Additional comments by Senator Steve Hutchins
The Decision to Not Introduce Surrogate Testing for
Hepatitis C in Australia
are thousands of Australians who have acquired hepatitis C as a result of a
blood transfusion or receiving a blood product. Each of those people have at
least suffered terrible hardship and pain, while some face the possibility of
death as a result of their illness. In weighing up the evidence presented to
the committee, the effect this illness has had on the individuals concerned
must be at the heart of any conclusions drawn.
deciding whether the relevant authorities made appropriate decisions with
regard to the introduction of surrogate testing for hepatitis C in donated
blood, the following issues must be considered:
- when the seriousness of non-A, non-B hepatitis was generally accepted
by the medical profession;
- how effective surrogate testing is in excluding non-A, non-B hepatitis;
- whether the deliberative processes of the relevant authorities
regarding the implementation of ALT testing were carried out in a comprehensive
and expeditious manner.
have been raised that the inquiry, by its very nature, threatened the quantity
of blood available because negative publicity for the Australian Red Cross
discourages donors from providing blood. As the Tainted Blood Action Group
stated at the hearing in Sydney, the two years (2002 and 2003) when the issue of
tainted blood received the greatest media attention coincided with record
levels of donations of blood . In
other words, fear that findings of this committee would impact upon the future
viability of the blood supply are unfounded.
the heart of any decisions made regarding the implementation of surrogate
testing is what appears to have been the ethical balancing act at the time:
whether excluding hepatitis C infected blood was worth the exclusion of a
certain amount of blood which was actually uninfected.
Understanding of hepatitis C
determining whether the actions of the Australian Red Cross and CSL Ltd were
appropriate, it is essential to consider the knowledge of the seriousness of
hepatitis C (or non-A, non-B hepatitis). Clearly, one would expect any
organisation to introduce measures to prevent the transmission of an illness
which was known to be harmful, and which could potentially be
life-threatening. As a result, the knowledge of hepatitis C and its impact
upon the lives of its victims should be essential to the conclusions of this
Professor Burrell, the very first witness to give evidence to the
Committee, informed us that in 1974-75 'two key publications identified a
percentage of cases of hepatitis after blood transfusion not caused by
hepatitis A or hepatitis B'. At the same hearing Professor Burrell
gave evidence that the following was known about the infection:
'unless the blood recipients were tested for liver
function, it would not be evident that they had become infected. It was known
that chronic infection occurred in a percentage of these, though the exact rate
was not known. It was also known that some of these people remained infectious
for a long time. It was also known that there was a link to chronic active
hepatitis and to cirrhosis. The proportion of individuals was not known and the
time frame was not known.'
it was clear from as early as the mid-1970's that an unidentified type of
hepatitis was in the blood supply, and that it was detectable through testing
for liver function (also known as surrogate or ALT testing). The seriousness
of the illness, at least in terms of its longevity and its link to cirrhosis of
the liver, were known at the same time. There is no doubt that blood
authorities across the world were aware of the same information to which Professor Burrell
evidence to the Committee from the Australian Association of Pathology
Practices stated that 'by 1987, the problem of hepatitis C was well known.
International strategies to reduce the incidence of post transfusion hepatitis
caused by NANB in donated blood had been in place internationally since 1984'.
By 1986, the threat of hepatitis C was deemed serious enough for the United
States Food and Drug Administration to implement mandatory anti-NANB hepatitis
strategies. Not until February 1990 did Australia routinely test for hepatitis C in donated blood
when the first licensed testing kits became available.
was clear evidence more than a decade before the introduction of hepatitis C
testing in Australia that thousands of Australians were being regularly
exposed to an illness which can have long-lasting and terrible effects.
The Effectiveness of Surrogate Testing
evidence presented to the inquiry undoubtedly agreed that, if surrogate testing
for hepatitis C had been implemented, the following results, on the balance of
probability, would have occurred: a certain amount of hepatitis C infected
blood would have been excluded from the blood supply; and a certain amount of
hepatitis C free blood would have been mistakenly excluded. In other words,
the organisations and governments involved in the National Blood Transfusion
Advisory Committee knew that the decision not to implement testing for
hepatitis C would result in blood recipients acquiring hepatitis C. That is
the essence of this inquiry: whether it was right to keep blood which was known
to be infected to preserve the availability of blood which most likely was not
to 1990, the Australian Red Cross Blood Service estimates that the likelihood
of risk of hepatitis C, per unit of blood, was 1 in 333. That figure has,
thankfully, fallen to less than 1 in 3 million. When ALT testing and anti-Hbc
testing was introduced in the United States of America, the risk profile of
infection reduced from 5.5% to 4.1% from a transfusion.
While the arguments made concerning the higher incidence of hepatitis among
donors in the United States are compelling, it would have been foreseeable that
the implementation of the same tests in Australia would have reduced the incidence of blood
transfused hepatitis C by the same ratio. This is because surrogate testing
removes a fixed percentage of infected blood despite the overall level of
infected blood in the blood supply. As such, whilst Australia has a safer
population and hence a lower overall risk, this means that that overall risk
would have been reduced by a similar ratio to a much smaller overall rate of
means that the 1 in 333 likelihood could have been reduced to 1 in 500 at the
higher limit of ALT effectiveness.
While, in statistical terms, this may seem insignificant, it would have
undoubtedly saved some lives and would have improved the quality of life of
hundreds, if not thousands, of people. This would have also meant a net saving
by up to 1/3 in the total costs of health care, running possibly into the
hundreds of millions, of persons now unfortunately infected with hepatitis C
through the blood supply.
Department of Health and Ageing's submission dismisses the usefulness of
surrogate testing by stating that it is only as effective in ruling out hepatitis
C as using a 'random marker' such as a person's initials.
This assertion does not take the cumulative nature of risk associated with
exposure to infected blood, as is highlighted in the Australian Red Cross Blood
Service's submission, 'For instance, if the risk for a single unit is 1 in 1
million, then receiving a second unit means the cumulative risk to the
recipient is 2 in 1 million'. One
of the Department's most significant justifications of the decision not to
implement surrogate testing is based upon the false premise that each patient
only receives one unit of blood. The conclusions based on those calculations
are misleading because they fail to focus upon the victims of hepatitis C
Australian Red Cross Blood Service estimates that 1.5% of all donations would
have tested positive using surrogate testing (based on findings in the United
States), and that 70% of blood excluded would have, in fact, been the result of
a false positive. It
is undeniable that the Commonwealth, the States and Territories, the Australian
Red Cross Blood Service and CSL were placed in an unenviable position. They
were compelled to choose between the quantity of the blood supply and its
fact that the Queensland Red Cross Blood Transfusion Service, under leadership
of Dr Catherine Hyland, chose to implement surrogate testing and that no
other Red Cross Blood Transfusion Service chose to demonstrates the difficulty
of the question. But it also shows that a blood supply could be maintained and
function without the 1.5% of false positive donations. The lesson from Queensland
is that other Australian blood services may have been unnecessarily cautious in
their protection of the quantity of blood available.
role of various governments and organisations in providing direction for the
collection of and transfusion of blood, prior to 1996, were undoubtedly
complex. As far as the Department of Health and Ageing could advise in
hearings in Canberra, the Australian Red Cross regularly convened
meetings of a national blood transfusion advisory committee, and that committee
had representatives from the Red Cross, the Commonwealth and State and
Territory governments. Each state Red Cross blood authority made its own decision
regarding the implementation of surrogate testing for hepatitis C, but was
advised by the national committee. At no stage did the national committee
advise that surrogate testing should be implemented, although Queensland
later decided to introduce surrogate testing of its own accord.
Red Cross commenced a study of the effectiveness of surrogate testing in 1987
(a study into the transfusion rate of hepatitis C was conducted in 1979). So,
significantly after knowing the seriousness of the illness and years after the
test became available, an Australian study was first instigated. By the time
the study was concluded, the first generation test for hepatitis C was on the
verge of being widely available.
international standards, Australia was slow in studying the prospective effectiveness
of surrogate testing. In fact, Australia did so at the recommendation of 'experts from the US and Europe'.
It would appear that, up until the establishment of that study, Australia
relied upon information from overseas, much of which was seen as irrelevant
because of differences in the way blood was collected.
Without timely and relevant domestic studies, the
true impact of surrogate testing could not have been adequately ascertained.
is undeniable that thousands of Australians have acquired hepatitis C as a
result of receiving a blood transfusion. The seriousness of hepatitis C (or
non-A, non-B hepatitis) was known in the early 1980's. By 1978, according to Professor James Mosley, it
was well-known that surrogate testing could reduce the incidence of hepatitis C.
In fact, he delivered a lecture in Melbourne on this matter, a lecture which representatives of
the Australian Red Cross Blood Service attended.
Yet Australian blood authorities chose not to recommend that surrogate testing
be implemented because its effectiveness was not deemed great enough to justify
the exclusion of some blood which returned 'false positive' results to
decision had to be made, and no amount of retrospection can replicate the
difficulties faced by those people at that time. Nonetheless, it remains that
many Australians today suffer from what can become a debilitating illness as a
result of the decision not to implement surrogate testing outside Queensland.
surrogate testing had been introduced, the incidence of post-transfusion
hepatitis C would most probably have been reduced from 1 in 333 to 1 in 500.
As a statistic the difference is negligible. But the negligible difference has
had a profound and sad effect on the lives of thousands of Australians.
decision not to introduce surrogate testing was what created that effect.
Senator Steve Hutchins
Australian Labor Party, New South Wales
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