THE PENROSE INQUIRY
Final Report

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Chapter 9

Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 1

Introduction

9.1 The impact of HIV/AIDS on National Health Service (NHS) patients receiving blood transfusions in the course of medical or surgical treatment or receiving blood, blood component or blood product therapy for coagulation disorders is part only of a much wider picture. The speed of response and the concentrated effort devoted first of all to understanding and then to dealing with AIDS, especially in the USA, reflected the apprehension that it was an epidemic threatening broad sectors of society.

9.2 In a paper presented to a group of experts at the World Health Organization (WHO) on 14-16 April 1986, Dr John Ziegler, Director of AIDS Research at the American Veterans Administration Medical Center wrote:

The epidemic forces policy decisions in political, social, journalistic, and ethical spheres. The cause, prevention, and cure of AIDS has induced collaboration between clinicians, virologists, immunologists, molecular biologists, epidemiologists and sociologists. Thus this epidemic has, in five short years, mobilized a response from virtually every arena of human society.^[1]

9.3 In this chapter, the evolving picture will be examined from a narrow perspective, tracing developing knowledge of the incidence of diseases associated with HIV infection from the end of 1980, when cases of AIDS were first observed in the USA, to 1984, when testing for antibodies for HIV began to become available in the USA. This is with a view to providing context for the exploration of medical and scientific research into AIDS and the response to it, principally in the UK and the USA.

9.4 However, it is appropriate also to take note, briefly, of the extent of the epidemic, particularly as it affected populations less able to respond to the challenges it presented, and still presents, than the cohorts with whom the Inquiry is particularly concerned.

A worldwide problem

9.5 In 2006, the 25th anniversary of the emergence of AIDS in western countries, there were close to 40 million people around the world living with HIV infection and over 20 million people had died of HIV-related diseases. By 2009, the joint UNAIDS^[2] and WHO publication Global Facts and Figures showed that since the beginning of the epidemic almost 60 million people had been infected with HIV and 25 million people had died.^[3] By 2011, 30 years since HIV/AIDS was first discovered, 30 million people had died. The number of people living with the disease worldwide was estimated at 34.2 million, with a prevalence of 0.8% overall.^[4] UNAIDS data showed wide variations in prevalence across regions, from 0.1% in East Asia to 5% in Sub-Saharan Africa. Western and central Europe were estimated to have 820,000 cases of infection, a prevalence of 0.2%. North America had 1.5 million cases, a prevalence of 0.5%.

9.6 The epidemic in the UK, with particular reference to Scotland, is the context in which the Terms of Reference have to be addressed. Though a small part of the wider picture, it is not representative of it. The prevalence of the disease in the UK, and the response to it, has been materially different from the global picture. The emerging position in the USA usefully defines the wider context in which experience in the UK has to be seen. Along with other western countries, the USA and the UK have benefited from the investment of intellectual and financial resources not widely available in most areas with a high prevalence of infection.

9.7 In the UK, AIDS surveillance began in 1982.^[5] By the end of 2011, 120,756 people had been diagnosed with HIV, of whom 27,361 had developed AIDS and 20,335 had died.^[6] The estimated prevalence of HIV in 2010 in the population of all ages was 0.15%: 0.18% in males and 0.09% in females. The Health Protection Agency (HPA) report for 2011 commented that the UK had a prevalence similar to other western European countries such as Ireland (0.2%), the Netherlands (0.2%) and Germany (0.1%), and lower than eastern and southern European countries such as Latvia (0.7%), Portugal (0.6%) and Spain (0.4%). Local social and environmental factors are reflected in those variations and, in geographical terms, a narrow field of study is required. However, it is not possible totally to isolate cases of infection in the UK from the wider world picture. A significant proportion of individuals diagnosed with HIV infection in the UK was originally infected abroad.^[7]

9.8 In the case of transfusion and blood disorder patients, experience was more clearly dependent on local factors: by definition NHS patients were treated in the UK. The risk of transmission of infection was related to the prevalence of infection in the donor population. Across western countries the picture varied. The prevalence of transfusion-transmitted AIDS in Australia was said in the mid-1980s to be 10 times greater than in the UK.^[8] It was reported at that time that the prevalence of seropositivity^[9] in the USA was 74% in people with Haemophilia A and 35% in people with Haemophilia B. In the USA, 15% of 'haemophilia wives' were seropositive, with the seroconversion rate still increasing.^[10]

9.9 By 1986, the Council of Europe had produced comparable data. For the UK, the data indicated positive findings in 896 (44%) of 2025 Haemophilia A patients tested and in 20 (6%) of 324 Haemophilia B patients tested. In severely affected Haemophilia A patients the proportion was 59%.^[11] Comparative analysis of the widely divergent numerical data contained in these reports, even as between the USA and the UK, would not be helpful in tracing the history of the epidemic in Scotland.

9.10 The numerical data on the prevalence of disease in Scotland are dealt with in Chapter 3, Statistics. The combined UK prevalence values are higher than comparable values for Scotland alone. The most up-to-date data available to the Inquiry indicate that for the UK, excluding Scotland, 1310 patients with bleeding disorders had tested positive for HIV by April 2012. Scotland has roughly 10% of the UK haemophilia population but only 73 patients treated in Scotland tested positive, around 5% of the bleeding disorder patients infected with HIV.^[12] Knowledge of these numbers would not emerge in the course of the period under discussion, 1981-1984.

Origins of the disease

9.11 AIDS was first reported in the USA in 1981. Data from the UK Haemophilia Centre Doctors' Organisation (UKHCDO) initially suggested that the first cases of HIV in haemophilia patients at Scottish centres were recorded retrospectively as having occurred in Aberdeen and Glasgow in 1982.^[13] Earlier cases were identified and reported by Simon Garfield in his social history of HIV/AIDS, The End of Innocence.^[14] The cases he noted appeared to demonstrate that AIDS was active in the USA and in the UK before 1981. Without verification, however, the reports gave no real insight into when AIDS first affected humans in western countries. It is clear, however, that none of these apparently isolated early cases was recognised or influenced medical and scientific thought when the first deaths in the modern epidemic came to light and were reported in 1981.

9.12 Developments in the science of genetics and increasingly sophisticated technology applied to historic blood samples stored in the USA and the UK have now demonstrated that HIV infection had entered the population in the USA by 1978 and in the UK by 1979. Blood specimens retained from early studies of other conditions, and in particular Hepatitis B, were available for re-examination when appropriate technology was developed. Re-examination of specimens from a study of Hepatitis B infection in a cohort of homosexual men in San Francisco carried out between 1978 and 1984 disclosed HIV antibodies in samples dating from 1978.^[15] Retrospective testing of samples from haemophilia patients in western Pennsylvania^[16] and New York^[17] also identified the first two cases of HIV seroconversion in that group of patients in samples from 1978. Similar testing in the UK has shown transmission of HIV to a haemophilia patient around June 1979.^[18] Research into the origins of HIV continues.^[19]

9.13 The same technology has probably excluded one earlier date.^[20] The death of a patient at the Manchester Royal Infirmary on 31 August 1959, aged 25, with a rare combination of symptoms, was reported in 1960 as a mystery.^[21] In 1983 it was speculated that it might have been a case of AIDS.^[22] In 1990, further study led to the conclusion that the patient had HIV infection.^[23] In 1995, however, US researchers cast doubt on the previous findings and speculated that they might have been due to cross-contamination of samples.^[24] Further studies followed.^[25] The conclusion of the Manchester scientists involved - two of whom had contributed to the Lancet article in 1983 - was negative: they agreed that the 1959 patient did not carry HIV. For them the case had again become a mystery. The final contribution to date is from Professor Hamilton and Mr Hooper, Oxford, who in 1996 again expressed the belief that the patient did not have AIDS.^[26] The debate so far suggests that the case is not an early example of HIV infection, notwithstanding that the patient had signs and symptoms of diseases of the AIDS complex at his death. It illustrates the role of technology in developing understanding of the epidemiology of the disease and in particular the late date at which a measure of confidence in diagnosis was achieved.

9.14 It can be said with greater confidence that knowledge of the emerging epidemic was disseminated first in 1981, with a great deal of literature published in and after June of that year. From the first clinical descriptions of the disease, concern began to grow. As seen from the perspective of staff at the Regional Haemophilia Centre, Glasgow Royal Infirmary (GRI), commenting on the early reports:

It was soon apparent that these cases represented the first reports of a new epidemic, one which medicine had not seen before, and one which has had dramatic consequences scientifically, medically and socially.^[27]

9.15 Within the UK, scientific and medical literature initially dealt mainly with experience in the USA and the literature most widely available to British scientists and doctors was published first in the USA and only later in the UK.

9.16 In order for the Inquiry properly to understand the response to the epidemic as it affected those who received transfusions of blood and blood components and blood product therapy, it was necessary to trace the origins of the AIDS epidemic, and the publicity that it attracted, at least to the USA, and to place in context the emerging understanding of its impact on haemophilia and other patients. Knowledge of the groups at risk of infection quickly became widespread, while knowledge of the prevalence and natural history of AIDS-associated disease developed more slowly. The Preliminary Report set out much of the information recovered in chronological form and will not be repeated in detail.^[28]

Early reports of infection in the United States of America: 1981-1982

9.17 Early reports in the USA presented a picture of rapidly increasing numbers of patients with perplexing signs and symptoms with high mortality and unknown cause. In The Tragic History of AIDS in the Hemophilia Population 1982 - 1984, Dr Bruce Evatt of the US Centers for Disease Control (CDC) wrote:

First apparent in the homosexual population in the USA in the last quarter of 1980, the disease possessed unusual properties that initially obscured it as a distinct infectious disease. Previously healthy victims had no specific symptoms but presented with either secondary infections or tumors associated with immune deficiency (i.e. Pneumocystis carinii pneumonia (PCP) or Kaposi's sarcoma)^[29]. A long incubation time made it difficult to identify person-to-person spread. Laboratory methods needed to culture and identify the etiologic agent were lacking.^[30]

First reports: the association with sexual behaviour

9.18 The first US reports of AIDS created, for a time, an impression that the disease was a purely US phenomenon associated with sexual behaviour. The published history begins in 1981 when physicians in New York, Los Angeles and San Francisco reported previously healthy homosexual men with Pneumocystis carinii pneumonia (PCP). The Los Angeles cases were described in the Morbidity and Mortality Weekly Report (MMWR) for 5 June 1981.^[31] That report is generally regarded as the first published recognition by a public health body of what was to become characterised in the 1980s as 'the AIDS epidemic'. Additional reports soon followed. Apart from the unusual nature of their illnesses, there was no common characteristic other than homosexual activity and in that respect the patients did not have a history of association with each other. As at 1981, the existence of what came to be known as AIDS was inferred from the constellation of very unusual tumours, such as Kaposi's sarcoma (KS), and other clinical signs and symptoms, including PCP, in patients who died fairly quickly after initial diagnosis.

9.19 Kaposi's sarcoma in young homosexual men was brought to the notice of doctors in the UK in The Lancet of 19 September 1981 but it was reported as a US phenomenon. ^[32]

A widening constituency: intravenous drug use

9.20 The range of people known to be at risk was extended when, on 10 December 1981, the New England Journal of Medicine (NEJM) reported PCP in seven intravenous drug users (IVDUs), only two of whom were homosexuals. It was suggested that IVDUs and homosexuals were at high risk for PCP but there was still an emphasis on male homosexuals as people particularly at risk.^[33] At the time, the term 'Gay Compromise Syndrome' was coined for the 'newly recognised syndrome of opportunistic infections and/or KS in homosexual males'.^[34]

9.21 In terms of published intelligence, at the end of 1981 and continuing into 1982, reports in the NEJM, The Lancet and the British Medical Journal (BMJ) added to general knowledge that IVDUs were affected in addition to members of the male homosexual population.

A widening constituency: haemophilia patients

9.22 The earliest case of AIDS-related disease in a haemophilia patient, so far as is known to the Inquiry, was identified in October 1981. The case was not fully reported until February 1983 but the circumstances of a patient discussed by Professor Oscar Ratnoff of Cleveland, Ohio (one of the authors of the later report on the case) and Professor Charles Forbes, Director of the Regional Haemophilia Centre, Glasgow, at the end of 1981 were probably related to it.^[35] Professor Ratnoff told Professor Forbes of haemophilia patients who were clearly ill with various opportunistic infections and tumours and of a patient of his who had a 'funny immune problem in his blood' and was obviously ill and eventually died.^[36] He asked whether Professor Forbes had seen such cases (he had not, at the time). Thus at least one haemophilia clinician in Scotland had personal notice of the emerging problem, beyond the sexual context, from this time.

The first year

9.23 By June 1982, a year after the first report of AIDS, KS and opportunistic infections had been reported in 355 relevant cases in the USA.^[37] The majority of the individuals infected (79%) were homosexual or bisexual men; 11% were heterosexual men; 4% were heterosexual women; and 6% were men of unknown sexual orientation. It was suggested that all of the cases were part of the same epidemic.

9.24 In light of the oral evidence heard by the Inquiry, it would be wrong to imagine that the published reports communicated a clear account of the developing picture to the medical community generally. Across the professions experience was patchy: the patients were widely spread and few doctors would have had direct experience. Professor Andrew Lever, Professor of Infectious Diseases at Addenbrooke's Hospital, Cambridge, distinguished those with direct experience, doctors looking after patients suffering from these infections and specialists such as epidemiologists with a specific interest, from clinicians generally. Individual physicians managing patients with AIDS and epidemiologists would have been trying to work out what was going on.^[38] Professor Lever explained:

Mostly the people who saw the initial cases were seeing a lot of [them] ... or at least several, and it would have been an unusual phenomenon for anyone to have seen one of these and certainly very unusual for them to see two or three.^[39]

9.25 Experience was concentrated in a relatively small cohort of specialist practitioners. For most clinicians the published reports and comments would have described events of which they had no personal knowledge or experience. In the UK medical community, the impression was created, and persisted, that the disease was a US phenomenon.

The second year

9.26 Experience of AIDS was beginning to spread internationally, however. The cases of four Danish men who had developed KS or opportunistic infections were reported in July 1982.^[40] It was apparent that the syndrome was occurring in homosexual men in Europe as well as in the USA.

9.27 In the same month, opportunistic infections among Haitian immigrants to the USA were reported.^[41] At that time, the explanation for a concentration of cases in Haiti had not been documented and there was not a very clear idea about how the disease had arrived there.^[42]

9.28 On 16 July 1982, the MMWR reported three cases of PCP in haemophilia patients.^[43] All were heterosexual males with no history of intravenous drug use. Two had died and one was critically ill. All had lymphopenia (abnormally low levels of lymphocytes, white blood cells important to the immune system) and the two who had been specifically tested had in vitro laboratory evidence of cellular immune deficiency. There had been a further material change in context moving away from an exclusive focus on the sexual behaviour of male homosexuals.

9.29 By July 1982, the US Centers for Disease Control (CDC), and Dr Evatt in particular, were convinced by evidence of infection in haemophilia patients that AIDS was a blood-borne disease, though there was no direct proof. It is important to bear in mind, however, that there was no consensus at this stage that AIDS was even an infectious disease.

9.30 In September 1982, it was reported again that intravenous drug use was a risk factor.^[44] An update in the 'Current Trends' section of the MMWR stated that the incidence of AIDS had roughly doubled every half year since the second half of 1979. Among the 14 cases involving males under the age of 60 who were not homosexuals, IVDUs or Haitians, two (14%) had Haemophilia A. It was suspected that the eventual mortality rate of AIDS might be far greater than the overall 41% case-mortality rate noted for the total of 593 cases identified at that point. The editorial note suggested that Haemophilia A was perhaps a risk factor.

9.31 There were further significant reports in the MMWR of 10 December 1982 of four more cases in the USA of heterosexual Haemophilia A patients with opportunistic infections, one suspected case in a 7 year old haemophilia patient and a report of a possible transfusion-related case of AIDS in a 20 month old child from San Francisco.^[45] The editorial comment on the group of four patients stated:

These additional cases provide important perspectives on AIDS in U.S. hemophiliacs. Two of the patients described here are 10 years of age or less, and children with hemophilia must now be considered at risk for the disease. In addition, the number of cases continues to increase, and the illness may pose a significant risk for patients with hemophilia.^[46]

9.32 The infant from San Francisco had received multiple transfusions which had included platelets from a male found to have subsequently developed AIDS. The editorial note stated that several features of the infant's illness resembled those seen among adults with AIDS but warned that, since there was no definitive laboratory test for AIDS, any interpretation of the child's illness would need to be made with caution. It proceeded:

If the platelet transfusion contained an etiologic agent for AIDS, one must assume that the agent can be present in the blood of a donor before onset of symptomatic illness and that the incubation period for such illness can be relatively long ....

....

This report and continuing reports of AIDS among persons with hemophilia A raise serious questions about the possible transmission of AIDS through blood and blood products....^[47]

9.33 Discussion of the case of the infant at the Inquiry's Oral Hearings disclosed varying opinions of its significance: see Chapter 11, AIDS Aetiology, paragraphs 11.24-11.27.

9.34 The initial reports of infections in homosexual men had left medical scientists in the USA unclear how the clustering of KS, PCP and other opportunistic infections were related. Over a short period of about 18 months, however, by autumn of 1982 thinking had moved on to the definition of a condition with specific signs and symptoms and identified groups at risk. People at risk in the USA included homosexual and bisexual men, IVDUs, heterosexual haemophilia patients, immigrants from Haiti and, more rarely, other heterosexual males and females without known risk factors.

Response in the United Kingdom 1981-1982

9.35 It should not be thought that the early US publications were immediately available in a practical sense, at or about the dates of their issue, to all clinicians and other doctors who would come to have an interest in the subject. The MMWR was a publication of particular interest to infectious diseases specialists. It was not likely to be widely read in ordinary course by many clinicians in the UK and, before AIDS became a matter of general interest, haemophilia clinicians and transfusion doctors (whether in the USA or in the UK) would not have been regular readers of the publication.^[48] The early stages of the AIDS outbreak in the USA would have been known to some infectious diseases specialists from reading and soon from direct contact with patients or from discussion.^[49] Haemophilia doctors also became aware of AIDS relatively quickly.

9.36 The HPA 2011 Report, HIV in the United Kingdom, noted the first reports of AIDS in Los Angeles of 5 June 1981 and commented:

Ten days later, the first UK case of AIDS was reported in a young man with haemophilia followed by further reports of AIDS among homosexual men. These first reports prompted the creation of the UK's AIDS surveillance scheme in 1982.^[50]

9.37 The Inquiry's investigations have disclosed that the HPA Report, which was reviewed in January 2011 and again in November 2012, is inaccurate in this respect: there was no report of AIDS in a young haemophilia patient in the UK in June 1981. Public Health England, the successor to the HPA, has explained that the HPA confused the date of a sample from 1981, which was tested retrospectively when a haemophilia patient in Scotland was first diagnosed with clinical AIDS in 1994, with the date of first diagnosis.^[51] The first reported case of clinical AIDS in the UK was the case of 'the Brompton patient'. The Lancet of 12 December 1981 published details of a 49 year old homosexual man (a frequent visitor to Florida), who had reported to Brompton Hospital. He was diagnosed with PCP and cytomegalovirus (CMV) but had no underlying immune deficiency.^[52] Information was now circulating about AIDS in a UK patient, albeit one with US and homosexual associations.

9.38 The Inquiry had the benefit of written and oral evidence from Dr Mark Winter, who became Consultant Haematologist at Kent and Canterbury Hospital in 1983. Dr Winter was a Senior Registrar at Guy's Hospital at the time of the Brompton Hospital case in 1981 and the topic was widely discussed among his colleagues.^[53] Professor Lever was working with Dr David Webster at Northwick Park Hospital at the time. Although Professor Lever could not be certain, it appears highly likely that the patient from Brompton Hospital was transferred to Dr Webster's care and that he was one of the first two AIDS patients seen by Professor Lever in 1981-82. The second was a child recently arrived from the southern USA or the Caribbean.^[54] The information given to Professor Forbes of Glasgow at the end of 1981 by Professor Ratnoff of what was probably the earliest case of AIDS-related disease in a (US) haemophilia patient known to a UK practitioner has already been mentioned in paragraph 9.22. A few doctors in the UK derived knowledge of the condition from direct contact with patients and from discussion with colleagues at the initial stages of the outbreak. As previously noted, surveillance of AIDS-related disease in the UK began in 1982.

9.39 By the end of 1981, no cases had been seen in Scotland. Professor Forbes had received personal communication from Professor Ratnoff, and Professor Christopher Ludlam (Director of the Edinburgh Haemophilia Centre) was familiar with the literature.^[55] It is not clear, however, how widely the emerging epidemic was known or studied at this point by Scottish haemophilia clinicians or other practitioners concerned with the use of blood, blood components or blood products. Early surveillance is more likely to have engaged physicians concerned with the diagnosis and treatment of AIDS-related diseases such as infectious diseases doctors, cardiologists, respiratory specialists and cancer doctors.

The Second International Symposium on Infections in the Immunocompromised Host

9.40 Information about the emerging epidemic was disseminated by a number of professional groups but not always shared on an interdisciplinary basis. In June 1982, the Second International Symposium on Infections in the Immunocompromised Host was held in Stirling. Professor Ian Hann, then at the Royal Free Hospital, London, but soon to move to The Royal Hospital for Sick Children, Yorkhill, Glasgow (Yorkhill), attended.^[56] One of his main interests at the time was infections in patients who had either immune deficiencies or, more commonly, leukaemia and cancers which made them very susceptible to infection. The symposium was to become the main regular meeting in the world of specialists dealing with such infections.^[57] However at the time of the second meeting, it is unlikely that specialists in other fields were aware of its existence. Apart from Professor Hann, none of the haemophilia clinicians who gave evidence to the Inquiry attended the meeting or knew about it.^[58] This provides a clear example of one of the consequences of professional demarcation: there is no evidence that information from the symposium was communicated by those attending to colleagues with different specialist interests.

9.41 In relation to widening knowledge of AIDS in the UK, the timing of the meeting is instructive. AIDS was not on the programme for the Stirling symposium as originally prepared. The topic of AIDS in homosexuals and drug addicts came to the fore later and a special lecture, 'Acquired Immuno-Deficiency Syndrome: infection and neoplasia in homosexual men and intravenous drug addicts', was added.^[59] The opening passage of the paper referred to experience in the USA and stated:

We are experiencing an alarming epidemic of an acquired immunodeficiency syndrome (AIDS) in certain cities in the United States. It is affecting homosexual men, intravenous drug abusers of either sex and Haitian refugees ....

We are seeing such cases on a regular basis in New York City .... AIDS patients are regularly seen in Los Angeles, San Francisco and other large cities in the United States and cases have also been reported from Europe. ^[60]

9.42 At the symposium, AIDS patients were reported to have developed opportunistic infections, KS and other malignancies.^[61] A high mortality rate was reported: 13 of 42 patients in New York had already died. PCP in particular was associated with high mortality. It was noted that those who took care of the patients realised how devastating this illness was.

9.43 The paper did not mention haemophilia patients as being at risk. Professor Hann recollected, however, that there was a 'corridor discussion' of other possible groups of affected patients including a very small number with haemophilia.^[62] The authors of the paper on AIDS were mainly from New York but also included Dr James Curran and others from CDC, Atlanta, who may have known of Dr Evatt's views (described in paragraph 9.29 above). Professor Hann's evidence is particularly telling. He remembered the meeting well as it was so shocking. At the time of the symposium, his interests did not include haemophilia and the 'corridor discussion' left him with the impression, as he moved into haemophilia care at Yorkhill at the beginning of 1983, that AIDS might possibly be relevant to his haemophilia patients; but, he said, AIDS was perceived at the time to be mainly a problem of sexual transmission and possibly also of intravenous drug use.^[63]

Official reaction

9.44 In UK government circles, the emerging problem was noted. On 16 July 1982, an internal Department of Health and Social Security (DHSS) memorandum advised that information had been received from the USA concerning the safety of US Factor VIII. The author of the memorandum (name redacted but probably written by a middle ranking official in the Department to another official who was medically qualified) stated that research was about to be published indicating that plasma taken from homosexual drug users contained a sort of virus and that, when the plasma was used for the production of Factor VIII, the virus could be passed on to haemophilia patients. It was claimed that '400 haemophilia patients in the USA [had] exhibited signs of the virus.' The memorandum noted that, with the UK's voluntary unpaid donor system, there was not the same problem of drug addicts being tempted to give blood for money. The author also noted, however, that about half of the concentrate used in the UK at this time was imported commercially from the USA.^[64]

9.45 In fact, up to the end of 1982, there was limited use of commercial concentrates by haemophilia centres in Scotland, with the exception of Yorkhill. Otherwise, the west of Scotland and the Edinburgh and east of Scotland centres used some commercial concentrates but mainly used Scottish concentrates or locally produced cryoprecipitate.^[65] It is quite unclear where the 'information received from America' came from and the Inquiry has found no evidence to support the statement (from July 1982) that 400 haemophilia patients in the USA had exhibited signs of this virus. In fact, by coincidence, also on 16 July 1982 the MMWR published an account of the first three haemophilia patients in the USA thought to have AIDS.^[66]

9.46 In the UK, the Haemophilia Centre Directors began exploring the issue of AIDS in the autumn of 1982, remitting to Dr John Craske, who represented the Public Health Laboratory Service (PHLS), Withington Hospital, Manchester, the task of looking into the report from the USA of the syndrome in homosexual men and recently reported in three haemophilia patients. At that stage, the impression reflected in the minutes of the Directors' meeting of 13 September was that '[i]t appeared that there was a remote possibility that commercial blood products had been involved.'^[67]

9.47 Dr Frank Boulton, Deputy Director of the Edinburgh Blood Transfusion Centre, prepared a note of the Directors' meeting. In relation to AIDS, he stated:

This is a wasting disease with deficient cell-mediated immunity, possibly associated with an infectious element ....

Mortality 40-50%.

Three cases have occurred in haemophiliacs in the USA, possibly associated with parenteral drug abuse.^[68]

9.48 Dr Boulton emphasised that the note did not express his personal opinion. He could not recollect who had suggested the association with 'parenteral drug abuse'.^[69]

9.49 Dr Winter was asked by the Inquiry about the reference to drug use in Dr Boulton's note; an association with drug use had not been mentioned in the MMWR of July. Dr Winter thought that there was a feeling at this time that only three haemophilia patients were affected, in the USA, and it was not absolutely certain that they were not part of some other risk group. He advised that a lot of attention was being paid to Germany where 'spectacularly high' quantities of imported Factor VIII were used. He said:

I think in fact the Bonn centre one year used more than every American centre put together, and one of the things that was said regularly at this time was, "If this is a new disease and it is in blood, why aren't the Germans getting it because, if anybody is going to get it, the Germans will."^[70]

9.50 Dr Craske asked the Directors to let him know if they had any cases of the syndrome. It was noted that the Hepatitis Working Party was considering the implications of the reports from the USA.^[71] The Hepatitis Working Party was a UKHCDO group but had a wider membership than Haemophilia Centre Directors exclusively. Dr Craske was to have a pivotal role in collecting and disseminating intelligence on the disease among UK clinicians and scientists. Study of the prevalence of AIDS in the UK haemophilia population had begun but, subject to the 'remote possibility' that commercial blood products were implicated (a factor which would have had relevance in the UK generally but in England and Wales in particular), it was viewed as primarily a US problem at that stage and few haemophilia patients in the USA were affected. Professor Ludlam thought that the explanation for the assessment of risk as relatively low was that three only out of 20,000 haemophilia patients in the USA had been reported as being infected.^[72]

9.51 There was still a lack of communication of emerging knowledge among different professional groups in Scotland. As noted in the Preliminary Report, the minutes of the meetings of SNBTS Directors for 1982 did not disclose discussion of AIDS by Transfusion Directors at any meeting during the year.^[73]

9.52 At the end of 1982, therefore, there was emerging interest in the UK in AIDS but there was no general understanding that AIDS was a problem for Scotland or for any particular cohort or cohorts of potential patients.

Developments in the United States of America: 1983-1984

9.53 On 21 January 1983, an article in Science (published in the USA but one of the most widely-read and most prestigious science publications in the world) described a recent CDC workshop on the new immune disease.^[74] Among topics discussed was the possibility that the disease might be spread through blood and blood products. The CDC had reported that haemophilia patients were at high risk of contracting AIDS. Dr Evatt, CDC, told the workshop that AIDS was the second leading cause of death for haemophilia patients in 1982.

9.54 A widening range of people at risk was reported in the USA in 1983 and 1984. In January 1983 two cases of AIDS in the female sexual partners of IVDUs were reported.^[75] Reports of infection in the Cleveland Hemophilia Center and other centres were published in the NEJM in February 1983.^[76] All of the patients had a disorder resembling idiopathic thrombocytopenic purpura (a recognised autoimmune condition characterised by abnormally low platelet counts). Three out of four of the patients studied in 1981 and 1982 demonstrated evidence of impaired cell-mediated immunity. It appears highly likely that one of these was the patient discussed by Professors Ratnoff and Forbes at the end of 1981. Further cases of AIDS in haemophilia patients in the USA were reported in March 1983.^[77] At the same time there were additional reports of immune abnormalities in young haemophilia patients who were otherwise apparently well.^[78] An editorial in The Lancet for 2 April 1983 referred to reports from the USA of haemophilia patients, who had received Factor VIII concentrates, developing AIDS.^[79] On 30 April, letters in The Lancet reported AIDS in 11 haemophilia patients in the USA and three in Spain who had received commercial concentrate.^[80]

9.55 A leaflet entitled Facts about AIDS was published by the US Public Health Service in September 1983.^[81] The opening paragraph advised that AIDS was the number one priority of the US Public Health Service. Since 1981 the service had received reports of more than 2200 cases with a mortality rate of almost 40%. The leaflet included information about the nature and extent of AIDS, identifying who was at risk and giving advice on preventative measures. In the paragraph headed 'What causes AIDS?', it stated: 'The best evidence for transmission of AIDS through blood products is the occurrence of AIDS in a small number of hemophilia patients receiving large amounts of Factor VIII, a clotting substance in blood.' The leaflet included a number for a toll-free AIDS hotline where up-to-date information could be obtained.

Joint meeting of the World Federation of Hemophilia and the International Society for Thrombosis and Haemostasis

9.56 Dr Evatt reached a wide audience for his views at a joint meeting of the World Federation of Hemophilia and the International Society for Thrombosis and Haemostasis, held in Stockholm in June 1983. He reported that, by that date, the total number of confirmed AIDS cases in the USA was marginally higher than would be predicted from an exponential growth of the disease.^[82] Haemophilia patients were in the group of infected people who developed opportunistic infections and there were 16 confirmed haemophilia patient cases in the USA (with eight dead by that date), three in Spain, one in Wales and one in Canada. Other delegates at the conference commented that there were more cases than that outside the USA (in Canada, Germany, Israel and Sweden) and that it was possible that these had not been confirmed by the CDC by that date. Of the 16 US haemophilia cases, one related to a mildly affected Haemophilia B patient.

9.57 Further data on the developing picture worldwide was provided at a WHO conference held in Geneva in November 1983.^[83] It was reported that it had been recognised by then that the cases already diagnosed had involved infection as early as 1978, implying a much longer incubation period before the appearance of significant disease than had previously been assumed. The fatality rate was high - less than 20% of those with AIDS were alive two years after diagnosis.^[84]

9.58 Data were updated to 5 December 1983 in the draft report of the conference.^[85] AIDS cases in the USA reported to the CDC by that date were:

Table 9.1: Patients at Risk, December 1983

9.59 In the USA, 0.7% of cases were in people with haemophilia and no other known risk factor and 1% of cases were in those who had received a blood transfusion in the previous five years.^[86] There were, in addition, paediatric cases linked with blood transfusion in which sexual transmission could be ruled out.^[87] The cases diagnosed were concentrated in five urban areas of the country.^[88]

9.60 The major part of the report dealt with surveillance, prevention and control of the disease. By this point there was no question that the USA was confronting a disease of epidemic proportions. Significantly, the draft report of the conference noted that the emerging epidemiological patterns in most western European countries were very similar to the pattern then established in the USA.

Further developments

9.61 The MMWR of 2 December 1983 noted that, based on CDC advice, as at 30 November 1983, 21 cases of AIDS had been reported among haemophilia patients in the USA, 19 among patients with Haemophilia A and 2 among patients with Haemophilia B. In addition, 7 cases from outside the USA had been brought to the attention of the CDC.^[89]

9.62 The retrospective studies referred to above (paragraphs 9.11-9.12), which were carried out on stored frozen blood samples of haemophilia patients using HTLV-III/HIV antibody assays, were enabled by the isolation and characterisation of the AIDS retrovirus in 1983 and 1984 and the development of antibody tests in and after 1984.^[90] These revealed that, in the USA, the peak in haemophilia patient seroconversion occurred in 1982 and 1983, with the earliest known seroconversions in 1978, shortly before the AIDS epidemic among homosexual men and intravenous drug users was first reported. By the end of 1983 and into 1984 the trends were becoming well established.

9.63 Experience of AIDS in the USA had been discussed at a conference of combined clinical staffs at the US National Institutes of Health (NIH) Clinical Research Center, Bethesda, Maryland, on 23 June 1983. An edited summary of the proceedings was published in the Annals of Internal Medicine dated 1 January 1984, giving wide publicity to the discussion. The article observed that there had been a doubling of the number of patients afflicted every six months since the original reports in June and July 1981. It proceeded:

Because the incubation period for adults is generally felt to be greater than 1 year, the full scope of the syndrome has not yet been realized. However, the syndrome's pattern of transmissibility suggests that it will remain largely confined to the groups already affected, with minor intrusions into other populations not at high risk.^[91]

9.64 Four major risk groups were identified: homosexual and bisexual men; IVDUs with no history of homosexual activity; Haitian immigrants; and persons with haemophilia. A fifth group (3.8% of reported cases) comprised cases where no association was apparent or known. While numbers of individuals infected would continue to grow, the focus changed from reporting the prevalence of AIDS to the identification of the virus and then to tests for infection and to treatment.

9.65 In relation to haemophilia patients, the situation was developing quickly. In July 1984, the first experimental antibody tests for the newly confirmed HIV became available in the USA. On 26 October 1984, the US CDC published an update on AIDS in people with haemophilia.^[92] A total of 52 cases had been reported of haemophilia-associated AIDS in the USA. Thirty patients had died and only three diagnosed more than a year previously were still alive. The CDC had studied over 200 recipients of Factor VIII and 36 recipients of Factor IX concentrates containing materials from US donors. AIDS virus antibody rates of prevalence were 74% for Factor VIII recipients and 39% for Factor IX recipients.

9.66 On 31 October 1984, Professor Elaine Eyster at the Milton S Hershey Medical Center, Pennsylvania State University, wrote to Dr Brian McClelland, Director of the Edinburgh Blood Transfusion Service, about work carried out by her team:

The data on sero conversion rates in 30 patients has not yet been put into abstract form or submitted for publication. I can tell you, however, that sero conversion began in 1979 when three of the 30 patients tested in 1983-84 became positive. The number steadily increased, with the big jump occurring in the year 1982.^[93]

9.67 Retrospective testing of stored serum samples was adding to the available knowledge of the history of transmission of infection.^[94]

9.68 By the end of 1984, the epidemic was well established in the USA, generally and in relation to haemophilia patients. The numbers of individuals infected were an indication of its extent but they were no longer relevant to whether there was a disease, or to diagnosis, or to treatment.

Reports from outside the United States of America

9.69 In the UK, the emerging epidemic was brought to the notice of the general public in media comment. An article published in The Observer in January 1983 entitled 'Mystery disease threat' stated: 'A commercial blood product imported into Britain from the United States may pose a grave threat to the health of haemophiliacs who inject it to encourage clotting'.^[95] The article continued by saying that the product, Factor VIII concentrate, was being linked in the USA with a devastating new disease which caused a serious breakdown in the body's immune system. It was noted that the spread of the disease was described by officials at the CDC as 'an impending epidemic' among haemophilia patients. The article went on to describe how the disease had advanced from the homosexual community to include haemophilia patients.

9.70 Data were made known to a significant number of UK doctors when Dr Craske's research up to the end of 1982 was reported informally on 24 January 1983 at a meeting held at Heathrow Airport chaired by Professor Arthur Bloom.^[96] The report dealt mainly with experience in the USA. Dr Craske reported that the population groups affected by AIDS in the USA included promiscuous homosexuals, heroin addicts, immigrants into the USA from Haiti and haemophilia patients. Up to 10 December 1982, some 800 people had been reported as suffering from AIDS and there was a 45% mortality rate. Ten haemophilia patients in the USA had been affected, including a 7 year old child, and five had died. By that stage, only one or two cases of AIDS had been reported from the Communicable Disease Surveillance Centre (CDSC), based in Colindale, London.^[97]

9.71 Dr Craske's report would have provided important and well researched information to those attending the meeting. In the case of the US haemophilia patients, all had prolonged treatment with Factor VIII but there was no implication of one particular product or batch. It would have been clear that the problem was not limited to a single production process or event. Cases involving blood and blood product transmission had included platelet transfusions. An association with transfusion was explicit in some of the cases.

9.72 Lack of understanding of the natural history of the disease was to have a bearing on the response of UK scientists and clinicians for some time. A report of the UKHCDO Hepatitis Working Party dated 1 March 1983 set out what was known of the origins of AIDS and the signs and symptoms of infection.^[98] The report noted that the CDC had asked UK Haemophilia Centre Directors to report cases possibly associated with US commercial concentrates and that cases should also be reported to the CDSC. UK haemophilia clinicians were brought into the wider survey of the disease at this time.

9.73 The report would not, however, have communicated the full extent of the implications for individuals with AIDS. It commented:

It is ... possible that the initial phase of the disease ... may not always progress to the final syndrome where marked depletion of the lymphoid cells is the most obvious appearance on histology of lymph nodes. It is therefore evident that the disease is not universally fatal and some patients may recover.^[99]

9.74 The natural history of AIDS was not then understood. Dr Winter commented that while, on the basis of the information then available, it was reasonable to suggest that not every patient infected with HIV would progress to AIDS, there was no basis for the statement that some might recover from AIDS: that was not the case, as events subsequently transpired.^[100] The report understated the risk to patients and this was to be a continuing feature of comment for a time.

9.75 Dr Peter Foster of the Edinburgh Protein Fractionation Centre (PFC - the manufacturer of NHS blood products in Scotland) gave a talk to Professor Ludlam's department on 8 March 1983 on methods for preparing non-infective blood products.^[101] The talk was concerned primarily with avoiding or minimising the risk of transmission of hepatitis viruses although, among other problems of interest to blood product manufacturers, he referred to other infectious agents, including AIDS.^[102]

9.76 The Haemophilia and Blood Transfusion Working Group met on 22 March 1983.^[103] There was concern that AIDS might appear in the UK and the Haemophilia Society was reported to be attempting to 'reassure its members and put fears of infection from blood products into perspective'. It was hoped that homosexuals and others at risk might be discouraged from being blood donors, although Transfusion Directors were reluctant to upset potential donors by asking questions to which they might take exception.^[104] When asked whether enough concern had been expressed at this meeting, Professor Ludlam assured the Inquiry that there was concern and also 'bafflement'. He said that it was clear that it was a possibility, or even probability, that AIDS would come into England and Scotland.^[105]

9.77 Professor Forbes also attended this meeting and, although he had little recollection of the discussions, he recognised that there was a wave of tremendous anxiety about HIV infection and its transmission and, he told the Inquiry, depression in the patients who were being exposed to the possibility of infection. He continued:

I think most people thought that it undoubtedly would appear in the course of time, and already we were starting to look rather differently at our patients to see if they had any of the features that might be an early warning of AIDS.^[106]

9.78 On 28 March 1983, the UK National Institute for Biological Standards and Controls (NIBSC) was sufficiently concerned about the US position (where steps were being taken to avoid blood from high-risk groups in the preparation of certain blood products) that it suggested that the problem of AIDS should be considered at a meeting of the Committee on Safety of Medicines (CSM). The author (name redacted) of a letter of that date thought it would be helpful if the Chairman of the Haemophilia Directors' group, Professor Bloom, could attend and advise the meeting. The author also requested the latest information on the surveillance of the condition in the UK.^[107]

9.79 Professor Bloom was frequently consulted at this time on matters relating to haemophilia patients. The CSM's functions were regulatory. The committee was concerned with the safety of medicines in general and this included the safety of blood. Any clinical investigation of the potential epidemic would have been carried out by the CDSC, the British equivalent of the CDC in the USA.^[108]

9.80 A report prepared by the Council of Europe dated 28 April 1983 summarised the AIDS situation in member states and other countries represented on the committee, as then reported.^[109] The report was discussed at the meeting of the Committee of Experts on Blood Transfusion and Immunohaematology in Lisbon held between 16 and 19 May.

9.81 Low numbers of infections were reported. The UK had eight possible cases, all males and almost all homosexuals. None followed the transfusion of blood or blood products. Most of the European countries reported fewer than five cases and, of those cases, the majority were homosexuals. Belgium had 15 cases affecting both male and female heterosexuals from Zaire (now the Democratic Republic of Congo). West Germany had the highest number of cases, 18, two of whom were haemophilia patients. The other European country to report several cases of AIDS in haemophilia patients was Spain, with three cases of haemophilia patients from the Andalusia region (two were brothers). Cases of AIDS in Canada were also included where there were 31 known patients, 16 of whom had died.

9.82 The three Spanish cases were reported in The Lancet on 30 April 1983.^[110] One patient had already died and a second was in hospital, seriously ill. The third had PCP, among other indications of advanced disease, but his general condition had improved with treatment. Prognosis for the survivors was not discussed but would not have been indicative of a benign outcome. Dr Spence Galbraith, Director of the CDSC in England and Wales, contacted the health authorities in Spain and discovered that the three patients had all received Factor VIII concentrate from the USA.^[111] As noted below at paragraph 9.99, Dr Galbraith was to take a particular interest in following up these reports.

Press reports

9.83 On 1 May 1983 an article published in The Observer summarised the impact on the US population of 'America's newest and deadliest epidemic'.^[112] The newspaper's US correspondent reported that more than 1350 patients in the USA had already been diagnosed as suffering from AIDS. No cure had been found and, given the long incubation period (up to three years), it was feared that thousands of people could be unwitting carriers. The most recent suspected victims were babies and adults who did not fall into any of the identified high-risk categories; it was feared that this disease was spreading to other groups within the community.

9.84 The article stated that more European sufferers had been identified, and that in France there were 29 patients, 13 of whom had died. Eleven haemophilia patients in Europe had been affected and this strengthened suspicions that AIDS could be passed on through blood. The US government was reported to be unwilling to stigmatise homosexuals, already a 'harassed minority', by banning them from donating blood. The US National Hemophilia Foundation, however, believed that this had to be the next step. The US government's official view, expressed by a spokesman for the Food and Drug Administration, was that: 'There [was] no clear cut evidence to show that AIDS [could] be transmitted through blood transfusion'.^[113]

9.85 Also on 1 May 1983, Susan Douglas, journalist for the Mail on Sunday, 'revealed exclusively' that two cases of AIDS in haemophilia patients had probably occurred in the UK already.^[114] An accompanying opinion piece stated that '[t]he victims were not homosexuals but patients who had been treated with plasma imported from America'. The article continued with speculation that Britain would not be self-sufficient in producing 'this special kind of blood' until 1986. The paragraph concluded with the comment: 'Fortunately there is an alternative. It can be bought from Switzerland'.^[115]

9.86 The tone of an article in The Daily Mail' on 2 May was equally uncompromising.^[116] It stated: 'Government health experts have begun investigating the possibility that Britain is importing blood products from America contaminated with the killer homosexual disease AIDS'. The article concluded: 'According to the Department of Health, the advantage of using imported blood products far outweighs the "slight possibility" that AIDS could be transmitted to patients through [Factor VIII]'.

9.87 The Daily Express also published an article on 2 May and described AIDS as 'The new killer-disease'.^[117] The focus of this article was fear of the unknown and fear that it could be a more general sexually transmitted disease also affecting heterosexuals. Dr Vernon Coleman (medical author and researcher) was quoted at the end of the article: 'If we could discover exactly what AIDS is - indeed, IF it is - we might be able to do something to counter it'.

9.88 These publications caused concern generally and particularly amongst at-risk groups, including haemophilia patients.

The position of the Haemophilia Society

9.89 With AIDS now reported and discussed in the UK popular press and the media generally, anxiety grew among people at risk. Anxiety was spread not only by the facts but also by the tone of media comment. Prompted by the media coverage to date, and in particular the Mail on Sunday article of 1 May 1983 referred to above, the Haemophilia Society distributed to its members on 4 May 1983 a letter containing a statement by Professor Bloom. He commented that the number of AIDS cases in haemophilia patients was small, that he was unaware of any proven case in 'our own haemophilia population' and (incorrectly) that none had been reported from Germany.

9.90 In an apparent attempt to reassure Society members, Professor Bloom wrote:

The cause of AIDS is quite unknown and it has not been proven to result from transmission of a specific infective agent in blood products .... Thus whilst it would be wrong to be complacent it would equally be counter-productive to alter our treatment programmes radically.^[118]

9.91 Mr David Watters, former General Secretary of the Haemophilia Society, told the Inquiry how the Society had come to send the letter. He explained that what had prompted the Society's letter was the assertion in the Mail on Sunday that the UK did not have to rely on the US for Factor VIII as there was an alternative source in Switzerland. He continued:

[T]hat simply was not true and it made it appear as if we had been allowing people to be treated with suspicious product, whereas there was a known safer source. And of course, the media on its high horse knows better than everyone else what is correct and good for society; in this case they got it quite horribly wrong.^[119]

9.92 Mr Watters further explained that the Society's letter was intended to reassure members that there were no known cases of AIDS in the haemophilia population. He felt that the Society had better information than the media and said: 'the Mail on Sunday had quite clearly diagnosed two entirely on its own'.^[120]

9.93 At this time, Mr Watters was receiving telephone calls day and night from people who were worried. He was happy with Professor Bloom's message, bearing in mind that '[p]eople with haemophilia were really between a rock and a hard place: do you discontinue treatment and run the risk of a fatal bleed or do you continue to treat and run a potential other infection risk?'^[121]

9.94 Everyone involved in the framing of the letter considered that reassurance was required. Mr Watters advised that members of the board who had access to faxes saw the letter and he was confident that it was also faxed to members of the medical advisory panel. Nobody expressed dissent from what was said in the letter.^[122]

9.95 The reassurance was, however, based on data that were incorrect and that could have been readily checked. The Mail on Sunday article specifically stated that the suspected UK case was in Cardiff where Professor Bloom was Director of the Haemophilia Centre. Based on reports from that centre, a bulletin from the CDSC, dated 6 May 1983, reported the case of AIDS in a 20 year old man with haemophilia in Cardiff. The patient had been ill with 'AIDS-related complex' (ARC) for three months.^[123] The report stated that this was the first case of AIDS in a UK haemophilia patient known to the CDSC. Dr Winter thought it possible that Professor Bloom was a laboratory-based specialist, not a clinician, and that he did not know of the case.^[124] Dr Winter did not think that a clinician would have made comments such as those made by Professor Bloom at the time.^[125] Professor Ludlam questioned whether the Cardiff case was AIDS, but at the time the CDSC recognised this and another case, from Bristol, as cases of AIDS.^[126]

9.96 There were also, by this stage, early reports of infection in West Germany. The Council of Europe report of 28 April 1983 dealt with AIDS in two German haemophilia patients.^[127] The report, perhaps prepared earlier in April, noted that there were no reports of cases following the transfusion of blood or blood products in the UK.^[128] By May the situation was changing.^[129] It is unclear how widely the deliberations of the Council would have been read. Dr Winter indicated that the deliberations of the Council of Europe were not perceived as relevant to haemophilia clinical practice.^[130] He thought that the recommendations in the report had clearly been written by people who were not 'haemophilia people'.^[131] Professor Lever had a similar view: the Council of Europe was not influential in his area of work.^[132] As appears in the discussion of screening for HCV, however, transfusionists and virologists did take note of the views of the Council and its expert committees.^[133] Whatever the degree of authority otherwise accorded to its statements, the report of infections in Germany was fact and further undermined Professor Bloom's letter. Later reports in December 1983 from the WHO conference in Geneva appear to indicate a significant acceleration in identification of infection between then and October, when 42 cases were reported from West Germany to the WHO.^[134]

9.97 In light of the Haemophilia Centre's report of the Cardiff case to the CDSC in time for the publication in the edition for the week ending 6 May 1983, it is difficult to understand the reference to lack of awareness of cases in 'our own haemophilia population'. The newspaper report had identified Cardiff as the location of the haemophilia patient who had been unwell with ARC for three months before the date of the published letter. Preparations must at least have been in hand by 4 May to report the case as a definitive case of AIDS for publication by the CDSC for the week ending 6 May. If publication by the CDSC was essential to the description of a case as 'definitive' or if the word 'proven' was being used because of the absence of identification of the causative pathogen, Professor Bloom's letter may have been literally accurate but then it would also have been disingenuous. If he did not in fact know of the case, questions would arise concerning arrangements for the dissemination of important and relevant information about patients within his centre.

9.98 In the UK, the systems for reporting instances of AIDS, which were introduced in 1982, were not well developed by this stage. However, absolute accuracy apart, it is of concern that commentators, such as Professor Bloom in these instances, could publish that there were no reports of disease in the UK and two only in Germany respectively, when of necessity they must have been proceeding on information that was quite wrong in fact. In the case of Professor Bloom, he could not have failed to discover the true position if he had sought information, even assuming that he could have headed the centre without being aware of such a critical matter affecting a patient there. In the result, the letter was misleading. It gave false reassurance to patients who read it.

Official responses in the United Kingdom

9.99 Dr Galbraith responded to the reports he had read. He wrote to Dr Ian Field, DHSS, in May 1983.^[135] He commented that the Cardiff case had involved US Factor VIII concentrate and that the case fitted the recognised criteria for a diagnosis of AIDS. He referred to the three Spanish cases (see paragraphs 9.81-9.82) and recent reports from the USA, in particular the case of the multiply-transfused child (see paragraph 9.31). In his supporting paper he commented that the mortality rate of AIDS at that point exceeded 60% and was expected to reach 70%. As a public health doctor, he took a serious view of the threat to haemophilia patients in the UK.

9.100 Media comment brought a further reaction. There was a special meeting of the Haemophilia Reference Centre Directors at St Thomas' Hospital on 13 May 1983.^[136] Recent media publicity about AIDS was said to have caused considerable anxiety to haemophilia patients and their medical attendants as well as the DHSS, making it necessary for the Directors to consider what should be done with regard to the surveillance and reporting of suspected cases and the management of patients. It was noted that, up to that date, one haemophilia patient in the UK was suspected of suffering from AIDS and that, in London, there were reported to be 10 cases of confirmed AIDS in homosexual males. The minutes proceeded:

It was felt that there might be many individuals with evidence of impaired cell-mediated immunity but only a very small number of these might progress to a full-blown picture of the condition. It is important that such individuals are not classified as suffering from AIDS. It was accepted that because of our lack of knowledge of the nature of AIDS, decisions about diagnosis and reporting of suspected cases would prove difficult.^[137]

9.101 At this stage, the viral aetiology of AIDS (that is, knowledge that a virus caused the disease) had not been established by generally accepted evidence. In particular, Robert Gallo and his colleagues had yet to disclose the identification of HTLV-III as the transmissible agent, satisfying US specialists who had not been persuaded by the French research previously published by Luc Montagnier and others.^[138] Narrowly defined reporting requirements risked suppressing the prevalence of infection with the (as yet unknown) agent of transmission, however.

Reporting criteria

9.102 It was decided that, for reporting purposes, CDC criteria would be used and the importance of opportunistic infection was stressed. A definitive diagnosis would be attached if the patient developed intractable disease. It was noted that many Haemophilia Directors had, up to that point, reserved NHS concentrates for children and mildly affected patients and it was suggested that it would be 'circumspect' to continue with that policy. It was agreed that there was insufficient evidence to warrant the restriction of the use of imported concentrates in other patients in view of the immense benefits of therapy. It was noted that, once the condition was fully developed, it seemed irreversible so that there would be no clinical benefit to be gained from changing from one type of concentrate to another.

9.103 The requirement for evidence of intractable disease added to the burden of proof of infection (as had happened previously when a requirement for clinically manifest disease was included in the definition of non-A, non-B Hepatitis infection - see Chapter 15, Knowledge of Viral Hepatitis 2 - 1975-1985). There was no requirement for notification of cases of impaired cell-mediated immunity. As a result, the data required for a comprehensive understanding of the epidemiology of the disease were incomplete.

9.104 Meanwhile, media coverage continued. On 18 May 1983 The Sun published an article 'U.S. Gay Blood Plague Kills Three in Britain'.^[139]

Developing knowledge

9.105 Apart from haemophilia clinicians, developing knowledge of AIDS was also of relevance to fractionation scientists (those concerned, that is, with the preparation of blood products). Dr Foster of the PFC attended the meeting of the World Federation of Hemophilia and International Society for Thrombosis and Haemostasis in Sweden in June 1983.^[140] He also recorded data provided by Dr Evatt about the spread of AIDS in the USA and elsewhere.^[141]

9.106 The Sub-Committee on Biological Products of the CSM discussed AIDS on 13 July 1983.^[142] Reported comments on AIDS provide a clear insight into the understanding of this important body about the epidemic in mid-1983. Transmissibility of the postulated transmissible agent was thought to be low. Risk was thought to be small, so small that it did not justify serious consideration of withdrawal of US commercial concentrates (as had been suggested by Dr Galbraith in his letter to Dr Field, DHSS).^[143] These outcomes had been anticipated in a 'suggested agenda' for the meeting.^[144] For the proposal to be considered unworthy of serious consideration, however, the perceived risk to the UK community must have been considered small indeed. Unfortunately, this was to prove an inaccurate assessment. It was also noted that both haemophilia doctors and their patients, who saw at first hand the benefits of Factor VIII over cryoprecipitate, did not wish US blood products withdrawn. The committee will have taken this into account. There were 2167 patients with haemophilia receiving treatment in the UK at the time.^[145] In England and Wales a high proportion received imported concentrates, while in Scotland the proportion was much lower. Only a relatively small percentage of blood products used in Scotland in 1983 came from the USA.^[146] Nevertheless, overall there was a high exposure to risk and a high incidence of infection emerged over time.

9.107 On 14 July 1983, in the House of Lords, Baroness Dudley asked how widespread AIDS was and what steps were being taken to prevent it spreading into the community.^[147] Lord Glenarthur (then the Parliamentary Under-Secretary of State, DHSS) replied that 14 cases had been reported to the CDSC and two more were being investigated. There were approximately 60 cases within member states of the Council of Europe. When asked why the UK imported blood products from the USA, Lord Glenarthur said: 'We have to import Factor VIII, which is an agent used in the cure for haemophiliacs. We shall need to continue to do that until we are self-sufficient ourselves'.

9.108 At this stage, there was doubt at UK government level whether a link between blood transfusion and AIDS had been established. In the course of his answer to Baroness Dudley, Lord Glenarthur stated:

Although there is no conclusive evidence that AIDS is transmitted by blood or blood products, the department [DHSS] is considering the publication of a leaflet indicating the circumstances in which blood donations should be avoided.^[148]

9.109 'No conclusive evidence', appears to have been a recurring form of words used with some frequency at this time. In a letter to the Association of Scientific, Technical and Managerial Staffs (ASTMS), undated but marked as received on 26 August 1983, Lord Glenarthur referred to the need to emphasise that 'there is no conclusive evidence that AIDS is transmitted through blood products'.^[149] The leaflet anticipated in Lord Glenarthur's reply on 14 July was issued on 1 September 1983 for use throughout the United Kingdom.^[150] A Press Release issued to accompany the leaflet stated: 'there is no conclusive proof that the disease [AIDS] can be transmitted in blood or in blood products'.^[151] On 14 November 1983, in answering a Parliamentary Question in the House of Commons by Edwina Currie MP, Kenneth Clarke MP, Minister of State for Health and Social Services, said: 'There is no conclusive evidence that acquired immune deficiency syndrome (AIDS) is transmitted by blood products'.^[152]

9.110 In contrast, the leaflet issued on 1 September 1983 for distribution to blood donors included in the series of questions and answers the following: 'Can AIDS be transmitted by transfusion of blood and blood products?' with an answer which began: 'Almost certainly yes ...', explaining that the risk of transmission was higher to people with haemophilia than to recipients of ordinary blood transfusions.^[153]

9.111 The Haemophilia Society was concerned that there should be no attempt to suspend the importation of US commercial products in the absence of 'definite evidence' that that would be necessary. On 15 August 1983, the Coordinator of the Society wrote to a government official regarding a meeting arranged between representatives of the Society and Lord Glenarthur to take place on 8 September 1983.^[154] Avoiding the banning of importation of concentrates from the USA was one of the issues the Society wanted to discuss. An undated file copy of a letter from Lord Glenarthur to the society records points made at the meeting.^[155] He commented that, in considering whether the importation of blood products from the USA should cease, it was deemed necessary to weigh the possible risks of infection with AIDS against the obvious risks arising from inadequate supplies of Factor VIII. He noted that the FDA in the USA had introduced regulations designed to exclude plasma donors presenting a high risk of AIDS but that there was still a considerable quantity of pre-March 1983 stock, both in the UK and in the USA awaiting export. The FDA had decided not to ban the use of this stock, since doing so would cause a crisis in supply, in both the UK and the USA.^[156] Importation would, on this view, continue.

9.112 By letter dated 13 December 1983, Lord Glenarthur wrote to John Maples MP, who had enquired about the government's assessment of risk in light of recent press reports. The letter stated that the cause of AIDS was as yet unknown and that there was no conclusive proof that the disease had been transmitted by US blood products.^[157] It proceeded to repeat the information given to the Haemophilia Society that importation would continue, including stock collected before the regulations introduced by the FDA from March 1983.

9.113 On 5 January 1984, another letter was sent by Lord Glenarthur to the ASTMS. The first full paragraph of the letter appears to indicate that the official view had become qualified (emphasis as in original):

It remains the case that there is no conclusive evidence of the transmission of AIDS through blood products, although the circumstantial evidence is strong.^[158]

9.114 The Department of Health papers also include a photocopy of an article from The Sunday Times of 25 March 1984 which records:

Doctors now have conclusive proof that the mysterious and generally fatal ailment known as AIDS has been passed to a hospital patient through a blood transfusion.^[159]

9.115 On what appears to be the reverse of this photocopy, someone has written:

We dropped "there is no conclusive proof that AIDS is transmitted through blood or blood products" from our standard line some time ago.^[160]

9.116 The evidence available suggests that the line was dropped between January and March 1984.

9.117 It appears that, until the spring of 1984, a highly nuanced use of language had been adopted in communicating the government's position and the Inquiry sought to explore the situation. Within the papers released by the Department of Health, there was a photocopy of an excerpt from The Guardian published on 19 November 1983 referring to the Bristol haemophilia patient who had died of AIDS (see paragraph 9.125 below). Along the foot of the photocopy, in a handwritten note which appears to have been dated 23 November, the following is written:

Have you seen [this]? On X [a section marked in the article about the Bristol patient] is it OK for me to continue to say "there is no conclusive proof that the disease has been transmitted by American blood products". PS Congratulations on your promotion.^[161]

9.118 In different handwriting, along the top, there is what appears to be a response:

Thanks. Yes it is OK.^[162]

9.119 In 2010, the Inquiry was advised by the Department of Health that the first note was written by a middle-ranking official and that the response was by Dr Diana Walford.^[163]

9.120 The Inquiry asked Dr Walford about the formulation and maintenance of the standard line. With particular reference to the question in November 1983 concerning whether it was OK to say that there was no conclusive evidence of a link between AIDS and blood products, Dr Walford replied that 'given the state of knowledge about AIDS and its causative agent at that time, this was the appropriate answer to the question as posed'.^[164]

9.121 Before testifying at this Inquiry, Dr Winter had provided evidence to the Archer Inquiry. He had said in his submission:

In November 1983, the Health Minister, Kenneth Clark [sic], announced in Parliament that "there was no evidence that AIDS is transmitted by blood products".^[165]

9.122 It was suggested to Dr Winter that his recollection of what Mr Clarke had said was incorrect. In relation to the words 'no conclusive evidence', Dr Winter commented:

What, if you like, I objected to is the clear sentiment. The sentiment is saying, "We have no good evidence that AIDS is due to blood products". I mean, all haemophilia clinicians by this stage clearly believed that commercial blood products could and were transmitting AIDS. So it would have been more appropriate if the Secretary of State had said something to that effect, rather than using that form of words, with its implication that there remained doubt. Technically he was correct but I don't think he realised how fortunate he was, in terms of that, really.^[166]

9.123 The Inquiry is sympathetic to Dr Winter's observations. It is not at all clear what evidence one requires beyond that required for 'near certainty' (the view of the association set out in the leaflet of 1 September 1983) to amount to 'conclusive proof' or 'conclusive evidence' of an association between blood and blood products and transmission of an infective agent in the public health area. The risk of misinterpretation, as evidenced by Dr Winter's comments, appears to have been real, though the Inquiry cannot know whether the use of the standard line did in fact mislead any individual or body. As matters stood, it was not until mid-1984 that there was general (though not even then universal) acceptance that AIDS was caused by parenteral transmission of HIV, as discussed in Chapter 11, AIDS Aetiology. As Dr Winter noted, the official position was 'technically' correct, but it risked contributing to a false sense of security. However, at this stage the incidence of AIDS in the UK remained low.

9.124 Of the 14 cases of AIDS reported to the UK CDSC by 31 July 1983, six were cases of KS without PCP, five were cases of PCP without KS and three involved other opportunistic infections.^[167] Five patients, all adult homosexual men, had died. One of the 14 patients, the youngest at 20, was a haemophilia patient.^[168]

9.125 On 10 September 1983, Dr Craske issued an update on the UKHCDO investigation of AIDS cases in patients with blood coagulation disorders.^[169] 'The Cardiff patient - reported as a possible case of AIDS in the CDSC Bulletin for the week ending 6 May 1983 - remained in reasonable health.^[170] 'The Bristol patient', a mildly affected haemophilia patient aged 57 and considered to be a mild or prodromal case of AIDS (signalling the onset of disease), had remained unwell through June and July and died in August. A post-mortem had revealed PCP. This was considered to be the first confirmed case of death from AIDS possibly associated with transfusion of blood products in the UK. The case clearly met the criteria decided on 13 May: the patient had developed intractable disease. The same cases were reported to the UK Haemophilia Centre Directors' Hepatitis Working Party on 14 September 1983.^[171]

Haemophilia Reference Centre Directors' meeting

9.126 A meeting of the Haemophilia Reference Centre Directors was held on 19 September 1983.^[172] Scotland was represented at this meeting by Professor Ludlam. The minutes of the meeting recorded that Dr Craske's paper updating the situation regarding AIDS in the UK was discussed at length.^[173] Professor Bloom said that Dr Galbraith of the CDSC was somewhat concerned that he had not heard about the Bristol patient who had died of AIDS. Differing views were expressed about whether it was the responsibility of the centre directors themselves to report directly to the CDSC as well as to Dr Craske. It was agreed that reporting to the CDSC should be through Dr Craske after discussion with the doctor involved in the patient's management. It was also agreed that patients who had received the same batches of NHS or commercial Factor VIII as the Bristol patient should be followed-up. Dr Craske stressed the need for a properly conducted epidemiological study of AIDS in the haemophilia population. It was noted that Dr Peter Jones (Newcastle Haemophilia Centre) and Dr Forbes were both taking part in a forthcoming international study.

9.127 Professor Bloom's update of the May AIDS circular prepared for the Haemophilia Society was approved by the Haemophilia Reference Centre Directors. It was released as a fact sheet, called 'Haemofact A.I.D.S. Release No 2', on 22 September 1983.^[174] It reported that there had been one death recorded in a person with haemophilia (the Bristol patient) and that there remained one other suspected case in Cardiff. There had been no other cases relevant to haemophilia patients reported to the PHLS. In the summary, the leaflet stated that the Society had maintained close liaison with all relevant personnel and government departments to ensure the Society's views were known.

9.128 A representative of the DHSS (probably Dr Diana Walford, the only representative of the Department in attendance) drafted a note of the Haemophilia Reference Centre Directors' meeting. She wrote that the relatives of the man who died in Bristol had taken legal advice and were keen to sue the manufacturers (Alpha and Immuno) of the commercial concentrate which he received in 1981. The author commented: 'If they go ahead, this could put the cat among the pigeons'.^[175]

9.129 The two confirmed cases were reported on 27 September 1983 to the UK Working Party on Transfusion Associated Hepatitis. The current position on AIDS was reviewed by Dr Craske.^[176] He reported 20 AIDS cases in the UK, including the two haemophilia patients. In discussion, Dr Howard Thomas of the Royal Free Hospital, London, questioned the diagnoses, especially in the case of the Bristol patient. There was renewed concern among the Directors about responsibility for reporting suspected cases of AIDS. The report of the UKHCDO Hepatitis Working Party (under the chairmanship of Dr Craske) for 1982-83 was published on 28 September 1983.^[177] It stated that, up to that time, 16 cases of the syndrome which fitted the criteria used by the CDC and were associated with the transfusion of Factor VIII concentrate had been reported in the USA. Five cases had been reported from Europe. This included a suspect case notified recently in the UK, notified shortly before publication. The report did not disclose the total number of UK cases within the European total. Having regard to the information provided on 27 September, the report was already out of date.

9.130 The varying descriptions of the patients and their signs and symptoms cause some uncertainty as to the precise numbers of haemophilia patients affected by AIDS at this stage. It appears highly likely, however, that there had been two only who had reached the stage of developing intractable disease, as stipulated by the CDC criteria, and that one of the patients had died in August 1983.

Medical Research Council Working Party on AIDS

9.131 On 10 October 1983, the Medical Research Council (MRC) Working Party on AIDS met.^[178] The position on AIDS was reviewed. The manifestations of AIDS were noted to vary according to both host and environmental factors. The underlying difficulties in assessing the extent of the disease at this time are reflected in some of the discussion reported:

The pattern emerging in early UK cases seemed different in some respects from the American experience .... The laboratory markers for disease were well established for AIDS itself but their relevance in screening and in a possible precursor state was not established. The problems of definition and interpretation of these so called precursor syndromes were outlined by several members.^[179]

9.132 The special features arising in relation to haemophilia were discussed. There were said to be varying and considerable periods of incubation (one to four years). It was noted that:

The possibility that AIDS as currently defined was the tip of an iceberg in terms of the range of clinical or subclinical responses to infection with a putative AIDS agent was mentioned; it was recognised that the existence of milder forms would be hard to establish without a marker for such an agent.^[180]

9.133 In reviewing available information on epidemiology, it was noted that in the USA the pattern of the number of cases doubling every six months appeared to be continuing. The UK figure (now standing at 24 cases) indicated that there had been a recent increase almost conforming to a six-month doubling time. It appears from the report of the discussion that, at least among the members of this group, there was an apprehension that the current definition of AIDS for reporting purposes was failing to produce data reflecting the full extent of the problem.^[181]

Further meetings

9.134 On 17 October 1983, at a meeting of the Advisory Committee of the National Blood Transfusion Service, Dr Walford, DHSS, said that there had been 24 cases of AIDS reported in the UK, two of whom were haemophilia patients and one of whom had died, and that comparison with 'reported incidence in the UK [sic - US^[182]] haemophilia population' suggested that the UK could anticipate between two to four deaths from the disease among people with haemophilia from the disease.^[183] Unfortunately this was to prove to be a considerable underestimate but it may have reflected her understanding of experience in the USA to that date. There was by that stage, in the official view as represented by Dr Walford, 'no conclusive proof of a link between AIDS and blood products' that might have instructed a different assessment of the risk.

9.135 At the 14th meeting of the UK Haemophilia Centre Directors on the same day, 17 October 1983, Dr Craske presented his paper on AIDS.^[184] He outlined his proposals for investigating the UK cases of AIDS in haemophilia patients and proposed follow-up for three years of patients who had received 'suspect batches of concentrate.'

9.136 Dr Robert Perry of the PFC prepared a note of the meeting in which he listed the numbers and categories of people with AIDS in the USA.^[185] He then wrote in relation to the USA:

Crude interpretation of these figures provides the following risk statistics.

Transfusion - 1 in 500,000 at risk
Haemophiliacs - 1.2 in 1000 at risk
Conclusion - Serious disease in haemophiliacs a low possibility??^[186]

9.137 For haemophilia patients the risk factor reflected the information that there had been 15 cases with AIDS in the USA reported at that time. Dr Perry noted the UK situation, as reported, to be that there were 22 patients who met the NIH criteria, 10 of whom had died, and two who were haemophilia patients. Again, comparison with US experience, as understood at the time, would have suggested that very few UK haemophilia patients were at risk of death from AIDS.

9.138 The Guardian of 19 November 1983 reported that the Bristol patient who had died of AIDS in August almost certainly caught the disease from contaminated supplies of imported Factor VIII,^[187] quoting from a letter by Bristol clinicians published in The Lancet of that date.^[188] The haemophilia patient, otherwise fit, had undergone surgery in December 1981 and had received intensive treatment with Factor VIII of US origin. Over 12 days he received 48,253 international units of freeze-dried Factor VIII, his first exposure to commercial concentrate having previously received NHS cryoprecipitate and concentrate manufactured at the Blood Products Laboratory (BPL - the manufacturer of NHS blood products in England and Wales), Elstree, over 10 years at an average rate of 5000 units per annum. His deteriorating condition was traced from the emergence of signs and symptoms early in 1982 until his death. The letter stated:

The diagnosis of AIDS is essentially clinical but our patient met the Centers for Disease Control's criteria in that, without any known cause for immunodeficiency, he had P. carinii pneumonia.

9.139 The patient had become unwell a few weeks after receiving the treatment. The writers thought it highly probable that the development of AIDS was related to his treatment.

9.140 Dr McClelland and Mr John Watt (Director of the PFC) represented the SNBTS at a WHO conference held in Geneva between 22 and 25 November 1983.^[189] The draft report of the conference was circulated on 14 December 1983^[190] and contained European data up to October 1983.^[191] By 20 October, 268 cases of AIDS had been reported to the European Regional Office of the WHO.^[192] These included 24 from the UK (17 diagnosed in 1983) and 42 from the Federal Republic of Germany, as already noted (but none from the GDR, the Soviet part of the country). Reported from France were 94 cases (47 in 1983) and, from Belgium, 38 cases (24 in 1983). For Europe, four per cent of cases were said to be in people with haemophilia.^[193] Coagulation factor concentrates had been implicated. Dr McClelland prepared an initial report on the meeting dated 5 December 1983 for the Scottish Regional Transfusion Directors.^[194] The directors met on 8 December and discussed AIDS.^[195] Dr McClelland reported that the WHO had received a report of two cases of AIDS in haemophilia patients in the UK. The number of reported cases remained low at this stage.

9.141 It is apparent that, apart from the general concerns noted by the MRC Working Party on AIDS on 10 October 1983, there was still little anxiety about the position in Scotland at this point. However, media comment was soon to follow. An article by Dr Galbraith in The Lancet of 10 December 1983 noted two new UK cases, bringing the total to 26, which included the two haemophilia patients previously recorded.^[196] This was taken up in The Guardian of 9 December 1983, in which Andrew Veitch, medical correspondent, commented on the emerging pattern, and also noted that the DHSS had reported two new deaths, bringing the total to 12.^[197] The comment was balanced and well informed but, in the wider political context, it provided a focus for increasing concern, though the numbers of British haemophilia patients reported as having symptoms remained small at the time. He reported the additional cases and, in the case of haemophilia patients, wrote:

The victims include two haemophiliacs, one of whom died, who are thought to have contracted the disease from contaminated supplies of Factor VIII, the blood clotting agent, imported from the US.

The risk of haemophiliacs developing the disease are put into perspective today by Dr Peter Jones, director of the Newcastle upon Tyne haemophilia centre.

He calculates, in a leading article in the British Medical Journal,^[198] that the incidence of Aids among haemophiliacs here and in US is about 0.8 per thousands.

....

Fears among British specialists that Aids arrived from the US two years ago and may reach epidemic proportions next year, are born [sic] out today by a report from doctors at West Germany's federal Aids working group headquarters in Berlin.

So far 44 cases have been registered and 14 have died, they write in the Lancet. Clusters of cases have been identified in Munich, Frankfurt and Berlin.

They warn: 'These data indicate ... that the epidemic is now spreading within the German homosexual community and may increase exponentially. The incubation period of Aids infection suggests that the increase will parallel that observed in 1981-82 in the US, but with a time lag of 1 ½ - 2 years.'

9.142 Dr Jones' calculation was no doubt intended to indicate that the incidence of AIDS among haemophilia patients was low (though broadly consistent with other contemporaneous data) but equating the UK risk with the risk in the USA was unlikely to be comforting to those who had believed that the disease was a phenomenon particularly associated with the USA. Nevertheless, although the trends were beginning to be well established in the USA, it remained the position that, at the end of 1983 and into 1984, AIDS was still not seen by clinicians and officials in this country as presenting a major threat to haemophilia patients in the UK.

9.143 A meeting arranged by the NIBSC to examine the infectious hazards of blood and blood products, with particular reference to hepatitis and AIDS, was held on 9 February 1984.^[199] The SNBTS was represented by Professor John Cash and Dr McClelland. Dr Thomas reported that the most recent information indicated that two UK patients and nine other European patients with haemophilia had contracted AIDS. A recent report from the CDC had also identified 31 people in the USA who had been recipients of a blood transfusion and who had subsequently contracted AIDS.^[200] Dr Craske reported on the two UK haemophilia patients who had contracted AIDS, one of whom had died.^[201] Concentrates had been received by 231 other patients from one or more of the nine batches used in the case of the two infected patients. These other patients were traced but none had developed AIDS by that point.^[202]

9.144 A report by doctors at the Glasgow Western Infirmary of what appears to have been the first reported case of AIDS in Scotland was published on 11 February 1984.^[203] The report, accepted for publication on 3 October 1983, concerned a man who had returned to the UK after working in east Africa for many years and who fulfilled the criteria for AIDS. The signs and symptoms of disease found were said to suggest a disorder of cell-mediated immunity but gave no insight into its cause. The discussion focused on the efficiency of serological testing.

European survey

9.145 On 30 June 1984 The Lancet published an article by Professor Bloom of Cardiff giving the results of his survey of European haemophilia centres.^[204] Together with previous data, the survey pointed to 11 cases of AIDS in 13,147 treated haemophilia patients (0.08%). Commenting on his survey of AIDS in Europe at the end of 1983 and early 1984, Professor Bloom wrote:

A relation of AIDS and the other reported disorders to transfusion of imported blood products was not established .... [T]he role of American concentrates in the causation of AIDS in European haemophiliacs must be regarded as unproven .... In view of the immense benefits that haemophiliacs have derived from treatment physicians are naturally reluctant to abandon these agents, with their hypothetical dangers, in the absence of alternative concentrates which have been proven safer. This attitude may change as information accrues, and haemophilia treatment needs to be monitored world-wide. ^[205]

9.146 He stated that no haemophilia patient with AIDS definitely related to transfusion of blood products was reported from West Germany where very large amounts of US Factor VIII concentrates had been used for many years.^[206]

9.147 Reports of cases outside the USA continued to be published. An example, which later came to have relevance in Scotland as part of a comparative study, was a letter in The Lancet of 7 July 1984 by Dr Mads Melbye and others dealing with a group of Danish haemophilia patients who had been treated with US Factor VIII concentrate.^[207] Of the 22, among the first outside the USA to be tested, 14 were anti-HTLV-III positive.^[208]

9.148 Until this point, reporting in the UK continued to be limited to cases of overt AIDS and AIDS-related diseases. That was to change in the second half of the year for reasons (discussed in Chapter 10, Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 2) relating to the discovery of LAV/HTLV-III and the consequent ability, shown by Melbye above, to test for the presence of antibodies to the virus, although those discoveries did not have an impact on reporting until the autumn of 1984. As discussed in Chapter 11, AIDS Aetiology, the cause of AIDS remained controversial into 1984. With important exceptions, there was little attention paid to the first of the discoveries, the isolation of a Lymphadenopathy Associated Virus (LAV) published in May 1983 by Montagnier and Barré-Sinoussi of the Institut Pasteur in France.

Summary

9.149 By July 1984 the following was known:

• AIDS first affected individuals in the USA in 1978 and in the UK in 1979.
• The first recorded cases of seroconversion in Scotland occurred in 1982.
• The first reports of AIDS in the USA were published in June 1981, indicating that the disease might be associated with a significant prodromal period before overt signs and symptoms became apparent.
• Throughout the period covered in this chapter, the disease was considered to be very largely a US problem.
• An early association of AIDS exclusively with sexual behaviour was undermined by emerging reports of cases not associated with such behaviour.
• Knowledge of AIDS among medical practitioners in the UK generally was patchy throughout this period, with few clinicians having direct experience of the disease. Published material was of specialist rather than general interest.
• Incomplete reporting of instances of AIDS, in the UK and throughout Europe, but especially in Germany, supported a misapprehension in the UK, prevalent until autumn 1983, that blood products imported from the USA were not likely to be associated with transmission of infection to blood disorder patients.
• The epidemic was well established in the USA by July of 1984 both generally and in relation to blood disorder patients.
• Until mid-1984, diagnosis of AIDS in UK patients receiving blood transfusions or blood, blood component or blood product therapy depended on clinical evidence of intractable disease, particularly opportunistic infection such as PCP.
• It was known that the development of opportunistic infection was preceded by cell-mediated immune deficiency, over a period that might be variable but remained significant. However, immune deficiencies, of whatever order of magnitude, were not thought to be diagnostic of a condition likely to progress to AIDS except in very few cases.
• It remained a common view among most commentators in the UK until July 1984 that the cause of AIDS was unknown and that it had not been established that it resulted from transmission of a specific agent in blood products.
• Some scientists, such as fractionation specialists, thought that AIDS was caused by a transmissible agent that could be found in blood and blood products.
• It was believed among haemophilia clinicians that there would be few cases of AIDS among UK blood disorder and transfusion patients.
• Throughout this period, blood disorder therapy continued to include the use of imported commercial factor concentrates from the USA.

10. Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 2 >