Selected Transcripts of the Archer Independent Inquiry

  
Monday, 4th June 2007


TAINTEDBLOOD.INFO

HAYDN LEWIS AND ANDREW MARCH

THE CHAIRMAN: Mr Lewis and Mr March, thank you very much for coming. We await your presentation.

HAYDN LEWIS: Thank you for asking us.

THE CHAIRMAN: Thank you for providing us with the notes beforehand.

HAYDN LEWIS: Well, I am going to start off this by kindly asking everybody to spare a few thoughts for all the people that actually are not able to attend here, through the fact that they have passed away and hopefully encourage and just to state that we have attended and hope that we can represent the people who remain and give them confidence that the closure that we all desire is not too far down the road. Thank you. I am now going to read a little introduction as to how tainted blood evolved, if you wish. So here goes.

Tainted blood is a concept formed primarily out of the two things; firstly, as you know, there was a very large, real need amongst our community to seek answers as to why their infections had happened. Why so many people had their lives and those of their loved ones destroyed and taken away through this. And secondly, in around April, May last year, our plight was once again brought under the media spotlight where people affected by haemophilia and HIV and hepatitis C and others as well, renewed calls for a public enquiry and proper compensation. At that time there was significant discussions occurring on the MacFarlane Trust bulletin board regarding coordinating a campaign across the country. Now, in order to mark this huge media interest that we were enjoying, a small group of us decided to take the initiative and the concept of Tainted Blood was born and formed into a website. At the time, we also hoped that all past and present campaign groups, who we sincerely thank for all the efforts if they have supported us in the past and may support us in the present, would see this media format as a tool. We all should embrace and use to further the agenda of closure for all infected and affected persons in the UK population.

Tainted Blood would like to thank firstly Lord Morris and the Haemophilia Society and all the campaign groups, whatever title they wish to be known as, for their determined "dog with a bone" attitude over the many years this issue has remained unresolved in the eyes of the haemophiliac community. We would also like to thank Lord Archer and his panel members for the time they give on a voluntary basis to this process.

We can both, that is Andrew and myself, place on record that as infected haemophiliacs, one of whom has submitted a personal application to be witness at this enquiry in a personal capacity, had no consultation concerning the title that we actually represent, TaintedBlood.info, which have been given to represent as witnesses. This is decided by the enquiry organizers and we thank them for that chance. We hope the mandated members of TaintedBlood will forgive us for not involving them in this decision. However, it is something we both feel will allow us to debate the subject matter at a level which might help clear the muddy waters which Lord Archer has to clarify. Sadly, this decision is an example of many choices in life the infected and affected have had taken away from them. The enquiry has given a platform to debate and record the facts in public and we at Tainted Blood welcome this process but if ever an issue needed a public debate, I can think of none more worthy.

We also, on behalf of Tainted Blood, would like to publicly commend Lord Archer on accepting this challenge. It will take someone of great courage to publicly state what has been so unpalatable and embarrassing for the government to speak of publicly: Can the inquiry panel explain to the public why government legal advisers felt the need to use Crown Immunity to exclude themselves from any liability, for instance, first, with regard to the charge of neglect, which is the only conclusion one can make when you read the inspector's report on the facility at Elstree. Once again, government used the same defence to the charge of duty of care during the HIV litigation; why use it?

In fact, by doing so, Tainted Blood would suggest they accepted their liability. Whatever route it came, commercial or UK, they are all involved in the systematic failure by Parliament and the public bodies they are responsible for and accountable to. It may help if the enquiry study a model within swimming distance of this room, southern Ireland. They had the common sense to see to see that this legal conundrum was and never should have been the responsibility of the victims to prove which product carried the infection. It was a matter of agreeing between those accused how much each was responsible for this patient treatment and furthermore, a public health catastrophe.

Then, with regard to the policy points, we would like to open up for debate with the inquiry panel, hopefully, points including from the Accusations Document and other important issues with regard to medical ethics, government influence over legal process and also government economic agenda affecting best and safest treatment and care of patients, the risk to the general public from any blood borne infection. We have clearly named some items of discussion that we would like to discuss with the panel and we would hope that the panel would actually suggest the ones that they deem to be needing clarification.

So, I am going to hand you over to my colleague how, Andrew, to talk about the aims of Tainted Blood and formally present the accusations document.

ANDREW MARCH: Hello. The aims of Tainted Blood are quite broad, in the sense that we want a solution to be something that is totally inclusive. First, to achieve closure on this. So that is inclusive of a broad spectrum of people and Tainted Blood in its fullest sense. We want a public query -- that is emanating from the government -- surrounding the events that led to thousands of British haemophiliacs infected with HIV and Hepatitis C. We would also like proper compensation and we say that because there has been all sorts of misnomers of -- references to compensation, when it has actually been both ex gratia and no fault compensation. So we feel there has never been proper compensation for the victims and families of those who have died and that is something else that is one of our key aims. We have mandated members, around 249 at the last count.

THE CHAIRMAN: 249?

ANDREW MARCH: Yes.

THE CHAIRMAN: We had it here just 229?

ANDREW MARCH: It is a mistake. We are a campaign group and a support group. Our support role has increased as we have become more publicly visible through the media attention and through the website. We have had to supervise lots of enquiries from people who might not have otherwise approached Tainted Blood for support and identifying their needs. We have an elected chairman, a secretary and a treasurer. We are not a direct action group. We prefer an academic approach, lobbying, and at most, we would describe ourselves as a pressure group and by far the most brave thing we have done is probably creating the Accusations Document and disseminating it.

HAYDN LEWIS: Can I make a point? The mandated members were created by the database that the MacFarlane Trust holds and we asked the MacFarlane Trust to mail to all registrants to see if they were willing for us to represent them as TaintedBlood and we have received the amount that you have recorded. But there is another database within the MacFarlane Trust and there are over 300 widows, whom the MacFarlane Trust do not seem to accept that they now meet the criteria that the trust is set to attain; one is helping those infected and affected. I would suggest the 300 widows no longer in contact with the trust are just as applicable for their attention but sadly, that would only come about if they approached the trust and also the trust would not allow us to write to them through the database that they hold.

This may have been through reasons of their being a charity but I think it was more to do -- it may have created an additional workload for the trust with the limited funds that they have, obviously, to distribute amongst the registrants that are still registered with the trust.

The matter of the widow being disregarded, as of any interest, when their partner passes away, I find a little bit -- well, uncompassionate, for want of a better word. To suggest that that widow can just carry on with her life after six months of their partner passing away; they may have spent 15 or 20 years looking after that partner and lost a lot of income -- I think you have heard from other witnesses suggesting the amounts that they would have actually lost --


THE CHAIRMAN: I think we have that clearly in mind. It may be that the trust is not at the moment concerned with the fact that it was set up to deal with the particular beneficiaries the government had in mind when it established the trust. It may be no more than that, I do not know.

HAYDN LEWIS: It was set up to maintain the needs of the infected and affected, which remains as it does today.

JUDITH WILLETTS: They support 200 unaffected widows, we were told earlier on today --

LORD TURNBERG: 270.

HAYDN LEWIS: Those are still non-dependants. Obviously, they do support widows.

JUDITH WILLETTS: You say there are a lot whom they do not support?

HAYDN LEWIS: Over 300, as it happens: do you want to formally present -- shall I carry on with that for the time being?

ANDREW MARCH: Yes.

HAYDN LEWIS: We would like to formally present the Accusations Document so it is publicly recorded and we would kindly ask the panel whether they have received anything that substantiates or questions, contrary to the content of the accusations document, so we can in some way accept that the content is factual and not discuss the content in some detail because if the panel accept that it is correct, and we are writing what we have stated as an accusation, then I feel that it is an easy job for yourselves to actually record that these matters did take place and it has been factually proven.

THE CHAIRMAN: We cannot predict at this stage what evidence we will get at later stages.

HAYDN LEWIS: No, of course. Would you agree though --

THE CHAIRMAN: We will certainly have it in mind and if it is challenged, I think we can come back to you --

HAYDN LEWIS: I would appreciate that because obviously we would wish to be party to that information.

JUDITH WILLETTS: We have had very helpful information on timelines, you know, the chronology of things, which has -- which is factual. So I am happy that we have got the right information on that.

HAYDN LEWIS: I am glad you mentioned the timeline. I wondered whether yourselves or any of the panel have actually read the timeline on Tainted Blood because I think it does actually give you a very clear picture.

JUDITH WILLETTS: We have had -- I certainly I have read probably three or four, now, comprehensive chronologies.

HAYDN LEWIS: I do understand it is very long.

JUDITH WILLETTS: That seemed to match up. It seems to contain the right facts. There is a lot of cross referencing to be done.

HAYDN LEWIS: Without having to go around the subject, I think that the timeline from Tainted Blood is by far the most extensive timeline that anybody has ever written, or read for that matter, with helpful little comments.

JUDITH WILLETTS: Thank you.

HAYDN LEWIS: I am going to turn the page now, where are we? I am going to continue with this for the time being but I am going to pass you over to my colleague. Just to say that we did not produce the accused document to be confrontational or inflammatory but we just felt that, actually, unless we made some statement publicly, we were never going to generate any public debate and sometimes, you know, words need to be stated and, as much as they might be uncomfortable and a bit accusational, as the document suggests, it was only by way of actually encouraging to get a debate on that level, if you want, on the topics that we have included in the document. So I am going to let Andrew speak a little bit about that.

ANDREW MARCH: The first thing I would like to say is that the Accusations Document was actually in the pipeline and being created prior to the inception of this enquiry, which I was quite pleased about but of course when the enquiry was announced, we found ourselves in a state of flux but we decided to continue with it in case it became useful.

THE CHAIRMAN: It can certainly provide part of our agenda.

ANDREW MARCH: Earlier this year there had been information coming out of the government via freedom of information. We suddenly found ourselves with a considerable amount of documentation and we basically designed a system for reading it, a three tier system of different groups of people reading it and filtering for the most helpful material. We then decided to -- somebody suggested to us, a helpful friend, it was time to lay accusations, and the French "J'accuse" document of the Dreyfus affair was referred to, and I thought that was a wonderful idea. So we decided to make it "We accuse", as opposed to "I accuse", and we went from there and basically crafted eight main accusations of -- that covered the timespan involved and from that we built evidence around them to elucidate and elaborate on further in the document. We also wanted it to be something that would create a debate, that would hopefully invite a response, which we have not really had. We have not had responses.

HAYDN LEWIS: Which I am pleased. We were waiting to be sued. So maybe their silence suggests something as well.

THE CHAIRMAN: We cannot be responsible for the responses you have had from the government.

HAYDN LEWIS: We have not had any.

THE CHAIRMAN: We cannot be responsible for responses you have not had.

HAYDN LEWIS: I think the silence speaks volumes.

ANDREW MARCH: I would like to talk about "displacements with responsibility". This is a phrase which we crafted for this point, which -- we feel it is unacceptable that individuals that are actually affected and infected are having to become researchers, full-time campaigners. We just feel that the very victims are having to untangle this mess and try to determine how this systematic failure has actually occurred. I came to London as a student to study music at the Royal College of Music on a four-year degree and I feel that is a vocation, it chose me, and it is something that I should be doing because not everybody has that gift. And yet I find myself unable to compose because I just cannot allow this situation with the contaminated blood catastrophe to go unchecked; it needs to be sorted out. And I cannot return to my career and nurture it until I know what happened. There are too many questions. Before, I had the bliss of ignorance and just being able to write and study but, as soon as I realised that things did not quite add up, I needed to become a campaigner and to sort this out.

HAYDN LEWIS: That is a very good example of the fact that we were all at different ages when the infections occurred, and the younger of the community have grown up and educated themselves to the history behind this and are just as shocked as the older community were at the time. But it should be a poignant reminder to government and anyone who is trying to sort this out that it will not go away because my sons will pick up the flag, and in any battle, if you want to use that term, when somebody falls, somebody else picks up the flag and carries on with that agenda. I hope that Lord Archer actually does bring closure because I think we are in for a long road otherwise because it is not going to go away.

THE CHAIRMAN: We are very impressed with the amount of work and research that members of the community have carried out on this.

HAYDN LEWIS: Thank you. We can pick up on any of the points that we have suggested in our presentation and I will speak at great length on any that you would suggest need clarifying. So maybe it might be a good time for me to look at the points that we have suggested we need to talk about and, if you have any questions about any specific point, we would be more than willing to answer, but if you want me to continue with a discussion about life support therapy, which is the next point, we are more than willing to continue.

THE CHAIRMAN: I do not know whether I can speak for my colleagues but I think what you have done is set out a vast number of questions which call for answers and I do not think that this is the stage for us to question you. I think what it probably indicates is that we should question other people.

HAYDN LEWIS: I think I was more implying that, if there is anything that you still feel ignorant about --

THE CHAIRMAN: Most certainly.

HAYDN LEWIS: I did not mean that disrespectfully.

THE CHAIRMAN: Quite right.

HAYDN LEWIS: Shall I carry on?

THE CHAIRMAN: Yes, please.

HAYDN LEWIS: I think the best way to actually try and explain my perception of life support therapy, which is an (inaudible) statement that is meant to preserve life, and save life -- when the first commercial products, for instance, came into the country, they came in through an ethics committee and were allowed into the country on a research basis, either on a named patient basis or a clinical trial basis but one of the fundamental hurdles that we needed to get over was to convince an ethics committee that they were for life support therapy. Now, I would have to concede that in a severe haemophilia, then there were many occasions where this was necessary as a treatment, for example, if a member of the public needed a pint of blood or was going to die then there are not many choices there. You take the risks and you accept the consequences but the scenario that unfolded was that the research needed perhaps previous haemophilia patients. So obviously at some stage you are going to run out of them and then you need to start using the mild haemophiliacs. I would suggest that life support therapy was not something that they could use as a reason for giving that product; an example being in 1974 at that stage I had never received any commercial product.

I had predominantly only been treated with cryoprecipitate. I started by profession as a self-employed carpenter which suggests that I was not very concerned about bleeding to death. Then I carried on doing that until unfortunately the HIV took over hence the consequences of me not being able to continue with that profession. But going back to 1974 no commercial products I had received up until then. I was on holiday with my then to be wife and attended a hospital in Cornwall where I was given a treatment unknown to me at the time to be a commercial product, without any consultation whatsoever with myself and I kindly thanked him for giving it to me. In hindsight I wish I had not but it suggests that if it was a commercial product, then it was most certainly on some kind of trial because the MRHA data that I have asked for and received suggests that there was no product licences pre-1976. So the product that I was given was definitely given under the heading of either a named patient or a clinical trial. I would suggest that that needs to be discussed the patient, which it never was.

And just to emphasise the life support therapy issue, I do not perceive that my life was in threat at all at that time. I had kicked my big toe, rather painful but certainly nothing that I could not have attained by just going home and sticking my foot in a cold bath of water or something. I suggest that the treatment was given not under the premise that it was a life threatening situation in any shape or form and I would suggest that many mild haemophiliacs experience the same procedure.

The only reason I was given that product, I might suggest, was up until then I had not received any commercial products so I met the criteria at the age of 17, which is rather unique I suppose, of being --

THE CHAIRMAN: What they called a pup.

HAYDN LEWIS: Yes, and in my notes that I have now been made party to, the records shows the treatment being given but there is no actual mention of the reasons why it was given, for what ailment or what, you know, trauma had occurred, only a reference to the organisation or whatever they are called, public body, and the name of the gentleman who was actually doing research at the time. So it suggests to me that the reason I was given that product was purely to attain some kind of information back from the recipient to the doctor, which I would suggest -- well, it goes without saying, was illegal. But that is for you to decide, not for me to suggest, I suppose.

So the premise of life support therapy and the bringing in of these products, I am not naive enough to realise that any product has a threat and there is a search stage where the medical profession need to assess its effectiveness and its safety and so forth but that does not exonerate them in any shape or form unless they communicate with the patients and gain consent. To date I have never seen any consent form in any patient records that I have ever looked through, my own included, and I would suggest that maybe it might be worthwhile the Inquiry asking the medical profession: can they provide any? In the recent Newsnight programme an eminent haematologist -- I will not name him but I am sure you will get his name from somewhere – suggested that he was not quite sure whether the consent was gained verbally or in a written form. Seeing as he is still alive, maybe it might be a good idea to just ask him if he can provide evidence to substantiate that because it clearly shows that in many cases the products were given not under the premise of a life support therapy, just one that was going to help the medical profession work out whether the product was actually safe or not. I do not think I need to actually elaborate too much on that --

THE CHAIRMAN: I think we have grasped that.

HAYDN LEWIS: The point is that this was -- this happened, and unfortunately I think the consequences were that many infections occurred. Also at the time -- I do not think the medical profession --

LORD TURNBERG: I think you make a very important point about the difference between severe haemophiliacs and the milder form because there is a risk/benefit ratio as you suggested, with any treatment, and you take greater risk the more severe the likelihood of someone dying or being severely incapacitated. So the less severe the illness, the smaller the risk has to be and I think that is the important point which may not have been recognised at the time. I think a lot of this was not recognised at the time. I used the term "recently" there. I think the haematologist -- and if you think of haemophilia being as a genetic condition, they were very maternal. They knew the families, they knew the generations and they traced back the generations.

HAYDN LEWIS: Myself had uncles from previous generations who passed away of course through this, but it did build up this fairly sort of close family community, if you want, within each and every hospital in Britain, and -- I do
not want to describe it as a Mr Chips attitude, where he looked on us as Chippy's children, if you want, which does not seem to sit well with looking on that as researching with his children. It is a bit uncomfortable. I think their intentions were genuine but I think they lost the plot slightly with their endeavours to research the matter and they slightly detached themselves from the personal concept of it. I do not particularly want to be disrespectful but they needed to look on us as patients not pieces of interest. I cannot think of a nicer way to put it really. I was going to use the word "meat".

ANDREW MARCH: Could I lead on to the named patient basis, which you will find on page 7 under point 11.

THE CHAIRMAN: Of the big document? Of this one?

ANDREW MARCH: Yes. I would like to talk about this because here we have pharmaceutical companies who need to get their product used, their unlicensed product, and in order to do that there are various ways available to them and one of them is the named patient basis. In order to have their product evaluated, it needs to be distributed and included in the human clinical trials in order to become eventually licenced. This system enables physicians to prescribe unlicensed medicines to a specific patient who is named and recorded. A discussion is supposed to take place where the prescribing doctor informs the patient of the improvement benefits and that there might actually be risks. To my recollection I do not ever recall this and certainly being very younger at the possible time of infection, nine or ten years old, I certainly do not recall it. So then I have to ask my parents who also do not recall a discussion of this type. So I would suggest that this needs to be looked into. We certainly need to look at how the doctor can protect themselves against liability and yet they can still act with incompetence in prescribing a drug.

THE CHAIRMAN: You say they can protect themselves against liabilities; presumably by observing these rules?

ANDREW MARCH: Yes.

THE CHAIRMAN: If they do not observe the rules then presumably they are not protected.

HAYDN LEWIS: Andrew has led me nicely -- going back to the life support therapy issue. The products were given, predominantly British products at the time, and the understanding and the good relationship between some of your (inaudible) volunteering a pint of blood slightly exonerated them from any consequences of what it may have contained, because it was voluntarily given, and the British system is a marvellous system where always, if there was a need for blood in any conflict in history, they always came to attention and actually provided the blood. But, because it was given altruistically, there was no liability to that donor and also it exonerated the doctor who used that product and that is fine and well and the recipient of those products were kindly grateful for that donation of blood but I think when the doctors are actually stepped over the line and imported, privately I might say -- and that is where we need to clarify some matters about how these products came into the country from commercial companies. They were purchased predominantly by consultants in the haematology department, they were not purchased through the NHS, and also the minute that you purchase a product commercially, you cannot expect the same insurance cover as you would from a British product given altruistically. So I would suggest that crown immunity, when it was used, actually was invalid because the Crown Immunity was meant and perceived to cover you for the prescription of a voluntarily donated pint of blood given freely. It should not and never was intended to cover you for giving a private commodity purchased, and gained profit for, the company that provided it.

JUDITH WILLETTS: So you are saying individual consultants took decisions about -- they basically had purchasing power to go to --

HAYDN LEWIS: The NHS was --

JUDITH WILLETTS: This is different from what we were told before.

THE CHAIRMAN: We had evidence about this from the officials if you remember.

JUDITH WILLETTS: I thought this was different.

LORD TURNBERG: It is very unlikely that consultants can buy it themselves.

THE CHAIRMAN: Certainly unlikely.

HAYDN LEWIS: I would suggest that actually --

LORD TURNBERG: We were actually told --

HAYDN LEWIS: I will try and clarify that.

THE CHAIRMAN: Just a minute. We were told that if a consultant went, for example to Singapore and purchased some and brought it back in his pocket he was not committing any offence and he could use it.

HAYDN LEWIS: Okay. I can see this really needs clarifying. Right. When the NHS evolved and Aneurin Bevan struggled to get the consultants on board and he had to make a lot of concessions and one of them was that consultants actually run the NHS. They handed in their receipts at the end of every year and the Chancellor of the Exchequer paid up duly and it was a constant thorn in the back of the government that you were never going to nationalise the National Health Service because you cannot control the budget and so it should be that way also because how can you predict the budget for the unpredictable health of the nation. So targets and everything else were not really an item of consideration but, predominantly because the consultant was in control of his budget and he was freely given that budget because his underlying concerns were one of patient care, not one of running a department within a limited target or within a limited budget, so they purchased these products, or most of them actually on the trial basis were given freely by the commercial companies. It is like a sprat to catch a mackerel: start the patient on this and then he must continue with it. Anyway, so in 1974 when Harold Wilson decided that he really needed to pull in the reins on the budget that the NHS was running out of control with, suddenly chains, and had an reorganisation of the NHS in 1974. That pre-empted an already premise and agenda by consultants of getting all haemophiliacs on home treatment because it was cheaper for the NHS. A mild haemophiliac might spend two weeks, four weeks in a hospital bed, not particularly unwell.

He has a really swollen knee which he cannot walk on and the treatment he was receiving, cryoprecipitate, had to be administered in the hospital. There are some exceptions and some doctors allowed haemophiliacs to be treated at home but the point I am making: when the organisation of the NHS occurred in 1974 it took the control of what the budget was away from consultants which also then meant that the health authorities who were then given the control of that budget were not that happy about having to pay consultants for commercial products that they were well aware were ten times more dangerous with regard to hepatitis C. So the budget and the outlay that the consultants had incurred meant that they were not getting the amount back from the Department of Health for the purchasing of that product. So that explains in some way, I think, that these products were not actually -- they were brought in privately by consultants and it was a way also of actually generating income, if you want, for other haematology matters and the budget was not just to attain the treatment of haemophilia, there were lots of other haematology conditions. And to provide us with a product which they would be given rather cheaply, I would suggest, and also the economics of how much it costs to keep a patient in a hospital bed for a month in contradiction to sending that patient home and being able to treat yourself at home, meant that the products did and were cost-effective. However much they might have been costing, it was certainly a lot cheaper than keeping a patient in a bed for a fortnight and all that that incurred to facilitate that.

One of these quandaries that you seem to not have quite sort of touched is how suddenly, right, with this target set in 1974 by Lord Owen and the department, who were meant to provide that product. If you go back to pre-concentrates, there were round about 2,000 haemophiliacs being treated with cryoprecipitate in 1973, 1974. Within the space of two years the demand for that doubled. Now that was not because there was a certain population boom in the haemophilia world. There may have been an increase in identified cases but it pre-dominantly came about because of consultants encouraging us to use the products more freely at home to pre-empt a bleed not happening and that would be all fine and dandy if the product was 100 per cent safe but I would suggest it was rather naive of them to suggest that we take the product freely with the then known threat of hepatitis. I can only speak personally obviously but I never had any perception that hepatitis was a life threatening condition and not really had much knowledge of hepatitis even after HIV came about.

Because my, in my youth, my only sort of recollection of hepatitis was post-transfusion hepatitis, where I think I had a bout of it when I got hepatitis B in 1968. I went yellow for a fortnight, was rather unwell but not particularly at death's door, if you want. So my understanding of the threat, as far as hepatitis was concerned, whether it was A, B, C, D or whatever, was one that I would probably be unwell for a fortnight, and go rather yellow but I would get better and I would be fine. But I did not have this sort of education that it was something that could kill you, unfortunately.

THE CHAIRMAN: Our evidence has been that it was not widely known -- first of all what hepatitis C was and secondly how serious it was.

HAYDN LEWIS: It is like anything else in the medical world, until you can categorically say that it is not that dangerous then you should always err on the side of caution and treat it as a worst case scenario. I think it was rather naive on the strength of what they knew hepatitis A and what they knew hepatitis B could do, to assume on the strength of actually only about 18 months of research, when it was discovered in 1972, that it was not something that was going to be a big issue in the haemophilia world and certainly probably something that would be for future governments to address because in 20 or 30 years' time they may start having problems with their livers and so forth. Whereas the same with the government's attitude, if you want, they only really need to be proactive for what is going to happen in their tenure of four years unless they wanted to be re-elected. Their budget is somewhat -- rather than be at the forefront to invest for the future, and a great example is the Life Resources facility that was bought by the British government to accommodate the threat from VCJD. They spent £78 million to secure plasma for the British population by buying Life Resources in America. Life Resources was set up in 1975 to accommodate the production and the fractionation of plasma into Factor VIII because they could see the profit that could be gained from that process.

I really wish that Lord Owen had been provided with the money in 1974 to accommodate that process because it would have been a very profitable business, a business run within the NHS, but one that actually incurred a lot of revenue for the NHS and one that probably would have made the treatment of haemophilia self-sufficient in itself, and actually generated profit to plough back into the NHS for treatment and care and it is a constant problem to myself: why did the government actually perceive that private money is more effective than state money. Why did government perceive?

THE CHAIRMAN: That is going a little wide.

HAYDN LEWIS: I can broaden it out as much as you like, they have looked at the NHS as a ball and chain in the last 50 years. Why could we not have looked upon it as Aneurin Bevan intended: a place of excellence, a place of research and study that would be the envy of the world, where there would never be a need for BUPA.

THE CHAIRMAN: We cannot investigate into that.

HAYDN LEWIS: No, pick anyone from 10 and we will discuss it with you.

JUDITH WILLETTS: What I think is particularly helpful is that reading what you have provided for us is obviously going to help with some of the perhaps quite probing and detailed questions that we need to ask of other people and for that I am very grateful. I am also quite interested in what you think about what your concerns are about the danger of history being repeated, if I can put it that way. Would you like to say a bit about that?

HAYDN LEWIS: This stems predominantly from the preliminary responses we have had from government over the past 20 years where an inquiry is now needed because lessons have been learnt. And I see examples of lessons in the NHS that have not been learnt. There is a classic one that has just occurred recently which my colleague is going to try and elucidate.

THE CHAIRMAN: Yes, Mr March.

ANDREW MARCH: I would like to talk about variant CJD and the threat of history repeating itself if we fail to learn lessons that could be learnt. This is page 9. This has come out of recent difficulties of discovering documents which suggest there has been secretive testing around the time -- possibly more than one occasion – of hepatitis C identification, which is actually a subjective debate in itself but there is a discrepancy between 1987 and 1989. The doctors -- the medical profession and government in the UK -- seem to go with the World Health Organisation's decree of having been identified and isolated in 1989. Tainted Blood recently wrote to the CMO of a company that makes tests in America, who actually vouched for a patent being established in 1987 in the UK and Europe for the identification, isolation and cloning of hepatitis C. Based on this, I would like to talk about variant CJD because there is this problem of we are awaiting a test and no one would deny there is an urgent need for that.

Persons with haemophilia have been anxiously awaiting the arrival of an accurate, reliable, variant CJD blood test since the BPL product recall and notification exercises of September 2004. In fact haemophiliacs have been living if fear of variant CJD from an as far back as January 2001 and possibly earlier when we received our first at-risk letters. We know that there are new blood tests as I have said already, and that different companies are making them. The Shouon (?)[Chiron] Corporation reported that they had developed a prototype prion essaye (?) [assay] with a very high sensitivity and specificity for screening variant CJD in blood and blood products. Then in February of this year a Canadian company, Amerfix~(?) [Amorfix] Life Sciences, announced that it was presented first time results for their prototype commercial blood test for the diagnosis of variant CJD and there are other laboratories.
There are other laboratories, at least seven, currently being subjected to a blinded panel at NIBS (?) [NIBSC]. That is probably to do with validation of these tests, which is currently underway. Now, I am suggesting that this research is much further on than, certainly that our Consultants have led us to believe. I tried to broach the subject with my consultant recently and I got stone-walled and basically told that there is no test. Go away and be quiet. I would much rather a situation where we are included in the consultation process, with regular updates of where they are with these tests and certainly if there is any possibility at all that retrospective frozen blood samples or sera of haemophiliacs are being used to validate these tests because that is just unacceptable.

HAYDN LEWIS: He has prompted me to actually try and clarify another matter, which is -- it is okay for governments to suggest that say, screening for hepatitis C was not available until September 1991 and that is when they started screening blood obviously. But to suggest that they were not aware about infections until that became available is absolute nonsense. And the same can be said for HIV.

I personally was tested for HIV a year before I was informed I was positive without any consultation with myself. More to the point is that once they knew I was positive, surely they were duty-bound to inform me because I was a threat to my wife and family, and I am just one example of many probably, but then even after 1985 when they told me in February of my HIV, there still was no discussion with me about the hepatitis C risk also. Then in 1988 my notes record hepatitis C test.

So if there was not a test until 1989, according to government and not screening of blood until 1991, how the hell was I tested for it in 1988, 1989 and 1990, which were all negative and then I was positive for hepatitis C in 1990. And why I am emphasising this matter? Because recently, a doctor revealed to the observer that they had stored frozen samples from 1979 to the 1990s in their fridges in the hospital in London here and they were going to make them available to the research that was going on with regard to VCJD. I do not think there are many haemophiliacs in the community who have actually been specifically given a date of when they became infected with hepatitis C. They have given me a date of my HIV infection to be some time in 1983, and my consultant attained this information by thawing out samples in 1988 that they had on storage as far back as was being suggested, 1979. This gave them a year by year analysis of negative, negative, negative, positive, which corresponded with my HIV occurring in 1983. But with regard to hepatitis C, when I asked my consultant, he said: unfortunately, the hepatitis C test was not available when we thawed these samples out, so we could not have ascertained when your hepatitis C infection occurred.

The big point I am trying it make here, I suppose, is that all haemophiliacs were excluded from the Consumer Protection Act judgment of 2001, Justice Burton's ruling on safe blood under the Consumer Protection Act. Haemophiliacs were excluded on a rather vague assumption that our hepatitis C infections must have occurred before the implementation of heat treatment of all products in October 1985. Now, that is an assumption they have made and they excluded haemophiliacs from meeting the criteria of that judgment on the premise of an assumption that our hepatitis C infection occurred pre-1985 because we then could not have come into the criteria when the Consumer Protection Act was enacted in May 1988.

So I think it is rather irregular and Lord Archer being a QC will understand this -- that surely the law cannot be based on assumptions. Law can only be based on fact and to make an assumption to exclude a patient group from a judgment on an assumption that the infection occurred pre-enactment of the Consumer Protection Act, I find absolutely unacceptable and my own records clearly state that I actually became infected with hepatitis post heat treatment in 1990. I would suggest that these frozen samples in a hospital in London right now, at this very moment, could be thawed out and if all the haemophilia patients could be told definitively when their hepatitis infection occurred -- retrospectively, obviously, but with some definition of when it occurred.

JUDITH WILLETTS: Is that not very difficult because of the incubation period? Would it be hard for them to say -- even though you were tested in 1988, diagnosed in 1990 -- would it be quite difficult for them to pin point when you would have become infected?

HAYDN LEWIS: They would just trace back the tests, and everyone who came back negative would obviously draw a line in the sand, if you want, that anything (inaudible) -- in the negative. As soon as you get a positive test, they can with some certainty say you were infected on that date, or in that year.

JUDITH WILLETTS: What, that the tests were robust at that -- earlier on?

HAYDN LEWIS: There is always going to be some contention about actually how reliable a frozen sample is anyway.

THE CHAIRMAN: I do not think we can do more than enquire about this later. We cannot take it further now.

HAYDN LEWIS: No, it is important that if they had the capabilities to define when hepatitis C infections occurred, that would also emphasise the fact that not all infections occurred before heath treatment started and also that we could have well been and more haemophiliacs, I would suggest, were eligible to actually be included in that judgment. But we were excluded on a strange assumption, one which I have never seen any evidence to substantiate it and my own records contradict it quite conclusively.

LORD TURNBERG: I am a bit confused about the role of the Consumer Protection Act in problems arising from medical treatments because all medical treatments have a risk associated with them. Some patients suffer badly because of the risk. Is that something covered by the Consumer Protection Act? I would not have thought so.

HAYDN LEWIS: Product liability is the premise of the Act as far as the public will expect the safety of British blood. I mean the normal perception -- it was not meant to show any liability, it was just to show that the enactment of the Consumer Protection Act was to say that we can assume or should assume that everything is attained possibly to make that the safest product possible.

THE CHAIRMAN: I do not think we can make off-the-cuff pronouncements about this. We will have to go back and look at it.

HAYDN LEWIS: It is just that he asked to clarify that.

ANDREW MARCH: I just wanted to clarify that we have recently seen minutes that detail that NIBS [NIBSC] – that is the National Institute of Biological Standards and Control -- are soon to make available sequential sera from UK haemophiliacs from the 70s to the 90s and the reason that this is so valuable to research is because it shows that delineated stages, where variant CJD --different strains of disease and incubation -- so these samples are incredibly valuable because there is not really any other group who are implicated for having been exposed to variant CJD that would have so many different samples of sera on record frozen, so they are technically valuable and I can quite see why the US food and drug administration are seeking to get hold of those.

THE CHAIRMAN: Yes.

HAYDN LEWIS: That actually adds to a recent submission that the panel received from, I think it is Gary Kelly, looking at a case where he was given blood that was clear, when it was donated with HIV, and then consequently two months later the donor tested positively. But blood cannot be heat treated. So obviously there is this little window of opportunity where the donor then can be called back and then obviously they would not take another pint of blood off him. With regard to these stored samples and the nvCJD test, because they have done a year by year analysis to test, they can with some certainty suggest how long a false negative would be a threat, if you want, because the test would be more specific to at what at a stage the incubation was at and earlier obviously the more confident they can be that that pint of blood donated is clear of that infection, so this sort of timescale of samples is crucial.

LORD TURNBERG: It is obviously very important research to be done, very essential that we have it. I understood -- I may be quite wrong -- this the prion that causes CJD and variant CJD is carried in the cells rather than in the plasmaral sera but you are suggesting that they have a serological test, test of serum, because they do not have the cells in there, the white cells in particular which they deplete from blood transfusions now. They remove those now in blood transfusion. I wonder whether they have a serological test or whether that is something that they want to find out about.

ANDREW MARCH: The prion that they are looking at is described as PRPSC which I believe is related to the Scrapie, which is more sensitive. The veterinarian tests are sensitive enough to pick this up and some of the technology is based on that and they have transferred it and used that sensitivity but we have definitely read about sequential sera and somehow this is useful -- it has been discussed in this context.

LORD TURNBERG: We are very interested to see how they do, very important.

THE CHAIRMAN: You say you have read about it. Do you have the texts?

ANDREW MARCH: Not with me, no.

THE CHAIRMAN: As a reference?

ANDREW MARCH: Yes.

HAYDN LEWIS: It will show that this is a good test and so far the only way of defining it is the autopsy stage and a sample of the brain and so forth. Unless the diagnostic readings suggest that there is a criteria, then if you succumb to certain elements that you would be identified as a possible case, but it is not confirmed at the moment, until you die. But what I find unacceptable is that okay, the test might not be cheap enough or robust enough at the moment to implement into the screening of donated blood but also right at the very moment the Department of Health have asked for the consultation as to the risk factors of any one pint of blood having this infection, because obviously it will be, in the Department's eyes, uneconomical to screen British blood if the chances of it being infected were so low that it was not cost effective to screen blood for VCJD.

An example, recently in Birmingham someone succumbed to HDRV1 [HTLV-I], and the Department conceded liability, because they had not implemented a screening procedure for HDRV1 [HTLV-I] because the risk factors were so low. It was uneconomical to screen every pint of blood to avoid that happening, so they allowed it to happen and paid the consequences to the tune of, I think, £750,000 to the unfortunate -- only one victim to date. But they have already screened over 10,000 donations of British blood in America anonymously gained from donations of blood to the national pool, if you want, and they have found three positive cases in 10,000, which is encouraging. I do not want I do not know what that works out statistically in a national population but it is encouraging out of 10,000 American donors there were almost no positive tests at all. So the BSE group, if you want, is a pretty low one.

THE CHAIRMAN: The question really is at what point does the cost risk -- affect risk factor merge into Russian roulette.

HAYDN LEWIS: But the same surely cannot be said for the known at risk and identifiable patient group. It is okay them having deliberations about risk factors with regard to screening blood for the national population but the same cannot be said with regard to a known and actually known group who they know have received an implicated batch.

THE CHAIRMAN: I think we have that on board.

HAYDN LEWIS: The same was done with hepatitis C, you see. There was a test available, but they put my family at risk by not immediately telling me in 1988 that I had actually had a test for it.

THE CHAIRMAN: I think we have grasped that.

HAYDN LEWIS: I can lose the plot as far as the Machiavellian approach that currently at that time in 1988 that writs had been issued against the Department Of Health with regard to my HIV infection and they certainly were not going to then inform all plaintiffs that they actually had hepatitis C, but I found it pretty disgraceful in 1991 to ask them to sign a waiver to disregard any future responsibility when at the same time they actually knew that I was infected with it. That really needs to be looked at in great detail but unfortunately the Department of Health do not particularly wish to discuss it with me. Maybe they will talk to you.

THE CHAIRMAN: It needs to be looked at, I agree.

HAYDN LEWIS: Thank you.

LORD TURNBERG: Perhaps one comment on the pharmaceutical companies and this business of named patient. I am not in the business of trying to defend the pharmaceutical companies but by and large the named patient use of drugs is of very little use to them in clinical trial terms. They do not find it very useful, so they are not in business of trying to sell it on the basis or give it for named patients. Their motives are certainly not in favour of the named patient. It is usually the doctors who think that there has been some marvellous advance like the Herceptin case for breast cancer, the doctors were really pushing it. It was a new treatment, it sounded as if it was fantastic and that is what is happening with this drug at the time, they pushed for it rather than -- I think the pharmaceutical industry may be at fault with all sorts of they think but that particular one is not arguable.

HAYDN LEWIS: Whatever the product is used for, surely if they say it is for a named patient, then the patient should be told about it and consulted. That never took place in many cases, I would suggest.

ANDREW MARCH: I would like to quote something from the minutes of the Committee of the Safety of Medicines on 13th July 1983, where they expressed concern about the named patient basis:

"The subcommittee learned that manufacturers were producing advertising material for the use in the UK which appeared to make unjustified claims concerning the safety of heat treated Factor VIII. It is advised that this should be stopped. It is feared that unlicensed material could be used on a named patient basis despite the fact that safety and effectiveness had not been established or considered by the licensing authority."

THE CHAIRMAN: Where do we find that?

JUDITH WILLETTS: Page 8.

ANDREW MARCH: I would like to draw your attention to the word "manufacturers" where the initiative here does seem to be coming from the pharmaceuticals.

THE CHAIRMAN: Thank you very much.

VIJAY MEHAN: Can I ask a very simple question. A simple question, it may be a difficult answer for you. What do you think would bring about closure; is it trust, truth, an apology, or financial recompense?

HAYDN LEWIS: What would bring about closure. I think a little bit of humility shown by the people responsible would be a big start as far as bringing some closure because to date I feel we have been treated with utter contempt and that surely is not acceptable in today's society. If you ask me as far as monetary matters, it is never going to bring closures but it certainly would bring some contentment to all the widows, for instance, who would feel that maybe their partners did not die in vain and there was maybe some recognition for that unfortunate event. As far as closure, I do not think any of the haemophilia community are on some lynch crusade, if you want; that we want to name and shame or bring people to account. That is not our intention.

I think it is difficult -- and I refer to the MacFarlane Trust, if you like, but they have hit a rock and a hard place. They are trying to address the needs of their registrants from a moral perspective because that is all that has ever been conceded by government at the moment, but how do you in all sincerity address the need of registrants from a moral perspective when the very registrants know full well the fact is that the government have a legal responsibility to us, even though it has never been judged that court of law. I will challenge anybody to defend that if you used Crown Immunity you accepted liability.

All it was was a way of exonerating the NHS which, as it stands I do not actually perceive the NHS as at fault here. If you go back to the self-sufficiency issue and the targets that were asked for, the Department of Health were clearly told in 1974 that the national targets to achieve self-sufficiency were 40 million units. So why do I read in the minutes of 1978 that the Department – and it actually was referred to in the self-sufficiency report -- that self-sufficiency targets had been attained in 1977 because the maximum capacity at Elstree had been reached, which was only 14 million. So that suggests that the department were heading for that target of 14 million, whereas the medical profession were expecting a target to be achieved by 1977 of 40 million. When you think of the doctors' mindset when he first started to bring those products into the country in 1974, he was doing it on the premise that the patients needed it, but he was also doing it with some assurance and some confidence that the government had stated that he would only have to be doing it for three years because then British voluntary work would overtake, but unfortunately in 1976 the government had eventually got to the stage where they had number crunched the costs involved in attaining 40 million units of national population of blood, which would meant 80 per cent of donated blood. It also would have meant investing 20 million plus pounds to facilitate that process, and they immediately I would suggest switched off from any policy of self-sufficiency in 1976 and we are all aware, then, of the consequences. But that also explains register Lord Owen's money was not used into the facility to produce Factor VIII. They had a capacity capable in 1974 of 14 million units of Factor VIII. All they needed to do to obtain that capacity was actually encourage more plasma into the process. So they never had any goal of attaining 40 million in 1975. Their goal was attaining maximum capacity at Elstree, but unfortunately nobody discussed this with the medical profession at the time and they were always going along this road of understanding that by 1977, 1978 at the latest we would have been self-sufficient.

Could I just make one final point about this: research is obviously necessary in any field of medicine or technology or anything, and there is an easy way and a hard way of achieving it, and sometimes, if you look at it along the lines that everything they had done, if you can either question the patients were not consulted with, doctors were not really forth coming about the risks and so forth but if they had attained all that research using only British donated blood they would have come up with the same answers as they did from using the American stuff, but they would have had a greatly reduced infection rate. And that is the shame in all this, that the British government, if you want, could not see the urgency, if you want, of actually putting some money into what it was at the time, a patient treatment issue, but actually they should have been thinking and more importantly from 1975 in Lisbon, they had already been trying to work out what was the future risks from hepatitis. But unfortunately they do not look further than the end of their nose, the British government.

We are all sitting here today discussing the consequences obviously, but going back to the question of closure, there is a perfect model within swimming distance, in southern Ireland. The emphasis of that scheme was not to look at where the infection came from. It does not matter who produced it. It does not matter who the donor was. What matters is, that citizen is infected and the Southern Ireland scheme sort of -- the Irish common sense if you want is let us concentrate on trying to help the person infected and we can sort out whether he was infected from a British product or a measure products or whatever country he came from. That is not the important issue, the issue is that they are a citizen of Southern Ireland and they deserve our attention to their infection because they are innocent in the way that they actually attained it.

THE CHAIRMAN: I think we have grasped that.

HAYDN LEWIS: Good.

LORD TURNBERG: That was a very helpful comment at the end. On a factual basis, do you have any numbers of patients who were given blood products on a name patient basis or on a private source, do you have figures for that?

HAYDN LEWIS: There are not any because there are no records of it. An example: There is no record in my importantly records of -- well, for instance, right, a day a consultant calls me into their office and says unfortunately, Mr Lewis, I am afraid you have HIV. How do you feel about this? I said what are the consequences of that. He said at the moment I would suggest that it will not even progress to aids because predominantly you have not received different infections as you would say the gay community, for instance, but you would have expected some kind of record in my notes, a consultation of that nature, you would think the doctor would make a note of it. There were no notes made of that consultation. There were no notes made of when I was told of my hepatitis C. There were no notes made of when my wife was told that she was also infected.

LORD TURNBERG: There might be some record of the prescriptions, though?

HAYDN LEWIS: From a pharmaceutical departments? In fact that is where you will find any consent forms or any --

THE CHAIRMAN: Do you have your records?

HAYDN LEWIS: Not on me, no!

THE CHAIRMAN: I do not mean on you! Do you have them in your possession?

HAYDN LEWIS: They are rather large, they will fill a Sainsbury's shopping trolley, that is for sure! I have looked through every page. There is no consent form in my records.

LORD TURNBERG: I was not asking about consent, I was asking about the -- (Overtalking)

HAYDN LEWIS: I am not aware of any numbers at all.

LORD TURNBERG: I think you might be able to get that.

HAYDN LEWIS: I would love to see them. I would suggest you are not going to find any.

THE CHAIRMAN: That has been a fascinating session, whatever else. Thank you very much, Mr Lewis, Mr March, I am most grateful. Thank you. I think our next evidence session is on 14th June?

(3.03 pm)

(The inquiry adjourned)

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