, on 17th October 1983, in the midst of the AIDS crisis, we know that a doctor present at a meeting of the UKHCDO stated that she could obtain "unlimited supplies of cryoprecipitate". The Press were right to dramatize, when more than two-thirds of the infected haemophiliac community have since passed away. 'Quality of life' hardly comes into it.

"Ministers will be aware that Factor VIII, the most significant blood product, has been produced in the laboratory by genetic engineering methods." (Point 7. Lines 1 & 2.)

"...it is considered that it will take up to five years at least for this product to be available on a commercial scale." (Point 7, lines 4 & 5)

"This possible development has been borne in mind and the plans for BPL are sufficiently flexible to allow the refining of such products from genetically engineering source material when available in the future." (Point 7. Lines 6-8)

Note: We know that Ministers had knowledge of genetically engineered Factor VIII from as early as November 1982. We should point out, that this knowledge was 3-4 years prior to the completion of the BPL re-development project of 1986.

Background: We know from a DHSS internal circular, around 3 years earlier, that a discussion of genetic engineering or the cloning of Factor VIII took place as early as November 1982. (See Additional Source below).

Also, as only haemophiliacs have died and they may have had Factor VIII from American blood, is it the case that we have not had one AIDS fatality from blood donated in this country yet?"

'...only haemophiliacs...' What does he mean by this? Whatever he meant, only 6 weeks later we find distasteful comments from the DHSS Finance Division regarding the potential SAVINGS that could be generated when haemophiliacs died. (see related entries link below)

Kenneth Clarke, 22 January 1985: "Do we need this and heat treatment of the blood?"

Note: The extent of naivety in these comments should not surprise us. We only need to remind ourselves that this apparent lack of understanding emanates from a man who had already stated 13 months earlier (in October 1983) that as far as he knew no human blood plasma was imported into the United Kingdom by the NHS. What rubbish. There should have been no question in his mind as to whether blood products (as opposed to plasma) were being imported from the USA in 1983.

Note: Even more remarkably, in November 1983, Mr Kenneth Clarke (then Minister for Health) offers us further counsel without knowledge: "There is no conclusive evidence that (AIDS) is transmitted by blood products." He obviously wasn't paying attention to the Council of Europe Recommendations on coagulation factors and AIDS at the Lisbon meeting in May 1983. (see related entries link below for a plethora of proof.)

No wonder in recent correspondence (2007) with Taintedblood, Mr Kenneth Clarke unfortunately appears to be experiencing 'selective memory loss'.

"[Deleted Name] expressed his unease at 'freezer' studies being carried out on samples collected from individuals attending STD clinics who would not necessarily have given consent for such investigations to be carried out." (Page 4, point 12).

Dr. McDonald asked the Secretary of State for Social Services how many applications for product licences in respect of imported heat-treated factor VIII have been received by his Department; and how many were granted in 1984 and in 1985.

Mr. Kenneth Clarke: Further to my reply on 20 February at columns 498–500, to my hon. Friend the Member for Peterborough (Dr. Mawhinney), all the seven applications made since November 1984 for product licences under the Medicines Act for heat-treated factor VIII were granted earlier this year. All of these were for imported products.

Dr. McDonald asked the Secretary of State for Social Services if exactly similar tests are applied to imported factor VIII products as to Blood Products Laboratory products; and if he will make a statement.

Mr. Kenneth Clarke: The Central Blood Laboratories Authority, which is a special health authority, ensures the safety and quality of products made at its blood products laboratory. Imported, commercially manufactured factor VIII is subject to the formal licensing arrangements under the Medicines Act 1968.

Dr. McDonald asked the Secretary of State for Social Services if he will place in the Library a copy of his Department's studies of the economics of self-sufficiency against the continued importation of factor VIII products.

Mr. Kenneth Clarke: I refer the hon. Member to my reply to the hon. Member for Portsmouth, South (Mr. Hancock) on 19 February at columns 446–47.

Note: note pending...

AIDS - Death of a Baby

"The death of a baby from AIDS, at Gt Ormond Street hospital on Wednesday night has been attributed to an American blood transfusion. It has stimulated Press interest in the safety of blood transfusions here; and particularly about progress on a blood screening test within the National Blood Transfusion service. The Coroner's inquest verdict of death by misadventure is likely to attract Press attention too."

"The Coroner of St Pancras recorded the verdict of death by misadventure without disputing the Consultant's view that the baby died of AIDS following a blood transfusion in America. No pathological examination has been attempted."

"Coroners may report any case of death by misadventure in which it is considered that future occurrences could possibly be prevented by some organisation. The St. Pancras Coroner is writing accordingly to CMO. Officials do not consider the need for proper evaluation should in any way be prejudiced by the Inquest result."

HTLV-III in the Brain:

"23. It is believed that the HTLV III itself is responsible for an encephalopathy. The titre of virus in the brain [of?] patients is known to be high. Transmission of HTLV III to chimpanzees has been achieved by using brain material from AIDS patients." (see page 5 of the pdf)

"I am writing to advise you that [deleted name] have recalled batch number Y69402 of the above product because one of the US donors of the original plasma, although passing all screening tests at the time, has subsequently developed AIDS."

Note: See link to Chimpanzee Oxford Letter (below), "Use of products on a named-patient basis is often justifiable but by-passes these controls which have been established in the interest of patients".

Background: Also commercial products imported into the UK would have been sourced two years earlier at which time (circa 1983) a screening test for HIV was not officially available.

"Further to my minute of the 26 June I have heard this afternoon that this patient is very ill indeed and not expected to live long. Initial antibody tests on his blood are positive but have not yet been confirmed however the clinical history is fairly indicative."

"It seems probable that in the event of his death the case will be reported to the Coroner which could result in an Inquest."

Note: It is interesting to see the degree to which the DHSS anticipated, possibly feared, the prospect of a Coroner's Inquest. We believe this still to be the case today - since an Inquest can always return the verdict of unlawful killing.

In clinical trials, patients given heat-treated factor concentrates still went on to develop NANB Hepatitis.

Dr. Prince said that the reason the chimpanzee study was inaccurate was because of a design flaw in the study, in that the amount of virus that was used to spike the factor concentrates given to the chimpanzees was too low.

"[Deleted name] of NIBSC has just informed me that since 19 December 1984, all imported Factor VIII cleared by NIBSC has been heat-treated. All Elstree material received since April has been heat treated and Scottish supplies have been heat treated since the 23 January 1985."

At the end of the circular we discover the following handwritten request:

"Can you please translate this into an assurance I can give to the SoS next week that no haemophiliacs will be infected in the UK from now on."

Note: Whether of not this assurance was given to the Secretary of State, we are saddened to report that in the same month (July 1985), there were two cases of seroconversion in haemophiliacs associated with the use of Armour's H.T. Factorate - an apparently heat-treated factor VIII concentrate.

Background: With regard to UK-produced Factor VIII, it should be pointed out that within just 4 more months, evidence is found of haemophiliacs seroconverting to become HTLV-III (HIV) positive, despite being given heat-treated Factor VIII manufactured in the United Kingdom.

The findings were contrasted with the absence of non-A, non-B hepatitis in chimpanzees given the same heated concentrate. The Hemofil-T lot numbers were: 820628A, 820817A, 840120A, 830121A, 833010A.

Of the 13 patients, 9 of them were aged between only 3 months old and 15 years of age. Five of these patients were just 12 month-old babies. In fact, there were only 2 patients who were over the age of 18.

Consent:
On page 2, under the heading 'Patients', it states that those who met the criteria "gave their written informed consent".

Note: Eight of these patients were in the age-range of a 3-month-old baby up to 3 years of age and would therefore not even have been able to write. In the case of the 9 patients under the age of 18, their parents would have been required to give their informed written consent.

We have to wonder if ANY parent would knowingly consent to hepatitis infectivity trials of this kind, especially if they were genuinely informed and cognizant of exactly what was involved.

• HLA3046 (557 vials)
• HLB3046 (559 vials)

"The plasma was prepared on 5th November, 1982 and fractionated at BPL in March, 1983. You received 170 vials of HLB3046 as part of your allocation for June, 1983." (page 1 paragraph 2)

"Obviously product recall is not relevant - the product date-expired in April, 1984 and was almost certainly used long before that." (page 1 paragraph 3)

"Patient's permission for hepatitis B testing was not always sought and, with a variety of tests being taken, it should not be necessary to inform the patient in all cases that these included a test for HTLV-III antibody." (Page 4, from line 8)

"It was also agreed that the result of the HTLV-III antibody test should not be awaited before undertaking other tests which might be critical in the treatment of the patient. [Deleted Name] said that with hepatitis B it was now acceptable that other tests should be done while the result of the hepatitis B test was awaited." (See page 4, from line 11.)

Dr E. Harris: (DCMO) I understand that all commercial Factor VIII imported into this country is also heat treated. There would thus appear to be no longer any need to use un-heat-treated Factor VIII concentrate.

Note: This statement turned out to be overconfident and wrong, as within only six months, Armour Batch A28306 infects haemophiliac boys in the Birmingham area (Lindsay Tribunal Report, pg 53) and by March 1986, Armour has to be questioned by the DHSS about the efficacy of its heat-treatment methods. (Krever Report, Volume 3, Part IV, Chapter 33, page 933).

"Preparations for the introduction of routine screening of all blood donations in mid-October are well advanced. The blood clotting agent Factor VIII needed by haemophiliacs is now being heat treated. And the major redevelopment, costing £38 million, of the Blood Products Laboratory in Elstree should ensure our self-sufficiency in blood products by the end of 1986." (page 2, paragraph 3, lines 4-6)

Note: The DHSS seem quite confident that the heat-treatment process is working effectively. However, it should be pointed out that 2 months later, (28th November 1985), evidence is found of haemophiliac patients seroconverting to become HTLV-III positive despite being given heat-treated Factor VIII.

"This new product, containing a nominal 600 iu per vial has been dry heated at 80°C for 72 hours to inactivate viral agents (including hepatitis and AIDS viruses) but it cannot yet be assumed to be free from viral infection." (Page 2 paragraph 2)

BPL, October 1985: "Clinical trials at specified Haemophilia Centres are now in progress to gain evidence of reduction or elimination of viral transmission, particularly NANBH virus transmission. If you have under your care, suitable patients who would be able to participate in a clinical trial, the enclosed protocol should be used only for this purpose." (Page 2, paragraph 5)

"In accordance with the regulatory requirements, the product should be issued by clinicians on a named patient basis until a product licence has been granted." (Page 2, Paragraph 6)

"The response from Centres had been good and information had been received from 81 Centres, giving results for HTLV-III tests on a total of 2,570 patients." (see page 6, last paragraph)

• Analysis of the results showed that 44% of the Haemophilia A patients tested were found to have HTLV-III antibodies.
• Therefore, 1,130 out of 2,570 Haemophilia A patients tested in the UK in October 1985 were HIV positive.

Note: We have to ask ourselves how infection rates with figures this high could have happened? Were we not informed by Dr Christine A. Lee via a Haemofact leaflet of May 1984, that the incidence of AIDS in UK Haemophiliacs was merely 1 in 1,000, representing only 0.1%? So how did this happen?

Background: The DHSS Finance Division were right about one thing, in March 1985 they expressed fears that the haemophiliac population (circa 5,000) could be very seriously affected indeed, with two-thirds possibly already positive with as many as 1,200 eventually going on to develop AIDS. (see Related Entries link below)

"Dr. Hill (Birmingham) agreed that back-up counselling was needed for the patients and families involved."

"Professor Bloom wondered whether, a comprehensive questionnaire could be handled by the peripatetic expert in sexual epidemiology."

"Dr. Jones (Newcastle) said that the proposed study had been discussed by the Reference Centre Directors at 2 recent meetings and he had made known his strong objections to the study. He thought the proposed study was insensitive, unscientific and unethical. It would cause great anxiety to the families and it did not take into account bisexuals or homosexuals."

"Professor Bloom emphasised that no one was forced to participate in the study. The Haemophilia Society's representatives were asked for their views and Mr. Knight replied that the Society was not yet convinced that Haemophilia Centres were the right place for this kind of study to be done."

"Dr Hill felt that patients would co-operate with Centres as they were already asking these questions about the risk of antibody positivity and transmission to wives. The validity of the study was queried if Centres provided only numbers of patients and contacts involved, rather than identifying individual patients and households."

"Dr. Craske replied that he would prefer the individuals and their families to be identified, rather than simply be given total numbers by each Centre."

Background: Two years earlier, the UKHCDO possessed detailed knowledge of the risk of AIDS to the spouses of haemophiliacs. That was in October 1983. Why then, 2 years later, are these physicians having difficulty deciding whether to issue an epidemiological questionnaire to haemophiliac patients and their families? There was NO question; the patients needed to know their status in order to avoid transmission to partners/wives.

Note: We are asking ourselves whether the questionnaire was designed to reinforce known statistics already held regarding transmission of HIV to partners, or was it designed to investigate possible modes of infection by seropositive haemophiliacs. We would suggest the use of the word 'epidemiology' implies that the questionnaire was merely a study of the incidence and distribution of HIV? This is further supported by Dr Craske's intriguing comment that: "In due course when the few HTLV III [positive] sexual partners are identified...". Does this mean that Craske was already aware of the number at this point?

Sir Donald Acheson, October 1985: "These data show that HTLV3 infection:

1. has increased in prevalence among homosexuals in London. Elsewhere it may also be increasing in prevalence but remains less common that [than?] in the capital;


2. It is prevalent among haemophiliacs, particularly sufferers from Type 'A' haemophilia. Fortunately however no new cases of infection should now occur in this group;


3. it has appeared, so far at low prevalence among female partners of haemophiliacs;


4. it remains relatively uncommon among drug abusers."

NOTE: We must point out that the CMO's comment was somewhat overconfident since that very same month, there was the third is a spate of cases of seroconversion in UK haemophiliacs associated with the use of an imported commercial concentrate; Armour’s H.T. Factorate - and this was only 2 and a half months after the Deputy Chief Medical Officer (Dr E. Harris, DCMO) had expressly stated that:

"all commercial Factor VIII imported into this country is also heat treated. There would thus appear to be no longer any need to use un-heat-treated Factor VIII concentrate." (August 1985).

By November 1985, there is hearsay evidence that even more haemophiliac patients are seroconverting to become anti-HTLV III positive despite having received heat-treated Factor VIII. Even as late as February 1986, we still have a new HIV infection in a UK haemophiliac caused by Armour batch A28306.

"I should add that we have screened over 24,000 donations by now, without discerning a single seropositive case...."

"I think the public and Parliamentary concern is exaggerated and misplaced. Much greater funds and concern should be invested in the more difficult area of influencing attitudes and behaviour rather than allowing them to be dissipated and assuaged in the area of blood transfusion."

Note: This statement is overconfident and unhelpful.

"Fortunately for us, we were able to start anti-HTLV-III screening unofficially from the 23rd September 1985."

"Naturally we cannot comment on quarantined stocks of pooled plasma for fractionation at Elstree but assume that the heat inactivation will cover that aspect."

Background: The NBTS are ASSUMING that BPL Elstree's heat-treatment process will inactivate any possible virus in pooled plasma that was QUARANTINED for some reason. They unwisely put a lot of trust in the heat-inactivation process, especially if they are using untested or virus-implicated plasma pools. We know that only 2 months later several haemophiliac patients become HTLV-III positive after receiving Factor VIII; despite it allegedly being heat-treated.

"They have seroconverted some months after having received a non-treated product"

"The Blood Products Laboratory at Elstree were rather late starters in heat treating their Factor VIII but are probably now producing the safest product in the world. There is good evidence that the prolonged and high temperature treatment, is inactivating the non-A non-B agent. It has been apparent for some time that commercial heat treated Factor VIII does not inactivate this agent."

"Doctors in Amsterdam reported that a 27-year-old man had been infected after being given supplies of the blood clotting agent which had been heat-treated to kill the virus..."

"Senior Department of Health and Social Security officials were studying the report yesterday."

"Two months ago the Government's Chief Medical Officer, Dr Donald Acheson, dismissed evidence that Dutch patients had been infected by heat-treated Factor 8, and assured British haemophiliacs that US supplies were safe."

Legal Note: There was little question, in this case, of a clear causal relationship between the conduct of a US blood product manufacturer and the result of this commercial product on the patient - since the Amsterdam-based physicians had reported in the Lancet that their patient had been given exclusively heat-treated Factor VIII originating from the United States.

NOTE: There were grave consequences to the CMO's dismissal of the Dutch evidence. Only a week later, (on 21 February 1986) Armour batch A28306 is found to be the likely cause of HIV infection in a UK haemophiliac. By late September '86, Armour's H.T. Factorate is again reported to have led to seroconversions in another two haemophiliacs in the UK.

"...She said that [Deleted Name] had made a statement at the Newcastle Conference in February to the effect heat-treated Factor VIII was not safe with regard to transmission of HTLV III..." (Page 4, Point 9.2)

Note: In England, 12 patients received treatment from the implicated batch. One of the patients who sero-converted as a result of this batch, was only a mild haemophiliac who had not received any treatment in the previous 6 years. (Page 4, Point 9.2, ii.)

Background: It is also worth noting that these infections occurred just 7 months after the Deputy Chief Medical Officer expressly stated that "all commercial Factor VIII imported into this country is also heat treated." (see link below to DHSS letter 15 August 1985)

"The patient who remains well has yet to be approached and this will not occur until the physicians return from annual leave."

Note: The poor decision was made not to approach the patient until the physician returned from annual leave. This meant that the patient himself was not informed of his test result and was thus NOT able to protect his sexual partner(s).

Background: As early as October 1983, the UKHCDO had shown knowledge of the risk of AIDS to the spouses of haemophiliacs, and we believe it to be quite outrageous that 3 years later physicians are still putting partners at risk.

Mr. Dobson asked the Secretary of State for Social Services when his Department first became aware that acquired immune deficiency syndrome could be transmitted through blood and blood products.

Mr. Newton [pursuant to his reply, 17 November 1986, c. 78]: We became aware in 1982 of reports from the United States of America that haemophiliacs were contracting AIDS. Although the mechanics of infection was not known it was presumed that it had been transmitted through the use of blood products such as Factor VIII. Evidence that the AIDS infection could also be transmitted by blood transfusion emerged from the United States of America in 1983.

Note: According to Hansard, Dr Gerard Vaughan, then Minister for Health, had knowledge, sometime in 1981, possibly from as early as May, of the threat of contaminated blood supplies which were being imported from the United States. This is one of the earliest warnings that we are aware of (so far) and we are astonished to learn of how early this awareness was, and that so little was done. Clearly, we are still not being told everything. (see related entries link below.)

We also know that in July 1982, the DHSS had early knowledge in of ‘a sort of virus’ found within plasma taken from ‘homosexual drug-takers’ which went undetected when the plasma was tested but when it was used for Factor VIII, it became active again.

“the final outcome would be some element of no fault compensation for all haemophiliacs”.

Note: It is extremely ODD that a solicitor should mention “no fault compensation” (which could be considered a ‘compromise’) in an opinion disclosed so early on. In fact, the opinion was committed to paper nearly 3 years prior to the inception of the Haemophilia / HIV Litigation in 1989.

The pioneering work of scientist Michael Houghton, Ph.D. and colleagues Qui-Lim Choo, Ph.D. and George Kuo, Ph.D. goes back as far as 1982.

...And so a campaign got underway. Letters went to MPs, sympathetic stories appeared in the press, people threatened to sue their district or regional health authority.

Margaret Thatcher had always insisted that the correct course of redress was through the courts and it was clear she had sought advice on the matter.

The announcement was seen as a breakthrough on the issue for the Government which, under Mrs Thatcher's leadership, had insisted that compensation would remain a matter for the courts.

Note: The arrival of this heat-treated product has been delayed by 2 years due to the Government dragging it's heels over the work on the new fractionation facility in Scotland which was begun in 1985.

"The BMA's annual representative meeting in Bristol voted by 183 votes to 140 for the motion, which would allow doctors to test patients at their discretion and without necessarily asking consent."

The Department's reaction was echoed by Dr Samuel Galbraith, the Labour MP who is a member of the General Medical Council:

Dr Samuel Galbraith: "I think the legality of the decision is in question. A test that involves withdrawal of blood is an assault unless the patient has consented to it."

Professor Michael Adler: "It's a very sad day... Allowing potential patients to feel that any doctor sticking any needle into them may be testing them for the Aids virus without their consent will inevitably drive risk groups underground."

General Practitioners, surgeons, and anaesthetists maintain that they could be infected when they treat patients...

Dr Laurie Allan: "It is time to be realistic. I for one feel my life and those of my medical and nursing colleagues are more important than the future insurance and employment prospects of infected individuals."

Mr Brian Hopkinson: "Don't die of ignorance. Test the lot - before surgery at least."

“I am glad to see that you have made an ex-gratia payment for haemophiliacs who, as a result of transfusion, find themselves HIV positive.”

“I would be grateful if you could let me know what happened to the extra money that was allocated to the regional transfusion centres, and why they did not become self-sufficient. I think I should in fairness warn you that I have it in mind to refer the issue to the Ombudsman on grounds of maladministration unless I receive a satisfactory explanation.”

During the trial the young haemophiliac patient develops raised transaminase activity of 894 IU when prior to the study, he had levels of only 5 IU.

Note: This 12-year-old haemophiliac boy was deliberately allowed to acquire hepatitis for the sake of a trial. [Clinical diagnosis of hepatitis defined by raised aspartate and alanine transaminase activity of over 150 IU; at least four times the upper limit of normal.]

"This batch was associated with the transmission of HIV to approximately 15 Edinburgh Haemophiliacs. The details of these seroconversions have been extensively reported in the literature of Dr Ludlam."

"FVIII Batch No 023110090 was manufactured in November 1983 from plasma collected in the Autumn 1983. Clearly this preceded the availability or introduction of plasma donation testing or product treatments to inactivate HIV (eg heat treatment) either in the UK or internationally."

"Following the reports of product infectivity, attempts were made to identify the specific donation(s) which led to the product being infective. These were unsuccessful."

"Attached is a summary of the action taken by Dr McClelland and Dr Cuthbertson to effect a batch recall after initial notification by Dr Ludlam of seroconversions."

"Batch No 023110090 was in all other respects compliant with the product specification at that time and there were no notable events during the manufacturing process."

NOTE:

Please click the 'Find Related Entries' link below to see how this Timeline entry relates to the one for 10th October 1983 regarding the Medical Research Council (MRC) and what should be referred to as a controlled AIDS study of UK Haemophiliacs; the Edinburgh Haemophiliac Cohort; a study which we believe to have been entirely unethical.

"The strongest evidence on the magnitude of risk of viral transmission from any particular product is derived from 'Virgin Patient' (VP) studies, of which there have been relatively few. It is generally considered that at least 60 patients with uneventful follow-up are needed to satisfactorily prove safety at the 95% level of confidence. To our knowledge, no studies yet carried out have fulfilled this criterion." (page 2, paragraph 1)

Of the products available, or soon to be available in May 1988, there were 8 which were unlicensed and should only have been used on a 'named patient' basis, whilst another 8 products had already been used in 'virgin patient' studies.

Background: In complete contrast to these 'recommendations' for the continued use of plasma-derived factor VIII products, Hyland, in 1987, had already commenced human clinical trials of recombinant Factor VIII concentrate. (Source: Baxter Vaccines - Milestones. See below for link.)

Note: If the UK Haemophilia Centre Directors had genuinely wanted to protect their patients from further risk of viral infection, they would have overcome their fondness for 'virgin patient' studies and directed their need for unlicensed products toward early recombinant trials. After all, we know from a DHSS memorandum that the technology for genetically-engineered factor VIII was known about as early as September 1983.

"One problem in determining efficacy of any inactivation technique, however, was the inability of various isolation and serologic assays to detect HIV viral particles, viral antigen or antibody in concentrates."

"Thus, products had to be spiked with infectious virus and the log reduction of virus established for in vitro studies; for in vivo studies, patients had to be followed for HIV seroconversion, hepatitis B markers or transaminase elevation {for non-A, non-B hepatitis}, in order to demonstrate safety or adequate inactivation." (see page 180, PDF page 9)

NOTE:

We are dismayed to see such a direct reference to seroconversion as a result of these studies. This wording makes it abundantly clear that 'spiked' infectious product made its way through to being administered intravenously to haemophiliac patients:

"...patients had to be followed for HIV seroconversion"

In vivo:
We should also point out that according to Wikipedia, in vivo refers to experimentation using a whole, living organism as opposed to a partial or dead one. Animal testing and clinical trials are two forms of in vivo research. In vivo testing is often employed over in vitro (in the test tube) because it is better suited for observing the overall effects of an experiment on a living subject.

Under the heading "Non-A Non-B Hepatitis" we read about the "need for a prospective study of post transfusion NANB in blood recipients or stored sera from haemophiliacs." (see page 2 of PDF link below)

Further on in the minutes, we read in handwritten notes:

"Data on Haemophiliacs to go to Dr A Rejman" (see page 4 of PDF link below).
Please note that Dr A Rejman was a Departmental haematologist, DHSS Med SEB/B.

"The Chiron test had been used in first time recipients of Factor 8Y. Preliminary results had shown no positives, while most recipients of earlier concentrates were Chiron positive. Further study of stored haemophiliac sera was advocated." (see page 6 of PDF below).

Note: It is worth remembering that the new Chiron HCV assay was being used much earlier than we previously thought, since these ACVSB minutes record the use of the HCV test in July 1989 - which in terms of HCV testing was considerably early.

LEGAL NOTE: We should point out that this non-consensual Hepatitis C testing was advocated by a Government advisory committee at a time when English and Welsh haemophiliacs were litigating against the Department. These vulnerable patients were kept in the dark about their HCV status by both the Department of Health and their treating consultants. It goes without saying that this knowledge would have impacted upon their cases. This is an example of material non-disclosure by the defence.

Since the rediscovery of the once-missing ACVSB minutes, we now have proof that the SNBTS conducted illicit HCV testing on 146 innocent Haemophiliacs in Glasgow. They found that 92 (63%) of these haemophiliacs were positive (and repeat reactive) for HCV as early as August 1989. (see pages 35 & 39 of PDF source below for proof.)

These clinical trials of the new HCV test were conducted almost certainly without the knowledge of the haemophiliac community and were also carried out at an inopportune time - whilst English and Welsh Haemophiliacs were involved in the HIV Civil Litigation against the Department of Health which had been filed 3 months earlier; back in April 1989. It is clear that this should never have happened during litigation because the information garnered from Scotland impacted on our case in relation to Whitehall and the fact that it was allowed to occur amounts to nothing less than a gross miscarriage of justice on behalf of Government.

Note: It never ceases to amaze us as to the level of the apparent deception and duplicity directed at us by Government. It is clear from the minutes of the ACVSB, a high-powered committee whose responsibility it was to advise Ministers, that they were fully aware that haemophiliacs had tested positive for Hepatitis C from as early as August 1989. This was well over one year before the waivers emerged, meaning that people with haemophilia were prohibited from suing in respect of HCV. It is now widely believed that these waivers were illegal.

In the minutes of the Twenty-First meeting of the Haemophilia Centre Directors (HCDO) held on Monday 9th October 1989, it is clear that one of the doctors present, Dr Mortimer of the PHLS, was:

"willing to accept samples for Hepatitis C (HCV) testing. The Working Party would be looking at HCV testing in haemophiliacs." (see page 10 of PDF below).

Note: We find this information appalling, especially since the date of the minutes is so early, i.e. October 1989. Many haemophiliacs (including two of the authors of this Timeline) were not informed of their HCV status until as many as 3 years later. This was also an extremely sensitive time, since persons with haemophilia in England and Wales were at least 6 months into the HIV Haemophilia Civil Litigation which had begun in April 1989.

From these minutes, we can determine that there was a drive amongst the HCDO Haemophilia Consultants to garner samples of UK Haemophiliacs’ blood for early HCV testing. The report of the Independent Inquiry, chaired by Lord Archer of Sandwell, was satisfied that some patients were subjected to tests without knowledge of their purpose and without their consent. It is our belief that results were deliberately withheld from patients until after the signing of the 1991 waivers.

"Dr. Jones said that the Secretary of State, Regional Health Authorities and Committee for Safety of Medicines were being sued; doctors were not being sued. Mr Justice Ognall wished to proceed with the trial quickly."

"Broadly the claim was that the DHSS had failed to stop the use of imported concentrate and had been slow to produce heat-treated concentrates."

"Dr. Rejman, representing the Department of Health, stated that the Governments position was that there was no case for an out of court settlement and that compensation must be sought in the courts. ....He drew attention to the problem that might arise with the Committee on Safety of Medicines (CSM) if individual members could be sued as this might lead to great difficulty recruiting people who would be prepared to serve on the Committee. It was not a simple problem."

"Dr. Green asked Dr. Rejman if the case could be settled out-of-court if the claim against the CSM was withdrawn. Dr. Rejman was unable to answer this question but said it was the policy decision of different Governments that was being challenged."

Background: At first glance, the above suggests a classic example of the State influencing legal process. For example, there appears to be a dropping of the 'Duty of Care' allegation. In 1990, Justice Ognall made a 'statement of direction' in which he invited all parties to give 'anxious consideration' to the prospect of a compromise of the proceedings. This was leaked into the press on 26th June 1990. It should be pointed out that the plaintiffs were not made party to this statement until October 1990, 2 months later.

NOTE: It would appear that an 'agenda of compromise' was being proactively worked towards long before Justice Ognall's statement of direction was made public. This can be substantiated by the fact that the government’s intransigent position was absolutely clear until it was confirmed that the Licensing Authority and Committee on Safety of Medicines (CSM) were to be left out of the proceedings. We know that as soon as the Department had confirmation from all parties that physicians and the CSM were going to be omitted from the allegations they conceded to an out-of-court compromised offer. It is clear to us now that the State and the medical profession influenced legal opinion and legal process.

"...It may well be that screening donor blood by such an assay could reduce the transmission rate of non A, non B hepatitis in single donor products and in some pooled plasma derivatives."

Note:

Professor Zuckerman, a member of the ACVSB Committee, looks forward to the Fifth Meeting of the Advisory Committee on the Virological Safety of Blood to be held on 17th January 1990, and states in his letter the following in relation to the introduction of the HCV Screening test:

Professor Zuckerman: "The projected cost of this screening test is, at least initially, very high, but considering the overall morbidity of chronic non-A non-B hepatitis (including apparently autoimmune liver disease and hepatocellular carcinoma), and litigation which would be indefensible, the introduction of screening could not be delayed much beyond FDA approval." (January 1990).

HCV Testing:

"Majority view was that sufficient evidence of test positive/infectivity correlation to justify implementation - overriding factor was question of Product Liability."

"Evidence that the USA FDA will recommend implementation for cellular/single donor products but not for fractionated product – two independent sightings of this of this rumour (Rotblat and Thomas) but as yet unconfirmed. Importance of policy decision on fate of pre-existing plasma stocks before implementation of test to avoid repeat of HIV story.”

Conclusion:

"No recommendation yet to ministers to implement test." (17th January 1990)

The Government, in acknowledgement of its responsibilities for haemophiliacs who contracted HIV from contaminated blood products, makes an ex gratia payment to each one (or to the bereaved families) of £20,000 each.

"The use of the Ortho Hepatitis C assay kit has confirmed anti-HCV seropositivity in all haemophiliacs with well documented NANB hepatitis." (See pages 44-45 of PDF link below)

"Between 1978 and 1983 there have been 50 haemophiliac studies, 31 of them prospective." "The majority of multi-transfused haemophiliacs are shown to be positive for HCV antibody."

Note: We find it quite scandalous that this paper should be submitted in April 1990 to the ACVSB, a government advisory committee - right in the middle of the proceedings of the HIV Haemophilia Litigation. We should also draw attention to the use of the "Ortho Hepatitis C assay kit", the new HCV test, which demonstrates that genuine HCV testing was being conducted.

Point 3.3 the document states:

"The object of validation is to estimate quantitatively the level of virus clearance obtained along the various stages of purification and/or any viral inactivation stages. This will be achieved by the deliberate addition (‘spiking’) of significant amounts of a virus to the crude bulk to be purified and to different fractions obtained during the various purification stages and its removal during the subsequent stage of purification determined."

Point 4.2:

"The selection of viruses should take into account viruses which are known to be potential contaminants of the source material or of the production method. Thus, e.g. consideration should be given to validating the removal of hepatitis B virus, HIV, etc, from products derived from human blood."

Point 6: Limitations of the Validation:

"In vitro virus validation studies will be required for marketing authorization of a biological produced from animal or human sources. However, such studies have limitations and extrapolation from in vitro virus clearance/inactivation studies to virus safety in clinical use has not always been justified. Indeed confirmation that the product is virus-safe will be given only by long-term post-marketing clinical studies. Recipients of the product should be monitored clinically for seroconversion and for viral illnesses.”

NOTE: This paper was included in the once-destroyed ACVSB minutes. It should be borne in mind that we were never meant to see these documents and those attending the meetings and providing submission papers would never have dreamt that we would be reading this today. The very purpose of the ACVSB was to provide advice to Ministers at a high-powered level - and by virtue of the exemptions provided for by Section 35 of the FOI Act, we most certainly would not have had sight of these minutes had a full set not resurfaced.

"It is a very serious matter if a department of state is acting in direct contradiction to the PM".

"She speaks for the government as a whole, and once she said that no obstacles will be put in the way that should be it".

A meeting of the authority representatives last month decided to ask the Department of Health to investigate ways of settling the matter out of court. If the action goes ahead, government legal cost will run into millions of pounds.

"Harriet Harman, Labour's health spokeswoman, claimed that the Government was concerned that if official papers were read out in open court the public would see that ministers had knowingly put lives at risk in order to penny-pinch on the NHS."

NOTE: Harriet Harman's claim is in direct contrast to the obvious implications of the following extract (regarding Kenneth Clarke) from the Scotsman on the same day in 1990:

"The Health Secretary, Kenneth Clarke, tried to insist that to the best of his knowledge the papers contained nothing that could help the claimants. But that begs the question why his department should then be so keen to keep them secret."

Lord Justice Bingham:

"The tragedy was avoidable in the sense that, had different measures been taken in the 1970s and early 1980s, it could, at least in large measure, have been prevented."

Further capital payments are made in settlement of potential litigation; these payments, which vary in amount according to the recipient’s age and family status, total (by May 1993) about £44 million (including £316,000 paid to 158 people who had begun litigation proceedings).

Note: Over a third of the surviving registrants would have been classified as 'INFANTS' at the time of the 1991 settlement payments and, in consequence, received only £21,500 each.

Surprisingly, in discussion, there was no agreement as to the degree of risk B19 posed in fractionated blood products. It was stated that although Parvovirus B19 could be eliminated, that effective testing could only be done on single donations and not on pools.

Detection of Parvovirus B19 in Blood Products:
In an Edinburgh study conducted over 3 months, the DNA of Parvovirus B19 "was detected in two-thirds (18 out of 27) separate batches of non heat-treated factor VIII and IX concentrate manufactured from plasma donations unscreened for B19 DNA."

"Dry heat treatment of 8O°C for 72 hours reduced but did NOT always eliminate detectable B19 from factor VIII concentrates, consistent with recent observations that current methods of viral inactivation during blood product manufacture are insufficient to entirely eliminate B19 infectivity." (see 2nd source below, page 3 of PDF.)

There is convincing serological evidence for transmission of B19 by non-heat treated factor VIII and prothrombin complex concentrates. In one study, serological testing of haemophiliacs found elevated rates of Parvovirus B19 infection in recipients of dry or steam-treated Factor VIII.

"The frequency of PCR-positive donations detected in the above study (1/3300 donations) indicates that B19 might frequently contaminate blood products where pools of 3,000-10,000 plasma donations are used as raw material in the manufacturing process."

NOTE: It is horrifying to learn that another pathogen, Parvovirus B19, made its way into our factor concentrates in the 1980s and early 1990s. We pose the question: How many people with bleeding disorders were exposed to Parvovirus in this period?

A statement from the Department of Health said:

"The National Institute for Biological Standards & Control have batch-tested all blood products released for use in this country including those from IMMUNO. No HIV contamination has been found in any products authorised for release by the NIBSC."

NOTE:

If no HIV contamination was found in the products authorised for release by NIBSC ~ which from the mention of Immuno clearly included imported products ~ how was it possible that 1,200+ UK haemophiliacs became HIV positive which led to the deaths of over 900 of them?

Legal Note: Should the batch release certificates ever be disclosed by NIBSC to our solicitors, we dare say that NIBSC could be held liable for releasing contaminated products which were batch-tested and deemed safe. We believe Crown Immunity will be of little use as a defence since the products being tested included imported commercial concentrates. The very fact that these were not manufactured in the UK from 'altruistically' donated blood weakens the aegis of Crown Exemption that applied to all NHS bodies and premises until 1st April 1991. NIBSC may well find that the provisions of the Medicines Act are, in fact, binding on them in this case.

Mr Justice Morland stated that the Scientific Steering Committee overseeing the manufacture of the hormone were told, the Clinicians' Committee is "deliberately kept in the dark".

That ruling resulted in compensation in 8 cases in which treatment had started after that date. Two other cases in which treatment was finished before that date were ineligible for compensation.

The Judge added:

"No amount of psychotherapy or counselling can obliterate the truth. Each plaintiff remains indefinitely at risk of [the disease], which is inevitably fatal and not subject to amelioration or treatment."

The test is expected to be available commercially in the U.S. by 2001.