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Chapter 28

Donor Selection - AIDS


28.1 As indicated in Chapter 12, HIV/AIDS: Response and Clinical Practice, 'donor selection' was among the several approaches taken to minimise the emerging risk of AIDS transmission. 'Donor selection' refers to the steps taken by the Scottish National Blood Transfusion Service (SNBTS) and others, before testing of donations was available, to prevent the donation of blood which might carry a risk of transmission of the cause, or postulated cause, of AIDS. These steps consisted mainly of public information, to make 'higher-risk' prospective donors aware of the disease and the risk that it could be transmitted through blood transfusion and treatment with blood products. The intention behind the dissemination of such information was to discourage from giving blood those donors perceived to be at higher risk of carrying the infective agent. This chapter discusses donor selection in the AIDS period, 1982-85. The questions for the Inquiry included, particularly, whether these efforts went far enough and began early enough.

First steps taken in 1983

28.2 It was evident that steps to deal with the perceived threat from infected donations were first taken in Scotland in the spring of 1983. In his statement,[1] Dr Brian McClelland, Director of the Edinburgh and South East Scotland Blood Transfusion Service (BTS) at the material time, explained that he received a copy of the Mortality and Morbidity Weekly Report (MMWR), published by the Centers for Disease Control (CDC) in the USA, dated 4 March 1983. The section on 'Current Trends' contained an article entitled 'Prevention of Acquired Immune Deficiency Syndrome (AIDS): Report of Inter-Agency Recommendations'.[2] Background information on the condition, as understood at that time, was given: over 1200 cases had been reported to the CDC from 34 states and the District of Columbia in the USA, and from 15 other countries. Over 450 people had died, the fatality rate being greater than 60% for cases first diagnosed over one year previously. Reports had gradually increased in number. Latterly, 11 cases of unexplained, life-threatening opportunistic infections and cellular immune deficiency had been diagnosed in patients with haemophilia. The article included the following recommendation:

As a temporary measure, members of groups at increased risk for AIDS should refrain from donating plasma and/or blood. This recommendation includes all individuals belonging to such groups, even though many individuals are at little risk of AIDS. Centers collecting plasma and/or blood should inform potential donors of this recommendation. The Food and Drug Administration (FDA) is preparing new recommendations for manufacturers of plasma derivatives and for establishments collecting plasma or blood. This is an interim measure to protect recipients of blood products and blood until specific laboratory tests are available.[3]

28.3 The reference to 'groups at increased risk for AIDS' was expanded in the article. The groups were described as follows:

[P]ersons who may be considered at increased risk of AIDS include those with symptoms and signs suggestive of AIDS; sexual partners of AIDS patients; sexually active homosexual or bisexual men with multiple partners; Haitian entrants to the United States; present or past abusers of IV drugs; patients with hemophilia; and sexual partners of individuals at increased risk for AIDS.[4]

28.4 It was suggested that the approach to dealing with the risk of AIDS from transfusion revealed by this article seemed to be to cast the net wider than might be strictly necessary when highlighting groups at risk, because of the priority of including those people who had to be identified. Dr McClelland agreed: it appeared to have been accepted that the criteria applied would result in the exclusion of healthy donors who happened to belong to the broadly defined groups of those being asked not to donate blood.[5] He explained that the inter-agency recommendation quoted was unusual and had 'quite a tortured origin'. The FDA had not been enthusiastic to issue a statement. The prime instigator of the statement was Dr Bruce Evatt of the CDC, whom Dr McClelland described as 'essentially the focal point of the discovery of the occurrence of AIDS in patients with haemophilia'.[6] Dr Evatt's role in promoting wider knowledge of the aetiology of AIDS and encouraging an appropriate clinical response has been discussed in Chapter 11, HIV/AIDS Aetiology, and, briefly, in Chapter 12, HIV/AIDS - Response and Clinical Practice.

28.5 In addition to the influential MMWR publication, Dr McClelland described the evidence which had started to emerge in July 1982, that AIDS was transmissible by blood and was therefore more likely to be due to a transmissible infectious agent than to any of the other causes then being considered. He also referred to an additional, local factor. During 1983 one or two local newspapers had taken up the suggestion that Edinburgh could become the 'AIDS capital of the North', relating this claim to the Edinburgh Festival and a supposed relationship between gay men and the arts.[7]

28.6 In this regard, Dr McClelland was asked if, at the time of first drafting a leaflet discouraging potentially high-risk donors from giving blood in 1983, he had knowledge of possible AIDS cases in Edinburgh. He answered:

From May 1983 or possibly a little earlier, Dr Anne Smith and I were meeting with Dr Sandy McMillan, a GU [genitourinary] medicine Consultant in the Royal Infirmary of Edinburgh and Mr Derek Ogg of the Scottish Homosexual Rights Group to work out ways of communicating to gay men the message that they should refrain from donating blood. Dr McMillan would have been restrained by clinical confidentiality from mentioning any specific cases, but it is my recollection that he was aware that some of his male patients who were known to be gay were showing clinical features that suggested that they could be suffering from this new form of immune deficiency disorder.[8]

28.7 Dr McMillan's remit as Consultant at the Royal Infirmary of Edinburgh (RIE) included sexually transmitted diseases and he was well known to and respected by the gay community. His recollection of events, after more than 25 years, was understandably hazy but in a letter to the Inquiry he also described meetings with members of the SNBTS, in particular Dr McClelland, and Mr Ogg of the Scottish Homosexual Rights Group (SHRG), to discuss how best to dissuade men who had sex with men from donating blood.[9] Open discussion in this group was to be of some importance as matters proceeded.

28.8 Against this background, Dr McClelland began work on a leaflet.[10] He explained that the obvious approach at the time was to follow the principles of the US Public Health Services Interagency Guidelines, as reported in the MMWR, slightly adapted for use in Edinburgh.[11] By 24 May 1983, when the SNBTS Coordinating Group met, Dr McClelland had prepared a draft, which he tabled at the meeting.[12] The leaflet stated:

What is AIDS?

It is a disease called

(A) (I) (D) (S)
acquired immuno deficiency syndrome

which is thought to be caused by an infectious agent, perhaps a virus. So far the cause is unknown. It is a rare disease but it can have serious consequences.


Who can get the disease?

AIDS has been occurring, particularly in the USA, in certain people who are apparently susceptible to the disease:

1) Homosexual men, particularly those with multiple partners;

2) Drug abusers;

3) Sexual contacts of people with AIDS - women can be infected if the males are bisexual;

4) Haitian immigrants to USA;

5) Haemophiliacs - who may be more susceptible or may become infected by their use of blood products which may have come from a blood donor with AIDS.

Most (but not all) cases have occurred in the homosexual male population. Why this should be is not yet known. A small number of young children have been affected.


Can it be Transmitted by Blood Transfusion?

It appears it can. This might cause the disease in people who are not normally at risk. It may have infected clotting factors that caused AIDS in Haemophiliac men in USA.

We have not had any definite cases of AIDS in Haemophiliacs in UK. If the clotting factor concentrate (factor VIII) can be infected, then cases could occur in UK because much of the factor VIII is imported to UK from USA.

The disease cannot be taken lightly. Those getting AIDS may die, because they are more susceptible to serious infections and cancer due to their impaired immune system.

The Blood Transfusion Service is therefore concerned to try and stop any chance of infection spreading by blood transfusion.

We want to ask people who may be at risk from the disease to avoid giving blood until we have a suitable screening test. Many donors will remember we did this with hepatitis until we had screening tests for the hepatitis virus.

Whose Blood Could be a Risk?

All our information about at risk groups comes from the USA. However, until more is known about the cause and spread of AIDS, we would ask the following groups to refrain from donating blood:

1) Homosexual men;

2) Women who continually have multiple sexual partners;

3) Partners of bisexual men;

4) Anyone who abuses drugs;

5) Anyone who has been in contact with a case of AIDS.

We hope that if we take precautions now, we can prevent the problem of AIDS which has become serious in USA.

Remember it is a rare disease but an important one.[13]

28.9 For comparison, the Inquiry examined some of the text from an early leaflet produced by the American Red Cross and apparently intended to be available at donation centres in the USA. The leaflet was entitled 'An important message to all blood donors'. The relevant section of the text is quoted at the end of a Council of Europe Recommendation, No. R(83) 8:

What are these illnesses?

Some persons may feel in excellent health but have viruses or other infectious agents in their blood that could cause illness in persons receiving a transfusion of their blood. If you think any of the following information pertains to you, please do not donate blood today:

1. Acquired Immune Deficiency Syndrome (AIDS). This newly described illness of unknown cause is believed to be spread by intimate personal contact and possibly by blood transfusion. Persons with AIDS have reduced defences against disease and as a result may develop infections such as pneumonia, or other serious illnesses. At this time there is no laboratory test to detect all persons with AIDS. Therefore we must rely on blood donors' health histories to exclude individuals whose blood might transmit AIDS to patients who will receive that blood.

The Office of Biologics of the Food and Drug Administration has identified groups at an increased risk of developing AIDS. These groups are:

  • Persons with symptoms and signs suggestive of AIDS. These include severe night sweats, unexplained fevers, unexpected weight loss, lymphadenopathy (swollen glands) or Kaposi's Sarcoma (a rare cancer);
  • Sexually active homosexual or bisexual men with multiple partners;
  • Recent Haitian entrants into the United States;
  • Present or past abusers of intravenous drugs;
  • Sexual partners of persons at increased risk of AIDS.


What should I do?

If you believe that you may be carrying one of the above-mentioned illnesses, or if you are an individual in a group at increased risk of developing AIDS, we ask that you refrain from donating blood at this time. You may leave now without providing an explanation. Or, if you prefer, you may proceed to be deferred confidentially, without further questioning, by the health history interviewer.[14]

28.10 Dr McClelland was asked about the detail of the drafting of successive versions of the early leaflets in Scotland. He pointed out that there were various reasons for adjusting the wording:

I think ... we were probably trying to make some adjustments in the wording for two separate reasons. One was, in successive drafts, trying to come up with wording which was not more offensive to people than it had to be. Secondly, wording that was as unambiguous as we could make it, and thirdly that where we felt there might be some areas that perhaps hadn't been adequately identified in the very first version, which had come from the United States, we were prepared to try and extend a little bit more because we had the advantage of coming second, if you like.


[T]he fourth one, of course, was that as the months went on, new information was becoming available quite rapidly, which also we attempted to reflect as accurately as we could in successive drafts of the document.[15]

28.11 At the meeting of the Coordinating Group on 24 May 1983, other Directors were asked what, if any, steps they had taken to address the AIDS risk. Dr Ruthven Mitchell, Director of the Glasgow and West of Scotland BTS, reported that he had introduced into the standard health questionnaire issued to prospective donors at West of Scotland sessions a question inviting those who were worried about AIDS to consult the doctor at the session. Professor Stan Urbaniak, then Director of the Aberdeen centre, had decided, after consideration, not to do anything locally, his view being that once a donor had entered the session it was too late to make an approach. He also thought that the problem was 'minor' in north east Scotland.[16] The responses underlined the extent to which Dr McClelland's leaflet preparations were ahead of other regions, although as it transpired, the problem in the Edinburgh area at that time was indeed more serious than elsewhere in Scotland.[17]

28.12 In the course of his oral evidence, Dr Mitchell was shown a copy of a leaflet produced by the Glasgow and West of Scotland BTS which appeared to include an early reference to AIDS. It took the form of a label or sticker attached to the bottom of the leaflet, with the following wording:


28.13 The date '16/6/83' had been written at the bottom of this leaflet. Dr Mitchell had checked with his then donor manager and she could not produce any other leaflets from that time. It appears that this copy leaflet reflected the information provided by Dr Mitchell at the meeting of the Coordinating Group on 24 May 1983 and was evidence of the question added for donors in the west of Scotland in the first half of 1983.[19] The advice to donors concerned about giving blood was to consult the doctor at the session, as mentioned by Dr Mitchell, or to follow one of the alternatives proposed in the leaflet.

Reaction to draft leaflets in Edinburgh

28.14 It was apparent to the Inquiry that the text of Dr McClelland's draft leaflet changed shortly after the meeting on 24 May 1983 and he was asked about the circumstances leading to those changes.

28.15 A press release on AIDS had been issued by the SHRG on 21 May 1983.[20] One of its headlines was 'Gays say "no" to ban on blood donors'. In its text, the release referred to AIDS as 'an American disease epidemic' and also recorded concern about the possible infection of haemophilia patients in the UK who relied on blood products 'supplied in part from the United States which may be infected by AIDS'. It continued: 'The disease has become known, wrongly, as "the gay plague", and has also been described erroneously as sexually transmitted'. There followed a statement that there were no confirmed cases of AIDS among people with haemophilia in the UK. Under the heading 'GAYS OPPOSE BAN ON GAY DONORS', the release stated:

SHRG in particular and, it is thought, the majority of the gay population reject any proposals for a voluntary or compulsory ban on British gays giving blood. This last proposal is the most panic-stricken of the many strange proposals aired in recent weeks.[21]

28.16 Characterising descriptions of the disease as sexually transmitted as 'erroneous' was unfortunate: it was wrong in fact. The statement that there were no confirmed cases of AIDS in people with haemophilia in the UK was made in a number of different contexts in May 1983[22] but this, too, was incorrect. The Communicable Disease Report of the Public Health Laboratory Service (PHLS) for the week ending 6 May 1983 recorded that AIDS had been reported in a 20-year-old man with haemophilia in Cardiff.[23] That information was not widely known. Dr McClelland had no recollection of being aware of it at the time.[24] The gay community felt unfairly targeted as a vector of disease, in the USA and in the UK, but adopting an extreme position of denial was unlikely to have been helpful to their position, if maintained. It is to the credit of all involved in Edinburgh and the South East of Scotland that it was not maintained.

28.17 The SHRG press release called for research and screening in relation to AIDS to be given greater priority and greater funding. It also called on the press to exercise restraint. Dr McClelland agreed that there had already been alarmist reports in the UK press.[25]

28.18 The stance of the SHRG was modified in relation to what must have been an early version of Dr McClelland's leaflet. A follow-up comment was published in the July/August 1983 edition of Gay Scotland at page 10:

SHRG secured a major success in its consultations with medical authorities by having a proposed leaflet withdrawn because it was seen as anti-gay and likely to cause panic. A revised leaflet drawn up jointly by SHRG and the South-East Scotland Blood Transfusion Service has now been agreed.[26]

28.19 An agreed form of words for the leaflet was a major step forward.

28.20 The magazine also reported that AIDS had, in fact, arrived in Scotland, with two cases 'highly suspected'. Much of the report narrated cooperation between gay organisations in Scotland and the medical profession, both in relation to people who might have symptoms of AIDS and in relation to blood donation. It reported that a monitoring group was being set up involving Dr McMillan, the SHRG and the Blood Transfusion Service.

28.21 Dr McClelland described the relationship between the gay community in Edinburgh and the blood transfusion service over this issue as follows:

At some point in the period between May/June of 1983 we became very much aware that there was a major issue among the gay community in Edinburgh, that they felt they were going to be stigmatised by this and that's an issue that persists to this very day. We felt that the only way to approach this was to very positively engage with the gay community, and the people who were the spokesmen were Derek Ogg ... and a colleague of his, Nigel Cook. We actually brought in somebody who had a very good working relationship with them, which was Dr Alexander McMillan who was one of the consultants in the sexually transmitted disease department. As a result of that, we tried to work with them on the creation of a wording that they were able to endorse. As you can see from this piece on the screen, they eventually did, and I think we were fairly clear that we were trying to get the best out of a difficult situation, and rather than producing a leaflet which perhaps had the wording that we would have chosen, that would be totally rejected by the gay community, we were trying to strive for something that could not only be accepted but endorsed, and quite a lot of work was done over that summer to ... promote this leaflet and the general approach within the gay community in Edinburgh.

So I'm sure the wording was amended possibly more than once as a result of dialogue - actually sitting round a table with these guys.[27]

28.22 In a paper on donor selection produced for the Inquiry, Dr John Gillon, Edinburgh and South East Scotland BTS, observed:

This [dialogue] was extremely productive in securing the co-operation of the Scottish homosexual community, and gave rise to formal collaboration in the establishment of the Scottish AIDS Monitor Group (SAMG), an information sharing group consisting of representatives of SHRG, SNBTS and a consultant genito-urinary medicine (GUM) physician, on 22 June 1983.[28]

Revised leaflet

28.23 A leaflet dated June 1983 was the first to be deployed for use at donor sessions.[29] In comparison with the first draft, a simpler approach had been adopted in the leaflet to the definition of the groups at risk of the disease and the groups asked not to give blood. There was a single list of groups that appeared to be at risk of AIDS, including men who had multiple partners of the same sex, and it was said to be unknown why the members of these groups were more susceptible to the disease. The tone of the leaflet had been softened. It stated:

[U]ntil more is known about the cause and spread of AIDS, we would ask people in any of the high risk groups described above to avoid giving blood until we have a suitable screening test.[30]

28.24 Dr McClelland was asked about a possible difficulty of interpretation in the reference to the group, 'men who have multiple partners of the same sex'. Dr McClelland said that there was no guidance as to what 'multiple' might mean and explained that this was a problem 'that has been discussed and explored again repeatedly'.[31] He emphasised the need to avoid a situation in which the precautions adopted ruled out the majority of potential donors; the question of 'how many sexual partners is too many' posed the same difficulty with heterosexual transmission.[32]

28.25 The geographical concentration of AIDS in particular parts of the world also raised issues of potential racial discrimination. Dr McClelland described these questions of what to include in publications as 'the tip of a huge iceberg of unresolvable problems'.[33]

28.26 Another noteworthy aspect of the leaflet was that the answer to the question, 'Who can get the disease?' included in its list 'haemophiliacs' and 'recipients of blood transfusion'. When asked about this, Dr McClelland said:

I think by this time Dr Anne Smith and myself who drafted this, we had little doubt that the evidence that had been assembled by the CDC had to be interpreted as showing that this was a blood transmissible disease. We think we really had no doubt about that.[34]

28.27 There were striking differences between the tone of this material and the information being given to people with haemophilia at this time, however, in particular a letter containing text drafted by Professor Bloom which was sent to members of the Haemophilia Society on 4 May 1983.[35] Dr McClelland was asked for his view:

Q. [T]he question which has been posed to us and which I'm therefore posing to you is: is there not an inconsistency between, on the one hand, people involved in blood transfusion saying that those with haemophilia, those receiving blood transfusion are at risk, even to the extent that they are asked not to donate their own blood, and the tone of this letter and other similar material, which is actually quite reassuring? This is all contemporaneous material. Is there an inconsistency?

A. Absolutely, clearly, there is.

Q. Yes.

A. I think this [the Bloom letter] is extraordinarily reassuring advice and it is one example of many very reassuring statements, as it were, risk-minimising statements, that were made over this period, which - I can't honestly say - I can't recall whether at the time I sort of scrutinised these statements and said, 'Gosh, that's very - that's a bit too reassuring'. I think our preoccupations were probably with doing our bit actually.

I think, if I was or had I been aware of this, I don't think it would have modified the text that we put in our leaflet because I think we felt our priority was trying to do whatever the available information could guide us to do to minimise the risk to patients. That was really our priority at that time.[36]

28.28 The contrast in approach between transfusionists, acutely aware of their responsibility for the collection of blood, processing donations and supplying blood, blood components and therapeutic products, on the one hand, and haemophilia clinicians torn between the need to treat potentially fatal conditions and recognising the risks associated with therapy, on the other, which arises at many points in this Report, is particularly clear in the present context.

Circulation of revised leaflet

28.29 Leaflets were again discussed at the meeting of the SNBTS Directors on 14 June 1983.[37] Dr McClelland is recorded as having tabled a revised version of the leaflet he had distributed at the Coordinating Group meeting on 24 May 1983.[38] Dr Mitchell circulated his blood donor questionnaire into which he had inserted the invitation to donors who were worried about AIDS to discuss it with the doctor at the blood donor session or to follow one of the other approaches suggested.

28.30 At this meeting, Dr Harold Gunson[39] reported to the Scottish Directors on developments in England and Wales, where a leaflet drafted by Dr John Barbara was in circulation for comment and amendment and arrangements for distribution of the leaflet were under discussion. Dr McClelland updated the other Directors on his liaison with the SHRG. The meeting discussed the need to deter certain donors without causing offence to others. The Directors are recorded as noting that the Department of Health and Social Security (DHSS) were closely involved in discussions about the approach to take to high-risk donors in England and Wales and recommending that the Scottish Home and Health Department (SHHD) should have a similar involvement in Scotland.

28.31 The next day Dr Albert Bell of the SHHD, who had attended the meeting, wrote a memorandum to Dr Archibald McIntyre, copied to Mr John Wastle, reporting on the discussions. According to the memorandum, Dr Gunson was still drafting the leaflet for England and Wales. The memorandum continued:

All the Directors present are now more aware of the complexity of the issues involved particularly in relation to the views of the homosexual community, the scope for misrepresentation by the press and the public, and the diplomacy required in presenting the AIDS issue in donor centres.[40]

28.32 Dr Bell also referred to continuing issues about distribution and advised Dr McIntyre that there was no doubt that the SHHD would have to involve their Minister and could not rely solely on the views of the SNBTS. When Dr McClelland was asked specifically about the comments in the memo, he did not accept the implication that, at some earlier point, the Directors had been unaware of the complexities of the situation. He wondered if the memo instead reflected a previous lack of awareness within the SHHD of the complexity of the situation.[41]

28.33 Later that day, Dr Bell wrote a second memorandum, this time to Mr Wastle in the SHHD and copied to Dr McIntyre.[42] Dr McClelland had informed Dr Bell that the leaflet tendered at the meeting the day before had now commenced circulation through the SHRG network. It was suggested that this appeared to have happened through some misunderstanding between the SHRG and the Edinburgh Regional Transfusion Centre. Dr Bell commented, however, that publication would seem to have demonstrated 'the acceptability of that particular presentation' to the SHRG.

28.34 In his evidence, Dr McClelland expressed his view that the circulation of the leaflet was not based on a misunderstanding.[43] Even if the leaflet was issued earlier than some people intended or expected, he felt it was a good thing that it had happened: 'it was the right thing [to do] to get it out there'.[44]

United Kingdom-wide leaflet

28.35 Meanwhile, work continued on a UK-wide leaflet, prepared in the DHSS, though 'progress ... was slow'.[45] The NBTS version had said that 'a person in any of the high risk groups of developing AIDS ... should not give blood even though they are in normal health ....'.[46] That had been amended to ask that anyone who thought they might have the disease or be at risk from it should refrain from giving blood. However, the first reaction of Mr Norman Fowler, then Secretary of State for Health and Social Security, had been that the wording was 'too strong' and that further revision might be required.[47] A meeting took place on 6 July 1983 involving the Minister of State for Health and the Under Secretary of State.[48] Further revision occurred and debate ensued about appropriate methods of distribution.[49] Ministers appeared keen on a 'low key' approach. When it was suggested, however, that the leaflet 'cannot be seen as a leaflet which you read and then change your mind about giving blood',[50] a medically qualified civil servant[51] was provoked to intervene:

I am afraid I cannot accept that the leaflet should not be seen "as a leaflet which you read and then change your mind about giving blood." To my mind this is precisely what it is intended for although the message has had to be slightly obscured for obvious reasons. Clearly we must bow to Ministers' wishes on the matter of handling the distribution ... but ... I am not sure that Ministers have fully understood the pros and cons.[52]

28.36 The civil servant's own view, on purely medical grounds supported by independent advice which he respected, was that the only sensible course was to send the leaflet out with call-up cards.

28.37 By contrast, in relation to the question of ministerial involvement in Scotland, Dr McClelland said that he was:

[Q]uite confident that there was never any interference. There may have been a lot of discussion within the SHHD but we were never given any direct or indirect verbal or written instructions not to do what we were doing.[53]

28.38 It is also evident from the DHSS documentation on this issue that many people were involved in the preparation of the leaflet and discussion of arrangements for its distribution. One memorandum, dated 4 July 1983, was addressed to a Mr Joyce and copied to 26 other people.[54]

28.39 A leaflet for distribution across the UK was ready in September 1983.[55] It was in the following terms:

What is AIDS?

... AIDS is probably caused by a virus, but this is not known for certain.

Who is at risk from AIDS?

Most of the information about AIDS has come from the USA where approximately 1500 patients have been found to be suffering from the disease, up to the middle of 1983. Certain groups of people appear to be particularly susceptible; these are:

1. Homosexual men who have many different partners.

2. Drug addicts, male and female, using injections.

3. Sexual contacts of people suffering from AIDS.

It has also been found in a number of immigrants to the USA from the island of Haiti.

Patients with AIDS also seem more likely to have suffered, at some time, from various other diseases such as hepatitis B, syphilis or other sexually transmitted diseases.


Can AIDS be transmitted by transfusion of blood and blood products?

Almost certainly yes, but there is only the most remote chance of this happening with ordinary blood transfusions given in hospital. However, in the USA a very small number of patients suffering from haemophilia, an illness in which the blood will not clot, have developed AIDS. Haemophiliacs are more susceptible to AIDS because they need regular injections of a product called Factor VIII. This is made from plasma obtained from many donors. Should just one of the donors be suffering from AIDS, then the Factor VIII could transmit the disease.

How can the risks be reduced?

At present, there is no screening test the Transfusion Service can use to detect people with AIDS. So, until there is and until more is known about this disease, donors are asked not to give blood if they think they may either have the disease or be at risk from it.[56]

28.40 In Scotland, this leaflet was issued with a press release by the Scottish Information Office dated 1 September 1983.[57] The press release reiterated that 'there is no conclusive proof that the disease can be transmitted in blood or in blood products'. Dr McClelland thought that the reference to 'no conclusive proof' (a line used in a number of government communications over this period) had an 'internal contradiction' in it.[58]

28.41 The Inquiry examined some press comment from the summer of 1983. The New Scientist of 11 August 1983 referred to the forthcoming leaflet under a headline 'AIDS Circular'.[59] The Sun of 12 August 1983 covered the same story under a headline 'Docs ban gays' blood.'[60] Dr McClelland agreed that the latter was likely to have been an example of the sort of coverage the SHRG had had in mind when they called for 'press restraint'.[61]

28.42 It was apparent from the minutes of an SNBTS Directors' meeting on 13 September 1983 that, by that time, the leaflets were in 'fairly wide' circulation in the Scottish transfusion centres, although it was not clear if they were publicly available in Glasgow.[62]

Reception of United Kingdom leaflet

28.43 The UK Working Party on Transfusion-Associated Hepatitis discussed leaflets at its meeting on 27 September 1983.[63] Different centres were trying different ways of presenting the leaflets to donors. It was minuted that the Working Party had a preference for deciding a uniform approach as soon as possible.[64] In the course of discussion, it was noted in relation to the lack of a uniform method of distribution:

Dr Lane presented the fractionator's view that a variable approach did not provide material of uniform specification but Dr Mitchell pointed out the problems associated with any infringements of the integrity of the donor.[65]

28.44 It appears that Dr Mitchell continued to resist any steps that might damage relationships between the blood transfusion service and donors.

28.45 Further discussion of the leaflet took place at a meeting of the (Scottish) Haemophilia and Blood Transfusion Working Group on 14 November 1983.[66] Dr McClelland was not present at the meeting; Dr Mitchell was the only Transfusion Director present. Members of the Working Group, which comprised Dr George McDonald (SHHD) Professor John Cash, Dr Charles Forbes, Dr Peter Foster, Dr Christopher Ludlam and Dr Robert Perry in addition to Dr Mitchell, were asked for their views on the effectiveness of the UK leaflet. The minute recorded that it was felt generally that the leaflet 'had not been particularly useful'.[67] This comment had surprised Dr McClelland when he read it in preparing for the Inquiry:

[T]his surprised me when I read this again because I hadn't picked up from any ... informal sources a sense that the leaflet was not useful. My impression of the general view, was, 'Yes, this is something that, you know, needs to be done because this is a serious disease and we don't want people to get it'.[68]

28.46 It was recorded that a few donors had responded to the leaflet by declaring that they were homosexual but that there remained a problem of how to screen out those who might present as donors in spite of the leaflet.[69] It is not clear who, apart from Dr Mitchell and perhaps Professor Cash, Medical and Scientific Director of the SNBTS, would have had occasion to take a practical interest in the usefulness of the leaflet. Professor Cash's view, expressed at the meeting, was that a reprint of the leaflet should include changes and that different ways of bringing it to the attention of donors should be sought but that the method of distribution should be left to the Regional Transfusion Directors (RTDs).

28.47 At the SNBTS Directors' meeting on 8 December 1983, which was attended by all of the RTDs, SHHD officials and Dr William Wagstaff from Sheffield, it was agreed that a more active approach to the distribution of leaflets was now appropriate.[70] It was felt that each donor should receive a copy, and the donor questionnaire should now include the question, 'Have you read and understood the leaflet on AIDS?'. No further action was to be taken, however, until a revised version of the leaflet had been issued. Dr McClelland agreed to produce a revised version of the leaflet for consideration by the Directors.[71]

Revision of leaflets

28.48 On 23 December 1983 Dr McClelland wrote to Professor Cash.[72] He reminded Professor Cash that the leaflet was not at that time being sent out to all donors and he felt that the text needed revision before that was done. The donor questionnaire had now been revised and specific questions and a specific reference to AIDS added. The questionnaire was to be completed and signed by all new and repeat donors.

28.49 On 3 January 1984, Dr Wagstaff wrote to the DHSS about the leaflet,[73] enclosing a summary of feedback on three months' distribution of it. He also mentioned a perception that revision was necessary and added that Dr McClelland[74] was rewriting the leaflet at that time. He continued:

Since it was his original draft which formed the basis for the present "official" leaflet, I am sure it would be wise to see his new draft before going to the printers.[75]

28.50 Dr McClelland duly wrote to Dr Wagstaff on 10 January 1984, enclosing his new draft.[76] The suggested changes were his and his alone; he had not, he noted in the letter, discussed the changes with 'the Scottish Transfusion Directors, Harold Gunson's AIDS Working Party of the CBLA Sub-Committee, the Transfusion Directors Hepatitis Working Party, or any of the other numerous groups who appear to be concerned with this problem'. Rather, the revisions had been based on discussions with colleagues at the South East Scotland BTS, of which Dr McClelland was Director, and contacts in the USA. He had also taken some ideas from the leaflet used in the New York Blood Centre. Dr McClelland indicated that he would be discussing the proposals with the Scottish Directors on 17 January 1984 and intended to send a draft to Dr Gunson.

28.51 In view of his comment about 'numerous groups who appear to be concerned with this problem', Dr McClelland was asked about the effect of the proliferation of contributors or commentators. Whilst he acknowledged that extensive scrutiny of drafts could be very useful, he thought that the number of people involved, 'risked standing in the way of actually doing anything'.[77]

28.52 On 9 February 1984, Dr McClelland attended a meeting at the National Institute for Biological Standards and Control (NIBSC) on the infectious hazards of blood products.[78] At the meeting, he explained the three main strategies for minimising the risk of infection. These were (i) avoidance of high-risk donor communities (such as prisons, 'known homosexual areas', etc), (ii) detection of clinical abnormalities by examination and careful questioning and (iii) exclusion of high-risk donors, or their blood, always allowing an 'escape route' for a donor who was deemed unsuitable.[79]

28.53 Further concern about the need for a re-draft was evident from a DHSS memorandum dated 14 February 1984.[80] The memorandum appears to have been written by Dr Diana Walford and contained the observation that, '[i]n view of the published evidence of transmissibility of AIDS by blood transfusion, our current advice to donors could seem too lax'. The Inquiry did ask Dr Walford for a statement on these matters but Dr Walford declined to provide one.[81]

28.54 A revised draft which was current in February 1984 was discussed at a meeting of the SNBTS Directors on 13 March 1984.[82] In their discussion on AIDS, they noted a previous agreement that the current leaflet should be sent to repeat donors with the call-up letter for their next session. Dr McClelland was to revise it and his revised draft had been circulated.[83] It appeared to the Inquiry that the specification of those who should not give blood was becoming simpler, with a request that people in any of the groups at risk not give blood and with the list of those at risk set out as follows:

AIDS has occurred mainly in these groups:

  • Intravenous drug users
  • Homosexual men
  • People from Haiti and some areas of Equatorial Africa
  • People who have had sexual contact with persons at risk in the above groups or with a person found to have AIDS.[84]

28.55 Dr McClelland explained to the Inquiry that the thinking was to identify groups where there was actual epidemiological evidence of transmission and that those should be the groups that the Service was asking to not donate.[85]

28.56 The text as it stood at 12 June 1984 was attached to the minutes of the meeting of the Directors of that date.[86] Some illustration of the difficulty of achieving an agreed draft is provided by the relevant paragraph in the minutes:

As agreed at the previous meeting Dr McClelland had revised the leaflet which he had drafted for circulation to blood donors with call-up letters. The revised draft had again received comments and a further one had been circulated with the agenda. Dr McClelland tabled another draft in substitute of the one which had been circulated and on the basis of comments made during the meeting this was again revised. (Final version attached.)[87]

28.57 A printed leaflet, with text very similar to that under discussion at the meeting on 12 June 1984 and called 'Important message to blood donors', was published by the SNBTS during 1984, probably as the product of this process.[88] The leaflet explained what AIDS was, including that it was frequently fatal and could be transmitted by blood or blood products, and stated:

For the present therefore, it is important that those who belong to certain groups, who have an above average risk of contracting this condition, should not donate. These groups are:

  • residents of or visitors to certain areas such as Chad, Haiti and Zaire
  • sexually active homosexual men
  • present or past abusers of intravenous drugs
  • sexual partners, male or female, of any of the above people.[89]

28.58 This leaflet is referred to in the Scottish Health Education Group leaflet, 'Some facts about AIDS' which bears the date '12/84'.[90] A chronology dated 30 November 1984 on actions taken in the South East Scotland to endeavour to make blood safe notes that the leaflet was published in August 1984 and was sent out with all call-up letters from 19 September 1984.[91]

28.59 Additional steps were taken from November 1984 in relation to advice to donors. From the chronology referred to above, it is evident that some additional measures were implemented in the week beginning 19 November 1984. These included the re-design of the donor questionnaire so that, with effect from 26 November 1984, donors were required to sign a declaration that they had read the leaflet and excluded themselves from the AIDS risk groups. Beside the date 26 November 1984, there is a reference to the 'established practice' that all signatures had to be witnessed by the donor attendant.[92] On 29 November 1984, Professor Cash wrote to the RTDs, summarising actions required in relation to the leaflet, including that donors had to sign a statement that they had read the AIDS leaflet and, to the best of their knowledge, were not in one of the risk groups identified.[93] Dr McClelland was asked if these measures in November 1984 were related to the discovery of infection in patients treated only with Scottish products and he told the Inquiry that he was 'fairly sure' that this was the case.[94] Later in his evidence, he commented that the introduction of the signed statement by the donor was 'probably one of the more important ... developments in this procedure'.[95]

28.60 The HIV infection of a group of people with haemophilia who had been treated at the RIE with NHS product ('the Edinburgh Cohort') is discussed elsewhere in this Report.[96] For present purposes, however, it is relevant to note that the 'implicated batch' (the batch of Factor VIII concentrate thought initially to have been associated with all of the cases of infection and latterly to have been associated with all but one or two of them) contained plasma collected from all five Scottish transfusion centres. Manufacture of the batch commenced on 7 November 1983.[97]

28.61 At the SNBTS Directors' meeting on 11 December 1984, leaflets were again discussed, including the possibility of further re-drafting.[98] Dr McClelland undertook to circulate a leaflet produced by the Terrence Higgins Trust giving to homosexuals a clear explanation that they should not give blood.[99] Dr McClelland described the Trust as 'a very constructive organisation'.[100]

28.62 By 17 December 1984, Dr McClelland acknowledged that the leaflet required to be revised again, although he considered that it would not be wise or practicable to issue another version just yet.[101] When he reflected on his letter in evidence at the Inquiry, however, he felt that the third proposal in his letter - changing 'sexually active homosexual men' to 'homosexual or bisexual men' - looked 'a bit like tinkering'.[102]

28.63 The Inquiry also studied the process of re-drafting the leaflet involving the DHSS. The position in England regarding revision of the UK leaflet is set out in various internal memorandums. A submission seeking authority from Ministers for revision of the leaflet was sent on 10 August 1984.[103] That submission was approved on 16 October 1984. The minute recording the approval by the Minister of State for Health of the leaflet being revised and distributed in the manner suggested, also records an apology for the time taken to clear the documents for use.[104] Around this time, the Chief Medical Officer (CMO) for England and Wales requested information about the problems of AIDS and blood donations. A memorandum dated 19 October 1984 was sent in response, detailing the current situation on testing of donations and blood/plasma-related cases of AIDS in the UK. The memorandum ended with the following statement:

A leaflet advising donors from high risk groups for AIDS to desist from giving blood was issued by Regional Transfusion Centres in August 1983. Ministers have just agreed a redraft of this leaflet which strengthens the advise [sic - advice] and includes all practising homosexuals as being in the high risk group.[105]

28.64 Publication of the revised leaflet was then delayed until it could be discussed at a meeting of the Working Group on AIDS on 27 November 1984. At that meeting, members had only minor comments to make on the draft, which was again submitted to the Minister of State for Health for approval.[106] As this chronology shows, the revised version of the 1983 leaflet did not appear until January 1985.[107] A DHSS Circular accompanied the copy of this leaflet sent to Regional Health Authorities and Special Health Authorities.[108] A copy of the circular was sent to the SHHD and Dr Bell replied to explain that the SNBTS was ensuring that all donors received a copy of the revised AIDS leaflet and were asked to sign a statement that they had read it and were not in one of the risk groups.[109]

28.65 When a further re-draft was being contemplated in July 1985, a memorandum explicitly recording regret at the delay which had occurred in the revision of the previous leaflet was written by someone in the DHSS.[110] Professor Cash also recorded his views about undesirable delays in the issue of leaflets in letters he wrote to Dr Wagstaff[111] and Dr Kenneth Calman[112] on 14 December 1990.

Subsequent leaflets

28.66 When screening of donated blood was introduced in October 1985, a new leaflet was given to donors in Scotland explaining that their blood would be tested and they were asked to sign a form indicating that they understood the new message.[113] The leaflet stated (all emphasis in original):


It is essential that although we are introducing HTLV-III testing you MUST NOT volunteer to give a blood donation if you are or have been:

1. A practising homosexual or bisexual man.

2. A drug abuser, either man or woman, who injects drugs.

3. Resident in or a visitor to central African countries.

4. A sexual partner of people in these groups.

28.67 In England at this time, the standard leaflet said that those in the high-risk groups 'MUST NOT GIVE BLOOD' (capitals as in leaflet).[114] The high-risk groups were said to be:

1. Homosexual and bisexual men.

2. Drug abusers, both men and women, who inject drugs.

3. Haemophiliacs who have been treated with blood products.

4. Sexual contacts of people in these groups.[115]

28.68 By August 1986, the South East Scotland BTS had developed a 'Flash Card System', whereby a card was given to donors by a member of the nursing or medical staff to read. The card read (capitals as in leaflet):







28.69 Dr McClelland explained that the flash card was a response to concern, which the service had held since the first leaflets, about how to ascertain that donors had read and understood the information:

The flash card was an attempt to move on a little bit from that and this was administered at the time when the donor was actually face-to-face with the member of the donor selection staff. You know, it went with the question, 'Have you clocked this?' 'Have you read this?' And, you know, 'Are you in any of those categories?'[117]

Confidential Unit Exclusion

28.70 Dr McClelland was also asked about a system whereby donors could indicate that their blood should not be used. The system - referred to as 'Confidential Unit Exclusion' (CUE) - had been devised in the USA and catered for those who realised, once they were at a donating session, that they should not be donating, allowing them to continue through the process but mark their health questionnaire to indicate that their blood should not be used.[118] Although a system of this nature was tried in Edinburgh, Dr McClelland said that it had little effect:

As I recall, our experience with a version of this, which we did implement in Edinburgh, was that we seemed to have an extremely low yield. There were actually very few people who utilised the option. I think we eventually dropped it, actually.[119]

28.71 Dr McClelland referred to a letter sent to him on 16 January 1985 by Dr Patricia Hewitt of the North London Blood Transfusion Centre.[120] Dr Hewitt commented on the considerable difficulties experienced in their West End Donor Centre in obtaining satisfactory answers to the questions posed in their questionnaire. Men were reluctant to pick up and read a leaflet on AIDS. A new leaflet, 'Some reasons why you should not give blood', had proved very popular, however, and the Centre provided a room where the donor could have privacy. Dr McClelland's 'escape route' appears to have had some of the characteristics of the CUE approach in the USA.

Rest of Scotland

28.72 From the narrative of the evidence already set out, in particular relating to the efforts made to achieve progress, it appears to the Inquiry that the lead in drafting and revising leaflets for Scotland was taken by Edinburgh and South East Scotland BTS. It was obvious that the process must have absorbed a great deal of the time and energy of Dr McClelland as Director and others in that region at the time.

28.73 In the circumstances, the Inquiry was interested to establish the position in the rest of the country. As noted above, at the meeting of the Co-ordinating Group on 24 May 1983, Dr Mitchell outlined action taken in the West of Scotland BTS which probably did not constitute effective communication to donors of risk to the recipient of blood or blood products. Professor Urbaniak explained that he did not feel it necessary to take any action in the north east.[121]

28.74 Dr Mitchell was asked further questions about the position in Glasgow. He was handicapped by lack of contemporaneous correspondence from Glasgow.[122] In his evidence, he referred to the multitude of leaflets that were around at the time. Unsurprisingly, he remembered the general position concerning public information over the whole period of 1983 onwards, rather than the detail of individual leaflets. He was asked if, on seeing Dr McClelland's draft leaflet at the meeting on 14 June 1983,[123] he might have taken it back for circulation in Glasgow. He answered:

I know that in Glasgow in some places this kind of leaflet would be met with a certain amount of derision from some of the rather hard-working donors who give blood in Glasgow.[124]

28.75 This response suggests that Dr Mitchell would not have distributed Dr McClelland's leaflet. It seems likely, as Dr Mitchell thought, that before the UK-wide leaflet was issued in the autumn of 1983, Glasgow would probably have been distributing the standard questionnaire with the added question on a label, asking donors if they had heard of AIDS.[125]

Effect on donors

28.76 It was evident to the Inquiry that Dr Mitchell was particularly concerned about the integrity of the donor - as he pointed out in terms at the meeting of the UK Working Party on Transfusion-Associated Hepatitis on 27 September 1983.[126] At that meeting it was agreed that it might be helpful if RTDs would provide details of how they got information to the attention of the high-risk groups of donors. As far as the effect of the leaflet on donors in the west of Scotland is concerned, Dr Mitchell was referred to a table prepared around the end of 1983 to record reactions in different parts of the UK. Glasgow was the only Scottish centre included in the table. The entry for Glasgow reads:

Uptake by donors averages one or two leaflets per session. A handful of donors have been resigned after volunteering information about homosexuality.[127]

28.77 More generally, of the 14 centres included in the table, only two referred to offence being caused and, in both instances, that was by handing leaflets to donors. Some other centres merely made the leaflets available. Usage ranged from 500 leaflets in three months in Cardiff, to Lancaster where an average of 9500 leaflets per month had been used, no doubt because in Lancaster the leaflets were issued when donors were called up. In his evidence, Dr Mitchell referred to complaints from hall-keepers because of the large number of leaflets left on the floor after a donating session.

They [the leaflets] weren't taken away by donors, they were dropped on the floor by donors. That can either mean two things: One, the donor had read and understood; or, two, the donor was very upset and concerned to see such a reference to what he thought or she thought had been a group of well meaning people and of which they hoped to be a member. Certainly, to be confronted with this thing which said, 'Wait a minute, maybe you are not wanted here.' They may have come miles and miles, just for the sake of doing good, to be turned away.[128]

28.78 Dr McClelland referred in his statement to the fact that some Directors were very concerned about the risk of offending donors by giving too much prominence to the leaflet.[129] In his paper, Dr Gillon highlighted the meeting of the English RTDs on 18 May 1983, where it was minuted that the Directors rejected the option of questioning donors about their private lives.[130] However, Dr McClelland had 'no recollection of having to deal with major donor complaints that reached my level about any version of this leaflet or the subsequent ... questioning process'.[131]

28.79 It was clear that all those connected with transfusion in 1983 and 1984 were concerned that these new measures should not alienate donors and were conscious of the sensitivity of asking donors about their sexual behaviour, an unprecedented step which there was deep-seated reluctance to take.[132]

28.80 The scope for differences of opinion (valid or otherwise) about the risks of undermining blood collection was considerable. Commenting on public education leaflets available in England and Wales, warning higher risk individuals against donating, Hugh Barnes said in an article in Nature dated 13 December 1984:

Leaflets are, of course, only as effective as their circulation. A receptionist at a NBTS centre was recently asked why no such warning to prospective blood donors was on display. 'We did have them out', she said, 'but they frightened our customers away'. Dr Harold Gunson of NBTS admits to some haphazard distribution in the past, but promises 'efforts will be made to ensure that all donors attending the clinic receive a copy'.[133]

28.81 'Haphazard distribution' appears to be an accurate description of the situation in Scotland in 1983 and 1984. Dr Mitchell, and others of a like mind, had the capacity to frustrate the public education programme. On the other hand, Dr McClelland's experience demonstrated that there was no unavoidable problem where there was a predisposition to inform and a sensitive approach was adopted in making information available to prospective donors.

28.82 A further aspect of the concern for donors was that there appeared to be fear that giving blood carried a risk of contracting AIDS. This concern was demonstrated in the responses to a series of surveys commissioned by the South East Scotland BTS.[134] In a revision of the leaflet in 1984, Dr McClelland introduced into a revision of the leaflet a question and answer about this, making it clear that donating blood carried no such risk.[135]

28.83 These concerns about the effect on donors had a basis in experience as it evolved. Dr Gillon advised the Inquiry that there was a fall of 5-6% in the number of donations in the first quarter of 1985, necessitating an advertising campaign.[136]

The donor population

28.84 Dr McClelland was asked about the AIDS outbreak in Scotland, with particular reference to a report dated March 1993 by a Working Group convened by the CMO. This showed that, from 1984 to 1989 inclusive, among those testing positive for HIV, the largest single group in terms of mode of transmission was the group of intravenous drug users. However, as between Glasgow and Edinburgh (more precisely, Greater Glasgow and Lothian Health Board areas), of 321 people testing positive in the former area, 30% were intravenous drug users; whereas in the latter area, of 913 people testing positive, 53% were intravenous drug users.[137]

28.85 Dr McClelland said that these figures showed the effect to a very large extent, in the years before testing, of the 'Muirhouse Outbreak'. Muirhouse is an area in Edinburgh which experienced a major outbreak of HIV/AIDS in people who had a history of injecting drug use. The outbreak had an impact on Scottish statistics generally as well as locally. Dr McClelland said that the figures for HIV infection associated with intravenous drug use in Scotland were heavily biased by this one rather dramatic, highly localised outbreak.[138]

28.86 The significant question was whether there would have been an overlap between the people in the outbreak described among the drug-using population and the blood donor population. Dr McClelland's view (ultimately vindicated by scientific investigation) was that it was highly unlikely that there would have been individuals from that outbreak presenting as blood donors.[139]

28.87 Dr McClelland was also asked about features of individual donors which may have made leaflets less successful, such as illiteracy or lack of fluency in English. His recollection was that such issues were not addressed in 1983.[140] In fact, in the chronology 'Action Taken in S.E.B.T.S. To Endeavour to Make Blood Transfusion Safe', one of the steps highlighted as taken with effect from the week beginning 19 November 1984 specifically referred to donors who were unable to read or were blind. In those circumstances, staff had to satisfy themselves that these people understood the declaration and definition of risk groups. This was noted at the time to be 'established practice' anyway for the medical questionnaire.[141] Dr McClelland observed that issues of the presentation of information for those with difficulties in accessing it were less well addressed in the 1980s than they are now.[142] As Dr Hewitt's letter (paragraph 28.71 above) makes clear, some issues were well-recognised in London and shared with Dr McClelland in January 1985.


28.88 The first questions that arise in relation to this topic are:

  1. 1. Whether steps should have been taken in Scotland earlier than May/June 1983 to alert blood donors to the risks of transmitting AIDS via donated blood and to prevent higher risk donors from giving blood.
  2. 2. Whether there were other measures which should have been adopted but were not.

28.89 Any answer to the first question has to take account of the reality that regional autonomy meant that individual RTDs were free to adopt their own policies, an important factor that has arisen frequently throughout this Report. In the Edinburgh and South East Scotland BTS, Dr McClelland responded to the lead from the USA, where the outbreak was more advanced than in the UK, as soon as could have been expected. Advice was issued in the USA in the first months of 1983 and by May of that year Dr McClelland, Dr Anne Smith and Dr MacMillan not only had a leaflet in draft form but had established a liaison group with representatives of the SHRG to revise the advice. Dr McClelland's speed of response, and the effort he dedicated to making progress in preparing leaflets and securing the agreement of the gay community to an acceptable formula, were not universally applauded in Scotland. Dr Mitchell, in particular, did not do so. However, much that happened in Scotland, then and later, was as a result of Dr McClelland's efforts. His views were remarkably prescient and it is appropriate to recognise in this Report that, insofar as progress towards an acceptable solution was made, the credit is due to him.

28.90 It was to become clear in time that HIV infection had already entered the blood donor population in Scotland. In 1983 blood was collected and pooled that, processed to produce Factor VIII concentrate, led to the infection of the 'Edinburgh Cohort'. As noted in paragraph 28.60, the 'implicated batch' associated with the Cohort, eventually shown to have infected the vast majority of the Cohort, contained plasma from all five Scottish transfusion regions. Sophisticated genetic analysis has shown that the infected donations probably involved were not collected from the intravenous drug using population or from those known to have been infected by heterosexual contact. So far as published, the geographical source of the donations has not been identified: they might have been collected anywhere in Scotland. Earlier cases of transfusion-transmitted infection would in due course be identified, and their sources are no better defined so far as the Inquiry's investigations have discovered.[143]

28.91 AIDS cases among coagulation defect patients occurred in all areas except the Dundee and Inverness regions. Whether or not steps taken earlier than May/June 1983 to alert blood donors to the risks of transmitting AIDS via donated blood and to prevent higher risk donors from giving blood might have been effective to prevent transmission of infection, the distribution of the leaflet in the Edinburgh and South East Scotland BTS, as revised following consultation with the SHRG, on 15 June 1983 could not reasonably have been earlier. In that area, the answer to the first question is clearly no.

28.92 There is more difficulty with the rest of the country, so far as the evidence disclosed what happened. The position in Dundee and Inverness is not known. The problem of AIDS may indeed have been seen as 'minor' in north east Scotland at the time but the objective of the exercise was related to preventing or mitigating future risk. As to that, past experience could not be conclusive. Assessment required to take account of the magnitude of the harm that was targeted: AIDS was already known to be an extremely serious disease. The balance of opinion among transfusionists was moving towards a viral aetiology: HIV was apparently transmitted by blood. A precautionary approach to the possibility of risk required action.

28.93 Dr Mitchell's observation about Dr McClelland's draft leaflet of 14 June 1983, that in some places in Glasgow 'this kind of leaflet would be met with a certain amount of derision...' by donors, reflects an unconstructive attitude to the use of leaflets aimed at discouraging high-risk donors. If the comment was a true reflection of his opinion of his donor population, as distinct from an observation reflecting on Dr McClelland, it was less than complimentary. One would not have expected the donor population of Glasgow, or any part of the West of Scotland region, to have responded to advice about the transmission of AIDS in that way. If they had, it would have been reasonable to expect Dr Mitchell and his colleagues to have corrected them. On any view, however, the observation disclosed an attitude that might have influenced less senior and less experienced Directors in framing their own policies.

28.94 Dr Mitchell's own response, putting a stick-on label on his own questionnaire, was inadequate given the AIDS threat to the blood supply. Its wording was inapposite. The first sentence, 'Have you heard of AIDS ...' has no connection with the second, either textually or as a matter of substance. By May 1983 (which seems to be the likely date of adoption of the label) there would have been few people who had not heard of AIDS. That was never the issue to be addressed.

28.95 The second sentence, 'If you have any doubts about giving a donation consult the doctor ...', was obscure. It left it open whether the prospective donor's doubts related to the risk of acquiring AIDS from the donation procedure (a misconception that was in fact entertained at the time: see paragraph 28.82 above) or the risk of passing on infection. So far as the risk of transmission of infection was concerned, it gave no guidance on who might be expected to have such doubts. It might reasonably be inferred that advice sought from the doctor at the session would relate to giving a donation, if that had been the whole advice, but reference to the prospective donor's own GP clouds that issue also. It is unclear what a GP would know about, or have concern about, in relation to blood donation. The final suggestion that the donor write to the Regional Director offered no assistance at all.

28.96 The terms of Dr Mitchell's stick-on label gave no specification of the nature of the risk. The notice was lacking in guidance on reasons that might have been relevant to the prospective donor's decision. In this respect the label was in marked contrast to the rest of Dr Mitchell's leaflet.[144] The leaflet listed, among other things, infectious diseases such as mumps, chickenpox and measles, and serious illnesses such as jaundice, asthma, blood diseases and diabetes, as conditions to be reported for consideration by the session doctor who would decide whether or not the individual would be allowed to donate blood. It was very specific about the factors that might give rise to concern.

28.97 Dr Mitchell's sensitivity to the interests of donors, as he saw them, was highly developed. It was illustrated in his response to the pressure to discontinue collections in prisons and other penal institutions.[145] In relation to AIDS, and in retrospect, it appears likely that he gave those interests too much weight, given the gravity of the threat.

28.98 The adoption of the UK-wide leaflet, with the support of the DHSS and the SHHD, put an end to controversy about whether it was appropriate to have such documents in issue. Dr Mitchell's suggestion that few were taken and that premises were strewn with discarded leaflets indicates that making leaflets available for distribution was not a sufficient solution to the problem of communicating the seriousness of the AIDS threat to recipients of blood and blood products. It required action on the part of the blood transfusion service. The resistance of an intransigent Director would have been difficult to overcome.

28.99 Outside Edinburgh and South East Scotland BTS, an earlier initiative by the SHHD would have been required to give emphasis to the risks of transmission of AIDS by blood donation. As discussed in Chapter 17, Blood and Blood Products Management, the Common Services Agency (CSA)[146] and its sub-committees, while nominally having delegated responsibility for the SNBTS, were not proficient in technical transfusion matters. Consequently, any initiative would have had to come from the SHHD, which retained policy control over such matters.

28.100 The SHHD recognised the regional autonomy of RTDs. Short of a major re-organisation of the service, such as was to take place many years later, there was nothing that could have been done to bring other regions into line with Dr McClelland's pioneering work in Edinburgh. Dr Mitchell was free to apply his own views within his own region in relation to advice to prospective donors.

28.101 So far as central government action is concerned, it is impossible to avoid the conclusion that, to some extent at least, leaflet preparation and distribution were hampered by the number of interests involved. This is true of the UK revision in the course of 1984 (conceded in memorandums exchanged at the time: see paragraph 28.65 above) and also of the Scottish revision in 1984, though that at least was achieved by August. In both these instances, there were leaflets already in circulation but, to borrow Dr Perry's expression from another topic, there were points where the best was the enemy of the good. Nowhere was this more clearly demonstrated, perhaps, than in the memorandum on the matter circulated to 26 recipients. It is paradoxical that the Scots made faster progress with their leaflet, almost certainly because of the lack of government involvement, particularly when one reads the comments in the minutes of the SNBTS Directors' meeting of 14 June 1983 where the Directors were hoping for a close involvement of the SHHD in the process. If they had succeeded, Dr Bell's comments on 15 June 1983 suggest that circulation of the leaflet, which was undoubtedly a good thing, would not have begun when it did. The involvement of government not only increased the number of those involved in an already crowded and unwieldy field, it also threatened to prioritise the wrong issues, as can be seen in the DHSS memorandums about the purpose of the leaflet.

28.102 In the end, this was an issue which was largely practical and dependent on the knowledge and expertise of the transfusionists. It was probably inevitable that it would be thought best left to them to deal with the issue, with government kept informed, notwithstanding that the agreed approach had to accommodate the very widely differing views of individual Transfusion Directors.

28.103 As for other participants, notably the representatives of the gay community, it looks remarkable from a current perspective that a body of lay people became so involved in the debate about a health issue. In the light of current medical knowledge, it is clear that their initial reaction to the draft leaflet was based on significant misconceptions. However, without their cooperation it is likely that the leaflet exercise would have been less successful and their involvement was, undoubtedly, to the benefit of all concerned.

28.104 So far as the second question (whether there were other measures which should have been adopted but were not) is concerned, none of the many groups and individuals involved has suggested what else could have been done but was not done. The isolation of the virus, HIV, and the development of a screening test were investigations pursued with unparalleled vigour, in France, the USA and England in particular. The English researchers were successful in a timescale that, but for the unfortunate loss of priority described in Chapter 29, The Discovery of HIV and the Development of Screening Tests, almost certainly could not have been improved on. Any possible alternative approach would have been a temporary expedient, similar to the leaflet campaigns. If there had been an obvious step to take, it is not unreasonable to think that someone among those with the primary interest to make the suggestion would have thought of it.

28.105 The second question, which was formulated in advance of the oral hearings, was designed to bring out any representations that interest groups or individuals might wish to make. There were comments critical of the lack of leaflets in languages other than English and the lack of attention to those with literacy problems. It is not possible to dismiss these comments but they perhaps reflect values that have developed much more recently than in the early 1980s. Against a background in which preparing and distributing any written advice at all was controversial, they appear to be something of a counsel of perfection. In a practical sense, adopting these suggestions could not have failed to hold up the process of production and distribution of the leaflets that were made available. In the end, in the view of the Inquiry, there was nothing more that could have been done that would have improved the situation.

1 Dr McClelland's Witness Statement [WIT.003.0036]. See also Day 12, pages 3-7

2 'Current Trends: Prevention of Acquired Immune Deficiency Syndrome (AIDS): Report of Inter-Agency Recommendations', Morbidity and Mortality Weekly Report, 04 March 1983 [LIT.001.0568]

3 Ibid [LIT.001.0568] at 0569

4 Ibid [LIT.001.0568] at 0569

5 Day 12, pages 5-6

6 Ibid page 7

7 Witness statement [WIT.003.0036] at 0037. See also the summary of the accumulating evidence in the Preliminary Report at paragraphs 8.12-8.31.

8 Ibid [WIT.003.0036] at 0039

9 See Dr McMillan's comments to this effect in his letter at [PEN.014.0102]

10 A newspaper article dated 20 November 1984 [DHF.001.6009] was shown to Dr McClelland, and he was asked about the comments in it by a Dr John Seale that the UK was slow in 'clamping down' on higher-risk donors. Dr McClelland did not agree, and referred to the near simultaneous commencement of the issuing of similar advice in the UK and the USA in 1983 - Day 12, pages 68-70 and Dr McClelland's Witness Statement [WIT.003.0036] at 0044.

11 Day 12, page 10; Witness Statement [WIT.003.0036] at 0038. See also: 'Current Trends: Prevention of Acquired Immune Deficiency Syndrome (AIDS): Report of Inter-Agency Recommendations', MMWR, 04 March 1983 [LIT.001.0568]

12 Meeting minutes [SNB.003.7116] at 7120

13 Leaflet: 'AIDS AND BLOOD TRANSFUSION: Some background to the recent publicity' [SNB.003.7153]. (Note the handwritten note in the top right hand corner which reads 'Item 15 of 24.5.83'). Council of Europe Recommendation, No. R(83) 8 [DHF.001.4550]

14 Information leaflet [DHF.001.4550] at 4551-52. Dr McClelland could not recall if he saw this leaflet in 1983: Day 12, page 109

15 Day 12, pages 13-14

16 Meeting minutes [SNB.003.7116] at 7120

17 The first positive HIV test results obtained in the Grampian Health Board area were from blood samples taken in 1984. By contrast, samples taken in the Lothian Health Board area in 1983 yielded 68 positive results. See table 3, page 32 within (last accessed 24 December 2014)

18 Label on information leaflet [PEN.013.1395] (Caps in original)

19 Day 9, page 171

20 Press statement [SGH.002.6759]

21 Press statement [SGH.002.6759] at 6760

22 See Chapter 9, Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 1.

23 PHLS bulletin for week ending 6 May 1983 [DHF.001.4349]. See discussion in Chapter 9, Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 1, paragraphs 9.95-9.97.

24 Day 12, page 17

25 Ibid page 19

26 Gay Scotland, July/August 1983 [SGH.002.6698]. A summary of the revised leaflet is set out in the magazine.

27 Day 12, pages 20-21

28 Report [SNB.014.3125] at 3132

29 The leaflet [SNF.001.3397]; Dr McClelland - Day 12, page 26

30 Leaflet [SNF.001.3397] at 3398

31 Day 12, page 27

32 Ibid page 28

33 Ibid page 28

34 Ibid pages 28-29

35 Letter [DHF.001.4474] - discussed in Chapter 9, Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 1, paragraphs 9.89-9.95.

36 Day 12, pages 30-31. See also Day 12, page 94 where Dr McClelland tempered his comments slightly, saying he should perhaps have said 'in my opinion inappropriately reassuring' rather than 'extraordinarily reassuring'.

37 Meeting minutes [SNF.001.0085] at 0086-87

38 Meeting minutes [SNB.003.7116] at 7120

39 Chairman of the Regional Directors of the NBTS in England and Wales

40 Memorandum [SGH.002.6755]

41 Day 12, pages 106-107

42 Memorandum [SGF.001.0960]

43 Day 12, page 35

44 Ibid page 36

45 File note of 28 June 1983 [SGH.002.6752]

46 Memorandum of 6 July 1983 [SGH.002.6732]

47 Dr Bell's memorandum of 6 July 1983 [SGH.002.6732]

48 That is, Kenneth Clarke and Lord Glenarthur. See minute of meeting [DHF.001.4580] and ensuing memorandum [DHF.002.0412]

49 Memorandums of 19 July 1983 [DHF.001.9912] and 20 July 1983 [DHF.001.9913]

50 Memorandum of 21 July 1983 [DHF.001.9914]. In evidence, Dr McClelland stated that this was, in fact, the 'sole purpose' of his leaflet - Day 12, page 43

51 This appears to have been a Dr Oliver - see Day 12, page 47 and memorandum of 4 July 1983 [SGH.002.6736]

52 Memorandum of 25 July 1983 [DHF.001.9915]

53 Day 12, page 46. See also pages 107-108

54 Memorandum [SGH.002.6736]

55 Leaflet [SGH.002.6675]

56 Ibid [SGH.002.6675] at 6676

57 Press Notice [SNF.001.0416]

58 Day 12, page 51. See the discussion on this form of words in Chapter 9, Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 1.

59 New Scientist, 11.08.1983 [DHF.001.4689]

60 The Sun, 12.08.1983 [DHF.001.4690]

61 Day 12, page 53. See paragraph 28.17 above.

62 Minutes of meeting [SNF.001.0072] at 0073-4 and Dr McClelland: Day 12, pages 112-113

63 Meeting minutes [SNB.014.3030]

64 Ibid [SNB.014.3030] at 3032

65 Ibid [SNB.014.3030] at 3032

66 Meeting minutes [SNB.001.5188]

67 Ibid [SNB.001.5188] at 5189

68 Day 12, page 55

69 Meeting minutes [SNB.001.5188] at 5189

70 Meeting minutes [SNF.001.0178] at 0179

71 Ibid [SNF.001.0178] at 0179

72 Letter [SNB.014.3104]

73 Letter [DHF.001.5119]

74 Although the name has been redacted, the identity can be deduced from the rest of the letter.

75 Letter [DHF.001.5119]

76 Letter [SNB.014.3185]

77 Day 12, page 58

78 Draft minutes [SNB.004.8628]

79 Ibid [SNB.004.8628] at 8634. While not specified in the minutes, it appears that the 'escape route' typically involved accepting a suspect donation 'for research' or 'not for clinical use', enabling the collection of blood to proceed without exposing the donor to embarrassment.

80 Memorandum [DHF.001.5266]

81 See correspondence [PEN.019.1279] and letter in reply [PEN.010.0103]

82 Meeting minutes [SGH.001.0484] at 0485

83 The revised draft is [SGH.001.0499] which has Dr McClelland's initials on it and the month '2/84'

84 Draft leaflet [SGH.001.0499] at 0501

85 Day 12, pages 60-61

86 Meeting minutes [SGF.001.0150] with the last page, 0155, being the leaflet.

87 Paragraph 3(a) of the minutes [SGF.001.0150]

88 Leaflet [SGF.001.0932]

89 Ibid [SGF.001.0932] at 0933

90 Leaflet [SNB.004.9329]

91 Booklet [SNF.001.3381] at 3385

92 Ibid [SNF.001.3381] at 3387

93 Letter [SGF.001.0908]

94 Day 12, page 72

95 Ibid page 80

96 See Chapter 10, Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 2.

97 Report - Actions Surrounding FVIII Batch 023110090 [PEN.016.1258] at 1263

98 Meeting minutes [SGF.001.0137] at 0140

99 Leaflet [SGH.001.0346]

100 Day 12, page 72

101 Letter to Professor Cash dated 17 December 1984 [SGH.001.0343]

102 Day 12, page 67

103 Memorandum [DHF.002.2192]; Submission [DHF.002.2193]

104 Memorandum [DHF.002.2208] and leaflet [DHF.001.5849]

105 Memorandum [DHF.002.0040] at 0041

106 Memorandum dated 3 December [DHF.002.2233]

107 Leaflet [DHF.001.8919]

108 Circular [DHF.001.8929]

109 Letter dated 21 January 1985 [SGH.002.6907]

110 Memorandum [DHF.001.7438]

111 Letter [SNB.012.5019]

112 Letter [SNB.012.5017]

113 The final leaflet is [SGH.002.7077]; (A draft of this is [SGH.002.6981]).

114 Leaflet [SGH.001.8292]. A memo dated October 1985 narrating the introduction of the new leaflet and of testing was prepared for the Advisory Committee to the National Blood Transfusion Service [SGH.001.8295]

115 Ibid [SGH.001.8292] at 8293

116 Flash card [SNB.004.8150]

117 Day 12, page 74

118 Ibid pages 76-77

119 Ibid page 77. Some of the relative documentation is in a memo dated 18 January 1985 [SNB.014.3119]

120 Letter [SNB.014.3110]

121 See paragraph 28.11.

122 Witness statement [WIT.003.0033] at 0034

123 See paragraph 28.29.

124 Day 9, page 173

125 Glasgow and West of Scotland leaflet [PEN.013.1395]. See Dr Mitchell - Day 9, page 176

126 Meeting minutes [SNB.014.3030] at 3032

127 Table [PEN.010.0305]

128 Day 9, page 177-178. In his statement, Dr Mitchell described a single instance of this: [WIT.003.0033] at 0334.

129 Statement [WIT.003.0036] at 0041-42

130 Statement [SNB.014.3125] at 3131. See Minutes [SNB.001.3489] at 3491-92.

131 Day 12, page 42

132 Ibid pages 24 and 42

133 Barnes, 'Paper prophylaxis backfires', Nature, 13 December 1984 [PEN.017.0658]

134 Dr McClelland - Day 12, pages 61-62

135 Draft leaflet [SGH.001.0499] at 0502

136 Report - Donor Selection Policies and Procedures [SNB.014.3125] at 3131

137 Report - Acquired Immune Deficiency Syndrome and HIV-Related Disease in Scotland [SNF.001.0284] at 0296

138 Day 12, page 85

139 Ibid page 86. Subsequent genetic analysis of blood samples from the Edinburgh Cohort of haemophilia patients supports Dr McClelland's view: IVDUs were excluded as sources of the infected donations. Holmes et al, 'The molecular epidemiology of human immunodeficiency virus type 1 in Edinburgh', The Journal of Infectious Diseases 1995; 171:45-53; [PEN.012.1679] at 1686. See Chapter 10, Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 2, paragraphs 10.121-10.124.

140 Day 12, page 89

141 Booklet [SNF.001.3381] at 3387

142 Day 12, page 90

143 Details are set out conveniently in Chapter 12 HIV/AIDS: Response and Clinical Practice.

144 Leaflet [PEN.013.1395]

145 See Chapter 26, Donor Selection - Higher Risk Donors

146 Section 19 of the National Health Service (Scotland) Act 1972 provided for the constitution of the Common Services Agency (CSA) for the Scottish Health Service with effect from 1 April 1974. Amongst its several responsibilities was the operational management of the blood services. See Chapter 17, Blood and Blood Products Management, paragraphs 17.23-17.25.

29. The Discovery of HIV and the Development of Screening Tests >