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7.1 Under the second term of reference, the Committee is required to
report on whether CSL or CSL Ltd, the National Health and Medical Research
Council (NHMRC), the Department of Health and Family Services (DHFS) or
any other Commonwealth department, agency or employee failed to adequately
protect public safety in relation to the Australian Human Pituitary Hormone
Program (AHPHP).
7.2 In their submissions to the Committee, many recipients expressed
disquiet at the way the AHPHP was conducted and raised issues of accountability.
For example, one recipient submitted:
...all of the agencies that were connected with the Australian
human pituitary hormone program are at fault. The revelations of the
Allars inquiry are mind-boggling to say the least. The irony of all
of this is that no one will ever be made accountable for their improper
actions, actions that have left a number of people dead, others at risk
and families devastated by a dreadful disease.[1]
And:
No-one from CSL - whose actions in harvesting the pituitary glands
under completely uncontrolled conditions must border on criminal negligence
- has ever been held to account. Nor have any members of HPAC, who sought
kudos and career advancement ahead of prudent medical practice and patient
safety.[2]
Further, some recipients concluded that there were breaches of the law
by persons involved in the program:
We believe that the report completed by Professor Allars, her
executive summaries and Dr Lawrence's speech to the House prove beyond
any question that there had been significant breaches of the law as
it applies to a wide variety of areas. These include the manufacture
of the hormone, including the collection of glands, distribution of
the hormone by various agencies, including HPAC, CSL and others as detailed
in the Allars report, and non-disclosure of possible side effects.[3]
7.3 Other recipients expressed concern that CSL's manufacturing practices
were `unsafe' and `negligent' and that they may have been treated with
hormone that was not only potentially contaminated with CJD but hepatitis
as well.[4]
7.4 For many recipients lack of knowledge about the future implications
for their children is a further source of anxiety:
As a human pituitary hormone recipient and as member of the Australian
public, I feel that my life, my safety, has been jeopardised. I now
have an increased risk of contracting CJD and it is not known to what
extent all my 4 children (who were all breastfed) are also at risk of
contracting CJD.[5]
7.5 An additional matter raised in submissions was the time taken to
notify recipients of the risk of CJD. It was also noted that many recipients
had donated blood between the time the program was suspended in 1985 and
when the majority of recipients were notified in 1992-93. This had caused
concern within the recipient community.
7.6 The Allars Inquiry report provided extensive detail on the government
bodies and agencies involved in the AHPHP. Many recipients believe however,
that the Allars Inquiry did not adequately address the issue of accountability
because the terms of reference did not go to the question of liability.
Professor Allars in her submission to the Committee noted:
Neither compensation nor the issue of criminal or civil liability
of medical practitioners were part of my terms of reference. Consequently
I made no recommendation on these issues. I make no comment now.[6]
7.7 In considering whether there was a failure to adequately protect
public safety in relation to the AHPHP, the Committee has relied extensively
on the findings of the Allars Inquiry. Comments are provided in relation
to the particular areas of :
- the production of the product, including collection of pituitary glands;
- supervision of the product and program by government agencies including
the Health Department, the National Biological Standards Laboratory
and the Human Pituitary Advisory Committee; and
- action taken by the Department following the suspension of the program
in 1985 in relation to tracing of recipients, information provided to
recipients, epidemiological studies, and blood and organ donation.
7.8 The Allars Inquiry reported that from the commencement of the AHPHP,
CSL and HPAC believed that there were two avenues for ensuring the safety
of hormone product from viral contamination. Firstly, through the criteria
established to exclude the collection of glands from certain cadavers
and secondly, through the method of processing the glands.
7.9 A brief summary of the very detailed account in the Allars Report
of the development of the exclusion criteria is given in Chapter 2 of
this report. The Committee also notes that a letter from the Director
General of Health to CSL in June 1963 stated:
...that all medical superintendents of hospitals with pathology
departments (and State authorities responsible for accident autopsies)
should be induced to arrange for the collection of glands, the recording
of particulars of all autopsies...and the regular transmission to a
central depot.[7]
The first instructions on the selection of glands was issued by CSL in
1966. Over the period of operation of the AHPHP the exclusion criteria
were amended, but as Allars notes `in a reactive fashion as problems of
possible sources of infection came to light'.[8]
Further, with one exception in 1971, HPAC took no action to keep abreast
with current scientific knowledge of disease potentially affecting human
pituitaries. This caused delays in formulating new criteria, as demonstrated
by the delay in responding to HIV/AIDS and the delay in incorporating
into the criteria `presenile dementia (Creutzfeldt-Jakob Disease)' in
1982. The Allars Inquiry described the latter as `an unacceptably belated
response to the series of papers commencing with Traub in 1974 and culminating
in a 1977 paper of Gajdusek'.[9]
7.10 Dr Whitten in his submission also noted that `in a surprising move
NPA [the USA National Pituitary Agency] in early 1978 took the lead from
Australia and excluded glands from patients with "viral dementia",
one of the names used for CJD and kuru'.[10]
7.11 Although exclusion criteria were established, the Allars Inquiry
found that there was a failure to communicate the criteria to the pathologists
and mortuary attendants who removed the glands. No one institution or
individual was made responsible for the distribution of, or compliance
with, the exclusion criteria. The Allars Inquiry found that most of the
pathologists and mortuary attendants contacted by the Inquiry were unaware
that any written exclusion criteria issued by HPAC existed. Most relied
on verbal and self-imposed criteria to exclude unsuitable material.
7.12 The Allars Inquiry concluded that as screening of glands for compliance
with the exclusion criteria could only be done by the pathologist at the
time of removal, CSL and HPAC had no means of ensuring that glands within
the exclusion categories would not be collected. This was particularly
so when glands were removed by mortuary attendants without supervision,
`as was usually the case'.[11]
Thus, as infected glands may have been forwarded for processing, the ability
of the manufacturing process `to eliminate viruses and bacteria was essential
to the production of hormones with the least amount of contamination possible'.[12]
7.13 The Allars Inquiry noted that the glands were not removed by sterile
technique, nor was the post-mortem room a sterile environment. The Inquiry
also found that in most institutions no specific procedures were in place
in relation to the sterilisation of the equipment or the handling of tissue.
It was not until 1977 that CSL provided instructions for the removal of
the gland. This arose from concerns about the presence of extraneous material
with the gland and the impact of such material on CSL's estimations of
hormone yield.
7.14 In relation to the lawfulness of collection of the glands, the Allars
Inquiry found that prior to the introduction of uniform human tissue legislation,
the lack of hospital records meant that the Inquiry was unable to come
to a firm conclusion as to whether glands had been collected lawfully
or unlawfully. Following the introduction of uniform legislation, glands
were generally not removed for the purposes of post-mortem examination
but for the purpose of supply to CSL. Thus, the use of glands during the
period of the human tissue legislation was unlawful.[13]
7.15 In submissions and evidence before the Committee, many recipients
expressed concern about the way in which the glands were collected and
the lack of information provided to recipients about the source of the
material:
The revelation of the way in which pituitary glands were collected
for use in the AHPHP came as a great shock to many recipients and continues
to be a source of great anger today. The pressure exerted on hospitals
to increase the rate of gland collection; the incompetent, reactive
and slow revision of exclusion criteria; the inadequate communication
and monitoring processes that were employed and the unlawful removal
of glands contribute to a situation where people want answers to a lot
of questions and want people to explain their actions and be made accountable
for the circumstances we find ourselves in today.[14]
7.16 The CJD Support Group Network stated:
The focus of HPAC was on maximising collection. Scant regard
was paid to the law or to basic measures to safeguard the health of
endusers.[15]
7.17 In its submission, the Department stated:
It is now recognised, with the benefit of hindsight, that the
precautions taken by HPAC and pathologists were insufficient to completely
rule out collection of a pituitary gland (or for that matter an organ
or tissue) with the potential to infect a recipient with CJD. This is
because a person carrying the CJD prion may, on clinical examination,
show no symptoms of the disease. No level of protection could completely
guard against collection of glands from people in the preclinical stage
of CJD. The HPAC relied upon the professional expertise of pathologists
in deciding whether a gland should or should not be released for therapeutic
purposes. Through their medical training pathologists were aware that
a cadaver likely to be infected with hepatitis, CJD or other viral or
neurological diseases should be retained for microscopic examination.
This was the standard medical procedure. The fact that the pathologist
knew the gland was to be used for therapeutic purposes was a further
incentive not to release the gland for extraction of the hormones. This
same situation applied where dura mater, organs or tissues were also
being collected for therapeutic purposes.[16]
7.18 The Committee considers that the Department's statements above raise
serious concerns about its understanding of the ethical matters and accountability
issues raised by gland collection and the monitoring of exclusion criteria
as detailed in the Allars Report. As the Allars Inquiry reported:
Nor was it an adequate excuse that on account of the incubation
period for slow viruses scrupulous attention to the criteria would not
have prevented a gland from a person who had incubated the disease from
slipping through. Exclusion criteria were established to ensure the
product was safe. Adequate steps should therefore have been taken to
ensure compliance with them. HPAC failed to take those steps.[17]
7.19 The Committee also notes that following the introduction of uniform
tissue legislation, the Health Department failed to act to ensure that
glands for the AHPHP were collected in a lawful manner. Not only did the
Department have a role in oversighting the AHPHP, but it also had representatives
on HPAC and should have ensured that legislation was complied with.
7.20 CSL processed glands using mainly the Ferguson method and, from
late 1984, the Chapman method, although for some time CSL also produced
hormone using the Brown/Catt method. Details of these methods are given
in Chapter 2.
7.21 From the Allars Report, it appears that until 1977 frozen pituitaries
were received at CSL and ground with dry ice without any visual inspection.
However, following concerns about yield estimates, a sample of glands
were examined and it was found that 12 to 15 per cent of the tissue collected
was extraneous matter. This led CSL to issue in 1977 instructions on the
removal of glands. From July 1982, CSL began separating glands into four
classes based on their appearance and those in the `poor' and `rejected'
gland classes were not processed.[18]
7.22 Allars reported that laboratory screening of pituitaries was not
carried out by CSL because it would make the glands unavailable for processing.[19]
The Committee notes that the practice adopted in the UK was that small
batches of pituitaries, eventually 100, were extracted and, if the extract
proved positive for hepatitis, the batch was rejected.
7.23 A summary of measures taken by CSL in relation to quality assurance
and contamination is given in Chapter 2 of this Report. The Allars report
also contains the list of batches processed by CSL and indicates those
it believed were not distributed or withdrawn because they failed quality
control.
7.24 In relation to contamination, the Allars Inquiry stated:
The proposition that the larger particles of viruses and bacteria
would come off the column first in the Ferguson process, leaving the
hormone product free from contamination was soundly based until the
late 1970s.[20]
7.25 In its submission to the Committee, CSL stated that:
The Ferguson gel filtration fractionation method as used by the
Laboratories in the manufacture of hormones clearly demonstrated its
effectiveness, and reinforced the trust placed in it by both the Commission
and the HPAC, by excluding the hepatitis in the void volume of the four
batches (082, 93, 100 and 128) referred to in the Allars Report which
tested positive to hepatitis B antigen in the void volume.[21]
7.26 The Allars Inquiry noted that in 1966, Dr Wes Whitten, then of NBSL,
warned that because large particles, including viruses, would precede
the hormone through the column, the line would become contaminated.[22]
In their submission to the Committee, Drs Whitten and McCullagh noted
concerns about the sterility procedures in place at CSL to ensure that
the products were `free from contamination by infectious agents and their
products'. They commented:
We believe that procedures to maintain sterility were patently
inadequate by the standards of the time and that CSL failed to recognize
or to acknowledge this.[23]
7.27 Dr David Howes, former NBSL officer, submitted that CSL and HPAC
had an over simplistic and over optimistic view of the fractionation process
and put forward the following points:
- that only some of the virus particles and some CJD particles would
be removed in the `void volume' of the process;
- that in the column of gel beads there were very small and acute angled
crevices to trap various sized particles which could become dislodged
later in the process to mix with the hormone extractions; and
- there could be cross-contamination of runs.[24]
Dr Howes concluded that `virus contamination was unavoidable'.[25]
Further, he stated:
In relation to the CJD and hepatitis B contaminations of pituitary
hormones, the failure of both CSL and HPAC to subject the gel chromatography
technique to a very detailed critical analysis in relation to the possibility
of contamination with viruses as a general problem was, in my view,
a major contributor to the disaster.[26]
7.28 The matter of hepatitis B contamination was also raised in submissions
and evidence. Issues canvassed include that:
- HPAC was advised before the screening for hepatitis B commenced in
1978 of the risks of hepatitis and failed to act. First in 1973, then
by the Assistant Director-General of Health in 1975 and also by CSL's
Production Manager in 1976.[27]
- Although the Allars Inquiry reported that a batch of hormone tested
positive for hepatitis B, but not to a sufficient level to fail quality
control,[28] the Senate Community
Affairs Legislation Committee had been told by the Department at an
estimates hearing that `there is no safe level for hepatitis contamination,
and that it would be illegal to distribute products that were contaminated
with hepatitis'.[29]
- Hormone prepared in the UK was extracted from batches of 800 glands
and later sub-batched to 200 and then 100 glands because of hepatitis
contamination. CSL knew of this but did not employ the same strategy
and continued to use pools of 1,350 glands.[30]
- CSL tested the final product before ampouling and not the homogenate
as was done in the UK.[31]
- Only two batches of hGH were tested for hepatitis.[32]
- CSL underestimated the risk of hepatitis B by using a chimpanzee infectious
dose to constitute a human infectious dose.[33]
7.29 In evidence before the Committee there was extensive discussion
concerning batch 128. In the Allars Report it is stated that hPG batch
128 was not distributed. However, this batch was distributed and received
by APQ and it is now acknowledged in submissions to have been distributed.[34]
CSL suggested this discrepancy in the Allars report was a `transcription
error'.[35]
7.30 Dr Peters in evidence asserted that CSL records show that batch
128 tested positive for hepatitis B. An internal CSL memo indicated that
tests of batch 128 resulted in a positive test in the column charge and
negative in the void volume.[36]
Reference was also made to batches 003, 004 and 024 as being non-sterile
but distributed.[37] Dr Peters
stated:
In my submission of 12 July I attached the batches received by
a number of recipients, with the names removed to protect liability.
This shows that batch 24, which was a non-sterile batch, had been given
to a recipient.[38]
7.31 In its submission to the Committee, CSL stated that `at no stage
did the Commission distribute any product known to be contaminated
with a pathogen'.[39] Further,
all material issued by the Commission `was considered acceptable by the
HPAC adopted and introduced'. CSL went on to state that:
Of these batches [which tested positive for hepatitis in the
void volume] 082 was withheld from distribution; Batches 93 and 100
were combined and reprocessed into Batch 110, however this batch was
withheld from distribution because it failed pyrogen testing; Batch
128 was released following further tests for hepatitis.
40
7.32 In evidence, Mr Kaufman of CSL, commented further:
[batches 82 and 93] tested positive in the void volume which
is that peak that comes out first where the viruses will be concentrated
selectively into the void volume. That is the part that tested positive.
The fractions that have come off the column have not tested positive,
did not test positive from the start of hepatitis testing in the program,
which really validates the separation efficiency of the column. We know
that in batches 82, 93, 100 and 128 we could detect it in the early
phase of the separation. It was not present in later fractions.[41]
7.33 Mr Kaufman also gave a detailed explanation of the processing of
batch 128. He concluded by stating that:
Having reviewed the results recently, I would still come to exactly
that same conclusion. So there is no question of batch 128 having been
issued despite it being positive for hepatitis because it was not positive
for hepatitis.[42]
7.34 In relation to hepatitis in recipients, CSL stated:
No hormone recipient in Australia (or in the world for that matter)
has been reported as being hepatitis B positive (or HIV positive) as
a result of receiving pituitary hormone therapy.[43]
7.35 This statement was questioned by Dr Howes who stated:
A much more recent flaw in CSL's knowledge and reasoning can
be seen in its attempt, in the department's submission, to establish
that recipients were demonstrably not at risk of hep B infection. It
is said that one hormone recipient had been tested for hep B antibodies
and that the test was negative. Most hep B infections are acute, and
the woman tested had been treated with hormones many years earlier,
but antibody levels decline progressively over time and some infections
may come to test negative as a result. It also uses the argument that
no cases of hep B infection have been reported. That begs the question
of who has looked and what proportion of those at risk have been checked.[44]
7.36 In answering a question on tracing recipients to test for hepatitis
B, the Committee was told that there had not been any attempt to ascertain
the hepatitis status of recipients. Further, Mr Kaufman of CSL stated
`I think, Senator, there are no potential contaminated batches as far
as hepatitis B goes' based on CSL's testing.[45]
Tracing of recipients is discussed later in this Chapter.
7.37 Mr Kaufman also replied to concerns about pool size. He stated:
We had a look at the UK practice. The fact remains that we had
at least two steps in the process that were capable of eliminating virus.[46]
7.38 Following the Committee's hearing on 13 August 1997, CSL provided
further detailed information concerning the above matters raised by Drs
Peters, Whitten, Howes and McCullagh. This information included:
- the test results of batch 128;
- that batch 003-1 failed sterility test and was reprocessed as batch
003-2 which was sterile;
- that the records of batch 004 do not show sterility problems;
- that there are no records that batch 24 was issued; and
- that hGH was tested for hepatitis B.[47]
7.39 The CSL's response to evidence was further responded to by Dr Howes.
He provided evidence in relation to the pool of fractions used to produce
batches 121 and 128, the testing for contamination with hepatitis B antigen,
invalid tests for hepatitis B antigen in hormone samples and reduction
in risk of contamination of batches of pituitary hormones with infectious
hepatitis virus.[48] Macedones
also provided the Committee with further comments regarding the processing
of batch 003-2.[49]
7.40 In relation to CJD contamination, the Allars Inquiry report includes
a detailed assessment of the development in the awareness of transmissibility
of CJD. CJD was first described as a disease in 1920 and knowledge of
CJD grew from the late 1960s as research was conducted into other spongiform
encephalopathies including kuru. In 1968 transmissibility of CJD by inoculation
of chimpanzee brains was reported. The first iatrogenic person-to-person
transmission by corneal transplant was reported in 1974. In the same year
warnings, including those by Traub, appeared in the literature regarding
the need for special precautions beyond routine sterilisation procedures.
In 1977 Gajdusek's Noble prize winning paper was published. This paper,
which dealt primarily with kuru, continued warnings of the possible general
implications of current knowledge of kuru and CJD. Gajdusek also published
another paper in 1977 which further highlighted concerns in relation to
CJD and the precautions which should be observed in dealing with patients
with CJD or handling their tissue.[50]
7.41 Having reviewed the early developments of knowledge of CJD, the
Allars Inquiry found that by 1967 when HPAC was officially established,
scientific knowledge of unconventional slow viruses was developing, but
was limited to a small group of scientists and neuropathologists. Neuropathologists,
including Gajdusek, did not make the link between the transmissibility
of CJD and the use of human pituitaries in hormone programs. While there
was a great deal of interest in Gajdusek's work on kuru, there was little
understanding of the mode of transmission of the disease. The Inquiry
found that during `the 1970s and early 1980s paediatric endocrinologists
and obstetrician gynaecologists who treated patients under the AHPHP knew
little or nothing about CJD'.[51]
CSL and HPAC did however recognise the importance of eliminating viruses
and bacteria for the final hormone product. It relied on firstly, the
exclusion criteria for the collection of glands and secondly the extraction
method to achieve this.[52]
7.42 In 1976, UK scientist Dr A Dickinson expressed concerns about the
possibility of CJD contamination of growth hormone produced in the UK.
In 1979, a grant was made to Dr Dickinson to undertake a study of the
extraction method used in the UK. Although the results of this study were
not published until 1985, it was known that the study was being conducted
and the results became known informally in 1982. The Allars Inquiry noted
that HPAC had taken comfort from the findings of the study conducted by
Dickinson. However, the Allars Inquiry pointed out that this study was
conducted on the Lowry method of processing - a more sophisticated method
than that used by CSL with two additional purification steps.[53]
7.43 In 1979 Gross published important information about slow viruses
including CJD and in 1980 Prusiner published research which demonstrated
the small size of the infective agent of unconventional slow viruses.
[54]
7.44 The Allars Inquiry found that from 1971 (Dr McGovern's warning)
to 1980 there was no record of discussion of unconventional slow viruses
in the minutes of HPAC or its Subcommittees.[55]
The Committee's perusal of the minutes of HPAC and its Subcommittees similarly
found no record of discussions of slow viruses until 1980. In 1980, the
Chairman of HPAC, Professor Lazarus, and the Director of the Medical Research
Council in the UK, discussed recent developments in the UK in regard to
the possibility of slow virus infection in pituitaries. Professor Lazarus
wrote to Dr Ferguson, Chairman of the Fractionation Subcommittee, about
the problem.[56] The Allars Inquiry
noted that the Fractionation Subcommittee discussed the possibility of
slow viruses at its meeting of 19 May 1980. The Subcommittee concluded
that `as, at present, a slow virus is not positively linked with a disease
present in the community and, moreover, as the technology did not now
exist to detect a slow virus, acknowledgment of the potential dangers
is all that is possible'.[57]
HPAC concurred with this conclusion.
7.45 The Allars Inquiry found that the Subcommittee's conclusion was
incorrect in the light of scientific knowledge in 1980 as cases of CJD
had been reported in Melbourne as early as 1963 and in Adelaide in 1965.[58]
Further, neither the Subcommittee nor HPAC sought expert advice or re-assessed
the program. Although there was no technology to detect the virus, other
options were available to the Subcommittee for re-assessing the safety
of the product.[59]
7.46 The Allars Inquiry also concluded that conferral on HPAC and the
Fractionation Subcommittees the responsibility for monitoring all aspects
of the production of the hormone was fundamentally flawed. Further, members:
...are not to be blamed for their lack of expertise or lack of
familiarity with the developments in knowledge of CJD. They were not
neuropathologists or virologists. They are to be blamed for their failure
to recognise the limits of their expertise and the need to seek advice.[60]
7.47 The Inquiry also noted that `like the Fractionation Subcommittee
and HPAC, CSL failed in 1980 to consider or adopt options which were appropriate
with regard to the risks of treatment with the hormones in the light of
scientific knowledge at the time'.[61]
7.48 The Committee notes that in a judgement handed down in regard to
the UK growth hormone program, Mr Justice Morland, found that the UK Department
of Health should have acted on warnings of CJD contamination and suspended
the program from July 1977. In her submission to the Committee, Professor
Allars, while noting the date of July 1977, stated:
I placed the date in Australia as at least 1980 when the HPAC
pushed aside the issue of risk of slow viruses, as evidenced in its
minutes. I did not have sufficient evidence to be able to pinpoint precisely
a time in the period between 1977 and 1980 when Australians who were
members of HPAC and its subcommittees gained knowledge of the risk through
their attendance at international scientific meetings with their English
counterparts.[62]
7.49 The Committee received evidence on the awareness of CJD transmissibility
and when HPAC should have become aware of the risk. Dr Peters submitted
`Professor Allars implies that there was only limited knowledge of CJD
in Australia until the late 1970s. This is incorrect'.[63]
He went on to note early work on the transmission of scrapie and that
`the connection between scrapie and human diseases was postulated in 1956'.
Dr Peters also noted that papers were published on kuru in the 1950s and
1960s and that CSL scientists published at least five papers on kuru between
1961 and 1972. Dr Peters also submitted `from 1973 onwards, Health Department
files expressed concerns about the possibility of transferring CJD by
medical goods and instruments. Some of these concerns were relayed to
HPAC, which the files show ignored the warnings'. He concluded `there
was sufficient knowledge about CJD within CSL, the Health Department and
the medical profession to have required extreme caution about the hormone
program even at the beginning'.[64]
7.50 Drs Whitten and McCullagh submitted that there were recurrent reports
of transmission of CJD between 1968 and 1973 in widely read medical and
scientific journals, including Science and Nature. Further,
they noted at one stage HPAC had included in the exclusion criteria neurological
disease, and submitted that `its framing can only be construed as evidence
that HPAC was aware, at an early stage, of transmissibility risks'. They
went on to state:
We believe that it should have been apparent by the mid 1970s
to biological scientists with a familiarity with the general scientific
literature that CJD and related conditions were likely to be transmissible.[65]
7.51 Recipients also raised the matter of knowledge of CJD by members
of HPAC. Whilst not having scientific training, many recipients have made
the effort to become as informed as possible as a way of diverting the
impact of CJD risk awareness. In doing so, many recipients have reached
an opinion on the HPAC's knowledge of the awareness of CJD:
Clearly, in the light of scientific knowledge, the Human Pituitary
Advisory Committee failed to respond appropriately to the knowledge
of the risks of treatment with hormones, and demonstrated incompetence
and disregard for public safety. Those responsible for administering
the program must be asked to explain their actions and be brought to
account for the consequences. Matters of alleged illegality should be
thoroughly investigated and appropriate action taken. The lives of so
many people have been adversely affected as a result of their conduct.[66]
7.52 Professor Colin Masters of the CJD Case Registry also commented
on the knowledge of CJD and stated:
In 1977 the paper of Gajdusek and his colleagues was published,
drawing world attention to the fact that one needed to take precautions
in handling material from people with this class of disease. Between
1977 and 1985 I could say that the world body of medical opinion was
developing progressively to the point that by April 1985, when the first
case of CJD occurred in a human pituitary hormone recipient, that was
enough to set off alarm bells and to cause cessation of the pituitary
programs nearly everywhere in the world except France.[67]
7.53 In evidence, Dr John Loy, First Assistant Secretary, DHFS, in commenting
on the developments in awareness of CJD, stated:
The description of the state of knowledge in the various structures
of the program that is given in the Allars report I would judge to be
a pretty fair description. The description of the state of knowledge
and the state of knowledge in Australia amongst the people concerned
with the program seems to me from my own reading, and I am not an expert,
to be a pretty fair description. Professor Allars goes on to make some
judgments about, if you like, what should have been known or what inferences
should have been drawn. I think there is an area where people can make
different judgments and where it is very difficult to separate out what
you are doing with the benefit of hindsight from putting yourself back
in the position of the people in 1980 or 1977, but I think the description
of people coming slowly to some grasp and understanding of what was
going on seems to me to be a broadly accurate one... I am sure they
were familiar with them [articles concerning CJD], but making the leap
from saying that corneal grafts, that neurosurgical instruments transmit
the CJD agent, to saying that this is a possibility through pituitary
hormones, and then going further and saying it is such a possibility
that the program should be re-examined and stopped is a substantial
leap that was not made in this country and was not made in any other
country.[68]
7.54 Dr Whitten submitted that `the medical historian Pfeffer reported
rumours of cases of CJD in patients treated in fertility clinics in the
British Midlands in the early 1970s which have since been confirmed'.[69]
7.55 Once the hGH and hPG had been produced it was tested for potency.
CSL used bioassay and radioimmunoassay. Bioassay involved a sample of
each batch of hormone being injected into a test animal and the response
measured against a standard. The amount of response obtained indicated
the amount of hGH or hPG in the sample. A potency value in international
units (IU) was then assigned to each batch. Radioimmunoassay is the measurement
of a radioactively labelled substance using as the measure the amount
of antigen bound to an antibody.[70]
7.56 The measure of potency was particularly important for hPG recipients
where there was a risk of multiple pregnancies or hyperstimulation of
the ovaries, a potentially fatal condition, if dosage was incorrect. CSL
stated in its submission to the Committee that every single batch of pituitary
product was assayed for potency. It also developed additional assays requested
by HPAC, for example the luteinising hormone assay, introduced in 1972.[71]
7.57 The Allars Inquiry reported that throughout the period of operation
of the AHPHP treating practitioners found that batches of hPG varied in
their potency. Treating practitioners also reported that some batches
appeared inert and some were more potent than others. The FSH Subcommittee
frequently made requests of CSL to improve the means of determining the
potency of batches. 72
7.58 Dr Whitten submitted that `CSL was set an impossible task to bioassay
hPG because it was a very impure and variable mixture of FSH and LH, and
these two hormones may synergise or antagonise each other depending on
the ratio in the mixture. Thus the potency is indeterminate'. Dr Whitten
raised other matters concerning problems with potency: that assay for
LH content, should have been carried out by the Parlow method; that degraded
FSH (antiFSH) can assay as FSH using radioimmunoassay; batches were too
small for economical standardization; vials were labelled as the equivalents
to a fraction of a pituitary, thus origin, the quality of the storage
and the efficiency of extraction would impact on potency; and hPG was
not adequately standardised for LH. 73
7.59 In their submission to the Committee, Drs Whitten and McCullagh
described the bioassay procedures applied by CSL to hPG as `incompetent
(by the standards of the day)'.[74]
In a detailed review of CSL's bioassay procedures by Dr Whitten attached
to the submission, he stated that evidence that CSL never overcame problems
of bioassay of hGH is found in the minutes of the Fractionation Subcommittee
meeting held in June 1981, which states `It is evident to the Subcommittee
that the real issue of throughput for hGH was directly linked to bioassay'.[75]
7.60 Drs Whitten and McCullagh also submitted that CSL concealed from
practitioners these poor bioassay procedures. Product information distributed
with the hormone `failed to convey a reasonable indication of the questionable
value of data concerning potency'.[76]
7.61 In evidence before the Committee, Dr Whitten went further:
The other aspect of that is that CSL's assays were almost incredibly
primitive. They state in their submission that every single batch of
pituitary product was assayed for potency. They do not say how accurate
those assays were, and they do not say in what species they were assayed.
But six members of HPAC or its committees published a paper which said
clearly that they were assaying in the patients themselves. The patient
was the guinea pig! That is the assay; an 'in-patient assay' they call
it. They started the patients on a small dose of pituitary extract -
FSH as they called it, although it was really hPG. Then they followed
that patient for five days to see if her ovaries were producing oestrogens.
In the early days these were measured in the urine and at a later stage
by radioimmunoassay in the blood. If the patient did not respond, the
dose was increased by a factor of 1.3. If she did not respond to that,
it was increased again. These people clearly describe three patients
who received, I estimate, between nine and 10 cycles of treatment. They
started off with 0.3 or 0.5 and finished up getting a daily dose of
three pituitaries for five days and, in this case, they decided that
it was not the patient that was irresponsive, it was the hormone that
was inactive. That was evidenced by a rather crude bioassay that had
been done, but it was different from the radioimmunoassay that they
had used. The radioimmunoassay that was used by CSL was such that it
could not distinguish between FSH and inactive FSH - in other words,
the work I had done earlier with the FSH. It is inactivated by enzymes
that are present in many organisms and many tissues, and it is converted
from an active FSH to an inactive one - in fact, it is an anti-FSH.
The altered FSH sits on the receptors in the ovary and prevents the
normal FSH from acting. I have said enough.[77]
7.62 Dr McCullagh stated:
At page 30 [DHFS submission], for example, there is a specific
reference to the effect that an assay system to determine the correct
treatment regime for hPG patients was developed and resulted in fewer
cases of multiple pregnancy and hyperstimulation. Fewer cases than what?
We have already heard - and you can doubtless confirm this - about the
pitiful state of bio-assay that was applied. It is an incredible statement.
On the preceding page it is stated that a lower hyperstimulation rate
was identified in Australia compared with results achieved overseas.[78]
7.63 CSL responded to this evidence and disputed Dr Whitten's assumptions
concerning the assays used by CSL and stated:
The assays used for both hPG and hGH were based on the standard
British Pharmacopoeia [BP] biological assay. A full statistical analysis
was done on each assay in exactly the manner recommended by Dr Whitten...The
assay employed was a 2+2 design which (as pointed out by Dr Whitten)
has some limitations in terms of testing for linearity - nevertheless
it was the standard (and only) BP bioassay design for all products until
the December 1980 edition of the Pharmacopoeia. The bioassays were subject
to the normal variation seen in such assays, and were conducted in rats.
CSL had a wide experience in bioassays across many different products
- its expertise in this field was supplemented by regular assistance
from NBSL.[79]
7.64 In its submission to the Committee, CSL stated that it has always
placed a high emphasis on quality manufacturing and had established an
independent quality control section at the Laboratories as early as 1961.
CSL submitted that this was before the Australian code was first published
in 1970 but was consistent with WHO recommendations at the time `which
demonstrates that the Commission was up to date in its thinking and prepared
to accept advancements in manufacturing practice and regulatory aspects
of the pharmaceutical industry'.[80]
7.65 CSL went on to note that it had been actively involved in the development
of the Australian Code and had a representative on the Therapeutic Goods
Sub-Committee that had revised the Code in the mid 1970s. It also stated
that NBSL inspected the Laboratories in 1971 and that by the time the
Commission ceased in 1991 to become CSL Ltd, approximately twenty inspections
had been conducted.
7.66 The Allars Inquiry reported that while it had been told by officers
of CSL that it did submit itself to inspections pursuant to GMP, officers
of the Department during the 1970s and 1980s told the Inquiry that `CSL
strongly resisted having the Code applied to it, and this included a resistance
to participating in inspections of its manufacturing premises pursuant
to GMP'.[81]
7.67 In evidence, Dr Peters stated:
I say in my submission that CSL resisted compliance with the
Code of Good Manufacturing Practice. A reading of section 5 of the CSL
submission gives the impression that CSL complied with the Code of Good
Manufacturing Practice. This is incorrect. Documents on the CSL file
say that CSL did not implement the Code of GMP because it would have
been too expensive. Page 4 says that by the time the commission ceased
in 1993 it had been inspected approximately 20 times. It did not say
that most of these inspections were after 1985. As far as the hormone
program was concerned there was only one inspection and this followed
a complaint about labelling. There was never an inspection of the manufacturing
program.[82]
7.68 CSL responded by providing the Committee with a list of inspections
between 1971 and May 1994. In all 27 inspections were conducted. 14 were
made to June 1985, with one relating specifically to hormone products,
that made in June 1974 concerning labelling of FSH. CSL also provided
the Committee with documents relating to the preparation and approval
of master formulae and manufacturing instructions.[83]
7.69 Concerns were also expressed about the mixing of batches. CSL responded
that there is nothing in the GMP to preclude batch mixing if the manufacturing
protocol allows for it, and provided documentation to enable tracing is
maintained.[84]
7.70 The possible hepatitis contamination of hGH and hPG produced by
CSL and the general questions raised about CSL's production method and
standards of production are of great importance to many in the recipient
community. For the information of recipients, the Committee has provided
an outline of both the evidence received from Drs Peters, Whitten, Howes
and McCullagh and CSL's response to that evidence.
7.71 The Committee does not have the expertise to make an authoritative
evaluation of the detailed technical information provided in evidence.
It considers that to make such an evaluation would require a panel of
independent scientific experts. The Committee considers that an epidemiological
study of recipients would be of use in establishing the impact of possible
contamination, other than CJD contamination, on recipient health. This
was discussed in Chapter 3.
7.72 In relation to awareness of the risk of CJD by HPAC and its Subcommittees
or CSL, the Committee acknowledges that information on CJD generally,
and its transmissibility, was available in leading scientific and medical
journals. However, coming to a decision on whether or not the link between
treatment with human pituitary hormone and CJD should have been made earlier
is difficult. Such a decision involves making a personal judgment about
the level of knowledge and individual understanding held at various times
between 1965 and 1985, as well as the degree to which that knowledge was
disseminated within the key groups of decision-makers.
7.73 The Committee does however make the following comments. First, the
Committee's perusal of the minutes of HPAC and its Subcommittees also
indicates that there was concern about the need for accurate information
about the potency of the hormones produced by CSL during much of the period
of operation of the AHPHP.
7.74 Secondly, the Committee is concerned about the quality of the information
provided to the Allars Inquiry about batches. It has now been confirmed
that batch 128 was distributed and according to CSL was not contaminated
by hepatitis. The Allars Inquiry reported that this batch was contaminated
and not distributed. The Committee finds it difficult to accept that this
was simply a `transcription' error. Likewise, CSL has now indicated to
the Committee that batch 003 was reprocessed as batch 003-2. CSL indicated
that 003-2 was sterile and that batch 004 had no problems with sterility
and was issued.[85] The Allars
Inquiry lists batches 003 and 004 as being not distributed or withdrawn.
7.75 The publishing of incorrect information in relation to batches 003,
004 and 128 can only have added to the anxiety of recipients already reeling
from the knowledge that they were at risk of CJD and who realised that
they had in fact received these batches of hormone. It would also have
raised doubts in the minds of recipients as to the reliability of other
information contained in the Allars report concerning batches. The Committee
considers that the supply of incorrect information to the Allars Inquiry
may require further review in the light of the information now available.
See paragraph 7.181.
7.76 The Allars Inquiry Report provides an in depth examination of the
role of relevant government agencies in relation to the production and
use of hPG and hGH. The following highlights the findings of the Allars
Inquiry in relation to government agencies.
7.77 In June 1964, the Pharmaceutical Benefits Advisory Committee (PBAC)
recommended to the Minister that the addition of new preparations to the
list of benefit be subject to satisfactory analytical reports being received
from NBSL.[86] From 1966, compliance
with a specific or general standard was legally required for goods for
therapeutic use which were supplied as pharmaceutical benefits.
7.78 The Allars Inquiry found that NBSL had first become involved with
human pituitary derived hormones in 1966. At that time the Health Department
requested NBSL involvement in certain matters concerning the hormone.
Consequently, Dr Whitten, then an NBSL officer, warned of the problem
of viral contamination in the preparation of the hormones. While there
was action arising from this warning, the Allars Inquiry reported that
the product was not tested by NBSL. NBSL's next involvement with the hormones
was not until 1979 when NBSL contacted CSL about labelling of the product.
In 1984 NBSL again became involved over the proposed supply of hGH processed
in New Zealand and the need to improve manufacturing and quality control
standards for hPG and hGH.
7.79 The Allars Inquiry found that the reason for failure by NBSL to
test hormones for standard compliance was: an 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.[87]
7.80 The Allars Inquiry found that there was a lack of initiative on
the part of NBSL to develop an official standard, although the HPAC saw
the need for this and undertook a project in the 1970s and 1980s to isolate
highly purified hormones for the purpose of developing a radioimmunoassay.[88]
Further:
The Director-General of Health had a discretion in making arrangements
for the testing of pharmaceutical benefits. In the case of the pituitary
hormones, prior to the listing of the product, the Assistant Director-General
made a particular request for involvement by the 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 to advice. The Director-General
failed to insist that the advice be provided prior to making the recommendations
to the Minister that the hormones be listed.[89]
7.81 The Allars Inquiry also reported that NBSL was involved in evaluation
of commercial hGH in 1978 and 1981. Advice on the product from NBSL drew
attention to hepatitis and slow viruses and raised the issue of a warning
upon the labelling. The product was not approved for marketing in Australia.
90
7.82 In evidence, Dr Howes stated, in relation to NBSL's role:
In my submission I told how the viral products section of NBSL
was often prevented from exercising its statutory responsibilities.
I want to add to my submission a postscript about a statement to a Senate
committee in 1994 made by Dr Geoffrey Vaughan, then head of TGA. It
appears to confirm my story. I quote:
The relationship with the then National Biological Standards Laboratory
was such that the government elected not to regulate CSL through the National
Biological Standards Laboratory. Regulation of CSL and blood products
did not take place until the enforcement of the Therapeutic Goods Act
of 1989, which came into activity in February 1991.
7.83 In his submission, Dr Howes also noted that:
In 1966, Dr Lazarus, the Chairman of HPAC, was advised by Dr
Raby of NBSL, in writing, that the Ferguson fractionation technique
could not be relied upon to remove virus infectivity during the production
of pituitary hormones. HPAC evidently rejected that advice, for CSL
continued to make these hormones and HPAC permitted their clinical use;
in the IVF program in particular.[92]
7.84 Dr Whitten also submitted, in relation to the Allars Inquiry comments
on NBSL's failure to develop a standard, there were great difficulties
with developing a standard and pointed out that the US Food and Drug Administration
`did not produce standards but relied on collaboration with industrial
firms such as Ely Lille to produce the US and the WHO Standards'.[93]
7.85 The Pharmaceutical Benefits Scheme (PBS) was established to ensure
that all Australians had access to drugs and to secure government control
over the use and pricing of drugs. The Pharmaceutical Benefits Advisory
Committee (PBAC) was established to make recommendations to the Minister
about drugs which it considered should be available as pharmaceutical
benefits and to advise the Minister. The Director-General of Health had
the statutory discretionary power to make such arrangements as he considered
necessary for the testing or analysis of pharmaceutical benefits or of
drugs which may be used as pharmaceutical benefits.[94]
The policy, from 1962, in relation to this discretion was that when an
application was made for listing of a pharmaceutical benefit, a sample
of the product was provided to NBSL for testing.[95]
7.86 Under the National Health Act, the Minister may declare certain
drugs or medicinal preparations or classes of drugs or medicinal preparations
to be pharmaceutical benefits. The Minister may also make `special arrangements'
under s.100 of the Act to make pharmaceutical benefits available to certain
persons.
7.87 In March 1964, PBAC recommended that hPG and hGH be made available
as pharmaceutical benefits under s.100 of the Act on certain conditions.
In May that year, the Minister formally approved the recommendation for
hGH but that hPG be left as a matter between CSL and the expert group.
(This, according to the Allars Inquiry, may have been due to concern about
multiple births.)[96] The Allars
Report notes that this approval was not immediately implemented. In March
1967, the Minister approved the listing of both hGH and hPG when cooperation
of States health authorities in the national collection of pituitaries
had been gained.
7.88 The Allars Inquiry found that although the PBAC approval was conditional,
the hormones were listed without PBAC reconsidering whether the conditions
had been fulfilled. The approval of 1967 was an approval of a recommendation
of the Director General of Health, following correspondence between HPAC
and the Director General, rather than a recommendation of PBAC and appeared
to have been given `in haste'.[97]
7.89 The Allars Inquiry concluded:
(a) on the listing
...the history of the listing of the hormones is one of circumvention
of the PBAC and direct dealings between HPAC and the Director-General
of Health and the Minister. These decision-makers determined the details
of the scheme.[98]
(b) on testing by NBSL:
PBAC proceeded to list the hormones without having followed the
policy which applied to ensure appropriate exercise by the Director-General
of his discretion under the National Health Act, namely to list as pharmaceutical
benefits only those products which had been tested by NBSL.[99]
(c) on the Guidelines
The distribution of the hormones under s.100 of the National
Health Act appears to have been regarded by PBAC as a vehicle for delegating
to the expert committees [of HPAC] its normal function of setting restriction
for use of these pharmaceutical benefits. However, no formal delegation
of the powers of HPAC were made. HPAC did not get PBAC's approval of
the initial Guidelines...for approving patients for treatment with hGH
or hPG.[100]
(d) on the use of s.100
...it was sought to create a role for the expert committees which
would be responsible for approving patients for treatment.[101]
Further
It was an improper purpose and the Minister's decision to list
the hormones was an abuse of the power under s. 100.[102]
(e) on the role of government decision-makers
The government decision-makers who established the scheme of
regulation by expert committee must also take responsibility for having
placed these medical practitioners and scientists [members of HPAC and
its Subcommittees] in a position where they had such a responsibility,
and where the normal mechanisms for testing and review by NBSL and other
Departmental bodies, in the light of scientific knowledge, had been
circumvented.[103]
7.90 In relation to the Allars recommendation that s.100 be repealed
and replaced with a different provision, the Committee has noted in Chapter
3 that the recommendation is still under consideration as part of a review
being undertaken by the Attorney-General's Department.
7.91 ADEC was established in 1963 with an advisory role in relation to
the safety of drugs. From 1970 imported drugs had to be considered by
ADEC. However, the Allars Inquiry found that ADEC could have played a
role as the hormones were pharmaceutical benefits and PBAC could have
requested that ADEC play a role.[104]
The Inquiry also found that the potential for effective regulation was
undermined because of the leading role played by members of HPAC and its
Subcommittees. For example, when ADEC needed advice as to the safety of
imported hGH it sought advice from the Chairman of HPAC, Professor Lazarus,
and when it considered biosynthetic growth hormone, it sought advice from
the Endocrinology Subcommittee of ADEC, which was made up of members of
HPAC.[105]
7.92 From 1970 ADRAC undertook post-marketing surveillance of the safety
of medicinal drugs. Unless it received an adverse drug report, ADRAC has
no power to investigate. The Allars Inquiry reports that no report was
ever made to ADRAC by HPAC or any health professional about adverse reactions
to hPG or hGH.[106]
7.93 In relation to the referral of an adverse reaction report to ADRAC,
the Inquiry noted that ADRAC would have sought expert advice from HPAC.
This matter would have been referred to the FSH Subcommittee. The Inquiry
noted `this Subcommittee included amongst its members the medical practitioners
who were potentially the subject of such reports or who were colleagues
of the other practitioners who belonged to the small group of gynaecologists
approved to provide hPG treatment'. Thus ADRAC's potential for effective
regulation was undermined. In fact, the case of nontuplets was not reported
to ADRAC. Instead a report was made by HPAC to the Minister.[107]
7.94 Allars reported that there is no general legislation in Australia
regulating research conducted on human subjects. There is however general
regulation through the funding of projects meeting requirements of the
NHMRC as assessed by institutional ethics committees and the scheme for
general marketing approval for new drugs.[108]
7.95 The NHMRC funds research projects and requires grantees to comply
with its Statement on Human Experimentation and Supplementary Notes as
a condition of grants. The monitoring of compliance of research projects
with the Statement and Supplements is undertaken by institutional ethics
committees which have been established in hospitals and other research
institutions.
7.96 The NHMRC released its first statement on Human Experimentation
in 1966. The Statement was developed as a result of concerns that experimentation
such as that revealed in the Nuremberg trial should not re-occur and concerns
about the increasing incidence of medical negligence litigation in the
USA. Allars found that the Statement did not make a distinction between
therapeutic research in a clinical setting and non-therapeutic research
conducted upon `normal' subjects. The Statement was presented for guidance
only. Allars noted that the Statement was not referred to in any minutes
of HPAC meetings.[109]
7.97 The 1966 Statement was amended in 1973 in relation to consent; in
1976 to require all applicants for NHMRC grants involving human experimentation
to have their applications submitted to institutional ethics committees
for approval; and, in 1982 substantial amendments were made including
in relation to the maintenance of records and consent involving children,
the mentally ill and those in dependant relationships.[110]
7.98 The Allars Inquiry found that there was need for a definition of
what constitutes experimental medical treatment and it noted:
It is a dangerous situation if no attempt is made to draw the
lines between ordinary exercise of clinical judgment, research, experiment
and clinical trial, even if those lines be blurred lines. The absence
of lines is most dangerous when new advances in medicine are being explored
through new procedures, a particular problem in the field of reproductive
technology, as is illustrated by the treatment regimes operating under
the AHPHP and the Egg Project.[111]
7.99 As a result, Allars recommended that the NHMRC review the Statement
on Human Experimentation and issue a Supplementary Note on Reproductive
Technology Procedures. Allars also recommended that the NHMRC review the
General guidelines for medical practitioners on providing information
to patients and revise the Code of Practice for Transplantation
of Cadaveric Organs and Tissues. The implementation of these recommendations
is discussed in Chapter 3.
7.100 The Allars Inquiry investigation of the HPAC and its Subcommittees
exposed a number of matters of concern. These concerns and others raised
in submissions are highlighted below.
7.101 `Research allocations': Supply was approved for a number
of research projects some of which involved the clinical use of hGH and
hPG in breach of Guidelines for approved patients, for example the `Egg
Project' and women suffering from infertility due to reasons other than
anovulation. HPAC also did not insist upon submission of a research protocol
in relation to some projects. Further, HPAC generally 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 from 1966.
7.102 Ethical considerations: The FSH Subcommittee failed to have
sufficient regard to ethical considerations in regard to a number of matters
including: the approval of the use of out of date hPG for ovarian stimulation
tests in spite of CSL's disclaimer of responsibility; failure to sanction
adequately practitioners who failed to forward treatment sheets, failed
to return hormone when their participation in the program was suspended
or treated patients without approval; and its consideration of the problem
of hyperstimulation.
7.103 Conflict of interest: The Committee notes that some members
of the FSH Subcommittee were also treating practitioners and in 1973,
the FSH Subcommittee resolved that out of date hPG be issued to members
of the Subcommittee for patient use.[112]
Further, the CJD Support Group Network noted `the conflict of interest
in having a Subcommittee consisting largely of treating doctors was never
acknowledged or addressed'.[113]
7.104 Knowledge of CJD: As described above, HPAC failed to respond
appropriately to the knowledge of the risk of CJD. Members of HPAC and
its Subcommittees failed to recognise the limits of their expertise in
relation to unconventional slow viruses. However, the Allars Inquiry concluded
that some of the blame for this must also be shared by government decision-makers
who established the regulation of the scheme by expert committee.[114]
7.105 Exclusion criteria: As already noted, the Allars Inquiry
found that HPAC's response was reactive and it failed to keep abreast
of developments of scientific knowledge. The Committee also notes that
it appears that even some members of the Subcommittees did not know that
there were restrictions on the collection of glands. (See paragraph 2.23)
7.106 Regulatory role: Allars stated that although the expertise
of the medical practitioners who comprised HPAC and its Subcommittees
made them eminently qualified to provide advice on clinical and research
issues, their expertise disqualified them from serving in the role of
regulator. Allars found, for example, that HPAC failed in its regulatory
role as it did not act to stop the unregulated production of hormone by
Dr Brown in Melbourne. Further, the Inquiry found that in establishing
HPAC and its Subcommittees, the Minister, on the advice of the Director-General
of Health, `placed in the hands of those who ought to have been the subject
of regulation the very power of regulation itself'.[115]
Power to regulate quality control was conferred on the Fractionation Subcommittee,
in effect assuming the role which normally ought to have been performed
by NBSL. The Chairman was Dr Ferguson, whose process was used to extract
hormones, and members included Dr Brown and representatives of CSL. Thus
`CSL's representative participated equally in the decision-making of the
Subcommittee which was CSL's regulator'.[116]
7.107 The Committee considers that the Allars Inquiry raises serious
concerns about the role of government agencies in the establishment, control
and accountability of the AHPHP. Recipients have also pointed to the lack
of proper control over aspects of the AHPHP:
Reading the Allars report is a chilling experience if you are
an Australian who thinks we have a really good health system with lots
of checks and balances, that people cannot do things that are unsafe,
that all clinical trials are regulated and that the left hand does know
what the right hand is doing. Reading Allars is just horrific. It was
really Dracula in charge of the blood bank after 1976. Four people who
were intimately involved with the program are actually controlling the
program. The regulation of product is being conducted by somebody who
works for the organisation who is controlling the product and who invented
the process. There were no checks and balances. There was no independent
review. There was no scope of expertise. It was a very narrow, a very
self-interested group, who were running the Australian human pituitary
hormone program.[117]
7.108 The Committee considers that there is evidence to suggest that
treatment under the AHPHP was of a more experimental nature than has previously
been suggested. In this regard, the Committee notes that: HPAC made a
number of research allocations of hormones to projects outside the Guidelines;[118]
HPAC also allocated to its members out of date hormone for therapeutic
use on patients and for stimulation tests;[119]
hormone was used in patients who were not approved under the program;[120]
did not insist on the return of unused hormone;[121]
HPAC failed to insist upon submission of a research protocol in relation
to some projects; HPAC generally did not seek to reassure itself that
the consent of the subjects of the research had been gained;[122]
and anecdotal evidence of witnesses concerning the information provided
to them, the method by which the treatment was undertaken, especially
in the case of hGH where recipients described the methods of assessment
used during their treatment.[123]
7.109 Comments by Allars regarding the role and operation of HPAC and
its Subcommittees have been noted in paragraphs 2.82-83. In addition to
those comments, the Committee notes the following matters arising from
the Committee's examination of the minutes of HPAC and its Subcommittee.
The HGH Subcommittee minutes contain detailed discussion of difficult
cases and cases under review and the recommendations arising from those
discussions. The FSH Subcommittee minutes do not record discussions of
problems to the same extent. Further, the HGH Subcommittee invited observers
to its meetings in order to foster understanding of the Subcommittee and
its methods of working.[124]
The FSH Subcommittee did not undertake this practice. The Committee also
notes that the HGH Subcommittee met quarterly, while the FSH Subcommittee
met twice a year to 1979 and only annually from 1980 with its last meeting
before the cessation of the program being in December 1983. There also
appears to have been a lack of a consistent approach to issues between
the Subcommittees, for example, the FSH Subcommittee approved the use
of out of date hormone by its members while the HGH Subcommittee did not.[125]
7.110 Further, the Committee considers that the Department's comments
about the decision-making process in relation to the AHPHP and the matters
addressed by the Allars Inquiry concerning the role of government agencies
and accountability issues raise doubts as to whether the Department understands
its responsibilities in this area. The Committee notes that in her opening
statement on 13 August 1997, Professor Whitworth, Chief Medical Officer,
stated:
First, in reviewing the decisions made and the actions taken
in the establishment and management of the Australian human pituitary
hormone program during the 20 years the program was in operation, it
is important to be mindful of the fact that the program commenced 30
years ago. In the late 1960s through to the early 1980s, while the program
was in operation, the level of scientific knowledge was less and the
clinical standards and guidelines were different from those of today.
Developments in medical technology have brought with them a greater
focus on the importance of comprehensive guidelines and standards for
the conduct of medical programs. Modern communication technology speeded
the dissemination of information in a way that simply was not possible
even 10 years ago. In examining the Australian human pituitary hormone
program it is important to recognise that many people feel they have
gained significant benefits from their participation in the program
in that it assisted them to have a family or to overcome the problem
of short stature. With the benefit of hindsight, significant improvements
in knowledge and a substantial change in community expectations and
standards we are able to look back at the Australian human pituitary
hormone program, just as Associate Professor Allars did in her detailed
inquiry, and identify areas where actions do not accord with the standards
of today.[126]
7.111 While the Committee acknowledges that the decisions regarding the
establishment of the AHPHP were taken up to 30 years ago, the program
ran for 20 years and during that time it was open for the Department to
recommend and institute changes in administrative arrangements as standards
changed. In particular, the Committee notes that the power to regulate
was entrusted to those who ought to have been regulated and it appears
that this arrangement was never challenged. Further, matters such as the
unlawfulness of pituitary gland collection after the introduction of uniform
tissue legislation appear to have never been pursued by the Department
or raised by the Departmental representative on HPAC.
7.112 The Committee therefore considers that it is no excuse for the
Department to say that `the decisions taken regarding the establishment
and administration of the AHPHP were taken up to three decades ago and
were based on the standards of the day'.[127]
In fact this statement is erroneous. The Allars Inquiry reported matters
in relation to the listing of hPG and hGH which indicated that the hormones
were `dealt with in a manner inconsistent with the normal course of listing
and testing of a pharmaceutical benefit'.[128]
For example, PBAC's normal function of setting restrictions for the use
of pharmaceutical benefits were delegated to HPAC without any formal mechanism
and the Allars Inquiry noted that no other product listed under s.100
was monitored by an expert committee. Further, the Minister's decision
to list the hormones was an abuse of power under s.100.
7.113 It also must be remembered that during the 1970s and 1980s the
issue of accountability of government departments and agencies was a matter
of considerable debate within the public sector and examination by both
government and non-government agencies. Indeed, during that time the then
Senate Committee on Finance and Government Operations presented a number
of reports on the accountability of government agencies, statutory authorities
and non-statutory bodies.
7.114 The Committee also notes comments by the CJD Support Group:
The AHPHP did not happen long ago or in a different cultural
context. It was only eleven years ago that the Human Pituitary Advisory
Committee (HPAC) reluctantly accepted its own demise.[129]
7.115 Following the death of an hGH recipient in the USA, and consideration
of this by HPAC, on 24 April 1985 HPAC wrote to treating medical practitioners
advising them that no new patients were to be treated and that patients
currently under treatment with either hPG or hGH could continue treatment
but only if they had been informed of the possible risks and had consented
to continue therapy. This letter only advised practitioners to inform
their current patients of the risk. They were not requested to trace and
contact former patients. On 29 May 1985 a further letter from Professor
Lazarus to treating practitioners indicated that a hormone recipient had
died in the UK and that the program had ceased there. It advised that
practitioners cease immediately the use of hGH and hPG, except in the
case of childhood hypoglycaemia, and that hormone stocks be returned to
hospital pharmacies and CSL. No request was made to trace and contact
former patients.[130]
7.116 In a letter of 20 August 1985, approved hPG treating practitioners
were requested to verify information on patients believed to have been
treated over the period of AHPHP. The Department did not hold the address
of hPG recipients. This information was to be used by the Department to
conduct an epidemiological study. Due to lack of resources, this study
was gradually abandoned.
7.117 The next contact with treating practitioners was made in November
and December 1990 when the Chief Medical Adviser wrote a standard letter
advising treating practitioners that there had been one confirmed and
a possible second unconfirmed CJD death. He told practitioners to advise
recipients never to donate their blood, corneas or other tissue and to
arrange for recipients to receive appropriate counselling.
7.118 In early 1991, further letters were sent to practitioners. The
letter depended on the response the letters of November and December 1990
had elicited from the practitioner and expressed the view that:
...the medical practitioner was in the best position to provide
counselling and it would be inappropriate for the Department to intrude
in an area most effectively dealt with through clinical judgement and
an ongoing patient-doctor relationship.[131]
In this letter, practitioners were provided with a paper providing information
to assist in counselling and were asked to contact an officer in the Therapeutic
Goods Administration, who had a list of names of patients approved for
treatment under the AHPHP. 7.119 In January and February 1992, the Chief
Medical Adviser again wrote to treating practitioners confirming the second
death from CJD. Practitioners were reminded of the recommendation that
recipients be counselled about the possible health risks and were requested
to determine how many patients had been traced and counselled. Following
the fourth death from CJD, the Department wrote to treating practitioners
advising them of the death.[132]
7.120 In January 1992, the Department established a the CJD Unit. The
main function of the Unit was to answer telephone queries and to determine
whether callers had been treated with human pituitary derived hormones
under the AHPHP. From December 1992 the CJD 008 hotline was available
to callers inquiring about fertility and growth hormone treatment and
CJD.
7.121 In December 1992 and January 1993, advertisements were placed in
the Australian Women's Weekly and the New Idea magazines
asking people who thought they had been treated under the AHPHP to contact
the Department. A further advertising campaign was run in August/September
1994.
7.122 In March 1993, the CJD Unit sent standard letters to all treating
practitioners advising them that the Department had obtained assistance
from the Health Insurance Commission in tracing patients. The practitioners
were provided with a list of patients who appeared not to have been contacted
or counselled and were requested to indicate those not contacted and where
assistance from Medicare records was required.[133]
7.123 In October/November 1994, data matching was undertaken using the
Commonwealth Electoral Roll.
7.124 The Allars Report details the response to requests to trace recipients
by treating practitioners and hospitals in each state. The response was
varied. For example a treating practitioner at the Royal Children's Hospital
Adelaide commenced in 1985 to trace and contact hGH recipients, giving
them some information on the problems overseas and advising that they
should not donate blood or organs. Others remained reluctant to trace
recipients with one practitioner indicating to the Allars Inquiry that
he was concerned that `the nature of the disease and its rarity, and the
lack of a diagnostic test, all outweighed the benefit of disclosing the
risk'.[134]
7.125 In answers to parliamentary questions on notice, contact details
with hPG recipients were progressively disclosed: to 26 June 92, 352 women
contacted, to 31 December 92, 450 women contacted and to 11 August 93,
995 women contacted.[135] The
then Minister for Health indicated that 78 per cent of recipients had
been contacted by October 1993.[136]
Evidence to the Committee indicated that, at the present time, 90.2 per
cent of officially listed recipients have been contacted.[137]
7.126 The Allars Inquiry concluded that the response by medical practitioners
was slow, mainly due to lack of resources to undertake the task and the
need to devise methodologies for contacting patients. The Inquiry also
concluded that the Department should have taken steps to ensure that recipients
were made aware of the risk when the AHPHP was suspended in 1985. It did
not request treating practitioners to trace and counsel former patients
until 1990, the 1985 request being limited to current patients. The Inquiry
concluded that the Department had a moral duty to take steps to ensure
that recipients were made aware of the risk in 1985. It was stated in
the Allars executive summary that:
Such a response would have been in accordance with the fundamental
`right to know' of patients which finds its legal manifestations in
freedom of information legislation and the common law duty of disclosure
of medical practitioners.[138]
Further, the Inquiry found the Department should have provided assistance
in 1985 to practitioners through a coordinated program of tracing in connection
with the epidemiological study. 7.127 In its submission to the Committee,
the Department, in response to the Allars conclusion relating to tracing
of recipients, stated:
Given that there were not Australian cases of hormone recipients
having acquired CJD when the AHPHP ceased, no immediate action was taken
to trace recipients and advise them of the risk of CJD associated with
their treatment. With the benefit of hindsight it is now clear that
the Department should have made every effort to trace all hormone recipients
immediately following the cessation of the AHPHP in 1985.[139]
7.128 The Committee considers that it is quite clear that initially a
course least likely to draw attention to the risks of the program was
adopted, that is, the letter of 1985 which only asked practitioners to
advise their current patients of possible, unidentified, risks
associated with the use of pituitary extracts.
7.129 From 1985 to 1990 no effort was made by the Department to contact
recipients directly or to even ensure that practitioners had contacted
those who had been current patients in 1985. However, the Committee notes
three important developments during the period which it believes should
have raised significant concerns about the issue of public safety within
the Department. First, in February 1988 it was agreed by the National
Blood Transfusion Committee (NBTC) that the Red Cross would permanently
defer individuals who had received human pituitary-derived growth hormone
from being able to donate blood. Secondly, in July 1989 the Department
advised State Departments of Health that they should take action to ensure
that recipients of pituitary-derived treatment were excluded from organ
and blood donation.
7.130 Thirdly, and most importantly, on 27 April 1988 the Executive Secretary
of HPAC was informed that a patient at the Flinders Medical Centre, Adelaide,
appeared to have all the signs of CJD and that the patient had been treated
under the AHPHP. Allars reports that senior members of the Department
were informed of a possible case of CJD on 3 May 1988.[140]
The diagnosis was confirmed at post-mortem in November 1988. Due to confusion
about who was responsible for making a report to the Adverse Drugs Reaction
Advisory Committee (ADRAC), no report was ever made.[141]
7.131 The Committee considers that these three events were significant
and should have, at the very least, caused the Department to reconsider
its policy on contacting recipients. There is no evidence that these events
triggered any concerns about recipients `right to know', the impact on
recipients who did find out about the risk of CJD when trying to donate
blood, or public safety concerns arising from those recipients who may,
inadvertently, not have relayed to Blood Banks or organ donation agencies
that they had received human-derived pituitary hormone treatment and therefore
been excluded from donation.
7.132 When the Department decided in 1990 that a more concerted effort
should be made in relation to contacting recipients, it decided that the
contact should be made through the treating practitioner. The reason for
this decision was given in an answer to a question on notice in October
1993:
The Department took this approach because practitioners who supervised
the original treatment, and explained its potential benefits and risks,
should be in a better position to provide continuing counselling; and
because departmental records show whether treatment was approved. Clinical
records held by individual doctors are the only accurate guide to treatment
actually carried out.[142]
7.133 From the Allars Report, the Committee notes that some treating
practitioners had died, some had retired, in some cases there was no continuing
patient/doctor relationship and some practitioners were reluctant to contact
former patients. Further, treating practitioners at one Brisbane hospital
wrote to the Department pointing to the need for a coordinated approach
organised by the Department.[143]
Not surprisingly, the response to the 1990 letter was poor and the Department
wrote again to treating practitioners in January and February 1992. However,
even by November 1992 only 33 per cent of former recipients had been traced.[144]
7.134 The Committee considers that there may have been some justification
in the Department's 1990 decision to rely on medical practitioners to
trace patients. However, its continued reliance on this method of tracing
when such poor results were obtained was not justified. The Department
should have explored other avenues for tracing recipients well before
the further letters to practitioners were sent out in 1992 and its failure
to do so raises serious questions about the Department's decision making
processes.
7.135 The doubts over the Department's approach to tracing recipients
are brought in to sharp focus when the response of United States authorities
is considered. Following the death of three hGH recipients in the USA
in early 1985, an interagency committee met in May 1985 and decided that
an extensive epidemiological study should be conducted. By June 1986,
the National Institute of Health, the Food and Drug Administration, the
Centers for Disease Control and a contracted private company began the
design and execution of a systematic epidemiological study of the entire
recipient population. The primary goal of the study was to identify and
ascertain the health status of every individual treated with growth hormone.
To identify recipients, a tracing plan was devised using telephone records,
postal records, credit record system searches and driver's license record
searches. The results of this study were published in JAMA in February
1991.[145]
7.136 Between November 1992 and October 1993, the percentage of recipients
traced increased from 33 per cent to 78 per cent. While it may appear
that the Department's tracing efforts had been successful, it was not
always the case that it was the Department's initiatives that led to contact
with recipients. In evidence to the Committee many recipients indicated
that they had not found out about the risk of CJD from contacts initiated
by their treating practitioner or the hospital where they received treatment.
Rather, many found out the risk of CJD through the media, in particular
the 7.30 Report and Hinch program in 1992 or magazine articles.
Others discovered that they were at risk when they attended the Blood
Bank to donate blood. Many contacted the Department following this or
already new of their status by the time letters arrived or telephone contact
was made.
7.137 In her submission to the Committee, one recipient stated:
The way I found out about CJD was when I went to give blood at
the Blood Bank. Nobody can imagine the horror of 1. The way I found
out that I may have a fatal disease and 2. About the disease in general.
This whole matter has been dealt with extremely poorly and has caused
a great deal of anguish and stress.[146]
7.138 The Committee cannot but agree with recipients that to find out
about the risk of CJD through the media or at the Blood Bank was a horrifying
experience. As noted by the Allars Inquiry, for those receiving news of
the risk of CJD from the Blood Bank, different explanations from Blood
Bank staff were given to recipients for their exclusion, very little information
regarding the nature of the problem was given and no referral to counsellors
was provided. The Inquiry also found that there appeared to have been
no mechanism in place for dealing with requests by recipients that a note
be taken of their earlier donations.[147]
This would have no doubt added to the distress of recipients.
7.139 The Department's attitude displays a want of compassion and care
for a group of people who were receiving news which would impact on them
for the rest of their lives. The Department also displayed a lack of planning
as to how to deal with and provide services for those recipients who may
have found out about the risk of CJD at a Blood Bank.
7.140 In evidence, it was stated that tracing by the Department has largely
ceased.[148] The Committee considers
that while there remains a group of untraced recipients, there will be
doubts as to whether the Department has taken adequate steps to protect
public safety by informing recipients of the risk of CJD and not to donate
blood or organs. Recommendation 12: The Committee recommends that the
Department review all possible tracing methods in an attempt to identify
the remaining 190 or so untraced approved recipients.
7.141 In evidence provided to the Committee, recipients commented that
initially there was little information available about CJD. Some treating
practitioners provided an outline of the risks and description of the
disease to recipients while others, according to recipients, passed it
off as not being overly important. One recipient was told by their treating
practitioner that there was more chance of being run over by a bus than
contracting CJD. Other practitioners could provide little information
about CJD. One recipient commented:
I first learnt of the risk of CJD from a work colleague who heard
a radio segment which referred to a brain disease which was related
to hormone treatment. My early knowledge of CJD was basically from newspapers.
I found that difficult to obtain, inaccurate and often quite inconsistent.
It often left more questions unanswered than answered. I was later contacted
by my treating doctor, and that was the start of the formal process
of learning about the Creutzfeldt-Jakob disease.
7.142 In October 1993, in debate on the CSL Sale Bill, Mr Peter Costello,
MP, made the following comments:
For quite a long time I found that Australian women were ringing
me to get information about their medical risk status because the Commonwealth's
system of notification was so poorly organised in the initial stages,
and the Commonwealth was so reticent about making sure that the information
actually got to the women concerned.[149]
7.143 Initially telephone contact with the Department by recipients was
made through the general 008 number. From December 1992, the CJD 008 hotline
was established. Information concerning recipients was held on Departmental
patients' files and a database established by the FSH Subcommittee. The
latter was written in an archaic computer language and was transformed
into a new data base in January 1992. This database was used until March
1994. The Allars Inquiry found that there were persistent problems with
the information stored on the database.[150]
In 1994 a new database, the AHPHP Database, was established. The Allars
Inquiry had recommended that a new database be developed `so that it provides
a useful resource for recipients'. This database has been expanded to
include sections which relate to batch numbers and children of hPG recipients.
7.144 The Allars Inquiry found that Departmental officers were unduly
guarded in their response to recipients who sought information about their
treatment. They also declined to provide information to recipients directly,
requiring that they receive information about their own treatment through
a nominated medical practitioner. The Inquiry found that Departmental
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. The Inquiry concluded that this restrictive approach appeared
unnecessary. The Department's interpretation of s.135A has been discussed
in earlier chapters.
7.145 The Allars Inquiry found that initially, the Department's policy
was not to release batch numbers. Following the death of the third recipient,
the policy was changed and batch numbers were released. This information
was forwarded in letters to the nominated medical practitioner. The letter
also included the batch numbers known to have been received by the recipients
who had died of CJD. From 1995, recipients were provided with the opportunity
to obtain their batch numbers direct from the Department, by signing a
consent form. In both the letter to medical practitioners and to recipients
who requested batch numbers is a note that information on batch numbers
may be incomplete and that another source of information may be the clinical
records held by the treating practitioner. However, many recipients experienced
serious difficulties in gaining access to their medical records. The recommendations
of the Allars Inquiry concerning this matter are discussed in Chapter
3.
7.146 From 1993 the Department produced a newsletter known as CJD News.
The Allars Inquiry noted that there were concerns amongst recipients about
the level of information provided in the newsletter. This newsletter is
now known as the HPH newsletter.
7.147 The Committee considers that the Department's response to the information
needs of recipients were totally inadequate prior to the Allars Inquiry
investigation. Little attempt appears to have been made to prepare concise,
consistent and accurate information about CJD that could be conveyed quickly
to recipients. The Department, when requesting treating practitioners
to contact former patients failed to ensure that consistent information,
to an acceptable level, would be conveyed to recipients. It is clear from
the Allars Report that some practitioners themselves had little knowledge
of CJD and the level of potential risk.
7.148 From evidence the Committee received, there still appears to be
some problems with recipients accessing information. One `unapproved'
recipient indicated in her submission that the Department had questioned
her request to have her records corrected, refused to give her `correct'
records let alone the batch numbers of treatment received. This recipient
believed that the records had been made available to Rennick Briggs under
discovery.[151] At the Committee's
hearing in Melbourne the recipient indicated that the information on the
batch numbers had been provided on the Thursday before the hearing after
a two year wait.[152] The matter
of availability of information is also discussed in Chapter 3.
7.149 The Committee considers that it is imperative that recipients have
easy and quick access to the information they require. This would not
only act to remove a potential source of stress but it is also of paramount
importance that recipients have access to information concerning their
treatment in order to make informed decisions not only concerning their
health and any future medical treatment, but also in determining whether
to accept the settlement offer (as discussed in Chapter 5).
7.150 From 1988, recipients of human derived hormone were excluded from
donating blood and steps were taken to exclude recipients from donating
organs and tissues. See Chapter 2 for details. 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. In evidence to the Committee, Mr Hughes,
DHFS, stated:
...it followed concerns that had been raised by the recipient
community, by members of parliament and by the media in terms of protecting
the community from possible transmission through blood of CJD - ensuring
that it did not occur...The information that was released at that time
related to the names of the pituitary hormone recipients, date of birth,
gender and treatment type. At that time, only about 35 per cent of the
hormone recipients had been traced. The whereabouts of the majority
of recipients was still not known, so they could not be contacted.[153]
7.151 Concern has continued to be expressed by many recipients about
transmission of CJD through blood and organs. In an answer to an estimates
question on notice on 4 June 1997, the Department responded that `there
is no epidemiological evidence that human CJD has ever been transmitted
through blood or blood products'. An international consultation of experts
held in Geneva from 24 to 26 May 1997 concluded that blood transfusions
continue to be safe.[154]
7.152 Privacy issues have also been raised by recipients in relation
to their names being released by the Department to the Red Cross and organ
donation agencies. Following the release of names to the Red Cross, the
Department did not inform recipients that such action had been taken.
Mrs Sue Byrne stated:
It never seems to occurred to anybody to even tell that group
that this list of names had been released to the Red Cross. It seems
to have been a genuine oversight because there is a reference to information
being released but, from the way Professor Allars wrote it down, the
department knew what she was talking about, but none of the other people
that read the report realised what the report was saying, that the Red
Cross had listed our names. In February 1995 I was in casual conversation
with the head of the CJD task force at the time, talking about the Red
Cross, and people's feelings about not being able to be blood donors.
She said, 'Are you trying to tell me that you do not know that the Red
Cross has lists of your names?' I was most surprised. I said, 'No, we
most assuredly do not know that the Red Cross has lists of our names.'
The department appeared to be genuinely unaware that, somewhere between
1993 and 1995, someone had forgotten to tell us. The department took
steps immediately to let all recipients that were on their mailing list
know. In March 1995, there was an [edition] of the HGH news which told
all recipients exactly what information was held and who held it.[155]
7.153 The husband of a recipient also commented:
In 1992, the department started to distribute information without
notifying the then contacted list of recipients or attempting to discuss
the issue. In our submission to Professor Allars in 1993, we noted major
concerns about databases and their management while the department was
disseminating data, without informing those recipients what it had found,
or adding more resources to find the other recipients. The department
notified support group coordinators in February 1995, not recipients
directly, regarding the dissemination of information. There is still
a question regarding how many recipients actually know. Nobody can give
us a straight answer.
And further:
In December 1994, a letter from Ms Dunlop, giving an outline
of the database structure, was supplied to us. Children's names, birth
dates and sex are listed as fields within the database. I ask the question:
why? It appears that the department adds fields to the database on an
as required basis. What does this mean? Where is the information sent,
who collates it and who controls it?[156]
7.154 The Department advised that information identifying hormone recipients
had been released to blood and organ tissue donation banks pursuant to
paragraph 135A(3)(a) of the National Health Act as being necessary in
the public interest. The release of hormone recipients' details was done
in accordance with Information Privacy Principle 11(1)(d) of s.14 of the
Privacy Act. The Privacy Commissioner confirmed in December 1995 that
the disclosures complied with the Privacy Principle and were authorised
by law. However, the Privacy Commissioner was concerned that the Department
did not:
apparently attempt to contact those people whose personal details
were on the list, and whose current contact details were known. Such
contact prior to the publication of the lists, would, at the very least,
have alerted those listed to the intended course of action and given
them an opportunity to express any concerns that they held.[157]
7.155 Information on the details of the information fields retained in
the database was also provided by the Department. Comments on the response
to the Allars Inquiry recommendation relating to the database is in Chapter
3.
7.156 Evidence was also given that as part of the epidemiological study
undertaken in the USA following the cessation of its hormone program,
de-identifiers were applied to maintain the confidentiality of individuals.
Mrs Byrne also indicated that work is proceeding on a method of coding
of the lists of recipients that have been provided.[158]
7.157 The Committee considers that as there were delays in informing
recipients of the risks of CJD blood and organ donations, some recipients
may have inadvertently made donations. Further, there appears to have
been some confusion over who was to be excluded from donation and the
NBTC did not exclude explicitly hPG recipients until November 1990.
7.158 The Committee concludes that the Department failed to act promptly
to minimise the possibility of a person treated with human pituitary-derived
hormone from donating blood and organs and thereby calls into question
its commitment to maintaining the highest levels of public safety in Australia.
7.159 In relation to the privacy issues raised, the Committee considers
that the establishment of a method of coding names held by the Blood Bank
and other organisations be undertaken as a matter of priority. Recommendation
13: The Committee recommends that the coding system being developed for
lists of recipients distributed to Blood Banks and organ and tissue agencies
be completed as a matter of priority.
7.160 The Committee has considered the matter of an epidemiological study
in Chapter 3 of this Report and has recommended that the decision not
to proceed with an epidemiological study be reconsidered.
7.161 The Allars Inquiry found that there were a group of recipients
of hormones including those who received hormones who were not approved
to do so by HPAC or its Subcommittees. These include individuals who received
hormones before the official commencement of the AHPHP, those who received
hormone produced by other groups (VPG and Dr Brown), those who only received
a simulation test, those who were treated for cervical mucus problems,
those treated with research allocation of hormones for example, the Egg
Project and IVF Program and those who were treated with `left over' hormones
by a treating practitioner.
7.162 The Allars Inquiry reported that the Department had experienced
great difficulty in tracing unapproved recipients. Details are often held
on records held by treating practitioners and would require a time consuming
search to locate all persons treated. Some treatments were not recorded.
However, some treating practitioners who treated persons not approved
have provided the Department with names of recipients and the Department
pursued a number of practitioners who had undertaken research programs.[159]
7.163 The Department's AHPH Database records 188 people as unapproved
recipients. In evidence it was stated:
According to our tracing figures, 28 per cent of those people
have been traced. The very nature of the fact that they were not approved
for treatment by HPAC means that the department has no record, or very
little record, of the people involved. We attempted to trace them by
contacting doctors who had indicated that they had treated people outside
the program or were involved in the various research protocols. On the
basis of their work we have tracked about 28 per cent, as I said.[160]
Those unapproved recipients who have been traced are included on the
Database, receive the HPH Newsletter and took part in the Department's
survey. 7.164 In evidence, concerns were voiced about the status of unapproved
recipients:
It is people who know that they have been treated and the doctor
has actually advised the health department about and yet are unofficial
who I am concerned about. They are at the same risk. I am also concerned
whether or not their names are on the blood bank lists. It only takes
one injection to be at risk...Some doctors have come clean and told
the department, others haven't. This is why there are bound to be a
lot of unofficial people out there that doctors have treated like this.
The doctors are keeping quiet and these people do not know and will
never know of their risk.[161]
7.165 The Committee considers that the Department's efforts in identifying
and tracing unapproved recipients have been inadequate. Further, this
lack of effort raises serious questions about the Department's commitment
to `adequately protect public health and safety'. This is highlighted
by the measures in place in respect of official recipients with lists
of names being provided to blood banks and recipients being provided with
letters concerning precautions to be taken by health care personnel when
treating the recipient.
7.166 Evidence received from the Department added to the Committee's
concerns about unapproved applicants. It was stated by Mr Hughes of DHFS
that there were 500 to 600 unapproved recipients.[162]
When the Committee requested clarification of this information, DHFS only
provided the number of unapproved recipients on its database. It did not
clarify the figure of 500 to 600 as requested nor did it provide any information
as to how it came to this figure or the groups it covered. The Committee
considers that the answer provided was unacceptable and a further example
of the Department's lack of effort in relation to unapproved recipients.
7.167 The Committee considers that although it is obviously very difficult
for the Department to trace unapproved recipients, resources should continue
to be devoted to this task. Until tracing of both approved and unapproved
recipients is complete, there will still be concerns about whether public
safety has been adequately protected. Recommendation 14: The Committee
recommends that the Department continue to devote resources to tracing
unapproved recipients of human-derived pituitary hormones.
Recommendation 15: The Committee also recommends that once it is established
that a person did receive hPG or hGH from the AHPHP, the recipient's status
should be of no difference to that of approved recipients. In the event
of a dispute between the Department and a person who claims to have received
human pituitary derived hormone, the matter should be referred to an independent
arbitrator for resolution.
7.168 Very late in the Committee's inquiry, evidence was received that
there was a probable sixth case of CJD. This information has been circulated
on the Internet and throughout the recipient community since July 1997.
The Committee acknowledges the ramifications this evidence has for the
recipient community.
7.169 At the hearing of 25 August 1997, the following evidence from Dr
Cathy Mead, Director, National Centre of Disease Control, was taken:
The department has not formally received any
clinical information on the possible sixth case. The
information would initially go to the CJD case register and the register
would consider whether to include such a case in their register of cases.
The department would also receive the information officially to consider
the eligibility of the person for access to the trust fund but, to date,
we have not received any application for that, so we have not received
any clinical information. The process for considering eligibility for
the trust fund involves referring the clinical information to an independent
panel. We have established the independent panel, but we have not yet
got the material to refer to them. As soon as we do, we can refer it
to the panel. As soon as they have formed their advice, we could act
on it.[163]
[emphasis added]
7.170 On 19 September, a report in the Sydney Morning Herald stated
that a sixth recipient believed to have contracted CJD has been offered
compensation by the Commonwealth. The report also stated that Rennick
Briggs is negotiating on behalf of the recipient who is seeking compensation
for common law damages, loss of life expectancy, loss of income and pain
and suffering. The Committee notes that this claim is in accord with the
settlement offer that has been made to all recipients.
7.171 The report also stated that `the Government was about to alert
APHPH recipients through a newsletter that the patient's treatment appeared
to include injections from CSL batch 003-2'.
7.172 On the same day as the report appeared in the SMH, an edition of
the HPH Newsletter was distributed. The Newsletter advised
that a former recipient had `developed a neurological condition for which
no definitive cause has been found. On the basis that the woman concerned
was treated under the AHPHP, CJD must be considered high on the list of
probable causes.' It was also reported that the case had been considered
by the independent panel of experts which had stated that `further evidence
would be required before a definitive diagnosis could be made'. The Department
did however indicate that, based on advice from the independent panel,
it had decided that `assistance should be provided to the former recipient
and her family through the Human Pituitary Trust Account. Assistance to
the family has already commenced'. The Department also confirmed that
the recipient had received batch 003-2 and that treatment was received
sometime between 1968 and 1971. 164
7.173 It is with regret that the Committee learnt of the confirmation
of the probable sixth case of CJD. The Committee expresses its sympathy
for the recipient and her family. Such news is also causing renewed anxiety
within the recipient community, particularly as the recipient was treated
very early in the program.
7.174 In relation to the Health Department's response to the probable
sixth case, the Committee is concerned that it appears that the Department
has again failed to respond adequately to a situation which has far reaching
implications not only for one particular recipient and her family but
also the whole recipient community.
7.175 First, the Department stated to the Committee that it was waiting
on an `application' from the recipient or her family before making any
decisions about assistance to be provided. This appears to the Committee
to be a passive and overly officious response to a very grave situation.
Given the Commonwealth's commitment to ensuring that any recipient contracting
CJD is adequately cared for, and the possible rapid onset of the final
stages of the disease, the Department should have been more proactive
in regard to the news that a recipient may have contracted CJD. The Committee
considers that Departmental officers should have made personal contact
with the recipient when it first became known that the recipient may have
contracted CJD. This not only would have provided support to the recipient
and her family at a very distressing time, but may have forestalled the
difficulties that now appear to have arisen between the family and the
Department (see paragraph 7.177). Further, the Committee notes recent
Ministerial statements emphasising that sympathetic, personal and `customer
friendly' approach was required in service oriented departments.[165]
The Committee believes that the Department should be acting upon this
approach and that given the circumstances of this recent case, early intervention
on a personal level was called for.
7.176 Secondly, the Department did not inform recipients that there may
be a sixth victim before the matter was raised in the media. Learning
such news through the media must have added to the anguish of many recipients.
The Committee considers that the Department should have taken steps to
inform recipients about the probable sixth case and of her treatment circumstances
before the news was reported in the media and to provide as much information
as possible.
7.177 The Committee also understands that there are difficulties in the
Commonwealth negotiating the settlement with the recipient's family and
that it is possible that the matter will need to be arbitrated. The Committee
considers that this action increases anxiety at this particularly difficult
time.
7.178 The Committee also notes that there are other matters relating
to batch 003-2 which was received by the recipient. Further, the recipient's
husband has raised with the Committee additional concerns at the actions
by officers of both CSL and the Health Department.[166]
The Committee considers that in the present difficult circumstances, there
is a need for all Commonwealth officers to be careful to avoid any misinterpretation
of their communications with families under stress. Nevertheless, the
Committee notes that officers at times have to undertake duties which
sometimes involves passing on or seeking information from people which
may be disturbing to those people. Recommendation 16: The Committee
recommends that the Department put in place protocols to ensure sympathetic
early intervention so that information and assistance is provided to a
recipient suspected to have contracted CJD as soon as the recipient's
condition becomes known, rather than await official confirmation.
Recommendation 17: The Committee recommends that the Department inform
the recipient community of the steps to be taken to make an application
to the Department for assistance, including the persons to be contacted
and the information required, in the event that it is suspected that a
person may have contracted CJD.
7.179 Many recipients and their supporters consider that matters disclosed
by the Allars Inquiry and other information they have provided establishes
that there has been a failure to adequately protect public safety in relation
to the AHPHP. In some instances, recipients have indicated that they feel
this amounts to negligence and that criminal prosecutions should be launched
where the evidence indicates illegality.[167]
7.180 The Committee has highlighted many of the concerns and adverse
findings reported by the Allars Inquiry in relation to the establishment
of the AHPHP, the preparation of the hormones, the role of government
agencies and the decisions and actions of the Department following the
suspension of the AHPHP.
7.181 As has already been indicated, the Committee is unable to make
an authoritative judgment on the merits of the scientific and technical
information provided in evidence to this Committee. However, the Committee
considers that some of the further information which came to light during
the inquiry does raise serious concerns and warrants a further review.
It also appears that some of this information was not available to the
Allars Inquiry. Recommendation 18: The Committee recommends that in
view of the availability of further information (much of which is conflicting
in its nature) which may not have been considered by the Allars Inquiry,
Professor Margaret Allars be invited to review, with the necessary independent
scientific advice, this further information on scientific and other matters
concerning the AHPHP which has become available since the Allars Inquiry
reported. If Professor Allars is unavailable, another suitably qualified
independent person be invited to undertake the review. 7.182 In making
this recommendation, the Committee does not in any way dispute the findings
of the Allars Inquiry. Rather, the Committee believes that Professor Allars
be given the opportunity to weigh up the new material in the light of
her earlier findings.
7.183 The Committee has, however, come to a number of conclusions in
relation to the role and actions of the Health Department:
- the Department appears to lack an understanding of the ethical matters
and accountability issues raised in the Allars Inquiry;
- the Department's failure to respond to developments between 1985 and
1988 raise serious concerns about the decision-making processes within
the Department;
- the Department's response to tracing and contacting recipients following
the suspension of the AHPHP was inadequate;
- the Department's failure to ensure that recipients were supplied with
information concerning the risk of CJD in a consistent, comprehensive
and organised manner points to a lack of planning within the Department
and a failure to understand the needs of the recipient community;
- it appears that some recipients are still experiencing difficulties
with accessing information held by the Department;
- the Department's failure to act promptly to minimise the possibility
that a person treated with human pituitary-derived hormone may have
donated blood and organs calls into questions its commitment to maintaining
the highest levels of public safety in Australia; and
- the Department failed to inform recipients that their names had been
supplied to Blood Banks and organ donation agencies.
Further, the Committee is concerned that incorrect or incomplete information
was provided to the Allars Inquiry concerning possible contamination of
batches of hormone and whether or not they were distributed for recipient
treatment. The Committee considers that this has added to the distress
of some recipients and should not have occurred.
Senator Mark Bishop
Chairman
October 1997
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Footnotes
[1] Submission No.12, p.4.
[2] Transcript of Evidence,
12.8.97, p.9.
[3] Transcript of Evidence,
12.8.97, p.32.
[4] See for example submission
No.41, p.1.
[5] Submission No.43, p.4.
[6] Submission No.92, p.4.
[7] Submission No.5, part 3, attachment
13.
[8] Allars Report, p.370.
[9] Allars Report, p.370.
[10] Submission No.5, part 3, p.3.
[11] Allars Report, p.68.
[12] Allars Report, p.68.
[13] Allars Report, p.396.
[14] Submission No 27, pp.5-6.
[15] Submission No.24, p.19 (CJDSGN)
[16] Submission No.85, p.30 (DHFS).
[17] Allars Report, p.371.
[18] Allars Report, pp.95, 738.
[19] Allars Report, p.95.
[20] Allars Report, p.372.
[21] Submission No.85, CSL Attachment,
p.5 (DHFS).
[22] Allars Report, p.411.
[23] Submission No.73, p.3.
[24] Submission, No.86, pp.4,
13-15.
[25] Transcript of Evidence,
13.8.97, p.92.
[26] Transcript of Evidence,
13.8.97, p.92.
[27] Submission No.1, 12.7.97,
p.1.
[28] Allars Report, p.100.
[29] Submission No.1, 12.7.97,
p.1. See also Submission No.73, p.4.
[30] Submission No.86, p.12.
See also Submission 1, 12.7.97, p.2.
[31] Submission No.1, 12.7.97,
p.2.
[32] Transcript of Evidence,
13.8.97, p.97.
[33] Transcript of Evidence,
13.8.97, p.91.
[34] Submission No.85, CSL Attachment,
p.5 (DHFS).
[35] Transcript of Evidence,
25.8.97, p.183.
[36] Transcript of Evidence,
13.8.97, p.84. Dr Peters also tabled a CSL internal memo in relation to
testing of batch 128.
[37] Submission No.1, 12.7.97,
p.1.
[38] Transcript of Evidence,
13.8.97, p.87.
[39] Submission No.85, CSL Attachment,
p.4 (DHFS).
40 Submission No.85, CSL Attachment, p.5 (DHFS).
[41] Transcript of Evidence,
13.8.97, p.130.
[42] Transcript of Evidence,
13.8.97, pp.129-30.
[43] Submission No.85, CSL Attachment,
p.5 (DHFS).
[44] Transcript of Evidence,
13.8.97, pp.91-92.
[45] Transcript of Evidence,
13.8.97, p.146.
[46] Transcript of Evidence,
13.8.97, p.153.
[47] DHFS supplementary information,
22.8.97, Appendix 1-CSL response, pp.1-6.
[48] Dr Howes, supplementary
information, 22.9.97.
[49] Macedones, supplementary
information, 25.9.97.
[50] Allars Report, pp.292-94.
[51] Allars Report, Executive
Summary, p.2.
[52] Allars Report, p.333.
[53] Allars Report, p.346.
[54] Allars Report, p.372.
[55] Allars Report, p.350.
[56] Allars Report, p.353.
[57] Allars Report, p.357.
[58] Allars Report, pp.310, 357.
[59] Allars Report, pp.361,372.
[60] Allars Report, p.373.
[61] Allars Report, p.373.
[62] Submission, No.92, p.4.
[63] Submission No.1, 1.8.97,
p.2.
[64] Submission No.1, 1.8.97,
p.3.
[65] Submission No.73, p.6.
[66] Transcript of Evidence,
13.8.97, p.79.
[67] Transcript of Evidence,
13.8.97, p.124.
[68] Transcript of Evidence,
25.8.97, pp.230-31.
[69] Submission No.5, part 3,
p.4.
[70] Allars Report, p.96.
[71] Submission No.85, CSL Attachment,
p.5 (DHFS).
72 Allars Report, pp.200-01.
73 Submission No.5, part 3, pp.7-8. See also submission No.1, 1.8.97,
p.4.
[74] Submission No. 73, p.4.
[75] Submission No.73, Attachment
3, p.5.
[76] Submission No.73, p.4.
[77] Transcript of Evidence,
13.8.97, pp.89-90.
[78] Transcript of Evidence,
13.8.97, p.94.
[79] DHFS supplementary information,
22.8.97, Appendix 1-CSL response, p.4.
[80] Submission No.85, CSL Attachment,
p.4 (DHFS).
[81] Allars Report, p.447.
[82] Transcript of Evidence,
13.8.97, p.88.
[83] DHFS supplementary information,
22.8.97, Appendix 1-CSL response, Attachment 4.
[84] DHFS, supplementary information,
22.8.97, Appendix 1-CSL response, p.5.
[85] DHFS, supplementary information,
22.8.97, Appendix 1 - CSL response, pp.1-6.
[86] Allars Report, p.436.
[87] Allars Report, p.488.
[88] Allars Report, p.490.
[89] Allars Report, pp.494-95.
90 Allars Report, p.503.
[91] Transcript of Evidence,
13.8.97, pp.92-93.
[92] Submission No.86, p.11.
[93] Submission No.5, part 3,
p.9.
[94] Allars Report, p.434.
[95] Allars Report, p.496.
[96] Allars Report, p.495.
[97] Allars Report, p.496.
[98] Allars Report, p.496.
[99] Allars Report, p.496.
[100] Allars Report, pp.497-98.
[101] Allars Report, p.498.
[102] Allars Report, p.501.
[103] Allars Report, p.373.
[104] Allars Report, p.502.
[105] Allars Report, p.509.
[106] Allars Report, p.503.
[107] Allars Report, p.509.
[108] Allars Report, p.448.
[109] Allars Report, p.451.
[110] Allars Report, pp.452-53.
[111] Allars Report, p.722.
[112] FSH Subcommittee, Minutes
of meeting, 20.9.73.
[113] Submission No.24, p.19
(CJDSGN.)
[114] Allars Report, p.373.
[115] Allars Report, p.507.
[116] Allars Report, p.507.
[117] Transcript of Evidence,
12.8.97, pp.11-12.
[118] See for example, HPAC
Minutes of Meeting, 12.12.74, 2.6.82; FSH Subcommittee, Minutes of Meeting,
30.9.77, HGH Subcommittee, Minutes of Meeting, 1.6.72, 14.11.74.
[119] FSH Subcommittee, Minutes
of Meeting, 24.9.71.
[120] See for example Submission
No.4. The Committee also notes that the HGH Subcommittee did not approve
treatment but the practitioner proceeded nonetheless, Minutes of Meeting,
15.11.73.
[121] FSH Subcommittee, Minutes
of Meeting, 30.3.73.
[122] Allars Report, Executive
Summary, p.7.
[123] See for example, Submission
Nos: 12, pp.1-2; 14, pp.1-2; 35, p.2; 41, p.3; 49, pp.1-2; 63, p.1; 71,
p.1; 75, p.1; 90, pp.1-2.
[124] See for example, HGH
Subcommittee, Minutes of Meeting, 29.8.74.
[125] FSH Subcommittee, Minutes
of Meeting, 24.9.71; HGH Subcommittee, Minutes of Meeting, 8.12.77.
[126] Transcript of Evidence,
13.8.97, p.119.
[127] Submission No.85, p.33
(DHFS).
[128] Allars Report, p.495.
[129] Submission No.24, p.20
(CJDSGN).
[130] Allars Report, p.604;
DHFS, supplementary information, 29.8.97, Attachments 1 & 2.
[131] Allars Report, p.605.
[132] Allars Report, p.606.
A copy of the letter dated 31.1.92 is in DHFS, supplementary information,
29.8.97, Attachment 3.
[133] Allars Report, p.598.
[134] Allars Report, p.608.
[135] House of Representatives
Hansard, 18.8.92, p.88; 27.9.93, p.115; 5.10.93, p.1699.
[136] Senate Hansard, 21.10.93,
p.2326.
[137] Submission No.85, p.12
(DHFS).
[138] Allars Report, Executive
Summary, p.9.
[139] Submission No.85, p.33
(DHFS).
[140] Allars Report, p.588.
[141] Allars Report, p.590.
[142] House of Representatives
Hansard, 5.10.93, p.1699.
[143] Allars Report, p.610.
[144] Submission No.85, p.12
(DHFS).
[145] JAMA, February 20, 1991,
Vol 265, No 7, pp 880-04; Westat Inc, Protocol for Phases III and IV of
the Human Growth Hormone Recipient Followup Study, 7 April 1987.
[146] Submission No. 6, p.1.
[147] Allars Report, pp.660-01.
[148] Submission No.24, p.3
(CJDSGN).
[149] House of Representatives
Hansard, 27.10.93, p.2666.
[150] Allars Report, p.600.
[151] Submission No.18, p.2.
[152] Transcript of Evidence,
12.8.97, p.15.
[153] Transcript of Evidence,
13.8.97, p.144.
[154] CA Legislation Committee,
Transcript of Evidence, 4.6.97, CA 258.
[155] Transcript of Evidence,
13.8.97, pp.110-11.
[156] Transcript of Evidence,
12.8.97, pp.34-35.
[157] DHFS, information tabled
at hearing, 25.8.97
[158] Transcript of Evidence,
13.8.97, p.111.
[159] Transcript of Evidence,
13.8.97, p.142.
[160] Transcript of Evidence,
13.8.97, p.142.
[161] Transcript of Evidence,
12.8.97, p.26.
[162] Transcript of Evidence,
13.8.97, p.142.
[163] Transcript of Evidence,
25.8.97, p.185.
164 HPH Newsletter, September 1997.
[165] Prime Minister, Press
Release, Launch of Centrelink, 24.8.97; Minister for Social Security,
Press Release, New Centrelink Network Launched, 24.8.97.
[166] Mr Peter Bansemer, correspondence
dated 19.9.97.
[167] For example, Submission
No.63, p.4.
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