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MICHAEL J CARNAHAN

ALLIES OR ENEMIES
HOW THOSE NEEDING HELP LEARNED TO HELP THEMSELVES IN THE FACE OF BAD BLOOD

A LLIES OR E NEMIES : H OW THOSE NEEDING HELP LEARNED TO HELP THEMSELVES IN THE FACE OF B AD B LOOD

M ICHAEL J C ARNAHAN

2013 Michael J Carnahan Edited by Chantal Lauzon Published in 2013 by: Haemophilia Foundation of New Zealand Inc. (HFNZ) PO Box 7647 Sydenham Christchurch, 8240 New Zealand Email: info@haemophilia.org.nz Website: www.haemophilia.org.nz

NATIONAL LIBRARY OF NEW ZEALAND CATALOGUING-IN-PUBLICATION DATA Carnahan, Michael John, 1946Allies or enemies : how those needing help learned to help themselves in the face of bad blood / Michael J Carnahan. Includes bibliographical references and index. ISBN 978-0-473-26002-6 1. HemophiliaNew Zealand. 2. Hepatitis CNew Zealand. l. Haemophilia Foundation of New Zealand. ll. Title.

Disclaimer This work is the opinion of the author based on his recollection of events during the stated period. The information, views or opinions expressed in the document are those of the author and do not necessarily reflect the views of HFNZ. To the maximum extent permitted by law HFNZ excludes all liability for any loss or injury arising out of, or related to, the use, inability to use, authorised use, performance, or non-performance of information published in this document however caused, including by negligence The publishers will gladly receive any information that will enable them to rectify any inadvertent errors or omissions in subsequent editions. Copyright Notice This work is copyright. Except for the purpose of fair reviewing, no part of this publication may be reproduced or transmitted in any form or by means, but not limited to electronic or mechanical, including photography, scanning, recording, or by any information storage and retrieval system, without permission in writing by the author. Infringers of copyright render themselves liable to prosecution. The right of Michael J Carnahan to be identified as the author of this work in terms of Section 96 of the NZ Copyright Act 1994 is hereby asserted. Please note that each photograph reproduced in this publication is the property of the individual or organisation as per the acknowledgement noted next to or below each one. As such the copyright is held and asserted by them and requires their authority to use or reproduce in any form.

Cover Image: Message in a Bottle Evidence by Denz Zani 2

M ICHAEL J C ARNAHAN Born in Nelson in 1946, Michael Carnahan was one of two brothers with factor IX deficiency (haemophilia B). Born in an age where the only treatments for haemophilia were bed rest and crude blood transfusions, his father William helped to found the New Zealand Haemophilia Society in an effort to learn more about the condition and support other families. A long-time volunteer and advocate for the Society, Michael Carnahan served as President of the renamed Haemophilia Foundation of New Zealand Inc (HFNZ) from 2000 to 2004. The initiatives he began have had a lasting impact on the structure and function of the organisation, as well as the overall delivery of haemophilia care in New Zealand. He also believed in the need to restructure blood services in New Zealand in the 1990s and, accordingly, participated in a number of working committees to develop improved safety of blood services and to define care standards for people with haemophilia. Carnahan played a key role of the HCV Working Party to bring the issue of a Treatment and Welfare Package for people who contracted HCV though infected blood products to a conclusion. In addition, he was a participant in a number of international meetings to advance international blood product safety and to assist developing nations in structuring their voluntary services. Carnahan continues to live in Nelson with his wife Cheryl and remains involved with the haemophilia community as a Life Member of HFNZ and trustee of the Alan Coster Educational Endowment Trust.

Dedicated to all those who lost their lives too early or are living with the consequences of contaminated blood in the hope that history will not be repeated.

C ONTENTS
CHAPTER 1 - THE HAEMOPHILIA COMMUNITY CHAPTER 2 - THE EMERGENCE OF HIV/AIDS AND CONSEQUENT NATIONAL ACTIONS CHAPTER 3 - NZHS AS ADVOCATES FOR MEMBERS WITH HIV CHAPTER 4 - THE BLOOD SUPPLY AND HEPATITIS C CHAPTER 5- THE EVER LOOMING THREAT OF HCV CHAPTER 6 - BAD BLOOD COMES TO THE FORE CHAPTER 7 -THE PERSONAL IMPACT OF HCV CHAPTER 8 - ACCIDENT COMPENSATION SCHEME FAILS AGAIN CHAPTER 9 - LEGAL AND POLITICAL ENGAGEMENT CHAPTER 10 - MAKING CHANGE HAPPEN CHAPTER 11 - THE SITUATION IN 2012 POSTSCRIPT 13 15 21 25 29 31 39 43 47 53 63 67

Glossary References

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ILLUSTRATIONS FIGURE 1. SAMPLE NEWSPAPER HEADLINES ABOUT HEPATITIS C AND BAD BLOOD 33 FIGURE 2. WALL OF SHAME - THE 11 WEEK POLITICAL DEMONSTRATION AT PARLIAMENT, 1999 50 FIGURE 3. EFFECTIVELY USING THE MEDIA (THE PRESS, CHRISTCHURCH, 17 APRIL 2004) 53 FIGURE 4. MEDIA COVERAGE OF THE EMBARGO OF HELEN CLARK'S FILES (THE PRESS, CHRISTCHURCH. 9 APRIL 2005) 56 FIGURE 5. PREPARING THE SUBMISSION FOR THE DIRECTOR GENERAL OF HEALTH 57 FIGURE 6. HANDING OVER THE SUBMISSION TO DR COLIN FEEK, CHIEF MEDICAL OFFICER, MINISTRY OF HEALTH, BY STEVE WARING, HFNZ, AND MICHAEL CARNAHAN, HFNZ PAST PRESIDENT (2000-2004). 58 FIGURE 7. MEDIA FROM WORLD HAEMOPHILIA DAY, 17 APRIL 2006 60 FIGURE 8. PROFILE OF ONE OF THE ESTATES THAT WERE ABLE TO ACCESS THE TREATMENT AND WELFARE PACKAGE (THE PRESS. 28 OCTOBER 2006) 62 FIGURE 9. REMEMBRANCE SERVICE FOR PEOPLE WITH HAEMOPHILIA WHO HAVE DIED (CAMP KESWICK, ROTORUA, 2003). 67

Please note that further information and definitions on items in italics can be found in the glossary.

PREFACE
In New Zealand, advocacy in health for people with haemophilia began with a family seeking to gain the best for their child, their brother, or another family member. This desire to exchange experiences and knowledge combined with a desire to help each other probably was not called advocacy in those days - it was just doing the proper thing. As those affected began to see advantages in knowledge, a fertile ground was created for the formation of the New Zealand Haemophilia Society (NZHS) in 1958, which eventually became known as the Haemophilia Foundation of New Zealand (HFNZ). In these early days advocacy within NZHS was not about strength of numbers and demanding resources but rather about helping to overcome the effects of a dreadful disease. People just helping other people. Haemophilia is a sex-linked genetic disorder where the blood clotting process does not work properly making it hard for a person to stop bleeding. Following an injury the body forms a blood clot to stop bleeding quickly. This clotting process, called coagulation, changes blood from a liquid to a solid state. For blood to clot the body needs a type of blood cell called platelets and blood proteins called clotting factors. In people with bleeding disorders, such as haemophilia, the blood platelets or clotting factors do not work correctly or are in short supply; so these people bleed longer than normal. Most bleeds are the result of some trauma but some people may experience unexplained bleeding into joints, muscles, or organs. People with haemophilia are usually short of or missing the blood clotting factors VIII or IX. Thankfully with replacement medicines a normal blood clotting process can be restored in people with bleeding disorders. Although conditions that result in the lack of adequate blood clotting in some people have been known for centuries, in 1950 haemophilia was a very rare and little known condition, unable to be accurately diagnosed or treated other than by palliative care. Having haemophilia then meant a life expectancy of barely 21 years. Life was usually cut short as a consequence of a prolonged internal bleeding episode. Somewhat ironically the battlefields of World War II accelerated the understanding of blood from which the specialty of haematology emerged. The 1950s and 1960s saw blood plasma being used to stop a bleed into joint muscle or organ of the person with haemophilia; the first treatment to really be effective. Then in the 1970s fractionated blood products, the saviour for people with haemophilia, started to be developed by international pharmaceutical companies. People with haemophilia living in developed countries began to have a life; one where death from bleeding was not quite so imminent; where the need for pain relief diminished; and, where individuals could begin to participate in higher learning, career and normal home life. But the saviour, this miracle of science, this relief, was ripped away in 1983 when human immunodeficiency virus (HIV) was found to be transmitted in fractionated blood products. The whole blood or blood plasma provided to or purchased by international pharmaceutical companies and manufactured into fractionated blood products continued to be the route of transmission until such time as procedures were able to screen out the virus and neutralise the virus during manufacture. As an international product used in numerous countries, governments became immediately involved, as did funders and health service regulators. In New Zealand the governments focus was on public health. The safety of the blood supply became the major issue as blood is one of the cornerstones of an adequate health service. The era of HIV and acquired immune deficiency syndrome (AIDS) changed the nature of haemophilia advocacy. The leadership at the NZHS had to not only become knowledgeable about haemophilia but also about this new disease. Advocacy for these volunteers evolved into calling government and the Department of Health to account for their action and leadership; becoming knowledgeable about government and legal process; and securing entitlements from the likes of the Accident Compensation Commission (ACC), which failed to deal adequately with the individuals developing this often fatal new disease from their prescribed medication. 9

Meanwhile, science tried to identify the origins of this new disease and to develop ways of combating HIV and AIDS, using tools such as donor screening and application of heat during manufacture of products to kill the virus. Pharmaceutical companies, government and health-related government agencies went from allies in the 1970s to enemies in the 1980s as battles developed over a number of related issues: access to information; the propagation of misinformation; the safety of the blood supply; the adequacy of supply and manufacturing protocols for fractionated blood products; entitlements to accident cover; and, the evergreen issue of confidentiality of an individuals information. In the midst of these battles there was, however, another virus lurking. In the 1970s the transmission of non A non-B hepatitis (NANBH) associated with blood transfusion was known but in the mid-1980s an effective step to inactivate this virus, or indeed to characterise it, had not evolved. In 1989 this virus was mapped and re-named hepatitis C virus (HCV). Although HCV was known to be in the blood supply, people with haemophilia in New Zealand had no choice but to continue to use plasma-derived products manufactured from blood donations that were neither tested nor treated to eliminate the virus. The outcomes related to HCV were considerable. The New Zealand Society of Gastroenterology estimated that 1 by 2010 some 50,000 people in New Zealand would have contracted hepatitis C . Over 500 of these would probably have contracted their HCV from blood or blood products, including189 people with haemophilia. Some people with haemophilia were infected with both HIV and HCV. By 1990, the regular review of health service expenditure by government meant that the structure of the health service was continuously changing. As a result NZHS advocates had to consult on a variety of concerns or new issues directly with the Ministry or Minister of Health such as: HCV antibody testing; surrogate testing; the continuing use of random donors for cryoprecipitate; the introduction of super-heat treatment of haemophilia plasma-based products; and, the continuing use of unscreened plasma. Finally in November 1992 a television programme revealed that screening for HCV of blood donors was only partially effective in preventing HCV infection in users of blood and blood products. This claim and the ensuing information and misinformation resulted in an intense Parliamentary debate, questions in the House, calls for the resignation of the Minister of Health, a Parliamentary Inquiry, and claims for compensation. The era of HCV once again changed the nature of advocacy for NZHS. The volunteers in the leadership of the organisation had to learn about the various strains of hepatitis, become informed about HCV in particular, explore the processes of the blood transfusion service, and keep abreast of the political issues that continuously swirled around HCV in the period between 1992 and 2006. Although the Societys mission was still based on helping each other within the group, a more urgent role and responsibility developed in securing the rights of the group as politicians tried to duck for cover and blame others. The responsibilities on volunteers became immense. As the years went by some 35 people with haemophilia died in whom HCV played at least some part in their deaths. This caused the NZHS advocates enormous worry and intensified the pressure on them. Another battle with ACC developed which resulted in multiple claims for exemplary damages being filed against the Crown for negligence and breach of statutory duty. This option presented enormous implications and costs, but was pursued until new information and new strategies arose in 2005 leading to a negotiated financial settlement with Government. The Governments position of doing nothing to protect public health and relying on the likes of ACC legislation to protect individual decision makers became intolerable for recipients of blood products. After 14 years of activism a settlement, the Treatment and Welfare Package for New Zealanders who contracted Hepatitis C from products containing infected blood, was announced on 17 April 2006 International Haemophilia Day following new advocacy on strategies being adopted by NZHS/HFNZ. Bad Blood caused a chain reaction of events that ultimately resulted in payment of over $17 million in ACC compensation and $11 million in personal compensation from the health authority. It also forever altered the 10

lives of all 29 people with haemophilia who were infected with HIV/AIDS and the 189 who were infected with HCV and their families. The story told here hopefully conveys that Bad Blood has in time resulted in greater protection of the blood supply, a benefit for all. Treatment for those with haemophilia, especially the young, has also been enhanced. It also tells how a small group of people fought long and hard in the pursuit of justice; standing up for their peers who could not always stand up for themselves. Hopefully the reader will always remember the story of those infected by HIV and then HCV and vow to remain vigilant and have a high expectation of their government, their politicians, their health service, the activities of the likes of ACC, and indeed the lawyers that purport to set things right once they have gone wrong.

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12

CHAPTER 1 THE HAEMOPHILIA COMMUNITY


S TATUS OF H AEMOPHILIA P OST W ORLD W AR II L EADING TO N ATIONAL A DVOCACY
AND THE

C IRCUMSTANCES

In 1950, haemophilia was still an untreatable condition and, because of its rarity (1:5,000 male births), the average post-war medical practitioner might see only one case during a career. The treating medical practitioner most often a general practitioner had few tools in his or her kit with which to manage haemophilia. The first step to treatment of any disease is diagnosis and in this post-war period there was simply no laboratory test to confirm a suspected case of haemophilia. The only test available was a measure of the clotting time. Diagnosis was, therefore, confined to careful observation and the recording of family genealogy. Due to the lack of effective treatment options, advocacy at this time was confined to personal care for the individual. The patient and his family quickly learned the skills of advocacy to influence medical decisionmaking. This advocacy was based on the familys previous experience and encounters. For example, people with haemophilia learned how to manage pain relief in a system worried about narcotic addiction of people in chronic and also, at times, acute pain. Developments in the field of haematology and knowledge about blood subsequently led to treatment for haemophilia becoming available. By the 1970s, the earlier work by Edwin Cohn, an American biochemist who first developed the technique of blood fractionation, together with three decades of medical progress allowed commercial production of the first medium purity fractionated blood products for treating factor VIII and factor IX deficiencies (haemophilia A and B, respectively). For people with haemophilia in New Zealand, the use of these fractionated products began in the early 1970s. The advent of these plasma-based factor concentrates gave people with haemophilia their first glimpse of normality higher education, career, employment, and family life - accompanied by reduction in acute pain, a break from the cycle of crippling joint deformity and reprieve from early death.

F O RM AT I O N

OF

NZHS

Organised advocacy for haemophilia in New Zealand had its beginnings in 1958 when Robert (Bob) White, an Englishman with severe haemophilia and the associated crippling joint damage, hobbled into New Zealand on his crutches. Having seen and experienced the benefits of a haemophilia organisation in the United Kingdom he began to gather people to form the New Zealand Haemophilia Society (NZHS) in that year. The people involved in this early advocacy group had a clear vision of what was needed. The emphasis was on joining families together and publicising information about the needs of people with haemophilia and their aspirations. This was carried out via a newsletter and sporadic newspaper and radio stories. The founders of the NZHS also saw the need for collaborative involvement of others, principally: politicians as the inevitable providers of funds and of hospital services; the clinicians who were going to provide the care;

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the pharmaceutical industry; and business. Interestingly, one of the first Vice Presidents of NZHS was the Rt Hon Walter Nash, the then Prime Minister. And so began in New Zealand a unique national structure of a group devoted to improving a dreadful medical problem with all those likely or able to make a difference represented the families of children with haemophilia, adults with haemophilia, the politicians, the private sector and the clinicians. All were focused on advocating for the enhancement of care for people with haemophilia. Five years later, in 1963, another person with haemophilia, Frank Schnabel of Canada, saw the need for a similar international organisation. He established the World Federation of Hemophilia (WFH), involving the same stakeholders as the NZHS did in 1958. By 1963, the structure for organised advocacy for haemophilia was in place, both nationally and internationally. From its very beginnings the NZHS developed strong connections to advance haemophilia care. Collaboration with WFH also began after its formation, although the high costs of international travel prevented attendance 2 by NZHS representatives at their bi-annual conference until 1975 . These strategic links have been maintained to this day. The emphasis during the early era was on joining families together and publicising their individual needs using the developed advocacy streams. To carry out this advocacy role participants had to become informed on what constituted the worlds best practice for care of haemophilia. They also focused on ways that people learn, the various methods of advocacy and political lobbying, and most importantly, the personal needs of its members, the people the Society was established to serve.

E AR LY A D V O CA C Y
The first major campaign the NZHS initiated was in the late 1970s when lobbying began for a fractionation plant to serve New Zealand and so provide an assured supply of fractionated blood products. Until this point, relationships between the NZHS and the pharmaceutical industry, regulators, health administrators and politicians had been cordial and respectful, with NZHS often offering views and comments on proposals to enhance care and to develop the blood donor service in New Zealand. In the 1970s NZHS had responded to the Labour Governments White Paper on Health with the view that New Zealand needed to be self-sufficient for blood and blood products and needed to be able to process this community resource within the country. The National Transfusion Advisory Committee also recommended to the Department of Health that New Zealand be capable of producing its own blood needs. In 1976, the Department of Health recommended to the Muldoon Government that a blood fractionation plant be established within New Zealand. This proposal was subsequently declined by Government quoting at the time bioengineering 3 advances may render fractionation obsolete within 5 years . While this development was also supported by clinicians, government decided that the capital cost was also too high. This decision was to have significant consequences for the haemophilia population of New Zealand in the coming years. The bioengineered advances Government referred to did not emerge internationally until some 20 years later in 1995 and it was 1997 before recombinant blood products were funded for use in New Zealand. The decision not to develop a blood fractionation plant also committed New Zealand to dependence on international fractionators for processing New Zealand blood donations. In the late 1970s reliance on imminent bioengineering was an unjustifiable position, especially as 40 years on science still grapples with gene therapy as a bioengineering process to cure or relieve haemophilia. Some have argued that the decision not to introduce self-sufficiency probably resulted in the appearance of HIV in the New Zealand blood supply earlier than would have been the case had a blood fractionation plant been established.

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CHAPTER 2 THE E MERGENCE OF HIV/AIDS


At the beginning of 1982, a new and mysterious disease was concerning health officials in the United States (U.S.). By mid-1983 there had been 1200 cases of this disease reported, one third of which had proven fatal. This disease eventually became known as human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS). News of a common link between homosexuals, Haitians, heroin and haemophilia, and the apparent advent of a dreadful new disease began to be reported in the newspapers and so people with haemophilia in New Zealand slowly became aware of the association of AIDS with haemophilia. Some people in New Zealand had become sick as early as 1982 with this then unknown and unnamed disease. An infection of some sort was the diagnosis given to some patients. Others were aware they were unwell but clinicians could not define the problem. For most people with haemophilia in New Zealand, the first real information about the new disease was the NZHS newsletter of June 1983 that provided a brief summary on AIDS. This newsletter was, at the time, their only real source of information. There was of course no world wide web to quickly search it out; there was only what was reported in newspapers. This left special interest groups to find out what little information they could. The June 1983 newsletter pointed out that at that time no cases of AIDS had been reported in New Zealand. Probably one of the major reasons for this nil statistic was that at this point AIDS had not become a 4 notifiable disease . There were, however, people with haemophilia already becoming sick in New Zealand.

F URTHER

DETAILS OF DEADLY DI SEASE EMERGE

At the WFH biannual meeting in Stockholm in July 1983, attendees were informed that science had not defined the cause of the mysterious disease or exactly how it was spread. It was known the disease damaged the immune system and was spread by blood or semen, that it had a long incubation period and was probably a virus. Because of these transmission routes, rates of disease were therefore expected to be low in the general population but with individuals at high-risk identified as those engaging in male homosexual intercourse or heterosexual sexual intercourse, those using shared needles for intravenous drug use, those dependent on fractionated plasma-based blood products, and new-born babies of infected mothers. Those at the meeting also heard of steps to limit the spread of the disease. These steps included a call for countries to become self-sufficient in blood products rather than import commercial products from countries already reporting cases of infection. In hindsight, the New Zealand Gover nments decision of 1976 not to develop a blood fractionation plant of its own had ensured the disease would impact New Zealand. The introduction of stricter screening of blood donors was also encouraged. At the time the best clinical information on AIDS and its impact for people with haemophilia in New Zealand was provided by the NZHS, a volunteer organisation. The NZHS had ensured its medical director attended the WFH Conference in Stockholm, a meeting convened by another international volunteer organisation to get the most up-to-date information possible. NZHS then arranged a follow-up meeting in New Zealand to convey the information to members. 15

In August 1983, Dr Elizabeth Berry, haematologist at the Haemophilia Centre Auckland Hospital, convened a meeting in Auckland to convey this new information and to discuss the issue with members of the NZHS. The number of cases in the U.S. had climbed to 2,000 of whom 71 per cent were homosexual men and one third of 5 whom had died . It was seen as inevitable that the disease would emerge in New Zealand because of the flows of international travel. At the time, the onset of symptoms was the only signal that a person may be infected with the disease. There was still no laboratory kit available to test for the presence of the virus. In November 1983, the New Zealand Medical Journal contained an item by Doctors Elizabeth Berry and Peter Wyld pointing out that the only haemophilia treatment products available in New Zealand carried a risk of AIDS. The response by the Department of Health to hospitals was advice to find alternative sources of supply 6 and avoid imports from U.S. , an attitude that many people with haemophilia viewed as lacking in leadership. It was late 1984 before a laboratory test capable of diagnosing AIDS from a blood sample became available. Any samples had to be sent to the U.S. for analysis and therefore results took months to receive back. Even when these early results arrived a number ended up being false-positives. For many people who were tested, a reliable diagnosis did not emerge until 1986. A confirmed diagnosis often brought a bolt out of the blue or a ratification of their worst fears. Throughout this period those seeking information from hospitals or health administrators in the rest of New Zealand were met with silence. The individual clinicians caring for people with haemophilia, such as general practitioners and hospital clinicians, rarely had any information to add. It was only those haematologists intimately involved with treating haemophilia that had up-to-date information. The Department of Health was particularly silent on the issue, possibly because its structure at the time resulted in nobody having direct responsibility for such an issue.

N O R ISK

OF

AIDS A CCORDING

TO

H EALT H A UTHORITIES

In October 1984, the lack of understanding about HIV became public. Unnamed officers, called Health authorities, were quoted by the press as being confident haemophiliacs in New Zealand were not at risk of 7 AIDS . This comment contradicted the views that haemophilia products available in New Zealand did carry a risk of HIV that had been published 12 months earlier by Berry and Wyld. Although this comment was perhaps made to the media to calm the increasing fears such statements by the health authorities seemed illogical to the haemophilia community and were soon proven to be tragically wrong.

P ROTHROMBINEX B ATCH 694 C ARRIES AIDS


Only a month later the media headlines screamed B L O O D T A I N T E D B Y AI D S . It was confirmed that some people with haemophilia in New Zealand had been infused with HIV- tainted blood and their clinicians had not told them. At this time HIV or AIDS was still not confirmed to be present in New Zealand so the question became - how did HIV get into a fractionated blood product supposedly manufactured exclusively from New Zealand plasma? Was it a blood donation from a donor who was unknowingly incubating the disease or did it have another origin? On 5 November 1984, the Auckland Blood Service announced via the media that a batch of Prothrombinex, a factor IX concentrate processed from donated plasma by Commonwealth Serum Laboratories (CSL) in Australia, thought to contain AIDS antibodies had been distributed in New Zealand. Once discovered, the New Zealand health service had kept this information quiet for 4 days before the announcement was made. The batch of factor IX product that was to become infamous B A T C H 6 9 4 had been used in New Zealand between August and October 1984. On the same day the print media reported a story from Melbourne that 40 people with haemophilia in 9 Australia had received blood products suspected of carrying the virus that causes AIDS . One product, a factor VIII product, had been issued to 27 patients in Victoria, while the other product, Prothrombinex, had gone to South Australia, Tasmania, and Australian Capital Territory and New Zealand. Here was the answer. 16
8

Presumably Australian and New Zealand blood had been combined to produce a batch of fractionated blood products for use in New Zealand. This news was probably as much a revelation to individual clinicians and the health authorities as it was to people with haemophilia. People with haemophilia had been given repeated assurances that New Zealand plasma was not mixed or topped up with Australian plasma as part of the provision of haemophilia therapeutic products for New Zealand. Inquiry revealed that Prothrombinex batch 694 had been topped up with Australasian plasma apparently because of an insufficient supply of New Zealand plasma to make a whole batch of product. It was further revealed that the blending of Australian and New Zealand plasma was routine practice at CSL when there was insufficient New Zealand-sourced plasma to meet minimum batch size or when there was a shortage of plasma from New Zealand. When confronted the Department of Health claimed the practice of topping up was done with the knowledge of all concerned. This was later exposed as blatantly untrue by a 10 former NZHS President, the late John Milne . The contamination of batch 694 was the consequence of having an inadequate supply of New Zealand plasma while balancing the need or demand for adequate supplies of clotting products and a reasonable level of safety. At that time there were six independent blood services in New Zealand. All experienced difficulties with insufficient supply of haemophilia treatment products and were therefore trying to supplement supplies of locally produced product by importing plasma products. The earlier decision not to become self-sufficient in blood and blood products had again returned to haunt politicians, health authorities, clinicians, patients, and to a lesser degree the general public.

M INISTER

OF

H EALT H A CTS

Within two days of the media release on the contamination of batch 694 the NZHS and individuals with haemophilia were corresponding with the then Minister of Health Rt Hon Dr Michael Bassett. Dr Bassett moved quickly to authorise a range of measures which included stricter donor screening, expansion to testing programmes, enhancing laboratory workers skills and the withdrawal of existing products. The Minister confirmed the practice of topping up New Zealand production of fractionated products was to cease by instructing that in future New Zealand plasma was to be kept separate from Australian plasma. Donor screening began to exclude donations from men who had sex with men who had multiple partners. All blood 11 donations were to be tested using an antibody test , the only test kit then available. Local production of factor VIII concentrate manufactured by the Auckland Blood Transfusion Centre was initiated using femaleonly plasma. The local manufacture of factor IX concentrate, undertaken earlier on an experimental basis, was also resumed by the Auckland Blood Transfusion Centre. The withdrawal of the CSL products did, however, create problems. The New Zealand health system had a long 12 standing, but informal, arrangement with CSL Bioplasma (now CSL Biotherapies) in Australia to receive New Zealand plasma, process it, and return finished clotting factor concentrates to New Zealand. Indeed the New Zealand Health system relied solely on CSL for this service. They also relied on CSLs capability to have effective viral inactivation processes in place and to ensure that products were safe and effective. As CSL was its sole supplier for plasma processing, New Zealand was suddenly without adequate treatment for people with haemophilia. The Ministry of Health noted patients would need to rely on cryoprecipitate, a crude frozen blood product prepared from plasma that could be processed locally. The Ministry seemed to be unaware that cryoprecipitate was a concentrated form of factor VIII, and therefore ineffective for treating people with haemophilia B, who have a factor IX deficiency. This instruction was also despite the Departmental advice of November 1983 for hospitals to find alternative sources of supply and avoid imports from U.S.. The most important step in making blood products safer was the introduction of heat treatment to neutralise the virus in finished product. From November 1984, batches of CSLs factor VIII concentrate AHF (AntiHaemophilia Factor) for use in New Zealand were heat treated to 60C for 72 hours and the process was also 17

applied to batches of factor IX concentrate Prothrombinex from January 1985 . Additionally, New Zealand began only importing concentrates from CSL that were manufactured solely from New Zealand plasma. All of these measures were steps advocated for or supported by the NZHS.

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E XPOSURE

TO

C ONTAMINATED P RODUCTS C ONFIRMED

By the end of 1984, 149 people in New Zealand with haemophilia A (factor VIII deficiency), 54 people with haemophilia B (factor IX deficiency) and 90 others were known to have been exposed to blood products 14 contaminated by HIV . The storm was gathering as the evidence mounted that an HIV infection would eventually be diagnosed in New Zealand. It was as soon as 1985, when 86 people in New Zealand were 15 diagnosed as being HIV-antibody positive, roughly one-third of whom were people with haemophilia . Strangely, it was in 1986 before the New Zealand Medical Journal published views that it was inevitable that blood-transfusion induced AIDS would occur in New Zealand two years after the first exposure was made 16 public .

F EAR

AND

D ISCRIMINATION

Along with infection came discrimination. Members of the haemophilia community lost jobs, were suspended from careers and had difficulties accessing education. All these events occurred despite the state services stating that, In view of the limited method of transmission of the disease, we can be assured that people with AIDS are not placing their co-workers at risk by remaining at work. In no instances are infected employees to 17 be given notice or encouraged to resign . For example, a two month battle ensued for a Canterbury boy with haemophilia and HIV to access education until his school finally accepted he did not represent a danger to others. The fear of AIDS was widespread. For instance, hospitals introduced precautions such as staff gloving, masking and gowning up to deal with anyone with haemophilia. Surgery on people with haemophilia was also not promoted, but this was partly because of the supply situation with the necessary blood products. From November 1984, the print media featured regular AIDS-related headlines. The headlines did not always report fact or accurate information. Some headlines from the era demonstrate the depth of public fear that 18 19 existed around HIV/AIDS; examples include Ban male donors , AIDS Fear Has Some Seeking Own Donors and 20 AIDS Fear Prompts Appeal to Dr Bassett . Other headlines seemed to be designed to raise public concern: 21 22 AIDS Epidemic on the Way ; Dentists Cover Up as AIDS scare hits (shouldnt they have been doing this all 23 24 along to safeguard their patients?); AIDS Virus Carriers Found in NZ ; Rugby Kids at Risk of AIDS from cuts 25 26 and scratches; Transfusion Induced AIDS Inevitable ; and, Bedbugs linked to AIDS Spread (yes, bedbugs in motel bedding but they were referring to a situation in Africa). Some stories were simply appalling, for example an article entitled AIDS Flight Angers Crew described how the crew of an Air New Zealand plane 27 wanted to leave the flight on learning an AIDS patient was to be aboard . Another, Police fears of contact with saliva, described how police were worried about contracted AIDS from saliva on random breath-testing 28 equipment . It was March 1985 before protective clothing and resuscitation guards were made available to 29 New Zealand Police. Other scare-mongering headlines included AIDS will strike thousands in NZ , which 30 included a prediction of up to 60,000 infections, and AIDS Time Bomb Hell! . To counter these headlines New Zealand was fortunate to have Eve van Grafhorst, a child who was forced to leave Australia with her parents on account of communal discrimination towards her infection from contaminated blood. She was regularly in the news displaying a more moderate and reasoned picture of life with AIDS. Some newspapers decided to take on the role of protecting the public from those infected by AIDS, especially the Auckland Star. Friction was created between the paper and the NZHS as the paper tried to identify people with haemophilia and AIDS. 18

On 18 June 1987, the Auckland Star quoted the Department of Health as having discovered 13 cases of positive AIDS antibodies contracted through blood transfusions in New Zealand - all arising prior to the introduction of HIV antibody screening of blood donations and the introduction of the first test to screen out HIV from the blood supply, the ELISA test, in 1985. The exact number of cases of HIV virus is unknown, the Department stated. Then one month later, out of 200 people tested, 28 haemophiliacs were reported as 31 having tested positive for the AIDS virus . All 28 cases preceded the introduction of screening in October 1985. Of this number one had died and another had progressed to full-blown AIDS. In total, 29 people with haemophilia in New Zealand went on to be diagnosed with HIV, most of whom have passed away. The strength and spirit of those lost to HIV strengthened the resolve of the NZHS to ensure nothing like this could happen again. Unfortunately, fears of a new contamination and infection were slowly beginning to spread.

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20

CHAPTER 3 NZHS AS ADVOCATES FOR MEMBERS WITH HIV


Even though the focus of the Society during the early era was on connecting families and publicising their needs, the early NZHS committees also realised the importance of enhancing standards of care through advocacy. For NZHS volunteers, advocating for the needs of people with haemophilia, particularly for the 29 Kiwis affected by HIV or AIDS, became a trying issue. Their advocacy role expanded to include the safety of all recipients of blood products in New Zealand, not just people with haemophilia. Volunteer officers of NZHS, elected to help improve the circumstances of people with haemophilia, found themselves having to devote considerable time and energy on getting to grips with these issues and taking on critical advocacy roles. This included recommending measures to the Minister of Health to prevent transmission of a new, often, fatal disease, calling attention to ministerial failures, assembling and presenting submissions to New Zealand Law Commission and ACC Review Hearings, and reprimanding the Minister of Justice. There was also the more onerous role of presenting information to individual NZHS members in a way that allowed them to make major decisions that could affect their life expectancy and family finances. This information included the complexities of the disease, issues to consider in treating haemophilia when the clotting factor concentrates were potentially unsafe, and how to make successful appeals against ACC compensation decisions.

T HE

MANY NEEDS FOR ADVOCACY

HIV and AIDS were new diseases for everyone - affected people, medical staff and regulators. Although NZHS volunteers were already familiar with the biological process of clotting, the steps and methods used in the manufacture and production of fractionated plasma products needed to be better understood. Quickly the issue was distilled down to options to enhance safety. When the contamination of batch 694 became public NZHS informed Minister Bassett of three immediate needs: to improve safety of transfusion for all New Zealanders; to have safe concentrates for people with bleeding disorders; and, to develop self-sufficiency in production of blood products. Other expectations were the introduction of HTLV III (an early name for HIV) antibody screening and computerisation of donor records, the use of female donors for pooled plasma, and the separation by CSL of Australian and New Zealand plasma during processing. The volunteer advocates also had to consider the treatment needs of the 29 individuals and their families devastated by this viral contamination. While NZHS was not involved with direct care, they were nevertheless called upon for up-to-date information and for help in coping with the compensation problems created by ACC. They also felt a responsibility to provide information and recommendations to the whole haemophilia community as some people were so fearful of contracting HIV and AIDS that they had stopped using therapeutic products and resumed the old practice of suffering the consequences of each and every bleed irrespective of the future disability this would bring. The clinicians treating patients with bleeding disorders were faced with the dilemma of prescribing a remedy for one condition that in time might prove fatal to the recipient due to possible contamination with HIV. In the period from 1983 to 1984 the only effective therapy for haemophilia, replacement therapy using fractionated blood products, was not able to be heat-treated nor tested for the presence of HIV/AIDS. Therefore each 21

batch carried with it the possibility of HIV infection. However, from 1985 fractionated blood products in New Zealand were heat-treated and all blood donations were tested for the presence of HIV antibodies. Clinicians also had the problem of providing information about this new disease and their workload dramatically increased as they dealt with more serious bleeds resulting from people not using therapeutic products. In addition, they also had to care for the haemophilia treatment aspects of the people with haemophilia specifically affected by HIV who suddenly had to cope with a second major health issue where the majority of cases were to be fatal. The emergence of AIDS in the haemophilia population struck all people in this community. Those not infected were left wondering how they had escaped while some people were initially diagnosed HIV-positive only to find out later that their results had been false-positives. Everyone knew someone who had died. Being diagnosed as HIV-antibody positive brought multiple challenges. For some it further complicated issues associated with adolescence, for others it raised questions of how to care for a family with oncoming illness and probable death. Being HIV-antibody positive with the ever looming prospect of the condition developing into AIDS was devastating knowledge to have to live with and profoundly affected both individual and their family, seriously compromising their quality of life. The degree of public fear, the seriousness of the issues and the lack of real knowledge about the disease all created major difficulties for NZHS. Because individuals with haemophilia tried to avoid the spotlight it was up to NZHS, as an organisation, to take the Auckland Star to task about their behaviour and the hysteria they were spreading with some of their reporting.

P HARMACEUTICAL C OMPANIES
From 1985, NZHS had to embark on a whole new role and one that was outside the activities that had initially been envisioned, those of helping families, relieving hardship, and improving care through lobbying and advocating among politicians and the pharmaceutical industry. The Society found itself going to battle with one of their principal collaborators, the pharmaceutical companies, who had been considered friends and even saviours for over 10 years and then suddenly became the enemy. In retrospect it is obvious that with the sexual behaviour of many people and the interchange of people between countries, New Zealand was never going to escape the worldwide AIDS epidemic. Despite being a developed country, New Zealand did not have a self-sufficient blood supply and needed to import blood 32 product concentrates from U.S. . The New Zealand Blood Transfusion Service was unable to supply products in either sufficient volume or efficacy to meet the needs for regular treatment or surgery.

D IFFICULTIES

OF

A CCIDENT C OMPENSATION S CHEME C OPING W ITH AIDS

Difficulties with ACC were yet another advocacy issue never envisaged by the founders of NZHS. ACC had initially assured the NZHS that claims for HIV/AIDS infection could be considered on the grounds of medical 33 misadventure leading to a loss of quality of life . In practice, this proved to be far from the case. For example, by 1987 ACC was declining to accept cover for AIDS Related Complex (ARC) and, accordingly, declining lumpsum payments to affected people. People with haemophilia felt victimised by ACC legislation and the way it was interpreted by ACC staff. NZHS made strong representations to government ministers that the legislation and the way it was being applied in the case of AIDS were unjust, immoral and was creating delays and costs for people affected. The NZHS began advocating on behalf of individuals and funding legal action for individuals to access lumpsum payments through ACC. NZHS felt that it was crucial that they support these people because of the inequity and injustice in the way ACC were dealing with HIV and because of the emergent public attitude to the new disease. 22

Over the ensuing months and years, NZHS saw ACC making variable awards of lump-sum compensation. ACC and the Government were seen as adversaries to the NZHS for failing to ensure adequate care and social support for people and families affected by HIV/AIDS. For example, problems were caused by the statutory time limitation on claims for a known condition, set in the legislation at 1 year following the infection, and people were required to prove they had been injured before a claim could result. The sometimes long latency period between laboratory diagnosis and the onset of disease also created problems for most people with haemophilia who became infected by ARC or AIDS. In crafting the ACC legislation, the legislators had not foreseen the likes of the HIV situation and therefore the legislation did not provide the framework for adequately dealing with HIV (or subsequently hepatitis C). ACC staff were ill-equipped to deal with HIV and AIDS claims. ACC case workers could understand an accident in the bush resulting in a fractured femur and resulting 3 months off work giving rise to earnings related compensation and some medical expenses. These same people were greatly challenged by the emergence of a complex disease arising from infection through medicine. The NZHS requested that Government amend the ACC legislation to waive the limitations for claims related to HIV/AIDS infection in recognition of the unique qualities of this disease. By way of a Review Hearing, NZHS challenged the policy of the ACC n 1987 of accepting only full-blown AIDS. A case was also made to the New Zealand Law Commission. In spite of the facts known at that time that once HIV infection was present the immune system became permanently impaired in all cases, ACC made variable awards in its different regions, with some applications being declined. With no treatment options yet available, infection logically resulted in 100 per cent impairment. In these early days of ACC awards, all claims had to be taken to appeal; adding more stress and uncertainty for the individual. Advocating for members with ACC became an enormous responsibility for the NZHS officers, however, they realised their members were usually in no fit condition to fight for themselves. The NZHS were astounded to find the need to formally ask ACC, the media and politicians to respect the privacy of individuals on the very sensitive topic of AIDS. Individuals were distressed at having to apply for compensation and submit their personal cases, often being required to discuss the details of their case in very public ACC offices. NZHS also reprimanded the Minister of Justice when a person with haemophilia unexpectedly died and the news media revealed his HIV status. In the interests of safety, information about HIV status was disclosed to those responsible for handling the persons body and the details quickly found their way to the media. NZHS were mostly concerned about the impact on families from public stigma and social ostracism, a regular occurrence at the time, and the possible impact on surviving siblings, particularly if they also had haemophilia and possibly HIV but were too young to be informed of their status.

F AILURES

BY

P OLITICIANS

AND

H EALTH A UTHORITIES

Along with AIDS came a new attitude towards politicians and health bureaucrats for the advocates at the NZHS. The haemophilia community found the understanding of HIV/AIDS of both groups seriously wanting and lost faith in their sometimes sweeping statements. In 1976, officials appeared inadequately informed about bio-engineering. In 1983, they demonstrated a lack of knowledge and leadership about the processing of blood products, leaving it to health boards to individually source international supplies. In 1984, the confidence expressed that people in New Zealand with haemophilia were not at risk of AIDS seemed wishful thinking and highly unlikely. Likewise, suggesting everyone involved was aware of the practice of topping up plasma batches was only a partial truth and definitely misleading. NZHS felt new blood donor screening rules did not go far enough and should be expanded to exclude all men who have sex with men, as well as those who had had a blood transfusion in the past 5 years. In the early and mid-1980s, past recipients of blood were still able to be blood donors and it was some time before they also became excluded from the donor pool. 23

HIV/AIDS

IN

R ETROSPECT

The era of HIV/AIDS and haemophilia can be compared to the typical medical model of an incident, diagnosis, acute treatment and rehabilitation. Defining the exact beginning and conclusion of the HIV/AIDS and haemophilia era would vary, however, depending on whether you ask a person with haemophilia, a politician, an employee of ACC, or a health services administrator. From 1982 each of these sectors suspected a problem was looming but did not understand its cause or its impact; let alone how to overcome it. After recognising how the disease was transmitted the scientists were quick to develop methods to test for it, including a kit to allow screening of blood supplies across the globe. The pharmaceutical industry did have a substantial incentive to quickly establish a test kit both to restore damaged reputation but also to reap greater income from a new and demanded product. The second line of defence, a method to neutralise the harmful effects of the virus that may still be present in finished plasmabased fractionated blood products, took a little longer to perfect. The problem lay in maintaining the efficacy of the product while neutralising the virus. In the end this became a trade-off in clotting activity, as the efficacy of the new product was not as high. For administrators in the Department of Health, the HIV/AIDS incident highlighted an overlooked aspect of health that almost any health procedure, including a blood transfusion, poses a possible risk. The Department of Health reaped the consequences of years of ignoring blood transfusion and failing to remember that blood is a cornerstone of surgery and essential, in whole or fractionated forms, not only for haemophilia care but also in the treatment of immune deficiencies, leukaemia, other platelet deficient cancers, and infections. Because blood was not an important aspect of Department of Health activity, misinformation was often circulated by their spokespersons. As a result the only reliable source of public and individual information became the specialist haematologists and NZHS. The six blood transfusion services in New Zealand were under the control of the six adjacent Area Health Boards (AHBs). Each service had grown as a response to demand in their region, but operated with widely varying standards in donor management, processing, and the use of blood components and blood products. There was poor national inventory management and a lack of a national information system or overall service 34 plan . Indeed the loose arrangement with CSL was still conducted by an exchange of letters from time to time. Although CSL occupied the risky position of sole supplier of fractionated blood products to New Zealand, an alternative supplier would have also been affected by the emergence of HIV/AIDS. The extensive media interest in HIV/AIDS was both an advantage and disadvantage for both sides of the issue. For people with haemophilia, the media could be both useful and problematic. Another part of Government that failed to adequately cope with HIV/AIDS was the ACC. Officers were not helped by a statutory provision that had not foreseen a failure of the health service leading to permanent disability of a group of people who were administered the same medication. ACC proved to be a slow learner as their decisions were repeatedly challenged and overturned. Later, when dealing with HCV, they would demonstrate they had learned little from the HIV/AIDS experience. Prior to the emergence of HIV/AIDS, people with haemophilia were not conscious of informed consent. Up until this time this was just another piece of paper one signed upon admission to hospital. Any other treatments received, such as on an outpatient basis, never involved the signing of consent. The consent procedure was viewed as the patient granting consent to the clinician and the hospital to generally carry out procedures. It was never considered informed or specific. The emergence of HIV/AIDS transformed this. The basis of care was radically changed when the Code of Rights was introduced in 1994, describing the rights of consumers and the obligations and duties of providers to comply with regulations under the Health and Disability Commissioner Act. 24

CHAPTER 4 THE BLOOD SUPPLY AND HEPATITIS C


B ACKGROUND
ON

H EPATITIS C
35

Serum hepatitis, later known as hepatitis B, had been reported as a result of transfusion since World War II . In the 1970s, however, papers began to be published in respected science journals on both sides of the 36 Atlantic detailing the transmission of non-A non-B hepatitis (NANBH) associated with blood transfusion . At the time there was no way of directly testing for this presumed new virus. Throughout the 1980s there was discussion and debate in the literature about the accuracy of assays to detect the presence of antibodies to NANBH, about the natural history of this infection and the seriousness of its effects through varying degrees of inflammation of the liver. It was established that the infection could be asymptomatic, but once established, chronic infection could progress to scarring of the liver (fibrosis), and advanced scarring (cirrhosis). In some cases, people with cirrhosis go on to develop liver failure or other complications of cirrhosis, including liver cancer or life threatening oesophageal varices and gastric varices. The virus was renamed hepatitis C (HCV) in 37 1989 after the virus was finally identified using a molecular cloning technique. A Ministry of Health discussion document, Action on Hepatitis C Prevention (2002) , estimated that in 2000 approximately 25,000 New Zealanders were living with hepatitis C and approximately 1280 new infections occurred each year. The prevalence of HCV in New Zealand has more recently been estimated to be in excess 39 of 50,000 people . The discussion document noted that official notification rates, which only take into account acute cases, are a severe underestimate of new infections because of the slow onset and unspecific nature of symptoms. Because of the often silent initial infection, recognition of the seriousness of the effects of HCV infection was gradual. Being a viral infection of the liver, HCV could present initially as changes to the liver function but the natural history of HCV is not the same in all people. The symptoms range from a general feeling of being unwell with bouts of tiredness through to unending fatigue or chronic liver failure and death. HCV infection may also be accompanied by a range of vague symptoms that may include lethargy, fatigue, rash and skin eruptions, and disturbed digestion. Some people, however, became very unwell within weeks of initial infection with increasingly reduced quality of life. It has been estimated that approximately 75 in every 100 people who contract HCV develop chronic infection. Of those, after about 15 years of infection, 40-60 people will have some liver damage and symptoms, and after 20 years eight to 20 people will develop cirrhosis, with two to five people developing liver failure or cancer 40 after the onset of cirrhosis . Given the scale of prevalence in the population and the length of time most people have been living with chronic HCV, the developing level of need exceeds the capabilities of New Zealand liver transplant programmes. While treatment for the virus is available and outcomes have improved greatly over the last decade, treatment is not always successful and efficacy is often associated with which genotype of HCV one is infected with. Most people with haemophilia in New Zealand were infected with HCV genotype 1, the genotype which has been shown to be less responsive to interferon treatment than other genotypes. 25
38

At present HCV infection cannot be prevented by administration of a vaccine. Prevention is therefore based on careful surveillance and treatment of blood donations, public health and other harm reduction measures such as the use of needle-exchange programmes and education of groups at high-risk of exposure. Before considering the HCV crisis which occurred in New Zealand between 1992 and 2008, or B A D B L O O D issue as it became known, further background on the blood supply and options to safeguard it are necessary.

T HE B LOOD S UPPLY
After 1985, the blood supply in New Zealand continued to operate as six independent blood supply organisations, under the organisational structure of the local health board. But the continuing absence of a national approach to the service, its structure and its procedures over the next 10-15 years were, in retrospect, detrimental to the safety of the products. To enhance the safety of the blood supply following the emergence of HIV/AIDS, new exclusions were added to the range of people deferred from being blood donors in New Zealand. For instance, men who had had sex with a man and people who had injected non-prescription drugs were excluded as donors. Methods of maintaining the safety of the blood supply and an adequate supply of blood and blood products was a worldwide concern. Internationally, the concern was how to neutralise not only the HIV/AIDS virus but also a virus that had been a worry for some years- NANBH, later known as HCV. These methods focussed on the application of heat to the finished fractionated product, the use of surrogate testing to identify possible virus in the starting plasma, and tests for HCV antibodies.

V I R A L I N A CT I V AT I O N

BY

H E AT I N G

An undated paper in the Haemophilia Foundation of New Zealand (HFNZ) archives from the Department of Health indicates virus inactivation of factor IX complex concentrate began in the mid-70s in Germany with the use of P-propriolactone and ultraviolet irradiation, a method unsuitable for factor VIII concentrates because of factor VIII inactivation. This concentrate did not transmit hepatitis, but the method was not used in the U.S. because of concerns about the carcinogenicity of P-propriolactone. In 1978, the German company Behringwerke began clinical trials with a concentrate of factor VIII that had been protected with stabilising amino acids and sugar and heated in solution at 60C for 10 hours. By the early 1980s Behringwerke began trials with a similarly treated factor IX complex concentrate. Results of prospective studies, reported much later, indicated that these concentrates did not transmit hepatitis. Heating in solution, however, was associated with very low yields of factor in the concentrates and the process was not considered practical for large-scale production. By the early 1980s, most U.S. manufacturers were beginning to develop their own viral inactivation processes, primarily by using heat to prevent transmission of hepatitis. Because of the competitive nature of business, however, specific details about the effectiveness of these methods were kept confidential. Two problems were soon apparent; there was no laboratory model to determine the success of each approach, and a single method of viral inactivation was not suitable for all products. The first dry-heated (at 60C for 72 hours) factor VIII concentrate, licensed in 1983, proved capable of transmitting hepatitis B to chimpanzees but did not appear to transmit NANBH. In a later study in humans, however, this product transmitted NANBH to 84 per cent of infants and children who were treated exclusively with it. In February 1983, CSL in Melbourne examined without success the possibility of dry heat treatment to reduce the risk of NANBH. Given the failure to inactivate hepatitis and the fear that factor VIII, a strong antigen, might provoke more frequent inhibitor formation if altered by heating, the advent of heated concentrate was initially treated with caution by the Medical and Scientific Advisory Council of the National Hemophilia Foundation in the U.S. Their caution seemed warranted when in July 1983 it was shown that people with haemophilia who had been given the Behringwerke heat-treated factor VIII concentrate were more likely to develop inhibitors that would cause 26

resistance to factor VIII concentrate than were patients receiving non-heat treated product. It was also reported that Behringwerke's heat-treated concentrates had led to cases of NANBH, reinforcing doubts about the efficacy of heat-treatment for factor concentrates. Despite these results other dry-heated concentrates were introduced in 1984 and 1985. Heating methods varied, including using temperatures of 60C for 24 hours, 60C for 30 hours, and 68C for 72 hours for factor VIII concentrates, and 60C for 144 hours or 68C for 72 hours for factor IX concentrates. Heating in moist conditions was introduced in the U.S. in 1984. Freeze-dried factor VIII or factor IX concentrates heated in a moist condition and then suspended in n-heptane at 60C for 20 hours were licensed that year. This method proved effective at eliminating HIV but not HCV. A new technique though soon being used by Plasma Fractionation Laboratory/Blood Products Laboratories in Oxford, England, where factor VIII was being heat treated to 80C for 72 hours a process that became known as super-heat treatment. This method was successful in neutralising HCV. Scotland became the first country to provide super-heat treated HCVinactivated factor VIII to cover the needs of all people in its country in 1988. While NANBH had been worrying the likes of CSL since 1983, they and others were unsuccessful in their attempts to apply dry heat and wet heating to plasma products while maintaining adequate factor activity. The Lyndsay Inquiry in Ireland later determined that an effective method of viral inactivation preventing transmission of NANBH/HCV was simply not available in 1985 and 1986. It was not until other manufacturers began to be able to super-heat their plasma products that HCV could be inactivated and transmission prevented. During the time before super-heat-treated products were available the attention of manufacturers had to turn to trying to preclude infection and/or reduce the amount of virus in the starting plasma to try and prevent infection with this puzzling disease.

S UR RO G AT E T E ST I N G
Although it was 1989 before the virus that causes hepatitis C became characterised, NANBH had already long been recognised as a problem, as were the difficulties in neutralising it while maintaining product efficacy. A case could have therefore been made for the early introduction of surrogate testing for HCV, such as had been done in some places such as Queensland before HIV assays were available. Surrogate testing does not involve direct testing for the disease itself but testing a sample for other markers capable of pointing to the likely presence of a virus. Two options for surrogate testing for HCV were to test for abnormalities in the liver or to test for markers of hepatitis B. Although tests for both these options were available from 1986, adoption of surrogate testing was variable across nations. In New Zealand, the tests available at that time were considered to lack sensitivity. The option of surrogate testing of blood donations was taken up mainly in individual states of the U.S., probably due to their practice of using paid blood donors. The adoption of surrogate testing seems to have been based on safety profiles. The safety profile associated with the infusion of a single blood donation is vastly different to the safety profile of a product produced from the pooled plasma of a large collection of donors. This was the situation for products used to treat haemophilia, but this fact seems to have been overlooked. The failure to use surrogate testing for HBV and antibody testing for HCV increased the need for funding to purchase alternative clean factor replacement products from overseas.

HCV A N T I BO DY T E ST I N G
While it is probable that screening for hepatitis B or similar markers would have been effective in greatly reducing HCV in blood donations, a more accurate method would have been to screen for the antibodies to the virus. The presence of antibodies indicated that a person has been exposed to the infection but they may not have an active infection at the time. The system was not fool-proof, however, as there may be a window 27

between infection and the development of antibodies. Still, even in the minority of cases where acute HCV can be eliminated by the bodys immune response, a process known as spontaneous clearance, the antibodies will remain. The most accurate screening is to detect the genetic material of the virus itself, viral RNA. This level of screening was not available until 2000 for HIV and from 2001 for HCV. Some HCV-antibody tests became available internationally in 1988, and in 1990 a test kit which screened for HCV antibodies became commercially available. Much was still to be understood about HCV and experts of the time often gave conflicting evidence and recommendations. As such, processors in Australia initially decided to allow HCV-infected plasma to be processed, but only in the manufacture of plasma proteins known not to transmit HCV. HCV-infected plasma was not supposed to be used in the manufacture of clotting factors where virucidal steps were necessarily reduced to preserve efficacy. Australia have routinely screened all 41 blood donations for HCV since February 1990 and ceased the practice of using non-screened plasma in July 1990. Although they were a huge step forward, these first commercial test kits were not without fault; for example, they produced a considerable number of false positive and false negative results. Testing was also complicated by the varying times before antibodies appeared in the blood. It is also important to understand that testing positive for antibodies only indicates exposure to the disease, not whether the person has gone on to develop an infection. Notwithstanding these complications, the first generation HCV-antibody test kits have 42 since reportedly identified 85 per cent of potentially infective donors in Australia . Despite the availability of these first generation tests, HCV antibody testing was not immediately introduced in New Zealand. This is in spite of the comments from the office of the then Minister of Health Simon Upton that, .while screening donated blood for the presence of hepatit is C antibody would significantly lessen the 43 danger of hepatitis C infection, it would not remove all risk . It was 1992 before diagnostic accuracy was improved with the development of second-generation tests for 44 HCV .

28

CHAPTER 5 THE EVER LOOMING THREAT OF HCV


T HE E RA
OF

R T H ON H ELEN C LARK

AS

M INISTER

OF

H EALT H

By the early 1990s, the advocacy and assistance for people with haemophilia who had contracted HIV/AIDS had largely been passed to NZHS outreach staff. The advocates at NZHS, all volunteers, now had a new infection to focus on HCV. For them, advocacy roles varied from: lobbying central government to get an adequate standard and volume of blood products to halt the spread of HCV; to lobbying for access to care for those with HCV; and, monitoring ACC compensation outcomes. Although the medical community had long known that blood transfusions or the use of blood products could lead to hepatitis infections in recipients very little was understood about the long-term effects of HCV infection or the severity of the disease until it was characterised in 1989. As discussed in Chapter 4, there were, however, measures available that may have reduced the risk of transmission. During the era when the value of surrogate testing and first generation HCV-antibody testing as ways to protect the New Zealand blood supply where being discussed, the Rt Hon Helen Clark held positions as the Minister of Health and Opposition spokesperson for Health. Clark became Minister of Health in January 1989, holding the position until the general election in November 1990 when a change of government took place and she became Opposition spokesperson for Health. The HIV crisis meant that the need for viral inactivation of fractionated blood products was accepted internationally. As discussed, application of heat to haemophilia products had been attempted by a number of pharmaceutical companies but resulted in a marked reduction in specific activity of the heated product and, unfortunately, the methods that appeared to work in preventing transmission of HIV did not eliminate HCV. The focus instead moved to various methods of improving the purity of the donated starting plasma, such as surrogate testing, then HCV-antibody testing and ultimately testing for the presence of the actual active HCV virus. These genetic tests for the virus itself were, however, still 10 years away. Meanwhile people with haemophilia in New Zealand had no choice but to continue to use plasma-derived products manufactured from possibly infected plasma donations. In September 1990, the NZHS met with its Medical Advisory Group to discuss a range of safety measures that should be applied to blood products. From this meeting some strong recommendations were made to Minister Clark, including: The immediate phase out of random donor cryoprecipitate for routine haemophilia A (FVIII deficiency) management; Super heat (80C) treatment as a minimum standard for factor concentrates; Expansion of the membership of the Transfusion Advisory Committee to include a representative of NZHS; and All blood donors to be tested for HCV.
45

Yet when the issues were placed before Clark there was unfortunately no action . Clark deflected all issues 46 back to the AHBs . This decision appeared to have been based on the Governments philosophy of 29

decentralising all funding to AHBs. As their Minister, Clark must have known her advice or the decision to refer the issue of protective measures to the respective AHBs was nearly impossible to implement as six Boards would have been involved. An AHB did not deal with manufacturing standards of blood products and nor did AHBs control membership of the Transfusion Advisory Committee. NZHS again wrote to the Minister the following month, highlighting the refusal to fund HCV testing of collected 47 blood . No response was received. The NZHS then conveyed their recommendations directly to the Transfusion Advisory Committee together with letters of support from treating clinicians. This resulted in the Transfusion Advisory Committee recommending the introduction of HCV antibody screening of all blood donations collected in New Zealand to the Director General of Health. This screening was supported by Regional Transfusion Directors, Communicable Disease Control Advisory Committee, and a leading article in the New Zealand Medical 48 Journal . But still no action occurred. Neither surrogate testing, nor the first generation of HCV-antibody tests were introduced to the New Zealand blood supply, nor did Minister Clark phase out use of random donor cryoprecipitate nor press for the introduction of super-heat treatment as a minimum standard for haemophilia treatment products. No funding was provided to procure alternative clean products for use in haemophilia care either. The political decisions ensured a crisis in the New Zealand blood supply would occur. On 26 November 1992, when the use of unscreened plasma to manufacture Prothrombinex was revealed by the media, Clark said she would have resigned had she known, as the Minister of Health Mr Upton did [tha t 49 blood products were contaminated] .

30

CHAPTER 6 BAD BLOOD COMES TO THE


FORE
T HE E RA
OF

H ON S IMON U PTON

AS

M INISTER

OF

H EALTH

In November 1990, New Zealand had a general election bringing a change of government. A National Government was elected and Hon Simon Upton became Minister of Health, replacing Rt Hon Helen Clark. And so NZHS began another long battle with Government to try and convince another Minister of Health that doing nothing to protect a national resource the blood supply - was unacceptable. In June 1991, the new super-heat treated CSL factor VIII product, AHF-HP, was introduced in New Zealand for children with haemophilia A who had not previously been treated with low-heat treated factor VIII (and therefore would not have already been exposed to product that may contain HCV). While this was welcome news, the health authorities did not seem to realise that the only factor IX product available in New Zealand for treating people with haemophilia B was not super-heat treated. The supply of safe replacement factor concentrates continued to be an issue for most of the haemophilia population. The NZHS wrote to Minister Upton to point out that the supply of the CSL super-heat treated product was inadequate and that people with haemophilia A, who had been treated in the past with low-heat 50 treated factor VIII, were continuing to receive products that carried a risk for transmitting HCV . In an effort to bolster supplies of treatment products some people with haemophilia A in the Auckland area were also being treated with locally produced cryoprecipitate and factor VIII concentrates, neither of which were superheat treated either. In addition, the donor plasma used in these products was not being tested for HCV. Statistically every batch had the potential to be infected with HCV. In the words of the Directors of the Regional Blood Transfusion Service, P E O P L E A R E B E I N G U N N E C E S S A R I L Y I N F E C T E D W I T H H E P A T I T I S C
VIRUS THROUGH BLOOD TRANSFUSION SIMPLY B ECAUSE OF THE LACK OF A POLICY DECISION FROM GOVERNMENT
51

In July 1991, Upton was sent further letters from the NZHS Medical Advisory Panel and the Regional Blood Transfusion Directors. The latter wrote that they were appalled and dismayed there has still been no decision 52 on the funding of hepatitis C testing . As a group they went on to inform the Minister that if HCV testing was not forthcoming they would publicly absolve themselves from responsibility for the safety of the New Zealand blood supply. Eventually the correspondence had an effect and in August 1991 Upton approved funding to allow the introduction of screening to the New Zealand blood supply. This screening consisted of the testing of small batches of multiple donations for the presence of the HCV antibody. When seven months had passed since the Ministerial approval was granted and screening of blood donations 53 for HCV had still not been initiated, NZHS again wrote to Upton to remind him of the situation . For the first time NZHS also made a media statement regarding the situation which led to the airing of a television documentary in April 1992 illustrating NZHS role in advocating on behalf of its members. In May 1992, Dr D G Woodfield , the Medical Director of Auckland Blood Transfusion Service, asked the Department of Health to supply the super-heat treated Prothrombinex HT that was available from CSL for some young patients who have not yet been exposed to hepatitis C As you know blood units in New 31

Zealand are not screened for hepatitis C and thus the present type of Prothrombinex issued is likely to infect 54 patients with this disease . This was soon followed by a letter that would subsequently become the centre of much scrutiny and scandal. In July 1992, a letter from the NZHS Medical Advisory Panel signed by Dr Elizabeth Berry also informed the Minister that the current factor IX product from CSL, Prothrombinex, was being produced from plasma unscreened for HCV and was not super-heat treated. Dr Berry also noted that until a supply of super-heated Prothrombinex HT manufactured from screened plasma was available a clean but expensive factor IX 55 alternative was available from overseas . Instead of agreeing to supply Prothrombinex HT, the response from the Minister of Health explained how AHBs were bulk funded and how they were required to meet the health service needs of people in their regions but that the Auckland AHB received an additional grant to fund fractionated products from CSL. He also advised that as Prothrombinex HT was a new product it had to go through medicines registration and 56 consent procedures both in New Zealand and Australia . The NZHS wrote to Upton on six separate occasions seeking change . The Minister was asked to implement the safety measures proposed by the NZHS Medical Advisory Panel, the New Zealand Medical Association, the New Zealand Blood Transfusion Service, and the Regional Blood Transfusion Directors, as well as many requests from individuals with haemophilia, who were dependant on blood products. Screening of blood donations for HCV was finally implemented in July 1992. When screening was put into effect Upton publicly 58 stated that AHBs can now be assured of the safety of the blood they use . In a letter to Dr Elizabeth Berry in August 1992, Upton indicated he was aware that Prothrombinex was not yet 59 super-heat treated but he suggested [Prothrombinex-HT] would be available shortly . This proved not to be the case and it seemed to NZHS members that Upton was not concerned about the implications of his decisions, or perhaps he simply did not understand the potential consequences and was more concerned about costs than health outcomes. It was during this time that, for many people with haemophilia, faith in government and its health system evaporated. In the space of 20 years, people with haemophilia had gone from being extraordinarily grateful for the efforts of their clinicians and all those involved in alleviating their suffering to a position where one of the main players, the health authorities, seemed prepared to use medicines known to be infected with a virus that could cause further suffering and death. Under Director General Lovelace the Department of Health appeared to be side-lined with respect to clinical policy formation and decision making, and either incapable of or unwilling to provide leadership in this specialist area. The Department repeatedly demonstrated a woeful lack of detailed knowledge of the organisation of and the management of the blood transfusion service, the process for manufacturing blood products and the treatment of haemophilia. In the view of some within the haemophilia community, health authorities were not even meeting a basic health care principle, one of the philosophies Florence Nightingale learned while nursing soldiers at Crimea, that the treatments provided should not place patients in additional jeopardy.
57

TVNZ T ON I GH T

P R O G R A MM E

On 16 November 1992, a TVNZ Tonight programme revealed how screening for HCV of blood donors was only partially effective in preventing HCV infection in end users as the factor IX product Prothrombinex was still being manufactured from pooled plasma donated before screening was introduced in July and the finished product was not being super-heat treated. On the programme Dr Arvind Patel, Principal Medical Advisor for the Department of Health, stated that the Department of Health did not know Prothrombinex was manufactured from unscreened plasma. NZHS President Mike Mapperson and Dr Elizabeth Berry were both interviewed on air to refute the statement and point out that repeated letters that had been sent to Minister 32

Upton on this issue. The following day Minister Upton admitted he did know Prothrombinex was potentially tainted. A comment made by Patel on the programme possibly explains the Governments underlying motives for not being more proactive in trying to prevent HCV infection from blood products. Dr Patel noted that: IN AUSTRALIA HEALTH AUTH ORITIES HAD TO SCREE N TO PROTECT THEMSELVES FROM LEGAL A C T I O N S . B U T H E R E W E W E R E P R O T E C T E D B E C A U S E AC C W O U L D C O V E R T H O S E W H O B E C A M E 60 CONTAMINATED. The TVNZ Tonight programme also reported that people with haemophilia were considering charges under the Crimes Act against Minister Upton and others for wilful and unlawfully causing and producing a disease or 61 sickness in another person . Ron Paterson, then a lecturer in medical law at Auckland University, offered the view that such outcomes would become more likely if those affected were not ultimately covered under ACC law. The programme also raised several issues which would later prove to be significant for the health sector. For example, NZHS President Mike Mapperson explained how some people with haemophilia were aware their medicine may be contaminated with HCV, there were others who did not know. This raised the issue of informed consent an issue which became a hotly debated health topic later in the 1990s. Were all people treated with blood products for haemophilia fully informed of the implications of using the medicine? Had all these people given their consent to this?

F URT H ER M E DI A F R EN ZY
In less than a week, the front page of the New Zealand Herald announced that Minister Upton had ordered an inquiry into the issue and noted that questions need to be asked over whether the blood centres had raised concerns over factor IX 62 product . Concerns about tainted blood products had also spread to include children with immune deficiencies, who were at risk as their therapeutic product, gamma globulin, had 63 also been manufactured from unscreened plasma . The Sunday News of 22 November 1992 printed the story of how Dr Elizabeth Berry had written to Upton several months before on behalf of the NZHS Medical Advisory Panel and warned him of the medical issues with the supply of factor IX products and the legal implications of failing to act. Upton responded on the Tonight programme that the letter was treated as a funding request, presumably justifying why the
F IGURE 1. S AMPLE NEWSPAPER HEAD LINES ABOUT HEPATITIS C AND B AD B LOOD

$1.3m cost was declined and the other contents of the letter ignored.

There were inevitably calls for Upton to resign as Minister of Health. In response, the Prime Minister, the Rt Hon Jim Bolger, commented that Upton would act honourably when the inquiry had completed its report into the blood scandal64. The then chairman of the Medical Association, Dr Alistair Scott, also commented, the debacle over hepatitis C testing showed the true weakness of the Governments new health policies 65. The intense newspaper and television interest resulted in a 2-hour Parliamentary debate on 24 November, 1992. Minister Upton led the debate with a vigorous defence wherein he claimed the news media were publishing extraordinarily misleading and inaccurate statements many of which were from the Leader of the Opposition, the Rt Hon Mike Moore. The Hon Jonathan Hunt accused Upton of allowing hepatitis C to be 33

transmitted through a blood product. In response, Upton claimed that there was an unavoidable risk to the blood supply and the products manufactured from blood until the first tests for hepatitis C antibody became available in New Zealand in 1990. He also claimed that a sufficiently reliable test was not available until late 1991. Upton repeatedly claimed that HCV was not identified until 1990. Upton confirmed that factor IX would be potentially infectious until such time as the product was super-heat treated and that it was still being manufactured from unscreened plasma. He tabled the 31 July 1992 letter from Dr Elizabeth Berry, maintaining the primary issue in the letter to be funding for alternative factor IX products which were available from the U.S. In response, the Leader of the Opposition focused on the costs that the people who were infected and the health system might now have to bear, such as undertaking remedial interferon treatment. Compensation for costs, however, may not have been applicable as a result of the recent changes to accident compensation law. Review of the Hansard record of this debate makes for unsettling reading. Speakers claimed the debate needed to be informative; that the debate was important and the subject a vital issue. Unfortunately by the end of the record these objectives were lost in cross party bickering. While Upton did bring some facts to the House he also relied on the oft quoted phrase that he had acted on the advice he h ad received from the 66 Department of Health . He claimed that, like his predecessor as Minister of Health Helen Clark, he had been advised the HCV test kits available in 1990 were not sufficiently reliable to warrant immediate introduction. While Hon Michael Cullen raised the issue of delayed introduction of test kits, nobody challenged the Minister on the delayed introduction of second generation test kits that had been approved in August 1991 but not introduced until the end of June 1992. Nobody challenged the Minister on his June 1992 statement that AHBs 67 CAN NOW BE ASSURED OF THE SAFETY OF THE BLOOD [SUPPLY] . The issue of Prothrombinex still being manufactured from unscreened plasma was also partially raised by Cullen but not in the context of knowing the finished product was not super-heat treated to eliminate any potential hepatitis virus. While Upton did table Berrys letter of 31 July 1992, he did not reveal the detail of his response on 31 August, which indicated he was aware that Prothrombinex was not super-heat treated and assured that Prothrombinex HT would be available shortly. He tried to deflect blame, saying important questions needed to be answered about the way the Department of Health had handled the initial complaints. With respect to treatment for HCV, the only issue referred to was the one of personal cost. The Hon Jenny Shipley claimed that 75 per cent of haemophiliacs actually had hepatitis C prior to 1990they have always 68 known. with consent, that they were exposed to a number of risks . It is difficult to see how Shipley had compiled these figures as testing of people with haemophilia was incomplete as at 1992 and many who had been tested were not aware of their test results. In reference to the structure of the Blood Service, Hon Bill English indicated that reform was required to create accountability, quality control, and the registration of products as medicines. Perhaps English was aware that the Directors of the New Zealand Blood Transfusion Service had raised these issues with the Department of Health in May 1990 and that therapeutic products 69 fractionated from New Zealand plasma by CSL were not registered as medicines in New Zealand . In August 1990, the Department of Health was made aware that the formulation of national standards was needed to 70 commence product registration . Questions in the House continued to be raised over the following days and weeks. On 26 November 1992, an assurance was requested that those infected by HCV from contaminated blood would have access to the ACC 71 compensation scheme and to interferon treatment at no personal cost . In response to another question on 8 December 1992, Upton responded that as soon as a reliable test kit became available the expenditure was 72 considered essential .

34

A N I N Q UI R Y
In response to the intense media interest, the Director General of Health moved quickly to establish an inquiry. The Minister of Health said the Inquiry Panel was to be independent and would focus on a lack of action by the blood transfusion service and the Department of Health. The terms of reference required the Panel to determine the circumstances surrounding the supply of blood products after 1 July 1992 and to examine the responsibilities, functions and interrelationships of the Minister of Health, the Department of Health, the Blood Transfusion Advisory Committee and the Regional Blood Transfusion Service, expressly with respect to policy advice and management of fractionated blood products. The Inquiry had to determine the circumstances of supply after 1 July 1992 of Prothrombinex and report to the Director General of Health on 73 recommended changes to process of policy advice, responsibilities and functions . NZHS immediately wrote to Prime Minister Bolger pointing out that with control of the Inquiry under the Director General of Health it was not independent given the Department of Health had already been cited by 74 Upton as warranting investigation . NZHS also felt the terms of reference were too limiting with respect to time span, a time span which excluded correspondence between 1989 and 1992. The matter of the welfare of affected New Zealanders was left out of the terms of reference and, as such, the Inquiry failed to address or devise a plan to cope with people now living with a second and sometimes a third major illness. NZHS wished to give evidence to the Inquiry but as a voluntary organisation it did not have financial resources to fund the travel and accommodation expenses associated with giving of evidence in Wellington and accordingly asked the Department of Health for a reimbursement of actual and reasonable costs. Although it initially declined, the Ministry eventually agreed and NZHS did appear before the panel. NZHS told the Inquiry that both Ministers and the Department of Health had been told of concerns over the lack of screening of blood donations and continued use of unsafe blood products over the preceding 2 years, however, a plan to provide adequate and safe products and to secure a national supply of funds to finance the purchase of product has never been established. The Inquiry reported back on 15 December 1992. Their findings were that screening of blood for HCV was in place at 27 July 1992 but because of the lead time required to collect and process plasma, blood products for haemophilia continued to be processed from plasma not screened for HCV in the period 1 July until 30 75 November 1992 . The Inquiry reported that for those with factor IX deficiency this was not the case as there was no readily available product guaranteed to be free of HCV. The Inquiry also reported that 70 per cent of people with a bleeding disorder were HCV positive and that this level of infection took place before any screening tests were available. The Inquiry concluded that neither the Minister nor the officers of the 76,77 Department of Health had been alerted that a small group of patients were potentially exposed . The Inquiry attributed the continuing restructuring of the health service along with delays in the transfer of information as the cause of the failure to introduce screening, and concluded that there was a lack of clear 78 communication channels and an absence of strong national policy . Countries such as Canada, France, Ireland and the U.S. had also initiated public inquiries into the presence of HIV/AIDS and HCV and the overall safety of their national blood supplies. These inquiries were much more comprehensive than the brief and limited Inquiry into blood safety in New Zealand. For example, as a consequence of investigations into blood safety Japan and France made convictions for criminal negligence, 79 and some 20 countries provided financial compensation to people with haemophilia who became infected . NZHS found the entire inquiry process lacking as the Inquiry had no power to compel witnesses to provide evidence or to protect anyone giving evidence. While acknowledging the Inquiry had to carry out its terms of reference, it nevertheless, did not investigate a number of issues that contributed to this systemic failure. For example, the Inquiry did not acknowledge that the first call to test the blood supply for HCV antibodies was made by the Transfusion Advisory Committee in December 1989. It also did not acknowledge that for people 35

with factor IX deficiency, infection with HCV was almost inevitable as the manufacturing process for Prothrombinex could not use super-heat treatment to kill viruses; nor that the plasma the product was being manufactured from was not being tested for HCV during this period. The Inquiry did not investigate the outcome had alternative measures to identify HCV, such as surrogate testing, been implemented. Another shortfall was that the Inquiry failed to note that the policies put in place in 1984 in response to the HIV crisis banning the use of Australian plasma in the manufacture of New Zealand fractionated products were not being followed in 1992. The Inquiry did not follow up the evidence of the Tonight programme that alternative HCV-free products were available on the market. The Inquiry was never informed specialist fractionated products manufactured in U.S. from prison sourced plasma were used in New Zealand as this practise had not yet been revealed in U.S. Another major deficiency from the terms of reference was the lack of investigation into how to treat people infected with HCV. The Inquiry did, however, conclude that: [the haemophilia community is] a very vulnerable group of patients already carrying a significant 80 burden of illness, and they warrant special attention . Following the Inquiry, Upton immediately appointed the Principal Medical Officer of the Department of Health to chair the Blood Transfusion Advisory Committee, and ordered the formalising of the contract with CSL for supply of products to New Zealand. An immediate request was made to CSL to produce Prothrombinex from HCV tested NZ-plasma and introduce super-heat treatment to the product.

T H E P R O B L E M S M U LT I P L Y
By early 1993 some of the requests made by NZHS in its 1990 submission to then Minister Clark had finally been put into action; yet Bad Blood remained in the headlines as problems such as delays in implementing super-heat treatment, a failure to identify people with haemophilia infected by HCV, and the discovery that blood donations had been collected from prisoners continued to emerge. SUPER-HEAT-TREATED BLOOD PRODUCTS Batches of the newly formulated factor VIII concentrate AHF manufactured from New Zealand plasma that had been screened and tested for HCV and then super-heat treated to 80C for 72 hours had become available for use in New Zealand in 1991. Unfortunately it was February 1993 before the factor IX concentrate Prothrombinex-HT manufactured from New Zealand plasma that had been screened and tested for HCV and 81 then super-heat treated to 80C for 72 hours became available in New Zealand . The reasons for such a long delay between the introductions of the two products have never been explained. It took U.K. scientists 3 years from the discovery of the heating process in 1985, to production in 1988, to perfect the manufacturing process for super-heat treatment. It is not known when the know-how for superheat treatment became available to CSL but they certainly had problems in solving the issue of low yield the 82 super-heat treatment process caused . The problem of achieving an adequate yield of factor in the concentrates also created a problem for the six independent blood services in New Zealand. Additional volumes of plasma for processing were needed to compensate for the loss of yield in the manufacturing 83 process as well as a growth in demand for fractionated blood products . While CSL seemed to have the manufacture of super-heat technology factor concentrates mastered by mid-1990, it was 1991 before the independent blood services could supply adequate volumes of HCV-screened and -tested plasma from which CSL could manufacture AHF-HP for New Zealand. LOOK-BACK PROGRAMME In October 1994 blood transfusion centres began a look-back programme to identify people involved with any blood donations found to contain HCV. The programme aimed to identify, test and counsel transfusion recipients of HCV-positive blood donations from when HCV donor screening was recommended in August 36

1991 and the beginning of nationwide screening in July 1992 . As at 1994, approximately 408 people were 85 thought to be involved . All of these people were to be alerted to the possibility that they had contracted HCV, and accordingly offered testing and counselling. People with haemophilia were excluded from this programme on the grounds that having received pooled donations their donors could not be readily identified. Despite the high prevalence of HCV from infection via blood products among people with haemophilia no attempt was made on a national basis by health services to test people with haemophilia and establish their HCV status, nor to provide counselling or make antiviral treatment available. PRISON BLOOD DONATIONS In Canada in November 1997, Justice Krever submitted his Commissioned Report to the Canadian Parliament which brought to light the international trade in blood and the practice of collecting blood from state 86 prisoners . This report also strongly criticised the lack of action to protect people with haemophilia and transfusion recipients resident in Canada. There had been international concerns about the safety of using blood donated by prisoners since the early 87 1970s. The Canadian Red Cross discontinued the practice in 1971 . In Australia, New South Wales and South Australia banned the practice in the mid-1970s, but it continued in Western Australia until the early 1980s, 88 and Victoria and Tasmania until 1983 . This extract from Krevers report describes the collection of blood in U.S. prisons. During 1981-2, the number of AIDS cases in the United States reported to the Centers for Disease Control in Atlanta grew at an alarming rate. The vast majority of the reported cases were of homosexual men and intravenous drug abusers. During 1982, cases of AIDS transmitted through the use of blood and blood products began to be reported. The U.S. blood and plasma centers regularly collected from two groups of persons who were at high risk of contracting AIDS: homosexual men and prison inmates. Plasma was collected at centers, licensed by the Food and Drug Administration, in prisons in Arkansas, Florida, Louisiana, and Mississippi. By way of contrast, because of the high prevalence of hepatitis B in prisons, the Canadian Red Cross Society had stopped collecting 89 donations from prison inmates in 1971. The U.S. Food and Drug Administration (FDA) discontinued the practice of using blood collected from prisoners 90 within the U.S. in 1982 but did not prohibit the export of this blood . U.S. companies harvesting blood from paid and unpaid sources continued to export plasma to Canada, France, Iran, Iraq, and Japan. The significance of using prison populations as a source of blood is the high prevalence of HCV in the 91 incarcerated population . In New Zealand, for example, the prevalence of HCV in a prison population has been shown to be many times greater than in the general population; especially greater than the blood donor 92 population . People requiring fractionated blood products, therefore, were placed at an increased risk of contracting HCV if they received products manufactured from blood collected from prisons. Christchurch newspaper The Press reported that blood was also collected in New Zealand prisons until around 93 1983 . Although no specific details were provided, the Minister of Corrections confirmed there had been a practice of collecting blood from prisoners in New Zealand. It became evident from reviewing individual patient records that blood collected from prisons in the U.S. had also been imported to New Zealand as processed product between 1975 and 1992 in situations where specialist blood products were required for the likes of surgery. NZHS had been unaware that blood collection had taken place in New Zealand prisons prior to 1983 or that specialist fractionated products imported from U.S. may also have been manufactured from blood or plasma 37

84

collected in prisons. These and a number of other problems highlight how NZHS had to continue its advocacy role with regard to HCV.

38

CHAPTER 7 THE PERSONAL IMPACT OF HCV


While initially most people with haemophilia infected with HCV did not feel the full effects of infection, by the end of 1995 deaths had begun to occur where HCV was identified as the primary or secondary cause of death. A number of people were feeling unwell but did not necessarily realise the cause. There was also a considerable level of dissatisfaction over both treatment and non-treatment issues. These feelings compounded the anger felt over the Governments handling of the Bad Blood affair.

N UMBER

OF

A FFECT ED P EOPLE

Virtually all people with haemophilia who received pooled plasma products before 1986 were exposed to 94 HCV . Although the numbers of people in New Zealand who contracted HCV from blood or blood products has never been fully defined, the prevalence of HCV in adults with severe haemophilia in other developed countries treated with factor concentrates prior to the introduction of viral inactivation methods or screening 95,96 for HCV is reported to be from 75 to 98 per cent . Writing in the New Zealand Medical Journal, Dr Paul Harper noted Viral transmission of both HIV and HCV has had a devastating effect on the haemophilia 97 community . In Australia the prevalence of HCV has been reported to be 95 per cent of adult patients with 98 severe haemophilia exposed to locally produced coagulation factor concentrates prior to 1992 . As at July 1997, the look-back programme, which excluded people with haemophilia, had identified 56 people with chronic HCV infection contracted from transfusions in the period August 1990 to July 1992 and a further 76 99 people who were HCV-antibody positive who may or may not have progressed to chronic infection . In total, this look-back programme identified 281 people transfused with blood products possibly contaminated with HCV. Statistics gathered in 2005 by HFNZ recorded that 189 people with bleeding disorders contracted HCV from blood products in New Zealand. Some of these people were co-infected with both HCV and HIV.

A CCESS

TO

HCV T REATMENT

As a newly defined disease, the first step to accessing treatment in the 1990s was diagnosis. In the early part of the 1990s, AHBs directly controlled their purchase of pharmaceuticals, resulting in regional differences in the availability of diagnosis and treatment for HCV. So while some people with haemophilia were tested for HCV and when found to be positive offered treatment using the drug interferon, others either were tested but not offered treatment or, in some cases, not even informed of their results. Those AHBs which did undertake some testing did so because their clinicians could see the importance of testing and the consequences of not treating HCV. Other health boards provided no testing for diagnosis and therefore no treatment. This failure to diagnose HCV in all people with haemophilia, even after HCV had been officially recognised and genetically sequenced, created another need for active advocacy by NZHS/HFNZ. When reports of a treatment option for HCV began appearing in the print media, treatment with interferon was immediately termed expensive. In 1994, it cost approximately $4,000 for 6 months of interferon but treatment regimens of the time only achieved a sustained virological response (SVR or clearance) in no more 100 than 25 per cent of cases . The low response rate and high cost were used to justify its limited use. With such 39

a relatively low success rate and difficulties encountered with patients complying with treatment because of horrendous side effects, some clinicians question ed the effectiveness of interferon treatment for HCV. The advent of PHARMAC in 1993 to undertake pharmaceutical purchases for New Zealand also brought national policies on access to various treatments. Initially, people with haemophilia were not seen as likely responders to interferon treatment and the health dollars were devoted to those most likely to achieve viral clearance. Treatment for HCV genotype 1, the type of hepatitis infecting most people with haemophilia, was initially not funded because this genotype did not respond well to treatment. Response to treatment was higher for people with HCV genotypes 2 and 3 but for them access to treatment required a liver biopsy; a requirement that further excluded people with haemophilia as for them, the procedure was considered serious surgery, requiring the use of blood products to control bleeding at a cost far exceeding the cost of interferon treatment. Treatment was not available to those co-infected with HCV and HIV or hepatitis B, and of course many people with haemophilia had contracted both types of hepatitis. For those who did meet PHARMAC criteria, treatment was initially funded for 6 months and eventually expanded to 12 months when this regimen proved more effective. After fighting hard for a number of years, Society members were now being asked to represent people who use blood products on a number of national committees. Dealing with the demands of health funding, public perception and a growing membership, it was time for the Society to move towards becoming a more 101 professional and proactive organisation . As such, in June 1998 NZHS adopted a new constitution and became known as HFNZ the Haemophilia Foundation of New Zealand Inc. The new name and structure brought an added degree of professionalism and leverage with other stakeholders in haemophilia care and government. HFNZ recognised a need for people with haemophilia to access HCV treatment. The Foundation started its campaign by researching the HCV status of its members and was surprised with the results. It became evident that most people with haemophilia were unsure of, or did not know, their HCV genotype, possibly due to a lack of access to testing for many. More than 50 per cent of those surveyed had tried various self-treatments to combat their HCV, such as herbal remedies and diet modifications. What did not surprise HFNZ leaders was that most members were dissatisfied with the treatment options available to them. This information regarding the health status and opinions of people with haemophilia and HCV was conveyed to the Ministry of Health, along with a recommendation that a regular review of the national management and 102 approach to HCV care was needed . By this time international standards in HCV management included tracing and testing every individual who had received clotting factor concentrates and offering testing to their sexual partners. It was recommended that people with HCV showing abnormal serum ALT or AST levels should be incorporated into a regular 6-monthly review and that those showing liver disease should be treated with combination alpha-interferon and ribavirin irrespective of their HCV genotype. Recommendations also included performing an upper gastrointestinal endoscopy every 5 years on people with HCV aged over 45 103 years or who had been infected for 30 years or more . With this strong management consensus from overseas, the Ministry of Health had little choice but to consider a change in clinical policy. At this time interferon and ribavirin therapy was only available via a District Health Board (DHB) specialist. HFNZ also proposed access to personally funded treatment, but the proposal and access to treatment was declined. Undeterred, HFNZ continued its efforts to gain access to treatment for people with haemophilia. As a result of consultation, in May 2004 PHARMAC finally agreed to extend access to interferon and ribavirin to people 104 with haemophilia and HCV and began urging high risk groups to be tested .

40

S OCIAL & F AMILY L IFE


As a blood-borne virus, HCV can be transmitted sexually (although this is rare in monogamous, heterosexual 105 relationships ) as well as in the course of general family life, such as being passed from parent to child. As with the early days of HIV, discrimination against those with HCV was also encountered. In New Zealand some people lost their jobs when employers became aware their employee was carrying an infection, in particular in the food and health services. The ability to work was also compromised as a result of symptoms experienced by many people infected with HCV, especially the fatigue. For similar reasons, higher education easily became disrupted. Symptoms, however, are variable between individuals. Some people were able to continue working both with the disease and during treatment, while others experienced complete exhaustion that made working impossible. In addition to reduced income, most individuals experienced an increase in costs of living as a result of medicines to relieve symptoms and because of dietary requirements in the form of supplements, fresh foods, 106 and higher quality foods to promote liver health .

41

42

CHAPTER 8 ACCIDENT COMPENSATION SCHEME FAILS A GAIN


In the social contract established when the first ACC Act was introduced, New Zealanders gave away their right to sue for personal injury in exchange for a universal compensation scheme. In the 1990s, the Government began a series of changes to compensation laws and entitlements to reduce business costs. The Bolger Government introduced changes to ACC legislation via the Accident Compensation and Rehabilitation Act 1992, effective from 1 April 1992. The effect of the changes to legislation was considerable: the criteria for access to ACC entitlements became more restrictive; lump sum payments were abolished; time limits for making claims were tightly fixed; and, the definition of medical misadventure was changed thereby reducing entitlements and compensation. These changes were introduced from 1 July 1992, and any claim lodged after 1 October 1992 was no longer eligible to receive lump sum compensation. The right to ACC cover for people infected with HCV through blood products became a complex issue to interpret. The critical issue seemed to be which ACC legislation was in force at the time the individual contracted HCV. A person with haemophilia who contracted HCV before 1 July 1992 (which would have been the situation for most people with haemophilia) could be subject to the 1982 Act and, therefore, may not have been entitled to compensatory damages and therefore might be able to bring a claim for damages at common law. There was a small window for entitlement to compensatory damages for those able to prove infection after 1 July 1992 and before 1 July 1993. A similar position existed for those who may have been infected after 1 July 1993. People with haemophilia could, therefore, not all be treated the same. The date of their infection and date of the diagnosis, as well as the date they registered their claim determined which ACC Act they were subject to. Those who suffered injury before 1 July 1992 and who lodged their claim before 1 October 1992 were dealt with under the 1982 Act. Those lodging a claim after 1 October 1992 were dealt with under provisions of the 1992 Act. Those dealt with under the 1982 Act became entitled to lump sum payments and a different scale of recompense to those dealt with under the 1992 Act. Under the 1992 Act infection became more complex, as medical misadventure also had to be proven. Proving a claim was, however, a formidable task given the associated issues of access to testing at the time of suffering the injury but was nonetheless the critical issue. The NZHS wrote to Hon Bill Birch, then the Minister for ACC, in April 1993 pointing out that the new 12 month time limit for making a claim was unjust for people infected with HCV from blood products because in some cases HCV testing had not been available and for most the disease takes longer than 12 months to manifest a 107 functional disability . There were also problems with non-settlement of established claims because a legal interpretation of entitlement was required in view of the way the legislation was composed. Minister Birch responded that he was confident about the processing procedures for future claims and did not accept that 108 any special exceptions needed to be made with regard to claims related to HCV infection . In the view of NZHS representatives Birch seemed to have completely misunderstood the issue. An exception was not being sought for HCV-related claims, merely parity for people unaware that they were carrying an injury because they could not be tested or because the injury had not yet manifested. Most people with haemophilia A would have contracted HCV before 1 July 1992 when screening and heat-treated factor VIII products became 43

available (although the date could be over a year later for those with haemophilia B). Despite this, those people who had not lodged an ACC claim before 1 October 1992 were unlikely to have any entitlement to compensation or any right to sue for damages. Not only did the deadline cause problems, but the process of lodging a claim was difficult. Many people had not been able to access the HCV testing that was necessary to allow a claim to be initiated. In some areas test kits were not available, while in others testing was delayed in laboratories as they were not equipped to 109 process the blood. This led to delays of up to 6 months in receiving results . Some people with haemophilia had been tested but had not been informed of their HCV status or their right to ACC support. A number of people with haemophilia, particularly in the Wellington area, discovered their medical records had gone missing. People in the position to clearly identify the incident of their infection (i.e., where therapeutic products have been used only for a specific administration such as surgery) were forced to accept the date of diagnosis often years later after they acquired the infection as the starting date of their entitlement. All these complications meant that there were not many people with haemophilia in a position to make an ACC 110 claim before 1 October 1992. A further appeal to the Minister Birch had no effect . These circumstances added to the widespread suspicion that it was not a coincidence that the introduction of restricted ACC entitlements coincided with the Bad Blood Affair. According to ACC, medical misadventure could be classified either as a medical error or medical mishap. Medical error required the failure of a medical professional to observe an adequate standard of care and skill that could reasonably be expected in the circumstances. Medical mishap was defined as an adverse consequence of treatment properly given by, or at the direction of, a registered health professional and that the likelihood of the adverse consequence of the treatment occurring was rare an d severe. Rare was defined as not occurring in more than one per cent of cases where the treatment was given. The definition of rare was further modified to rule out medical mishap if the risk was known to the individual or their guardian. Severe was defined as resulting in death, hospitalisation greater than 14 days, disability lasting more than 28 days or ACC acceptance of their claim for an independence allowance. The definitions also ruled out a number of clinical situations such as abnormal reaction to treatment, the absence of informed consent, a failure to 111 correctly diagnose or a failure to provide treatment, and treatment as part of a clinical trial . For a few people with haemophilia, the ruling for their ACC claim for HCV was one of medical misadventure. Quite rightly the finding was not considered medical error due to the failure of a registered health professional but a medical mishap that was rare and severe. Accordingly these few were paid lump sum compensation up to a total of $10,000 under Section 79 of the 1982 ACC Act. Some of these claimants were then able to go on and seek a claim under Section 78 of the 1982 Act for permanent loss or impairment for up to $7,000. In situations where death occurred, however, accessing the sum of $17,000 available for each claim was complicated. The assessment of claims was based on scoring an adequate number of points based on a system to gauge the scope of physical disability. While this system may have been satisfactory in the event of a motor accident, it was inappropriate for a chronic and sometimes slow developing viral infection. Meanwhile, people with haemophilia B and some with haemophilia A had continued to receive treatments with blood products containing unscreened plasma after 3 August 1992 because already processed treatment products had not been withdrawn. Even the recipients who had been advised by the Ministry of Health in November 1992 that their treatment product could be contaminated found their access to ACC remained curtailed. Dealing with ACC on a district basis became a nightmare of confusion and frustration. On paper, the process at ACC for considering medical misadventure claims seemed fair and reasonable. Access to cover was controlled by the Act but also the Medical Misadventure Regulations 1992. As with any claim a causal link also had to be demonstrated. Upon receiving a medical report from the treating clinician on the affected individual a claim for medical misadventure was considered by a Medical Misadventure Advisory Committee. The 44

Committee then advised ACC on whether a medical misadventure had occurred and whether medical negligence was evident. In reality, it is this part of the process from which many of the subsequent problems with ACC and HCV arose. Trying to deal with the Ministers responsible for ACC was equally frustrating. Ministers Birch and later Hon Bruce Cliffe were not interested in the anomalies created by the new ACC legislation. When challenged, the consistent response was to describe and re-describe the requirements of the new law. For the next 5 years, the ACC system provided a continuous source of problems and led to a series of long legal wrangles. NZHS had decided to finance the legal costs of those having difficulties accessing their entitlements under ACC legislation. These difficulties covered a number of issues, such as: ACC determining that entitlement to cover commenced on the day of diagnosis rather than the day of likely injury; ACC cover requiring the individual to demonstrate that both medical misadventure and personal injury had occurred; Inconsistency in ACC rulings, for example applying the 1992 Act based on their delayed decisionmaking rather than the 1982 Act, the legislation at the time of an individuals application; and, Extensive delays in ACCs processing of claims and correspondence.

Further delays were also caused when issues were taken to a District Court with ACC claiming the ACC Appeal Authority should be hearing the issue. The first case tried in court resulted in the District Court awarding lump sum compensation to the claimant. Before an ACC settlement could occur ACC appealed the decision to the High Court and, after a long delay, their appeal was upheld. The continuous delays were only one issue. Some people felt reticent about airing their personal health issues in public court and were reluctant to pursue their entitlements. All felt aggrieved about the escalating legal 112 costs and most people simply not having sufficient finance to mount a legal action . Because of legislative changes enacted in 1992, each claim by a person with haemophilia and HCV appeared to be treated differently by ACC. Some had a claim accepted by ACC and received a lump sum. Others qualified under new legislation and received $8.00 per week income compensation. Probably the greatest irony for NZHS was in the inconsistency of application of two sections of the 1982 ACC Act in the numerous branches of ACC on the degree of disablement. Despite standard guidelines being available internationally, some medical professionals were still of the understanding that HCV was a disease of little consequence that caused minimal disability and impairment. A number of people were told payments could be made at a later date when and if their health deteriorated, but such later applications for review were not successful. ACC was never proactive in diagnosing, treating or rehabilitating people with haemophilia and HCV. Despite the advertising by ACC at the time that they sought to prevent injury, provide the best care for injuries and to quickly rehabilitate people back to work, this never occurred with respect to the Bad Blood issue. For NZHS officers it felt as if they were repeating the wrangles with ACC they had encountered over HIV/AIDS. The timing of new legislative changes to reduce entitlements was seen as directly intended to limit liability for HCV. It was when rights to lump sum ACC entitlements were found to be cut off by the new provisions of the Act that the attention of individuals began to focus on the possibility of a class action for exemplary damages against the Minister and the Department of Health. A major stumbling block, however, was the legal requirement that the treating clinician and the AHBs had to be jointly challenged through the class action. This was a step many people with haemophilia were loath to take, both out of respect for their individual clinicians but also because of their ongoing reliance on hospitals for haemophilia care. Most people with haemophilia 45

did not hold their clinicians responsible for this second viral infection. Their clinicians often had a very strong record of advocacy on behalf of people with haemophilia. In the view of NZHS advocates, the cause of the disaster of a second blood borne virus infecting people reliant on blood products was laid clearly at the door of Ministers Clark and Upton and the Department of Health. The Society was convinced that these officers of the Crown had failed to act adequately and neglected to address issues of care for the affected individuals via the 1992 Inquiry.

46

CHAPTER 9 LEGAL AND POLITICAL ENGAGEMENT


A LTERNATIVE L EGAL A CTIONS - E XEMPLARY D AMAGES
Dissatisfaction with a range of issues related to ACC and access to ACC entitlements created widespread anger amongst people with haemophilia. The anger was directed against Government and health bureaucrats as it was felt that this group had not had taken a proactive approach to blood safety. The sentiment was that nothing had been done to minimise, let alone stop, the impact of HCV for individuals, nor for the nation. The decision to do nothing and watch developments proved to be catastrophic. In the view of many affected people, the Government and Health Departments had failed to see the importance of super-heat treatment for fractionated products; they failed to see the need for dual inactivation steps in manufacture, and they failed to ensure a speedy update to manufacturing processes. Their inaction was perceived be to a result of a total absence of ethics. Once steps were finally adopted to reduce the spread of HCV, operational errors and mistakes compounded the situation. On top of this the Government made changes to ACC laws making access to entitlements more difficult or unattainable. Many people felt that their media statements were unreliable and less than wholly truthful, not to mention the sham that was the Inquiry. To allow a group of people deemed as medically vulnerable to become infected by their medicine firstly with HIV and then HCV was felt to transgress one of the basic ethics of medicine that of non-maleficence not once but twice. The emphasis of the legal action between 1992 and 1995 was on trying to access fair ACC compensation for affected individuals through meticulous examination of the statues and case law, by political appeal for fairness, pointing out anomalies, and by highlighting systemic deficiencies. As a result of all the unsatisfactory outcomes, by 1995 attention was turning to alternative ways of achieving justice. One legal alternative was to mount a case for exemplary damages against the Ministry of Health, AHBs and the New Zealand Transfusion Service for a multitude of failures, including: Failure to secure the safety of the blood supply; Failure to implement safety measures such as donor screening; continuing to use medicines known to be infectious; Failure to warn recipients with haemophilia of potential contamination of blood products they used; Failure to provide correct information when most patients had been told that their risks of contracting HCV were negligible; and, Failure to explore safer treatments alternatives.

The intent was to bring a selective range of cases before the High Court. Individual claims were filed in the High Court alleging negligence and breach of statutory duty, breach of contract, breach of fiduciary duty, battery, and breach of the New Zealand Bill of Rights Act and seeking amounts varying from $50,000 to $250,000 in exemplary damages and $1m to $1.7m in compensatory damages. Unlike the situation in the U.S. where awards of exemplary damage were often sought, pursuing this type of legal action had been infrequent in New Zealand on the grounds that the government of the day funded most, if not all, medically related expenses either by way of Vote: Health or schemes such as ACC. For example, in 47

2001, NZHS was contacted by a San Francisco-based law firm indicating New Zealanders using specialist factor VIII products may be able to join a settlement for damages against Cutter Laboratories. The case, which involved less than ten people from New Zealand, was eventually settled out of court. In 2003, the settlement was also expanded to include specialist factor IX products manufactured by other international processors. The emerging class action in New Zealand was managed by a legal team involving two firms appointed earlier by individuals. In the period between 1995 and 1999 this group filed over 100 proceedings against the Crown in the High Court. As issues evolved, however, none of these cases came to trial. No doubt the reasons for not coming before the Court was different in each case, but collectively part of the problem was probably a lack of ability to adequately establish the standard of evidence required by the Court. Alleging negligence and breach of statutory duty against a Minister of the Crown and Crown agencies was no simple matter. The legal costs would inevitably be high as the Crown could be anticipated to vigorously defend any claims. Identifying and recruiting overseas expert witnesses would also be necessary. Assembling evidence would be difficult and thus to mount such a case was not to be embarked on lightly. In the opinion of the legal minds engaged in the class action, there was certainly a case of exemplary damages to answer. After all this was not a simple cold virus but an insidious disease that would cause suffering and economic loss to the individual, and might hasten or cause death in a significant proportion of cases. The argument was that Ministers of Health Clark and Upton failed in their duty of care their responsibility to protect their people especially for a group already considered vulnerable. While both failed to implement super-heat treatment of plasma products or to introduce alternative products as a safeguard to continuing treatment, Upton also failed to introduce timely HCV testing of the donor pool, failed to inform users of the risks associated with the use of blood products and, therefore, failed to achieve informed consent from users for the continuing use of the medicine. Even after the infection and the method of transmission became public knowledge in November 1992, Upton failed to include people using fractionated blood products in any look-back programmes and therefore failed to pursue diagnosis for individuals. Overall, some 250 individuals contemplated legal action, half of whom were people with haemophilia.

LI MI T E D O FF E R F R O M

G O V E R N M EN T

The General Election of 1996 had resulted in a Coalition Government. One of the elements in the coalition agreement between New Zealand First and the National Party was a commitment to investigate whether adequate compensation had been received by those who contracted HCV and HIV from contaminated blood products. Unfortunately, after the election the issue did not appear to progress despite Crown Law signalling a desire to negotiate in 1997. Frustration continued to grow among people with haemophilia, For some individuals this was fuelled by a belief that they had a genuine entitlement to ACC, but that in most cases the ACC system was prohibiting access to a claim. Further cynicism towards ACC was created by reading in the media how the Act allowed payments to be made to recognise stress arising from being refused a bank loan but did n ot recognise a claim for stress arising from dealing with HCV infection. Another example that fuelled frustration was when Government reached a compensatory agreement with Cave Creek victims in 1996, separate to ACC provisions, as a result of the failure of a look-out structure constructed by inexperienced staff of the Ministry of Conservation. On 28 April 1995, a tourist viewing platform at Cave Creek near Punakaiki on the West Coast of the South Island collapsed, killing 14 of the young people standing on it. A contributory cause of this fatal accident was seen by the public to be under-funding of the Conservation Department by the National Government of the early 1990s. This issue was seen to have similarities with the Bad Blood affair. The Commission of Inquiry into the Cave Creek tragedy found no one to be negligent but rather identified a 113 systemic failure as the cause . The findings were remarkably similarity to those from the 1992 Inquiry into the Bad Blood affair which also pointed to a systemic failure in Government processes. 48

By April 1998 people with haemophilia were extremely frustrated by the lack of progress from the class action. Delays were attributed to the tactics employed by the Crown Law Office as the Governments legal representative. For example, requests for information went unanswered or were returned incomplete. Accordingly, notices for discovery were issued in at least two cases. Some claimants considered the delays as intentional on the part of the Government. Crown Law frequently, and rather conveniently, claimed documents could not be located. There was some truth to this claim, as already noted with respect to clinical records at Wellington Hospital. Unfortunately, an agreement for both parties to identify issues resulted in the Crown Law Office never completing its issues. There was also a lack of action on behalf of Government in response to requests from the legal team. For example, the Government agreed to appoint a liaison officer to improve communication and then failed to carry through the commitment. The Government also agreed to review three representative claims with a view to awarding a lump sum to the claimants and, 5 months later, unilaterally decided not to proceed. The frustrations for people with haemophilia grew to new level in July 1998 when Rt Hon Jenny Shipley, then Minister of Health, made a settlement offer to the legal team representing the class action. The offer only applied to 32 claimants who had been infected by blood transfusion between August 1990 and July 1992. This offer provided a lump sum of $20,000, cover for the cost of hepatitis A vaccination (approximately $200), and contribution towards legal expenses. The offer was to be considered a full and final settlement, made in confidence and with no admission of liability. The conditions of the offer excluded all people with 114 haemophilia. It is understood most of the 32 eligible claimants declined the settlement offer .

P OLITICAL A CTIONS
As 1999 progressed with still no meaningful legal action being achieved, people with haemophilia began to pin their hopes on a change of government at the upcoming elections. The election year was an opportune political climate to bring pressure on politicians for a resolution to HCV compensation issues. There was concern that should a National government be re-elected it was extremely unlikely to result in a resolution for people with HCV. Hopes began to rise in August 1999 when Opposition Health Spokesperson Annette King sent a message of support pledging that when her party was in government, Labour would seek to bring about A F A I R A N D 115 S P E E D Y S E T T L E M E N T . This pledge was to be used to good effect, but not for several years. This political sentiment was also spoken to individuals who questioned local politicians. The statements all inferred when Labour would be in Government they would be prepared to review the situation facing claimants and that they intended to resolve the matter. In the months leading up to the elections, members of HFNZ and other victims of Bad Blood staged an 11week vigil outside Parliament. A Wall of Shame was created, with photos and personal stories of families affected by the hepatitis tragedy. The media took a great interest in the protest and raised public awareness of the issue. The vigil became a political irritant to Government who continuously adopted petty constraints such as disallowing the use of toilets within Parliament to protesters. Additionally, the vigil raised politicians familiarity with the issues.

A S E CO N D S ET T L E M EN T O FF E R
The November 1999 election brought a change of government and Labour Health spokesperson Hon Annette King became Minister of Health. A commitment had been made to calling a meeting between the Ministries of Health and Finance and claimant representatives to finalise the claim. This meeting took place before Christmas, which suggested a real commitment on the part of the new Government. At the meeting King conveyed that, although Cabinet was concerned over the plight that HCV claimants found themselves in, the Government had many other concerns as well. A desire was expressed to find a solution that included all 49

F IGURE 2. W ALL OF S HAME - THE 11 WEEK POLITICAL DEMON STRATION AT P ARLIAMENT , 1999.

people who had contracted HCV through blood products, not solely those signed up to the class action and not solely people with haemophilia, including the estates of those who had died. The Minister was made aware of the feelings of distrust that had developed on the p art of the claimants toward Crown Law and that offices reluctance to commit to a defined procedure to work through the issues. By February 2000, the legal team indicated they represented 226 claimants and 13 next of kin. As requested by the Minister, the legal team compiled a revised claim they would be prepared to recommend to their claimants. The basis of the claim was a recognition and acknowledgement of suffering, of fairness and justice, and to enable some degree of financial recompense for losses and expenses incurred. This proposal included a payment of $75,000, with special provision to deduct any earlier ACC payments, and with particular provision for those that had died from causes related to HCV. ACC rights would remain in place, an apology would be made, and legal costs would be able to be deducted. As evidence of good faith, the legal team undertook to cease filing further actions in the High Court. As a result a second settlement offer was made by Government in April 2000, based on the regret that the implementation of HCV screening had been delayed. Unfortunately the Ministers desire to cover all claimants was clearly not strong enough as only those able to prove they probably contracted HCV in or after February 1990 were eligible for the settlement. The basis of claim had also been changed, resting instead on the timing between when a reliable testing regime became available internationally (February 1990) and when New Zealand introduced HCV testing in August 1992. This window of infection did not cover the situation with non- super-heat treatment of Prothrombinex and factor products continuing to be manufactured from unscreened blood. The offer was, however, a small step forward as for the first time people with haemophilia were intentionally included. Nevertheless, because most people with haemophilia did not have a reliable testing history or the ability to pinpoint when they had been infected less than five people with haemophilia qualified for the offer. The offer included a sum of up to $40,000 and a contribution to legal expenses of up to $4,000. A top-up payment was proposed for any claimants who had accepted the earlier offer under Shipley. One troublesome condition of the offer was that all surviving claimants had to accept the offer for a payment to be made to anyone. Apparently of the 77 people who qualified for the settlement, approximately 29 accepted the offer. After this revamped Government offer was rejected, all subsequent correspondence and requests for meetings with Government went unanswered. With the matter far from settled, the requirement 50

for all surviving claimants to have to accept the offer before a payment could be made to anyone was withdrawn in August 2000 allowing those who wanted to settle their individual claim to proceed. For the rest of the claimants preparations for High Court resumed. The relationship between the Bad Blood campaigners and the Government was further soured when, in August 2000, a High Court review hearing considered an application from New Zealand Blood Service (NZBS) appealing an earlier Court decision requiring it to produce blood donor records as a necessary step in the discovery of information relevant to the renewed High Court hearings. The High Court maintained the decision requiring the Blood Service to produce donor records. While the NZBS was rightly concerned that divulging confidential matters about the health and sexual practices of blood donors may have an impact on the availability and recruitment of donors, thus threatening the New Zealand blood supply, justice could not be assured without all the relevant information being available to the legal teams.

C O MP LAI N T S

OF

C R I MI N A L N UI S AN C E

Frustration from not knowing how to bring the issue to a conclusion led 60 people with haemophilia from across New Zealand to walk into their local police station on a specific Saturday morning in December 2001 and say to the duty officer, I wish to file a complaint of criminal nuisance against the Prime Minister Rt Hon Helen Clark and against Hon Simon Upton. Not surprisingly the response to this statement was variable, with some police officers taking it in their stride as if recording just another job and others telling their complainant to, Go away - you cant claim against a Prime Minister, or Come back Monday. An act of criminal nuisance is: any unlawful act or omission to discharge any legal duty, such act or omission being one which he knew would endanger the :- lives, safety or health of the public (or) life, health or safety of an 116 individual. While the Prime Minister made no comment, she was allegedly not at all happy at being personally targeted. Clark had, however, been Minister of Health at the start of the HCV issue, and although she was in Opposition when the issue became public it had been reported that she: sympathised with Mr Upton and his concerns over the dissemination of information by the Health Department. It was a matter that needed to be sorted out. The Inquiry [into contaminated blood products] needs to look not only at the responsibility of the Minister but the advice structure to him. 117 Was it timely? Was it accurate? Not one complainant received confirmation of the filing of a complaint, nor notification of progress in police investigations. The Police did not take any statements, prepare any briefs of evidence, prepare statements of prosecution witnesses, or make copies of police job sheets or copies of any police officer notebook entries. In fact HFNZ was asked to prepare a summary of the issue! In response to a letter sent by a complainant to the Commissioner of Police in July 2003, 20 months after the laying of complaints, HFNZ was advised that the police would not be pursuing any of the complaints against the Ministers. The Commissioners reasoning was that for criminal nuisance to be shown, the Ministers had to: Know that their act or their omission would endanger the lives, safety or health of the public or an individual; Perform an illegal act by contravening a statutory provision by failing to take action, or failing to warn, or failing to prevent contaminated blood from being used; Contravene a legal duty and have in their charge, or under their control, the blood products in question; 51

Fail in a statutory duty, but they did not have the statutory requirement on them to act in any particular way; or Engage in conduct able to be foreseen to expose others to harm. In this test the Ministers were considered to be responsible to Cabinet rather than the public.

In the Commissioners view all complaints failed to meet these tests and therefore the Ministers had not acted unlawfully or in breach of their legal duty.

52

CHAPTER 10 MAKING CHANGE HAPPEN


By 2003, HFNZ realised that their approach to resolving issues of compensation and treatment of HCV for their members over the preceding 12 years had not been effective. The ACC system had failed most people with haemophilia. The class action for exemplary damages did not achieve a single case being heard in the High Court. The political pressure applied via the legal team had settled no more than three to five claims for people with haemophilia. The initial campaign was for financial compensation but in retrospect this was probably never likely to succeed. In retrospect, the class action and the criminal nuisance charge, brought about by extreme frustration and a sense of hopelessness, probably had a negative impact on the chances of reaching a settlement with Government. Officials refused to negotiate unless the class action was withdrawn, thus undermining the ability of HFNZ to communicate and negotiate with government about their concerns. HFNZ decided a change of context was needed and to realign their campaign to one that was more in tune with the directions in which Government was wishing to move. Their emphasis moved from a demand for compensation to a focus on treatment and recompense for injustice. Both aspects were high on the Governments priority list in 2003 as it tried to right many past injustices by apology, access to increased resources and lump sum compensation. The public health system was also being restructured again. HFNZ Council could also see that the HCV issue was absorbing a disproportionate volume of its resources, both in terms of money and volunteer effort, and agreed that a major and sustained push was needed to try and bring the issue to a close. The practices used since 2000 of intermittently responding to issues and opportunities as they arose were not achieving results. The methods of applying political pressure on specific matters and arranging media releases and articles from time to time was reactive rather than proactive. HFNZ Council decided it needed a sophisticated plan of action to cover the period from 2003 to the 2005 election. As a consequence a number of interrelated steps were planned.

F IGURE 3. E FFECTIVELY USING THE MEDIA ( T HE P RESS , C HRISTCHURCH , 17 A PRIL 2004)

C OLLECTING

THE

F ACTS

As the HCV and Bad Blood Affair had now spanned more than a decade, by the early 2000s no one person at HFNZ was personally acquainted with all the facts, issues and actions. By now chronic HCV infection was also having an impact on the health of many of the affected people. In addition, because of such widely varying personal situations and access by a handful to ACC, people infected with HCV ended up with widely varying financial situations and thus inequity was becoming a major issue.

53

To try to better establish the health status and priorities of people with haemophilia and HCV, HFNZ undertook to survey their membership in 2003. This survey revealed that the main concern of members had moved from compensation to the need for treatment. The survey also revealed essential facts such as; of the 189 people with haemophilia infected by HCV, 80 had filed a medical misadventure claim with ACC or sought compensation for loss of earnings. Of those who had filed a claim, only 60 people had had their claim accepted resulting in 21 people receiving a lump sum settlement; 19 had received the $10,000 for pain and suffering and only six had received some or all of the $17,000 for permanent disability. Regional variations were evident in the numbers and proportions of claims accepted by ACC. Deaths had also occurred directly as a result of HCV. Of all those people with haemophilia who had been infected, approximately 20 people had spontaneously cleared the virus, less than ten were in active treatment, 17 were not aware of their current viral status and over 110 were awaiting treatment. Over the next few years HFNZ undertook to study each case individually to determine if ACC rights had been exhausted. The result was that 99 claims had been accepted by ACC by January 2005. A small group from HFNZ also began to research the HCV issue internationally and nationally. They aimed to establish: the magnitude of the HCV problem; the impact of HCV on people with haemophilia; treatment options available in New Zealand relative to other developed countries; to research compensation agreements in other countries; and, to document the nature of compensation offers in New Zealand. HFNZ also decided it was essential to offer members further information on the nature of HCV and its treatment, and to update their position on legal aspects of HCV. The research group was also aware Government was contemplating further changes to ACC legislations. The HFNZ membership survey revealed significant variation around New Zealand with regard to access to treatment for HCV. Access to interferon was only available via a specialist and, unfortunately, it seemed that although improvements has been made in both the treatment regimen and efficacy some clinicians were still of the view expressed in New Zealand Doctor Magazine in 1994, nearly a decade earlier, that: A number of gastroenterologists will not treat hepatitis C at all because they do not believe the risks of the medicine are justified until there is stronger evidence of a long term improvement in outcome.
118

I NTERNATIONAL L IAISON
New Zealand was not the only country where justice was being sought for victims of contaminated blood. With the advent of the internet, the World Federation of Hemophilia (WFH) based in Montreal, Canada became a wonderful conduit for HCV information. HFNZ was able to quickly establish developments around the world and learn new information. As mentioned previously, the Canadian government had initiated the Krever Commission after the discovery that some 22,000 people had become infected by blood and blood products. In Ireland, the Lindsay Tribunal was set up in 1999 to investigate the infection of people with haemophilia with HIV and HCV from contaminated blood products. The consequent 274 days of high court action in Dublin allowed the facts on 119 HIV, HCV and haemophilia in Ireland and the personal devastation wrought in families to be vividly told . The result was the establishment of a needs based compensation system for the victims. On 24 May 2004, 77 countries present at the XXVI WFH General Assembly in Seville, Spain approved a unanimous resolution: The WFH recognizes the pain and suffering caused to people with haemophilia and related bleeding disorders by iatrogenic infection with the hepatitis C virus. The WFH calls on all governments to 120 make available suitable recompense to all those affected and their families . 54

Following this HFNZ decided to bring Brian OMahony and Raymond Bradley from Irelan d to New Zealand to learn from them the process they had used to get results for people infected with HCV through blood in Ireland. OMahony, Past President of the Irish Haemophilia Society and then President of WFH, and Bradley, Legal Counsel for the Irish Haemophilia Society, had been intimately involved in the Lindsay Tribunal. The guests were invited to attend a national HFNZ conference on HCV and to help launch a sustained course of action towards gaining compensation in New Zealand. The visitors began by coaching HFNZ about communication, for example on how to distil a considerable volume of information into five main points which could be supplied to the media and public and easily grasped by all. HFNZ planned a strategy to release the collected evidence. First they appointed a spokesperson for each issue; each spokesperson knew their subject and spoke only on their assigned issue, giving correct and consistent information and establishing and staying with the facts. HFNZ ensured that each spokesperson was better informed than the people with whom they were dealing and endeavoured to focus on what was morally right. During this phase sound bites became more powerful than prolonged and detailed information. The continuously repeated central themes included: access to leading edge treatment for HCV; an apology from Government; lump sum compensation commensurate with ACC compensation; and then these would be followed by withdrawal of common law action.

I NTEGRATING P OLIT ICAL , L EGAL

AND

M EDIA P LANS

The campaign plan was to apply pressure to the Government via three key areas. With the introduction of mixed member proportional representation (MMP) as its electoral system for the House of Representatives in 1994, recent governments were being formed by coalitions thus making alternative party support essential. With this in mind, the campaigners committed significant resources to getting a commitment from the smaller parties to resolve HCV treatment and compensation issues. Secondly, HFNZ intended to keep the media well informed of developments and relevant information. Thirdly, dialogue was to be maintained with the Ministry of Health. The three activity streams were worked in parallel and supported by each other. From April 2005, the integrated plan combining and interrelating political, media and legal steps was put into effect so as to increase pressure on Government and the Ministry of Health and to build momentum as the election approached. These steps were carried out by educating key people, informing the public of the facts and about the injustice that had occurred, and pressing the Government for a settlement. HFNZ made sure it knew its members wants and needs, and the 2005 HFNZ hepatitis C conference provided an opportunity to educate members and achieve a mandate for action. By informing the membership, individuals could also become active at a local level. Because of demand from members, sessions on HCV became part of every national adult workshop programme. Members attending the conference also provided a unanimous resolution giving HFNZ the mandate to proceed with its stepped action plan to pursue a fair and equitable treatment and welfare package.

C O MM UN I C AT I N G
To improve communication, HFNZ actively developed relationships with television, radio and press journalists. Reporters were first cultivated and then kept updated. Some brave people with haemophilia shared their personal stories in the media so the public could see the human consequences of the bureaucratic disaster. Members of Parliament were petitioned via a series of fortnightly newsletters, with the simple aim of keeping the issue alive and increasing its political value in the run up to the election. Three major opposition parties committed active support, thereby giving the Foundation hope for the post-election period and

55

enhancing its bargaining position with the current Government. Media releases were regularly issued and information was dressed up as new. By regularly providing updated information HFNZ attracted the attention of the print media, resulting in regular headlines that demanded a response by the Minister of Health and by the Prime Minister on access to care. Headlines of the time included: Bad blood keeps on killing Bad blood
122 123 124 121

NZ slow to stop inmate blood collection

Haemophiliacs call for Inquiry into bad blood US exported high-risk blood products to NZ A small number, a large injustice
126

125

In March 2005 a chance enquiry to the computerised Archway index at National Archives with the search term hepatitis C revealed that Helen Clark and Mike Moore had deposited papers relevant to the issue. Not surprisingly both required permission to access. Moore was happy to assist by granting access. Clark declined. Access to some of Clarks papers are controlled until 2020, others for her lifetime. This embargo meant the papers could not be used to determine her part in the Bad Blood incident. A controlled release to the media detailing this embargo quickly saw the issue covered on television news and in 127 the newspapers .

F IGURE 4. M EDIA COVERAGE OF THE EMBARGO OF H ELEN C LARK ' S FILES ( T HE P RESS , C HRISTCHURCH . 9 A PRIL 2005)

A B R E AK T H R O U G H
In the days following the April 2005 HCV conference HFNZ representatives also used their new found knowledge and international expert visitors to lobby the Director General of Health, Chairman of the Accident Compensation Corporation and other politicians. The Director General of Health was acquainted with the crucial facts and reluctantly received a visit from the campaigners. While the Government acknowledged the delay in implementing a nationwide testing regime to the blood supply in the period 1990 1992, the campaigners felt that there were other issues that also significantly contributed to Government culpability. Both sides agreed that establishing fact was difficult; some 15 to 20 years had passed and with some information not available within the current Ministry of Health and the inability to refer to a key politicians files the process did not allow full discovery or examination of information. The Director General agreed to consider a submission from HFNZ detailing the new and collected information and a settlement proposal. The new plan of attack had achieved its first pivotal success. With the help of visitors Brian OMahony and Raymond Bradley and drawing on overseas models, the HFNZ team quickly prepared a brief to the Minister of Health. Just days later, the submission was hand delivered to the Ministry of Health by HFNZ members. The submission provided a further opportunity for media attention and turned into a lead story on the evening news. HFNZ requested tha t the Ministry provide a meaningful response within 14 days and officials withdrew to consider their reply - under the watchful eyes of HFNZ and the national media. The Director General of Health initially gave an interim response , followed by a more detailed response in 129 late May 2005 . The response commented that arrangements entered into by countries to compensate people infected with contaminated blood products arose through a unique sets of circumstances in each country and in differing legal jurisdictions and statutory regimes: due to this, the Ministry felt that any comparison between what gave rise to such arrangements in such countries and New Zealand was difficult and probably impossible. It conceded that the relevance of the compensation arrangements as they relate to New 56
128

F IGURE 5. P REPARING THE SUBMISSION FOR THE D IRECTOR G ENERAL OF H EALTH L EFT TO R IGHT : M ICHAEL C ARNAHAN (P AST P RESIDENT [2000-2004], HFNZ), B ELINDA B URNETT (C HIEF E XECUTIVE O FFICER HFNZ), N OVA G UERIN (N ATIONAL I NFORMATION C OORDINATOR , HFNZ), R AYMOND B RADLEY (L EGAL C OUNSEL TO THE I RISH H AEMOPHILIA S OCIETY ), B RIAN OM AHONY (P RESIDENT , W ORLD F EDERATION OF H EMOPHILIA )

Zealand's circumstances needed to be established. The response also noted that the Government had already made an offer of settlement in relation to persons infected with hepatitis C as a consequence of receiving contaminated blood and blood products, subject to certain conditions. The Ministry stated that once the facts in the HFNZ submission and their response had been gathered and it was clear what facts were agreed and not 130 agreed, then advice could be sought on the issue of legal settlement .

P O LI T I C A L P A MP H L ET S
The three-pronged approach was still in action. To try to increase pressure on the Government, a member of the campaign team developed a pamphlet intended for a letterbox drop into all households in the Mt Albert and Rongotai electorates the seats held by Rt Hon Helen Clark, the then Prime Minister, and Hon Annette King, the then Minister of Health. Based on the promises made by King before the previous election that 131 Labour would seek to bring about A F A I R A N D S P E E D Y S E T T L E M E N T to the HCV compensation issue, the pamphlets asked: Labour Lies to people with Haemophilia are they lying to you? Annette King lied to people with Haemophilia is she lying to you? HFNZ had learned from the Irish that the threat to carry out an action can sometimes be far more powerful than actually carrying it out. With this in mind, before the pamphlet was distributed, a copy of the Mt Albert pamphlet was conveyed to the Labour Party. The Rongotai pamphlet was also passed directly to Annette King before a meeting in her electorate, with the suggestion that immediate action on the HCV issue might avoid a series of difficult questions being raised at that evenings meeting. 57

This was followed by a number of exchanges of letters through to September 2005, yet no resolution was proposed. Leaders of HFNZ soon became anxious that virtually 6 months after submitting their paper to the Ministry of Health a solution had still not been agreed. To them, it was as if the Government intended to get through the upcoming election before reaching a settlement.

A RUSH

TO

N E GO T I AT E

This threat of pamphlet drops had its intended effect and re-opened the door to negotiations. In the process it also provided HFNZ with a stronger negotiating position. Unbeknown to the campaigners, there was also an element of serendipity at play. In the week King became acquainted with the pamphlet, political polls revealed a drop of several points in Labour party support. This, in combination with the threat of possibly losing more votes as a result of the pamphlet, led King to ask her Health Ministry if the HCV issue had been resolved. The morning following the Rongatai electorate meeting, the HFNZ HCV negotiating team received a call from the Ministry of Health with a request to urgently resolve the HCV issue. Within 3 days the HFNZ negotiating team was given assurance that action would be taken and a meeting with senior officers of the Ministry of Health and other key government agencies was set. After years of struggling to even get around a table, negotiations were suddenly easy and a resolution was reached within 30 minutes - just 10 days out from the October 2005 general election. The HFNZ team were more than ready for negotiation as they thoroughly understood the issues and, for the first time, had a strong negotiating position. It was around the negotiating table that the value and success of the integrated plan for political, media and legal action was proved. Instead of being just a group of people believing they had been wronged and meeting to beg some relief, or a lawyer threatening a personal action, the HFNZ team were able to negotiate from a position of knowledge and therefore strength. The facts that had been communicated to the Ministry in April and May 2005 were accepted as true by all around the table. Now, as a result of direct political pressure, the team found themselves in a strong strategic position. An additional request to provide HFNZ with resources for outreach services to support people with haemophilia and HCV was also agreed to.

F IGURE 6. H ANDING OVER THE SUBM ISSION TO D R C OLIN F EEK , C HIEF M EDICAL O FFICER , M INISTRY OF H EALTH , BY S TEVE W ARING , HFNZ, AND M ICHAEL C ARNAHAN , HFNZ P AST P RESIDENT (2000-2004).

58

In September 2005, HFNZ was able to signal to members in confidence that a proposal for a treatment and welfare package had been agreed between HFNZ negotiators and the Ministry of Health and was to be put before Cabinet following the election. At this point it had been 13 years since the media had first reported that blood products used in New Zealand were still being manufactured from blood plasma unscreened for HCV despite the commitment to screen. The Treatment and Welfare Package for victims of HCV provides a fine example of how timing either planned or fortuitous - can make or break a situation for advocates in the voluntary sector. The HFNZ team had realised that any solution would come with compromise. The solution agreed upon with Government met the requirements of the law and the team found that the earlier difficulties with ACC legislation were miraculously overcome. Various objections voiced during earlier meetings by a continuous stream of ever changing ministerial advisors were suddenly overlooked. The greatest change in the negotiation process was in the total silence from the Crown Law Office, which had continuously been such a stumbling block for the class action lawyers. In hindsight, it is believed that officials at the Ministry of Health were not truly aware of issues being experienced by people with haemophilia and HCV, thus the submission produced in April 2005 was an important turning point. Throughout the negotiation process the HFNZ team tried to be professional and to provide administrators with correct and sincere comments. During negotiations credit was given to the Ministry for the positive things that had been accomplished in recent years, such as creation of a National Haemophilia Management Group to manage haemophilia services in New Zealand, but there were also deep criticisms of the lack of action in other areas, especially in the area of treatment for HCV.

A T L AST ! A S ETTLEMENT P ROPOSAL

FROM

G OVERNMENT

IS

A NNOUNCED

On World Haemophilia Day 17 April 2006 the settlement was announced in the media. The Press labelled the announcement a Government turn-around and detailed how the package included guaranteed access to lifesaving treatment, up to $60,000 as a non gratia payment, and an apology from Prime Minister Helen 132 Clarke . A one-stop shop at ACC to deal with the claims was also to be initiated. As the proposal had yet to be passed by Cabinet, the Ministry of Health did not provide a comment. Months passed and the HFNZ team became increasingly concerned that what had been agreed to in principle in September 2005 had still not become a reality. Finally, in December 2006, the new Minister of Health Hon. Pete Hodgson announced the Treatment and Welfare package for people who contracted HCV through 133 contaminated plasma products . The package consisted of two main parts. Firstly, the treatment offer was available to all people in New Zealand infected by HCV, irrespective of how they were infected. This part of the package provided an ongoing sum of $5 million per year to improve hepatitis services in New Zealand and the establishment of an advisory group to review and improve treatment protocols. The second main part of the package applied to welfare and was available to not just people with haemophilia but to anyone who had been infected with HCV via the New Zealand blood supply, either from blood or blood products where the blood was collected in New Zealand before 27 July 1992 - the date Upton gave his 134 assurance that AHBs can now be assured of the safety of the blood they use . Provision was also made for those infected as a result of close personal contact with a person infected through the blood supply, such as a child, partner or third party. The financial part of the package consisted of a one-off ex gratia payment with the value based on the $27,000 provision in the 1982 ACC Act, for people who developed permanent disability as a result of their injury (adjusted for inflation from the 1992 value to 2006 value). The maximum entitlement became $69,600, with deductions to be made for those who had already received a partial payment via ACC or who had already 59

F IGURE 7. M EDIA FROM W ORLD H AEMOPHILIA D AY , 17 A PRIL 2006

accepted the previous settlement offers from Shipley or King. The payment was also available to the estates of people who qualified but had passed away as a result of their HCV infection. A contribution to legal fees of up to a maximum sum of $4,000 was also available. The Treatment and Welfare Package also included the establishment of a single national point of registration for ACC entitlement and ACC provision for ongoing care for HCV and earnings-related compensation for people with HCV infected by blood products. In addition, an expression of regret by the Prime Minister Rt Hon Helen Clark of the suffering incurred was provided. To qualify, applicants for the package had to been infected by HCV and also be able to show they had to have suffered a personal injury according to the ACC definition. To demonstrate a personal injury, applicants had to produce a positive PCR test for HCV (indicating they had developed chronic hepatitis C) or have undergone treatment for HCV and consequently cleared the virus. Those who had been infected and whose immune system had managed to clear the virus without treatment were not entitled to the financial package. Access to the package also required applicants to cease all legal action against Government. The Ministrys media statement on the package acknowledged the important role of HFNZ in working to meet the concerns of all those infected with HCV through contaminated blood and blood products. Accordingly, a service contract was awarded to HFNZ for support services for individuals and families affected by both haemophilia and HCV.

C LASS A CTION L AWYERS S EEK F ULL F EES


Unfortunately the announcement of the Governments Treatment and Welfare Package did not bring an end to all HCV matters for people with haemophilia. The Ministry of Health chose not to deal with and settle directly with individual applicants, apparently on the grounds that they wished to see an enduring settlement 60

where each and every claimant had been correctly advised from a legal point of view. The consequence of this was that all applicants who had been part of the class action had to handle their settlements through the original legal team. The problem with this was that the legal team had not been a party to the final negotiations for the Treatment and Welfare Package. These negotiations had been carried out solely by the group appointed by HFNZ to bring a conclusion to the issue which consisted of HFNZ volunteers and staff, not a single one of the class action lawyers. Over the years, most people with haemophilia had signed up to a representation agreement with the class action lawyers. In retrospect, the agreement document proved to be flawed and unfavourable to the claimants because it allowed fees to be charge at the maximum of $500.00 per hour, a sum based on specialist skill, the risk of no payment at all and a prolonged process. The fee was to be a first charge on any proceeds achieved in excess of $6,000. The legal team was to have investigated recovery of damages, conduct proceedings, and negotiate a settlement. A disputes clause was also included. The wrangle over legal fees became a sideshow to the main event. Several issues were seen as problems. For example, the settlement was available to all people who qualified irrespective of whether they were part of the class action or not, yet those people who had been part of it became responsible for many years worth of legal fees despite the lawyers not contributing to reaching the settlement. The package included a contribution towards legal fees, but the maximum of $4,000 was not going to cover the bills the claimants were now confronted with. The charges that had been accumulating by the lawyers over the last decade had never been disclosed previously and the magnitude left the claimants shocked. By November 2006 legal costs had reached about $2.7m; this was to be divided among 127 claimants, of which 63 were people with haemophilia. The average cost of fees per claimant worked out to approximately $15,000 including GST. The situation was judged grossly unfair by those who had signed up for the class action, especially as the settlement had not been achieved through the lawyers and not a single case had ever been heard in court. To try to rectify the situation, HFNZ engaged independent legal advisors in January 2007. The task of the new advisors was to provide individuals who had been part of the class action an independent legal opinion that examined the advantages and disadvantages of pursuing a claim at common law and the advantages and disadvantages of accepting the Treatment and Welfare Package as final settlement. They were also to advise HFNZ on a possible resolution on the situation with the legal fees. To do this the new legal advisors needed to explore the alternatives available to HCV claimants at the commencement of the HCV issue in 1992. Initially, the alternatives available depended on whether the individual had access to ACC cover for their claim or not. It had already been identified that not all people with haemophilia could be treated the same. The Bad Blood incident was caught between two ACC Acts and a set of transitional arrangements. ACC entitlements, therefore, depended on the date of infection and the date of injury, together with the date a person registered their claim. Should a person be entitled to ACC and consequently cover, then the individual was barred from bringing an action for damages under common law. The new legal advisors considered there were considerable difficulties in proving a claim for compensatory damages and, therefore, could not have recommended such a course of action. That left the possibility of seeking exemplary damages, which in limited circumstances are intended to punish a wrongdoer for their neglectful conduct. The new legal advisors considered the prospects of a successful claim for compensatory and exemplary damages should not have warranted the costs and risks involved. The legal advisors then turned their attention to the issue of legal fees incurred by members over the period 1992 to 2007 with the class action legal team. While noting the early legal action had focused on securing rights to ACC, around 1996-1997 attention turned to pursuing exemplary damages, as well as the need to pool resources to contain costs and cope with the expected cost of $100,000 to go to court. This course of action resulted in the class action legal team having a substantial pecuniary interest in the outcome of any 61

settlement, bringing their interests into conflict with those of the claimants. The actual agreement for legal services signed by the claimants also gave rise to concerns, especially with regard to the legal representative being able to decide the course of action rather than the claimant. The methodology for calculating the fees, especially the generic part of the fee, for time spent on an aspect related to all claimants, was the area of greatest contention. In considering the Treatment and Welfare package settlement the original class action legal team was advising claimants that the offer from the Government still fell short of fair compensation but their strong advice was to accept the package. These lawyers also pointed out You have authorised us to receive the payment. You cannot revoke this authority. You have transferred to us the right to receive whatever part of the payment is 135 necessary to pay our fees. In a step that greatly annoyed claimants, the class action legal team went on to register the assignment contained in the agreements as financing statements under the Personal Property Securities Act, with an expiry of March 2012. This action resulted in HFNZ advising members not to accept any offer until the issue of legal fees had been settled. In early 2008, HFNZ representatives met with the class action legal team in an attempt to achieve a compromise over fees. They highlighted that, in retrospect, it was the view of HFNZ that the legal team was never going to achieve a settlement regardless of what party was in government as the lawyers had a substantial pecuniary interest in litigation. Because of the international collaboration in haemophilia, HFNZ had successfully applied a lobbying technique that had already proved successful in Dublin. It was as a result of this that HFNZ had secured a commitment by the Director General of Health to review new information and allowed its research to be presented. HFNZ had also been able to use timing to get the attention of Government to achieve the settlement offer. They emphasised that the importance of the Treatment and Welfare package to people with haemophilia was the access to treatment, something which the delay over legal fees was preventing. The dispute over legal fees was finally resolved after both parties agreed to mediation in August 2008, clearing the way for settlement of all claimants over the following few months. At long last many of HFNZs members were able to reach a conclusion to a devastating chapter of their lives. Others, of course, those that continue to live with chronic HCV or related liver damage and who lost a family member as a result of HCV, will never be able to fully reach a resolution.

62

F IGURE 8. P ROFILE OF ONE OF THE ESTATES THAT WERE AB LE TO ACCESS THE T REATMENT AND W ELFARE PACKAGE (T HE P RESS . 28 O CTOBER 2006)

CHAPTER 11 THE SITUATION IN 2013


P ROTECTING
THE

B LOOD S UPPLY

In 1996, the Ministry of Health undertook a review of blood services in New Zealand which resulted in a recommendation that a national blood service be established to ensure consistency of quality, to enable development of a national strategic direction and to achieve rationalisation of the service. A complete reorganisation began to minimise risk to the recipients of blood and blood products and to reduce the risks to the Crown. The new organisation, the New Zealand Blood Service (NZBS), was to be responsive to situations such as emergencies or potential infection risks that threaten the safety of blood and fluctuations in the supply 136 of, or demand for blood . The NZBS practice is based on haemovigilance, a process that recognises that blood and blood products are 137 biologic in nature and carry inherent risks in respect of infection or reactions in the recipient . Donor selection is now more rigorous with donors required to be within policy age ranges and in good health. A detailed health questionnaire is completed by each donor at each donation, a step to protect the health of the donor and to ensure any disease the individual may be incubating or carrying is not transferred to the donor pool. This first step checks on recent travel and countries of residence, risk behaviours as well as the health of the donor. The second step is to test each donation for blood group and diseases such as HIV, HCV, hepatitis B and syphilis. A further eight tests might be performed on specific donations. The risk of transmission of viruses such as HIV or HCV is now relatively low and a small number of other problems now account for the majority of difficulties and dangers associated with transfusion. For example, delays in obtaining urgently needed blood products, transfusion of blood products intended for another patient, over-transfusion leading to heart failure, or transfusion-transmitted bacterial infections. In 2001, NZBS introduced leucodepletion, a process for removing white cells or leucocytes from blood components, as one of a series of precautionary measures to cope with the potential risk of transmission of variant Creutzfeldt-Jakob disease (vCJD) by blood transfusion. NZBS also traces every blood donation from the vein of the donor to the vein of the recipient. In 2012, there are now very few transfusion-related adverse events. For example, only three life-threatening transfusion-related adverse events were reported to the 138 national haemogivilance programme in 2011 . NZBS expects notification of all adverse transfusion reaction and investigates all such occurrences. A recent audit by the Controller and Auditor General found that safety 139 is the cornerstone of the Blood Service operation . NZBS also has systems and controls to manage the safety of blood and processed blood products in all aspects of its operation. For example, NZBS has a sophisticated computer system to manage blood donations and all its operations that allows the Service to trace and recall any donated blood or blood product at any stage of processing if there are concerns over safety, a huge contrast to the systems that were in place in 1984 when a media statement was required to ascertain who may have used Prothrombinex batch 694 and determine who may have been exposed to HIV. Protecting the blood supply has become a chain reaction of dependence. NZBS relies on donors not donating if they are carrying virus but have provided a second line of defence in the haemovigilance programme. In the event of a new viral event, the manufacturers are dependent on scientists to both identify the nature of the virus and develop a defence in the form of a test. But the manufacturers also have a second line of defence as, in addition to testing starting plasma, steps to eliminate any possible viruses are included in the manufacturing process. 63

P EOPLE C ARRYING V IRAL I NFECTIONS

FROM

B AD B LOOD

In the period between July 1992 and April 2005, 467 HCV-related claims were lodged with ACC, of which 322 were accepted. Of those 467 claims, 153 were from people with haemophilia. From 1992 to 2010, the total net cost in compensatory payments was $8.60 million. In addition to this sum, $6.9 million was paid out as weekly compensation and another $1.9m for treatment, rehabilitation, loss of earnings, independence allowances and support, funeral costs, survivor benefits, and, in a few cases, lump sum settlements, was paid out by ACC. By 2012, HFNZ established that in total 189 people with bleeding disorders were infected with HCV through blood products in New Zealand. Of those people, 41 have died, 38 per cent directly from causes related to their HCV infections, 29 people have cleared the virus naturally and 58 people have cleared the virus through interferon treatment. Of the remaining 61 people with chronic HCV, nearly half have tried interferon 140 treatment but were unsuccessful in clearing the virus . These people with haemophilia and chronic hepatitis C eagerly await the availability of the next generation of interferon-free antiviral treatments. In 2012 there were still people living with haemophilia, HIV and HCV. Many of these resilient people are still able to sustain full-time employment and care for their families; a testament to their fortitude and the care of their clinicians.

T REATMENT

OF

H AEMOPHILIA

A long term benefit of the HIV/AIDS and the HCV issues has been the contribution to improvements in treatment of haemophilia both internationally and nationally. People with haemophilia in New Zealand are now managed by tertiary hospitals under the auspices of a multi-disciplinary haemophilia centre, providing comprehensive care on a demand and a preventative basis. In the mid-1980s treatment in New Zealand was limited by insufficient supplies of treatment products, a situation experienced around the world. One of the keys to treatment is to prevent day-to-day bleeds by using prophylactic treatment, but this preventative approach could not be contemplated until the supply of treatment products became adequate. The HIV/AIDS crisis accelerated the development and the commercialisation of recombinant clotting factors, made in the laboratory from cloned factor VIII and IX DNA instead of derived from donated plasma. The use of recombinant therapies became part of haemophilia care New Zealand in 1997, allowing children and adolescents to have regular twice/three-times weekly therapy. Prophylactic care has prevented most of the debilitating joint and muscle bleeds usually experienced by a person with haemophilia, allowing this younger age group to complete their education and commence a career and adult life with a body in a condition that was only dreamed of in the 1950s. Recombinant technology has also brought therapy for those with inhibitors, whose immune systems prevented the factor replacements products from supporting their clotting processes. The development of recombinant products brought these patients treatment alternative to plasma-based products, including bypass therapy, and a steady supply of product to be able to trial immune tolerisation therapy. Using such innovative products means haemophilia continues to be a very high-cost disease. Recombinants products are now available for all people with haemophilia A and B, but plasma-based treatment products are still in use. Older people with haemophilia who have been using plasma based concentrates for many years who continue to use plasma-based products know the standards required for their manufacture is markedly different to the 1980s.

64

O UTLOOK

FOR A

N EWBORN

WITH

H AEMOPHILIA

A child, almost always a boy, born in 2013 with severe haemophilia in New Zealand who is diagnosed early and treated with a combination of good clinical and parent management can be expected to lead a near normal life, to undertake education and a career of his choosing that does not expose him to unreasonable risks. From the age of about 12 months he will be treated twice to three times a week with infusion of recombinant clotting products to avoid crippling bleeds into joints and muscles. As a result he will not need the strong analgesics of the past. He will not run the risks of viral contamination from using human blood plasmas in his treatment. He will not endure HIV or HCV like his predecessors. So long as his immune system tolerates the treatment, it will continue regularly until he is through adolescence, which he will reach with mobility and health intact. At this point, he will decide with his clinicians whether to continue with prophylactic treatment or he might prosper with only intermittent therapy. But should another virus, health threat or bureaucratic error find a way to menace the lives of people with haemophilia, the volunteers and staff of HFNZ now have the knowledge, skills and experience to advocate on their behalf.

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66

POSTSCRIPT
In the view of this writer, this sad commentary is not the standard one should expect or accept from either elected politicians or a publicly funded health services. Both major political parties become soiled by this commentary. Clinical staff working to provide health services should not be subjected to such political impediments to carry out their duties and do what is best for their patients. And nor should the public accept such appalling performance from their politicians, their House of Representatives, nor their health service. The haemophilia community has been devastated by HIV, AIDS and HCV. We hope that we will not continue to be devastated by vCJD or TNV The Next Virus. The complexity of the condition and its treatment is likely to ensure that issues from the past will recur. It is essential, therefore, that the haemophilia and medical communities learn from the past and apply its lessons in a meaningful way. The reader is left to ponder how advocacy by a voluntary group NZHS/HFNZ helped bring about change and then consider what might befall this country if voluntary groups did not take up advocacy for a cause such as health. The keys to look for as we move through nearly two decades of the Bad Blood Affair is to see how, in retrospect, the initial political thrust for compensation was made in an environment where it was unlikely to be successful. This was followed by a legal thrust that bore little benefit for people with haemophilia and a political/public campaign of shame. It was 2004 before the volunteers undertook major research and 2005 before a proactive and strategic approach was adopted that combined political, media and legal elements to achieve a solution. Knowing more about the issues than the people they were dealing with and always knowing what the next step would be, whatever the response from officials, proved invaluable. It was also learned that a threat could be more powerful than an action itself, as it allowed advocates to hold some cards up their sleeve and gives politicians room to reach a decision without losing precious face. Never be surprised at the ingenious steps politicians might take to conceal information from the public. The end of this story will not be the end of the need for advocacy in haemophilia. There will always be battles to be fought to ensure the best available healthcare for this rare disease.

F IGURE 9. R EMEMBRANCE S ERVICE FOR P EOPLE WITH H AEMOPHILIA

WHO HAVE DIED

(C AMP K ESWICK , R OTORUA , 2003).

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68

GLOSSARY
ACC

Accident Compensation Cooperation and/or Accident Compensation Commission. Set up in 1972 to become the compulsory national insurer in event of an accident. Legislation provides for a range of recompenses and in exchange bars most forms of personal injury litigation, irrespective of whether it was the fault of the injured party, or the fault of any other party. The bar prevents claims if there is cover, irrespective of the amount of compensation which the injured party receives. The scheme operates on the basis that a person who has cover under the Act is entitled to the compensation under the Act (irrespective of the value of that cover) and nothing from the person who caused the injury. The scheme provides cover for accidents suffered on a "no fault", "no blame" basis. If there is cover for personal injury or death under the legislation, no civil claim for compensation may be brought in the courts. There are exceptions to the statutory bar to civil actions for personal injury. Claims for exemplary damages only (because they are not compensatory in nature) may be pursued. In addition, claims for some forms of medical misadventure and in some circumstances for nervous shock/mental injury may be pursued because of limitations in the extent of the statutory cover. Such claims remain rare in practice.

AHB

Area Health Board Between 1938 and 1983, the New Zealand health system developed as a dual system of public and private provision under the Social Security Act 1938. In 1983, the Government began two decades of structural reform of the health system. The Area Health Boards Act 1983 established 14 Area Health Boards (AHBs) funded by a population-based formula. In 1993 the Health and Disability Services Act 1993 made further changes focused on separation of the purchase from the provision of health services. Four Regional Health Authorities (RHAs) were established to define and purchase health services and the 14 Area Health Boards were reconfigured into 23 Crown Health Enterprises (CHEs) structured as for-profit organisations and subject to ordinary company law. Public health services were unbundled and a separate public health purchasing agency, the Public Health Commission, was established. Further changes were enacted in 1997-98 and the New Zealand Public Health and Disability Act 2000. In 2001, 21 District Health Boards (DHBs) were formed. Primary Health Organisation (PHOs) were then developed in 2002 to manage primary care, including general practitioners and their services.

69

AIDS

Acquired Immune Deficiency Syndrome A severe immunological disorder caused by the retrovirus HIV, resulting in a defect in cell-mediated immune response that is manifested by increased susceptibility to opportunistic infections and to certain rare cancers, especially Kaposi's sarcoma. It is transmitted primarily by exposure to contaminated body fluids, especially blood and semen. AIDS is what happens as a result of a compromised immune system, when your body is no longer able to protect itself against infections which a normal immune system would otherwise be able to control. Different people with AIDS may experience different clinical problems, depending on which of the specific opportunistic infections they develop. There's no cure for HIV/AIDS, but there are medications that can dramatically slow the progression of the disease. See also HIV

ALT

Alanine aminotransferase ALT is one of the two liver enzymes commonly tested for, along with AST. It is a protein made only by liver cells. When liver cells are damaged, ALT leaks out into the bloodstream and the level of ALT in the blood is higher than normal. ALT levels go up and down in most people with hepatitis C. The ALT level does not tell you how much scarring (fibrosis) is in the liver and it does not predict how much liver damage will develop. Many people with hepatitis C will have a normal ALT level; they can have very severe liver disease and cirrhosis and still have a normal ALT level. It is helpful to see if the ALT level goes down during treatment for hepatitis C.

ANTIBODY TESTING

An antibody is a protein in the blood helps remove disease organisms or their toxins. An AIDS antibody test determines the presence of HIV antibody in the patient's blood. Similarly an HCV antibody test establishes the presence of HCV antibody, thus indicating exposure to HCV and a possible chronic infection.

ARC

Acquired Immune Deficiency Syndrome (AIDS) Related Complex ARC was defined as the signs and symptoms seen in a less severe stage of HIV infection, characterised by chronic generalised disease of the lymph nodes, fever, weight loss, prolonged diarrhoea, minor opportunistic infections, reduced blood cells, and T-cell abnormalities of the kind associated with AIDS. At this stage in the epidemiology of the disease infected people were not considered to have yet progressed to the more severe stages of AIDS infection. People with HIV are diagnosed as having AIDS when they develop certain infections or cancers or when their CD4 count becomes less than 200.

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AST

Aspartate aminotransferase AST is one of the two liver enzymes most commonly tested for, along with ALT. When liver cells are damaged, AST leaks out into the bloodstream and the level of AST in the blood becomes higher than normal. AST is different from ALT because AST is found in parts of the body other than the liver--including the heart, kidneys, muscles, and brain. When cells in any of those parts of the body are damaged, AST can be elevated. The AST level is not as helpful as the ALT level for checking the liver. Many patients with hepatitis C will have a normal AST level. Patients can have very severe liver disease or cirrhosis and still have a normal AST level.

CSL

Commonwealth Serum Laboratories CSL is a global specialty biotechnology company that researches, develops, manufactures and markets products to treat and prevent serious human medical conditions. CSL's product areas include blood plasma derivatives, vaccines, antivenom, and cell culture reagents used in various medical and genetic research and manufacturing applications. Founded in 1916 as the Commonwealth Serum Laboratories, an Australian government body, CSL was privatised as CSL Ltd in 1994. In 2000, CSL acquired Swiss plasma company, the Bern-based ZLB Bioplasma AG and in 2004 the company expanded again with the purchase of the German medical company Aventis Behring. According to the CSL website (http://www.csl.com.au/), CSL believe that behaving responsibly is critical to the sustainability of our company. Our Corporate Responsibility Priority Areas (include) ensuring our therapies are safe and of the highest quality by maintaining the highest standards throughout all stages of the product life cycle. Over the years CSL has manufactured several plasma-derived haemophilia treatments products, including AHF, AHF-HP, and Biostate (factor VIII) and Prothrombinex, Prothrombinex-HT, and MonoFIX (factor IX).

CRYOPRECIPITATE

A precipitate formed from fresh human plasma that has been frozen and thawed. Cryo contains fibrinogen, von Willebrand factor, factor VIII, factor XIII and fibronectin. A unit of whole blood can produce 15 ml of cryoprecipitate, which provides 80-100 units of factor VIII for treatment of haemophilia A. Introduced in 1968, cryo was a common treatment for haemophilia throughout the 1970s. Many uses of the product have been replaced by factor concentrates, but it is still routinely stocked by many hospital blood banks.

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DISCOVERY

A category of legal procedural devices employed by a party to a civil or criminal action, prior to trial, to require the adverse party to disclose information that is essential for the preparation of the requesting party's case and that the other party alone knows or possesses.

DONOR SCREENING

Blood donor screening now comprises a number of checks that starts with a registration and health questionnaire. The donor is examined and asked specific questions about their medical history to make sure that donating blood is not hazardous to their health. The donor's haemoglobin level is tested to make sure that the loss of blood will not make them anaemic. Pulse, blood pressure, and body temperature are also evaluated. Donors are examined for signs and symptoms of diseases that can be transmitted in a blood transfusion, such as HIV, malaria, and viral hepatitis. Elderly donors are sometimes also deferred on age alone because of potential health concerns. The safety of donating blood during pregnancy has not been studied thoroughly, and pregnant women are usually deferred. Donors are also screened for health risks that could make the donation unsafe for the recipient. Some of these restrictions are controversial, such as restricting donations from men who have sex with men for HIV risk. Autologous donors are not always screened for recipient safety problems since the donor is the only person who will receive the blood. Donors are also asked about medications. Screening may include questions about risk factors for various diseases, such as travel to countries at risk for malaria or variant Creutzfeldt-Jakob Disease (vCJD). These questions vary from country to country.

EXEMPLARY DAMAGES (OR PUNITIVE DAMAGES)

These are damages requested and/or awarded in a lawsuit when the defendant's wilful acts were outrageous, oppressive, or grossly reckless. These damages are awarded both as a punishment and to set a public example. They reward the plaintiff for the terrible nature of what she/he went through or suffered. Although often requested, exemplary damages are seldom awarded. Because of the accident compensation procedural bar to pursuing compensatory damages for personal injury in New Zealand, it is possible in such cases to pursue and obtain an award of damages which is purely punitive or exemplary. Awards of exemplary damages are relatively small and New Zealand courts have a history of only awarding modest amounts.

FRACTIONATION

A separation process in which a liquid such as whole blood, is separated by centrifuging into a clear solution of blood plasma in the upper phase, the buffy coat, which is a thin layer of leukocytes (white blood cells) mixed with platelets in the middle, and red blood cells at the bottom of the centrifuge tube.

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FRACTIONATED
BLOOD PRODUCTS

The production of specific blood components as a medicine from human blood plasma. Examples included factor VIII and factor IX as concentrated fractions for treatment of haemophilia.

HEAT TREATMENT

Heat treatment is used to neutralise viruses in finished plasma products. The two proteins crucial to people with haemophilia, factors VIII and IX, are unstable in their natural state and do not survive the somewhat harsh manufacturing processes of heat application needed to make them safe to use. The proteins require stabilising with sugars and amino acid prior to processing. A freeze drying process in a vacuum chamber was developed instead of heating liquid, replicating conditions that allow water to boil at -10C followed by heating to -20C. This process is followed by conventional heating to 60C for 72 hours. The process was sufficient to inactivate HIV in blood products but not HCV. See also Super-heat treatment

HCV

Hepatitis C / hepatitis C virus HCV is a blood-borne virus that damages the liver, resulting in scarring and inflammation. Worldwide, an estimated three per cent of the population has HCV. In New Zealand approximately 50,000 people have chronic hepatitis C; 75 per cent of these people are unaware they are living with the virus. It is often referred to as a "silent epidemic", as it is common for patients to not notice any symptoms for 20 to 30 years after infection. If left untreated, hepatitis C can cause serious damage to the liver, resulting in cirrhosis. A cirrhotic liver cannot function normally. Cirrhosis can progress into liver cancer or liver failure.

HIV

Human immunodeficiency virus. HIV is a retrovirus that causes AIDS. By damaging your immune system, HIV interferes with your body's ability to fight the organisms that cause disease. HIV is a sexually transmitted infection. It can also be spread by contact with infected blood, or from mother to child during pregnancy, childbirth or breastfeeding. It can take years before HIV weakens the immune system to the point that a person develops AIDS. See also AIDS

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HIV-ANTIBODY
POSITIVE

People who become infected with HIV develop antibodies (proteins the body makes to fight germs). Antibodies to HIV can usually be detected within 2 to 12 weeks following infection with the virus. These antibodies can be detected by a blood test. When antibodies are found in the blood of people who are infected with HIV, these people are said to be HIV antibody positive. See also HIV

HCV TESTING

Testing for hepatitis C is a two-step process. The first step is an Anti-HCV test. Anti-HCV test to detect the presence of antibodies to the virus, indicating exposure to HCV. These tests cannot tell if a person still has an active viral infection, only that they were exposed to the virus in the past. Usually, the test is reported as positive or negative. An Anti-HCV test cannot, however, diagnose a chronic hepatitis C infection. A further test known as a PCR (Polymerase Chain Reaction test) is required to ascertain if the virus is currently present in your blood. It measures the amount of virus in the blood and determines the genotype or strain of hepatitis C you have. Qualitative HCV RNA is reported as a positive or detected if any HCV viral RNA is found; otherwise, the report will be negative or not detected. The test may also be used after treatment to see if the virus has been eliminated from the body. Other types of HCV tests include Viral Load or Quantitative HCV tests measure how much virus there is in your blood. Viral load tests are often used before and during treatment to help determine response to treatment by comparing the amount of virus before and after treatment (usually after 3 months); successful treatment causes a decrease of 99% or more (2 logs) in viral load soon after starting treatment (as early as 4-12 weeks), and usually leads to viral load being not detected. Viral genotyping is also used to determine the kind, or genotype, of the virus present. There are six major types of HCV; the most common (genotype 1) is less likely to respond to treatment than genotypes 2 or 3 and usually requires longer therapy (48 weeks, versus 24 weeks for genotype 2 or 3). Genotyping is often ordered before treatment is started to give an idea of the likelihood of success and how long treatment may be needed.

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HFNZ

Haemophilia Foundation of New Zealand Inc. Formerly known as the New Zealand Haemophilia Society, HFNZ aims include support for people with haemophilia and related bleeding disorders and their families/whanau; the education of families, health professionals and other key stakeholders in all aspects of the disease; monitor treatment and rehabilitation guidelines for a high standard of treatment of haemophilia and related bleeding disorders throughout New Zealand; to represent haemophilia at a government level and to be a responsible member of the global haemophilia community. A national organisation with a head office in Christchurch, HFNZ is dedicated to improving the lives of people with haemophilia and related bleeding disorders. For more information see: www.haemophilia.org.nz/ See also NZHS

INHIBITORS

An inhibitor is an antibody produced by the body's immune system that identifies factor concentrate as a foreign substance and attempts to attack and neutralise the factor concentrate, thereby making the factor ineffective or less effective in stopping bleeding. Approximately 30% of individuals with severe haemophilia Athose with factor VIII levels less than 1% of normaldevelop inhibitors. Inhibitors are more common in people with severe haemophilia due to the need for more frequent infusions. About 3-5% of people with severe haemophilia B develop an inhibitor.

NANBH

Non-A non-B hepatitis (hepatitis C) The most common cause of post-transfusion hepatitis in patients who receive blood or blood products, all cases of hepatitis C (HCV) were referred to as "nonA, non-B hepatitis" when it was shown that there were not caused by hepatitis A or hepatitis B viruses. The virus was first characterised in 1989 and renamed hepatitis C. See also HCV

NON-MALEFICENCE

A Latin phrase that means "First, do no harm". Another way to state it is that "given an existing problem, it may be better not to do something, or even to do nothing, than to risk causing more harm than good." It reminds the physician and other health care providers that they must consider the possible harm that any intervention might do. It is invoked when debating the use of an intervention that carries an obvious risk of harm but a less certain chance of benefit.

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NZHS

New Zealand Haemophilia Society NZHS was established in 1958 to serve the needs of people with haemophilia and other related bleeding disorders. The organisation was reorganised and renamed the Haemophilia Foundation of New Zealand Inc in 1998. See also HFNZ

PCR

Polymerase chain reaction PCR is a technique which is used to amplify the number of copies of a specific region of DNA or RNA for viruses, in order to produce enough genetic material to be adequately tested. A qualitative RNA test, such as a PCR test, will report whether the hepatitis C virus is present in the bloodstream or not. The result is reported as either "detected" or "not detected." If the PCR is positive (detected), then it is confirmed that the patient has chronic hepatitis C. The PCR test will be negative if a person has cleared the hepatitis C virus, whether on their own (spontaneously) or after successful treatment. See also HCV Testing

PLASMA

The yellow protein component of blood. Plasma is the fluid portion of blood and comprises approximately 50% of the total volume of blood. It contains the clotting factors essential for treating haemophilia as well as platelets, glucose, proteins, amino acids, other nutritive materials, excretory products, hormones, enzymes, vitamins, and minerals.

PLASMA-BASED
FACTOR CONCENTRATES

See Fractionated blood products

PROPHYLAXIS

Protection or prevention of disease. In haemophilia, prophylaxis can be defined as the regular administration of clotting factor concentrate in anticipation of or to prevent bleeding. Prophylaxis is now considered the gold standard for the treatment of severe haemophilia in childhood and adolescence. Its use in adults is more controversial and usually limited to short periods of time. Historically adequate supply of replacement products hindered the use of prophylaxis and its regular use was only made possible after the introduction of recombinant factor replacement.

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RECOMBINANT
CLOTTING PRODUCTS

Recombinant, or genetically engineered, factor VIII and IX are not made from human plasma. They are made by isolating the human factor VIII (or IX) gene through genetic engineering and inserting the gene into non-human cells, such as baby hamster kidney cells or Chinese hamster ovary cells. As these cells are grown in a cell culture they produce factor VIII (or IX). The recombinant era for haemophilia began in the early 1980s with the cloning and subsequent expression of functional proteins for both factors VIII and IX. Since their transition into the clinic, the recombinant versions of both factor VIII and IX have proven to be remarkable facsimiles of their plasma-derived counterparts. The broad adoption of recombinant therapy throughout the developed world has significantly increased the supply of clotting factor concentrates and helped advance aggressive therapeutic interventions such as prophylaxis. Recombinant DNA technology remains the platform to address ongoing challenges in haemophilia care such as reducing the costs of therapy, increasing the availability to the developing world, and improving the functional properties of these proteins. In turn, the ongoing development of new recombinant clotting factor concentrates is providing alternatives for patients with other inherited bleeding disorders.

SUPER-HEAT
TREATMENT

A viral inactivation method for plasma-derived concentrates. Heat treatment of factor concentrates began with dry-heated at 60C for 72 hours. As this method was not sufficient to inactivate HCV, super-heat treatment, heat treatment to 80C for 72 hours was developed. See also Heat Treatment

SURROGATE TESTING

Surrogate testing does not involve direct testing for the disease itself but testing for other markers capable of pointing to the likely presence of a virus. The Next Virus A light-hearted term used cynically in haemophilia circles to imply the next disaster that will affect the community.

TNV

VCJD

variant Creutzfeld-Jakob disease. A rare and fatal human neurodegenerative condition caused by the consumption of food of bovine origin contaminated with the agent of Bovine Spongiform Encephalopathy (BSE), a disease of cattle, has been strongly linked to the occurrence of vCJD in humans. This disease resulted in a world wide effort to prevent BSE from entering the world wide blood supply.

WFH

World Federation of Hemophilia. This international organisation provides global leadership to improve and sustain care for people with inherited bleeding disorders, including hemophilia, von Willebrand disease, rare factor deficiencies, and inherited platelet disorders. See www.wfh.org for more information.

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REFERENCES
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New Zealand Society of Gastroenteroly. Hepatitis C. Retrieved from: http://www.nzsg.org.nz/cms2/research/hepatitis/hepatitis-c/. Accessed 29 March 2013. 2 Lauzon, C. Still Standing: Haemophilia Foundation of New Zealand 1958-2008. Christchurch: HFNZ. 2008. page 56. 3 Comment in 1983 by Health Minister Aussie Malcolm reported in Fractionation Plant. NZHS Newsletter. Vol.12(1); March 1984. 4 HIV became a notifiable disease in August 1983 and the final stages of AIDS became notifiable in 1986.
5

Wheeler, J. New Zealand Womens Weekly. 12 Sept 1983. The Press Christchurch. 30 Nov 1983. Blood scare. Auckland Star. 5 Nov 1984.

Lauzon, C. Still Standing: Haemophilia Foundation of New Zealand 1958-2008. Christchurch: HFNZ. 2008. page 77
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Blood scare sparks trans-tasman hunt for haemophiliacs. Nelson Evening Mail. 5 Nov 1984. Harris, J. AIDS Time Bomb Hell. NZ Truth. 2 April 1985.

10

11

In January 1985 the U.S. Food and Drug Administration (FDA) licensed the first blood test for AIDS. The test indicated the presence of antibodies to HTLV-III/LAV.
12

Formerly the Commonwealth Serum Laboratory, an Australian government laboratory, CSL was made a state enterprise in 1991 and privatised in 1994. The arrangements for processing New Zealand plasma were put in place by exchange of letters in 1962 and formalised by letters of intent and understanding in 1987 between the Director General of Health and the Managing Director CSL.
13

Letter from CSL Bioplasma to HFNZ, 30 August 2000.

14

Lauzon C. Still Standing: Haemophilia Foundation of New Zealand 1958-2008. Christchurch: HFNZ. 2008. page 77
15 16

Five youngsters infected by AIDS. New Zealand Herald. 29 April 1986. Woodfield, D G. AIDS and blood transfusion. N Z Med J. 1986; 99(805):494-5. Rudman, B. Protecting basic human rights of AIDS victims. Auckland Sun. 18 Sept 1987. Ban male donors. Auckland Star. 20 November 1984. Chisholm, D. AIDS Fear Has Some Seeking Own Donors. Auckland Star. 6 December 1984. Chisholm, D. AIDS Fear Prompts Appeal to Dr Bassett. Auckland Star. 25 November 1985. Parker C. Epidemic on the Way. Sunday News. 25 November 1984. Dentists Cover Up as AIDS scare hits. 8 OClock. 1 December 1984. McNicholas, M. AIDS Virus Carriers Found in NZ. Auckland Star. 18 December 1984.

17 18 19

20 21 22 23

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24 25 26

Rugby Kids at Risk of AIDS. Sunday Star. 6 July 1986. Transfusion Induced AIDS Inevitable. Auckland Star. 14 July 1986. Bedbugs linked to AIDS Spread. Sunday Star. 6 July 1986. AIDS Flight Angers Crew. Auckland Star. 10 February 1984. Police Fears of Contact With Saliva. Auckland Star. December 1984.

27

28 29

US Expert: AIDS will strike thousands in NZ. News clipping in HFNZ archive from approximately April 1985; source unattributed.
30

Harris, J. AIDS Time Bomb Hell ! NZ Truth. 2 April 1985. Tests find AIDS virus in 28 haemophiliacs. New Zealand Herald. 15 Aug 1987.

31

32

Letter from NZHS Secretary to the Epidemiological Advisory Committee, Department of Health, Wellington, 6 July 1983.
33 34 35

Letter from NZHS Secretary to all members. 6 Oct 1986 Carter J, Marshall K. Review of the blood sector [Report for the Ministry of Health]. 1996. Alter HJ, Klein HG. The hazards of blood transfusion in historical perspective. Blood. 2008:112; 26172626.

36

Feinstone SM, Holland PV, Morrow AG, et al. Clinical and serological analysis of transfusion-associated hepatitis. The Lancet. 1975:306(7940); 838 841.
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Choo Q, Kuo G, Weiner A, Overby L, Bradley D, Houghton M. Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. Science. 1989:244 (4902); 35962.
38 39

Available in the Ministry of Health Library, www.moh.govt.nz

Figure based on an estimated prevalence rate of 1.2% of whole population; or 1.5% of population 15 years or older as per Australian data.
40

Chen, SL and Morgan, TR. The Natural History of Hepatitis C Virus (HCV) Infection. Int J Med Sci. 2006; 3(2): 4752.
41

News from President. NZHS Newsletter. 1992;20(4).

42

Report of the Expert Advisory Group on Hepatitis C and Plasma in 1990. Canberra: Department of Health and Ageing. 2003. p 1
43 44

Letter from Minister of Health Assoc. Katherine Regan to NZHS. 22 May 1991. Alter HJ, Klein HG. The hazards of blood transfusion in historical perspective. Blood. 2008:112; 26172626.

45

Rodger S, Morey S. Inquiry into Matters Relating to the Safety of Blood Products in New Zealand. Wellington: Department of Health. 1992.
46

Letter from Minister of Health Helen Clark to NZHS, 10 Sept 1990. Letter from NZHS to Minister of Health Helen Clark, 15 October 1990. Tasman-Jones C. Hepatitis C - a viral disease of community importance. NZ Med J. 1990: 103(897); 421-2. 79

47

48

49 50 51 52

Uptons position intolerable. Nelson Evening Mail. 26 November 1992 Letter from NZHS to Hon Simon Upton, Minister of Health, 17 June 1991. Letter from the Regional Blood Transfusion Directors to Hon Simon Upton, Minister of Health, 25 July 1991. Ibid. Letter from NZHS to Hon Simon Upton, Minister of Health, 24 March 1992

53

54

Letter from Dr D G Woodfield on behalf of Auckland Hospital to the Department of Therapeutics, Department of Health, 7 May 1992.
55

Letter from Dr Elizabeth Berry for the NZHS Medical Advisory Panel to Hon Simon Upton, Minister of Health, 31 July 1992.
56

Letter from Hon Simon Upton, Minister of Health, to Dr Elizabeth Berry, NZHS Medical Advisory Panel. 31 August 1992.
57

Letters from NZHS to Hon Simon Upton, Minister of Health, 22 April 1991, 17 June 1991, 11 July 1991, 31 January 1992, 24 March 1992, and 22 June 1992.
58

Health Hepatitis C. [audio recording, digital file]. Contr. Kim Hill, Tui Slater and Simon Upton. Sound Archive Ng Taonga Krero (SANTK). 16 July 1992. 5min 49sec. SANTK ref. 9366.
59

Letter from Hon Simon Upton, Minister of Health, to Dr Elizabeth Berry, NZ Medical Advisory Panel, 31 August 1992.
60

Dr Arvind Patel, Chief Medical Advisor for the Department of Health, speaking to the Tonight programme, 16 November 1992.
61

TVNZ Tonight programme, 16 November 1992 Upton orders inquiry on blood supply. The New Zealand Herald. 20 November 1992, page 1.

62

63 64 65 66

Blood centre director rejects Govt claims. The New Zealand Herald. 21 November 1992 Osman, B. Inquiry key to Uptons future. The New Zealand Herald. 24 November 1992, page 1. Ibid. Edwards, B. Wait for blood screening inquiry results, says Clark. Evening Post. 25 November 1992.

67

Health Hepatitis C. [audio recording, digital file]. Contr. Kim Hill, Tui Slater and Simon Upton. Sound Archive Ng Taonga Krero (SANTK). 16 July 1992. 5min 49sec. SANTK ref. 9366.
68

Shipley, J (Minister of Social Welfare). Inquiry into Safety of Blood Products. New Zealand Parliamentary Debates, 34555. 24 April 1992.
69 70

Letter from Dr J M Faed, New Zealand Blood Transfusion Service, to Department of Health, 31 May 1990.

Letter from Dr D G Woodfield, New Zealand Blood Transfusion Service, to Department of Health, 17 August 1990.
71

Dalziel, L. Blood Infection---Accident Compensation Cover. New Zealand Parliamentary debates. 26 November 1992. Retrieved from: http://www.vdig.net/hansard/archive.jsp?y=1992&m=11&d=26&o=15&p=15. Accessed 3/4/2013. 80

72

Upton, S. Hepatitis C Testing. New Zealand Parliamentary debates. 8 December 1992. Retrieved from: http://www.vdig.net/hansard/archive.jsp?y=1992&m=12&d=08&o=22&p=22. Accessed 3/4/2013.
73 74

Uptons office to be investigated. Nelson Evening Mail. 24 Nov 1992 Letter from NZHS to the Prime Minister, 24 November 1992. This finding varies from a letter from the Ministry of Health to HFNZ on 3 February 2005 which quoted

75

batches of the newly formulated factor VIII concentrate AHF, manufactured from New Zealand plasma screened and tested for HCV and super-heat treated to 80C for 72 hours became available for use in New Zealand at the earlier date of 1991.
76

Bad blood inquiry shares blame Nelson Mail. 18 December 1992. Appalling failure in blood system. The New Zealand Herald. 19 December 1992.

77

78

Inquiry into matters relating to the safety of blood products in New Zealand. Wellington: Department of Health. 1992. pp7
79

Angelotta C, McKoy JM, Fisher MJ, et al. Legal, nancial, and public health consequences of transfusion transmitted hepatitis C virus in persons with haemophilia. Vox Sang. 2007; 93: 159165.
80

Inquiry into matters relating to the safety of blood products in New Zealand. Wellington: Department of Health. 1992. pp 2.
81

Letter from the Ministry of Health to HFNZ, 3 February 2005. Dr Terrance Snape of Blood Products Laboratory (BPL) in Government of Ireland. Report of the tribunal of

82

inquiry into the infection with HIV and hepatitis c of persons with haemophilia and related matters. Dublin: Stationery

Office. 2002. pp.72


83

NZ Blood Transfusion Service statistics 1989/90 show an 11% reduction in donated units as well as an increase in unusable units giving an overall 15% reduction in units available for producing blood products.
84

Bullen, C. Hepatitis C lookback programme highlights the value of blood donor screening. The New Zealand Public Health Report. 1997;4(10): 73-75.
85

Delays in Hepatitis C Trace Will Cost Lives. The New Zealand Herald. 8 June 1994.

86

Krever H. Final report: Commission of Inquiry on the Blood System in Canada. Ottawa: The Commission. 1997.
87

Senate Community Affairs References Committee Secretariat. Hepatitis C and the Blood Supply in Australia. Canberra: Commonwealth of Australia. 2004.
88 89

Ibid.

Krever H. Final report: Commission of Inquiry on the Blood System in Canada. Ottawa: The Commission. 1997.pp 371-372.
90

Why Did U.S. FDA Approve Sale of Prison Blood?. . . And Why Did Canada Buy It? Health Freedom Watch. 1999: 19 April. Retrieved from: http://www.forhealthfreedom.org/Publications/Monopoly/HighRiskBlood.html on 4 April 2013.
91

Incarceration has been identified in several studies as a risk factor for transmission of HCV (Kemp R, Miller 81

JSL & Baker M. Injecting behaviours and prevalence of hepatitis B, C, and D markers in New Zealand injecting drug user populations. NZ Med J, 1998;111: 50-53. ; Miller E, Hellard M, Bowden S, et al. Markers and risk factors for HCV, HBV and HIV in a network of injecting drug users in Melbourne, Australia. J Infect. 2009; 58: 375-382.; Patrick D, Tyndall M, Cornelisse P, et al. Incidence of hepatitis C virus infection among injection drug users during an outbreak of HIV infection. CMAJ. 2001;165(5): 889-895.) 92 Brunton, C. "The outbreak that wasn't". Hepatitis C in a New Zealand prison . Paper presented at the Australiasian Corrections Health Conference. Pakatoa. 1994. Note: This 1991 study of 273 prisoners in Paparoa showed 23% tested positive for HCV antibodies. The only New Zealand study attempting to measure prevalence in a general population sample in 1996 found the prevalence of HCV in their population sample (0. 3%) was similar to that found in blood donors during similar years (Chapman B, Burt M, Frampton C, et al. The prevalence of viral hepatitis (HAV, HBV & HCV) in the Christchurch community. NZ Med J. 2000;113: 394-396.). Modelling estimates have suggested a seroprevalence of 1% in the adult population in 2000 (Nesdale A, Baker M, Gane E, et al. Hepatitis C infection in New Zealand: estimating the current and future prevalence and impact . Wellington: Institute of Environmental Science and Research, Kenepuru Science Centre. 2000.).
93

NZ slow to stop inmate blood collection. The Press, Christchurch. 24 April 2004.

94

Harper P, Brasser M, Moore L, Teague L, Pitcher L, Ockelford P. The challenge arising from the cost of haemophilia care: an audit of haemophilia treatment at Auckland Hospital. N Z Med J. 2003; 116(1180): U561.
95

Brettler DB, Alter HJ, Dienstag JL, Forsberg AD and Levine PH. Prevalence of Hepatitis C Virus Antibody in a Cohort of Hemophilia Patients. Blood. 1990: 76: 254-256.
96

Yee TT, Griyoen A, Sabin AC, Dusheiko G, Lee C. The natural history of HCV in a cohort of haemophilic patients infected between 1961 and 1985. Gut. 2000; 47:845851.
97

Harper P, Brasser M, Moore L, Teague L, Pitcher L, Ockelford P. The challenge arising from the cost of haemophilia care: an audit of haemophilia treatment at Auckland Hospital. N Z Med J. 2003; 116(1180): U561.
98

Kitson M, Roberts S, Kemp W, Iser D, Walsh M, McCarthy P, Street A, Tran H . The prevalence of significant liver fibrosis and cirrhosis in haemophilia patients infected with hepatitis C using fibroscan. Haemophilia. 2010;17(2):316-317.
99

Bullen, C. Hepatitis C lookback programme highlights the value of blood donor screening. The New Zealand Public Health Report. 1997;4(10): 73-75.
100

Saracco G, Rizzetto M. The long-term efficacy of interferon alfa in chronic hepatitis C patients: a critical review. J Gastroenterol Hepatol. 1995;10(6):668-73.
101

Lauzon, C. Still Standing: Haemophilia Foundation of New Zealand 1958-2008. Christchurch: HFNZ. 2008. page 135.
102 103

Letter from HFNZ to Ministry of Health, 11 January 2004.

Booth JC, Brown JL, and Thomas HC. The management of chronic hepatitis C virus infection. Gut. 1995; 37(4): 449454.
104

New drug in war on hepatitis C. The Press. 22 May 2004.

105

Zylberberg H, Thiers V, Lagorce D, et al. Epidemiological and virological analysis of couples infected with hepatitis C virus. Gut. 1999; 45(1): 112-116. 82

106

Ross, J. Haemophilia and Hepatitis C: The Case for Financial Assistance . Melbourne: Haemophilia Foundation of Australia. 1999
107 108

Letter from NZHS to Hon William Birch, Minister responsible for ACC, 4 April 1993. Letter from Hon William Birch, Minister responsible for ACC to NZHS, 30 April 1993. No Lump Sum for Hep C. Evening Post. 13 Jun 1994. Letter from Hon W F Birch, Minister for ACC, to NZHS, 9 October 1992 Letter from ACC to an individual with haemophilia and HCV, September 1993. Letter from lawyers hired by NZHS to assist claimant members, 21 April 1995.

109 110 111 112

113

Commission of Inquiry into the collapse of a viewing platform at Cave Creek near Panukaki on the West Coast. Wellington: Department of Internal Affairs. 1995.
114

Letters from the class action legal team to claimants: Letter to all Hepatitis C claimants dated 15 July 1998 and Hepatitis C compensation dated 11 August 1998.
115 116 117 118 119

Letter Annette King Opposition Health Spokesperson to Steve Waring 20 August 1999. Crimes Act 1961 s 145(1) Uptons position intolerable. The New Zealand Herald. 27 November 1992. Baker, S. Conflict over course of treatment for Hep C. New Zealand Doctor. 9 June 1994. p.18 See Daly, R. A Case of Bad Blood. Dublin: Poolberg Press Ltd. 2003.

120

World Federation of Hemophilia. WFH Resolution on Hepatitis C Virus Compensation. Retrieved from: http://www.wfh.org/en/page.aspx?pid=1408. Accessed 7 April 2013.
121

Bad blood keeps on killing. Dominion Post. 17 April 2004. Bad Blood. The Press, Christchurch. 17 April 2004. Martin, Y. NZ slow to stop inmate blood collection. The Press, Christchurch. 24 April 2004. Martin, Y. Haemophiliacs call for Inquiry into bad blood. The Press, Christchurch. 12 May 2004. Martin, Y. US exported high-risk blood products to NZ. The Press, Christchurch. 8 May 2004. A small number, a large injustice. The Nelson Mail. 19 April 2005. Bill may keep govt file secret forever, says former archivist. The Press, Christchurch. 11 March 2005. Director General of Health to President, HFNZ, 29 April 2005. Director General of Health to President, HFNZ, 26 May 2005.

122

123

124

125

126

127

128 129

130

Ministry of Health. A Factual Response by the Ministry of Health & ACC to the Submission of 19 April 2005 by Haemophilia Foundation of New Zealand. 26 May 2005.
131 132

Letter from Annette King, Opposition Health Spokesperson, to Steve Waring. 20 August 1999. Govt recognises dilemma of haemophiliacs. The Press, Christchurch. 17 April 2006. 83

133

Hodgson, P. Way ahead on Hepatitis C blood product infection. 5 December 2006. Available at www.beehive.govt.nz/release/way-ahead-hep-c-blood-product-infections. Retrieved 6/07/2012.
134

Health Hepatitis C. [audio recording, digital file]. Contr. Kim Hill, Tui Slater and Simon Upton. Sound Archive Ng Taonga Krero (SANTK). 16 July 1992. 5min 49sec. SANTK ref. 9366.
135

Letter from class action legal team to claimant member of HFNZ. 26 March 2007. Carter J, Marshall K. Review of the blood sector [Report for the Ministry of Health]. 1996.

136

137

New Zealand Blood Service. Transfusion Medicine Handbook 2008. Auckland: New Zealand Blood Service. 2008. Available at:http://www.nzblood.co.nz/Clinical-information/Transfusionmedicine/Transfusion%20medicine%20handbook
138

Controller and Auditor General. New Zealand Blood Service: Managing the Safety and Supply of Blood Products. Wellington: Office of the Auditor-General. 2012.
139

Controller and Auditor General. Ibid.

140

Lauzon, C. Like a curse: Outcomes of the New Zealand 2011 people with hemophilia and hepatitis C survey. Abstract PO-MO-106. Haemophilia. 2012; 18 (Suppl. 3): 83.

84

ISBN 978-0-473-26002-6

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