Dáil Éireann díospóireacht -
Thursday, 5 Jul 2001

Vol. 540 No. 3

Adjournment Debate. - Irish Blood Transfusion Service.

Mr. Allen

The Irish Examiner today published a report which stated that 20 patients requiring blood have received blood supplied by three donors who were subsequently diagnosed as having classical CJD. While health experts may say that there is no cause for alarm, and the indications are that the deadly brain disease cannot be contracted through blood transfusion, there is no scientific certainty of this so we cannot be complacent.

The Irish Blood Transfusion Service when contacted confirmed the story and has also confirmed that the blood transfusion service doctors were contacting the GPs of the individuals concerned and that the persons affected will be informed eventually. However, I would submit that there is no guarantee that the patient will be told. It is at the discretion of the individual GP and I am questioning the principle of the right to know.

Scientific studies undertaken to date show that classical CJD can be spread through organ donation, surgery and blood transfusions, but unlike variant CJD, is not contracted by eating BSE infected beef, even though the effects of both diseases are similar. This issue is of major public interest and the explanation given by the IBTS spokesperson that the facts had not been made public on the grounds that they were contacting the recipients' doctors, is unacceptable in view of the scandals that have occurred to date and which are the subject of the Lindsay tribunal hearing. Have any lessons been learned from the past? Surely the IBTS has a responsibility to contact the affected persons directly rather than using a third party. It has some questions to answer on this issue.

I am asking if the Minister is aware of this issue; when did he become aware; why was the public not informed and, more importantly, why were the patients concerned not informed directly? The worst health scandals in the history of the State have been caused by appalling mistakes in the use of blood and its products by official agencies. I call on the Minister to make a full and frank statement and I demand that he carry out a full inquiry into the whole affair.

Since this matter is just one of a long series of incidents involving the Irish Blood Transfusion Service, I am also asking the Minister why he is suppressing the Philip Flynn report on the Irish Blood Transfusion Service. In response to a parliamentary question which I submitted to him last Tuesday, the Minister said that the report had been available to individuals within the IBTS and he welcomed the commitment given by that body that it would implement the recommendations in that report. This is a suppression of the facts. It is essential that the Flynn report be made public because we are being subjected daily to a series of selective leaks. The editorial in the Irish Examiner stated this morning that bad blood memories will not be dispelled with words. When it comes to possible links between CJD and blood, the only certainty is that there are no certainties.

It is essential that the full facts be disclosed by the Minister and that a detailed explanation be given by him. A commitment to a full inquiry into this latest incident and the full publication of the Flynn report is required. Anything short of this will demonstrate serious political negligence on the part of the Minister for Health and Children.

Dr. Moffatt

I thank Deputy Allen for raising this issue on the Adjournment. CJD, which is also referred to as classical or sporadic CJD, is a rare disease affecting approximately one person per million per year worldwide. In general, the majority of cases arise spontaneously. However, much less commonly, cases can result from exposure to infectious material. The international scientific evidence available to date indicates that CJD is not transmissible through blood or blood products.

There are around three cases of CJD per year in Ireland. CJD mainly affects older people and the average age of onset is 65 years of age. The typical duration of the illness is only a matter of months, and the clinical hallmarks are rapid progression of dementia together with a loss of control of movement. CJD has been a notifiable disease in this country since November 1996. A national surveillance system has been established and is based at Beaumont Hospital. Cases of clinically suspected CJD are referred to the hospital for further pathological diagnosis.

The policy of the Irish Blood Transfusion Service is to permanently defer potential donors who may be at risk of carrying CJD, including persons who have received a dura mater transplant, human pituitary-derived growth hormone, or who have one or more blood relatives with CJD. It is important to note that in the matter raised by the Deputy, the donors in question were diagnosed with classical CJD and not variant CJD. An appreciation of the distinction between these two conditions is essential to understand the actions taken by the IBTS in the matter raised by the Deputy.

There is no proven instance of classical CJD having been transmitted through blood or blood products. With regard to variant CJD on the other hand, the theoretical possibility of transmission cannot be excluded at this time. As a result, the IBTS has implemented a number of precautionary measures to protect against this theoretical risk. Experimental animal models suggest that the infectivity may be associated with white blood cells in animal systems. White blood cells can be removed from blood donations using special filters, by a process called leucodepletion, and the IBTS, as a precautionary measure, introduced leucodepletion for cellular products in 1999. In addition, the IBTS has recently commenced to defer donors who resided in the UK during the period 1980 to 1986 on a phased basis, to further address concerns about the possible risk of transmission of variant CJD by blood transfusion.

With regard to the matter raised by the Deputy, there is no question that the IBTS failed to disclose that donations were transfused from patients who later went on to develop CJD. The question of informing recipients is not an easy one and must be considered in the light of the international evidence that the condition is not transmissible through blood transfusion. In the US, the Food and Drugs Administration advises informing "the physician or other qualified personnel responsible for the care of the recipient so that recipient tracing and medically appropriate notification and counselling may be performed at the discretion of care provider". In both the UK and Australia, my understanding is that recipients of donations from donors who later develop CJD are not informed, precisely because of the absence of risk.

In December 2000, the CJD advisory group, on which the IBTS is represented, considered the issue of a look-back programme on the previous donations of donors who were subsequently diagnosed with CJD. After a detailed discussion on the matter and taking into account the extremely low risks, if any, associated with such donations, the group agreed with the IBTS policy of contacting the treating doctors and informing them of the situation. It was agreed that the final decision as to whether to inform the recipient was to be left with the individual clinician.

Mr. Allen

That is a disgrace.

Dr. Moffatt

The CJD advisory group also decided to commission a study by the Royal College of Surgeons on the psychological impact of informing recipients who received donations from donors who later developed any form of CJD.

The question of informing recipients of donations from classical CJD donors has also been carefully considered by the American Red Cross committee for the Prevention of Human Subjects, who strongly discourage the sharing of this information. The basis for their advice is: evi dence showing the absence of risk of transmission classical CJD through blood components; the inevitable stress which is likely to result from such disclosure; and the absence of any test or treatment which would help to alleviate this stress.

It must be stressed that the most important of these reasons is the absence of risk of transmission. This is also the international consensus of advice on this matter and the advice of the CJD advisory group.

As a result of the IBTS's look-back programme, three blood donors have been identified who were subsequently diagnosed with classical CJD. As part of the look-back programme the IBTS wrote to the clinicians involved, and found that 20 recipients received the donations of these apparently healthy donors. As explained the decision whether to inform the recipient rests with the clinician, in view of the negligible risk involved.

My colleague the Minister for Health and Children, Deputy Martin, has informed me that he has requested a full report on the current position regarding the look-back programme from both the IBTS and the CJD advisory committee.

With regard to the second matter raised by the Deputy, the report referred to is entitled Recommendations to the Board of the Irish Blood Transfusion Service on the Implementation of the Reorganisation plan, and was prepared by management consultants at the request of the board of the IBTS. The Minister understands that at a special meeting of the board held on 23 June 2001, the board accepted the consultants' recommendations. The Minister also understands that the board is arranging to make copies of the report available to relevant staff in the organisation. The board is also commencing the implementation of the recommendations within the best principles and practices of change management, involving all staff in the consultative process.

Mr. Allen

Are we entitled to see the report?