Just how do you break the news? That was the dilemma facing officials of the Department of Health when they discovered that blood products potentially infected with CJD had been given to 270 people as part of a medical procedure.
After the initial shock of discovery there would naturally be questions from the patient about the health implications of receiving such a product. Unfortunately, there are few definitive answers.
"It is quite some Christmas present to be giving to people," said a Department official yesterday. "You are telling them that they have received this product; that you do not know the level of risk, if any; that there is no test you can offer and that if they are going to get sick it may not be for five, 10 or 20 years or not at all. It is a huge dilemma."
A source who advises the Department of Health on CJD said yesterday: "This is an incredibly complex problem, the biggest I have ever faced in my career. We have all been working on this on a daily basis. It was decided to tell people but we had to work out the best way to do it."
The Department is now considering the appointment of a representative to the CJD Advisory Committee who specialises in medical ethics because of such difficulties arising in the future.
Those involved were loath to simply send a letter. They wanted to set up counselling services and inform general practitioners. This was a major criticism of the handling of the hepatitis C controversy - GPs were not informed in time and those involved found counselling services provided by the BTSB hopelessly inadequate.
We are likely to assume, given what has gone before, that the response to this incident will be weak. It does appear that lessons have been learned, but there are some outstanding issues.
The week-long delay by the Irish Medicines Board in informing the Department of Health is a legitimate issue to raise.
The chief executive of the board, Dr John Kelly, said yesterday action was taken as soon as the board was informed of the difficulty, and the plan was to inform the Department as soon as the board had a handle on how much of the product was in circulation and how many people had received the potentially infected batch.
It is puzzling, though, in light of what has gone before, that they did not pick up the telephone and inform the secretary general of the Department of Health, Mr Jerry O'Dwyer, of the problem. This would have given the Department extra time to formulate its response.
As it happened, the Department was informed by Dr Catherine Keohane, a member of the CJD Advisory Committee, who became aware of the recall at Cork University Hospital where she works. Not surprisingly, the Minister has informed the IMB that in future it is to notify him immediately of such a difficulty.
Mr Cowen stressed yesterday how seriously his Department had taken the product recall. "We were in contact with the CJD Advisory Committee on an almost daily basis. From the time we heard about it I believe we have acted in a proper, prudent and sensitive manner."
The delay has actually made little practical difference. Little is known about how CJD is transmitted, though new variant CJD is believed to be caused by consuming BSE-contaminated beef. There is no known danger that those involved, even if they had been infected, presented any danger to others.
If any had attempted to give blood they would have been excluded under the Blood Transfusion Service Board donor selection criteria. The BTSB asks prospective donors a number of questions before taking blood, including whether they have undergone tests or medical procedures in the recent past.
Interestingly, the UK has taken the opposite approach and decided not to inform people, which raises questions about the risk of further infection of the blood supply. "The British authorities have come to a different conclusion and have decided so far not to inform patients," said Dr Jim Kiely, chief medical officer of the Department of Health yesterday. "The difficulty of the blood supply is one that we will not have to deal with in the future but they will."
On Friday Mr Cowen and his advisers decided those people involved had a right to be informed. They are now likely to face future difficulties with life assurance and critical illness cover. What is truly appalling is the manner in which many of these people found out - while watching the 6 p.m. RTE news on Sunday. The product was given to around 270 people but there must have been a large number who may have undergone such a procedure, who feared they were also included, but had nowhere to call.
By now, hopefully, they have had their fears allayed. But it is those who did receive the potentially infected batch of Amerscan Pulmonate 11 who are in the unenviable position of not knowing where they stand, unable to get a definitive answer from the medical profession. However, they should take comfort from the consistent medical line that the risk is infinitesimally small. To date, studies have failed to confirm any transmission of the disease via blood plasma.
Now the important task of dealing with these people properly must be undertaken. The Department of Health must act swiftly in getting the relevant information to the nine hospitals where the Amerscan Pulmonate 11 was used and the patients affected must be dealt with quickly and sensitively.