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Chapter 30

Screening of Donated Blood for HIV


30.1 This chapter deals with the general introduction of screening of donated blood in the UK for the AIDS virus, HIV. Although adopted later than many of the events discussed in this chapter, the name HIV is used in the narrative, except where context requires the use of one of the alternative historical names for the virus, since it is now well understood that the various names used historically (such as HTLV-III and LAV) referred to the same virus. The introduction of the screening of donated blood for HIV was dealt with in the Preliminary Report at paragraphs 8.122-8.139. Since the writing of that section, the Inquiry has obtained more information about the process which led to the introduction of screening for HIV and has perused more documents. The account which follows is therefore fuller than the account in the Preliminary Report and varies from it in part.

30.2 Screening for HIV infection was designated as a topic which required to be considered at the Oral Hearings of the Inquiry. The topic was described as follows:

The decision not to use kits from the United States of America for testing donated blood for the virus as soon as they became available but, instead, to follow a process of evaluation of the kits before any such use.

30.3 As defined, the topic focused on tests developed in the USA, reflecting a view held by some interested parties that progress there provided criteria against which to measure what happened in the UK in general and Scotland in particular. As the discussion in Chapter 29, The Discovery of HIV and the Development of Screening Tests, shows, however, the position was altogether more complex and there had been significant developments in knowledge in France and the UK in 1983 and early in 1984. It is appropriate, nonetheless, to deal with the development of screening in the USA in the first instance, since there was, on the part of some parties, a clear conception that the perceived leadership of the USA in this area was of central importance.

30.4 While the topic was originally narrowly expressed, the hearings were not, in the event, restricted to decision-making in relation to the evaluation of kits but also examined, so far as practicable, the whole sequence of events leading to the introduction of screening of donors. It was clear from the evidence before the Inquiry that a significant focus in the UK in the second half of 1984 was on developing a British test to screen blood donations for AIDS. Whether that took priority over the introduction of US test kits became a significant question. The Inquiry has not sought direct evidence from US scientists and clinicians involved in research and development of test kits in the mid 1980s but has relied on indirect sources in narrating material events, in particular published material. Where secondary sources are relied upon, the facts have not been independently validated.[1]

30.5 In summary, the issues covered in this chapter are: the development of HIV test kits in the USA following Dr Robert Gallo's announcement that he had identified the AIDS virus in April 1984; the steps taken prior to the introduction of testing in the UK, including evaluation of all available kits; Government involvement in the decision-making process; and, finally, the issue of whether matters could have been handled more expeditiously. Issues related to the identification of the virus, the initial development of the British test and the nature of the tests are discussed in detail in Chapter 29, The Discovery of HIV and the Development of Screening Tests, and are referred to in this chapter only where necessary to provide context.

30.6 The period covered in this chapter runs from early 1984, when it was understood that serological tests for antibodies to HTLV-III were likely to become available imminently, until October 1985, when routine screening of blood donations for antibodies to HIV was introduced throughout the UK. It was a time when many issues regarding the screening of blood for HIV infection were being progressed simultaneously.

The development of tests in the United States of America

Initial reaction to the isolation of HTLV-III

30.7 In the USA, reports of Dr Gallo's isolation of HTLV-III[2] immediately acquired a high political profile. On 23 April 1984, a press conference was held in Washington DC, involving Dr Gallo and Margaret Heckler, the US Secretary of State for Health and Human Services. At the press conference, Ms Heckler predicted that a test to screen the blood supply with 100% certainty would become widely available within six months.[3] This was to prove over-optimistic: on the evidence available to the Inquiry, it was to be some time before an acceptable test was developed.

30.8 A period of intense activity sponsored by the US Federal Government followed the announcement of Dr Gallo's work. A notice in the Federal Register, the official journal of the federal government of the USA, dated 3 May 1984, invited proposals for the manufacture of a blood test for HIV.

30.9 On 14 June 1984, the journal Nature reported that the companies selected by the US government to manufacture a blood test for HIV were expected to be announced that week.[4] The chosen companies would be provided with Dr Gallo's method for mass-producing the virus in return for a royalty payment, expected to be 5%.[5] Five companies were chosen by a committee of the Department of Health and Human Services.[6] Of these, Abbott Laboratories, thought by Crewdson to be the most formidable competitor, had links with the Scottish National Blood Transfusion Service (SNBTS) in Glasgow and the West of Scotland and development of the Abbott test was particularly relevant to the course of events in this country. As anticipated, they were given the then-current version of the isolate, HTLV-IIIB, in return for a royalty payment. Nature reported that members of the scientific panel said that they had given emphasis to the ability to manufacture the product quickly and in large quantities, as millions of test kits would be required annually.[7] None of the companies, however, achieved the goal set by Ms Heckler: by the end of October 1984, Ms Heckler's deadline, no test to screen the blood supply was widely available. Abbott and other licensees were still field-testing their screening kits, enzyme-linked immunosorbent assays (ELISAs),[8] in cities where significant numbers of potential blood donors were presumed to be infected with the AIDS virus.[9]

30.10 In order to understand developments in the USA, it is necessary to have some regard to the structure of the blood services complex in that country. In 1974, the Federal Government had published a National Blood Policy, reflecting the national interest in assuring an adequate and safe supply of blood.[10] The policy set out a broad statement of goals with respect to blood collection and distribution. No legislation was enacted, however. Rather, the Federal Government accepted and partially funded a private sector plan to establish an American Blood Commission to implement most of the objectives of the National Blood Policy. The American Blood Commission had no powers of enforcement and became, rather, a forum for discussion, and in many cases resolution, of blood banking issues among the private sector components of the blood services complex in the USA.[11] The regulation of health and safety, including blood collection and distribution, remained primarily a matter of local concern, as it had been historically.[12]

30.11 The advent of AIDS prompted a new Federal initiative. In March 1983, the Food and Drug Administration (FDA), in consultation with the major blood banking and plasma derivative organisations, the National Hemophilia Foundation, the National Gay Task Force, the Centers for Disease Control and the National Institutes for Health, issued recommendations to initiate, among other measures, educational programmes to promote self-deferral and expanded medical screening of blood and plasma donors.[13]

'The psychic costs to donors labelled as suspect': the problem of false positive results

30.12 As of May 1984, the FDA Blood Products Advisory Committee was considering whether specific 'surrogate' tests[14] should be instituted for all whole blood and plasma collections.[15] At that stage, such testing had been initiated in some centres, with two types of surrogate tests in use: (i) detection of abnormalities associated with AIDS or the preclinical stages of AIDS and (ii) evidence of past infection with diseases that had a high prevalence in population groups that were at increased risk of AIDS. A high level of false positive results (where the test result for the surrogate marker was positive but the AIDS virus was not, in fact, present: a frequent problem with any surrogate test) had been tolerated with surrogate testing for the AIDS virus. It was commented in January 1985 that:

Current surrogate tests lead to exclusion of far more donors than are ever expected to actually have or develop AIDS, and seem to have been instituted more to allay patients' and physicians' fears rather than in hopes of decreasing exposure to AIDS.[16]

30.13 It was recognised that the approach adopted was detrimental to the interests of donors:

[T]he psychic costs to donors labelled as suspect have been subordinated in order to reduce the psychic costs of potential and actual recipients and their physicians.[17]

30.14 It is against that background that the announcement of Gallo's findings, and the race to produce HIV tests, has to be understood. It was expected that the balancing of interests would be the same with direct laboratory tests for the AIDS virus as with surrogate testing. In the paper published in January 1985 already referred to, it was commented in relation to prevailing practice that:

The criterion used in decisions to institute these programs appears to be whether the added costs can be handled, not whether in fact AIDS will be reduced. However, these decisions seem entirely compatible with public reaction to the threat of AIDS in the blood supply. The risk is very small, but the fear is great, and the perception that something is being done is important to public confidence.

A highly accurate, AIDS-specific test should decrease the perceived need for adopting any of the surrogate tests that have been proposed, but reassuring the public will probably mean that these tests can also be expected to be applied far beyond the application that would be scientifically justifiable.


Thus, it can be expected that the test for HTLV-III will be a requirement for all blood and plasma collections, regardless of the relative degree of risk among blood banks and geographical areas. Even if not required for all, blood banks and plasma collectors will feel compelled to perform the test anyway because of the public confidence factor and the threat of lawsuits.[18]

30.15 Testing of all blood donors for HIV was expected to become a general requirement, not conditional on scientific proof of its effectiveness. It was concluded that the prudent course was to continue with the cooperative arrangements in-hand and to monitor key developments. Discussion placed emphasis primarily on the safety of the recipient. The paper noted that blood banking and commercial plasmapheresis organisations were 'currently grappling with the social and ethical issues surrounding the imminent availability of the blood test'[19] but there was no explicit recognition of a duty of care towards donors such as underlay the UK approach to blood collection.

30.16 By 1990, the official position had not changed. The disadvantages to donors in tolerating large numbers of false positives was, however, discussed in an article for the journal Transfusion by Dr Merlin Sayers of the Puget Sound Blood Center, Seattle, entitled Duties to Donors.[20] He expressed the view that blood bankers had inescapable responsibilities to donors. In respect of the implications for the donor, the article said:

What can be done about the 'nonspecificity trap'? In this context, heavy reliance is placed on laboratory testing in pursuit of the risk-free blood transfusion. This emphasis is not surprising, if one bears in mind the extent to which our society has enshrined technology. Though there is a beguiling simplicity in the idea that a test that could even slightly enhance transfusion safety should be implemented, technology-driven donor screening carries a price.

As 100-percent specificity does not exist, at least not side-by-side with 100 percent sensitivity, some donors have had to contend with false-positive results. As more screening tests are introduced, so will their ranks be increased. This does not bode well for anxious donors or for blood bankers trying to explain why, if some test results really are false, donation is still forbidden. Concepts such as test sensitivity, test specificity, and indeterminate results are difficult to translate into lay terms. There is scant enlightenment, let alone consolation, for the donor deferred with a 'false-positive' result ....[21]

30.17 Sayers' article reflected concern, continuing in 1990, that the interests of the US donor were not taken fully into account. The more-or-less exclusive emphasis in US practice on the interests of the recipient (and of the industry, ever-anxious about exposure to litigation) is relevant to the acceptance of a high incidence of false positive results as HIV tests were rolled out in the USA, first for evaluation and then commercially. The problem in the UK relating to the efficacy of the tests was similar, although the solution was to be different and took time to develop. An issue for the Inquiry was whether the introduction of testing for HIV was unduly delayed and whether the interests of donors came to be a factor in the developing picture.

30.18 Once testing began in the USA, problems with false positive results were evident. Abbott's product licence application, dated 19 December 1984, disclosed that, of 42 positive tests from 7758 samples, 17 proved to be true positives and 25 proved to be false, a false positive rate of about 60% relative to the initial positive results.[22]

30.19 On 13 December 1984, Nature reported that the 'crash effort' by the Public Health Service to develop a blood test for AIDS had run into difficulties.[23] The article referred to significant variations in the sensitivity and specificity[24] of the tests being developed by the five contractors and to the suspicion that the tests were subject to significant false positive and false negative rates. Scrutiny of the performance of the kits had not been assisted by the fact that each company had received a different set of 6000 samples. Each company had run its own ELISA test and then its own confirmatory test (all using Western blot technology), complicating the interpretation of their findings.[25]

The pressure to introduce screening grows

30.20 Despite these problems, US government agencies pressed forward with arrangements for the introduction of screening. On 11 January 1985, the Morbidity and Mortality Weekly Report (MMWR)[26] published Provisional Public Health Service Inter-Agency Recommendations for screening donated blood and plasma for antibody to the virus causing AIDS,[27] anticipating that tests would be licensed and commercially available in the USA 'in the near future'. The recommendations provided that all donors should be told that their blood would be tested for the virus and that they would be notified if the test was positive. The article commented on the efficacy of the US kits expected to be available, stating:

In the early phases of testing a number of false-positive tests may be encountered. Adjustments in interpretation are anticipated as more is learned about the performance of the test in an individual laboratory and about the specific proportion of falsely positive or falsely negative tests in the screening setting where the test is used.[28]

30.21 The proportion expected to be false positives was not disclosed. However, the article noted:

When the ELISA is used to screen populations in whom the prevalence of HTLV-III infection is low, the proportion of positive results that are falsely positive will be high.

30.22 Repeat and alternative testing systems were recommended before the donor was notified of a positive result. At the end of January 1985, Ms Heckler said that AIDS test kits would be licensed by the FDA by mid-February.[29] When this did not happen, Ms Heckler explained that the FDA needed more data from the manufacturers.

30.23 In the article in Nature dated 13 December 1984, Dr Peter Page, Director of the American Red Cross, was quoted as having expressed concern that political pressure was rushing the process so much that there was no time to resolve the problems of false positive results that were arising.[30] Dr Page thought that, having regard to improvements in the blood supply brought about by appeals to high-risk groups to abstain from donating, there was no compelling case to rush ahead with blood tests. The conclusion of the article, by Stephen Budiansky, was that the ELISA test might prove to be problematic, a marked contrast to the government's push for the introduction of testing.

The introduction of screening in the USA

30.24 The Abbott test was licensed on 2 March 1985. Ms Heckler again made the announcement. According to Crewdson, the first blood bank in the world to get the AIDS test was the Red Cross Blood Center on Ohio Street in downtown Chicago. A leaflet with the kits contained a warning that 'false positive test results can be expected with a test kit of this nature'. Crewdson also reports that, at this point, Abbott only had 60,000 ELISA kits on hand, which was not nearly enough to fill the nationwide demand.[31]

30.25 More licenses followed in quick succession. A second US test, the 'Virgo' test manufactured by Electro-Nucleonics Inc, was licensed on 7 March 1985[32] and in May 1985 a US patent was granted to the US National Cancer Institute for their ELISA HIV test. Testing of blood donations was introduced in the USA in April 1985 and by the summer there were six brands available in the USA. Dr Thomas Zuck, a haematologist, was the FDA official in charge of monitoring the performance of the AIDS test. He is reported by Crewdson to have believed that the decision to grant licences had been made in haste.[33] Initial supplies were still not sufficient to meet demand in the domestic market.

Difficulties with the first generation of tests

30.26 One source of difficulty with the first generation of tests was the cell line, H9, in which the virus had been grown.[34] A more technical explanation is set out in Chapter 29, The Discovery of HIV and the Development of Screening Tests. In short, the cultivated virus released from the cell in which it had been growing for the purpose of test manufacture took with it certain human proteins from the membrane of the cell. Those human proteins stimulated an antibody response in some groups of individuals. Thus those individuals tested positive, although the positive result indicated antibodies to foreign proteins other than HIV.[35] The problems persisted and ultimately the FDA intervened to require Abbott to improve the specificity of its test.[36] As well as the problem of false positives, the Abbott test also gave false negative results.[37]

30.27 The 'pure' antigen required for effective operation of the US ELISA tests had proved difficult to achieve with HTLV-IIIB grown in the H9 cell line and some highly unsatisfactory outcomes from the use of the early ELISA tests were reported. Professor Richard Tedder, Professor of Medical Virology at UCL Medical School, London, provided an extreme example from 1985 relating to an epidemiological survey of malaria among Ugandan children. The children were bled and tested for HTLV-III by Dr Carl Saxinger and Dr Gallo. The results purported to show that 85% of the children were HTLV-III antibody positive although none had, in fact, been exposed to the virus. The antigen used was not 'pure' HTLV-III: it included other proteins that were recognised by the test and erroneously characterised as HTLV-III. The children's history of malaria would have caused their plasma to be more 'sticky', resulting in proteins other than the target, HTLV-III, adhering to the antigen on the plastic strip used in the test, resulting in a false positive result.[38]

38.28 Some of the practical problems caused in the USA by this flaw in the tests are outlined by John Crewdson in his book on the history of AIDS research, Science Fictions.[39] For example, the Red Cross blood centre in Springfield, Illinois, had elicited 200 positive results after one round of testing but, when those donors were re-tested with another ELISA, only 86 remained positive. Of those 86, Western Blot testing revealed that only two were true positives.[40] Crewdson provided another extreme example: a group of black farmers in South Carolina, whose risk for AIDS was virtually zero, exhibited a false positive rate of 300% (that is, there were three false positive for every true positive).[41]

Supplies of test kits

30.29 According to Crewdson, Ms Heckler reported in mid-April 1985, at an international AIDS conference at the Centers for Disease Control (CDC), that the domestic backlog of supplies had been filled. She said:

As a result ... our manufacturers will now be able to turn their attention to your needs ­- meeting the foreign demand for the test, which has been significant ....[42]

30.30 As the situation was understood by Crewdson, however, at this stage Abbott still could not make enough tests to satisfy the domestic demand.[43]

Lack of supplies for export

30.31 An arrangement for cross-approval of test kits between France and the USA (whereby US tests would be approved in France and French tests approved for use in the USA) could not be brought into effect as had been intended in May 1985. At the time, Abbott still did not have enough tests to supply the US market, much less the French. The company intended to meet European demand from a factory in Delkenheim, Germany. In the event, the factory did not begin production until the autumn of 1985.[44]

30.32 It is noteworthy that, as at 11 March 1985, there were no Abbott kits available in the UK for general use. A small quantity was being imported so that some preliminary examination of the kits and apparatus could occur.[45] With the information now available, the comment in the Preliminary Report (paragraph 8.139) that kits manufactured by US companies were 'available' in March 1985 requires to be qualified by the observation that it appears that these kits were not near to being available in sufficient numbers in the UK to have allowed general screening of donated blood to commence.

30.33 The capacity of other manufacturers to meet demand is not known. Abbott's capacity was taken generally to be the appropriate reference for discussing these issues. Irrespective of the reasons, if Abbott could not meet an existing contractual commitment to supply kits to France until mid-July 1985, it is most unlikely that there would have been stock available for supply to the UK for general use (as distinct from limited use in test evaluation and research) before that time and likely that there would have been some further delay before adequate supplies could have been made available for routine screening across the UK.

Testing in the United Kingdom: background

The pressure to introduce testing in the UK

30.34 In the USA, the comments on and after 23 April 1984 of Margaret Heckler made it clear that screening tests, expected to be widely available within six months, would be applied generally.[46] The prediction proved inaccurate but, in the spring and summer of 1984, UK blood transfusion experts were aware that testing donated blood for the AIDS virus would be introduced generally in the USA. One of the major issues anticipated was that considerable pressure would then be put on the UK Transfusion Services to introduce an HIV test in the UK as in the USA.

30.35 Although there was relief that the virus had been identified and that tests were being developed, there was also anxiety about the practical problems which testing would involve. In particular, as noted above, there was concern about false positive and false negative results and about how to counsel donors whose blood had tested positive.[47]

30.36 Against this background, there was a powerful body of opinion in the UK, especially among the scientific community and transfusion practitioners, that all kits, whether produced in the USA or in the UK, should be evaluated locally before being recommended for use by Regional Transfusion Centres. The contrary opinion was expressed by some haemophilia clinicians who were concerned about delay, especially after the FDA had licensed kits for domestic use in the USA.

The UK regulatory framework

30.37 As noted in paragraph 30.2, the topic discussed in this chapter questioned 'the decision not to use kits from the USA for testing donated blood for the virus as soon as they became available but, instead, to follow a process of evaluation of the kits before any such use'. Apart from the problem of lack of supplies for export discussed above, 'availability' of kits imported from the United States may require definition. Unlike the USA, where kits had to be approved and licensed by the FDA before they could be used for screening, UK authorities had no powers, under the Medicines Act 1968 or otherwise, to regulate the sale of kits imported into this country.[48] The FDA might grant an export licence before approval of a kit for domestic, US, use.[49] Kits might therefore be 'available' in the UK despite having no regulatory approval for domestic use in their country of origin.

30.38 The Department of Health and Social Security (DHSS) responded promptly to the announcement of Abbott's US licence, congratulating the company three days later in a letter dated 5 March 1985.[50] The letter gave a clear indication of the regulatory context and, notwithstanding the lack of statutory control over the importation and use of test kits, the expectations of the Department regarding the assessment of available test kits before their introduction to the UK:

You will know that we have no legal powers to prevent the sale of these products in the UK. However, an evaluation is needed because we know that would-be purchasers in the NHS will be looking to the Department for objective information which will help them in decision making. Of necessity, it will take a little time to get underway and we appreciate that you will wish to start selling now. In the absence of an evaluation report from the Department, we should be grateful if you would provide inquirers with as much information as you can in response to their questions about performance.[51]

30.39 From the outset, it was left to Abbott to decide whether to provide their own performance claims and supporting data and enter the market immediately. The Department's intention, as intimated in the letter, was to devise an evaluation protocol, on which all companies in the field would be given an opportunity to comment. Data in support of performance claims would be required and Abbott were invited to submit data confidentially for early review. Internally, a draft test protocol was prepared on 8 March 1985.[52] The Virus Reference Laboratory, CPHL Colindale, was to be involved in the evaluation and detailed requirements were drafted.

30.40 As matters had developed in 1984 and early 1985, there were problems with the American ELISAs, including Abbott's kit, other than adequacy of supplies. As noted above, once testing began in the USA, serious problems with false positive results were evident.

The evaluation programme debate

30.41 As discussed in Chapter 18, Collection of Blood - General, the voluntary principle embedded in blood collection, in the UK generally and in Scotland in particular, imposed on the public sector transfusion services obligations of care towards donors, for their safety and general well-being in the course of the management of donation procedures.

30.42 Regional Transfusion Directors (RTDs) in the UK considered that local evaluation was necessary. In Scotland, the emphasis remained on the use of commercial kits. On 12 February 1985, Professor Cash, National Medical Director of the SNBTS, wrote to Dr John Reid, Chief Medical Officer (CMO) at the Scottish Home and Health Department (SHHD).[53] He set out his concern about the rate of false positive results anticipated with the use of commercial kits and highlighted a number of factors supporting the need for a national kit evaluation programme. On 21 February 1985, Professor Cash and others from the SNBTS and National Blood Transfusion Service (NBTS) sent a letter to The Lancet, published on 2 March substantially repeating these views. The letter stated:

We believe that current commercial kits for HTLV-III antibody tests are likely to give a high rate of false-positive results. We would therefore recommend that careful consideration be given before they are introduced for the screening of all voluntary blood donors, for the amount and degree of unnecessary stress and hardship that a fair number of our donors and their families would thus have to undergo is unacceptable. This in turn could lead to a sizeable drop in the supply of blood and blood products. Of no less importance, for the safety of transfused patients, is the need to ensure that the first priority for the introduction of any HTLV-III antibody tests into a community is given to patients attending special (venereal disease) clinics and other members of the general public who wish to have access to these tests. If this is not done, many high-risk people, from a blood transfusion point of view, may present themselves at blood-donation sessions simply to find out their HTLV-III antibody status.

We do support, strongly, the screening of all blood donors for HTLV-III antibody testing, but we would advise that this is delayed until test systems have been appropriately evaluated and efforts have been made to give all members of the public access to HTLV-III antibody testing.[54]

30.43 The letter was signed by 11 NBTS Directors and seven Directors from Scotland, the five SNBTS Directors, Professor Cash as National Medical Director and Dr Robert Perry, Director of the Protein Fractionation Centre (PFC, the manufacturer of NHS blood products in Scotland). The emphasis on the interests of donors and their families highlighted the policy differences between the USA and the UK. The US policy of subordinating the 'psychic costs' of false positives to donors was not acceptable in the NHS environment.

30.44 The letter was published on 2 March 1985. A different point of view was expressed in the same edition by Dr James Carlson and others of California, who advocated using a test with high sensitivity followed by confirmatory testing.[55] They concluded that, with proper procedures, the use of the most sensitive ELISA would not result in a major disruption in the procurement of blood or in the significant loss of future blood donors. However, the view of the UK transfusion specialists was strongly expressed and it is unlikely that a US view would have prevailed given the differing policy background circumstances.

30.45 The need for local evaluation was acknowledged by others. For example, a widely attended international conference on AIDS, sponsored by the US Department for Health and Human Services and the World Health Organization (WHO), was held in Atlanta, Georgia (USA), from 15-17 April 1985. The conclusions and recommendations for member states included:

  • Each country should assess the risk that AIDS poses to its population and establish methods of diagnosis through surveillance and laboratory testing, including specific tests for LAV/HTLV-III.
  • Where feasible, potential donors of blood and plasma should be screened for antibody to LAV/HTLV-III....[56]

30.46 In addition to the need to evaluate the tests' effectiveness in local populations, it was necessary, as with any new test system, to develop the practical, technological and procedural aspects of the introduction of HIV tests in Scottish laboratories, and laboratories elsewhere in the UK, to ensure that the kits adopted could be used rapidly and reliably for diagnostic and for screening purposes. A DHSS draft protocol of 8 March 1985 anticipated an evaluation report on each product submitted which would cover, among other practical issues, the compatibility of the assay with the needs of diagnostic, blood transfusion and research laboratories.[57]

30.47 Any evaluation exercise had to be carried out on the actual assays proposed for introduction. As will appear later, there were significant differences in experience between different versions of fully developed commercial products marketed for general use. Starting some time after March 1985, when the US kits became available for research purposes, a UK evaluation would have taken some months. It was, however, a necessary step: Professor Tedder spoke of the general experience of assays, in transfusion and diagnostic settings, which had not been tried on the target population, giving rise to devastatingly high levels of false positivity. His view, which is accepted, was that:

You conduct a field trial to make sure that assays are giving you useful and as accurate as possible results and, of course, without having your repeat reactive panel from your donors, you do not know what form of confirmatory testing you need. So, until you have got the substrate for your confirmatory testing, which is your repeat reactive donors, you can't define what's going to be the best algorithm or the best protocol for confirmation. You really don't want to be screening donors and developing a large panel of repeat reactors without knowing how to deal with them. That would be very damaging to transfusion practice.[58]

Development of a United Kingdom HIV test

30.48 The background to the development of scientific tests for HIV infection in the UK is described in Chapter 29, The Discovery of HIV and the Development of Screening Tests. In short, Professor Tedder and Professor Robin Weiss,[59] following rebuff by the DHSS[60] initiated research and developed an effective serological assay on a commercial basis on behalf of their institutes, the Chester Beatty Cancer Research Institute and the Middlesex Hospital, and in due course established unchallenged right to the intellectual property developed. As matters transpired, all of the test kits that became relevant to progress towards screening had one thing in common: research institutes, pharmaceutical companies and individuals had intellectual property rights in the science underlying the tests. In the USA, Dr Gallo's know-how was licensed to pharmaceutical companies for development.

30.49 The work of Professors Weiss and Tedder was known, in general terms, to the UK government but, throughout the development stages and, in particular, until 4 July 1984, when the prototype assay was ready for laboratory application, it was funded by their institutions.[61] As commented in Chapter 29, The Discovery of HIV and the Development of Screening Tests, paragraph 29.42, it would have been highly unlikely that Professor Weiss and Professor Tedder would have disclosed details before publication of the patent specification: until that stage, the validity of the patent could have been undermined.

30.50 Professor Tedder sought UK government funding for the scale-up of the Middlesex Hospital/Chester Beatty Cancer Research Institute test (MH/CB test) for industrial production in a letter to Dr Alison Smithies, DoH, dated 18 December 1984.[62] At the end of the year and early in 1985, Dr Smithies prepared draft submissions to Ministers supporting the application and seeking approval for the introduction of the screening test.[63] Her advocacy in support of the project marked the beginning of a new phase in the progress towards routine screening for anti-HIV in the UK as a whole. As she presented the project, it was 'a product of the co-operation of British Science and British Industry', implicitly acknowledging the non-governmental character of the test.[64]

30.51 In following the history of events in 1984 and 1985 relating to the development of a UK test for HIV below, it has to be borne in mind that institutions which had sought intellectual property rights, in common with all manufacturers of test kits, had interests which depended in part on maintaining the confidentiality of their work.

The progress of introducing a test to the United Kingdom

Establishment of expert groups

30.52 At a meeting of the UK Central Blood Laboratories Authority (CBLA) Central Committee for Research and Development in Blood Transfusion in June 1983, a Working Group on AIDS in relation to Blood Transfusion was set up and first met on 14 October 1983.[65] By that stage, the Medical Research Council (MRC) had set up a similar committee which had its initial meeting on 10 October 1983.[66] The MRC committee noted that, while the laboratory markers for AIDS were well established, their relevance in screening and in a possible 'precursor state' was not. As reported, screening was not among the topics discussed in detail by the working group on 14 October. Although it appears that there was nothing of importance to note at that point specifically relating to the development of serological assays for HIV identification other than uncertainty, the interest of two important UK advisory bodies had been engaged.

30.53 In Scotland, a special meeting of the Co-ordinating Group of the SNBTS took place on 7 February 1984.[67] It was agreed that Professor John Cash, Medical Director of the SNBTS, should write to Dr Harold Gunson, Director of the Manchester RTC and Chairman of the Regional Directors of the National Blood Transfusion Service for England and Wales (NBTS), recommending that there should be a single UK Working Group on AIDS with Scottish representation. Instead of writing to Dr Gunson directly, Professor Cash wrote to Dr Albert Bell, SHHD, reporting the recommendation on 15 February 1984 and suggesting that the group should be responsible to the health departments (DoH and SHHD) for coordinating research covering the interface between blood transfusion and AIDS.[68] He included in the major areas requiring attention a prospective clinical study to determine the value of existing AIDS tests.

30.54 Professor Cash's hopes of a UK-wide advisory group, including Scottish representatives with the wide remit he proposed and a direct relationship with the health departments, were not realised. Professor Cash would later write, on 24 January 1985, that he did not know whether the SNBTS Directors' views, communicated to Dr Bell on 15 February 1984, had been transmitted to the DHSS.[69] It appears from his letter that he, and other officials in the transfusion service in Scotland, were frustrated by the arrangements made in England. Professor Cash complained that they were left 'completely in the dark' about developments.

30.55 Professor Cash's protestation was not wholly justified. Dr Gunson met with Dr David Tyrrell, Chairman of the MRC Committee on AIDS, Professor Tedder and two NBTS Directors, Dr Tim Wallington and Dr Marcella Contreras, on 28 June 1984 to discuss issues surrounding the introduction of tests. Dr Wallington was Consultant Clinical Immunologist at NHS Blood and Transplant and the North Bristol NHS Trust. Dr Contreras was Director at the Regional Transfusion Centre at Edgware, London, and that centre was believed to be most likely to show early evidence of the virus entering the donor population.[70] Dr Brian McClelland, Director of the Edinburgh BTS, had been invited but was prevented from attending the meeting by travel problems.[71]

30.56 Dr Gunson sent a letter, dated 3 July 1984 and copied to Dr McClelland among others, recording the discussions which had taken place at the meeting on 28 June.[72] He narrated that Dr Tyrrell had taken the initiative by proposing that the MRC could help in setting up a research project on blood donors using the detection of anti-HTLV-III as a possible marker of donors at high risk of transmitting infection. The development of a viable test for anti-HTLV-III by Professors Weiss and Tedder was identified as promising. The stages in the evaluation project then envisaged included testing at the Middlesex Hospital, North West Thames RTC and Bristol and Manchester RTCs. Dr McClelland thought that, if he had attended the meeting, he would have suggested that it would have been useful for the evaluation to be extended to include a Scottish centre: the West of Scotland centre was very experienced in evaluation and it would have been a valuable learning experience to get in 'at the ground floor'.[73] That did not happen, however.

30.57 Dr Gunson's letter stated:

[We] all agreed that at the present time this test should be regarded as a research project and that it should not be introduced as a routine screening test on blood donations without proper appraisal. It is important, however, that a study should be started as soon as possible so that it would be possible from a practical point of view to answer questions on the use of the test in the U.K.[74]

30.58 Dr McClelland sent a copy of the letter to Professor Cash on 7 August 1984. In the covering note, he wrote:

I will be keeping in touch with Richard Tedder about the development of assay reagents and I feel this is something we should discuss in the near future.


I imagine there is likely to be a breathing space of many months before a test is available and relevant trials come forward to put us under pressure to introduce screening. Nevertheless ... it would seem very important indeed that we do whatever is necessary to retain participation in this development.[75]

30.59 It appears unlikely that Dr McClelland was fully informed of developments at this stage. The first results of research using the MH/CB assay developed by Professor Weiss and Professor Tedder were published in an article by Dr Rachanee Cheingsong-Popov and others on 1 September 1984.[76]

The practicalities of introducing screening

30.60 In the autumn of 1984, the emphasis turned to the practical implementation of screening. A working group was proposed by the DHSS to provide guidance about the consequences for the NBTS of the introduction of a screening test for HIV.[77] The initial list of proposed members did not include any from Scotland but, as a result of the intervention of the SHHD, Dr McClelland was allowed to join the group.[78]

30.61 The working group held its first meeting on 27 November 1984.[79] Although the DHSS view was that the meeting had gone reasonably well,[80] Dr McClelland reported back to his fellow Directors in Scotland on 11 December 1984 that he had found the outcome of the meeting 'disappointing'.[81] He recorded, however, that it had been agreed to test all donors once an antibody test for HIV was available. The minute of the Regional Directors' meeting on 23 January 1985 described the November meeting as 'unproductive'.[82] Professor Cash's reaction to the report in his letter to Dr Bell of 24 January 1985, describing the meeting as 'wholly inadequate' and 'a waste of public money',[83] was perhaps extreme but may reflect a view still held by some Scottish transfusion experts that they were not fully engaged with developments in England.

30.62 There was an attempt to engage directly with Professor Tedder's team. On 20 December 1984, Dr Robert Crawford of the West of Scotland BTS visited Professor Tedder at the Middlesex Hospital, apparently to obtain information about the tests being developed and, possibly, to assess whether there might be potential for the development of tests in Scotland.[84] Dr Crawford reported that he had been told of the Weiss/Tedder test in radioimmunoassay (RIA) format (though, as discussed below, that had already been superseded by work on an ELISA format) and had a description of the US tests. He knew of the different cell lines employed to propagate the virus antigens. He told Professor Tedder that, given the cells and virus and his support, Scotland might 'go it alone' and discussed the capacity of Glasgow to do the work. Dr Mitchell explained that the West of Scotland had 100,000 specimens that could be tested and could help the development programme.[85] By this stage West of Scotland BTS staff were experienced in investigating the Hepatitis B virus.[86] The proposal did not find support, however. Dr Mitchell thought (probably correctly, even at this late stage) that there were difficulties in sharing information. As commented already, the MH/CB assay was a proprietary test. Wellcome Diagnostics had entered into a commercial contract for development of the MH/CB test. It appears that there was no reasonable prospect of scientists in Scotland becoming involved in the English programme.

30.63 The development of the English evaluation programme to the end of 1984 had not involved the Scottish scientific service to any material extent. Work carried out in Scotland included collaboration with French and US colleagues and that continued into 1985. Encouraged by Professor Cash, Dr Perry wrote to Dr Luc Montagnier on 8 February 1985, discussing a number of projects and, in particular, attempted to obtain supplies of LAV (that is, HIV) test kits from the Institut Pasteur, in order that these kits could also feature in a Scottish evaluation.[87] Professor Cash said that the initiative with the Institut Pasteur failed after 'the lawyers moved in'.[88] It appears, however, that scientists working in Scotland would not have been able to carry out an independent virological evaluation of the kits available: what they were engaged in was a practical assessment of the mechanics of introducing US test kits.[89]

Scottish concerns at lack of progress

A perceived lack of effective coordination

30.64 Professor Cash's frustration at a perceived lack of progress is reflected in documents recovered by the Inquiry: he was clearly concerned about what he saw as the lack of effective coordination of the UK approach to transfusion and AIDS. In his letter to Dr Bell dated 24 January 1985, he said:

[I]t is with dismay that I must conclude that there are just no mechanisms in the UK for these crucially important topics to be discussed, openly and confidentially, and for clear, co-ordinated policies to emerge. The biggest anxiety of the NBTS Directors with regard to this problem is the Scots: that they will unilaterally move to come in line with the American proposals. They're right: we are in detailed discussion with commercial (kit) companies, our technical staff are already looking at ways of introducing the technology within existing staff establishments, we have the Western Blot technique (HQ and SE labs). We are already liaising with local (Communicable Disease) physicians with a view to securing care for our positive donors and we are currently arranging our financial planning accordingly. I advised the NBTS Directors that we would do everything possible to avoid such a development. They were not impressed ... I had much sympathy with them ....[90]

30.65 The threat in Professor Cash's letter, that the SNBTS would proceed unilaterally to introduce US test technology, had some basis. At the time, commercial companies were approaching Regional Transfusion Directors (RTDs) in Scotland with ELISA tests. In his witness statement, Professor Cash said that the SNBTS had evidence that the FDA was by then well-advanced in its assessment of HIV donation screening kits, which was later published.[91] As far as the SNBTS could judge, there was no evidence that their pleas for interdepartmental collaboration were succeeding.[92]

30.66 Professor Cash said, with reference to the national blood transfusion services generally:

We, the people responsible, were not in control of actually, urgently getting together, looking at these tests, to actually determine: is it 1 per cent or 0.5 per cent or 10 per cent? What are we dealing with here? For me, as a manager, it's a madness when the whole thing is drifting away here, and there are very serious matters that, in my view, were not being properly addressed.[93]

30.67 Professor Cash was not alone in expressing concern about progress. Dr McClelland was also concerned, though the focus for his frustration was different. On 8 January 1985, he wrote to Wellcome on behalf of the RTDs in Scotland expressing continuing concern about the lack of a screening test for blood donations:

I am not reassured by the information available to me at present.


I am concerned at the apparent lack of progress and I sincerely hope that you can reassure me that Wellcome will shortly be in a position to make some form of antibody detection system available. I feel certain that I am speaking not only for my Scottish colleagues but for other Regional Transfusion Directors in the UK if I say that it would be a tremendous step forward if even a limited supply of materials for HTLVIII antibody testing were to be made available in the near future ....

I really cannot over emphasise the urgency of this situation. I am sure that from the recent press coverage, you can be under no doubt of the extreme pressure being placed on the transfusion services to ensure that no 'high risk donors' donate blood - a task which is essentially quite impossible unless some form of screening test is available.[94]

30.68 He was looking for a positive proposal from Wellcome. He explained the background to his letter in evidence to the Inquiry - he was frustrated that 'we weren't getting on with it'.[95] Wellcome did not respond. Dr McClelland thought they were 'up to their ears in trying to make the test'.[96]

30.69 Against this background, Professor Cash took steps to progress matters, at least insofar as Scotland was concerned. He was keen that a Scottish centre should be involved in any evaluation exercise and attempted to promote such an exercise involving the west of Scotland centre.[97]

30.70 Professor Cash's frustration is clear, particularly because he and his Scottish colleagues were not more closely involved. It is less clear what Scotland could have done alone, however. If Scotland had followed an individual path at this time there would still have been a need for a prior assessment of local data on the specificity of each proposed test.[98] That would have required the growth and propagation of HTLV-III. While that could be done at CAMR Porton,[99] Dr McClelland thought it highly unlikely that there was a facility in Scotland that could undertake the virology involved.[100] The containment facilities required to handle live virus were not available.

The proposal to commence test kit assessment in Scotland

30.71 On 21 January 1985, Dr Mitchell wrote to Professor Cash, advising that Abbott had visited 'with a view to starting some evaluation of the Abbott ELISA test system'.[101] Abbott were frequent visitors to check on Glasgow's progress with the testing of other products.[102] Professor Cash was also visited by Abbott.[103] Dr Mitchell noted that some problems had arisen from FDA requirements for blind testing and ethics review board approval.[104] He thought that these problems could be overcome and he had been asked to write a letter to Abbott setting out the position in terms advised by the company.

30.72 In a minute to Mr Alexander Murray, SHHD, coincidentally also dated 21 January 1985, Dr Bell said that '[t]he RTC at Law [Hospital, Glasgow] is testing the Abbott (USA) screening test'.[105] In the light of Dr Mitchell's letter to Professor Cash, Dr Bell's understanding that testing was already in hand was incorrect: it was about March or April 1985 that an Abbott HIV test kit was first available for initial evaluation, at Ruchill Hospital.[106] However, the SHHD understood the intentions of the SNBTS at the time. It appears that Professor Cash, Dr Ewa Brookes (Director of the Dundee RTC), Dr William Whitrow (Director of the Inverness RTC), Dr McClelland and Dr Mitchell had discussed the issue when they were at Trinity Park House in Edinburgh in the week beginning 14 January 1985.[107] According to Professor Cash, the outcome of those discussions was a decision that the Scottish Directors had to take action themselves.[108]

30.73 Meanwhile, and in response to Dr Mitchell's letter, Professor Cash developed his proposals:

1. That the [West of Scotland BTS] should undertake, on behalf of the SNBTS, initial evaluation studies of commercial HTLV-III antibody kits, but that the current pressure from commercial organizations to meet their deadlines should be resisted and priority given to SNBTS interests - particularly in terms of confidentiality and ethical clearance.

2. That retrospective studies (on donor samples) currently in store should be used provided:

(a) Steps are taken to ensure that no one can identify the donors.

(b) That the selection of donor samples is representative and random (not exclusively high risk donors and does not deliberately exclude high risk donors by virtue of previous tests).

(c) That the donors associated with factor VIII batch 023110090[109] are not used for these evaluation studies.

(d) That the donor samples would come exclusively from the WBTS donor panel.

3. That initial donor samples should be of sufficient volume to enable the following:

(i) Initial test

(ii) Repeat test if necessary

(iii) Reference test (? Western Blot) if necessary

(iv) As many residual 1 ml aliquots (at least 2) so that the same samples can be tested with other emerging kits and the results compared.[110]

30.74 He also discussed ethics approval and offered his assistance to secure that if necessary. He reported that the manufacturers had readily agreed to supply the kits necessary for evaluation free of charge.[111] He copied his letter to all the RTDs in Scotland and also to Dr Bell at the SHHD. At that stage, there were no commercial tests available for donor exclusion purposes but it was envisaged that initial evaluation studies would not be restricted to Abbott.[112]

30.75 In his oral evidence, Dr Mitchell thought that the proposal would not have been practicable. He said:

I think the difficulty would have been to pursue this idea would be - firstly, the availability of samples, availability of commercial tests. I think there would be a difficulty in any manufacturer at that level, at this time, supplying sufficient tests for us to have a look at and - I think they were busy as it were, in their own backyard, trying to develop the tests. I think what Abbott might have been saying was, 'In the event that we were willing to do this, we would ask you to do the following things', or insist on the following things.

I always said to all companies that ever approached us about any test, 'We will look at your test, we will analyse it, quite unknown to you, we will look at the results, we will publish the results, fear or favour.' We believe in telling what exactly we find. We will not be stampeded into making allowances for this, making allowances for that. We had to be sure that the test was fit for purpose. That was for mass screening, day in, day out. Same test today, same test tomorrow, the same expected results, the same expected performance.


I think the reason that we couldn't pursue this was just because the materials were not available, weren't readily available.[113]

30.76 As he saw it, 1000 kits might have enabled an exercise that was worth doing but he did not think that a manufacturer would have been prepared to supply such a number of kits.[114] Further, he did not think that access would have been allowed to the MH/CB material necessary for evaluation of that assay.[115]

SHHD opposition to the SNBTS undertaking its own kit evaluation

30.77 The proposal was not put to the test, however. Professor Cash advised the Inquiry that, some days after this letter was sent, he was invited to discuss the situation with Dr McIntyre who 'made it clear that SHHD was strongly opposed to the prospect of SNBTS undertaking its own kit evaluation'.[116] Dr McIntyre also advised Professor Cash that the SHHD had assured the DHSS that they were content with the evaluation of the kits being managed by the DHSS and that 'the commencement of routine HIV donation testing in Scotland would be determined by Ministers, on the advice of DHSS and that this date would apply across the UK'.[117] On that approach, the question was answered conclusively by policy decisions made by the SHHD, which Professor Cash described as 'hostile' to the initiative.

30.78 Dr Mitchell and his colleagues were disappointed at being excluded from the overall UK process: it hurt their sense of pride.[118] While he was less than certain, the general tenor of Dr Mitchell's recollection was that the proposal did not proceed because there had by this time been agreement between the DHSS and the SNBTS that the Tedder/Weiss process should have priority.[119] Professor Cash's approach was different: he was not willing to accept that the SHHD and the DHSS might have a legitimate interest in avoiding duplication of costs. He thought that responsibility lay with the SNBTS and that they should have been allowed their investigation.[120]

30.79 From the sequence of events, it appears that decisions taken by the Expert Advisory Group on AIDS (EAGA, a non-departmental body established to provide the UK Health Departments with Expert advice on AIDS) contributed to the discontinuation of the Scottish initiative.[121]

30.80 Professor Cash maintained that the SNBTS initiative had to be stood down 'in view of the hostile reaction of SHHD'.[122] The Inquiry sought comments from Dr McIntyre on this account of events and his response came in an e-mail from the Scottish Government.[123] Dr McIntyre took issue with the proposition that he ever spoke to Professor Cash in a hostile manner. He commented that 'SHHD treated Dr Cash and his colleagues in a professional manner and did all they could to help as this was a major health problem'.[124]

30.81 Professor Cash thought that he had discussed the matter with Dr Mitchell and Dr McClelland. In a further attempt to shed light on this episode, both Dr McClelland and Dr Mitchell were asked for their recollections. Dr McClelland had 'no recollection of this whatsoever'.[125] Dr Mitchell had no recollection of actual discussions on the subject in 1985, although he could remember it being said that the SNBTS were not going to do the evaluations.[126] Professor Cash's account of the Department's 'hostility' to an SNBTS initiative was not disputed, including by Dr McIntyre, however, and it is appropriate to conclude that the SHHD did indeed express strong opposition to an independent Scottish evaluation.

30.82 The question of an independent Scottish evaluation was effectively settled at this point by the EAGA. The EAGA was set up around the turn of 1984-85[127] with the purpose of providing 'advice on such matters relating to HIV/AIDS as may be referred to it by the Chief Medical Officers of the Health Departments of the United Kingdom' and first met on 29 January 1985.[128] The membership of the group was announced in the House of Commons on 20 February 1985.[129] The Group had a wide range of specialist interests: Genito-Urinary; Blood Transfusion; Epidemiology; Physicians and Nurses; Virology; Immunology; and Microbiology were all represented.[130] Professor Cash and Dr McClelland both attended the first meeting.

30.83 At that meeting it was agreed that a screening test for all UK blood donors should be made available as soon as practicable and a sub-group on implementation was set up to consider screening tests for AIDS and, in particular, the best way of introducing the service when the tests became available.[131] The sub-group comprised Dr Gunson, Dr McClelland, Dr Philip Mortimer (Consultant Virologist), Dr Tony Pinching and Dr Philip Rodin (GUM specialists) and Professor Tedder, under Dr Smithies as Chair. It was not the specialist UK advisory group envisaged by Professor Cash, although Scottish interests were now fully represented at the national level. At a meeting of the SNBTS Co-ordinating Group held on 19 February 1985, the evaluation programme (monitored by an EAGA sub-group) was noted and it was agreed, after full discussion, that the proposals for a west of Scotland study should not be pursued at that time.[132] Professor Cash reported to Dr Bell that the SNBTS directors had agreed to hold off from validation of kits until protocols had been agreed through EAGA.[133] Dr Bell welcomed the news on 6 March.

30.84 The decision to await the completion of the tests arranged by EAGA was reinforced on 20 June 1985, when the SNBTS Directors again considered the introduction of testing for HIV.[134] It was noted that the SHHD had undertaken to provide funds for testing kits once it had been agreed to commence routinely.[135] On 27 June 1985, Professor Cash wrote to Mr Davies, SHHD, giving advance notice of a need for additional resources for screening.[136]

30.85 In his evidence to the Inquiry, Professor Cash commented that it was his view that, if the SNBTS had been allowed to 'go it alone', testing of donated blood for HIV in Scotland with commercial kits could have been introduced around the same time as such screening commenced in the Netherlands and Australia.[137] In round terms, that would have involved a saving of about four months.

30.86 Dr Scott was asked to comment on Professor Cash's position but, apart from noting generally that Professor Cash's views were not always entirely favourable to the SHHD, felt he could not comment on the impression Professor Cash gave, that the SHHD were holding him back.[138] He deferred to Dr McIntyre on the sequence of events that led to the abandonment of the proposal for a Scottish evaluation but Dr McIntyre was not able to assist.[139]

30.87 It should be borne in mind that the first meaningful supplies of Abbott kits for evaluation did not arrive in Glasgow until April and scientists in the West of Scotland BTS did not have access to the MH/CB assay. There was, on the balance of evidence, no real prospect of Scotland being able to introduce screening four months before 14 October 1985.

Development of an HIV test in the United Kingdom

Choosing the test format: radioimmunoassay or enzyme-linked immunosorbent assay

30.88 The need to scale up testing from an assay working in the laboratory to kits which could be used for hundreds of thousands of tests in the blood transfusion services raised questions as to the nature of the test to be taken forward as well as to the selection of a manufacturer. The characteristics of the two test formats considered are discussed in Chapter 29, The Discovery of HIV and the Development of Screening Tests, at paragraph 29.27.[140] Professor Tedder's test was initially developed as a radioimmunoassay (RIA), in which radioactive isotopes are used in the detection of the target antibody.[141] Within the NBTS in England and Wales in 1984, there was a preference for RIA testing[142] and Professor Tedder's initial work reflected the reality of that preference. In his letter of 3 July 1984 to Dr Smithies, Dr Gunson expressed the view that '[i]t would be an advantage for the NBTS if [the new test] was in the format of the Blood Products Laboratory (BPL) RIA test for [the Hepatitis B surface antigen]'.[143] The BPL were familiar with RIA testing and that was an obvious attraction. On 23 January 1985, at the meeting of the RTDs in England, the position was still that '[t]he preference within the NBTS [was] for an RIA'.[144]

30.89 Within the public service in England and Wales, it was also hoped that the CBLA might become involved in the preparation of the test kits.[145] At official level, there was interest in involving other public sector institutions in the development work, in particular CAMR Porton, who were thought to have the necessary equipment and expertise.[146]

30.90 Initially, official support for the principle of a UK test reflected the BPL's preference. For example at the 16th meeting of the CBLA on 1 February 1985, the subject was discussed. The minutes record:

The Director [of BPL] advised that if given the antibody BPL could produce a test as an alternative to the Chester Beatty's work in association with industry, at a much lower cost. Dr Gunson confirmed the necessity for the test and referred to a Departmental working party considering the matter. It was noted that the CBLA role in this matter was not yet established but there would be a related capital requirement for equipment for RIA tests.[147]

30.91 Throughout the industry, however, RIA technology was being superseded in routine testing because the radioisotopes employed in such assays were potentially dangerous.[148] It was increasingly recognised that radioactivity involved risk and, while the risk could be contained in the laboratory, it was considered undesirable to have a 'widespread proselytization' of RIAs into the community.[149] Once Professor Tedder and Professor Weiss had decided to work with the diagnostic industry it would have been difficult to resist the global move towards ELISAs and away from RIAs.[150] ELISA technology carried no biological hazard and Wellcome had scientists highly skilled in producing the enzyme ligands used in such assays.[151]

30.92 Professor Tedder remembered attempts being made to involve the BPL and meetings being held with Dr Lane, the CBLA and the BPL. Eventually, however, it became necessary 'to let them down and say, "We don't want to do a radioimmunoassay, we are going to run with Wellcome"'.[152] Wellcome Diagnostics was engaged to carry out the research and development necessary to achieve the ELISA-based test kit and CAMR Porton were enlisted to help with the scaling up as sub-contractors to Wellcome.[153] Engagement with Wellcome led to the abandonment of Professor Tedder's RIA in favour of ELISA technology.

30.93 Although in the end Wellcome was selected, the choice of a manufacturer for the MH/CB test was not straightforward. Professor Tedder told the Inquiry that he made contact with the five diagnostic companies licensed in the US to develop tests and a number of British companies. None of the US companies would work with the British scientists, although they were discarding large quantities of the antigen required for the British test.[154] Professor Tedder thought that the reason for rejection was twofold: (i) the terms of the contracts to which the US companies were party and (ii) scepticism about the effectiveness of the competitive assay which he and Professor Weiss had developed.[155] In order to work with companies outside the National Cancer Institute franchise it was necessary to have an independent UK-based isolate, such as the isolate he and Professor Weiss were developing. Wellcome were 'the most enthusiastic and the quickest off the mark'.[156]

30.94 The question of scale-up of the test reagents, including quantities of the virus, had been moving forward since the previous summer, with implications for the type of test which would eventually be manufactured. As Professor Tedder commented, references in the DHSS minutes around this period to the development in the UK of an RIA for screening were inaccurate because, at that time, the test which he was developing with Wellcome was already an enzyme-based test, not an RIA, though that does not seem to have been understood by officials.[157] The research group had already begun work on the ELISA with Wellcome in October or November 1984.

30.95 Failure to appreciate that there had been a decision to adopt the ELISA format appears to have continued. At the meeting of EAGA on 29 January 1985 Dr Gunson reported that BTS were in overwhelming favour of an RIA test on the view that it was more accurate than an ELISA test on which all the US tests were based and suited the equipment which they already had for Hepatitis B testing. Professor Arie Zuckerman (Professor of Microbiology, Royal Free Hospital School of Medicine, London) was in favour of the evaluation of the US test before an RIA test was adopted.[158] A note prepared by Dr Covell, SHHD, of the meeting of EAGA on 29 January 1985 reported that Professor Weiss was negotiating with Wellcome Diagnostics to develop a test for BTS.[159] The note did not reflect an understanding that there had been a move to adopt an ELISA format. The assumption that the MH/CB test would have an RIA format appears to have continued.

30.96 While it is necessary to be aware of this issue, having regard to the extensive references to it in the evidence already noted and noted later in historical context, in the end it did not impact on progress. In this, as in other areas, Professor Tedder and his industrial collaborators got on with the work necessary to develop their assay, adopting the test format thought best to suit market demand.

Progress with scale-up

30.97 As already noted, CAMR Porton were enlisted to help with the scaling-up as sub-contractors to Wellcome.[160] CAMR initially did not provide antigen appropriate for use in the assay, however, as they did not follow the exact protocol Professor Tedder and his colleagues had developed for engendering maximal antigen retention in the cell component. Professor Tedder acknowledged the difficulties CAMR had in scaling up for industrial production: the conditions of the culture they used encouraged antigen to come out of the cell into the supernatant, whereas it was necessary for the assay under development that the virus remained in the cells.[161] It was not until late spring 1985 that the CAMR antigen came on-line.[162] That did not affect the progress of research or cause delay, however, since enough high-quality antigen was produced by Professor Tedder's laboratory-scale equipment to enable the research programme to continue.[163] When it was decided that Wellcome should develop a test based on the MH/CB patent-protected competitive technique, Professor Tedder and Professor Weiss supplied their own British isolate.[164]

30.98 Reports of work in hand at the first meeting of EAGA on 29 January 1985 indicate that research was continuing.[165] The availability of screening tests was discussed and Professor Weiss reported on the work with Wellcome Diagnostics. There were still problems to be solved.[166] There was still intent among the RTCs to proceed uniformly across the transfusion services, a point stressed at a meeting of the RTDs on 17 April 1985: their interest was in having 'uniformity of action'.[167]

30.99 Dr Covell, SHHD, prepared a note of the meeting of 29 January 1985 that indicated that the choice of test systems was still open. He reported:

Prof Weiss said that he was negotiating with Wellcome Diagnostics to develop a test for BTS which would be as reliable as other tests and would detect serum antibodies specific to HTLV III. Negotiations were just beginning and he could not give a date when it would be available. It may turn out that overseas tests may be produced quicker and could be more reliable.

Prof Zuckerman said that three United States firms, Travenol, Dupont and ? [third firm not named in the text] have tests ready which he hopes to evaluate within the next three months and to compare with Dr Tedder's test. He hoped they would not only be available for BTS, indeed even if there was a delay they should wait until others could also be supplied.

Dr Whitehead said there were technical difficulties in the scaling up of the test. He also mentioned the possibility of patent restrictions on the viral strain involved.[168]

30.100 Dr Covell's note disclosed a significant move from the earlier concentration on the interests of the blood transfusion services in discussing the approach to the development and introduction of HIV assays. Professor Tedder commented that a test would have to be made available to all who wanted it, reflecting his understanding that many individuals attending genito-urinary medicine (GUM) clinics, haemophilia patients and those who encountered needle stick injuries in the course of their work wanted access to the test, even though doctors could not tell them its full significance. Appropriate resources had to be provided for that demand.[169]

The evaluation project

30.101 As noted above, unlike the USA, where kits had to be approved by the FDA before they could be used for screening, the UK did not have a requirement for test kits to be licensed under the Medicines Act 1968 or otherwise.[170] The DHSS had no statutory authority to force manufacturers to have their products evaluated before sale to the NHS was permitted.[171] There was thus no legal impediment to sale of such kits in the UK. Abbott were informed of that position on 5 March 1985.[172]

30.102 The DHSS had decided that an evaluation of all the competing kits (including any developed in the UK) was necessary, however: it was seen as important that the most suitable tests were chosen for NHS use and that there was uniform introduction throughout the transfusion services.[173] As already noted in paragraph 30.50, Professor Tedder wrote to Dr Smithies on 18 December 1984, seeking funding for monitoring the efficiency with which the MH/CB test and the forthcoming commercial kits detected antibody to HIV.[174] It appears that by this stage the need for an evaluation of test kits in the specific context of the UK population had been recognised, although a specific date for a decision to that effect has not been identified. The intention behind the assessment was described as being to 'inform the NHS through suitable media of those products which were worthy of consideration. Thereafter the would-be purchasers could make a decision based on price and the results of appraisal with local circumstances in mind'.[175]

30.103 On 16 January 1985, a draft of the evaluation programme was sent to Dr Smithies in the form of a letter to be sent to the producers of test kits.[176] The formulation of plans to conduct a detailed evaluation of test kits may have occurred in part during telephone conversations of which the Inquiry has no formal record. For example, the minute to Dr Smithies dated 16 January 1985 refers to 'our telephone conversation about setting up an evaluation programme'. What is evident is that a letter was sent by the DHSS to all those known to be developing tests, including Wellcome, around 21 January 1985.[177]

30.104 The draft was discussed within the department and there was some consideration of whether only kits approved by the FDA should be 'accepted' in the UK. On 21 January 1985 Dr Smithies commented:

We also discussed whether or not any reference should be made to tests not being accepted in the UK unless they had FDA approval and decided that such stipulation might not act in Wellcomes best interests in the short term.[178]

30.105 Professor Tedder commented:

There is little difference in having an American manufacturer or the FDA pontificating on the performance of a test and then accepting matters as gospel in this country. That would run completely counter to everything that we had ever done in the transfusion service in the UK and anything that we do nowadays. And indeed, if we had been tied to FDA ... we would have been locked into an antediluvian regulatory system.[179]

30.106 The letter sent to manufacturers on 21 January 1985 made clear that the results of the evaluation exercise would form the basis of 'firm advice' to the NHS on which materials might be used and that it was likely that the NHS would also be advised not to use materials not tested in the programme.[180] The programme was to comprise a systematic study of each candidate material's performance against a panel of patients' samples, both positive and negative; investigation of the controls provided; and the convenience and time required to carry out each test. Information to substantiate claims made for each product would be required.

30.107 All those manufacturing tests agreed to participate.[181] Wellcome responded almost immediately, replying on 29 January 1985 and agreeing to submit their product to evaluation but noting that their main priority was to make a kit available to the blood transfusion services as quickly as possible.[182] Professor Tedder interpreted the letter as indicating that, while Wellcome were willing to participate in the evaluation programme, they would not have prepared the usual, fully detailed portfolio of manufacturers' claims for its product and the data normally submitted for evaluation: there was not time to do that.[183]

30.108 In Scotland, the SHHD were kept informed of developments. The DHSS submission to Ministers regarding the need to introduce screening into the NBTS was sent on 17 January 1985.[184] Dr Bell acknowledged receipt of these documents from Mr Murray by minute dated 21 January 1985.[185]

A potential conflict of interests

30.109 Initially, it was considered that Professor Tedder's laboratory might provide the evaluation service. The proposal that Professor Tedder and Professor Weiss should be funded to do this work was quickly dropped, however, when it was recognised that there was a potential conflict of interests in this approach.[186] As matters had developed, Professor Weiss and Professor Tedder had independent interests in promoting their distinctive technology in collaboration with Wellcome Diagnostics. On 11 February 1985, the DHSS wrote to Wellcome noting that commercialisation was a separate issue from the evaluation programme that was being set up.[187]

30.110 The potential for a conflict of interests if Professor Tedder had been selected to do the evaluation was acknowledged in a DHSS memorandum dated 13 February 1985.[188] When he had sought funding, Professor Tedder had wanted to be able to look at the performance of the various kits in order to define the best algorithm for use, but that did not require extensive access to assays.[189] The full evaluation process would require much more access to assays while Professors Tedder and Weiss were, at the same time, working on their own test. Professor Tedder commented:

You know, I tore my hair out with our colleagues in DHSS over these early years. I think it's actually correct to have some form of Chinese walls because otherwise there is a conflict of interest, and I can't see how you can have a commercialisation of a test being carried out under the same umbrella as the evaluation programme. I think you do need to separate them because they are different issues.[190]

30.111 Professor Tedder was anxious to avoid potential conflicts of interests. He was particularly concerned that no favours should be shown to his assay; his institution had financial interests in benefiting from its own intellectual property. He said that there had been no intention to delay the evaluation process to favour Wellcome and agreed with the refutation by Dr Barbara and Dr Hewitt that there had ever been any such idea.[191] Professor Tedder said:

Looking back I'm relieved that we were not asked to undertake such an evaluation, it would have been a massive deflection. It would also have constituted ammunition for the comment of conflicts of interest. I see ... the potential for a conflict of interest had we been asked to conduct an evaluation of commercially available assays while working with an industrial collaborator at the same time. To be in such a position would have rendered it extremely difficult for us to have meaningful conversations with the diagnostic firms concerned.[192]

Preparatory work

30.112 On 13 February 1985 there was an internal DHSS meeting at which it was noted that Dr Mortimer had expressed a willingness to carry out an evaluation for the department and it was agreed that he would be acceptable to the DHSS.[193] At the time, Dr Mortimer was Director of the Central Public Health Virus Reference Laboratory of the Public Health Laboratory Service (PHLS). Dr Mortimer was selected to do the work[194] and an ad hoc Expert Working Group would be set up to help in the management of the evaluation.

30.113 Professor Tedder said that there was a multiplicity of groups with different interests involved in monitoring the evaluation exercise.[195] There was a screening test sub-group of EAGA, which was to look at broader issues than the DHSS technical group, and the RTDs had a working party. By the time of the meeting on 13 February 1985, Dr Mortimer was drafting a protocol for the exercise.[196] The report of the evaluation exercise, dated September 1985, refers to the protocol having been drafted by an ad hoc Expert Working Group set up by the DHSS.[197]

30.114 Dr McClelland said that, in his view, the ad hoc Expert Working Group established by the DHSS and the Screening Test Sub-Group of EAGA had 'two completely different tasks'. The first group was 'to design and possibly oversee the technical evaluation', whereas the second was 'to look at the broader group of issues for the transfusion service that had to be addressed in preparing to introduce large-scale screening testing of blood donors'.[198] Both groups played useful, timely and important roles as matters developed in 1985.

30.115 On 15 February 1985, the screening test sub-group of EAGA met.[199] Dr McClelland had tabled a paper, dated 11 January 1985 and prepared by the Division of Biometrics of the FDA's Department of Health and Human Services, reporting on phase 1 of the Public Health Service evaluation of US kits.[200] It was reported that the kits had not been tested by the participating companies on the same serum samples (a point made in the Nature article of 13 December 1984)[201] and it was agreed that it was essential to repeat the process in the UK using the same samples for each test. It was also agreed that the evaluation would have to embody confirmatory procedures and the requirements for field trials were discussed and agreed. The evaluation exercise would consist of initial testing by PHLS against a panel of sera with a follow-up evaluation in RTCs and in laboratories serving sexually transmitted diseases (STD) clinics also undertaken. Dr Gunson and Dr McClelland were asked to consider the feasibility of collecting samples and preparing aliquots from them at transfusion centres while Dr Pinching was to deal with STD clinics. It was noted that:

Regional Transfusion Directors had been unanimous in wanting a common date for the introduction of a test into the NBTS. The group considered that individual RTCs should be dissuaded from implementing tests on a local basis. In fact it was agreed by the sub group that tests should better be made available for the clinical setting first.[202]

30.116 The reference to 'NBTS' was intended to apply to the UK as a whole.[203]

Development of the evaluation programme

30.117 The EAGA sub-group met next on 1 March 1985.[204] Dr Gunson and Dr McClelland tabled a paper outlining a proposal for the second phase of evaluation, a BTS field trial using 10,000 specimens collected routinely from blood donors, to follow on completion of the PHLS evaluation coordinated by Dr Mortimer. Dr Pinching confirmed that he could collect the required specimens from STD clinics. There was general discussion of the technical problems involved and of the counselling and other services thought to be required.

30.118 Dr McClelland described the plan to have a laboratory assessment of the kits using a smaller number of samples and then a field assessment as 'a fairly conventional sequence of events'.[205] Later, he said that the first stage, carried out by the PHLS and funded by the DHSS for the UK transfusion services, was a 'perfectly reasonable position for the first part of the evaluation'.[206] The second part of the evaluation then had to involve the transfusion services directly because 'that was the operating environment in which the test would have to be proven'.[207]

30.119 An internal DHSS memorandum dated 11 March 1985 set out the anticipated arrangements for the introduction of screening tests.[208] All manufacturers known to be making diagnostic reagents had been informed that the DHSS intended to evaluate their kits and five had agreed to cooperate. The steps envisaged were:

  • An initial evaluation against 300 to 500 serum samples by the Virus Reference laboratory at the PHLS Colindale.
  • A field evaluation of the kits prompted by the experiences of the FDA as disclosed to the DHSS. This could not be started until completion of the initial evaluation. The required sera were already being collected and stored.
  • The PHLS laboratories were to provide panels of standard sera and would provide a reference service.
  • Kits satisfying the evaluation, including the UK test if produced on a large enough scale, would be listed.
  • The Regional Transfusion Directors had agreed to commence testing at the same time and had indicated a wish to use the same test.

30.120 On 15 March 1985, the DHSS wrote to the RTDs describing the two-phase programme then envisaged.[209] The letter commented that it was the intention of the Department to evaluate any commercially produced tests which were marketed and to give advice to the NHS on the suitability of the tests. It noted the view of the RTDs that there was an imperative need for a coordinated introduction of screening tests into all centres simultaneously, and EAGA's endorsement of that view, and that the view had been endorsed by Regional Medical Officers in discussion with the Department the previous day. The RTDs' interest in having a cohesive position was stressed at their meeting on 17 April 1985.[210] The DHSS was anxious that all blood transfusion authorities should wait until the results of the evaluation process were available and coordinated arrangements had been made to use the tests at all centres.

30.121 It was considered very important that testing begin simultaneously throughout the UK. Dr Mitchell said that it was very clear that 'we were all to sing from the same hymn sheet' and he agreed with that approach.[211] Arrangements were in hand for the preparation of protocols for the evaluations and other procedural matters. Abbott's kit was to be tested and a small quantity was to be imported for that purpose. As the DHSS understood it, there were no kits in the UK at that point. Professor Cash observed that Dr Mitchell had not envisaged any problem in obtaining kits.[212] However, it is not clear that Professor Cash was well-informed about the availability of kits at the time.[213]

30.122 'Singing from the same hymn sheet' would not be easy: not all relevant agencies were up-to-date. The minutes of the meeting of the CBLA Central Committee for Research and Development in Blood Transfusion held on 2 April 1985 indicate that, until that date, the Chairman was not aware that UK evaluation studies of the tests had been set up or that a protocol for the evaluation had been sent to manufacturers.[214] However, in light of the information provided:

The importance of evaluation of the tests was emphasised and it was agreed that an adequate confirmatory laboratory service was required, especially in view of the high incidence of false positive results.

In answer to a question raised by the Chairman about testing in the haemophiliac population in the UK, [Dr Rizza] and Professor Luzzatto informed the Committee of tests they had carried out in Oxford and at the Middlesex Hospital and the results of these had confirmed the importance of evaluation.[215]

30.123 In Scotland, Dr McClelland prepared a paper dated 15 May 1985 for the RTDs, outlining some of the practical issues that would arise from the evaluation programme.[216] He emphasised the need for the evaluation of test systems in the light of evidence that some tests gave significantly lower false positive rates than others. He outlined the practical problems for Transfusion Directors in interpreting screening test results and in dealing with donors who were 'screen positive' on initial testing but unconfirmed and the need for confirmatory tests. He commented on the need for documentation and for communication with donors and donors' GPs, for the purposes of monitoring and counselling, among other matters. Dr McClelland's paper would have informed any Director who had been less than fully involved in the preparations for the evaluation programme of the range and complexity of the preparations required, as well as providing a valuable check-list for all Directors.

30.124 The views of Ministers were communicated to the PHLS on 31 May 1985.[217] It was intended to review the position on 7 June and the PHLS was asked to prepare a flow chart projecting dates for completion of the evaluation and for countywide introduction of testing, with take-up facilities for confirmatory testing. The PHLS prepared a flow chart and explanatory paper in June.[218]

30.125 From the terms of the PHLS paper it appears that the initial evaluation process was not limited to Professor Tedder's work on the MH/CB test at the Middlesex Hospital and Dr Mortimer's wider exercise at the PHLS Virus Reference Laboratory, Colindale. Four other public health laboratories, at Newcastle, Leeds, Oxford and Birmingham, were testing for antibody to HIV.[219] Wellcome was developing the competitive MH/CB assay and Abbott, Electro-Nucleonics Inc, Organon, Litton/Ortho, Travenol and Production Pasteur were developing indirect assays. Abbott and Electro-Nucleonics Inc had said that they could supply the British transfusion and clinical markets immediately but both had withdrawn the kits originally delivered to the PHLS Colindale and supplied replacements, raising doubts about the claims. At Colindale, the first stage evaluation of Abbott, Electro-Nucleonics Inc and Wellcome test kits had begun with each company demonstrating their products. Colindale and Middlesex Hospital were proceeding to test the available assays. The summary of the paper suggested that the ideal position would be to have one UK kit (Wellcome) and one US kit available for use.[220]

Concerns about perceived delay revisited: should US kits be introduced before evaluation is complete?

30.126 Among some haemophilia clinicians in the UK, including Professor Arthur Bloom,[221] there was still a degree of anxiety about delay. At the meeting of EAGA in May 1985, Professor Bloom expressed concern at delaying the introduction of a screening test in the blood transfusion service.[222] On 31 May 1985 he wrote to the chairman of the group to reinforce his views.[223] He was concerned for people with haemophilia, patients undergoing surgery, leukaemia patients and others needing blood and blood products, given the rising prevalence of HIV positivity. He thought that one or more of the FDA-approved tests should be introduced immediately for testing donations, leaving over re-testing, confirmatory testing and donor counselling to be dealt with as separate issues.

30.127 At the meeting of the screening test sub-group of EAGA on 10 June 1985, there was a proposal to allow the three commercial kits due to have been evaluated by the end of June to proceed to the field test stage. However, the counter view - that it was better to wait until the PHLS had evaluated more tests, including that of Wellcome - appears to have prevailed.[224]

30.128 Professor Bloom continued to advance his similar suggestion. With Dr Forbes and Dr Charles Rizza (Director of the Oxford RTC), he wrote to the British Medical Journal (BMJ), his letter being published on 22 June 1985.[225] By this time, three commercial HIV screening kits had been approved by the FDA. The authors wrote:

[People receiving] whole blood, platelet transfusions, cryoprecipitate or other blood derivatives from 50 or more donors in a short space of time [may be exposed to the risk of HTLV-III infection]. The risk of HTLV-III infection in such patients could now be as high as one in 20 in certain areas of Britain.

All these considerations underline the need rapidly to introduce screening for HTLV-III antibody for all blood donations. Three commercial test kits have now been approved by the American Food and Drug Administration and, although there may be a small number of false positives, it is unreasonable to delay testing until this possibility is eliminated.[226]

30.129 Professor Cash was angered by the letter. He drafted and distributed to Professor Bloom, Dr Forbes and Dr Rizza a severely critical response, but did not submit the letter for publication. He criticised them for publishing matters more appropriately discussed in established professional forums and speculated that they had done so in the hope of causing a media and public reaction (as, he said, had happened). He challenged as unfounded on any evidence the statement that the risk of HTLV-III infection in such patients could now be as high as one in 20 in certain areas of Britain and characterised as 'an extraordinary and cruel distortion' of the evaluation process the notion that it was concerned merely with logistical problems that could be dealt with after testing was introduced.[227] Though not noted by Professor Cash, Dr Rizza had been present at the meeting of the CBLA Central Committee for Research and Development in Blood Transfusion on 2 April 1985 when it was agreed that evaluation was necessary.

30.130 Professor Cash sought to explain his position in oral evidence. He believed that there was a 'major error of fact' by Professor Bloom and his fellow authors in their letter relating to the assessment of the risk of false positives. Beyond that:

At the time I thought this is a direct attack on the UK transfusion services. And here we were battling away with our colleagues in DHSS to get the kits evaluated quickly, to get them into use. But Arthur [Bloom] didn't seem to follow that, nor did Charles Forbes, so I reacted pretty angrily ....[228]

30.131 The position of Professor Bloom and his co-authors was surprisingly close to the policy applied in the USA and at odds with the ethos of the UK blood transfusion services' voluntary donor system. Professor Cash's response is at least understandable, albeit expressed in particularly strong terms.

30.132 The competing advice and representations of interest groups required discussion: the issue of whether US test kits should have been introduced as they became available was real. These exchanges illustrate deep divisions of opinion among those on whom official agencies would normally depend for independent advice.

30.133 The factors that were most relevant to the issue whether to introduce US tests were clear:

  • The anxiety of Professor Bloom and others to limit the risk of HIV transmission.
  • The reliability of foreign (US) validations of test systems in the UK.
  • The implication of a high rate of false positive results arising from use of the US kits.

30.134 The DHSS was anxious that all blood transfusion authorities should wait until the results of the evaluation process were available,[229] although the CMO was concerned to monitor what was happening in other countries.[230] Not only was there monitoring of developments elsewhere, there was also pressure being brought to bear concerning the completion of the evaluation exercise.[231] It is also apparent that, during the process, two of the companies whose kits were involved in the evaluation withdrew material in order to replace one or other of the agents originally supplied.[232]

30.135 At a meeting of the Central Committee for Research and Development in Blood Transfusion on 9 July 1985,[233] Professor Bloom said that, while he appreciated the need for a proper evaluation of the tests, his immediate priority, as a representative of 'users', was the protection of recipients of Factor VIII. He therefore considered that any undue delay in introduction of the tests would be unreasonable. That had been his consistent position. Since by July 1985 all Factor VIII used in the UK was heat-treated to exclude transmission of HIV, the specific risk he mentioned had been reduced, although risk remained at the same level for recipients of Factor IX. Recipients of blood transfusions also remained at risk. At the meeting, the state of play was described as follows under the heading 'Anti-HTLV III Testing in the NBTS':

The Chairman confirmed that ... [it] was his view ... that until a proper evaluation of the tests had been carried out within PHLS and the BTS the introduction of the tests should not be used for routine screening of blood donations. By not knowing the prevalence of antibodies in the donor population, the BTS was [as] yet unaware of the most effective test especially as far as false positive results were concerned. It was noted that 6000 donor samples were due to be tested at Edgware and Manchester and results would be analysed as the studies continued. Six PHLS laboratories in addition to PHLS Colindale were being set up as reference laboratories.


[Name redacted] informed the committee that excess plasma products released onto the market from BPL were likely to require licensing by FDA and, in addition, any intermediates shipped to other manufacturers could also precipitate inspection of BPL's facilities and the plasma collection centres by FDA in due course. He said that part of the FDA requirement would be routine screening of donations by an FDA approved test for HTLV-III antibody. The Chairman said that it was possible that an FDA approved test was not necessarily the most appropriate for the BTS.[234]

Political interest continues

30.136 The preference for having a British test evaluated as a possible candidate was referred to in a briefing note for the private office of the Minister of State on 30 May 1985.[235] In a further background note, 'Screening blood donations for HTLV III antibody', the CMO explained the need to evaluate the screening tests:

More than two million blood donations are collected each year and it is clearly essential to ensure that any tests introduced on this scale must be known to give consistent results and be specific and sensitive. Specificity in this context means that a test which does not give rise to an unacceptable number of false positives each of which would require extensive further investigation and would waste the blood donations involved. Sensitivity is also of paramount importance in order that no genuine positives should be missed.

While the commercial products already on sale have been evaluated elsewhere on an individual basis no comparative evaluation is available. This requires that their performance should be compared against a single carefully chosen panel of sera and that the tests should be conducted under controlled conditions. The PHLS are currently conducting such an evaluation. A field trial designed to explore both the specificity of the test and the operational aspects of its routine use throughout the country is also essential. Ease of use and consistency in large scale screening are prime requirements in selecting a suitable product for use in screening blood donations. Laboratory and field evaluations, both undertaken on a large scale, will enable an informed choice to be made and will promote confidence in those kits which are subsequently chosen .... It has been suggested that testing should be introduced immediately, before the reliability of the tests available has been evaluated. Early experience of other countries and the considerations outlined in this note have led Ministers to decide that it would be wrong to introduce a screening test until the further evaluations mentioned above have been carried out.[236]

30.137 The need to introduce testing was also raised in the House of Commons when, on 27 June 1985, Kenneth Clarke, Minister of State for Health, gave a written reply to a parliamentary question. He stated:

[A] test will be introduced within the next few months to screen all blood given by blood donors for antibodies to the virus which causes AIDS ....

I understand and share the concern to get these tests in use as soon as possible. However, we must have tests which are accurate and can be trusted. A number of test kits are already available and in use abroad, but reports from those countries suggest that the tests are not entirely reliable. We believe that no test should be introduced in the United Kingdom until its reliability has been established. There is no point in introducing a test which often fails to detect antibodies in blood or detects antibodies where there are none. An evaluation programme is being undertaken by the Public Health Laboratory Service and National Blood Transfusion Service experts as a matter of urgency.... Contrary to reports in today's press, no decisions on choice of test kits have yet been made. We hope that we will be able to introduce a test within four to five months.[237]

Progress in the summer of 1985

30.138 Scottish officials knew of progress over the summer of 1985 as the evaluation process continued. On 8 July 1985, Dr Scott wrote to all Chief Administrative Medical Officers (CAMOs):

As you know the various tests for HTLV III antibodies are being evaluated; in due course routine screening and confirmatory tests will be recommended. It is probable that routine screening of blood donors will begin before the end of this year. Experience elsewhere has shown that in order to prevent people from presenting as blood donors solely to establish their antibody status the provision of alternative screening facilities is essential.

It would be helpful if you would inform the Department of how you propose to provide this facility.[238]

30.139 On 11 July 1985, the working party of the Regional Transfusion Directors' Committee produced a report on the first phase of the evaluation exercise, entitled 'Screening of blood donations for anti-HTLV-III in regional blood transfusion centres'.[239] It narrated the agreement of the Regional Transfusion Directors' Committee of the NBTS and the SNBTS Directors' committee that routine screening tests for HIV should not be introduced until the following had taken place:

3.1 The proposed evaluation in the N.B.T.S. of different test kits has enabled satisfactory system(s) to be selected.

3.2 The establishment of Reference Centres for the purpose of carrying out nationally agreed confirmatory tests on sera giving positive results upon screening.

3.3 The establishment of alternative venues for anti-HTLV-III tests on members of the General Public who are not blood donors.[240]

30.140 An amended report on the first phase of the evaluation programme (presented as paper EAGA (5) 6) was tabled by Dr Gunson at the fifth meeting of EAGA held on 30 July 1985, with an amendment to item 3.[241] Paragraphs 3.2 and 3.3 remained unaltered. The preamble, that routine screening tests for HIV should not be introduced until items 3.1 to 3.3 had taken place, was deleted and item 3.1 was amended to read:

3.1 That an evaluation in the N.B.T.S. of different test kits should be performed to enable satisfactory system(s) to be selected.[242]

30.141 Dr Gunson explained that the working party recognised the pressure to introduce routine screening in the BTS as soon as possible.[243]

30.142 The revised form of the report, probably reflecting growing concern about the time taken to complete the evaluation, recognised that there was a degree of urgency for the introduction of routine anti-HTLV-III screening of blood donations which precluded the completion of the NBTS second phase evaluation prior to arrangements being undertaken for the introduction of routine screening. The RTDs were being advised, therefore, to make arrangements with their respective Regional Health Authorities for the introduction of routine screening whilst the NBTS evaluation was proceeding, the selection of kits for use being made on the recommendations from the PHLS study. They were advised that long-term contracts with a particular manufacturer should be avoided until the results of the NBTS evaluation were available.[244] It was thought that by this means it might be possible to commence screening of blood donations by October 1985 and it was agreed that the introduction of the tests should take place throughout the UK over the shortest period practicable.[245]

30.143 Professor Cash thought that the RTDs were concurring with the message that Dr Smithies had brought them.[246] However, there was more substance to the change than that implies. It appears to be reasonably clear that the discussion at the CBLA research committee meeting on 9 July was reflected in the change of emphasis within the report. Following the revised version of the report, the procedure was truncated. The NBTS would continue to evaluate tests but it would be local Directors who would carry out local evaluations and proceed to make arrangements to obtain kits for their regions. The full stage two evaluation was not completed.[247]

Evaluation first round completed

30.144 On 30 July 1985, it was announced, by way of a DHSS circular, that the first round of the evaluation was complete.[248] The fifth meeting of EAGA was also held that day and the Group considered the circular (tabled as paper EAGA(5)11) which would be issued to health authorities as a report on the evaluation of the kits.[249] The circular was sent to regional and district managers, scientific officers and medical officers among others. The recommendations from the exercise were attached. A more detailed account of the evaluation was to become available later. It was noted that the NBTS was undertaking its own second stage evaluation covering the aspects of use of the kits particular to the context of blood screening. Confirmatory testing was to take place at PHLS laboratories funded by the Department.[250]

30.145 The kits had been tested against a panel of sera from unselected blood donors, from groups of patients with AIDS or AIDS-related diseases and from groups of patients in whom false positive results were a possibility. The kits recommended as most suitable for use in diagnostic laboratories were again Vironostika anti-HTLVIII (Organon Teknika Ltd), Wellcozyme anti-HTLVIII (Wellcome Diagnostics) and HTLVIII BioEnza Bead (Ortho Diagnostic Systems Ltd). These kits had provided a clear distinction between positive and negative results, had a low rate of false positives and gave reliable results with heat-treated sera. The later report of the first phase of the evaluation revealed that 220 samples from blood donors were used, as well as samples from those in high risk groups and those thought likely to give rise to false positive results.[251] Wellcozyme anti-HTLVIII and Vironostika anti-HTLVIII were considered to be particularly suitable for use in blood transfusion centres, being easy to use. These kits would be the first to be investigated in the second stage of the evaluation which was designed to investigate performance in large-scale screening of blood donors.

30.146 The only documentation the Inquiry has in relation to the second part of the evaluation is a draft report about the second phase.[252] It is not clear when this draft was prepared, other than that it post-dates 5 September 1985 (a date referred to in the text). The second phase study at the Manchester and Edgware RTCs covered 6160 samples, using the two kits which had emerged as the leaders after the first phase of the evaluation. Not all of the 6160 samples were actually tested: the breakdown of samples tested at each centre is shown in a table.[253] Given that the document is described as a 'first draft', that it was written in September 1985 at the earliest and that there is no reference to it in the detail of the other information about testing from that time, it does not appear that this material was disseminated to assist Directors in their choice of kit before testing began in October 1985. In essence, the second phase of the evaluation exercise appears to have been truncated and information about it appears not to have been communicated before decisions about purchasing kits were made in the late summer of 1985. This was probably because, in Dr McClelland's words, 'additional delay was not acceptable'.[254]

30.147 It was clear from Dr McClelland's evidence that, at least in retrospect, he found the evaluation process to have been less rigorous as a result of departure from the full two-phase plan.[255] Although it was not simply a matter of numbers, the quantity of blood donor samples that were included in the first phase was very small, particularly as a basis for conclusions on false positivity. A more robust estimate of false positives would have been provided by the second phase of the evaluation, though it would not have provided information about false negatives. Dr McClelland contrasted the use of tests in a hospital diagnostic context with their use in blood transfusion. The evaluation of a test for use where a patient is ill and there is a need to find out what is wrong was a different exercise from the evaluation of a test for the more problematic matter of scanning a very large part of the population, most of whom could be assumed to be healthy, for the purpose of picking out the very few who were not suitable as blood donors. Evaluation for blood transfusion purposes had been the focus for the second phase and Dr McClelland clearly thought it necessary for a valid decision, although he thought the decision to choose Wellcome was probably right. In the event, the report of the first phase of the evaluation process would prove to be the principal basis on which the candidate tests were identified as suitable for blood donors.

30.148 Professor Cash was also concerned about the process. He thought that the rate of progress changed with the publication of Professor Bloom's letter to the BMJ of 22 June 1985. He expressed reservations about the appropriateness of the evaluations and opined that HIV screening was introduced in the UK without according the priority that he considered proper to the welfare of blood donors.[256]

Media controversy

30.149 On the other hand, there was some controversy in the media at that time as to whether the evaluation process had been delayed deliberately in order to allow Wellcome to catch up with the US companies. On 8 August 1985 the New Scientist reported the facts noted above: that the UK government had recently approved three AIDS virus test kits for use in diagnostic laboratories and that two, made by Organon and Wellcome Diagnostics, had been chosen to enter the second phase of assessment for daily use at blood transfusion centres in Edgware and Manchester.[257] According to the New Scientist, Abbott Laboratories accused the government of delaying approval until a British test was available.

30.150 Abbott wrote to the editor on the same day to deny that they had made any such accusation.[258] The immediate response of the DHSS was sent out in a briefing note for Ministers dated 16 August.[259] On 22 August 1985 the New Scientist published a letter by Dr Tony Napier, Medical Director, Cardiff BTS, defending the policy in respect of the introduction of testing.[260] It was a spirited defence of the official position. As noted at paragraph 30.111 above, Dr Barbara and Dr Hewitt of the BTS at Edgware also wrote to the New Scientist on 29 August 1985, to similar effect.[261] A DHSS press release of 23 August 1985 intimated the introduction of testing by mid-October and the availability of new facilities for testing elsewhere.[262]

Local evaluation in Scotland

30.151 Organon and Wellcome kits became available in Scotland in about July or August 1985 for the purpose of evaluation and choice of kit for routine application and local evaluations followed.[263] In his written statement, Dr Dow explained the technical evaluation by the West of Scotland Blood Transfusion Centre: it performed a 'mini-evaluation' of the two kits recommended after the first phase of the evaluation, the Wellcome Diagnostics Wellcozyme assay and the Organon Diagnostics Vironostika assay.

30.152 Dr Mitchell's views on the exercise were similar to those of Dr McClelland. He noted that the second phase of the evaluation was on 'a much smaller scale because ... the test materials were not available'. He said:

[A]t that time I think a number of people were saying, 'Look, hallelujah, let's get on, we have got something, let's look at it.' But remember... that the Mortimer study looked at 360-odd samples, which were selected. Some of them were pretty obviously going to be positive, they were known cases of the disease, whereas when you had to scale that up to the point of technical know-how - Mortimer's group was a group of very eminent virologists, who didn't run a blood transfusion centre, didn't run anything to do with blood transfusion.

What they said was good, their evaluation was very thorough, and I don't think we could have done it at that level of virology, molecular virology. But at the same time 300-odd samples did not really add up to mass screening.

And we had to evaluate - they were telling us what to do but we knew how to do it, if you know what I mean.


But, in the knowing how to do it, there was a considerable amount of work still needed to be done. We had to do all sorts of things about sample identification, computerisation, all sorts of things. My centre was the first one in the world to have a computer on line to ... test the system.[264]

30.153 The results of the mini-evaluation favoured the Wellcome kit and it was therefore chosen for use in the west of Scotland. In the event, after the commencement of screening, as explained by Dr Dow, staff in the west experienced 'horrendous problems with plate validation failures'. The test kit was less sensitive than the original (developmental) version which they had evaluated in July 1985.[265] Dr Mitchell commented:

I think, if I remember rightly, the early samples that we got were good, they were fine, and we could detect known positives and known negatives and so on with the small amount we got, but when that was scaled up, then we ran into all sorts of difficulties ... [and] that's an example of where what looks good suddenly goes bad in your hand when you scale it up. You see, a virology department has all the time in the world - I don't mean that literally, but lots of time to look at a thing: Two hours, two days, four days, next week .... That's fine.


Blood transfusion has to get this stuff on the shelves this afternoon .... When you start scaling it up and you discover that you have got to repeat your tests over and over and over again on the same day to get any sense out of it - that is that the manufacturer's own controls are working okay as against the samples, to be sure the results are genuine - then you begin to see, 'My goodness, this isn't really fit for purpose at the moment'.[266]

30.154 In the first few months of testing, the West of Scotland centre also used some Abbott kits, which were provided by Abbott free of charge in the hope that the poor specificity found in earlier studies (and during use for diagnostic purposes in Ruchill Hospital around March/April 1985) had been resolved.[267] In Dr Dow's laboratory, however, the Abbott kit proved less specific than the Wellcome kit and it was not considered suitable as a replacement.[268]

30.155 The third meeting of the EAGA ad hoc working group on evaluation took place on 25 September 1985. The conclusion then, after the further evaluation at Manchester and Edgware, was that both recommended kits were suitable for the routine screening of blood donations[269] although some reservations were expressed about the operation of each.[270]

Other necessary steps: the 'magnet effect' and confirmatory testing

The 'magnet effect' and alternative testing sites

30.156 There was, as previously noted, some concern about a possible 'magnet effect' once screening of blood donors for HIV was introduced. The concern was that individuals who feared that they might have become infected would donate blood simply in order to be tested for HIV. The solution to that anticipated difficulty was to ensure that there were alternative testing sites, where worried individuals could access testing in as straightforward a manner as possible.

30.157 Dr McClelland described the reasoning behind the requirement for alternative testing facilities:

Our concern was that a lot of individuals would be extremely reluctant to go to the GP.... [W]e had good reason for that concern, and equally other people, you know, might also be reluctant to go to what would then have been called the 'VD clinic'. It didn't have a fantastically good image amongst some people.


So we wanted to have this completely neutral [facility]. And we wanted to be able to actually publicise it, and ... to disseminate information as widely as possible that this facility was available.[271]

30.158 He commented further that 'it was one of our absolute objectives that this should be operating and open for business before we started our donor testing'.[272]

30.159 Professor Cash had written to Mr John Mutch of the CSA on 26 February 1985, urging him to liaise with his counterparts in Area Health Boards on this issue.[273] This point was discussed at the meeting of EAGA on 30 July 1985.[274] Dr Graham Scott, Deputy Chief Medical Officer (DCMO) in Scotland, had written to the CAMOs on 8 July 1985, asking for details of the arrangements they had made to secure alternative testing sites.[275] That letter referred to an earlier letter of 16 April 1985, copied to all CAMOs, mentioning that 'Health Boards should consider what facilities should be made available for testing persons other than bona fide blood donors'.[276] Further information about the need for alternative sites and for counselling of those found to be positive was communicated in a letter from Dr Scott to the CAMOs dated 14 August 1985; it was 'essential' that the arrangements made by each Health Board were finalised and publicised before the end of September.[277]

30.160 The Inquiry also obtained information from Dr Ray Brettle, a retired Consultant Physician at the City Hospital in Edinburgh. Dr Brettle confirmed that his recollection was of the City Hospital Screening Clinic for HIV starting operation in October 1985.[278] The Inquiry asked Dr Mitchell what equivalent facilities existed in Glasgow but Dr Mitchell's recollection was that individuals seeking a test for AIDS at that time would have required to go either to their GP or to one of the specialist clinics (a drug users' or genito-urinary medicine clinic).[279]

30.161 There was no evidence that the need to establish alternative testing sites delayed the introduction of screening of blood donors. There was some evidence obtained after the commencement of screening that blood donation would indeed have been used by some worried individuals to obtain a test, had there not been other facilities available.[280]

Confirmatory testing

30.162 Another factor that had the potential to disrupt progress, but was resolved, was the selection of a laboratory for confirmatory testing.

30.163 Dr McClelland was asked whether it would have been possible to introduce screening without confirmatory testing being available, with the result that donations testing positive on initial screening would be discarded and that there would be no further use of donations from that donor. Dr McClelland explained that, at the time, the view was taken that donors should not be tested without being told and that positive results should be communicated to them. Donors should not, however, be informed that their result was positive unless it was beyond reasonable doubt that a result was a true positive rather than a false positive.[281] In his view, it was necessary to be 'completely upfront and open' with donors about testing[282] and confirmatory testing therefore had to be in place before screening started. That view was common.[283]

Adoption of the United Kingdom decision in Scotland and Ministerial approval

30.164 This section deals with the process by which Scotland came to follow the UK model in and after January 1985.

30.165 As noted already, the DHSS had decided that an evaluation of the competing kits for screening of donated blood for AIDS (including any developed in the UK) was necessary, so that the blood transfusion services could be advised as to which tests were most suitable for them.[284] The DHSS submission to Ministers in England and Wales was copied to the SHHD in January 1985. On 7 February 1985, Mr Davies sent a minute dealing with the issue to Dr Scott, DCMO, and copied it to Mr Macpherson, Mr Robertson and Dr McIntyre, colleagues at the SHHD. He wrote:

DHSS Ministers have now agreed (apparently with great reluctance) that all donations of blood in England should be tested for the presence of antibodies to HTLV-III. We now have to decide whether we have any alternative to advising our Ministers that it is necessary to follow suit in Scotland.[285]

30.166 He referred to experience to date and outlined the safety procedures already in place. He suggested that donor selection measures being implemented should reduce the number of infected donations, which he said was already 'vanishingly small'. He correctly concluded that people with haemophilia were not at risk, due to heat-treatment of Factor VIII, but perpetuated the misconception - then widely prevalent - that only a small proportion of those with antibodies would develop AIDS, from 10% down to one in several hundred. He proceeded:

Also, as you yourself have said, there is a considerable danger that people considering themselves at risk may attend blood donor sessions specifically for the purpose of having their blood tested.


It seems to me that the balance of rational argument would be heavily against introducing a test on all donations. I accept, however, that there is little rationality to be seen where AIDS is concerned .... I should be grateful for your guidance as to what we should tell Ministers.[286]

30.167 The next day, Dr Scott sent a reply to Mr Davies' minute. He commented:

Testing for HTLV III antibodies is technically different from testing for hepatitis B antigen. In addition, the test is much more expensive as well as being seriously unreliable. Until a test which identifies the virus itself is available matters will remain unsatisfactory.

From a cold objective scientific viewpoint the case for the introduction of a test for HTLV III antibodies in the present state of development and without being properly validated is not clear cut .... It is most unfortunate that a policy decision on this matter was not made at a UK level, though understandable given the degree of public and media hysteria.

It would be helpful if we could have an office meeting to discuss our advice to Ministers. It is for consideration whether Dr Cash ... might also be invited to the office meeting; if he strongly advocated introducing the test despite its limitations the Minister would be open to criticism if he did not agree to the introduction of the test.[287]

30.168 Mr Macpherson also replied to Mr Davies' minute.[288] He took a more pragmatic line: if England introduced the test, it would be difficult for Scotland not to introduce screening. Although he accepted the validity of Mr Davies's comments, he thought that the pressure to follow the English example and introduce testing would be irresistible.

30.169 On 21 January 1985, Dr Bell of the SHHD gave his response to the DHSS submission. Although the matter was for the SNBTS, Dr Bell apparently envisaged that Scotland would follow the same approach as the rest of the UK.[289] Dr Bell was well informed of developments in England and it is implicit in his letter that the real issue for Scotland, although the matter was for the SNBTS, was which test method would be adopted in Scotland.

30.170 In oral evidence, Dr Scott agreed with the suggestion that the tone of Mr Davies' minute suggested that he was not terribly sympathetic to the idea of introducing screening. He commented, however, that if it were to go ahead, finance was not going to be a problem: that had been cleared.[290] At the Inquiry's Oral Hearings it was noted that, at the date of the letter, Factor IX was not heat-treated and that, therefore, Haemophilia B patients remained at risk. Dr Scott was unable to comment on Mr Davies' state of knowledge at the time.[291]

30.171 The Regional Transfusion Directors met on 23 January and 18 February 1985. Dr Smithies and Mr Williams attended after the close of business at the reconvened meeting on 18 February and provided unspecified information on testing.[292]

Scottish evaluation

30.172 Within the SNBTS, it was agreed at a meeting of the Co-ordinating Group on 19 February 1985 that no Transfusion Centre in Scotland would commence routine donation testing for HIV unilaterally under any circumstances, whatever pressures might be applied. It was hoped that there would be a Ministerial statement to the effect that testing would not be introduced for blood donations until the tests were likely to yield more accurate results.[293] The decision was noted at the meeting of SNBTS Directors which followed on 27 February 1985.[294]

30.173 Abbott kits were available for evaluation in March 1985. At a meeting between the SNBTS Directors, Haemophilia Directors and the SHHD on 7 March 1985 dealing with AIDS, including heat treatment, Dr McClelland reported on plans for the new US screening tests for HIV antibodies to be evaluated on a UK basis.[295] He reported that, at that stage, there was deep concern about reports indicating a high proportion of false positive tests in the trials carried out in the US. The Inquiry has not found evidence of marketing of test kits as early as March 1985: rather, test kits were available in small numbers for evaluation purposes only. Abbott kits were used, and evaluated in use, in virology laboratories in Glasgow and Edinburgh as a start to providing an HIV testing service, not as a blood donor screening service.

30.174 The concern in Scotland, and the rest of the UK, about the high incidence of false positive results was in marked contrast to the position in the USA, already noted, which was tolerant of false positive results in those early US test systems.

30.175 Some in the SHHD continued to have reservations as to the necessity for blood donor screening: a draft memorandum of 21 February 1985[296] suggesting that policy in Scotland should avoid the early introduction of testing became a final recommendation to that effect on 21 March 1985, when the office meeting proposed on 8 February 1985 took place. In respect of tests, the revised memorandum noted:

Tests are becoming commercially available for the screening of blood donations for the presence of HTLV III antibodies. The first of these tests, from the USA, was marketed in the UK at the beginning of March. DHSS Ministers have agreed in principle that, in England, all blood donations should be screened and that Regional Health Authorities should meet the cost of this. Regional Blood Transfusion Directors throughout the UK have written to the Lancet ... strongly supporting the screening of all blood donors, but advising that such a screening programme should be delayed until the available test systems have been evaluated and until alternative testing facilities are made available to individuals who may be at high risk of transmitting AIDS.

We consider these views of the Transfusion Directors to be sensible and responsible, and support them, particularly in the Scottish context ....

The tests becoming available from United States companies are likely to give a high rate of false positive results - maybe 4%. On that basis about 10,000 ... Scottish blood donors could be identified as having antibodies to HTLV III who are in fact quite free of them. The implications for the individuals concerned, and for the resources required for further testing and counselling, would be profound and substantial. The tests also have an unpredictable false negative rate, so that an infected person might not be identified; and since the test is for antibody and not antigen it will not in any case identify a person who has been infected with the antigen but not yet developed antibodies.[297]

30.176 The submission, which discussed the possibility of making AIDS a notifiable disease as well as the introduction of screening of blood donations, went to Scottish Ministers on 21 March 1985. A copy of the Transfusion Directors' letter in The Lancet was attached and their recommendation of an evaluation process and the establishment of alternative testing facilities as pre-conditions for the introduction of screening was highlighted and supported. The perceived drawbacks of testing were mentioned: false positive results, with consequent effects on donors and needless loss of donations, false negative results, cost and the 'magnet effect' (discussed at paragraphs 30.156-30.161 above and paragraph 30.194 below). The recommendation was that a phased policy leading to routine screening should be pursued, taking into account the results of the evaluation, the need for alternative testing facilities and the requirement for additional testing and counselling of donors.

30.177 Mr John Mackay's private secretary responded by telex on 22 March 1985.[298] Mr MacKay, at that time the Scottish Health Minister,[299] fully appreciated the logic of the advice, especially that 'at risk' men might use the transfusion service as a screen. The recommendation of alternative testing sites was 'essential'. He observed that Scotland had to keep in line with, or ahead of, England to avoid severe criticism.

30.178 The views of George Younger, Secretary of State for Scotland, followed on 26 March 1985: the Secretary of State also 'agreed the recommendation'[300] and a decision in principle to proceed with screening had been reached by this point, in March 1985.[301]

30.179 In Oral Hearings, it was suggested to Dr Scott that the advice to Ministers reflected a lack of urgency regarding the introduction of screening on the part of the SHHD at this time. Dr Scott did not accept that proposition.[302] Scottish Ministers took the view that screening should be introduced as Mr Mackay's telex had indicated.

30.180 At this stage, the CMO for Scotland was, in Dr Scott's term, an 'absentee landlord', often away from Scotland on business for the World Health Organization at which times Dr Scott acted on his behalf. It therefore fell to Dr Scott to follow up the Ministers' decisions. It was Dr Scott's view that it would not have been correct to introduce a screening test before it had been evaluated, because of the risk of false results among other things.[303] As noted above, on 16 April 1985 he wrote to all CAMOs commenting that health boards should consider what facilities should be made available for testing persons 'other than bona fide blood donors'.[304] Implementation, as in England, was seen as a matter for the local health authorities.

30.181 On 28 June 1985, the SNBTS Directors again discussed the introduction of testing for HTLV-III antibody.[305] Dr Gunson had been invited to attend the meeting and he described the operation of the UK trial of FDA-licensed kits in his own Centre and at Edgware.[306] The kits to be made available for routine screening would be selected from those currently on trial. Dr Gunson agreed to notify Professor Cash in due course which were the likely tests and the Scottish Directors could choose, if they wished, to evaluate them in their own Centres. The Directors acknowledged the need to choose a screening methodology suited to each Centre. It was agreed that the reference centres for confirmatory testing for Scotland would be the laboratories of Professor Morag Timbury (Glasgow) and Professor Gerald Collee (Edinburgh).[307]

30.182 Dr Gunson explained the work of EAGA, which had established working parties on the counselling of donors and on HTLV-III antibody testing.[308] It had been concluded that a test could be considered positive if it was still so after initial screening, re-testing by the same technique, a test of a sample from the donation itself[309] and after further testing by the reference laboratories.

30.183 There was discussion of the issue of informing donors. It was agreed that:

[D]onors should be informed that their donations would be HTLV-III [antibody] tested and should indicate by signing they had understood this.

[T]he first contact (counselling) of all confirmed antibody positive donors would be the BTS medical staff.

That BTS doctors would use their best efforts to encourage donors to agree that their GPs/ dentists be informed by BTS of their positive [antibody] status.

That BTS medical staff would ensure the establishment of appropriate counselling and medical follow up of [positive] donors.

The BTS would take steps to track the recipients of [antibody] positive blood products produced at RTC's by informing the consultant responsible for the care of the patient. All subsequent actions would be determined by the clinician.[310]

30.184 Dr Gunson wished to see an agreed SNBTS approach so that he could table it for discussion at the next meeting of the NBTS Directors.

30.185 It was agreed that the ideal would be to retain donor samples as long as possible. Professor Cash was investigating the matter of a central library of samples for Scotland; meantime, all samples would be retained pending the introduction of testing.[311]

30.186 Finally, a system for Scotland for laboratory reporting of HTLV-III positive antibody tests would be agreed with the Communicable Disease (Scotland) Unit.

30.187 Practical arrangements to introduce screening and to deal with the associated issues were then made.[312] On 2 August 1985, Professor Cash sent a letter to all Directors, setting out a very detailed summary of the issues and a 'countdown' to testing.[313] The detail of arrangements was canvassed in evidence with Dr McClelland, who described Professor Cash's letter of 2 August 1985 as 'very good briefing'.[314]

30.188 Professor Cash noted the need to plan for the introduction of screening and advised that the target should be to introduce testing slowly, on a selective basis and at a low level of activity in the later weeks of September, so that the move to full screening in early October would be an operationally smooth exercise.[315] He advised that initial contracts for supplies of kits should be short-term, in order to give flexibility to change suppliers if that should prove necessary. He also encouraged the use of both available kits with a view to obtaining advantage in price negotiations and set out a range of practical guidance for implementing testing. It was a comprehensive briefing, while leaving decisions open for individual Directors in respect of their own regions. On 7 August 1985, Dr McClelland assigned tasks to staff; there was a staff meeting on 19 August 1985 to discuss implementation; and there was a decision to commence routine testing on 23 September 1985.[316]

30.189 Meantime, Dr Scott had received copies of the DHSS documents and distributed them to the CAMOs and to Professor Cash on 6 August 1985.[317] For confirmatory testing in Scotland, Dr John Peutherer in Edinburgh would handle Southeast (Edinburgh), East (Dundee) and Northeast Scotland (Aberdeen), and Dr Edward Follett in Ruchill would handle Glasgow and Inverness.[318]

30.190 On 14 August 1985, Dr Scott again wrote to CAMOs and to Community Medicine Specialists with an up-to-date report on progress.[319] To achieve screening of blood donations from mid-October, it was said to be essential that alternative testing facilities should be in place by the end of September. The letter noted that genito-urinary/STD clinics had relevant experience and would be suitable facilities but that there was also a need to provide for those who did not regard themselves as appropriate clients for such clinics. He advised that GPs had to know the local arrangements and that courses were available for training at St Mary's Hospital in London. Attached to the letter were copies of the guidelines produced by the DHSS Expert Advisory Group on AIDS. There was also reference to further advice yet to be circulated. Dr Scott commented that there would be an opportunity for general discussion at the meeting of the CAMOs and the CMO to be held on 4 September 1985.

30.191 A scoping exercise was carried out on 19 and 20 August 1985 by a group from Edinburgh and by the Transfusion Directors' Co-ordinating Group.[320] There was to be an evaluation of the Organon and Wellcome kits before selection; the NBTS information on false positive results would be reviewed; and it was noted that there was no commitment to having a single kit for use by the SNBTS. After completion of the evaluation, the SNBTS would move directly to testing incoming donation samples. The practical start date of 23 September 1985, before the official start date in October, was confirmed.[321]

30.192 In the South-East BTS region, proposals for the study of alternative venues for screening were submitted for grant on 18 September 1985, as a pilot for other health boards.[322] It appears that the work was already well advanced, since the clinic required was in operation at the Infectious Diseases Unit at the City Hospital, Edinburgh before the commencement of routine screening by South East BTS.[323]

30.193 On 20 September 1985 Mr Liddle of the SHHD distributed a minute on AIDS to Scottish Ministers and to senior colleagues, including the CMO, the Director of the Prison Service and the Director of the Scottish Information Office. The purpose of the minute was to provide an update on Mr Macpherson's minute of 21 March and Mr Davies' minute of 28 June. It noted:

The testing of blood for the detection of HTLV-III antibody, whether by the NHS or by the Blood Transfusion Service is to commence in mid-October and we have impressed on Health Boards the importance of adequate publicity being given to the facilities available outside the Blood Transfusion Service. However, there is a likelihood of a Ministerial Statement ....[324]

30.194 The decision had been taken. The commercially available test kits had been evaluated by a panel of experts from the PHLS and a summary of the results had been made available to health boards. Confirmatory testing of positive donations was in hand. A start date of mid-October had been fixed.[325] In addition:

  • The cost of confirmatory testing was being met through the Advisory Group on New Developments in Health care; health boards were to absorb the cost of screening facilities but the 1985-86 revenue allocation for the SNBTS had been increased by £322,000 to provide for the purchase of screening test kits.
  • Steps were to be taken to provide NHS facilities to protect the SNBTS from the 'magnet effect'.
  • Counselling was to be provided.

30.195 Wellcome were in a position to provide kits to allow routine donor testing at Ruchill in mid-September 1985. The West of Scotland BTS had problems with plate validation failures, as already noted at paragraph 30.153. It was apparent that the production kit was less sensitive than the original (developmental) batch tested in July 1985. The report of the results of field tests of the kits in England and Wales also produced mixed results.[326] Scottish scientists managed to overcome these validation difficulties, for which Wellcome were grateful.[327]

Final preparations

30.196 A press release on 1 October 1985 announced the screening of all UK blood donations from mid-October 1985 and emphasised how important it was that those who believed themselves at risk refrain from donating blood simply in order to be tested.[328] The DHSS published a booklet, distributed on 1 October 1985, containing information for doctors concerning the introduction of the HIV antibody test.[329]

30.197 The covering letter, signed by Dr Donald Acheson, CMO, emphasised the continuing need for exclusion of high risk donors, noting that even a reliable test could not detect early infections to which antibodies had not yet been generated.[330] The booklet stated that the tests were being introduced routinely to screen all blood donations. Donors were to be informed that the test was being done and would be asked to agree before blood was taken. It was explained that the tests introduced had been the subject of careful evaluation by the PHLS and the NBTS.[331]

30.198 Blood testing positive would not be used for transfusion. The blood was to be re-tested and a sample sent to a Reference Laboratory for testing by 'another test method'. On confirmation by this procedure, the donor was to be contacted and called in for discussion and counselling. The booklet emphasised that counselling had to be careful: it was still thought that not all those who seroconverted would progress to AIDS and that there would be less serious outcomes for many, although all who seroconverted had to be considered capable of transmitting the disease through sexual contact or through transfusion or inoculation of blood. A further blood sample would be taken for confirmatory testing. The risks of false positives and false negatives were highlighted but fully confirmed positive tests were to be followed by an offer of full clinical evaluation. Doctors were told of possible clinical signs and symptoms.[332]

30.199 The booklet reflected the general perception of the disease at the time: seropositive patients were likely to react badly to confirmation that they were infected with HIV. Quite apart from longer-term prognoses, life patterns would be affected immediately and the risk of adverse reactions from the public and employers was also anticipated. The booklet prescribed procedures for the collection and laboratory testing of samples and for the protection of health workers. It also dealt with confidentiality:

The strictest confidentiality must be maintained when an HTLV III antibody positive individual is identified. Where a person is tested for HTLV III infection or for its complications and it is thought to have been sexually transmitted, health authorities have an obligation to maintain confidentiality of information under the terms of the National Health Service (Venereal Diseases) Regulations 1974 (SI 1974.9). Unless the patient has given his consent, personal health data relating to him must not be disclosed to anyone for any purpose other than the health care of that patient, except where the disclosure is necessary to prevent the spread of infection. Disclosure of this information for purposes other than medical or public health reasons could lead to serious consequences for the informant. Adequate safeguards to protect individuals against unauthorised disclosure must be adopted.[333]

30.200 Appendix 1 of the booklet dealt with 'Laboratory Investigations'. Appendix 2 dealt with 'Guidance to individuals on measures to control the spread of HTLV III'.

30.201 The booklet was adapted for use in Scotland.[334] It noted the arrangements made by the SNBTS for screening and the alternative testing facilities available through GUM and STD clinics. As in the case of the English booklet, it outlined the procedures to be followed with positive donations and advised caution in the light of the risk of false positive results. The importance of alternative facilities to prevent people donating blood simply to determine their antibody status was set out. There was a warning of the risk of false negative results arising from the 'window-period' phenomenon of HIV infection. The need for counselling was emphasised.

30.202 Copies of the booklet, and a 'dear doctor' letter to accompany it, were sent to CAMOs on 1 October 1985 for distribution.[335] The 'dear doctor' letter emphasised the essential elements in the proposals, the need for synchronous provision of alternative arrangements, the need for counselling and the need for very strict confidentiality.[336]

30.203 The two booklets provided reasonably comprehensive information for GPs and other doctors likely to have to deal with the problems of AIDS.

Screening begins

30.204 Testing was introduced officially on 14 October 1985, although the SNBTS began testing donations before the official date. In the South East Scotland region testing began on 23 September 1985. There and throughout Scotland, all blood in stock (both the SNBTS stock and that already distributed throughout the NHS) was tested before the official start date.[337] McClelland explained to the Inquiry that testing began slightly early in this manner, in order that all blood in stock could be said to have been tested by 14 October 1985.[338]

30.205 On 2 October 1985, the SNBTS Directors, with the exception of Dr Mitchell, who was ill, met.[339] All four regions represented had chosen the Wellcome test; the minutes do not record which test had been chosen in the West area.[340] It was noted that the Wellcome test might be subject to substantial variations between batches. Dr Mitchell was to evaluate the Abbott test in the West, subject to Dr Gunson supplying the material and DHSS authority being obtained. The BTS staff had attended counselling courses. At the PFC, all finished product and plasma was being screened.[341]

Post-screening surveillance

30.206 On 7 February 1986 there was a meeting at NIBSC on the Virological Aspects of the Safety of Blood Products.[342] The various test kits available and their performance were discussed, as was the experience of screening blood donations so far.[343] Thirteen donations out of more than 600,000 tested had been confirmed to be positive, an incidence of one in 46,000 donations, which was very low in international terms.[344]

30.207 In a Parliamentary answer on 12 December 1986, Tony Newton, a junior Minister in the DHSS, said:

No cases of HIV transmission through blood transfusion have been reported since testing was introduced. Although there is as yet no corresponding test for new strains, there is no evidence from preliminary monitoring to suggest that these are prevalent in the United Kingdom. Thus there is no reason to believe that blood supplies are at risk from this source although we are keeping the matter under close review.[345]

30.208 Mr Newton explained that the safety of the blood supply in the UK was maintained by (i) those who may have been exposed to known particular risks of infection being asked not to donate blood and (ii) testing of all donations.[346]

30.209 The effectiveness of screening came into focus again in January 1987. On 5 January 1987 Miss P A Cox of the SHHD sent a note to the Minister of State and others including Dr Covell, commenting on press coverage of a leukaemia patient in Glasgow who was found to have HIV following a blood transfusion in August 1986.[347] Miss Cox said that the DHSS had been informed of the infected donation, that no Ministerial statement was recommended and that any further information should come from Professor Cash. The incident resulted from viral transmission from an HIV infected patient in the 'window' between infection and the appearance of antibodies in his blood.

30.210 Although the data extend beyond the current period, it is worth noting at this stage that the Wellcome HIV test became very effective after its initial teething troubles.[348] In the period from October 1985 to about the end of 1986, 176,149 tests were carried out by West of Scotland BTS on donations in their area using the Wellcome test. The results were:

Table 30.1: Donations referred for confirmation by West of Scotland BTS

Number of Donations Tested 176,149 Oct 1985-end 1986
Initial Screen Positive
(Manufacturer's Protocol)
73 0.040%
Repeat Reactive 31 0.017%
Confirmed HIV-positive 6 0.003%

30.211 Twenty-five of the 31 repeat reactive results were false positives. Data on use of the HIV tests on blood donors since 1986 showed that around 99% of repeat reactives were false positives. During the first few months of testing, the Abbott HIV test was used sporadically (with fewer than 5000 tests used). In the West of Scotland, the Abbott test proved less specific than the Wellcome test: around 30 repeat reactive samples (all false) were referred after testing for a short period of time.[349]


The need for local evaluation of US pharmaceutical companies test systems

30.212 As noted above, concern grew in 1985 that the UK evaluation exercise was delaying progress and some haemophilia experts proposed that at least one US test system should be introduced without full evaluation having been completed. In the event, however, no witness at the Inquiry's Oral Hearings or in providing a written statement disputed the necessity of an evaluation exercise. Professor Cash,[350] Dr McClelland,[351] Dr Mitchell,[352] Dr Scott[353] and Dr Iain Macdonald[354] (DCMOs for Scotland) and Dr Archibald McIntyre (SHHD)[355] all considered that it was necessary to assess how kits, developed in another part of the world, functioned when used to test donors in the UK. As set out in paragraph 30.45, it was recognised internationally that it was for each country to assess the risk AIDS posed to its population and to establish, among other things, appropriate testing systems. Local evaluation was clearly justified.

30.213 There was contemporaneous material illustrating the commitment to evaluation. Professor Zuckerman in January 1985 supported the introduction of US tests as soon as practicable but not before his own studies were complete: a clear practical demonstration of the principle that there should be local evaluation before the use of the tests in practice. Similarly, Professor Bloom was an enthusiastic supporter of the introduction of US tests in the early part of the year but, on 9 July 1985 at a meeting of the Central Committee for Research and Development in Blood Transfusion, acknowledged the need for a proper evaluation of the tests. The Chairman, Dr Gunson, expressed the view that until a proper evaluation of the available tests had been carried out within the PHLS and the BTS the tests should not be used for routine screening of blood donations.[356]

30.214 The risk of false positive results in the routine use of the available US test systems was a significant issue at least until August 1985.[357] This was a substantial issue affecting donors and the blood transfusion services. In addition, the deficiencies in the US test kits (in particular the lack of uniformity and comparability among the several manufacturers' tests due to inconsistencies in the test sera provided) undermined the reliability of the results. It would not have been responsible to have introduced test kits manufactured in the US without evaluation in the UK.

30.215 Most other experts were consistently in favour of evaluation. The EAGA ad hoc Expert Working Group was set up to design and possibly oversee the technical evaluation project. Professor Tedder commented that field trials were required and he expected the MH/CB assay to be subjected to evaluation. On the evidence as a whole, evaluation was clearly a necessary step to provide assurance of the acceptability of any test for application in the UK and in Scotland in particular. Timing, and in particular whether the process became excessively protracted, remains a contentious issue.

The timing of an evaluation exercise

30.216 It seems clear that, in the circumstances of the development of HIV test kits, the evaluation of any given test kit, whether by a regulatory body or by the manufacturer, involved at least two stages: (i) the progressive testing of prototypes until the manufacturer was in a position to proceed to full-scale marketing and (ii) the validation of the kit supplied for routine application as conforming to the specification and level of performance developed by prototype testing. Marketing would be impossible without the conventional set of claims having been exposed to evaluation and found to be consistent with the evaluation results. However, the issue whether to proceed to marketing was squarely one for the manufacturers. There was no regulatory control in the UK, though manufacturers had a clear indication of the likely attitude of the UK health authorities. The letter of 21 January 1985 sent to producers intimated that information would be required at the evaluation stage to substantiate claims made for the product.[358] The views of the health departments would be likely to affect market perceptions. There was no obstacle, however, to submitting kits for evaluation: Abbott were able to do so before they were able to meet market demand in the autumn of 1985. What was required was enough material to meet the requirements of the body carrying out the evaluation. Abbott duly began the process.

30.217 Although not selected for the second stage UK evaluation exercise, Abbott was originally the principal candidate as supplier of US systems in Scotland. The West of Scotland BTS in particular had a long association with the company. In the period following the general introduction of testing, using the selected Organon and Wellcome test systems, Abbott kits were obtained to carry out the continuing evaluation of that system in comparison with Wellcome's system. It appears to be a reasonable inference from what happened in fact that obtaining an alternative supply of US test kits in Scotland would have depended on Abbott, at least in 1985, when the choice of system was a live issue. As indicated in paragraphs 30.151-30.153, Dr Dow's 'mini-evaluation' of the Organon and Wellcome test systems favoured Wellcome's and, as between Wellcome's kit and Abbott, the Abbott kit proved less specific than the Wellcome kit.

30.218 Lack of specificity had been the issue with Abbott's test kit since the company had entered into arrangements with British evaluators in February 1985 to carry out clinical trials of small quantities of the Abbott HTLV-III EIA Diagnostic test kit at the Regional Virus Laboratory at Ruchill, the North London Blood Transfusion Centre, Edgware, and Middlesex Hospital.[359] Dr Dow obtained Abbott kits for evaluation in the spring of 1985. If the company had obtained the support it sought from these contractual trials, there was no regulatory impediment to their introduction in the UK market. The company was unable to satisfy the FDA until March 1985 that the kit should be licensed in the US and it was found that there were problems of poor specificity with the first kits supplied for evaluation in Scotland.[360]

30.219 It is apparent that Abbott's problems had not been resolved when Dr Dow's mini-evaluation began and had still not been finally resolved when Wellcome's Wellcozyme test emerged as the favoured test system. As Dr Dow commented, the Wellcozyme test was British, appeared to be more robust and was user-friendly.[361] It was demonstrated by the evidence that evaluation of available US pharmaceutical companies' kits from the spring of 1985 showed an unacceptable lack of specificity and that, when improved Abbott kits became available for comparison with the Organon and Wellcome test systems, the original problems had not been resolved so as to be competitive. In the circumstances, timing of the evaluation of imported kits is not a live issue. By the time acceptable kits became available, Wellcozyme was proven in evaluation.

Priorities in risk assessment in the United States

30.220 Policy makers and transfusion practitioners in the UK emphasised the need to protect donors from risks associated with test system that produced high percentages of false positive results. The comparative positions in the United Kingdom and the United States of America have been set out in paragraphs 30.41-30.47 in discussing the need for local evaluation of imported products. As noted in those paragraphs, it had been commented as early as 1985 in the paper Blood Policy and Technology (paragraphs 30.12-30.17) that the US approach subordinated the interests of donors to those of recipients, a position unacceptable in a public sector transfusion service.

Timing of routine screening

30.221 Specificity was a substantial issue affecting donors and the blood transfusion organisation and resolving it was critical to progress towards routine screening. There were, however, other factors that required time to deal with.

30.222 Dr Dow discussed the practical issues that arose from the introduction of ELISA testing.[362] Completely new washing and reading equipment was required. A spectrophotometer was required. Trained staff, working space, pipetting equipment, timers and incubators were required to perform the tests. Staff had been accustomed to RIA technology (in Scotland largely through use of Abbott Diagnostics Ausria-II HBsAg test) since 1975 and the introduction of ELISA technology required re-training. Similar considerations had been behind the NBTS preference for RIA technology at the early stages of development of the MH/CB assay. It is difficult for the Inquiry to put a value on the work involved in carrying the changes into effect but the impression given was that it was not inconsiderable. On any view it was a factor that had to be dealt with relative to the test system selected for routine use. The preparations were set out in Professor Cash's letter dated 2 August 1985 (paragraph 30.187). The work was put in hand and there is no basis in the evidence for criticism of the rate of progress thereafter towards full implementation of routine screening.

Availability of US test kits in 1985

30.223 In the circumstances, the ability of commercial companies to supply the needs of the UK, and in particular Scotland, for test kits for routine use is a secondary matter, although it is not wholly irrelevant. Abbott's intention to supply the European demand from Delkenheim, Germany was delayed: their factory there did not begin to supply kits until the autumn of 1985. Abbott's test appears to have been approved for use in France on 24 July 1985.[363] How the official position evolved in France is unclear.[364] A WHO publication indicates that a 'surveillance scheme' was commenced there in July 1985.[365] While that was in progress, routine screening for antibodies to HIV was officially implemented in August 1985.[366] It appears that approval for use of the Abbott kit was granted before surveillance was begun and before routine screening became official policy. Whatever the regulatory position, it appears to be clear that, from approval in July 1985 until Delkenheim began production, Abbott could only have supplied France from Chicago and that Chicago did not have enough kits to satisfy domestic demand until mid-July 1985.[367] To provide kits for France, Abbott had to modify its method of cloning H-9. That was achieved in mid-July 1985 and supplies to France began a week later.[368] It is not possible to form a view whether Abbott could have supplied the UK, and Scotland in particular, on a commercial basis before the opening of Delkenheim but it is reasonably clear that supplies could not have come on-line before late July 1985 and only then if they could have been shipped from Chicago at that time.

30.224 Dr Dow's evidence is conclusive as to availability of Abbott kits in Scotland from about July 1985. His mini-evaluation in July 1985 was restricted by the shortage of supplies of kits for evaluation. Fewer than 5000 kits were supplied for the continuing evaluation of Abbott's system until the selection of Wellcome's system was finally decided in West of Scotland. On the evidence available to the Inquiry, there was not a sufficient supply of Abbott kits to suggest that the company could have met Scottish market demand for general use for screening of blood for transfusion before the first phase of evaluation was complete.

Delay caused by or contributed to by administrative decisions

The United Kingdom position

30.225 In an Inquiry such as this it was inevitable that there would be questions as to whether the administrative process caused or contributed to delay in the implementation of routine screening for HIV. The resolution of issues surrounding the decisions of UK Ministers and Departments relative to the use of test kits in England and Wales is not within the competence of this Inquiry. It is not a 'Scottish matter', a matter that relates to Scotland and is not a reserved matter. In addition, at a practical level, decisions taken in England could not have been investigated fully in the absence of representation of the Department of Health. Dr Smithies, a central figure over the material period, did not feel able to assist the Inquiry.[369] It appears, further, that either not all of the discussions at the time were recorded or the Inquiry does not have all of the relevant records (paragraph 30.103).

30.226 That apart, it is clear that, at the time, the introduction of HIV testing was not treated as a UK policy issue. Dr Scott's minute of 8 February 1985 (paragraph 30.167) expressed regret that a policy decision on testing had not been taken at a UK level. Whether his regret was appropriate is immaterial: the minute reflected the reality that Scottish transfusion policy on this matter was the sole responsibility of Scottish Ministers and their SHHD advisers.

The Scottish position

30.227 Before discussing the role of Scottish officials and Ministers, it is important to recall the overall time-frame for the critical discussions and decisions. The announcement of the isolation of HTLV-III by Dr Gallo's team, and their prototype ELISA to screen blood, on 23 April 1984, included Ms Heckler's prediction that a test to screen the blood supply with 100% certainty would become widely available within six months. There was, in fact, no test available for marketing until early March 1985. Continuing problems with lack of specificity postponed the date at which an effective screening test was available from Abbott until late July 1985 (if one accepts the approval of the kit by French authorities on 24 July as a reliable indicator that the test had achieved a level of specificity acceptable to France). The MH/CB research test was in use from 4 July 1984 and the Cheingsong-Popov article on 1 September 1984 showed that the test was highly specific: there were almost no false positives. Following scale-up, and the resolution of production problems, the CAMR Porton antigen came on-line in late spring 1985. The MH/CB project was not government controlled: it was a private sector commercial project. Kits were in Dr Dow's hands for testing in July/August 1985.

30.228 Progress in developing test kits, in the USA and in England, was rapid. In England, it was driven by Professor Weiss and Professor Tedder. The UK Government was informed of progress, albeit to a limited extent. The scope for Scottish Government agencies to influence the rate of development was limited. Realistically, it was in the hands of those with commercial interests in the success of their products.

30.229 However, whether or not to introduce screening in Scotland was plainly a Scottish matter. The SHHD elected to follow the lead of the DHSS in relation to evaluation. A joint approach to resolving issues relating to the introduction of screening is not obviously inappropriate. A number of specifically Scottish issues arise, however:

  • Whether Scottish officials and advisers were fully integrated into the process so as to be able to represent Scottish interests and positions.
  • Whether the information Scottish officials and advisers had was adequate to enable them to assess Scottish interests.
  • Whether factors that materially affected the process were of equal weight throughout the UK, or differed in weight so that a separate outcome for Scottish practice would have been possible or appropriate.
  • Whether purely Scottish factors could or should have resulted in earlier introduction of screening in Scotland than in the rest of the UK.

Participation of Scottish officials and experts

30.230 From a purely Scottish point of view, specifically the view of the SNBTS, it was unfortunate that the very experienced team at the West of Scotland BTS did not have the opportunity to participate in the initial field tests of kits proposed at the meeting on 28 June 1984 referred to in Dr McClelland's oral evidence. It was envisaged that the results would influence practice throughout the UK. There is nothing to indicate, however, that if they had participated the outcome would have been different and Scottish experts were involved in oversight of the process.

30.231 From early 1985, the EAGA was the most influential advisory group dealing with matters relating to HIV/AIDS. Professor Cash and Dr McClelland were members and Dr McClelland was also a member of the sub-group set up to consider screening tests. Dr McClelland was an active contributor to the work of EAGA and its sub-group. He and Dr Gunson were responsible for the design of the programme for the evaluation of test kits. The discussion and amendment of the proposals at the meeting of the sub-group on 1 March 1985 supported a laboratory assessment of the kits followed by a large scale field assessment. The scale of the main evaluation (10,000 specimens) and the sub-division of specimens into aliquots sufficient to ensure that all kits could be tested at the PHLS, leaving sufficient specimens for evaluation tests in the proposed second phase of the exercise, were developed in discussion to which Dr McClelland was party.[370]

30.232 Professor Cash was critical of the approach adopted by the DHSS to the evaluation programme, in his written statement and in the course of his oral evidence.[371] Professor Cash's comments do not help to answer the question whether the information Scottish officials and advisers had was adequate to enable them to assess Scottish interests. Apart from other considerations, he accepted that there were never enough test kits available to do what he wanted, a fact which he came to appreciate.[372]

30.233 That there were limited supplies of test kits was clear from the evidence of Dr Mitchell and Dr Dow. Dr Dow's work was directly affected. Much of Professor Cash's argument about the relative efficiency of a NBTS/SNBTS evaluation fails in light of the evidence about supplies.

30.234 The first phase of the evaluation, involving 220 samples, seems to have taken about four to four and a half months to the end of July 1985[373] and the extensive field study stage was never carried out as an integrated exercise. There was an extensive evaluation in Manchester and Edgware and other transfusion centres carried out tests to inform the selection of kits. There is a need to consider whether there were factors relevant to Scotland that indicated that Scotland could and should have taken an independent approach. There may have been factors that materially affected the process that were not of equal weight throughout the UK, or differed in weight so that a separate outcome for Scottish practice would have been appropriate.

30.235 The possibility of a Scottish evaluation exercise was mooted at the start of 1985. The Scottish Transfusion Directors decided to take action themselves. Professor Cash intimated the decision to all Scottish RTDs and to Dr Bell.[374] There was a clear will at that stage to proceed independently in Scotland.

30.236 That proposal was stopped by Dr McIntyre, SHHD and by the discussions that followed his intervention. Professor Cash's evidence was clearly to the effect that the proposed Scottish evaluation in West of Scotland could have led to earlier screening in Scotland. From the evidence of Dr Dow and Dr Mitchell, however, it appears that there would have been problems in obtaining kits in sufficient numbers to carry out an evaluation of the scale required to provide reliable data, as already noted. Not only would it have been necessary to get access to all of the relevant US kits, it would have been necessary to have access to the MH/CB assay. Professor Weiss, Professor Tedder and Wellcome all had interests in aspects of that assay as developed for further use. Scottish attempts to become involved in work with Professor Weiss and Professor Tedder were not successful. It is not apparent how access to their material could have been obtained otherwise. Without that, any Scottish evaluation would have been seriously deficient. In the event, the proposal was probably stopped to maintain the concord with the UK Department of Health. However, in substance, without satisfactory evidence that an evaluation of appropriate scale could have been undertaken, all that one is left with is Dr Mitchell's evidence that West of Scotland was well placed to do the work in terms of skill and experience and that pride was hurt by being denied the opportunity.

30.237 There is a theoretical possibility that, had there been an independent Scottish evaluation and had it produced reliable findings, cases of infection might have been prevented. The necessary hypothesis for that, however, includes so many elements that the possibility becomes vanishingly small as they are applied sequentially. Scotland did not have the necessary containment facilities. Timing is an issue; the availability of test kits to complete the project is an issue; availability of commercial kits on the market to meet the demand of the treating centre is an issue; and the risk of false negatives compounds the difficulties as a whole. Further, the wide range of issues around dealing with donors had not been addressed, in the UK as a whole or in Scotland in particular, by this time. So far as the SNBTS was concerned, the need for decisions on these matters had been identified in Dr McClelland's paper of 15 May 1985. It was necessary for these issues to be dealt with before screening began. Professor Cash's view that routine screening could have been introduced earlier in Scotland than in the United Kingdom as a whole is not supported by the evidence as a whole. It is also difficult to reconcile with the views of Dr McClelland and Dr Mitchell.

Concern about delay

30.238 It was evident to the Inquiry that, from the beginning of 1985, there was anxiety about when testing of donated blood for the AIDS virus would be introduced in the UK. Haemophilia doctors, and Professor Bloom in particular, were anxious that US test kits should be introduced as soon as they became available. His letter of 31 May 1985 put concern for haemophilia patients and patients undergoing surgery above other interests, including those of donors, and proposed that re-testing and confirmatory testing and donor counselling should be left over to be dealt with as separate issues.[375] Professor Bloom's concern at the delay, as he saw it, is understandable: he represented a particular and specific interest. The same can be said of the letter sent by Professor Bloom, Dr Forbes and Dr Rizza to the BMJ in June 1985 to advocate the rapid introduction of screening for HTLV-III antibody of all blood donations, particularly since three commercial test kits had been approved by the FDA by that date. It also referred to the risk to patients with haemophilia of using cryoprecipitate or unheated blood products and also to the risk to patients undergoing blood transfusion.[376]

30.239 Although the June 1985 letter was said to be written on behalf of the Haemophilia Reference Centre Directors throughout the UK, the situation for patients with haemophilia in England and Wales was more difficult than in Scotland at that time. NHS heat-treated Factor VIII and Factor IX products were not in routine issue in England and Wales and the only heat-treated products available were commercial. Patients in Scotland had the benefit of heat-treated Factor VIII products produced by the PFC from December 1984 and would have heat-treated Factor IX from October 1985.

30.240 On the other side of the debate, transfusion doctors had concerns about whether the tests being developed in the USA were sensitive and specific enough for large-scale screening in the UK. Again, the topic was discussed in terms of the whole of the UK. Professor Cash raised some of these issues in his letter to The Lancet published in March 1985 and signed by all of the Scottish Regional Directors and most of the English Reference Centre Directors.[377] It recorded the authors' belief that commercial testing kits were likely to give high rates of false positive results. They contended that careful consideration should therefore be given before such kits were introduced for the screening of blood donors in the UK, both for the benefit of the blood supply and for the sake of the donors themselves. The contemporaneous letter from physicians in California also highlighted the danger of missing positive samples if the cut-off value for a positive sample was set too high.[378] The views of the Transfusion Directors were strongly expressed and, in view of the differing policy positions adopted at the time in the US, presented a more acceptable position for the UK in general, and Scotland in particular, relative to the need for evaluation.

30.241 The March 1985 letter represented Professor Cash's point of view at the time. That view was also reflected in his unpublished response to the letter sent by Professor Bloom, Dr Forbes and Dr Rizza, published in the BMJ in June 1985.

30.242 Professor Cash's evidence on these matters suggests that in his view, at mid-1985, the introduction of testing should have been postponed. There may be some attraction in the argument: in an ideal world one would cross all the 't's and dot all the 'i's before proceeding. That would have added to delay, however, and it is inconceivable that such a suggestion would have been acceptable against the background of growing pressure for testing to be introduced.

Abandoning the second phase of evaluation

30.243 Pressure to introduce screening increased over the summer of 1985. The events are set out in the Preliminary Report at paragraphs 8.130-133 and in the paragraphs above. The Transfusion Directors themselves, in their Working Party advising on screening, concluded that the evaluation of the kits in the Blood Transfusion Service should take place but that it was not possible to complete that evaluation prior to arrangements being undertaken for the introduction of screening.[379]

30.244 The second phase, which was the field study in transfusion centres, was truncated and information about it does not appear to have been available to Directors when they made their final preparations for screening, including their choice of kits. So, all that was available was the information from the first phase, which (as far as blood donors were concerned) only involved 220 samples.

30.245 The evidence of Professor Cash, Dr Mitchell and Dr McClelland, though differently expressed, was to the effect that the second phase was an important element in the evaluation process and that abandonment of it weakened its reliability. That must be so, if the original decision was valid and more than a laboratory test with local evaluation was required for confidence in the selected test systems.

30.246 However, the exercise that took most time, and was the principal cause of any potentially unacceptable delay that may have occurred, was the CAMR laboratory process. The perception of EAGA at the time (as expressed by the Chairman, Dr Acheson) was that the exercise had been carried out with expedition.[380] Professor Cash and Dr McClelland were both present at the EAGA meeting on 30 July 1985, as was Dr Covell. This was an important meeting concerned with progress towards the local evaluation of the two selected kits, among other topics. The Inquiry has not uncovered contemporaneous evidence of complaints that the CAMR exercise had not been carried out with the speed appropriate for a virological evaluation of the sensitivity required. Professor Tedder was also at the meeting on 30 July 1985. He had an opportunity to protest if progress with the production contract had been affected by delay caused by the Phase 1 evaluation. From the minute of the meeting it is not possible to identify any critical comment relating to the time taken.

30.247 If the first phase of the exercise was required in any event, local evaluation, whether a requirement of the original specification or not, would have followed. There was no unnecessary delay in Scotland and no delay overall. Whether a different approach, perhaps involving virologists with transfusion expertise, as advocated by Professor Cash, could have been carried out more expeditiously involves considerable speculation as to who would have been engaged, how much time would have been required and whether the exercise would have succeeded. In his letter to Professor Cash dated 7 August 1984, Dr McClelland noted one significant problem: it was highly unlikely that there was a facility in Scotland that could have undertaken the work of producing significant quantities of HIV antigen.[381]

30.248 Further, the change of direction does seem explicable. In January 1985 it was probably not anticipated that the first phase of evaluation would take the four to four and a half months it did and by the summer the landscape was different: new 'editions' of the tests were coming on-line with assured increased effectiveness. Screening had become even more urgent and the idea of completing and reporting on the field evaluation had to be abandoned.

30.249 So, in short, it appears not unreasonable to have decided in January 1985 to assess all available kits in an attempt to guide transfusion services as to which to purchase. Even if it was unreasonable, the alternative of simply buying whatever US kits could be obtained as soon as they were available and starting with them would have led to other problems. If it had been decided to take that alternative approach, a sufficient supply of test kits would not have been available until the end of July 1985. Further, the false positive issue would not have been avoided.

30.250 More significant, perhaps, is to consider what would have happened had the UK simply begun routine testing as soon as Abbott kits were licensed in the United States and were available for marketing abroad. This would have been after late July 1985 at the earliest. Undoubtedly, if they had been first generation kits, similar sorts of problems to those which occurred in the US would have ensued, given the problems with the H9 cell line discussed above. The alternative policy, of awaiting the development of improved kits before acting, would have been open to serious criticism: until improved kits were actually developed and tested, it would have required an article of faith to promote a testing strategy on the hypothesis that they would necessarily appear.

30.251 The Inquiry has not found reliable evidence of (i) what happened with the Electro-Nucleonics kit, which was assessed in the UK evaluation and which was approved in the US only days after Abbott, or (ii) what kits were used in the other countries which started screening early, such as Australia. There cannot have been insurmountable supply problems in these other countries unless they had developed their own test systems. Even if the Electro-Nucleonics kit had been available and used in the UK, however, it would also have suffered from the 'H9 problem' and therefore liability to false positive results, because it too was manufactured from the HTLV-IIIB isolate.

Other questions

30.252 One further question is material: the necessity for kits to have the approval of the FDA for use in the USA before introducing them for screening of blood in Scotland. Dr Lane suggested in July 1985 that this was necessary for BTS marketing purposes. That would not have been relevant in Scotland, however, as, in terms of the chronology set out, the FDA approval was granted before any kits were introduced for screening in Scotland. More generally, the decision that local evaluation was necessary implied that the FDA approval was not conclusive of the suitability of kits for screening in Scotland or the UK more generally.

30.253 Further, it was considered that, as Dr Smithies put it, such a stipulation might not act in Wellcome's interests. It would not have been in the best interests of any UK manufacturer to have imposed on top of the requirements of UK evaluation a requirement to satisfy the FDA under a regulatory system that had no direct applicability in the UK. On any view that would have exposed the domestic product to two separate evaluation processes and, in the case of the FDA's procedures, at least a risk of significant delay.

30.254 In addition, there were serious concerns about the US process that had been applied in 1985 in evaluating the systems for use in the US, in particular about the provision of different sera samples to each manufacturer, undermining the comparisons that could usefully be made among test results. It would not have been possible to be confident that the FDA's assessment of any UK-produced test system would have been on an equal basis with the earlier exercise: there was no reference panel of samples against which to test that.

30.255 In short, subjecting UK products to a need for approval of the FDA before introducing them for use in Scotland would not have been a rational exercise of judgment by any UK or Scottish Government agency.


30.256 The production of screening tests for antibodies to HIV in 1984 and 1985 involved research and development work, in the USA, in France and in England, that was carried out with remarkable expedition and commendable success.

30.257 In the UK generally, and in Scotland in particular, the role of government agencies in relation to HIV research is best understood as that of interested spectators as private sector institutions proceeded to build on earlier research in investigating human retroviruses and to develop (i) an independent British HIV isolate and (ii) a unique anti-HIV assay, conceptually distinct from US models, using proprietary systems and methodology which were commercially confidential generally and in part protected by patents.

30.258 Suggestions that UK BTS researchers, and in particular SNBTS researchers, could have made more rapid progress with evaluation of an acceptable assay than was achieved by private sector researchers are without foundation. Scotland, in particular, had no laboratory with containment facilities sufficient for the safe handling of live HIV and, in addition, the MH/CB assay was proprietary and information about it was not made available to Scottish scientists when it was requested. The DHSS-sponsored first phase evaluation was the best public sector process available. If progress had depended on the public sector bodies involved, the criticism of the patient core participants that they represented 'a startlingly diverse and unstructured collection'[382] might have been relevant, though variety is not necessarily adverse to progress. The criticism is, however, without substance.

30.259 Progress towards implementation of screening was not inhibited by the involvement of government agencies, largely because those who had commercial interests to promote pursued solutions independently and succeeded in producing marketable products on a commercial basis that enabled policies on the introduction of screening to be implemented as soon as was practicable.

30.260 The UK Government had an interest in the development of a UK test which government agencies were keen to promote. This could have delayed implementation of routine screening if imported products of acceptable quality had been available in appropriate quantities to meet UK market demand before British commercial products were available. In the event that did not happen. Though truncated in the end, the evaluation programmes applied equally to all manufacturers.

30.261 By the date of implementation of routine screening, imported products had not matched British commercial products in terms of specificity.

30.262 There is no legitimate ground for criticism of the processes adopted for the introduction of anti-HIV screening that can be founded on delay. It was achieved as soon as was reasonably practicable. In any evaluation exercise, carried out in such circumstances, a tension is likely to exist between the exigencies of full scientific rigour and the need for progress.

1 The Inquiry has drawn on information in John Crewdson's book, Science Fictions (2002; London: Little Brown & Co) [PEN.017.0568]. Crewdson was a journalist formerly of the Chicago Tribune. His book was cited extensively by Dr McClelland in his statement [PEN.017.1337] at 1361 and in evidence on Day 50, pages 69-79. Professor Weiss had reservations about some aspects of Crewdson's book, specifically where it attributes emotions to those quoted and discussed after the fact (Day 48, pages 151-2). Those reservations are accepted. Leaving aside Crewdson's comments, his account of events was accepted as generally accurate.

2 See Chapter 29, The Discovery of HIV and the Development of Screening Tests, paragraphs 29.11-29.14

3 See the narrative of events given at the commencement of proceedings on Day 48, pages 6-8. The press conference is also described by Douglas Starr in Blood [LIT.001.2936] at 2968.

4 Budiansky S, 'NIH to License HTLV', Nature, 14 June 1984; vol 309 [SGH.002.6605]. This cutting was distributed within the DHSS with a note asking if testing would be done routinely in the UK and, if so, whether US kits would have to be bought for that purpose.

5 Crewdson, J. Science Fictions [PEN.017.0568] at 0572

6 Ibid [PEN.017.0568] at 0572

7 Budiansky S, 'NIH to License HTLV', Nature, 14 June 1984; vol 309 [SGH.002.6605]

8 ELISA tests use an enzyme to detect antibodies in a sample and include various reagents which give a colour reaction. Dr Dow - Day 4, pages 85-86; Professor Weiss, Day 48, pages 160-161

9 Crewdson, J. Science Fictions, page 185 [PEN.017.0568] at 0589

10 See Blood Policy & Technology (Washington, DC; US Congress Office of Technology, OTA-H-260 January 1985) [LIT.001.4558] at 4566. The policy was National Blood Policy: US Dept. of Health, Education and Welfare. Fed Reg 1974; 39(47): part 3.

11 Ibid [LIT.001.4558] at 4566

12 Hillsborough County v Automated Medical Labs 471 U.S. 707 (1985)

13 Blood Policy & Technology (Washington, DC; US Congress Office of Technology, OTA-H-260 January 1985) [LIT.001.4558] at 4576

14 A surrogate test detects a 'marker', a directly measurable physical entity that has a statistical association (correlates) with a disease where it is not possible to test directly for the disease or where any direct test would be problematic. See Chapter 27, Surrogate Testing of Donated Blood for non-A, non-B Hepatitis.

15 Blood Policy & Technology (Washington, DC; US Congress Office of Technology, OTA-H-260 January 1985) [LIT.001.4558] at 4576

16 Ibid [LIT.001.4558] at 4579

17 Ibid [LIT.001.4558] at 4579

18 Ibid [LIT.001.4558] at 4579-80 (emph. orig.)

19 Ibid [LIT.001.4558] at 4605

20 Sayers, 'Duties to Donors', Transfusion, 1992; 32/5:465-466 [PEN.017.0649]. Though published in 1992, the article was originally submitted in January 1990.

21 Ibid [PEN.017.0649]

22 Crewdson, J. Science Fictions, page 567, footnote 'e' [PEN.017.0568] at 0598

23 Budiansky S, 'False Test Results Raise Doubts', Nature, 13 December 1984; 312:583 [PEN.017.0658]

24 'Sensitivity' is a function of a test's ability to capture all cases of infection with the target pathogen. 'Specificity' is a function of a test's ability to identify only the target pathogen.

25 The article drew on comments by Dr John Petricciani, head of the FDA's division of blood and blood products. Petricciani and colleagues from the public service published a short report of their findings in a letter, 'An analysis of serum samples positive for HTLV-III antibodies', to the New England Journal of Medicine vol 313. no 1 47-48, 4 July 1985 [PEN.017.0651]

26 The MMWR is published by the Centers for Disease Control and Prevention (CDC), a US government public health agency with its headquarters in Atlanta, Georgia.

27 'Provisional Public Health Service Inter-Agency Recommendations for Screening Donated Blood and Plasma for Antibody to the Virus Causing Acquired Immunodeficiency Syndrome', MMWR, 1985; 34/1:1-5 [SNB.004.9195]

28 Ibid [SNB.004.9195]

29 Crewdson, J. Science Fictions [PEN.017.0568] at 0589

30 Budiansky S, 'False Test Results Raise Doubts', Nature, 13 December 1984; 312:583. [PEN.017.0658]

31 Crewdson, J. Science Fictions [PEN.017.0568] at 0591. The date of the announcement must have been 2 March, the first Saturday in the month, having regard to the timing of the licence granted to Electro Nucleonics Inc.

32 See product material from Electro Nucleonics Inc [DHF.001.9700]

33 Crewdson, J. Science Fictions [PEN.017.0568] at 0605

34 Ibid [PEN.017.0568] at 0593

35 Professor Weiss - Day 48, pages 165-169

36 Crewdson, J. Science Fictions [PEN.017.0568] at 0605 and 0606. See also a comment by Jean-Pierre Allain that the specificity of the Abbott test during the first six months to a year was not very good: Science Fictions [PEN.017.1057] at 1066

37 Ibid [PEN.017.1057] at 1063

38 Professor Tedder - Day 49, page 48

39 Crewdson, J. Science Fictions [PEN.017.0568] at 0600

40 Further examples of the problems caused by false positive results in the US in the second half of 1985 are set out at Science Fictions [PEN.017.0568] at 0605 onwards.

41 Ibid [PEN.017.0568] at 0594. (See also: Professor Weiss - Day 48, page 168.)

42 Ibid [PEN.017.1057] at 1059

43 Ibid [PEN.017.1057] at 1061

44 Dr McClelland - Day 50, page 79

45 Memorandum dated 11 March 1985 'Introduction of Test to AIDS Related Antibody' [DHF.002.5475] at 5476. Although this is redacted, it is evident from the reference to the 'first US firm to have been given FDA approval' that it refers to Abbott.

46 See narrative of events given at the commencement of proceedings on Day 48, pages 6-8. The press conference is also described by Douglas Starr in Blood [LIT.001.2936] at 2968.

47 The atmosphere of the time was described by Dr McClelland - Day 50, pages 7-10

48 A point made to Abbott in a letter to the company dated 5 March 1985 [DHF.002.6938]

49 See Chapter 31, The Introduction of Screening for Hepatitis C Antibodies in the Blood Donor Population in Scotland, paragraphs 31.169-31.170. Ortho had an export permit for their Hepatitis C ELISA before the test was licensed for routine use within the USA.

50 DHSS Letter [DHF.002.6938]

51 Ibid [DHF.002.6938]

52 Draft test protocol [DHF.002.6939]

53 Professor Cash's letter [SNB.013.2233]

54 Ala et al, 'HTLV-III antibody screening of blood bank donors', The Lancet, 2 March 1985, page 524 [LIT.001.0374] at 0375. Consideration of 'alternative testing sites', for non-blood donors who might wish to be tested for HIV, are discussed below at paragraphs 30.156-30.161.

55 Carlson et al, 'HTLV-III antibody screening of blood bank donors', The Lancet, 2 March 1985, [LIT.001.0374] at 0374-75

56 Acquired Immune Deficiency Syndrome (AIDS) - WHO Consultation [DHF.001.7253] at 7253-54

57 Draft Test Protocol for the Evaluation of Commercial Kits for AIDS - Related Virus Antibody Screening [DHF.002.6939] at 6942

58 Professor Tedder - Day 49, page 77

59 Currently Emeritus Professor of Viral Oncology at UCL Medical School, London.

60 Professor Tedder and Dr Philip Mortimer (PHLS) attended a meeting at the DHSS early in 1983. See Chapter 29, The Discovery of HIV and the Development of Screening Tests, paragraph 29.17.

61 See Chapter 29, The Discovery of HIV and the Development of Screening Tests.

62 Professor Tedder's letter [DHF.001.8856]

63 See Chapter 29, The Discovery of HIV and the Development of Screening Tests.

64 Dr Smithies' Paper 'Further Development and Establishment for Routine Use In the Blood Transfusion Service of a Screening Test for Acquired Immunodeficiency Syndrome (AIDS)' [DHF.001.9036]

65 Minutes of CBLA meeting [DHF.002.4834]

66 Minutes of MRC meeting [SNF.001.3759]

67 Minutes of SNBTS co-ordinating group [SNB.011.1393]

68 Professor Cash's letter to Dr Bell [SNB.004.8639]

69 Professor Cash's letter [SNB.005.7304]

70 Dr McClelland - Day 50, pages 2-3

71 Ibid pages 2 and 7

72 Dr Gunson's letter to Dr McClelland [SNB.006.5978]

73 Dr McClelland - Day 50, pages 6-7

74 Dr Gunson's letter [SNB.006.5978]

75 Covering note [SNB.006.5977]

76 Cheingsong-Popov et al, 'Prevalence of antibody to human T-Lymphotropic virus type III in AIDS and AIDS-risk patients in Britain', The Lancet, 1 September 1984 [LIT.001.0417]

77 Memorandum dated 13 August 1984 [DHF.002.5897]

78 Letter dated 26 September 1984 [SGF.001.0929]

79 Agenda [DHF.001.6026]

80 Memorandum dated 27 November 1984 [DHF.001.6037]

81 Minutes of SNBTS Directors' meeting of 11 December 1984 [SGF.001.0137] at 0139

82 Minutes of the Regional Directors' meeting of 23 January 1985 [SNB.011.1971]

83 Professor Cash's letter to Dr Bell, dated 24 January 1985 [SNB.005.7304]

84 Dr Mitchell - Day 51, page 3; Report on visit [SNB.004.8803]. Dr Mitchell did not remember this event when questioned about it.

85 Dr Mitchell - Day 51, page 10

86 Ibid page 11

87 Letter [SNB.007.4920]. Dr Perry could not recall ever receiving a response to this letter - see his Witness Statement [PEN.019.0860]

88 Professor Cash - Day 48, page 49: it is not clear what aspect of Dr Perry's proposals failed in this respect, but there appears to have been no progress on any part of it.

89 On 25 November 1985, Dr Perry wrote to Professor Weiss [SNB.007.5427]. He noted that progress on earlier proposals had been interrupted by Health and Safety problems. The PFC had not been technically equipped to handle live virus.

90 Letter [SNB.005.7304]

91 Witness Statement [PEN.017.1038] at 1040; Patricciani et al, 'An analysis of serum samples positive for HTLV-III antibodies', New England Journal of Medicine, 4 July 1985 [PEN.017.0651]

92 Witness Statement [PEN.017.1038] at 1040

93 Professor Cash - Day 48, page 43

94 Dr McClelland's letter of 8 January 1985 [SNB.005.9501]

95 Dr McClelland - Day 50, page 20

96 Ibid page 20

97 Professor Cash - Day 48, pages 54 and 77

98 Ibid page 130

99 Formerly the highly secretive MOD technology park DSTL Porton Down, the establishment closed as an MOD facility in 1979 and re-opened in 1980 as the Centre for Applied Microbiology and Research (CAMR) within the Public Health Laboratory Service (PHLS).

100 Letter dated 7 August 1984 [SNB.006.5977]

101 Dr Mitchell's letter to Professor Cash [SNB.005.9715]

102 Dr Mitchell - Day 51, page 16

103 Day 48, page 74

104 Dr Mitchell - Day 51, pages 17-18

105 Minute [SGH.002.7301]

106 Dr Dow's Witness Statement [PEN.017.1680]

107 Professor Cash - Day 48, pages 75-76

108 Ibid pages 75-76

109 That is, the 'implicated batch' thought to be responsible for the infection of 'The Edinburgh Cohort' of haemophilia patients with HIV in 1984. See Chapter 10, Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 2.

110 Professor Cash's letter to Dr Mitchell [SNB.005.9713]

111 Professor Cash's Witness Statement [PEN.017.1038] at 1040

112 Dr Mitchell - Day 51, page 23

113 Ibid pages 26-27

114 Ibid page 29

115 Ibid page 35

116 Professor Cash's Witness Statement [PEN.017.1038] at 1040

117 Ibid [PEN.017.1038] at 1040

118 Day 51, pages 37-39

119 Ibid pages 30-34; Dr Mitchell's Witness Statement [PEN.017.1002] at 1003

120 Day 48, page 86

121 See paragraphs 30.82 et seq below.

122 Professor Cash's Witness Statement [PEN.017.1038] at 1040

123 Email dated 26 September 2011 [PEN.017.1836]

124 Ibid [PEN.017.1836]. It is unfortunate that this response did not deal in detail with the substance of Professor Cash's observation.

125 Dr McClelland - Day 50, page 41

126 Dr Mitchell - Day 51, page 34

127 The group continues to exist at the time of writing this report: (last accessed 30 December 2014)

128 Minutes of meeting [SNB.001.0002]

129 Extract from Hansard [SNF.001.3323]

130 The members and representatives of government departments are listed in the notes of the first meeting [SNB.001.0002]

131 Ibid [SNB.001.0002] at 0005. Dr Covell also prepared a note of the meeting [SGH.002.7296]

132 Minutes of Meeting [SNB.003.9171] at 9177

133 Letter of acknowledgment from Dr Bell to Professor Cash [SGH.002.7260]

134 Minutes of Meeting [SGF.001.0203]

135 Ibid [SGF.001.0203] at 0205

136 Professor Cash's letter to Mr Davies [SNB.005.7915]

137 Professor Cash - Day 48, pages 185-187. According to a DHSS memo of 20 May 1985 [DHF.001.7323], screening had already begun by that date in Australia and in the USA. Other countries are discussed in the Appendix at 7325. An earlier version of the document, [DHF.001.7239] at 7240, refers to the Netherlands, where it is said that '[b]y mid June all except 2 blood collecting centres will be screening blood donations for antibody'.

138 Dr Scott - Day 49, Pages 133-135

139 Ibid pages 139-140

140 See also: Professor Tedder - Day 49, pages 65-67

141 Ibid pages 65-67

142 The preference within the NBTS in England and Wales for RIA testing did not appear to be replicated in the SNBTS: Dr McClelland's Witness Statement [PEN.017.1337] at 1358

143 Dr Gunson's letter to Dr Smithies [SNB.006.5978] at 5979

144 Minutes of RTDs meeting [SNB.011.1971] at 1974

145 Letter from Dr Gunson, NBTS, to Dr A Smithies, DHSS dated 3 July 1984 [SNB.006.5978] at 5979

146 Note: 'Aids Immune Deficiency Syndrome AIDS - Current Developments' [DHF.001.5555] at 5557 Date of 27 July 1984 is given on the covering memo [DHF.001.5554]

147 Minutes of CBLA meeting [DHF.003.0219] at 0224

148 Professor Cash - Day 48, page 136

149 Professor Tedder - Day 49, page 66

150 Ibid pages 65-66

151 Ibid pages 67-69. (In this context, ligands are 'enzyme labels' that create a coloured substrate, through binding to a receptor, in the presence of a positive sample.)

152 Ibid page 69

153 'Aids and its prevention in the United Kingdom - a position paper' [DHF.002.0431] at 0432

154 Letter dated 26 September 2011 from Professor Tedder to the Inquiry [PEN.017.1831] at 1832

155 Professor Tedder - Day 49, pages 63-64

156 DHSS paper dated 28 January 1984, which almost certainly should read 1985 [DHF.002.2267]

157 Professor Tedder - Day 49, pages 81-82, in relation to [DHF.001.9036] dated 4 January 1985

158 Minutes of EAGA meeting on 29 January 1985 [SNB.001.0002] at 0005, paragraph 21

159 Note of meeting [SGH.002.7296] at 7299

160 'Aids and its prevention in the United Kingdom - a position paper' [DHF.002.0431] at 0432

161 Professor Tedder - Day 49, pages 64-65

162 Professor Tedder's Witness Statement [PEN.017.1831] at 1832

163 Professor Tedder - Day 49, pages 11-12

164 Memorandum [DHF.002.0431] at 0432

165 Minutes of EAGA meeting [SNB.001.0002]

166 Ibid [SNB.001.0002] at 0005

167 Minutes of RTDs meeting [SNB.001.3172] at 3174

168 Note of SHHD meeting [SGH.002.7296] at 7299

169 Ibid [SGH.002.7296] at 7299

170 See letter from Travenol Laboratories Ltd to DHSS dated 19 December 1984 [DHF.001.8859] and (undated) form of certificate [DHF.001.8860]

171 Minute of DHSS meeting 30 January 1985 DHF.002.7016]

172 Letter to Abbott [DHF.002.6938]

173 Draft Submission to Ministers [DHF.002.2250] at 2251

174 Professor Tedder's letter Dr Smithies [DHF.001.8856]

175 Notes of DHSS meeting [DHF.001.9250]

176 Draft evaluation programme [DHF.001.9098] and minute [DHF.001.9097]. Compare the more developed protocol of 8 March 1985 [DHF.002.6939]

177 Copy of DHSS letter to manufacturers [DHF.001.9140]

178 Memorandum [DHF.002.7101]

179 Day 49, page 91

180 Copy of DHSS letter to manufacturers [DHF.001.9140]

181 Wellcome's confirmation of 29 January 1985 [DHF.002.7106]

182 Ibid [DHF.002.7106]

183 Professor Tedder - Day 49, page 84

184 Hand-written letter [SGH.002.7302] with enclosed Minute [SGH.002.7303] and Submission [SGH.002.7304]

185 Minute [SGH.002.7301]

186 See paragraph 8.127 of the Preliminary Report for further details.

187 DHSS letter [DHF.001.9175]

188 Memorandum [DHF.001.9212]

189 Professor Tedder - Day 49, pages 86-87

190 Ibid pages 85-86

191 Barbara and Hewitt, 'Delayed AIDS testing', New Scientist, 29 August 1985 [DHF.001.7755].

192 Letter from Professor Tedder to the Inquiry dated 26 September 2011 [PEN.017.1831] at 1834

193 Note of DHSS meeting [DHF.001.9250]

194 Professor Tedder - Day 49, page 88

195 Day 49, pages 93-95

196 Note of meeting [DHF.001.9250]

197 Public Health Laboratory Service and Department of Health and Social Security - Evaluation of Five Commercial Anti-HTLV III/LAV Assay Kits [SNB.004.8847] at 8850. The members of the ad hoc working group are listed in [SNB.001.0264] and included Dr Eddie Follett of Ruchill Hospital, Glasgow, and Dr Mortimer.

198 Dr McClelland - Day 50, page 35

199 Note of EAGA sub-group meeting [SNB.001.0170]

200 Memorandum dated 11 January 1985 from Division of Biometrics entitled 'Evaluation of Reactivity to HTLV-III Antibody Observed in Phase 1 of PHS Study' [SNB.001.0141] (See also note of meeting of 15 February 1985 [SNB.001.0170] at 0171)

201 Budiansky, 'False Test Results Raise Doubts', Nature, 13 December 1984; 312:583 [PEN.017.0658].

202 Note of meeting of 15 February 1985 [SNB.001.0170] at 0171

203 Dr McClellland - Day 50, page 37

204 Note of EAGA sub-group meeting [SNB.001.0172]

205 Day 50, page 38

206 Ibid page 42

207 Ibid page 42

208 DHSS memorandum [DHF.002.5475]

209 See letter to Chairmen of RTDs, 15 March 1985 - DoH copy is to Bristol [DHF.001.9430]

210 Minutes of RTDs meeting [SNB.001.3172] at 3174

211 Day 51, page 49

212 Professor Cash - Day 48, pages 88-89

213 Ibid page 43: 'There is a view that I see here, that there weren't many tests available, that this was a major problem. That never struck me'. See paragraph 30.232 below.

214 Minutes of CBLA Meeting [DHF.001.9652] at 9654

215 Ibid [DHF.001.9652] at 9655

216 Dr McClelland's paper [SNB.005.9600]

217 Memorandum dated 31 May 1985 [DHF.002.0119], confirmed by letter the same day [DHF.002.7010]

218 PHLS paper dated June 1985 [DHF.002.6785] at 6786

219 Ibid [DHF.002.6785] at 6786

220 Ibid [DHF.002.6785] at 6785

221 Director of the Cardiff RTC, Chairman of the UK Haemophilia Centre Directors Organisation and a member of the CBLA.

222 Minutes of EAGA Meeting [SNB.001.0365] at 0367 paragraph 5.4

223 Professor Bloom's letter to the Chairman of EAGA [DHF.002.5510]

224 See note of meeting of 10 June 1985 [DHF.002.7538] at 7539

225 Bloom et al, 'HTLV-III Haemophilia and Blood Transfusion', British Medical Journal, 1985; 290:1901 LIT.001.0333]

226 Ibid [LIT.001.0333]

227 Professor Cash's letter [SNB.013.2252]

228 Professor Cash - Day 48, pages 113-114

229 See letter to chairmen of RTDs, 15 March 1985 - DoH copy is to Bristol DHF.001.9430]

230 Memorandum dated 20 May 1985 [DHF.001.7323] - Screening already introduced in Australia and USA. Compare the earlier (fuller) version at [DHF.001.7239]

231 Memorandum 31 May 1985 [DHF.002.0119], confirmed by letter the same day [DHF.002.7010]

232 Memorandum [DHF.002.6784]

233 Minutes of meeting [DHF.001.7386]

234 Ibid [DHF.001.7386] at 7389 (name redacted in original)

235 Briefing note [DHF.002.2283]

236 Ibid [DHF.001.7376]

237 Extract from Hansard [SGH.002.6798]

238 Dr Scott's letter [PEN.017.0567]

239 Report [SNB.001.0357]. See also a discussion of the report in Mortimer et al, 'Which anti-HTLV-III/LAV assays for screening and confirmatory testing?', The Lancet, October 19 1985; 873-877 [PEN.017.0653]

240 RTDC Report [SNB.001.0357]

241 Meeting minutes [SNB.001.0432] at 0435

242 Revised Report [SNB.004.9046]

243 Meeting minutes [SNB.001.0432] at 0435

244 Revised Report [SNB.004.9046]

245 Ibid [SNB.004.9046] at 9047

246 Professor Cash - Day 48, pages 140-141

247 Ibid page 139

248 Circular letter from DHSS with attached summary of results [SGH.002.6953]

249 Minutes of meeting [SNB.001.0432] at 0434

250 Letter dated 1 August 1985 [SGH.002.6967]

251 Public Health Laboratory Service and Department of Health and Social Security - Evaluation of Five Commercial Anti-HTLV III/LAV Assay Kits [SNB.004.8847] at 8852

252 Phase Two Draft Report [DHF.002.9428]

253 Ibid [DHF.002.9428] at 9442

254 Dr McClelland's Witness Statement [PEN.017.1337] at 1353

255 Dr McClelland - Day 50, pages 47-49

256 Professor Cash's statement [PEN.017.1038] at 1041

257 'Ministers delayed launch of AIDS test', New Scientist , 8 August 1985 [DHF.001.7660]. At the Conference on AIDS in Newcastle in February 1986, it was stated that the evaluation at Edgware and Manchester had revealed several interesting findings but was still to be finalised. [DHF.002.0816] at 0822

258 Letter dated 8 August 1985 [DHF.001.7659]

259 Memorandum dated 16 August [DHF.002.0479]. See Preliminary Report paragraph 8.135 for further background material.

260 Napier, 'Delayed AIDS testing', New Scientist, 1985; 55 [DHF.001.7781]

261 Barbara and Hewitt, 'Delayed AIDS testing', New Scientist, 29 August 1985 [DHF.001.7755].

262 DHSS Press Release [DHF.001.7729]

263 Dr Mitchell - Day 51, page 40

264 Ibid pages 41-2

265 Dr Dow's Statement [PEN.017.1680] at 1683

266 Dr Mitchell - Day 51, pages 44-45

267 Dr Dow's Statement [PEN.017.1680]. There is contemporaneous correspondence referring to evaluation/use at Ruchill: letter dated 11 February 1985 from Abbott Diagnostic Products GmbH to DHSS [DHF.001.9169]. See also confirmation that this was infectious diseases testing: Professor Cash - Day 48, page 95

268 Dr Dow's Statement [PEN.017.1680] at 1684

269 Organon's Vironostika indirect ELISA; and Wellcome's Welcozyme competitive ELISA.

270 Note of the Third Meeting of the ad hoc Group in the Evaluation of Anti-HTLV III Kits [DHF.002.3976]

271 Dr McClelland - Day 50, page 57

272 Ibid page 58

273 Letter [SGH.002.7266] and enclosure [SGH.002.7267]

274 Minutes of meeting [SNB.001.0432]. See also: letter of 22 August 1985 from Professor Cash to DHSS [SNB.001.0430]

275 Letter [PEN.017.0567]

276 It has not been possible to locate a copy of this letter, although its content can be deduced from the later letter. Details of the research conducted by the Scottish Government on this topic are set out in a letter dated 18 August 2011 from the Scottish Government to the Inquiry [PEN.017.0565]; evidence on the matter was also given by Dr Scott - Day 49, pages 117-124

277 Letter [SNB.004.9017]

278 Letter from Dr Ray Brettle to CLO re: City Hospital Screening Clinic for HIV [PEN.017.0682]

279 Dr Mitchell - Day 51, page 53

280 Brettle et al, 'HTLV-III antibodies in an Edinburgh clinic', The Lancet, 10 May 1986; 1099 [PEN.012.1968]

281 Dr McClelland's Witness Statement [PEN.017.1337] at 1363

282 Dr McClelland - Day 50, page 82

283 See, for example, a DHSS letter to Health Service Managers in England and Wales dated 1 August 1985 [SGH.002.6967] and the DHSS/SHHD booklets published in October 1985, discussed at paragraph 30.196 below.

284 See letter to all kit manufacturers dated 21 January 85 - an example is [DHF.001.9140]; see also a briefing note dated 21 February 1985 by Professor Cash for the Chairman of EAGA [SNB.001.0162]

285 Minute [SGH.002.7295]

286 Ibid [SGH.002.7295]

287 Minute [SGH.002.7294]

288 Minute [SGH.002.7293]

289 Minute [SGH.002.7301]

290 Dr Scott - Day 49, page 132

291 Ibid pages 132-133

292 Minutes of meeting [SNB.011.1971] at 1976-78

293 Ibid [SNB.003.9171] at 9177

294 Minutes of meeting [SNB.002.3507] at 3509

295 Minutes of meeting [SNF.001.0241] at 0242

296 Draft memorandum [SGH.002.7282]

297 Revised memorandum [SGH.002.7226] at 7227-78

298 Telex of 22 March 1985 [SGH.002.7225]

299 Under-Secretary of State for Scotland with responsibility for Health and Social Work.

300 Telex of 26 March 1985 [SGH.002.7224]

301 Dr Scott - Day 49, page 117

302 Ibid page 143

303 Dr Scott's Witness Statement [PEN.017.0513] at 0514

304 The Inquiry has not recovered this letter. See a letter from Dr Scott to Chief Administrative Medical Officers in which he refers to his earlier letter dated 16 April 1985 [PEN.017.0567]

305 Minutes of meeting [SGF.001.0203]

306 Ibid Item 3 (d) ii. [SGF.001.0203] at 0205

307 Ibid Item 3 (d) v. [SGF.001.0203] at 0206

308 Ibid Item 3 (d) vi. [SGF.001.0203] at 0206

309 Presumably a fresh sample from the donation to exclude the risk that there may have been contamination of the test sample.

310 Minutes of Meeting: Item 3 (d) vi. [SGF.001.0203] at 0206

311 Ibid Item 3 (d) vii. [SGF.001.0203] at 0207

312 As reported in the minute to Mr MacKay dated 20 September 1985 [SGF.001.0831]

313 Professor Cash's letter to Directors [SGH.002.6977] This is a letter to Dr Whitrow, Director of the Inverness BTS, but Dr McClelland said in his statement [PEN.017.1337] at 1354 and in evidence that Professor Cash had written in these terms to all Directors.

314 Dr McClelland - Day 50, page 53

315 Letter [SGH.002.6977]

316 Witness Statement of Dr McClelland [PEN.017.1337] at 1354; HTLV III Testing - Countdown - List of responsibilities [PEN.012.1949]; Preparation for introduction of HTLV-III AB screening meeting [PEN.012.1950].

317 Letter [SGH.002.6982]

318 Dr McClelland - Day 50, page 68

319 Letter [SNB.004.9017]

320 Minutes of meeting: preparation for introduction of HTLV-III AB screening [PEN.012.1950]

321 Dr McClelland's Witness Statement [PEN.017.1337] at 1353. The SNBTS sought to ensure that all stocks of blood and blood products had been tested before the official start date - see paragraph 30.191 above and 30.204 below.

322 Proposal for self referral facility for HTLV-III testing - letter from Dr DBL McClelland to Dr A McIntyre [PEN.012.1956]

323 Letter from Dr Ray Brettle to CLO re: City Hospital Screening Clinic for HIV [PEN.017.0682]; Dr McClelland's Witness Statement [PEN.017.1337] at 1357 paragraph 29

324 Minute to Mr MacKay [SGF.001.0831] at 0832-3

325 Ibid [SGF.001.0831]; 'Countering the Spread of AIDS in Scotland' [SGH.002.7072]

326 'An Evaluation of Anti-HTLV III Test Kits in the National Blood Transfusion Service' - Report of the Results on the First and Second Test Kits [DHF.002.9428]

327 Dr Dow's Witness Statement [PEN.017.1680] at 1683; Professor Cash - Day 48, page 68

328 Press release [SGH.002.7099]

329 Covering letter dated 1 October 1985 and a copy of the booklet [SGH.002.7091]

330 Ibid [SGH.002.7091] at 7092

331 Ibid [SGH.002.7091] at 7093

332 Ibid [SGH.002.7091] at 7093-94

333 Ibid [SGH.002.7091] at 7095

334 Scottish booklet - 'Acquired Immune Deficiency Syndrome - AIDS - Booklet 2 - Information For Doctors Concerning the Introduction of the HTLV III Antibody Test' [SGH.002.7081]

335 Covering Letter [SGH.002.7079]

336 Letter [SGH.002.7080]

337 Dr McClelland - Day 50, pages 51-52; Letter from Professor Cash to Dr McIntyre, SHHD, dated 28 October 1985 [SNB.005.8091]

338 Dr McClelland - Day 50, pages 51-52

339 Minutes [SGH.001.6412]

340 As reflected in paragraph 30.210 below, the west area would select the Wellcome test also.

341 Minutes [SGH.001.6412] at 6413-14

342 Minutes [SNB.005.1495]

343 Ibid [SNB.005.1495] at 1505

344 AIDS Conference Newcastle - 11th-13th February 1986 [DHF.002.0816] at 0826

345 Hansard extract [SGH.002.7370]

346 Ibid [SGH.002.7370]

347 Note [SGF.001.1246]

348 Dr Dow's Witness Statement [PEN.017.1680] at 1684

349 Ibid [PEN.017.1680] at 1684

350 Professor Cash - Day 48, pages 43-44 and 130 - to buy a kit and start testing would be 'ethically unacceptable'. See also Professor Cash's letter of 12 February 1985 to the CMO [SNB.013.2233] - most of the emerging commercial kits seemed to have a false positivity rate which was 'embarrassingly high'.

351 Day 50, page 39

352 Day 51, pages 55-56

353 Day 49, page 102

354 Dr Macdonald's Statement [PEN.017.0559] at 0561

355 Day 51, pages 58-59; Dr McIntyre's statement [PEN.017.0552]

356 Minutes [PEN.016.1142] at 1145

357 When, approximately, the second generation Abbott and Organon tests, which were probably better than the original kits, became available.

358 A copy of one such letter is [DHF.001.9140]

359 Letter from Abbott to DHSS dated 11 February 1985 [DHF.001.9169]

360 Dr Dow's Witness Statement [PEN.017.1680]

361 Ibid [PEN.017.1680]

362 Ibid [PEN.017.1680] at 1681-82

363 Crewdson, J. Science Fictions [PEN.017.1057] at 1067

364 Ibid [PEN.017.1057] at 1066-67

365 Habibi, B. 'Summary of Experience in France Regarding Screening and Confirmatory Tests', in Petricciani et al (eds), AIDS The Safety of Blood And Blood Products (World Health Organisation) [LIT.001.5536]

366 The evidence of Professor Cash - Day 48, page 185 - that routine screening was introduced in France in about May 1985 appears to have been wrong.

367 Crewdson, J. Science Fictions [PEN.017.1057] at 1068

368 Ibid [PEN.017.1057] at 1067

369 Response from Patrick Hennessy at the Department of Health (on behalf of Dr Alison Smithies) dated 01 April 2011 [PEN.017.0504]

370 Meeting minutes [SNB.001.0172] at 0172-73

371 Professor Cash's Witness Statement [PEN.017.1038] at 1041

372 Professor Cash - Day 48, page 43. See footnote 215 of this chapter, above.

373 Discussion with Professor Cash left the period uncertain - Day 48, pages 104-105.

374 Letter to Dr Mitchell copied to Transfusion Directors and Dr Bell [SNB.005.9713]

375 Letter from Professor Bloom to DHSS re: introduction of FDA-approved tests [DHF.002.5510]

376 Bloom et al, 'HTLV-III Haemophilia and Blood Transfusion', British Medical Journal, 22 June 1985 [LIT.001.0333]

377 Ala et al, 'HTLV-III Antibody in Sequential Plasma Samples from Haemophiliacs 1974-84', The Lancet, 2 March 1985 [LIT.001.0374] at 0375

378 Carlson et al 'HTLV-III Antibody Screening of Blood Bank Donors', The Lancet, 2 March 1985 [LIT.001.0374]

379 First Version of Report [SNB.001.0357] plus corrigendum [DHF.001.7532]

380 Minutes of Meeting [SNB.001.0432] at 0434

381 Dr McClelland's letter to Professor Cash [SNB.006.5977]

382 Closing Submission - Patient interests [PEN.019.0552] at 0555

31. The Introduction of Screening of Donated Blood for Hepatitis C >