I welcome the Minister's speech. This dreadful incident has given us a knowledge of haematology which we would not have had before. I thank Senator Taylor-Quinn for explaining why the McCole family's fifth question was causing such difficulty. I also thank her for pointing out the most important fact, that this is an international problem. I know we are dealing with one specific case but this problem is in evidence all over Europe. Indeed, an article in today'sIrish Medical Times entitled “Canada hit by hep-C scare” tells of 5,000 recent donors who may have become infected, so this is an extremely serious problem on an international scale.
The editorial inThe Irish Times last Wednesday stated: “The real scandal is that it has come to this; that a tribunal of inquiry is necessary to establish facts which must already have been known in the Blood Transfusion Service Board (BTSB), in the Department of Health and, perhaps, in other State agencies”.
I support this statement. The real scandal is that there are those who could and should have spoken to the expert group and have not done so because I am sure far more information was available than that which they received.
When this débâcle started, I had two main concerns, the first of which related to the health care of the infected patients and how they were being treated. I think the patients have been well cared for from a health point of view. The natural history of infection by hepatitis C is really not well known yet, nor is there any adequate known treatment. However, whatever screening processes were necessary were put in place and carried out and, where it was felt advisable, liver biopsies were carried out and the results made known to patients. All those who need the care of a hepatologist are receiving it and all others are assured that their health care will be of no financial cost to them as it will be taken on by the State for the duration of their lives. I welcome all those provisions.
Unlike some others, I welcomed the setting up of the compensation tribunal because, as I said on several occasions, the adversarial system in this country, where patients must go to court to get damages which are due to them for injuries, can often be more stressful than the original injury. While we know that hepatitis C causes damage to the immune system as well as the liver, we are certain that a very great deal of damage is done to the immune system by stress. Therefore, the simpler it is made for those patients who do not want to go to court and want to go to the tribunal, the better. I quite understand that people were happy with the results of the tribunal because they feel a weight off their shoulders. They will now try to put it behind them and get on with their lives.
My second concern was that we should do all we possibly could to ensure that this sort of episode could not happen again. I say "do all we possibly could" because we must remember that blood products are biological and constantly open to infection and change. Therefore, even though one thinks a problem is solved, a few weeks later this may not be the case.
The initial episode causing infectious hepatitis C clearly came from the anti-D produced and sold by the Blood Transfusion Service Board from 1977. The source of the infection was a lady who was undergoing dialysis to lower her very high anti-D levels. The woman became jaundiced but her blood tested negative for hepatitis B. This is what one would normally expect, that one would try for hepatitis B, and I will go on later to the famous request form for information. Therefore, it was concluded that she had environmental hepatitis, infectious hepatitis, jaundice — whatever one would like to call it. At that time, these terms were not being used in a very precise manner. It is important to remember that jaundice really only means that the skin and the sclera go a green-yellow colour due to a pile up of bilirubin in the tissues and in the interstitial fluid. It could be due to numerous things. I think medical terminology is being misunderstood quite often along the way in this case.
They decided to use this blood because, at that time, it was felt that hepatitis A was not transmitted by blood. I want to say that it is probably not transmitted but there is such a change of knowledge in these fields that I am constantly terrified of anybody saying anything definite. Muir'sTextbook of Pathology lists the mode of spread for hepatitis A as “oro-faecal (parenteral)”. Even Muir is careful in case it emerges that a person might contract the disease in a manner other than oro-faecal. This is a very difficult area with which to deal. The blood bank resumed the use of blood from the 1976 donor thereby breaking its own rules that it should not use blood from jaundiced patients. This was not an international rule; it only applied to Ireland. Blood transfusion services in countries where hepatitis A is common would be forced to use such blood. In addition, it was considered that the disease was not spread by means of blood transfusion.
We must consider the information available regarding hepatitis at that time. It is always good to thank those who have helped with one's research because one might need them in the future. I thank the librarians of Trinity College, the Royal College of Physicians and Mercer's Library in the Royal College of Surgeons, Professor Donald Weir and my daughter, Dr. Meriel McEntagart, who carried out a computer search on my behalf.
The first evidence regarding suspicions about non-A, non-B viral hepatitis was given at a symposium in March 1975 at the National Academy of Sciences in Washington. Did any officials of the BTSB or the Department of Health attend that meeting or read the reports that were published the following November in theAmerican Journal of Medical Sciences?
Two important papers issued from the Washington symposium. The first, "The emerging pattern of post-transfusion hepatitis", discusses the possibility of a non-A, non-B hepatitis in transfusion hepatitis. It states, "additional human hepatitis virus(es) may exist". Experts at the time were not sure whether such viruses did exist. The paper refers to the fact that some voluntary donors who tested negative for hepatitis B appeared to have contracted another form of the disease which might have been transmitted by serum. It also suggests that perhaps this form is a variant of hepatitis A.
Another useful paper was delivered at that meeting which did not mention non-A, non-B hepatitis. However, the abstract stated: "The existence of additional viruses of human hepatitis is suggested by data concerning transfusion-associated disease and multiple episodes in the same individual".
The key indexing terms attached to the paper do not refer to non A, non B hepatitis. It was probably easy to miss the connection. The paper goes on to discuss viruses in human hepatitis and states that more than two viruses may cause the infection. It further states that this was not appreciated until 1962 because of a predominance in previously studied situations of transfusion-associated disease caused by pooled derivatives. The paper in question contains much technical information which is difficult to understand. However, it stresses that the possibility must be considered that there is more than one additional agent to hepatitis A and B. However, it is somewhat unsure in this regard.
In July 1975, an article appeared inThe Lancet under the leader headline “Non-A, Non-B?”. It begins by stating that blood transfusion is dangerous at the best of times and that the transmission of syphilis and malaria is well recognised. The article also points out: “Even when a case of hepatitis is recognised as being “transfusion-associated”, it is a long, and sometimes hard, road to trace the source with certainty and identify the virus with precision”.
All this seems to point strongly to hepatitis-B virus being the major hazard of blood transfusion so far as hepatitis viruses are concerned, although post-transfusion hepatitis is certainly not the exclusive preserve of hepatitis-B virus.
At that time, medical experts were still concentrating on hepatitis B. The article further states:
However, before a hypothetical hepatitis-C virus is produced, a touch of Occam's razor is not inappropriate. These patients might have a hepatitis A differing antigenically from the MSI of FEINSTONE et al.
This shows that there was a tremendous lack of knowledge and it does no one credit to state that things were as definite as certain people seem to believe.
Another paper published inThe Lancet, which is widely read in this country appeared under the title “Clinical and Serological Analysis of Transfusion-Associated Hepatitis”. It states: “The attainment of hepatitis-free blood-transfusions has been a frustratingly slow, but progressively realistic goal”.
In 1975 medical experts were experiencing difficulties in attempting to identify the viruses in question. The article goes on to state:
The aetiology of non-A, non-B hepatitis after transfusion remains obscure. One could argue that these transaminase elevations do not represent viral hepatitis, but every effort was made to exclude other known causes of hepatic enzyme elevation.
It appears that questions were being asked as to whether people were contracting hepatitis after a transfusion rather than an infection. Efforts were made to identify the virus but it proved difficult to do so.
Pathologic Basis of Disease by Stanley Robbins states that “The subject of viral hepatitis is one of the most exciting and rapidly unfolding areas in medicine”. So speaks an academic working well away from the coal face who does not refer to non-A, non-B hepatitis in his book. Churchill Livingstone, a well known publishing house in the medical field, published a more specific article, “Systemic Pathology”, in 1978. In the section dealing with the alimentary canal, a specialist on this condition states:
When the term viral hepatitis is used without further qualification it conventionally relates only to the conditions now generally distinguished as type A viral hepatitis and type B viral hepatitis.
It goes on to discuss type A viral hepatitis — epidemic hepatitis — and type B viral hepatitis — homologous serum jaundice. The individual in question knew his subject but he refused to include any information regarding non-A, non-B hepatitis. Davidson'sPrinciples and Practice of Medicine also refuses to mention non-A, non-B hepatitis. Our knowledge of this problem was inadequate at that time and it is fine to begin apportioning blame with the benefit of hindsight. Indeed, people have gone so far as to suggest that it is not a virus at all.
I inquired whether officials of the Department of Health or the blood bank attended that conference because I wish to know the level of interest shown by the BTSB in modern research at that time. Did the Department of Health provide sufficient funding for officials to attend the conference? For most of its existence, the blood bank has operated in a very isolated manner.
Definite information about non-A, non-B hepatitis appeared inThe Lancet on 10 November 1984 in an article entitled “Non-A, non-B Hepatitis”. This article refers to the usefulness of serological tests. By the date of publication, hepatitis A had been better identified but the authors remained unsure regarding non-A, non-B hepatitis. They state: “Two or more agents are believed to be responsible for NANB hepatitis but attempts to isolate these agents have hitherto been unsuccessful.” They go on to state:
The most convincing studies of NANB hepatitis in man have concerned its parenteral transmission... [that is through blood or injections. They are still not in a totally definite position.] Although hepatitis A and B are readily identifiable by serological methods, great difficulties have been encountered in devising tests for NANB agents... We cannot exclude the possibility that NANB viruses induce little or no antibody production.
There may be a number of immunologically distinct non-A non-B viruses which could explain the discrepancies which have been reported. Even when they have definitely decided there are non-A non-B viruses, there is still trouble. It is important to keep this in context with what is being discussed.
Hepatitis C was identified in 1989 and when the situation became very bad. The expert group has been very charitable in the way it has dealt with people involved. By that time tests had been developed internationally which were not accurate. However, I wonder why the blood bank appears to have decided to do nothing at that time.
The tests were throwing up too many false positive results. A false positive result is not nearly as serious as a false negative result. A false positive test means that one thinks that some people have the condition who do not have it. It is unfortunate if they are told and it turns out they have not got the condition. However, a false negative result means that people who have a problem are being let loose without it being recognised. At that time, did the blood bank do the tests even though they were not reliable? Did it decide to discard all blood which tested positive? I cannot work this out from the report.
There is a large information gap between 1989 and 1991. Did it decide to get rid of all the blood or was that the time when the second hepatitis C positive donor slipped into the net? There is a second donor because we know there is another serologically different hepatitis C donor. I have not been able to get much information on that point.
I have not been able to get much information about the supposed consultant's report done on the women in Baldoyle who had hepatitis in the late 1970s. Whatever about throwing out the fresh blood, did anybody think of testing the old blood products for hepatitis C? We know there had been an appalling problem before this with HIV infected Factor VIII. Did anyone realise that, although the tests were not accurate, the blood products should be tested? Did anyone alert the Department of Health to the presence of hepatitis C? Who was the representative from the Department of Health on the board of the blood bank? Did he or she report back along a chain of command to the Department and, if so, how high did that chain of command go?
Much has been made about the fact that Dr. Terry Walsh, for reasons best known to himself, only showed the letter from the Middlesex Hospital confirming the infection to his chief biochemist. However, people should have become suspicious without that. Having had the débâcle of HIV something more should have been done.
The report of the expert group states in section 3.70: "We could find no evidence that the BTSB formally reviewed its initial decision to supply an intravenous product at any stage prior to the discovery of the hepatitis C incident in February 1994". I find that almost unbelievable. Have the files of the various officials involved at that time been examined? They would be most important.
I will not quote Tennessee Williams about mendacity and the smell of it but somebody is being very economical with the truth. The whole matter needs examination. I was misled about the status of WinRho when it was brought in as an emergency in February 1994.
I want to try to sort out the medical details about which Professor Shaun McCann felt obliged to speak on Pat Kenny's radio show. I do not think that either Professor McCann or Mr. Liam Dunbar hid anything from the expert group. What turned up was a blood request form that goes with a blood sample. Thousands go to the laboratory every day and normally one throws them out. I do not think it significant that they did not see it. Neither the Minister nor the Minister of State lied to the House about this.
A biochemist, Dr. Caroline Hussey, who is an expert in industrial microbiology and a professor of haematology from London were on the expert group. If I go to work and someone hands me a report on a urine sample with indicates certain levels of bacteria, white cells, blood cells and pH, I do not need a request form saying "urinary tract infection". I know the form went to the laboratory because I know the answer I received. The same applies in the case of the blood bank. It is to denigrate these two experts to say they would not have understood from what came back from the virology laboratory what was being sought. Of course they would have known, just as any professional would have known.
I cannot understand why some people harp on and on about this point because there are more serious questions to be asked. There are questions about information not being passed between 1989 and 1991. There was a great fluttering in the dovecotes in early 1992. One should look again at sections 3.72, 3.73 and 3.74 of the expert group's report where the production of anti-D is suddenly being questioned. What started that fluttering in the dovecotes? We were told there was nothing to report until the admission in February. Frankly, I do not believe it. Something happened around that time, although I do not know what.
However, there is the fact that Terry Walsh did not produce the Middlesex letter. I do not know what the civil servants are doing keeping letters in their drawers. This is the second time this has happened in the recent past. Files need to be examined. Something happened then, although I do not know what.
It is wrong for people to harp on about the request form. I write them out every day and if I expected to get them back I would have to prepare for a mountain of paper because most of them return with a negative result. This is not an instance in which anything was hidden and people should stop accusing the Minister and the Minister of State, Deputy O'Shea of hiding it. The professional integrity of Professor McCann and Mr. Dunbarr is at stake as is the implied stupidity of Dr. Hussey and Professor Bellingham. Dr. Miriam Hederman-O'Brien's letter which is quoted makes this perfectly clear.
The request form is not of significance as it is the same as the one used in the urine analysis example I gave. If the results came back indicating other diseases I would know what was being looked for and I would not have to see the request form.
The McColes are most anxious to have these questions answered and if the final questions cannot be answered, perhaps the Minister will ensure it is answered outside the tribunal.
One other matter we should consider in this House is whether only certain doctors should be allowed prescribe blood and blood products. Do we need to go that far? We in the medical profession have perhaps looked on blood too casually. However, it can be seen from what I quoted how desperately difficult it is to constantly identify what is going wrong with viruses in blood products. Constant reporting is necessary in this situation. Another measure which could be adopted is to ensure people attend international conferences to keep up to date. The blood bank was allowed to be far too isolated and, perhaps, was grossly underfunded by the Department of Health who may have a considerable share of the blame for the period 1989 to 1991 because of that.