Concentrates warning more of a cry in the wilderness

Prof Ernest Egan's warning call in May 1984 against relying on commercial concentrates for the treatment of haemophiliacs was…

Prof Ernest Egan's warning call in May 1984 against relying on commercial concentrates for the treatment of haemophiliacs was something of a cry in the wilderness.

The Factor 8 and 9 concentrates had been in widespread use for up to 10 years and had made treatment more convenient and less painful for the State's 400 haemophiliacs.

Previously, haemophiliacs had to use cryoprecipitate, a bulky product which had to be stored frozen and was generally administered in hospital. In contrast, concentrates could be administered quickly and easily at home, thereby minimising damage caused by bleeding into joints.

Despite the benefits, however, Prof Egan, the regional director of haemophilia treatment services in Galway, called for concentrates to "have their use restricted to critical clinical situations".

READ MORE

In a letter to the National Drugs Advisory Board, he warned of a "significant risk" attached to the products and said: "They should not be used, as is often the case, for ordinary home care of patients with severe haemophilia".

How well-founded Prof Egan's fears proved, as commercial and Blood Transfusion Service Board (BTSB) concentrates went on to infect an estimated 220 haemophiliacs with HIV and/or hepatitis C.

It is clear few people disputed the risks at the time. As the concentrates were made from pools of plasma drawn from up to 1,000 donors, it was much more difficult to isolate infected batches than it was with cryo.

With commercial concentrates, there was an added concern about the source of donations, with plasma taken in Third World countries and from paid "skid row" donors.

Prof Egan said, however, that by mid-1984 "the pattern had been set". There was "very little re-discussion" of the issue and very little appetite for going back to cryo from either haemophiliacs or treaters.

This seems to be borne out by documentation shown to the tribunal which suggests that not even the Irish Haemophilia Society (IHS) considered a return to cryo.

Indeed, a number of haemophiliacs interviewed for a 1985 television documentary, which the IHS applied unsuccessfully to have shown in evidence, spoke of how they felt the benefits of concentrates outweighed the risks as they were known at the time.

One interviewee remarked that when one weighed "the certainty of pain, discomfort, eventually losing one's job perhaps, being a burden on your family" against "the very slight risk of AIDS, and with it leading a normal life" there was "no choice. I wouldn't want to go back to the pre-Factor 8 days."

However, one cannot assume all haemophiliacs shared this view. Nor can one assume they were all given adequate information about infection risks and alternative treatments to allow them to make informed decisions. Nor can one assume they were even given a choice.

Asked whether he told any of his patients about his concerns, Prof Egan said he could not recall a specific instance. However, he said he believed haemophiliacs knew about the risks.

As well as the treaters, the BTSB arguably had a duty to inform haemophiliacs about safety issues. It should be emphasised, moreover, that regardless of how haemophiliacs felt about using the products, the BTSB had a duty to make them as safe as possible.

The issue will be examined further on Tuesday when Mr Brian O'Mahony, the chairman of the IHS and himself a haemophiliac, takes the stand.