– in the House of Commons at 9:45 pm on 24th February 1997.
I am grateful for the opportunity to raise my concerns about Creutzfeldt-Jakob disease and human growth hormone treatment. Because of the clear connections, I hope that it will be in order to include some reference to concerns about the health aspects of new variant CJD.
My concerns are shared by many hon. Members on both sides of the House. A meeting was held last week to consider the matter on a cross-party basis. I am grateful for the attendance at the meeting last Tuesday of several hon. Members, some of whom are present tonight, including my hon. Friends the Members for Wallasey (Ms Eagle), for Barnsley, Central (Mr. Illsley) and for Cambridge (Mrs. Campbell), and my right hon. Friend the Member for Chesterfield (Mr. Benn).
I shall to set out briefly the background to this unfortunate affair. I imagine that the Under-Secretary of State for Health, the hon. Member for Orpington (Mr. Horam), will differ little with me on the historical facts. The human growth hormone programme began in 1959, after pilot studies undertaken on behalf of the clinical endocrinology committee of the Medical Research Council. In view of the results of those studies and developments in the United States, the CEC supported clinical trials of human growth hormone derived from pituitary glands as a treatment for growth hormone deficient children who would not otherwise have grown normally. The 17-year trials began under the direction of the MRC in 1959, and during that period it was responsible for all aspects of the work. When the trial was completed in 1979, the Department of Health and Social Security, as it then was, assumed responsibility and the trial ran for a further eight years.
By the end of 1976, a total of 642 children had been treated in the programme, which had demonstrated obvious success and became a standard treatment for failure to grow. From 1977 to May 1985, a further 1,243 children were treated, making a total of 1,885.
The programme was halted in 1985 after human growth hormone was withdrawn in the USA following the deaths of three recipients through CJD. It had been known since 1968 that CJD was transmissible, and contamination of human growth hormone by CJD was suspected. In April 1985, the first death from CJD in a recipient of human growth hormone in the United Kingdom—Alison Lay—was reported. The use of cadaveric human growth hormone was suspended in the UK during the following month, when 865 people were undergoing the treatment.
It is now clear that the human growth hormone was contaminated with CJD from some of the pituitary glands removed from almost 1 million human corpses used between 1959 and 1985. From projections of the incidence of CJD in the UK population, it has been suggested that as many as 200 pituitary glands from cadavers affected by CJD may have been used.
The Minister will be familiar with the detailed arguments presented last year in the High Court on behalf of the families of those affected, which concentrated on the known risk of CJD transmission and the methods of both the selection of cadaveric material and its extraction and purification. He will be aware that the judge concerned found that there had been negligence in the failure to act on clear warnings regarding the risk of contamination by CJD issued to the MRC in October 1976 and the failure subsequently to act on those warnings in the early months of 1977. He eventually ruled that negligence could be established in those cases where patients had started treatment after 1 July 1977.
The Minister is aware that that judgment excludes the cases of most of those who have died and of those who are still well but whose lives have been ruined by fear of developing CJD—the "worried well", as they have been termed. Their grievance is understandable in the light of that ruling because the human growth hormone was produced and administered entirely under the authority of the Minister's Department. Mortuary attendants collected and supplied pituitary glands, which were processed into cadaveric human growth hormone by Government servants. It was then prescribed by doctors working wholly within the national health service, who were unaware that the product had never been given a licence by the Committee on Safety of Medicines.
The Department of Health's processing committee, which oversaw preparation, became aware in 1976–77 of concerns that the product carried an unquantifiable risk of an untreatable fatal disease but failed to communicate that concern to the clinical committee that oversaw the treatment programme. Children treated after 1 July 1977 were treated on the false premise that they were receiving safe treatment with a product regarded by their doctors as having pharmaceutical quality. There is no dispute whatever that CJD among those patients treated with cadaveric growth hormone before 1985 had been caused by the infectious agent given during NHS treatment.
The Minister will recall that on 6 November I brought a delegation to his Department comprising the parents of three young people who died of CJD following human growth hormone treatment, and their legal representative, Mr. David Body. The parents included Alison Lay's mother who, on behalf of herself and others, expressed concern about the circumstances of the families of those victims whose treatment had commenced before 1 July 1977. In response to that point, the Minister advised me subsequently, in a letter dated 12 November 1996, that in relation to compensation it was not appropriate to go beyond the terms of the court judgment.
Exactly a week ago, the House debated the BSE crises on an Opposition motion drawing attention to the Government's handling of an affair which so far has cost the British taxpayer £3.5 billion. Included in that figure is the amount of compensation paid to the livestock industry, which exceeds £1 billion. On the following morning—last Tuesday—with some hon. Friends who are present today, I sat in a room with the parents of a young man who had died from CJD through human growth hormone treatment, and with a young woman whose husband died last year from new variant CJD. The woman has two young children, one of whom was born a week after her husband's death. Both families have gone through the tragedy of caring for a loved one dying from CJD, but the young mother faces the additional burden of the constant worry about the possible consequences for her own health and that of her children.
In the light of the debate the previous night, which concentrated on the economic circumstances of farmers, can the Minister not understand the feelings of such people who have suffered far more than any farmers in the BSE crises but seem to be treated much less favourably? Will he consider carefully which causes more distress to a family: the disease and death of their cattle, or the disease and death of their son or daughter, brother or sister, mother or father?
The total inconsistency of the Government's arguments were only too clear last week. On Monday the Minister of Agriculture, the right hon. and learned Member for Grantham (Mr. Hogg), was boasting of MAFF's no-fault compensation to farmers in relation to BSE. On Tuesday, the Under-Secretary of State for Health, in answer to a question from my hon. Friend the Member for Barnsley, Central (Mr. Insley) who was pressing for no-fault compensation for victims of CJD due to human growth hormone and for their families, stated that
it must be the first and overriding responsibility of the Department of Health to concentrate on preventing ill health and curing it where it occurs, not on compensating those who have contracted that terrible problem."—[Official Report, 18 February 1997; Vol. 290, c. 729–30.]
Although I do not argue with compensating farmers for BSE, could it not also be said—using the Minister's own logic—that the £1 billion-plus compensation could have been used instead on research into BSE prevention and treatment, and better resourcing of the disposal of culled cattle? Could it not also be argued that in the only other instance of a product liability claim being brought against his Department, following the development of human immune deficiency virus among haemophiliac factor 8 recipients, a scheme of no-fault compensation was established?
The Minister is aware that there is an appeal pending against a part of the judgment in the hope of compensation being extended, and that claims other than bereavement and fatal accident cases are being brought by a further group of growth hormone recipients who live in fear of developing CJD. I ask him, however, to consider seriously the alternatives to further lengthy and expensive litigation, which would not only involve one Government Department—the Legal Aid Board—funding action against another, the Department of Health, but more importantly would add to the appalling trauma already faced by those directly affected.
The alternative is agreement to no-fault compensation for all victims of infected cadaveric human growth hormone, including those suffering psychiatric injury as a result of knowing that they may contract CJD, and those who have contracted new variant CJD through the food chain.
I remind the Minister that more than a year ago, on 10 January 1996 in a similar Adjournment debate, I pressed for a judicial inquiry into BSE and CJD. After the announcement by the Secretary of State for Health on 20 March last year as to the likely cause of new variant CJD, I pressed the point again in early-day motion 676. I urged the establishment of an inquiry to investigate both new variant CJD and the contamination of human growth hormone.
The Minister will recall his comment, in his letter to me of 12 November 1996, that the judgment in the human growth hormone court action
was reached following a very detailed trial which was in many ways more akin to a judicial inquiry".
I remind him of Mr. Justice Morland's remarks in his 84 page judgment after the court hearing. He said:
Litigation of this scientific complexity on a subject of general importance might be better resolved by an inquisitorial rather than adversarial system".
It is clear that the lack of the kind of independent inquiry that the judge himself pointed towards and which resulted in last year's court action will, if not acted on, result in further expensive and, for the families concerned, distressing litigation. In the event of there being no such inquiry, I understand that the families of victims of new variant CJD will also being taking their cases to court.
I argue for a judicial inquiry because of fears put to me by some very eminent scientists that there has without doubt been a cover-up as to the extent of knowledge of both sources of CJD. I have received indications in the past few days from someone previously employed within MAFF, whose identity will become public shortly, that researchers there were aware of the potential link between CJD and food much earlier than the Government have claimed. He states that their research in 1991–92 identified pathological changes in the muscle of cattle with BSE. As it was known then that other species—goats, mink and hamsters—with a prion disease had muscles containing infection, it should surely have been assumed then that that could also be the case with cattle. No action was taken, and we need to know why this key development was ignored along with a considerable amount of other significant research material that was referred to the Spongiform Encephalopathy Advisory Committee.
I hope that the Minister will recognise that the direction that I am suggesting addresses not only the scientific concerns but also takes account of the desire of victims' families to know the truth in a way that is perhaps less painful and certainly less expensive than continuing litigation.
I am grateful to the hon. Member for Wakefield (Mr. Hinchliffe) for raising this issue and for allowing me briefly to intervene and to give him what support I can. I do so partly because I once held a post in the Department of Health—I should put it on record that I held it from September 1986 until December 1988 and was therefore not able to participate in the decisions that the hon. Gentleman has outlined—and partly because I have a constituency interest in a young man called Gavin Blandford whose mother has been to see me.
Gavin is one of the walking worried. He is a healthy young man in his 20s and is now 5ft 2in tall. His mother tells me that without the treatment that he has received he would probably not have grown much above 2ft tall, so he gained enormously from the treatment. Nevertheless, he was one of those who received the pituitary gland compound and as a result is very concerned, as are his family. His mother came to see me with great courage, fortitude and dignity, but she also expressed to me her sense of guilt because it was she who encouraged the child to have the treatment and took him to virtually every one of the treatments that he had.
I hope that these problems can be recognised in some way and that some form of recognition and perhaps compensation may be given to such families.
I support my hon. Friend the Member for Wakefield (Mr. Hinchliffe), who put the case for Creutzfeldt-Jakob disease victims most eloquently. I should like to impress upon the Minister the fact that a limited number of people are involved and that they have been divided by the court case and the cut-off date of 1 July 1977. I reiterate my hon. Friend's call for a no-fault compensation scheme for those desperate people.
The hon. Member for Wakefield (Mr. Hinchliffe) has raised an important issue. Although, mercifully, it affects only a few people, it is crucial to them. I have listened carefully to the debate and I am conscious of the close interest that the whole House, and particularly the hon. Gentleman, has shown in the issue. The matter was raised during Health questions last week.
I appreciated the opportunity, afforded to me by the hon. Member for Wakefield, of meeting some of the families of his constituents and others who are affected by this terrible disease. I am sure that he will agree that it was a most moving occasion in my office in the Department of Health. I have said many times, including several times in the House, that of course we have considerable sympathy for all the families who have lost loved ones as a result of that terrible disease and for those who are at risk of getting CJD in future. Of course, they are much larger in number.
I have personal experience of the "well but worried" people whom the hon. Member for Wakefield mentioned, because I have a constituent in that category. I am aware of the real anxiety and distress that the episode has caused. The hon. Gentleman went into the history of the matter and said that, at the time, the human growth hormone treatment programme was regarded as a success story. It was used not just in the United Kingdom but all over the world, to treat many thousands of children who, but for the treatment, would have suffered permanent short stature or in some cases disability or even death. At the time, there were few side effects.
As I am sure hon. Members know, the programme ran from 1959 to 1985 and just under 2,000 children in the United Kingdom were treated during that period. It was successful in helping children grow, and it was in great demand. We should not forget that. That it should now be associated with this appalling disease with these awful consequences is a very real tragedy.
Does the Minister accept that the Government's role in promoting and advocating that treatment imposed on this Government and the Government of which I was a member a moral and legal responsibility for the tragedy with which he has shown sympathy? We want a clear answer on the moral and legal responsibility.
That is precisely the question that the judge dealt with when he examined the case. As the hon. Member for Wakefield said in his opening remarks, it was an inquisitorial rather than an adversarial examination of the case.
The judge said that himself. Indeed, only 10 minutes ago, the hon. Gentleman quoted Mr. Justice Morland, who said that it was an inquisitorial examination rather than an adversarial one.
The Minister has misunderstood what I said: I said precisely the opposite. In his summing up, the judge argued that an adversarial system was inappropriate. He said that there should be an inquiry, which is what my hon. Friends and I and the hon. Member for South Derbyshire (Mrs. Currie) are arguing for tonight.
I am sorry if there has been a misunderstanding. Mr. Justice Morland said that it was in the nature of an inquisitorial examination and not an adversarial one.
No, in his summation he said that it was.
The use of human growth hormone ended in 1985, when the link with CJD was firmly established. The growth hormone used now is genetically manufactured by a totally different method, and, I am happy to say, is perfectly safe.
As we now know, CJD has been transmitted through this treatment, and the administration of the treatment programme by the Department of Health and Social Security, as it then was—my hon. Friend the Member for South Derbyshire (Mrs. Currie) will remember those days—has been the subject of a full, comprehensive and open hearing in the High Court before Mr. Justice Morland. I repeat the point that that hearing was, in the judge's own words, much more akin to an inquisitorial public inquiry.
I am using the judge's words. I have great regard for the hon. Gentleman on the matter, which he pursues with great persistence. I am using the judge's own words, which the hon. Gentleman quoted in his opening remarks. The judge said that the hearing was more akin to an inquisitorial public inquiry than to a conventional adversarial court hearing. The point of the judge's hearing was to try to get at the truth. It was a genuinely sympathetic attempt to get at the truth of the matter—there are possible parallels with the recent treatment in the law courts of Mrs. Blood, when it was apparent that Lord Justice Woolf was more concerned to get at the truth of the matter and to examine the case from the point of view of justice—
Let me finish this point.
Lord Justice Woolf was more concerned to examine that case from the point of view of justice and finding the truth than to examine the pure legalities of the matter. It is more difficult for the Department to depart from a judgment that the judge has formed in an attempt to find the truth.
I also have a constituent who is in the category of the worried well. The Minister pointed out that only 2,000 people are affected by the treatment and are worried about the danger, so to compensate them would not cost that much. Will the Government consider extremely sympathetically extending to that group of people the same procedures as were extended to the haemophiliacs who were infected with HIV? Surely that is the way forward, rather than more court action.
I shall come to that point, but I was dealing with the point that the hon. Member for Wakefield fairly raised about the nature of the inquiry and the judgment by Mr. Justice Morland, who considered the issue in a totally independent way. The hon. Gentleman called for an independent inquiry. Mr. Justice Morland provided an independent inquiry of an inquisitorial nature.
The Department co-operated as far as possible with the full production of all documents and witnesses that could help in the understanding and unravelling of the circumstances surrounding the administration of the treatment. In the end Mr. Justice Morland found that the Department had been negligent in certain aspects of the administration of the programme and we accepted that finding. At all times we have co-operated with the court and we are now anxious to comply with its judgment.
The judge found that the period of negligence started on 1 July 1977, and we accept that. He found that those whose treatment commenced after that date should be compensated and we accept that, too. As a result, we have been anxious to reach agreement on the terms of the compensation, so that a swift settlement can be reached. I am certainly conscious of the time that any Government Department—never mind which party is in power—can take to reach a settlement when such a judgment is delivered, and I assure the hon. Gentleman that I am keen to reach a settlement as quickly as possible.
We have only just received details of the claims for compensation. The schedule of damages was delivered on 7 February and further information is required before negotiations can commence. I hope that they will be conducted as speedily as possible, so that the matter can be settled rapidly. To some extent, it is still dependent on the legal process. As the hon. Gentleman said, the plaintiffs have made a further appeal against part of the original finding of Mr. Justice Morland.
The hon. Gentleman referred to those whose treatment commenced before 1 July 1977 and continued thereafter. Some of that group have lodged an appeal against the decision of Mr. Justice Morland that plaintiffs who commenced treatment before 1977 and continued afterwards should not get damages. It is their right to lodge such an appeal. The judge specifically stated on several occasions that, in his view, the Department was not negligent in respect of patients who commenced their treatment before 1 July 1977. He concluded that on the balance of probabilities—I believe that he was looking at what happened in 1985, when the treatment finally ended and there was clear proof of a link between the human growth hormone treatment and CJD—the treatment programme would not have been suspended for them and that treatment would have continued after 1977. That was not the Department's conclusion, but the judge's decision.
My constituent, Mr. Hefferon, whose son died of CJD and who is involved in fighting for others who are affected, will find it difficult to understand why the Minister is hiding behind the judge's words and is obviously intent on making people go to appeal instead of establishing a judicial review now, which is within his power.
As I said when I repeated the judge's words to the House, he took an independent view and the case was of an inquisitorial nature rather than an adversarial one. It is more difficult for the Department to depart from an independent view expressed in that way than had it been a plain, straightforward adversarial look at the facts.
The hon. Member for Wallasey (Ms Eagle) asked why we could not decide to have a no-fault compensation system, as did the hon. Member for Barnsley, Central (Mr. Illsley). The Department of Health has to consider the health facts and where health resources should be best spent. In our view, health resources are better spent on keeping people from getting ill and making them better when they fall ill, than on compensating the families of those who have died. The first call on the Department's funds has to be those who are ill and those who may fall ill. I am sure that the hon. Member for Wakefield understands that very well. In pursuit of that aim, we have funded a counselling service for patients who were treated with human growth hormone, and their families. That service, which is provided—