The taintedblood Timeline  -  what really happened...

"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.

Note: This letter suggests that some sort of early blood test was available for HIV (probably termed HTLV-III) as early as June 1983. The date of the test is June 30th at Walsgrave Hospital Blood Bank, and the letter goes on to offer the results by 11 July 1983, which is just 11 days later.

Internal Correspondence from DHSS - Diana Walford dated 6 June 1983. Under the general heading "Possible Implications of AIDS for Plasma Supply and Manufacture at BPL:

"There are increasing indications that the AIDS may be transmitted by blood and blood products. Because of the number of donations to which they are exposed, haemophiliacs receiving large pool factor VIII concentrates (such as that manufactured at BPL) might be at greater risk than those receiving single donor cryoprecipitate or small pool products. At a recent Council of Europe meeting (16-19 May 1983) a draft resolution was accepted which recommends that the use of coagulation factors prepared from large plasma pools should be avoided except where such a product is specifically indicated for medical reasons. The implication in the resolution is that there should be greater use of single donor or small pool products."

Note: We have been unable to find this internal correspondence of 6th June 1983 in any of the FOI releases. We have also been unable to identify it in the evidence submitted to the Penrose Inquiry, and there is no mention of it in either the Preliminary Report or the Final Report. Therefore, we question whether it was ever released? ...

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.)

"The Chairman outlined the problems caused by AIDS. Since it appeared to be transmitted through blood and blood products then it should be considered by the Committee."

Note: We note that Dr Diana Walford (on behalf of the DHSS) was present at this meeting.

1. "For mildly affected patients with haemophilia A or von Willebrand 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."

• The possibility is considered of withdrawing clotting factor concentrates from the market and replacing them with cryoprecipitate. It is concluded that this is not feasible in the UK on grounds of supply. (Minutes Agenda Point 5.3)

• The possibility is considered of withdrawing US preparations from the UK. It is concluded that this is not at present feasible on grounds of supply. Moreover, the perceived level of risk does not at present justify serious consideration of such a solution. (Minutes Agenda Point 5.4)

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

"There is need for research work on AIDS in the UK, especially in relation to the possible new introduction of this disease into the virgin soil of the United Kingdom.

The Sub-Committee was glad to learn that a number of groups, including the Medical Research Council, are planning and have started research work."

Note: We fail to understand why they talk about the "possible new introduction of this disease". Are we to believe that they somehow helped introduce it to the UK?

The Institute of Medicine Committee believes it is not possible to conclude that the FDA made a decision that was clearly in the interest of public health given available information as of July 19, 1983. A close reading of the data suggests that a policy, not only of automatic recall, but of delicensing AHF (anti-hemophilic factor) concentrate until further information was available concerning its role in the transmission of AIDS might have been justified on public health grounds.

"�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)

O"pportunities 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)

"Over the next three years the blood products laboratory will be redeveloped at a cost of �21m. When completed the laboratory will be of a size capable of making England and Wales self-sufficient in blood products".

Note: Mr Kenneth Clarke has clearly made the most of the way in which the original question was worded. This is a crafty answer, in that if the question had specified 'blood products' then he would have had to divulge information that indicated that blood products have, in fact, been imported into the United Kingdom since 1972. (Source: "Haemophilia Treatment in the United Kingdom from 1969 to 1974" Rosemary Biggs)

Background: There was no question that blood products (as opposed to plasma) were being imported from the USA when Mr Kenneth Clarke made this statement in 1983:

• In August 1983, Lord Glenarthur of the DHSS failed to ban pre-March 1983 imported American factor VIII. "Regarding blood products from the USA, in March this year the US Food and Drugs Administration (FDA) initiated new regulations for the collection of plasma designed to exclude donors from high-risk groups."
• It should also be pointed out that the MHRA's CSM (Committee on the Safety of Medicines) sub-Committee on biological products were reviewing product licences between March 1983 and July 1984 for commercial companies Armour, Alpha and Travenol with respect to their factor VIII products and antihaemophilic factor bulk cryoprecipitate.
• Five months earlier, (June 1983), written evidence can be found from the DHSS that as much as 50% of the Factor VIII requirements of the United Kingdom were indeed imported large-pool commercial concentrates, mostly from the USA.

Note: In response to Cutter's product withdrawal, the National Hemophilia Foundation astonishingly advises patients to continue the use of concentrates or cryoprecipitate.

"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.

"Professional advice has been made available to all such centres in relation to the possible risk of (AIDS) from this material".

How much proof did he need?

• In a Haemophilia Centre Directors' Organisation meeting in 13 September 1982, there is not only knowledge of AIDS infecting haemophiliacs in the USA, but also, there is some understanding of the possible involvement of commercial blood products.
• Then in January 1983, Desforges publishes an articles in the New England Journal of Medicine on Hemophiliacs and AIDS, recommending that cryoprecipitate rather than concentrate be used because of the risk of AIDS.
• By 6th May 1983, the CDSC telephones the DHSS to inform them that a 23 year old haemophiliac patient in Cardiff is now showing the appropriate symptoms for an AIDS diagnosis. N.b. This man had been infused with American Factor VIII.
• In a letter of May 1983, Dr N. Galbraith of the PHLS writes to the DHSS stating that he has 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. Both this suggestion and warning were ignored.
• Even when the Council of Europe made their draft recommendations on coagulation factors and AIDS at their meeting in Lisbon (16-20th May 1983), the UK seems to have difficulty remotely following these resolutions - which were, incidentally, accepted. The Council of Europe recommended that the use of coagulation factors prepared from large plasma pools should be avoided except where such a product was specifically indicated for medical reasons.
• In August 1983, the first UK haemophiliac dies of AIDS from US Factor VIII administered in December 1981.

Note: We have to question the speed at which the heat-treatment process was implemented by Armour. According to the Institute of Medicine Committee report, Hyland, Cutter, Alpha, and Armour claimed to have begun processing and distributing heat-treated factor concentrates immediately after receiving their licences, but none had converted production to heat-treated factor concentrates exclusively. (Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 755, paragraph 2, last 4 lines.)

• 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.

"(ii) Members discussed the suggestion that the production of cryoprecipitate could now be reduced. Dr Ludlam said that cryoprecipitate was preferred in the treatment of children at present, because of the new danger of AIDS. Dr Hann concurred..."

"...A policy seemed to be emerging however to use less cryo for haemophilia A patients."

"...It was agreed that a certain minimal amount of cryo was required and Dr Cash pointed out that TDs (Transfusion Directors) could produce it in emergencies."

Note: We have to ask what would constitute "an emergency"? Perhaps the fact that by this time, February 1984, we were several years into the AIDS crisis. The DHSS knew all too well that as much as 50% of the Factor VIII requirements of the United Kingdom were being imported as large-pool commercial concentrates, mostly from the USA. There had been numerous warnings (from the CDSC to the 1983 FDA regulations) yet, the DH and HCDO were still conducting trials on PUPs or as the physicians liked to call them 'virgin haemophiliacs'. This was after January 1983, when Desforges published an article in the NEJM on Hemophiliacs and AIDS, recommending that cryoprecipitate rather than concentrate be used, and in August 1983, the first UK haemophiliac had already died of AIDS from US Factor VIII.

So much for the emergency.

Dr Thomas (NIBSC): "The undoubted therapeutic benefit of Factor VIII concentrates was clouded by a well recognised side-effect, namely hepatitis, and also, more recently, AIDS. It has been shown that the first exposure to concentrate, from whatever source, is associated with a hundred per cent infectivity with non-A, non-B hepatitis."

Note: We are dismayed to read that they dared to consider hepatitis merely a well-recognised side-effect, and to include AIDS in the same context is deplorable. The minutes state that NIBSC was the Institute that gave 'scientific advice to the Licensing Authority and the Committee on the Safety of Medicines'. So this cannot be excused.

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.

Only Hemofil-T, manufactured by Travenol Laboratories Inc, had completed it's clinical trials.

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 achieved)." (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)

34% of tested English haemophiliacs have virus.

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/spouses?

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/spouses 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?

• We know that Dr Craske had detailed knowledge about the situation regarding AIDS in the USA, especially since he was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States in September 1982.

• Dr Craske even knew about the connection between AIDS and US commercial blood products.

• We also know that from October 1983, the UK Haemophilia Centre Directors had considerable, documented awareness of the risk of AIDS to the spouses of haemophiliac patients.

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)