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CHAPTER 2 - BACKGROUND
2.1 The following is a brief summary of the operation of the Australian Human Pituitary Hormone Program (AHPHP) and its impact on the lives of recipients and their families, the Inquiry into the Use of Pituitary Derived Hormones in Australia and Creutzfeldt-Jakob Disease (known as the Allars Inquiry) and the developments since the Allars Inquiry reported. The information contained in the summary of the AHPHP is drawn mainly from the report of the Allars Inquiry.[1] Comment and criticism of the AHPHP relating to the protection of public health and safety is discussed in Chapter 7
2.2 Individual medical practitioners began to collect human pituitary glands as early as 1959. During the 1960s processing of hormones took place at CSIRO and in research centres in hospitals and universities in Sydney, Melbourne, Adelaide and Brisbane. The hormone produced by these researchers was used in the treatment of patients.
2.3 In 1962, researchers in Melbourne commenced a human pituitary-derived hormone program. Members of the VPG arranged collection of glands by pathologists at the hospitals at which they were based.
2.4 In 1963 steps were taken to establish a national authority to collect glands and distribute them and for the Commonwealth Serum Laboratories (CSL) to participate in the preparation of hormones. Following discussion with the Director General of Health, a meeting of representatives of the Health Department, CSIRO, CSL, the Endocrine Society of Australia, Australian Medical Association, Royal College of Physicians, and Royal College of Obstetricians and Gynaecologists was held in February 1964 to plan the supervision of the collection and preparation of Human Pituitary Endocrine Preparation throughout the Commonwealth. It was agreed that this committee continue as an `unofficial' committee with no name. In 1965 it was agreed that the unofficial committee be called the Human Pituitary Advisory Committee (HPAC).[2]
2.5 The two hormones used under the Australian Human Pituitary Hormone Program were human pituitary gonadotrophin (hPG), used to treat infertility, and human growth hormone (hGH). Both are obtained from the same starting material, human pituitary glands.
2.6 As a precondition to the listing of hGH as a pharmaceutical benefit, the Minister for Health required that the HPAC obtain the cooperation of State governments, public hospitals and pathologists in the collection of glands. It was not until 1967 that cooperation was received and a national program could commence.
2.7 In August 1967, cooperation of all states having been obtained, the Minister gave formal approval under s.136 of the National Health Act 1953 for the establishment of the HPAC and its subcommittees. The subcommittees were: the Follicle Stimulating Hormone (FSH) Subcommittee, the Fractionation Subcommittee and Human Growth Hormone (HGH) Subcommittee.
2.8 There was no official charter or terms of reference for HPAC. However, an article published in the Medical Journal of Australia in 1969 stated that HPAC's aims were to organise the collection of pituitary glands, the extraction and purification of the hormones and their distribution. HPAC was also responsible for collecting and collating data obtained regarding the treatment of dwarfism and infertility.[3]
2.9 On formal establishment in 1967, the HGH Subcommittee's broad terms of reference were that `hGH should be made available for the treatment of children who are dwarfed due to a demonstrated lack of pituitary growth hormone'.[4] Its functions were to advise the HPAC on:
i.
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the criteria to be used for the assessment of candidates
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ii.
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the selection of patients for therapy
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iii.
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the distribution of growth hormone stocks
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iv.
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the collation of results of hGH therapy.
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2.10 The FSH Subcommittee was established to advise on the distribution of FSH. The fertility hormone produced by CSL was not pure FSH - it also contained luteinising hormone (LH). After 1979 it was labelled as hPG and is referred to as hPG in this report. The FSH Subcommittee's official functions were to advise HPAC on:
i.
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the criteria to be used for the assessment of candidates
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ii.
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the selection of patients for therapy
|
iii.
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the distribution of stocks of FSH
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iv.
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the collation of results of therapy and trial of FSH.
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2.11 The Fractionation Subcommittee was established in 1966 by the `unofficial' HPAC with the responsibility for overseeing the collection and processing of human pituitaries and the extraction, purification and assay of the resultant hormones. Its official function approved by the Minister in 1967 was to advise HPAC on methods of extraction, fractionation and assay of hGH and hPG. A representative of CSL was a member of this Subcommittee. The Subcommittee was formally established under the National Health Act in 1968.
2.12 The Chairperson of each of the three Subcommittees was a member of HPAC and copies of the minutes of each meeting were provided to HPAC.
2.13 The last meeting of HPAC was held on 8 February 1988 and the Minister formally disbanded HPAC and its Subcommittees from 1 December 1988.
2.14 CSL had the responsibility for the collection of glands from hospitals and morgues and for processing them to produce the final hormone product in ampoules. The hormones were manufactured for distribution in accordance with the approvals given by the FSH Subcommittee and the HGH Subcommittee to applications made by treating medical practitioners with respect to particular patients.
2.15 Initially, the VPG arranged collection of glands by making approaches to individual pathologists. Later the VPG offered an incentive fee of two shillings per gland to mortuary attendants who collected glands. Clinicians in other States and overseas requesting pituitary-derived hormones extracted by members of the VPG collected glands from the institutions in which they worked and sent them to Melbourne.[5] Approximately 9,000 glands were collected for processing by members of the VPG.[6]
2.16 In 1965 the `unofficial' HPAC committee attempted to organise collection of glands on a national basis and wrote to State health departments. South Australia and Queensland agreed to collect glands, with Victoria, NSW, Western Australia and Tasmania questioning the legality of the collection. These States agreed to participate in the AHPHP once the legal problems were overcome.[7]
2.17 The VPG collected glands from post-mortem examinations carried out at hospitals in Sydney, Melbourne, Adelaide, Perth and Brisbane. From 1964 to 1967 glands were collected from New Zealand, processed in Melbourne and returned to New Zealand with 25 per cent being retained by the processing doctor. The same doctor also processed glands from Nova Scotia and Singapore.[8]
2.18 Between 1965 and 1985, over 170,000 glands were collected by CSL. Glands were collected by pathologists or mortuary attendants from post-mortem examinations carried out in public hospitals throughout Australia except the Northern Territory.
2.19 Allars reported that CSL also obtained some glands from New Zealand, Mauritius and possibly Papua New Guinea.[9] Between 1976 and 1978, 4,518 glands were collected from New Zealand and processed by CSL, some with glands from Australian sources. In 1972, glands from Mauritius were processed with a batch of Australian glands for the treatment of a child in Mauritius. 200 ampoules of hGH were returned to Mauritius. In 1973 further glands were received from Mauritius. Allars reported that `it seems that these glands were processed with glands collected in Australia, although there is no direct evidence of what happened to them once they were received by CSL'.[10]
2.20 Allars also reported that a letter from the pathologist at Port Moresby General Hospital to CSL in 1966 indicated that glands from PNG had been sent to CSL. However, the Inquiry found no record in the CSL files of receipt of pituitaries from PNG.[11] Proposals to use glands from Hong Kong, Malaysia, India and Singapore did not proceed due to commercial and quarantine reasons.[12]
2.21 The VPG did not have any specific guidelines for the selection of pituitaries from cadavers although Allars was told that persons who had died from infectious diseases were excluded.[13]
2.22 Initially, no advice on exclusion of glands was given by the `unofficial' HPAC or CSL. In 1966, in response to a query from a medical administrator in Queensland, CSL recommended that glands be not collected from persons who died with:
i.
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known virus infections, particularly viral hepatitis; |
ii.
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disseminated malignant disease; |
iii.
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disseminated infections such as septicaemia or pyaemia |
iv.
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obvious pathology of the pituitary gland. |
2.23 The Allars Inquiry reported that in 1970 it was found that some hospitals did not comply with the exclusion criteria. It was reported that one member of the HGH Subcommittee queried the low rate of gland collection of by a Repatriation General Hospital in South Australia and was told by the CSL representative that this was due to restrictions on collection. The Subcommittee member reported that he:
was unaware of any restrictions upon the type of gland that could be collected. As far as he knew at the Royal Adelaide Hospital where he worked, pituitary glands were removed from all autopsies, irrespective of the cause of death or any associated diseases.[14]
Allars reported that the Subcommittee member was subsequently provided with a copy of the exclusion criteria. 2.24 The member then replied that upon checking with the Queen Elizabeth Hospital and the Royal Adelaide Hospital, he found that the exclusion categories were `not taken into consideration at all' with the exception of obvious pathology of the pituitary glands. Further, he stated that the matter had been discussed at a recent HGH Subcommittee meeting and `that the opinion was expressed by other members that these categories should not necessarily exclude glands from being processed'.[15]
2.25 At its next meeting in June 1970, HPAC reviewed the exclusion criteria and affirmed the 1966 exclusion criteria. The Director General of Health wrote to the Chief Director (Medical Services), Repatriation Department, requesting that pathologists concerned with the collection of pituitary glands be made aware of HPAC's recommendation.[16]
2.26 In 1971, the HPAC representative of the College of Pathologists, Dr McGovern, raised the issue of the danger of unconventional slow viral infection of collected pituitary glands. In response, HPAC wrote to the College of Pathologists seeking advice. The College provided the opinion of two members of its Special Virology Committee which stated that:
We both agree with the opinion given by Dr McGovern. There is good evidence that Kuru and certain diseases of sheep rarely transmissible to man caused by their small virus-like agents which are unusually resistant to heat, formalin and ultra violet light. It is also possible that all commonly demyelinating diseases such as multiple sclerosis come into the same category. It is our opinion that pituitary glands should not be collected from patients who have died from demyelinating or chronic neurological diseases of the central nervous system.[17]
2.27 In response to this opinion, the exclusion criteria were then amended to:
i.
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active viral hepatitis;
|
ii.
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neurological diseases of the central nervous system due,
or possibly due to viral infection;
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iii.
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obvious pathology of the pituitary gland.
|
Dr McGovern arranged for the revised criteria to be published in the Newsletter of the College of Pathologists of Australia. 2.28 In July 1977, following discussion in the Fractionation Subcommittee about how to increase the yield of hormone in the extraction process, CSL redrafted the instructions for collection of glands. The draft instructions listed the following exclusion criteria:
i.
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diseases of the pituitary gland;
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ii.
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infectious or serum hepatitis;
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iii.
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acute septicaemia.
|
2.29 The Allars Inquiry reported that no explanation was given in the minutes of the Subcommittee for the omission of `neurological diseases' from the exclusion criteria and interviews by the inquiry `failed to shed any light on the omission'.[18] The new instructions were endorsed by the Subcommittee and submitted to HPAC for approval.
2.30 In May 1980 the Fractionation Subcommittee and HPAC discussed the possibility of contamination by slow virus. A paper by Gajdusek entitled `Precautions in Medical Care of, and in Handling Materials from, Patients with Transmissible Viral Dementia (Creutzfeldt-Jakob Disease)'[19] was noted at a meeting of the Subcommittee in November 1982. The minutes of that meeting also noted that 500 glands had been destroyed after collection in NSW following an autopsy report indicating the possibility of CJD in a patient.[20]
2.31 In December 1982, the collection instructions were redrafted to provide that glands were not collected from persons `suffering from the following causes':
i.
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diseases of the pituitary gland;
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ii.
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infectious or serum hepatitis;
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iii.
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acute septicaemia;
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iv.
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presenile dementia (Creutzfeldt-Jakob disease).
|
2.32 These instructions were approved by HPAC on 1 June 1983. In 1984, HPAC first considered the implication of HIV for the collection of glands. The collection instructions were again redrafted by CSL and those finalised in May 1985 excluded the collection of glands from people with a history of:
i.
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diseases of the pituitary gland;
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ii.
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infectious or serum hepatitis;
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iii.
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acute septicaemia;
|
iv.
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acquired immune deficiency syndrome (AIDS);
|
v.
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dementia of any type.
|
For the first time, a brief explanation under each exclusion criteria of the reasons for exclusion of glands was also given.[21] 2.33 The Allars Inquiry concluded that amendments to the exclusion criteria `were drafted in a reactive fashion' as problems of possible sources of infection became known. HPAC, with the exception of one occasion, `took no steps to ensure that it was abreast of current scientific knowledge of disease potentially affecting human pituitaries'. HPAC also did not seek advice and thus `its responses to new developments in medical and scientific knowledge were always in danger of being delayed'. Allars pointed out that there were delays in HPAC's consideration of amendments to cover HIV/AIDS and that its insertion of `presenile dementia (Creutzfeldt-Jakob Disease)' was an `unacceptably belated response' to papers published on this matter. Further, the approval by HPAC of the 1977 Collection Instructions without noticing the change in the exclusion criteria `demonstrated the lack of interest by members of HPAC in the subject'.[22] The Committee has noted that even members of the HGH Subcommittee appear not to have known that there were restrictions of the collection of pituitary glands (see paragraph 2.23). This raises further questions about the commitment of the members of HPAC and the Subcommittees to ensuring that only suitable pituitary glands were collected.
2.34 In relation to the dissemination of the exclusion criteria, the Allars Inquiry found that no one institution or individual had responsibility for ensuring that pathologists and mortuary attendants were made aware of the exclusion criteria. Further, `the multiple methods of communication upon which HPAC relied were doomed to result in a fragmented, incomplete and unsustained pattern of communication with pathologists'.[23] It also reported that most of the pathologists and mortuary attendants contacted by the Inquiry `were unaware of any written guidelines distributed by CSL or HPAC'. Criteria for collection were `verbal and self-imposed' by pathologists.[24]
2.35 Allars noted that screening of the glands in order to ensure compliance with the exclusion criteria could only be done by the pathologist when the gland was removed from the cadaver. CSL or HPAC had no means to ensure that glands that were excluded were not collected, particularly where the glands were removed by mortuary attendants without supervision, `as was the usual case'. The Allars Report also noted:
The possibility that glands infected with viruses and bacteria may have been pooled with others and passed through the extraction process meant that the ability of that process to eliminate viruses and bacteria was essential to the production of hormones with the least amount of contamination possible.[25]
2.36 The pituitary gland is found beneath the base of the brain. The Allars Report noted that:
- the gland was in most cases removed by the mortuary attendant or pathology technician assisting the pathologist in the post-mortem examination, although in some cases only the pathologist removed the gland;
- supervision of attendants ranged from no supervision to full supervision by the pathologist conducting the examination;
- glands were not removed by sterile technique, nor was the post-mortem room a sterile environment; and
- in most institutions no specific procedures were in place in relation to the sterilisation of instruments (although they were cleaned with chemical cleaning agents) or the handling of tissue.[26]
2.37 CSL paid mortuary attendants for removal of glands (initially 20 cents, then increased to 30 cents and finally 50 cents).[27]
2.38 Until 1977 no instructions were provided as to the procedure for removing the pituitary gland. Following concern that CSL's estimates of hormone yield was misleading because of other matter included with the gland, protocols were drafted for the collection of the glands.[28]
2.39 Initially, CSL instructed that the glands be removed as soon as possible after death. In 1971, an internal memo noted that there was `no accurate information available as to the maximum time allowable between death and the collection of the gland' and continued that `unless the body is badly decomposed it is never too late to take the gland'.[29] From 1977 the Collection Instructions stated that glands should be removed `preferably within 24 hours'.[30] Once removed, glands were to be stored frozen in individual vials.
2.40 The Allars Inquiry also investigated the law relating to the removal of pituitaries.[31] In the 1960s and 1970s the lawfulness of collecting the glands relied on the common law or early human tissue legislation applying in some States. In Queensland the removal of pituitaries for therapeutic purposes was illegal. Where the common law applied, authorisation of the deceased persons estate should have been obtained. Due to the absence of hospital records, the Allars Inquiry was unable to reach a firm conclusion as to whether the bulk of the collection occurred lawfully or unlawfully.
2.41 With the enactment of uniform human tissue legislation, consent by a coroner, hospital authority or senior next-of-kin to a post-mortem is sufficient authority for use `for therapeutic purposes, medical purposes or scientific purposes' of tissue removed `for the purposes of the post-mortem examination'. The Allars Inquiry concluded that glands were generally not removed for the purpose of post-mortem, but for the purpose of supply to CSL. Thus the use of the glands collected during the period of the human tissue legislation was unlawful.[32]
2.42 The Committee notes that the issue of the unlawful removal of pituitary glands was not acted upon by the Health Department during the life of the AHPHP. The Health Department had oversight of the AHPHP and Departmental representatives were members of HPAC. The Committee considers that action should have been taken by the Department in relation to the unlawful collection of glands. This matter is discussed further in Chapter 7.
2.43 The VPG processed glands collected and stored in acetone. A combination of methods, which became known as the `Brown/Catt' method was used. Hormones were processed by the VPG for some time after the establishment of HPAC and the AHPHP.[33]
2.44 For a number of years HPAC used both the Brown/Catt method and Ferguson method for the purpose of comparison. CSL did not produce the batches using the Brown/Catt method. These were produced by the VPG and sent to CSL for sterilisation, ampouling and distribution. From 1972 to 1984, the Ferguson method was used. From 1984 to 1985 the Chapman method of extraction was used.[34]
2.45 Allars reported that CSL processed its first batch of glands on 17 January 1966 using 273 glands and `the first four batches were conducted as experimental fractionations'. The first production batch was batch 006, using 1,350 glands. From 1966 to 1970, CSL processed five batches. From 1970, CSL processed approximately one batch of 1,350 glands every one to two months.[35]
2.46 Based on available figures, 171,091 glands were collected from Australia, 4,518 from New Zealand and at least 15 from Mauritius for processing. CSL conducted 128 extraction runs from 1966 to 1985; four runs were conducted by Brown and Catt using glands collected by CSL; 12 runs were conducted using the Chapman method.[36] Two batches were imported and formulated at CSL. One batch of hGH was imported from New Zealand with the gland source being New Zealand and batches of hGH and hPG were imported from the USA with the gland source being Australia.[37] The batch of hPG imported from the USA was not distributed because it was highly pyrogenic.[38]
2.47 The processing of the glands was in two stages: preparation of the crude extract, and separation of the hormone.
2.48 To prepare the crude extract, glands were first homogenised and then centrifuged in a buffer. Some steps were taken to purify the extract at this stage.
2.49 Separation of the hormone undertaken by the Ferguson method used chromatographic techniques. This technique relied on the different size of virus, bacteria and hormone molecules for separation through a column of gel. The Allars Report stated that CSL adopted the Ferguson method because:
- frozen glands were used and this produced a relatively good yield of hGH and hPG;
- the chromatographic gel beads were more easily recovered for subsequent use, making the method more reproducible;
- as it utilised molecular weight to separate substances, it excluded high molecular weight materials, such as viruses and other particle matter;
- it was also considered that the acetone used in other methods to store glands, destroyed the hormone to be isolated; and
- it produced less aggregated forms of hGH than that produced by the Brown/Catt method.[39]
2.50 The VPG relied on alcohol and acetone during the extraction process to destroy viruses and bacteria. Hormones produced were also sterilised. The potency of the product was tested by bioassay in mice.[40]
2.51 Allars reported that at CSL, glands were not screened for disease when received as any test on the gland would require them to be manipulated thus making them unavailable for processing. In the late 1970s CSL did investigate the quality of the glands received after concerns were expressed about yield figures. It was found that 12 to 15 per cent of tissue collected was extraneous material. From July 1982, CSL carried out some screening of glands with the operators removing the glands from vials, viewing the glands and rejecting those not suitable.[41]
2.52 The Allars Inquiry reported that CSL products were manufactured according to the Code of Good Manufacturing Practice.[42] CSL's application of the Code to its manufacturing process is considered in Chapter 7.
2.53 The potency of each batch of hPG and hGH was tested using biological assay. Radioimmunoassay was also used as a measure of the amount of hPG and hGH present in any batch processed by CSL. From 1983 radioimmunoassay was used exclusively for determining potency of hGH because of problems at CSL with the standard bioassay procedure.[43] Concerns about the effectiveness of CSL's assays are discussed in Chapter 7.
2.54 Contamination of a batch of hormone could arise in two ways: first, the hormone could contain other hormones naturally present in the pituitary gland; and second, the product could be contaminated by pyrogens, bacteria and viruses such as hepatitis. CSL sought to remove the contaminating hormones in the gel filtration step of the processing procedure which separated the higher molecular weight substances, such as bacteria and viruses, from the lower molecular weight hPG and hGH and by the final filtration step in the purification process. However, it was not completely successful in removing contaminating hormone and the hPG distributed by CSL was not pure follicle stimulating hormone as it contained some LH. The Allars Inquiry reported, `in the case of hormones for clinical use, absolute purity was less important than maximum yield, even if impurities remained in the preparation'.[44]
2.55 The Allars Inquiry reported that in relation to the removal of contamination by bacteria and viruses `during the period CSL processed glands, a sterile extraction procedure was not used, and no special precautions were taken to avoid contamination'.[45] To remove contamination of bacterial and viral matter CSL relied on a number of methods during the extraction process: antibacterial substances were used at a number of stages in the processing; the gel filtration process separated higher molecular weight substances, such as bacteria and viruses, from the lower molecular weight hPG and hGH; and a final filtration of the hormones through a millepore filter. Allars also reported that `during the period CSL processed glands, no process was known which could be applied to the products to destroy viruses without destroying the hormone itself. Because of the problems with pyrogens in the early to mid-1980s, from extraction run 130, more stringent measures were introduced during processing to avoid contamination'.[46]
2.56 In late 1978 CSL commenced screening for the presence of the hepatitis antigen (HbS). The test used, radioimmunoassay, showed whether the hepatitis B antigen was present, but did not necessarily indicate whether the virus causing the hepatitis was present. Also, it did not show whether the hepatitis A or C antigens were present. Allars reported `in any case, at the time, there were no established techniques which would safely inactivate the virus without destroying the hormone itself'.[47]
2.57 In late 1984 CSL considered the problem of HIV/AIDS contamination but it was considered that many of the steps in the newly adopted Chapman method would inactivate the virus. However, AIDS was added to the list of exclusion criteria for gland collection.[48]
2.58 CSL carried out a number of quality control tests on the extracted hormones: sterility testing; pyrogen testing; abnormal toxicity testing; solubility testing; pH testing; identity testing; water content testing; and, absorbency testing and accuracy of fill and uniformity of fill testing. Products which failed any quality control tests were generally precluded from issue, although sometimes batches could be reprocessed with the approval of the Chief of Quality Assurance.[49]
2.59 The Committee received evidence that raised concerns about the quality and quantity of quality control tests conducted by CSL on the hormone products it manufactured. The matter is discussed further in Chapter 7 of this report.
2.60 From 1966, compliance with a specific or general standard was legally required for goods for therapeutic use which were supplied as pharmaceutical benefits. However, the National Biological Standards Laboratory (NBSL) did not test pituitary hormones produced by CSL for standards compliance. Allars reported three reasons for this failure: absence of an official standard, difficulty in developing a standard until the radioimmunoassay technique had been further developed and poor communication and coordination within NBSL.[50]
2.61 In 1979, NBSL made some recommendations regarding labelling of the product and in 1984 there was closer contact with HPAC after serious production difficulties at CSL. The Allars Inquiry found that NBSL should have attempted to take steps to address the practical difficulties associated with compliance with the legal requirement and should have renewed the issue of a standard with HPAC when the initial difficulties the development of a standard were, at a later stage, apparently removed. The role of NBSL is discussed further in Chapter 7. In particular the Committee highlights the failure to ensure that the usual steps in relation to the listing of a pharmaceutical benefit were followed in the case of hPG and hGH.
2.62 The Allars Inquiry also reported on the failure to test the product for viral contamination. Allars noted that in 1966 the Assistant-Director General of Health sought advice from NBSL in relation to the hormones. No advice was received and the Assistant-Director took no steps to press for `a written detailed assessment of the matter'. Allars also reported that while there was no formal request from the Pharmaceutical Advisory Committee to test the product, it was known in NBSL that the hormones were to be listed. Allars stated:
In the case of the pituitary hormones, prior to listing of the product, the Assistant Director-General [of Health] made a particular request for involvement by NBSL. This is another indication of how the pituitary hormone product was dealt with in a manner inconsistent with the normal course of listing and testing of a pharmaceutical benefit. NBSL failed to respond with advice. The Director-General failed to insist that the advice be provided prior to making the recommendation to the Minister that the hormones be listed.[51]
2.63 The Committee received evidence from former officers of that organisation about the role of NBSL in relation to the production of hormones and advice given to CSL. This matter is discussed further in Chapter 7.
2.64 Allars found that although the PBAC made recommendations in 1964 and 1967 for the listing of the hormones, it appears that the Committee's role was largely circumvented by direct negotiations between the Minister, the Director-General of Health and HPAC. The Guidelines for approval of patients for treatment with hPG and hGH were determined by HPAC and its Subcommittees. Allars also reported that PBAC and the Health Department did not `appear to have even "rubber-stamped" the initial Guidelines or the amendments made to the Guidelines over the years'.[52]
2.65 The hormones were listed as pharmaceutical benefits distributed in accordance with `special arrangements' under s.100 of the National Health Act 1953. In so doing, `it was sought to confer power upon HPAC and its Subcommittees to administer the AHPHP and determine the conditions for use of the drugs in accordance with the Guidelines and the expert judgment of the committee members'.[53] The Allars Inquiry found that the decision to list the hormones under s.100 involved an abuse of power and was legally invalid.[54] This is discussed further in Chapter 7.
2.66 The Health Department submitted that between 1967 and 1985, 1,976 persons approved under the AHPHP were treated with human derived pituitary hormones. 1310 women and 58 men were treated with hPG for infertility and 422 males and 186 females were treated with hGH for short stature. In addition, `150 people were known to have been treated with pituitary derived hormones in Australia as part of special projects associated with metabolic and growth problems and for IVF programs between 1972 and 1978'.[55]
2.67 The Allars Inquiry reported that the results of 153 children in the growth hormone program were published in 1979. It indicated that a group of 32 children with an `organic deficiency' of hGH grew an average of 6.25 cm per year after one year of treatment compared to 2.06 cm in the year before treatment. A group of 121 children with idiopathic deficiency of hGH grew an average of 7.24 cm per year after one year of treatment compared to 3.3 cm in the year before treatment.[56]
2.68 The Allars Inquiry also reported that in 1989 the results of 1,544 women officially treated with hPG to 1985 were published. The report indicated that 492 women withdrew from the program and details of the outcome for 196 were not recorded in the published data. There were 856 pregnancies, with details known for 711 pregnancies: 699 babies were taken home being 420 single and 279 multiple births. This report indicated that there were 108 spontaneous abortions and 92 perinatal deaths.[57]
2.69 Apart from multiple births, a risk of hPG treatment was hyperstimulation of the ovaries. The Allars Inquiry concluded from an examination of the minutes of the FSH Subcommittee that little attention was given to this problem, with the Subcommittee considering that it was a matter for individual practitioners. Allars reported statistics on the operation of AHPHP indicated that chance of hyperstimulation in a single treatment cycle was reported as 7.8 per cent. Since the average recipient had 3.8 treatment cycles, the chance of a recipient being hyperstimulated was approximately 30 per cent. It was reported that most of this hyperstimulation was minor, with 75 per cent being 0 or 1 on a grade of hyperstimulation of 0 to 6. The number of multiple births, which reflects overstimulation of ovaries, was nearly one in four.[58] The perinatal mortality rate (11 per cent) for multiple pregnancies and for all pregnancies (12.8 per cent) was much higher than in the normal population.[59]
2.70 In evidence Professor Whitworth stated:
The Human Pituitary Advisory Committee instituted a requirement that any specialist seeking to be approved by them to treat patients with hPG must have access to a laboratory to carry out the assays required. A computerised recording system was developed in the [Health] department which doctors were required to provide information to on the outcome of treatment. Certainly, hyperstimulation remains a side effect of gonadotropin treatment to this present day.[60]
2.71 The HGH Subcommittee and FSH Subcommittee established criteria to be used for the assessment of candidates for hormone treatment. The initial hGH guidelines included that the recipient be older than 7 years and be dwarfed due to demonstrated lack of pituitary growth hormones. These were amended frequently over the period of the AHPHP. The Allars Inquiry found that as a result of limits to the supply of hGH, the guidelines were strict, although there appeared to be some flexibility applied to assessing borderline cases.[61] The Allars Inquiry also found that the treatment regime for hGH was similar throughout Australia.
2.72 At the first meeting of the FSH Subcommittee, guidelines for the assessment of candidates for therapy with hPG were established. For men, the guidelines included absent gonadotrophin production and a sperm count of less than 5 million per ml; and for women, the only indication was infertility due to anovulation.[62] During the period of the program, the guidelines were amended frequently, for example from 1968 failure to respond to clomiphene citrate treatment was added to the requirements for female recipients. The Allars Inquiry investigated the treatment regimes using hPG and found that it differed from one centre to another.
2.73 The Allars Inquiry also found that for hGH patients treated at hospitals, the hospital pharmacies did not regard batch numbers as significant and did not always dispense the hormone to the recipient it was allocated to. Sometimes if hGH was in short supply, permission was granted by the Secretary of HPAC to `borrow' hormone from another patient's supplies.[63] In the case of hPG, Allars reported evidence of batch sharing amongst patients, of material from two ampoules being mixed `until a suitable level of potency was received', and of unused batches not being returned to CSL. 64 In 1973 the FSH Subcommittee resolved that out of date hormone could be used by members of the Subcommittee on patients.[65]
2.74 The Allars Inquiry found that there were instances of use of hormone in breach of the Guidelines for a variety of research projects for both hGH and hPG. hPG was approved for use in the IVF `Egg Project'[66] and for studies in malnourished Aboriginal children. The later project did not proceed. hPG was also used on patients for cervical mucous infertility outside the Guidelines. The Inquiry found that HPAC did not insist on research protocols for these projects and only from 1978 did HPAC pay attention to approval by institutional ethics committees. Allars reported `with minor exceptions, HPAC did not seek to reassure itself that the consent of the subjects of the research had been obtained in accordance with the NHMRC Statement on Human Experimentation which was in place in 1966'.[67] The Committee shares these concerns raised by the Allars Inquiry about use of hormones outside the Guidelines and the experimental nature of the treatment. This is discussed further in Chapter 7.
2.75 HPAC also regarded the supply of hormone for research as having been authorised by an Order in Council made in 1969 under s.9 of the National Health Act. The Allars Inquiry concluded that the Order in Council was made in excess of power and the research allocations of hormone were unlawful.[68]
2.76 The Allars Inquiry investigated the information provided to patients by their treating practitioner. Allars found that while a few hGH recipients were unclear about the source of the hGH, `normally the parents of hGH recipients were made aware to some extent of the source of the hormone'.[69] The Committee received contrary evidence, exemplified in one case where the parents of an hGH recipient were advised that the hormones were processed from the pituitaries of `animals'. The hGH recipient stated:
It was not until several years after my treatment that my mother discovered the source of the hormones...A clear understanding of the source of the hormone may well have made a difference to my parents decision to consent to my treatment.[70]
2.77 Allars reported that accounts given by hPG recipients constantly indicated that the source of the hormone was not disclosed and patients were not told of the alternative, human postmenopausal gonadotrophin (hMG). Most recipients were told of the risks of multiple births and some were told of the risks of hyperstimulation but did not realise it was life-threatening. The level of information provided to recipients is further discussed in Chapter 7.
2.78 The treatment regime for use of hPG was stressful and many patients felt they lacked support. Allars found that at many clinics it was nursing staff who provided the detailed information about the treatment and who dealt with the concerns of the patients on a day-to-day basis. Further, `a significant number of hPG recipients had poor doctor/patient relationships and felt that they could not ask questions'.[71]
2.79 The Allars Inquiry stated that the common law duty of medical practitioners to disclose information to patients requires that patients be advised of material risks in the treatment they receive. Allars accepted that the risk of CJD was not known by treating practitioners at the time of treatment. Further, `in the case of hGH treatment there were occasional risks for some patients, which could be avoided with careful management, and these were normally disclosed'.[72]
2.80 In the case of hPG recipients, the risks of multiple births and hyperstimulation were material. These risks `could not necessarily be avoided by careful management and ought to have been disclosed to recipients'. Further, given the risks of hPG treatment, alternatives should have been discussed. However, the Inquiry found that while alternatives may have been presented at the initial consultation, for many `there was no moment of decision presented at the later stage when the hPG treatment was entered into'.[73] hPG was the `next step' in treatment for their infertility.
2.81 The Inquiry also concluded that the source of the hormone was a matter associated with risk and should have been disclosed, as it may have influenced the decision to proceed with treatment. While treatment was given prior to the knowledge of the transmission of HIV/AIDS and ceased after the link was established for CJD, `the risk of infection from treatment with a product derived from cadavers at post-mortem was always a material one in view of other known transmissible diseases such as hepatitis'.[74]
2.82 The Allars Inquiry found that some decisions of both the FSH and HGH Subcommittees were open to criticism on ethical grounds. The HGH Subcommittee introduced a scheme for distribution of the hGH hormone where patients in one group of States were permitted a lower dosage than for patients resident in the remaining States. Allars stated that the intention was to ascertain by a comparative study the minimum effective dosage, but that this scheme stepped across the line between making clinical observations and conducting a research study.[75]
2.83 The Allars Inquiry found that members of the FSH Subcommittee did not address the issue of conflict of interest in being approved practitioners themselves. The Subcommittee failed to pay sufficient regard to ethical considerations in: approving the use of out of date hPG in spite of a disclaimer of responsibility by CSL for its use; failing to apply adequate sanctions in cases where medical practitioners treated patients without approval or without submitting treatment forms; failing to treat hyperstimulation as a central concern of the Subcommittee rather than a matter to be left to the treating medical practitioner; failing to respond in a decisive manner to cases of multiple births or congenital abnormalities by assessing the treatment regime and laboratory facilities of the treating medical practitioner; and failing to consider cases of maternal deaths when details became available.[76]
2.84 CJD belongs to a group of transmissible neurodegenerative diseases commonly called unconventional slow viruses or spongiform encephalopathies. Other human diseases in this group include kuru, Gerstmann-Straussler syndrome and fatal familial insomnia. The nature of the causative agent has not been unequivocally identified, but there is growing evidence that it is a modified form of a normal body protein, the prion protein.[77] The agent is extremely stable and can survive most conventional methods of decontamination.
2.85 There are three broad categories of CJD:
- sporadic spontaneously develops, usually in patients in their late 50s and early 60s;
- familial caused by a number of inherited pathological mutations in a certain gene; and
- iatrogenic occurs as a result of the accidental introduction of contaminated material into the body.
New variant CJD has been identified recently in the United Kingdom. 2.86 Iatrogenic CJD is divided into two groups - that acquired by central infection of the brain (through the use of contaminated instruments or infectious dura mater tissue used in surgery on or near the brain) and peripherally infected iatrogenic CJD which occurred during therapy outside the brain, for example the use of pituitary derived hormones.
2.87 CJD acquired through central infection manifests itself by dementia within months. Peripherally infected CJD results primarily in ataxic symptoms such as unsteadiness in walking, shaking and jerking movements and speech difficulties. The incubation period may be decades.[78]
2.88 The spontaneous incidence is about one per million of the population. From 1979 CJD was separately identified by a International Classification of Disease (ICD) Code. For the period 1979-91, the following deaths in Australia due to CJD were reported 1979-11;1980-7; 1981-6; 1982 -13; 1983-15; 1984-17; 1985-11; 1986-13; 1987-14; 1988-15; 1989-7; 1990-14; 1991-13; 1992-18; 1993-11; 1994-14; 1995-23.[79]
2.89 Professor Colin Masters of the CJD Case Registry indicated that of the total of 256 cases of CJD recorded in Australia, 237 cases (93%) are sporadic, 12 cases (5%) are familial and 7 cases (2%) are iatrogenic.[80]
2.90 CJD was first described as a disease in 1920. Knowledge of CJD grew as a result of research, chiefly conducted from the late 1960s in relation to other spongiform encephalopathies, in particular kuru.[81] Transmissibility of CJD (through inoculation of chimpanzee brains) was first reported in Science in 1968. The first suspected iatrogenic person-to-person transmission of CJD was reported in 1974 (in a corneal transplant patient). In 1974 warnings appeared in the literature regarding the need for special precautions beyond routine sterilisation procedures in order to inactivate the CJD infective agent. In 1977 Gajdusek published his paper Unconventional Viruses and the Origin and Disappearance of Kuru. In this paper he dealt with his work on kuru but also raised some broad concerns in relation to CJD. In a further paper published in 1977 in the New England Journal of Medicine (referred to in paragraph 2.31), Gajdusek outlined a list of precautions which should be observed by people caring for patients with CJD or handling their tissue.[82]
2.91 The Allars Inquiry Report gives a detailed chronology of knowledge and decisions related to knowledge of CJD from 1920 to 1985.[83] The Allars Inquiry concluded that knowledge of CJD was very specialised within the field of neuropathology and that `neuropathologists, including Gajdusek, did not make a link between their knowledge of transmissibility of CJD and the use of pituitaries in growth hormone programs'.[84] Further in the late 1960s and early 1970s there was little understanding of the mode of transmission of the disease. Paediatric endocrinologists and obstetrician gynaecologists who treated patients under the AHPHP knew little or nothing about CJD in the 1970s and early 1980s.
2.92 Allars reported that in 1980, the Fractionation Subcommittee and HPAC considered the risk of slow virus contamination following a discussion between the Chairman of HPAC and the Director of the Medical Research Council in the UK.[85] The Subcommittee and HPAC took the view, which Allars states was incorrect in the light of scientific knowledge in 1980, that a slow virus was not positively linked with a disease present in the community. Allars also reported that HPAC failed to re-assess the program or seek expert advice. The Subcommittee and HPAC assumed that since the technology did not exist for direct detection of slow viruses, acknowledgment of the potential dangers was all that was possible.[86]
2.93 The Committee comments on available knowledge and the links which should have been drawn in Chapter 7.
2.94 In November 1984 a US paediatrician made the first definite link between pituitary hormone therapy and the risk of CJD after the diagnosis of CJD in one of his patients.[87] On 2 April 1985, the US National Pituitary Agency contacted the Chairman of HPAC, Professor Lazarus, informing him of the link between CJD and hormone therapy. From then until the AHPHP was suspended on 29 May 1985 there were a number of extraordinary meetings of HPAC and its Subcommittees and regular contact with administrators of growth hormone programs in the UK and USA.[88]
2.95 All stock of hGH and hPG were recalled.[89] HPAC resolved that Dr Chapman and Professor Masters conduct a study to determine whether the Chapman method used at CSL from 1984 would eliminate the CJD infective agent from the final hormone product. This study concluded in 1988 and showed an extremely low risk of infectivity in the final product but that did not exclude the possibility of cross-contamination within the laboratory where the processing was done. However, the test was not done on the Ferguson method which was used throughout most of the period of the AHPHP.[90]
2.96 An epidemiological study of pituitary hormone recipients was commenced, but was gradually abandoned on account of lack of resources.[91]
2.97 At the time of the cessation of the AHPHP, CSL had certain Commonwealth indemnities provided to it as a Commonwealth agency: from 1983, CSL Directors, in common with all Commonwealth-appointed directors to boards of statutory authorities and Commonwealth companies, were extended equivalent protection to that provided to Commonwealth officers for defence and legal costs under Finance Direction 21.
2.98 In evidence, Mr Tuohy, Company Secretary, CSL, stated that in 1985 at the cessation of the APHPH, CSL received an indemnity for claims arising from pituitary gland hormones.[92] On 30 September 1987, the Minister for Health, provided CSL with indemnities for claims arising from certain CSL products including pituitary gland hormone. On 1 April 1991, CSL Ltd was incorporated as a wholly Commonwealth-owned public company and was granted, under its new legal status, all indemnities as previously granted. 93
2.99 In November 1992, the Government announced that CSL Ltd would be sold by means of a public float. In December 1993 an Indemnity Agreement was entered into by the Commonwealth and CSL. This Agreement provided indemnities for claims arising from use of some CSL products (including pituitary gland hormone) both pre- and post-sale. The indemnities do not apply in the case of claims resulting from CSL's culpable negligence. In evidence, Dr Loy, Health Department, explained the indemnity as follows:
The indemnity agreement indemnifies CSL for amounts for which it becomes legally liable by way of compensation for personal injury loss or damages through the use of growth hormones manufactured from human pituitary glands and human pituitary gonadotrophin manufactured before 31 December 1985. I gather there is a clause in the indemnity agreement, as you would expect to find, that if the liability arises from punitive and exemplary damages awarded against CSL as a result of CSL deliberately or recklessly endangering the health and safety of human life, then the indemnity does not operate.[94]
2.100 The first Australian death of an hPG recipient from CJD occurred in August 1988. The Allars Inquiry reported that this did not become widely known in the medical community until its publication in a medical journal in August 1990.[95] Three more deaths occurred between May 1989 and January 1991. The link between hormone treatment and CJD was made in the case of the first two deaths by medical practitioners at the time of diagnosis. In the case of the third and fourth deaths, the link was only made some years later. Only the last two cases were the subject of news releases by the Department in early 1993.
2.101 When the program was suspended in May 1985, Commonwealth health authorities did not contact patients directly. On 9 June 1985 the Minister issued a news release that the AHPHP had ceased because of the deaths of hGH recipients overseas. Medical practitioners who participated under the AHPHP were written to and requested to inform patients currently receiving pituitary hormone extracts of the possible risks associated with the use of these extracts.[96] The Department wrote again in November 1990 and in January and February of 1992 asking that patients be contacted and counselled about the risk of CJD.
2.102 In December 1992 and January 1993 a media advertising campaign was undertaken and people who thought they may have been treated under AHPHP were asked to contact the Department. In March 1993 the Department used Medicare records to assist in tracing recipients.
2.103 The Allars Inquiry found that the Department had `a moral duty to take steps to ensure that recipients were made aware of the risk when the AHPHP was suspended in 1985' and that they should not have been `left in the dark because they did not request information'. The Inquiry also found that the Department `should have provided assistance in 1985 to medical practitioners through a coordinated program of tracing recipients in connection with the epidemiological study'.[97]
2.104 The Allars Inquiry also found that Departmental officers `were unduly guarded in their response to recipients who sought information about their treatment'. Officers also declined to provide information to recipients directly, requiring that they receive information about their treatment through a nominated medical practitioner. The Inquiry found that officers feared that they would breach s.135A of the National Health Act which imposes severe penalties for disclosure of medical information to third parties. Allars concluded that `this restrictive approach appeared unnecessary in the light of the unproblematic procedures for access to information followed in many State hospitals in accordance with the spirit of freedom of information legislation'.[98]
2.105 In February 1988 it was agreed by the National Blood Transfusion Committee (NBTC) that Red Cross Blood Transfusion Services would permanently defer individuals who had received human pituitary-derived growth hormone from being able to donate blood.
2.106 In July 1989, the Health Department, acting on information that recipients of pituitary-derived hormones were excluded from organ and blood donation in the USA, advised State Departments of Health that they should take appropriate positive action to ensure recipients of pituitary-derived treatment were excluded from organ and blood donation.
2.107 In November 1990, the Health Department clarified with the Chairman of the NBTC that recipients of hPG should also be excluded from donating blood. This advice was immediately circulated to all Red Cross Transfusion Directors.
2.108 Following negotiations with the Privacy Commissioner, in March 1993 the Department provided a list of patients treated under the AHPHP to the Red Cross National Headquarters for distribution to blood banks.
2.109 In January 1992, as inquiries by recipients increased in response to media attention to the issue, a CJD Unit was set up within the Department to respond to requests for information. In May 1993 the Pituitary Hormones Task Force (PHTF) was established within the Department and included a scientific team to monitor scientific literature for the outcomes of overseas research to ensure that any new developments could be applied to the local situation quickly.[99] A new database of recipients was established.
2.110 The CJD Case Registry was also established in May 1993 to: collate the prospective analysis of CJD cases occurring in Australia over the period 1993-98; retrospectively analyse the CJD cases occurring in Australia over the period 1988-92; and use this data in the examination of theoretical risk factors and demographic trends to enable rational recommendations to the Australian Government on the best way to manage the problem of CJD and related diseases.[100]
2.111 In the early 1990s there was extensive media interest in the deaths from CJD of four recipients and the CJD risk to those who had participated in the AHPHP. Mr Peter Costello, MP, and other parliamentarians also pursued the matter. On 11 May 1993, the former Minister for Health, Senator Graham Richardson, announced that Associate Professor Margaret Allars from the Faculty of Law, the University of Sydney, would conduct a public inquiry into the matter.
2.112 The Inquiry into the Use of Pituitary Derived Hormones in Australia and Creutzfeldt-Jakob Disease (the Allars Inquiry) had as its terms of reference to examine the operation of the Australian pituitary hormone program and to report on issues arising from that examination. In particular, the Inquiry was to examine and report on:
- the decisions taken to establish and continue the program in the light of scientific knowledge of the risks and benefits at the relevant times;
- any applicable guidelines relating to the treatment aspects of the program, particularly the information provided to patients so as to allow informed consent;
- the applicable rules and guidelines relating to the manufacture of the hormones, including for the collection of pituitaries; and
- following cessation of the program, actions taken by the then Department of Health (subsequently DCSH, then DHHCS now DHHLGCS) and others in response to reports of deaths from CJD of patients on similar programs overseas and subsequently of Australian patients.
2.113 The Inquiry was asked to make recommendations on:
- further actions which the Government might take to identify people in Australia who received the pituitary derived hormones and to provide counselling and support to them;
- whether additional measures are necessary to regulate medical programs in the light of the experience of the pituitary hormones program and the current regulatory procedures;
- any measures which should be taken to strengthen the rules and guidelines relating to informed consent in similar medical programs;
- priorities for research into matters related to CJD and its transmission.
2.114 Professor Allars produced an 800 page report which was tabled in Parliament by the then Minister for Human Services and Health, Dr Carmen Lawrence, on 28 June 1994. The Allars Report made 11 major recommendations and covered a range of issues including:
- Medical and scientific knowledge of risks and benefits;
- Treatment, including information provided to patients and informed consent;
- Manufacture of hormones and collection of pituitaries;
- Regulation of product;
- Response by Department and others on cessation of Program;
- Tracing, identification, counselling and support;
- Regulation of medical programs;
- Consent; and
- Priorities for research.
2.115 A copy of the Executive Summary produced in association with the Allars Report is reproduced at Appendix 3.
2.116 The report of the Allars Inquiry provided the recipient community with information not previously available. In her submission to the Committee, Professor Allars stated:
I made factual findings utilising all information available to me and included in the Report footnote references to each transcript and submission upon which these findings were based. I did so believing that the major benefit of the Inquiry would be a Report which provided detailed factual information to recipients. When recipients were asked at interview what they wanted from the government, the vast majority said they wanted factual information. This had been absent at the time of treatment, when the risk was discovered and in the period of governmental response. Their only sources of information had been factually inaccurate and sensational media reports which had caused them distress.[101]
2.117 On 7 November 1994, the then Minister for Health, Dr Carmen Lawrence, announced a $10 million package of measures in response to the findings and to implement the recommendations of the Allars Inquiry. A $5 million Trust Fund was established to cover the medical and other care costs of recipients who contracted CJD and to continue the counselling services and support groups. $1.1 million was allocated to fund commissioned research, an epidemiological study, a survey of recipients and the CJD Case Registry. A further $3.9 million was allocated for the Pituitary Hormone Task Force to trace the remaining hormone recipients, further develop a database, publish a newsletter and provide community information. The action taken by Government since that time to implement the Allars Inquiry recommendations are considered in detail in Chapter 3.
2.118 In May 1993 legal action was commenced on behalf of the families of the hormone recipients who had died of CJD. This action was settled prior to trial in December 1994.
2.119 In September 1993, a recipient, APQ, commenced court action alleging that news of the possible risk of contracting CJD from hormone treatment had caused `nervous shock'. APQ's case was selected to be run as a test case. By April 1997, there were a total of 133 applications lodged with the Supreme Court of Victoria relating to claims against the Commonwealth and CSL for compensation in relation to nervous shock. Applications were also lodged in the Supreme Court of New South Wales.
2.120 On 4 April 1997, the Commonwealth settled with APQ. The Commonwealth agreed to pay legal costs of the existing proceedings; that if APQ subsequently contracts CJD, to pay compensation, assessed on common law principles as if the Commonwealth were legally liable, together with any legal costs related to that assessment; and the continuing benefit under the Trust Fund.
2.121 The Commonwealth denied liability and maintained that it was not liable to pay compensation in respect of APQ's alleged `nervous shock'. The settlement offered was described by the Minister as `compassionate' with a commitment by the Commonwealth to compensate APQ in the event of APQ suffering from CJD at any time in the future.[102]
2.122 Following the settlement with APQ, the Commonwealth extended the same common law coverage to all litigants and subsequently to all approved recipients treated under the AHPHP who were not involved in the litigation. Issues relating to the Commonwealth's settlement offer are discussed in Chapters 3 to 6 of this report.
2.123 Discussion on some of the major issues within the terms of reference has focussed upon the legal aspects of the settlement offer and the guidelines relating to the provision of legal aid. However, the impact that the AHPHP has had at a personal level on the lives of recipients and their families can not and should not be overlooked.
2.124 What effect does the knowledge that you have been placed at risk of death from a rare and fatal disease have - a disease for which there is currently no cure and no diagnosis of the possibility of its contraction? What effect do related issues have upon people such as the often `accidental' manner by which a recipient learnt of the risk associated with their treatment, that the treatment was experimental or part of a clinical trial, that in some cases they should not have even been given the treatment for various reasons, that they were treated `unofficially' by medical practitioners who had not obtained necessary departmental approvals, or the confusion and frustration arising from the inability to have accurate and comprehensive information provided at times when recipients were most vulnerable?
2.125 As with any group of people the response covers a broad spectrum. Some recipients have probably coped better than others by successfully putting the issue to the back of their mind, without there being any apparent significant impact on their everyday life. Other recipients approach life on a day to day basis, while others have been significantly effected by the revelations. Reference was made in a number of personal submissions to living with a `time bomb'.
2.126 The effects at a personal level have been described in many submissions and in evidence.[103] Some people have been effected to a greater degree than others. In an attempt to try and understand what many recipients and their families are going through, the following individual comments have been distilled from various submissions and describe a variety of effects. They are by no means comprehensive. One of the most unfortunate effects has been the problems created for some families. Family life has been disrupted and behavioural problems have occurred. A number of recipients made the following points in highlighting such problems. Individuals have withdrawn into themselves to the extent of living separate lives in their home environment. In other situations older children have been unable to cope with parental stress and anxiety and have left home; families have split up and marital breakdowns have occurred; and couples have decided not to have children to avoid any possibility of risk. In some instances reference was made to a sense of guilt which may develop within the child born through hormone treatment, while some parents who put their children through growth hormone treatment may also suffer a sense of guilt. The fear of CJD remains an issue which some people find difficulty in talking about within the family, and certainly with friends and workmates, thereby `bottling up' stress and anxiety. Conversely, there are many instances where family problems have been alleviated through strong family support and commitment, or through counselling and other support measures.
2.127 The effect upon an individual's quality of life was referred to in a number of submissions. There was a feeling that an individual's right to privacy had been diminished through recipient names being provided to blood banks and by being excluded from donating blood or organs. A sense of being an outcast in society develops. Some recipients expressed feelings of humiliation and embarrassment by having to produce a medical-in-confidence letter whenever they require medical or dental treatment. The medical response in some instances of rescheduling surgery or refusing treatment altogether reinforced the feeling of alienation within some individuals. A few recipients indicated that they have actually neglected health problems and not consulted dentists to avoid confrontation created by the medical-in-confidence letter. A number of individual recipients also indicated that they have developed a strong distrust of the medical profession, a similar distrust of the law as they believe they have been given poor legal advice, and a deep suspicion towards government and the bureaucracy.
2.128 Some recipients noted a feeling of discrimination due to what is perceived as the commonly held view regarding treatment under the program, which appears to be that only women received hPG and children hGH. However, there were a significant number of males treated with hPG and a number of hGH recipients were treated in their late teens.
2.129 Other effects on individual recipients referred to in submissions and evidence included difficulties in obtaining and holding down employment due primarily to anxiety and stress levels, additional direct and indirect financial costs, and the inability to obtain life and other insurance coverage.
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Footnotes
[1] Report of the Inquiry into the Use of Pituitary Derived Hormones in Australia and Creutzfeldt-Jakob Disease, AGPS, June 1994 (Allars Report). The Executive Summary of the Report is reproduced as Appendix 3.
[2] Allars Report, p.19.
[3] Allars Report, p.21.
[4] Allars Report, p.27.
[5] Allars Report, p.42.
[6] Allars Report, p.47.
[7] Allars Report, p.43.
[8] Allars Report, p.47.
[9] Allars Report, p.48.
[10] Allars Report, p.51.
[11] Allars Report, p.49.
[12] Allars Report, pp.52-4.
[13] Allars Report, p.56.
[14] Allars Report, p.57.
[15] Allars Report, p.58.
[16] DHFS, supplementary information, 22.8.97, pp.11-12.
[17] DHFS, supplementary information, 22.8.97, p.12.
[18] Allars Report, pp.61-2.
[19] D. Carleton Gajdusek et al, New England Journal of Medicine, Dec 8, 1977. This paper highlighted the need to take precautions in handling material from people with this class of disease. See also paragraph 2.90.
[20] Allars Report, p.63. See also DHFS, supplementary information, 22.8.97, pp.14-15.
[21] Allars Report, p.65.
[22] Allars Report, p.370.
[23] Allars Report, p.371.
[24] Allars Report, p.69.
[25] Allars Report, p.68.
[26] Allars Report, p.71.
[27] Allars Report, pp.74-81.
[28] Allars Report, p.71.
[29] Allars Report, p.72.
[30] Allars Report, p.73.
[31] See Allars Report, Chapter 6.
[32] Allars Report, p.396.
[33] Allars Report, p.82.
[34] The different processing methods are described in Appendix 3 to the Allars Report.
[35] Allars Report, p.87.
[36] Allars Report, p.91.
[37] House of Representatives Hansard, 5.10.93, p.1699.
[38] Allars Report, p.88.
[39] Allars Report, p.94.
[40] Allars Report, pp.94-5.
[41] Allars Report, p.95.
[42] Allars Report, p.96.
[43] Allars Report, p.98.
[44] Allars Report, p.99.
[45] Allars Report, p.99.
[46] Allars Report, p.100.
[47] Allars Report, p.100.
[48] Allars Report, p.100.
[49] Allars Report, pp.102-04.
[50] Allars Report, p.488.
[51] Allars Report, p.495.
[52] Allars Report, Executive Summary. pp.6-7.
[53] Allars Report, Executive Summary, p.7.
[54] Allars Report, pp.500-1.
[55] Submission No. 85, Attachment 1, pp.1-2 (DHFS). The Committee notes that there is some variation in the figures provided for the total number of approved recipients: in 1993, the then Minister of Health stated that there were 2,093 approved recipients based on Departmental records of patient approvals and may be subject to change as a result of advice from treating practitioners. House of Representatives Hansard, 27.9.93, p.1155.
[56] Allars Report, pp.273-74. Lazarus, L, 1979, `The Results of Growth Hormone Therapy in Australia', Patient Management: 22-23.
[57] Allars Report, p.276. Kovacs et al, `Induction of ovulation with Human Pituitary Gonadotrophin (HPG): The Australian Experience', Australia New Zealand Journal of Obstetrics & Gynaecology 29:315-381.
[58] Allars Report, pp.209-10. The figures used by Allars come from the paper by Kovacs et al. The figure of 7.8 was arrived at by totalling percentages in table 3 of the paper. This information was repeated by Professor Whitworth, Transcript of Evidence, p.225.
[59] Allars Report, p.213.
[60] Transcript of Evidence, p.225.
[61] Allars Report, pp.222, 223.
[62] Allars Report, pp.224-5.
[63] Allars Report, p.266.
[64] Allars Report, pp.268-9.
[65] FSH Subcommittee, Minutes of meeting, 20.9.73.
[66] The `Egg Project' was undertaken as part of early IVF research and involved hyperstimulating ovaries of women with tubal infertility to obtain oocytes by ovarian stimulation at ovulation.
[67] Allars Report, Executive Summary, p.7.
[68] Allars Report, pp.510-12.
[69] Allars Report, p.247.
[70] Submission No.27, p.5. Similar comments were made in Submission Nos.35, p.1; and 90, p.5.
[71] Allars Report, Executive Summary, p.4.
[72] Allars Report, Executive Summary, p.4.
[73] Allars Report, Executive Summary, p.4.
[74] Allars Report, Executive Summary, p.4.
[75] Allars Report, Executive Summary, p.8.
[76] Allars Report, Executive Summary, p.8.
[77] See also Transcript of Evidence, pp.120-23.
[78] Allars Report, pp.286-87.
[79] House of Representatives Hansard, 27.9.93, p.1156 and ABS update.
[80] DHFS, supplementary information, 22.8.97, p.1.
[81] Kuru was found in the Fores tribe in Papua New Guinea. In the late 1950s and early 1960s work by Gajdusek and others showed that this was caused by a slow virus. Its incubation period was long and the disease always fatal. See Transcript of Evidence, p.123.
[82] Allars Report, p.294.
[83] Allars Report, see in particular pages 324 to 331.
[84] Allars Report, Executive Summary, p2.
[85] Allars Report, pp.352-4.
[86] Allars Report, p.357.
[87] Allars Report, p.557.
[88] For full details see Allars Report, pp.557-62.
[89] DHFS, supplementary information, 29.8.97, Attachment 2, Letter from Chairman, HPAC to treating practitioners.
[90] Allars Report, pp.570-71.
[91] Allars Report, pp.573-78.
[92] Transcript of Evidence, p.217.
93 Australian National Audit Office, Audit Report No. 14, 1995-96, Performance Audit: The Sale of CSL,
94 AGPS, 1995, pp.28-29, 32.
94 Transcript of Evidence, p.217.
95 Allars Report, p.588.
96 DHFS, supplementary information, 29.8.97, Attachment 1 Letter from Chairman, HPAC to treating practitioners.
97 Allars Report, Executive Summary, p.9.
98 Allars Report, Executive Summary p.10.
99 Submission No.85, p.5 (DHFS).
100 Submission No. 85, p.8 (DHFS).
101 Submission No.92, p.2.
102 Media Release, Dr Michael Wooldridge, MW 25/97, 4.4.97.
103 While individual submissions speak for themselves, an overview of this aspect was provided by the hGH recipient member of NPHAC - see Submission No.27, pp.2-3.