Selected Transcripts of the Archer Independent Inquiry
Thursday, 24th May 2007
EVIDENCE OF ROBERT AND ALICE MACKIE
LORD ARCHER OF SANDWELL: I don't know how you would like to do it. Would you like to read your statement?
ROBERT MACKIE: Yes.
LORD ARCHER OF SANDWELL: It's a fairly long one.
ROBERT MACKIE: Well, we'll get there.
LORD ARCHER OF SANDWELL: I'm sure you will.
ROBERT MACKIE: We know it off pat.
LORD ARCHER OF SANDWELL: Would you like to tell us?
ROBERT MACKIE: My wife is going to do it.
ALICE MACKIE: Yes, I will just read it and you can ask him questions. "I have severe heamophilia A and I am co-infected with AIDS and hepatitis C through NHS treatment. Coming from a haemophiliac family, three uncles and one cousin, also with heamophilia A, and none of them bled to death but three out of four died of AIDS due to treatment of Factor VIII. I was diagnosed with heamophilia at about 1 year old and I survived without any treatment until my teenage years when we all began treatment with what was then Cryoprecipitates, and then in 1979 I started to receive Factor VIII. I became infected with hepatitis C at some point before 1994 when, according to my consultant, the first positive hepatitis C result is recorded but was not informed of my HIV status until my AIDS consultant in 2000 spoke of it in general conversation.
LORD ARCHER OF SANDWELL: So could I just interrupt you there. The significance of that is really quite startling.
ALICE MACKIE: Yes.
LORD ARCHER OF SANDWELL: You were infected in, you think, about 1979?
ALICE MACKIE: Well, Robert was infected with hepatitis C, and the doctor says the first test was in 1994.
LORD ARCHER OF SANDWELL: I gather that you were told in 1994?
ALICE MACKIE: No.
LORD ARCHER OF SANDWELL: I see. The treatment began in 79?
ALICE MACKIE: Yes.
LORD ARCHER OF SANDWELL: It doesn't follow that you were infected straight away, of course.
ALICE MACKIE: Well, we don't know that because there wasn't a test.
ROBERT MACKIE: Allegedly.
ALICE MACKIE: "My life before infection was just the same as any normal person. I ran, cycled, played "Scratch" golf, tennis, participate in salmon fly fishing and took part in just about every other non-contact sport you can think of without using Factor VIII. I, along with two of my uncles and one cousin, became infected with AIDS from Scottish National Blood Transfusion Service Factor VIII produced at Protein Fractionation Centre in Edinburgh with known batch number 023110090. This is confirmed in correspondence from my consultant between March 84 and May 1984, May being giving as the date of my seroconversion. This time of infection is regarded by some as "too late in the day" and at a time when it was well known about the risk of AIDS from Factor VIII. I do not know when I was first tested for HTLV-III but I was continually asking both my consultant and other doctors at my heamophilia centre about any risks from Factor VIII from mid-1983 when I was continually being told there was nothing to worry about."At no time was I ever informed of being tested for AIDS, HTLV-III to HIV. The first I knew of being tested was in 1987 when I was told I had been infected with HIV for several years. This delay putting my young wife, family and friends at risk. The question here that comes to mind is why I was never informed of either being tested or of my test result. Perhaps later information in my submission answers them.
"Most of the Factor VIII that I received during 1984 was given to me for prophylaxis, which means that I did not need the Factor VIII either for life-saving treatment or for a specific bleed, only to prevent future bleeds. The fact that it was known that the more Factor VIII the patient received the more chance he had of contracting AIDS makes me ask the question why I was given prophylaxis treatment. The practice of prophylaxis should by now have stopped due to the known state of AIDS. I must point out here that I received 124,850 units of Factor VIII during 1984, while on prophylaxis and 45,700 units of Factor VIII during 1985 when I was taking treatment for specific bleeds. "The circumstances in which I was informed of my HTLV-III status in 1987 are unforgettable, and when my wife and I attended the appointment my consultant asked my wife to leave the room. When we refused he left us alone to discuss her going. When he returned five minutes later and she insisted she stayed he showed his displeasure. He then went on to ask the questions -- have I used intravenous drugs, slept with any other women or slept with any other men -- and he then went on to tell us that I was infected with HTLV-III and that he had met the donor of the infected blood donation, that the donor had been a homosexual and that he was dead. According to him, my infection of HTLV-III was one of those things that could not be avoided. He then went on to advise us not to tell anyone about my status, not even our families, including my heamophiliac uncles and cousins who were also advised us not to inform anybody. When I asked what the prognosis was he stated that I had more chance of dying of a heart attack than I had of dying of AIDS.
LORD ARCHER OF SANDWELL: He, the doctor had more chance of dying of a heart attack?
ALICE MACKIE: Yes, than Robert had of dying of AIDS. "That was the end of the meeting. This flippant remark was stated to us after it was written and discussed in July 1983 that predicted mortality is 100 per cent in 25 months for haemophiliacs. The minute this meeting ended is a time that we began to live a life full of secrecy and lies. Neither at this meeting nor at any time afterwards was an HTLV-III test or counselling offered to my wife. "What we have yet to understand is why I was asked such questions when my consultant knew the batch that I was infected with, knew the blood donor and more importantly, knew that 15 other haemophiliacs were infected with the same batch as stated in the numerous research papers. At no time was I informed of being tested for any of the blood infections, nor was there any counselling offered before or after eventually being informed of the result. "However, we have since discovered that my consultant was indeed aware of the risks to haemophiliacs from AIDS from early 1983 and had he informed me of the risks, my infection could have been in avoided as I could have refused any kind of blood product treatment, altered my lifestyle and reverted to the way I treated my bleeds when I was younger: my bed rest. "After requesting my hospital medical records we found that the circumstances leading up to my infection of AIDS was not like we was led to believe, that AIDS and haemophiliacs did not just appear out of the blue.
We discovered that an AIDS study was being carried out on me from March 1983. This AIDS study was, it seems, the beginning of many years of research being carried out on me without my knowledge or consent. "The following was just a brief summary of events from before at the time, and after my infection. In March 1983, my consultant began his AIDS study. Then in May 1983, there is a matter of the response by my consultant to a letter published in the Lancet in April 1983 from Dr Robert S Gordon of the National Institute of Health in America -- Dr Gordon was chairman of the NIH AIDS Working Group -- in which my consultant seems to be offering up myself along with others under his care at the Royal Infirmary of Edinburgh as a candidate group for research/investigation to explore whether AIDS was caused by a transmissible agent such as a virus in blood products or whether Factor VIII itself from multiple donors was inducing a mild immune disorder without the intervention of an infection. "Dr Gordon says that these two hypotheses could be distinguished by a study of "similarly treated haemophiliacs in a geographic area to which AIDS has not yet been introduced". He concludes: "'The resolution of this question by a timely investigation in some country where cases of AIDS has not yet been reported would be an immense help to public health workers worldwide. In this situation, negative results would be of great significance.'
"The above exchange appears to suggest that my consultant was fully aware of the value to scientific endeavour of his Edinburgh patients, myself included and that I along with others were of value to him as a publishing scientist and potentially to global public health. Indeed he later published on this very question with Dr Gordon in the Lancet. "It is also known that Dr Amoz Chernoff of the National Institute of Health and also a member of the NIH AIDS Working Group, visited Scotland in 1983 and had preliminary discussions about the possible inclusion into the study of haemophiliacs who have received no American Factor VIII preparations".
LORD ARCHER OF SANDWELL: May I just clarify my own mind on this. It wouldn't be unknown, would it, for a doctor to conduct his own research on his own patients. What he learns from his patients may actually lead to the sum total of medical knowledge. It isn't that you were complaining of?
ROBERT MACKIE: That was non-consensual research. I did not give consent for this research.
LORD ARCHER OF SANDWELL: I got the impression that what you are really troubled about is the fact that you were not asked?
ALICE MACKIE: Yes, that is --
ROBERT MACKIE: No, he knew the risks. If he had been a decent doctor at all, he should have informed me of the risks.
LORD ARCHER OF SANDWELL: Yes, that's exactly what I've just asked you, and that's what you're complaining about.
ROBERT MACKIE: Yes.
LORD ARCHER OF SANDWELL: Please go on.
ALICE MACKIE: "We also discovered by reading my medical notes that the infected batch number, batch number 023110090, is the only batch number to be written out in full, in all of my treatment record sheets. This information is gathered from my treatment record sheets from 1980 until I've started receiving recombinant Factor VIII. This number is written out in full several times until after I complained of a very bad sore throat in April 1984 which would not get better. This, it seems was my seroconversion. Thereafter the batch number was abbreviated to 0090. Another AIDS study blood test is again carried out in June. We have evidence that HTLV-III, an AIDS test, was carried it in the UK on Factor IX patients. The results were known by February 1984 with patients testing positive for HTLV-III. Therefore we know it was possible to test before during 1984.
Perhaps this is the reason why batch number 023110090 was abbreviated to 0090 after my sore throat as it was possible to test for AIDS by the time I began receiving the infected batch. "On 24th May 1985 my consultant applies for Ethics Approval entitled 'Study for Immune Function and HTLV-III Infection in Haemophiliacs treated exclusively with NHS Factor VIII and IX Concentrate.' This application contains the following questions and answers: Will informed consent be obtained from all subjects? Yes. What information will be given to the subjects/patients? Patients and Controls are very well informed about our studies. How will consent be recorded? Written in case notes. If, as the ethics application form states, consent was obtained from all subjects, patients and controls are very well informed about our studies and consent will be written in case notes, how is it that I did not know my AIDS status until 1987, I did not know anything about his studies or research, and there is no record of my giving consent on my case notes? You may well ask how blood up to 30 mls was taken for this research without my knowledge. It seems according to this request, these blood samples were taken at the same time as blood for other routine blood tests to monitor the haemophilia and its treatment.
"Carrying on from this ethics request in May, he then writes to the Medical Adviser on 25th June 1985, formerly reporting infected batch to the Committee of Safety of Medicines. In this correspondence he states 'Although some of the patients realise they have received a contaminated batch and know they have developed anti-HTLVIII, other patients do not know of this and do not wish to know.’ "Apart from the Ethics request where it states 'informed's consent with be obtained from all subjects', I do not understand why it was expected that patients have to realise that they had received this infected batch. Was it not the consultant's duty to inform patients under his care of their status? That they were infected with not only a sexually transmitted disease but also a fatal disease? Also the fact that I was continually asking my consultant and other treating doctors if everything was all right and the answer that always came back was that there was no problem. "On 3rd August 1985 another research paper was published in which it is stated:
"'The probability of seroconversion was independently related to the pre-existing low T-helper/suppressor ratio, the number of vials of the implicated batch transfused and the total annual Factor VIII consumption.' Had they not been receiving prophylaxis throughout 1984 it way makes me one differ I would have become affected. My consultant also carried out an AIDS test on my wife without her knowledge or consent under the guise of genetic research. When my wife was 'donating' this blood we asked the Sister specifically what the blood was for and she told us it was for genetic research. When we queried this, due to the fact that my wife is not genetically related to me or heamophilia, she got very flustered and quickly left the room. It was only for many years later that we realised what this case was actually for. "Research papers written by my consultant are then continually published in the Lancet and other medical journals in which he mentions facts such as: 'This small cohort of heamophilia patients allowed us to study the antigen and antibody responses to HIV infection acquired after known time from a single source'."
"'The probability of seroconversion was independently related to the pre-existing low T-helper/suppressor ratio, the number of vials of the implicated batch transfused and the total annual Factor VIII consumption.' Had they not been receiving prophylaxis throughout 1984 it way makes me one differ I would have become affected. My consultant also carried out an AIDS test on my wife without her knowledge or consent under the guise of genetic research. When my wife was 'donating' this blood we asked the Sister specifically what the blood was for and she told us it was for genetic research. When we queried this, due to the fact that my wife is not genetically related to me or heamophilia, she got very flustered and quickly left the room. It was only for many years later that we realised what this case was actually for. "Research papers written by my consultant are then continually published in the Lancet and other medical journals in which he mentions facts such as: 'This small cohort of heamophilia patients allowed us to study the antigen and antibody responses to HIV infection acquired after known time from a single source'."
LORD ARCHER OF SANDWELL: I think these quotations are very helpful but I think they are probably best dealt with by going on to our finals so that we've got them.
ALICE MACKIE: I actually think it's quite important to state what this consultant is actually stating about a unique --
LORD ARCHER OF SANDWELL: I understand that you make a statement but I am not quite sure how long this statement is going to --
ALICE MACKIE: I'm only reading another 5 pages. I am not reading the abbreviated section.
LORD ARCHER OF SANDWELL: All right, that's a deal.
ALICE MACKIE: I didn't plan on reading the rest of it. I just wanted to read it concerning my husband.
LORD ARCHER OF SANDWELL: Please go on.
ALICE MACKIE: "He states in April 1988:
'The first cases of heamophilia were reported in 1981 and shortly thereafter it became clear that the route of the viral transmission was through the Factor VIII and Factor IX. I became interested in this area of investigation in 1983. It has been calculated that for an anti-HIV positive heamophiliac in a cohort, the relative risk of developing symptoms is increased approximately 13 fold if he has the A1 B8 DR3 haplotype.' "Also he states in 1988, '...
'The first cases of heamophilia were reported in 1981 and shortly thereafter it became clear that the route of the viral transmission was through the Factor VIII and Factor IX. I became interested in this area of investigation in 1983. It has been calculated that for an anti-HIV positive heamophiliac in a cohort, the relative risk of developing symptoms is increased approximately 13 fold if he has the A1 B8 DR3 haplotype.' "Also he states in 1988, '...
Assessed immunologically since 1983 ...the Edinburgh cohort study is unique in at least three aspects. The patients had all been assessed before exposure to the virus; the period of exposure to infection has been identified with some precision; ...all are presumed to have been infected from the same source, probably representing a single virus strain. Information on the subsequent clinical course of these patients is thus of special value.' "Then by 1990 he publishes: "'...Seropositive blood samples were donated by members of a cohort of HIV-1 infected haemophiliacs. The PBMCs used in these experiments were donated during 1988 and 89 by HIV-seropositive haemophiliacs who were believed to have been infected in 1984. Seropositive samples were collected ...and the staff of the Haemophilia Centre, Edinburgh Royal infirmary.'.
"Also in 1990 we find: "'Here we examine serial samples from a cohort of heamophilia patients who became infected from a common source in 1984', and: 'In Edinburgh we had the opportunity to study a unique group of haemophiliacs who became infected in the spring of 1984. These haemophiliacs have been very carefully followed up with close monitoring... Detailed monitoring has allowed us to identify some factors which are predictive of clinical deterioration and others that reflect declineof the patient's con tion, rapid regression to CDC Group IV disease is related to HLA type in this cohort. The haplotype is a marker of high risk. This cohort of haemophiliacs has become one of the most extensively studied groups of HIV infected individuals duals in the world and a great deal has been learned from the careful study of these unfortunate individuals.'
"By the end of 1990 we read: "'Five year longitudinal clinical and laboratory study... The early identification of individual patients who have a poor prognosis for HIV disease is an important objective. We previously described a unique group of haemophiliac patients infected with HIV from a single batch of Factor VIII concentrate used between March and May 1984. This led inadvertently to the establishment of a cohort of individual patients with a common source of infection whose times of HIV seroconversion were clearly recorded. Plasma samples collected at regular clinical follow-up appointments.
Information from this uniquely homogeneous cohort is of special value because its members were assessed immunologically before exposure to HIV and have participated in detailed follow-up studies at regular intervals.' "And: "'We have been studying HIV sequence change in a group of patients who became infected during 1984. The unusual circumstances surrounding the infection of these patients have permitted.' By 1991 we are still finding published research by the Edinburgh cohort stating that "... We have followed up these patients since their seroconversion. All 32 have been studied as part of an assessment of immunological changes in haemophilia during the two years before the use of contaminated Factor VIII within the Edinburgh heamophilia/HIV cohort, which is uniquely homogeneous with respect to time and source of infection, we have now shown that the course ofHIV-associated disease is related to at least two patient characteristics recognisable before exposure to the virus. We have now that individuals at risk of rapid disease progression can be identified in the earliest stages of infection and even before exposure. And 15 years after the AIDS study began, we find the following: the two UK domestic plasma fractionators decided to manufacture different types of high-purity Factor VIII concentrates. This offered us an opportunity to compare the effects of these two products on immune function, survival, HIV disease progression and use of anti-retroviral drugs in a three-year cohort study. We believe that an insufficient number of patients with severe heamophilia A and HIV agreed to be
randomised. For these reasons, a prospective cohort design was adopted rather than a randomised trial. The difference was principally accounted for by the comparatively low CD4 count of patients from a single centre in Edinburgh. The lower median CD4 count observed in the ion-exchange group at the beginning of the study was largely accounted for by comparatively low counts from a single centre: Edinburgh. Most of the HIV seropositive patients attending this centre had been infected from a single donor. Half of these patients were reported to be either dead or symptomatic from their HIV within four years of seroconversion, which suggests that they may have been infected with an unusually virulent strain of HIV.
"Half of these patients were reported to be either dead or symptomatic from their HIV within four years of their seroconversion, which suggests they may have been infected with an unusually virulent strain of HIV. If this was the case, and it took my consultant almost three years to inform his patients of their status, I find this absolutely unacceptable. If my consultant became interested in the AIDS area of investigation in 1983, then why did he not inform his patients of the possible risks of AIDS from Factors VIII/IX, and ask their consent to carry out testing and research on these patients? Why did he think it necessary to carry out research on his cohort for at least 15 years without informing them? I find this totally unacceptable and outrageous that a doctor can carry out non-consensual research on a group of patients under what he calls his 'pastoral care' and not be accounted for his actions. His research showed that his Edinburgh Haemophiliac Cohort were infected with an unusually virulent strain of HIV. Perhaps this is also a reason why we were kept in the dark about the events which were taking place at the Royal Infirmary of Edinburgh from March 1983.
"At no time was I ever informed that my consultant was carrying out AIDS research on me from March 1983 at a time when I was asking my consultant, along with other doctors, of the risks of taking Factor VIII, and they all denied any problem with Factor VIII. Nor was I informed, as stated by my consultant in 1985, when applying for ethics approval, that I knew all about his research and that I gave my consent. Considering I was not informed of my HTLV status until 1987, I cannot see how I gave consent. At no time did I donate blood for research, as stated in published research papers. The list is just endless. "Perhaps MRC Working Party on AIDS, October 1983 gives the answer to why he deemed it necessary to keep his research and my positive status to himself, but not, it seems, to the rest of the scientific world. At this meeting it is discussed:
"'... the need to ensure the best use be made of the special combination of suitable patients for study.'
"'... the need to ensure the best use be made of the special combination of suitable patients for study.'
"The special features arising in relation to heamophilia were discussed and the possibility of identifying the role of imported Factor VIII concentrates used for UK patients was outlined. It was noted that attempts to detect such an [AIDS] agent in the US were being made only in a few centres, and it might be better to look for an agent early rather than in the later stages of severe disease. "For this reason, reliable identification of the early phases of the disease/infection was crucial. It was noted that blood product associated cases could enable some of these alternative hypotheses to be tested. The fact that the epidemic was lagging some three years behind that in the USA was considered an important factor. This could enhance our ability to detect the emergence of AIDS and AIDS-related conditions in high-risk groups.
The underlying immunological and virological status of the high-risk groups before they encountered the AIDS agent could thus then be defined.
Further emphasis was given to the concept of identifying early phases of the disease for testing aetiological hypotheses. It was emphasised that at this stage national collaboration was possible and indeed essential on items such as an AIDS case-control study and active surveillance. This would need to be backed up by individual centres conducting cohort studies on patients in high-risk groups. "Because of my consultant's failure to inform patients of the risk of this known fatal disease, 16 haemophiliacs became infected from this one batch of Factor VIII, two uncles, one cousin and many haemophiliac friends have all died from AIDS from this one infected batch, at a time when their infection could have and should have been avoided. "I feel that the haemophiliacs at the Royal Infirmary of Edinburgh would have been better served if our consultant had informed us of the risks of AIDS instead of using us as guinea pigs for non-consensual research and scientific kudos for at least 15 years. I find this absolutely unacceptable and outrageous.
"I have mentioned my two uncles and one cousin who was co-infected with both AIDS and hepatitis C. What I failed to mention is that there are other haemophiliac members of my family who were infected with hepatitis C. "The worst and saddest thing that this disaster has brought to me is that my wife has given up the ultimate sacrifices of her career and her right to have children. She has perhaps not suffered physically, but has definitely suffered mentally, not only by having to watch haemophiliac family and friends die a most horrific death, but now she has to watch me suffer the same fate. Even after my wife has made all these sacrifices, she is still with me after all these years. This, most of all to me, is the ultimate sacrifice. "I cannot find the words to say how what is described as 'The worst medical disaster in the history of the NHS' has affected my family, other than to say it has devastated three generations. I do not wish for it to destroy the lives of future generations. Santanya states:
'He who does not learn the lessons of history is condemned to repeat them'.
'He who does not learn the lessons of history is condemned to repeat them'.