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APPENDIX 3 - EXECUTIVE SUMMARY OF ALLARS REPORT
INQUIRY INTO THE USE OF PITUITARY DERIVED HORMONES IN AUSTRALIA
AND CREUTZFELDT-JAKOB DISEASE
Index
1. Scientific Knowledge of Risks and Benefits
2. Treatment, including Information Provided to Patients and
Informed Consent
3. Manufacture of Hormones and Collection of Pituitaries
4. Response by Department and Others on Cessation of Program
5. Tracing, Identification, Counselling and Support
6. Regulation of Medical Programs
7. Consent
8. Priorities for Research
The purpose of the Inquiry was to examine the operation of
the Australian Human Pituitary Hormone Program (AHPHP) and to report on
issues arising from that examination. Under the AHPHP human growth hormone
(hGH) was supplied for the treatment of growth hormone deficiency and
human pituitary gonadotrophin (hPG) was supplied for the treatment of
infertility, to approximately 2,100 patients in Australia. The following
provides a summary of the findings and recommendations of the Inquiry
in respect of each of its terms of reference.
1. SCIENTIFIC KNOWLEDGE OF RISKS AND BENEFITS
Terms of reference. The Inquiry was requested
to examine and report on the decisions taken to establish and continue
the AHPHP in the light of scientific knowledge of the risks and benefits
at the relevant times (See particularly Chapter 5 and also Chapter 4)
The decisions taken in the 1960s to establish the AHPHP are examined in
pare 3(b) below. The program was administered by an expert committee of
medical practitioners established by the Minister for Health in 1967,
called the Human Pituitary Advisory Committee (HPAC) and by its three
Subcommittees, the Fractionation Subcommittee, the Human Growth Hormone
Subcommittee (HGH Subcommittee) and the Follicle Stimulating Hormone Subcommittee
(FSH Subcommittee). The decisions to continue the AHPHP until 1985, taken
by HPAC and the Fractionation Subcommittee, in the light of scientific
knowledge, are summarised here.
Developing knowledge of CJD. The Inquiry
found that from the first description of CJD as a disease in 1920. knowledge
of CJD grew as a result of research, chiefly conducted from the late 1960s
in relation to other spongiform encephalopathies, in particular kuru.
Transmissibility of CJD by inoculation of chimpanzee brains was reported
in 1968, and the first suspected iatrogenic person-to person transmission
by corneal transplant was reported in 1974. In 1974 warnings appeared
in the literature regarding the need for special precautions beyond routine
sterilisation procedures in order to inactivate the CJD infective agent.
The 1977 Nobel Prize winning paper of Gajdusek contained warnings of the
possible general implications of current knowledge of transmission of
kuru and CJD. The first confirmed case of iatrogenic person-to-person
transmission of CJD was also reported in 1977. [paras 5.01-5.37]
No link made by neuropathologists and little knowledge
of other specialists. Nevertheless this knowledge about
CJD was very specialised, falling within the field of neuropathology.
Neuropathologists, including Gajdusek, did not make a link between their
knowledge of the transmissibility of CJD and the use of pituitaries in
growth hormone programs. In the late 1960s and early 1970s, pathologists
and members of the medical community generally in Australia, took great
interest in Gajdusek's investigations into kuru in Papua New Guinea. However,
there was little understanding of the mode of transmission of the disease.
Throughout the 1970s and early 1980s paediatric endocrinologists and obstetrician
gynaecologists who treated patients under the AHPHP knew little or nothing
about CJD. [paras 5.38-5.561]
Two avenues for ensuring safety. From the commencement
of the AHPHP, CSL and members of HPAC believed there were two avenues
for ensuring the safety of the hormone product from viral contamination.
The first was through criteria excluding the collection of glands from
certain cadavers. The second was the method of processing the pituitaries.
Exclusion criteria, With regard to the
first avenue for ensuring safety, HPAC established criteria excluding
from the collection program pituitaries from cadavers affected by certain
diseases. These exclusion criteria are described in paragraph 3(a) below.
HPAC members were aware in 1971 of the danger of pituitaries infected
by slow viruses (which would have included CJD) and amended the criteria
accordingly. For a period of time from 1977 the criteria did not clearly
exclude cadavers infected by neurological diseases. In 1983 CJD was expressly
included in the criteria. However, in general during the operation of
the AHPHP, HPAC and Commonwealth Serum Laboratories Ltd (CSL) failed to
communicate the exclusion criteria to pathologists and mortuary attendants.
Even if the exclusion criteria had been effectively communicated and monitoring
for compliance attempted, this first avenue for securing safety from contamination
by the CJD pathogenic agent was a crude and unenforceable means of screening.
Given the long incubation period for CJD prior to the appearance of symptoms,
it was always possible for an infected pituitary to be collected and processed.
Statistically in a sample of 10,000 unscreened glands, at least one and
as many as ten glands would have come from patients either dying from
or incubating CJD.
Extraction method With regard to the second
avenue for ensuring safety, the extraction method at CSL was understood
by members of HPAC to exclude viral contamination. On account of their
higher molecular weight, viruses and bacteria were regarded as coming
off the fractionation column first, leaving the smaller sized hormone
particles free from contamination. However, in 1980 Prusiner published
research demonstrating the small size of the infective agent in unconventional
slow viruses. This research raised the possibility that not all "viruses"
would be removed in the Ferguson process. Some members of HPAC became
aware in the late 1970s, through their attendance at scientific meetings
overseas, that a study was being conducted by Dr Alan Dickinson to test
the capacity of the process used in the United Kingdom growth hormone
program to eliminate the CJD infective agent. In early 1980, following
a discussion about slow viruses with the Director of the United Kingdom
growth hormone program, Professor Lazarus, the Chairperson of HPAC, promptly
brought the issue to the attention of the Fractionation Subcommittee and
HPAC at their subsequent meetings.
HPAC fails to respond appropriately to the knowledge
of the risk The Fractionation Subcommittee and HPAC took the view,
incorrectly in the light of scientific knowledge in 1980. that a slow
virus is not positively linked with a disease present in the community.
Instead of re-assessing the program or seeking expert advice, the Subcommittee
and HPAC assumed that since the technology did not exist for direct detection
of slow viruses, acknowledgement of the potential dangers was all that
was possible. However, other options were available [paras 5.77, 5.78,
5.99].When the results of the Dickinson study became known informally
in 1982. HPAC members took comfort from the fact that infectivity had
been removed in the processing of hGH in the United Kingdom. However,
the Dickinson study was conducted upon a more sophisticated processing
method than that used by CSL, with two additional purification steps.
HPAC failed to choose options which were appropriate with
regard to the risks of treatment with the hormones in the light of scientific
knowledge in 1980. [paras 5.57-5.114]
2. TREATMENT, INCLUDING INFORMATION PROVIDED TO PATIENTS
AND CONSENT
Terms of reference. The Inquiry was requested
to examine and report on the treatment aspects of the program, particularly
the information provided to patients so as to allow informed consent.
(See generally Chapters 4 and 8)
Treatment regime. The Inquiry found that
the treatment regime for hGH was similar throughout Australia, and patients
were approved according to Guidelines applied by the HGH Subcommittee.
Patients treated with hPG were also approved according to Guidelines applied
by the FSH Subcommittee, although treatment regimes using hPG differed
from one centre to another.
Use of hormone in breach of Guidelines. From
1963, prior to the establishment of the AHPHP in 1967, patients in Sydney
Melbourne, Adelaide and Perth were treated with hGH and hPG manufactured
in an unregulated fashion in research centres.
During the AHPHP, generally only patients approved by the
HGH Subcommittee in accordance with Guidelines for Assessment of Patients
formulated by the Subcommittee were treated with hGH. The Inquiry has
received no evidence of any Australian medical practitioner providing
hGH to an athlete who was not approved for treatment on account of growth
hormone deficiency. However, there are instances of some use of hGH as
a "research allocation" approved by HPAC in growth hormone deficient
patients and in non growth hormone deficient people as part of research
studies.
During the AHPHP, the Guidelines for approval of patients
for treatment with hPG, established by the FSH Subcommittee, required
that female patients be anovulatory. HPG was used in some cases in breach
of these Guidelines, in particular for stimulating ovulatory women to
recover eggs in IVF programs in Melbourne from the early 1970s, and in
Sydney for cervical mucous infertility. Some of the hPG used in the IVF
programs in Melbourne was processed independently of the AHPHP within
a hospital laboratory in the late 1960s and early 1970s, whilst some was
the CSL product, supplied to researchers in the "Egg Project"
under a "research allocation" approved by HPAC.
Batch sharing and left overs. In the
case of both hGH and hPG, medical practitioners often used an allocation
of part of a batch of hormone intended for one patient to treat other
patients. The practitioners regarded this as necessary when hGH was in
short supply. In the case of hPG, when patients became pregnant, the medical
practitioner often used the left over supply of hPG for stimulation tests
in new patients, or for a patient who was awaiting a supply from CSL.
Particularly in stimulation tests, some practitioners used hPG which was
beyond its two year shelf-life.
Source of hormone, risks and doctor/patient relationship.
Most hGH recipients were informed, through their parents, of the source
of the hormone and how the treatment would work. Almost all hGH recipients
or their parents interviewed by the Inquiry described their doctor/patient
relationship as an excellent one, spanning many years.
The accounts given by hPG recipients were very different.
Most said that they were not told that the source of the hormone was pituitary
glands collected at post-mortems. Those who were told or who enquired,
received confusing and conflicting accounts of the source of the hormone
from nurses and other patients. Most medical practitioners did not mention
the alternative of human postmenopausal gonadotrophin (hMG). Although
hMG was equally efficacious, it was expensive, not being listed as a pharmaceutical
benefit. Most hPG recipients were told of the risk of multiple births.
Some were told of the risk of hyperstimulation, but few understood that
this was a life-threatening condition. When hyperstimulation occurred.
the patient usually did not realise how serious the condition was. At
many busy ovulation induction clinics, the medical practitioner relied
upon the nursing sisters to provide detailed information about the treatment
and to deal with the concerns of the patients on a day-to-day basis. A
significant number of hPG recipients had poor doctor/patient relationships
and felt that they could not ask questions. The treatment regime was a
stressful one and many patients felt a lack of support.
Common law duty of disclosure. The common
law duty of medical practitioners to disclose information to patients
requires that patients be advised of material risks in the treatment they
receive. The risk of CJD was not known to paediatric endocrinologists
and obstetrician gynaecologists at the time of treatment. In the case
of hGH treatment there were occasional risks for some patients, which
could be avoided by careful management. and these were normally disclosed.
In the case of hPG recipients, the risks of multiple births
and hyperstimulation were material, could not necessarily be avoided by
careful management, and ought to have been disclosed. In view of these
risks the alternatives to hPG treatment merited discussion. The alternative
of clomiphene citrate had normally always been tried before hPG treatment
commenced. However, the options of no treatment, delaying treatment or
adoption required discussion. Whilst the range of alternatives may have
been presented at the initial consultation, for most women there was no
moment of decision presented at the later stage when the hPG treatment
was entered into. It was "the next step" in what developed as
an inevitable progression of treatment for their infertility.
The source of the hormone was a matter associated with risk.
Most treatment was given prior to the knowledge of transmission of HIV/AIDS.
Treatment ceased when the link was made between the knowledge of CJD and
pituitary hormone treatment. However, the risk of infection from treatment
with a product derived from cadavers at post-mortem was always a material
one in view of other known transmissible diseases such as hepatitis. The
source of the hormone should have been disclosed to recipients. For many
it would have made a difference to their decision to enter into the treatment.
3. MANUFACTURE OF HORMONES AND COLLECTION OF PITUITARIES
Terms of reference. The Inquiry was requested
to examine and report on the rules and guidelines relating to the manufacture
of the hormones and the collection of pituitaries. The Inquiry's findings
are set out in Chapters 3, 6 and 7 of the Report.
(a) Collection of Pituitaries and Processing (Chapters
3 and 6)
Processing prior to AHPHP. The Inquiry
found that pituitaries were collected by individual medical practitioners
from as early as 1959. During the early 1960s processing of hormones took
place at CSIRO and in research centres in hospitals and universities in
Sydney, Melbourne, Adelaide and Brisbane. ,The hormone produced by these
researchers was used in the treatment of patients. One research group,
the Victorian Pituitary Group, processed glands collected in Australia,
Nova Scotia, Singapore and New Zealand. [paras 3.01-3.02, 3.11, 3.67-3.69]
Collection of glands through contact with pathologists
and some importation From 1966 the informal committee which preceded
the official HPAC encouraged pathologists to collect pituitary glands
for the proposed national program. Throughout the period of the AHPHP
from 1967 to 1985, members of HPAC approached pathologists on a personal
basis. Hospitals where the rate of gland collection was lower than expected
were pressured to increase the rate of collection. The glands processed
by CSL were collected mainly from hospitals and morgues in Australia,
with the exception of some glands imported from New Zealand in the mid-1970s,
a small number of glands from Mauritius in 1972 and 1973 and possibly
some glands from Papua New Guinea in 1966. The total number of glands
collected by CSL roughly equals the total of glands which would have been
required to produce the batches used in the AHPHP. [paras 3.03-3.24, 3.74]
Exclusion criteria. According to exclusion
criteria developed by HPAC in 1966, glands were not to be collected from
cadavers with known viral infections, particularly viral hepatitis, or
with obvious pathology of the pituitary gland. In 1971 a pathologist member
of HPAC warned of the danger of slow viral infection of the pituitary
glands. The exclusion criteria were amended so as to exclude glands from
cadavers affected by neurological diseases of the central nervous system
due or possibly due to viral infection. The criterion of "neurological
diseases" was by oversight omitted from the exclusion criteria in
1977. The exclusion criteria were amended in 1983 to exclude expressly
"presenile dementia (CJD)". The 1985 criteria excluded AIDS
and "dementia of any type". In general HPAC revised the exclusion
criteria in a reactive and slow fashion as possible sources of infection
came to light. [paras 3.25-3.38]
Failure to communicate exclusion criteria.
HPAC and CSL did not develop a coordinated and effective method for
making the exclusion criteria known to pathologists and mortuary attendants.
Most of the pathologists and mortuary attendants contacted by the Inquiry
were unaware that any written exclusion criteria issued by HPAC existed.
CSL representatives who dealt directly with mortuary attendants, paying
them a fee of 20 cents in the early years and later 50 cents per gland
collected, did not provide copies of the successive versions of the exclusion
criteria. Criteria for exclusion of glands from cadavers were verbal and
self-imposed by the pathologists. [paras 3.39-3.46]
Processing. Processing at CSL was done
using the Ferguson method' and from late 1984 the Chapman method. The
removal of contamination was regarded as achieved by the gel filtration
method which separated the higher molecular weight substances. such as
bacteria and viruses, from the lower molecular weight hPG and hGH, and
by the final filtration step in the purification process. [paras 3.70-3.101]
Lawfulness of collection in 1960s and 1970s.
The lawfulness of collection of the pituitaries in the 1960s and 1970s
depended either upon the common law or early human tissue legislation
applying in some States. Removal of pituitary glands for therapeutic purposes
was illegal in Queensland. In States where the common law applied' authorisation
by the deceased's executor should have been obtained. In several States
it was necessary for the hospital authorities to make due inquiry or to
have no reason to believe that relatives objected. In the absence of records
indicating the steps taken by hospital authorities to seek the views of
relatives, the Inquiry has not been unable to reach a firm conclusion
as to whether the bulk of the collection occurred lawfully or unlawfully.
[paras 6.38-6.46]
Lawfulness of collection under uniform human tissue
legislation. Following the Law Reform Commission's report
in 1977, uniform human tissue legislation was enacted in each State during
the late 1970s and early 1980s. Under this legislation consent by a coroner,
hospital authority or senior next-of-kin to a post-mortem is sufficient
authority for use "for therapeutic purposes, medical purposes, or
scientific purposes" of tissue removed "for the purposes of
the post-mortem examination". Under this legislation lawful use of
pituitaries for therapeutic purposes is conditional upon the pituitary
having been removed for the purpose of the post-mortem examination. Glands
needed for diagnostic purposes were taken by the pathologists for histological
examination. From information provided by pathologists and mortuary attendants,
the Inquiry has found that glands were generally removed by mortuary attendants
with little supervision, without inspection by the pathologist. Sometimes
when the pathologist required the gland for histological examination it
had already been removed by the mortuary attendant and stored in an unlabelled
container for collection by CSL. The Inquiry has formed the conclusion
that glands were generally removed not for the purposes of the post-mortem
examination, but for the purpose of supply to CSL. The use of the glands
during the period of the human tissue legislation was therefore unlawful.
[paras 6.49-6.50]
(b) Law and Policy applying to Manufacture (See
generally Chapter 7)
Standard. Compliance with a standard
was legally required from 1970 for goods for therapeutic use supplied
as pharmaceutical benefits. Although the National Biological Standards
Laboratory (NBSL) within the Commonwealth Department of Health was responsible
for testing for compliance with a standard, it did not test the hormones
for compliance. The reasons were the absence of an official standard,
the difficulty of developing a standard and poor communication and coordination
within NBSL. Following initial contact in 1966, further discussion was
delayed pending development of improved assay methods. There was no further
contact between NBSL and HPAC until some minimal contact occurred regarding
labelling in 1979 and closer contact in 1984 as a result of serious production
difficulties at CSL. The Inquiry has found that NBSL should have attempted
to take steps to address the practical difficulties associated with compliance
with the legal requirement and should have renewed the issue of a standard
with HPAC when the initial difficulties with development of a standard
were, at a later stage, apparently removed. [paras 7.145-7.154]
Viral contamination. The pituitary hormones
were dealt with in a manner inconsistent with the normal procedure for
listing and testing of pharmaceutical benefits. NBSL failed to test the
pituitary hormones for viral contamination. The Director-General of Health
failed to insist that advice from NBSL on viral contamination be provided
prior to making the recommendation to the Minister that the hormones be
listed. [paras 7.155-7.156]
Pharmaceutical Benefits Advisory Committee and Special
Arrangements. Although the Pharmaceutical Benefits Advisory
Committee (PBAC) made recommendations in 1964 and 1967 for listing of
the hormones, it appears to have largely been circumvented as negotiations
proceeded directly between members of HPAC and the Director-General of
Health and the Minister. The Guidelines for approval of patients for treatment
with hPG and hGH were determined by HPAC and its Subcommittees, and PBAC
and the Pharmaceutical Benefits Branch of the Department do not appear
to have even "rubber-stamped" the initial Guidelines or the
amendments made to the Guidelines over the years.
The hormones were listed as pharmaceutical benefits distributed
in accordance with "special arrangements" under section 100
of the National Health Act 1953 (Cth). Through this means it was sought
to confer power upon HPAC and its Subcommittees to administer the AHPHP
and determine the conditions for use of the drugs in accordance with the
Guidelines and the expert judgment of committee members. However, the
legislative intention behind section 100 was to make special arrangements
for the provision of pharmaceutical services to persons living in isolated
areas, or where convenience and efficiency indicated that pharmaceutical
benefits could not be supplied in accordance with the general provisions.
Section 100 makes no mention of a role for an expert committee. In other
cases of use of section 100, the convenience and efficiency has been established
on account of geographical difficulties, physical factors or the need
for emergency supply of an antivenom. The pituitary hormones were the
only section 100 benefits to be supplied in accordance with the determinations
of an expert committee. The Inquiry has found that the decision to list
the hormones under section 100 involved an abuse of power and was legally
invalid. [paras 7.161-7.162]
Australian Drug Evaluation Committee and Adverse Drug
Reactions Advisory Committee. There was no legal requirement
for evaluation and recommendation by the Australian Drug Evaluation Committee
(ADEC) for the CSL product since it was not an imported drug. Later, under
the Therapeutic Goods Act 1989 (Cth), locally manufactured products were
made subject to this process. However, because the hormones were pharmaceutical
benefits, ADEC could have played a role, and PBAC could have requested
ADEC to play a role. The Adverse Drug Reactions Advisory Committee (ADRAC)
could also have played a role had it received a report of an adverse reaction,
such as hyperstimulation or a multiple birth. However. no report was received
by ADRAC. [paras 7.163-7.171]
"Research allocations" of hormone.
Throughout the operation of the AHPHP, HPAC and its executive approved
the supply of hormone for a variety of research projects. Some of these
projects involved the clinical use of hGH and hPG in breach of the Guidelines
for approval of patients. HPAC approved, inter alia, allocations of hPG
for use in early IVF research in the "Egg Project", and of hGH
for studies in malnourished Aboriginal children, a project which would
have proceeded but for administrative difficulties encountered by the
researcher. In approving these supplies of hormone, HPAC did not insist
upon submission of a research protocol. Only from 1978 did HPAC pay attention
to approval by institutional ethics committees. With minor exceptions,
HPAC did not seek to reassure itself that the consent of the subjects
of research had been obtained in accordance with the NHMRC Statement on
Human Experimentation which was in place from 1966. [pares 7.81-7.126]
HPAC regarded this supply of hormone as authorised by an Order
in Council of the Governor General made in 1969 under section 9 of the
National Health Act, empowering HPAC to approve the issue of hormone for
research purposes. However, this provision in the National Health Act
is concerned with research services for the improvement of health or prevention
of disease, and is not intended to make provision for the distribution
of a pharmaceutical benefit otherwise than in accordance with the other
provisions of the Act. The Inquiry has concluded that the Order in Council
was made in excess of power and the research allocations of hormone were
unlawful.
The HGH and FSH Subcommittees. Some decisions
of the Human Growth Hormone Subcommittee (HGH Subcommittee), and to a
greater extent the Follicle Stimulating Hormone Subcommittee (FSH Subcommittee),
are open to criticism on ethical grounds. The HGH Subcommittee performed
a difficult task of deciding upon applications for a drug which was in
short supply. However. the Subcommittee introduced a scheme by which a
lower dosage of hGH was permitted for patients resident in one group of
states than for patients resident in the remaining states. The intention
was to ascertain by a comparative study the minimum effective dosage.
This scheme stepped across the line between making clinical observations
and conducting a research study.
Whilst the FSH Subcommittee played a valuable role in restricting
the use of hPG whose misuse by an unfamiliar practitioner could result
in the death of the patient, members of the Subcommittee were in a position
of conflict of interest in being approved practitioners themselves. The
Subcommittee failed to pay sufficient regard to ethical considerations
in: approving the use of outdated hPG in spite of a disclaimer of responsibility
by CSL for its use; failing to apply adequate sanctions in cases where
medical practitioners treated patients without approval or without submitting
treatment forms; failing to treat hyperstimulation as a central concern
of the Subcommittee rather than a matter to be left to the treating medical
practitioner; failing to respond in a decisive manner to cases of multiple
births or congenital abnormalities by assessing the treatment regime and
laboratory facilities of the treating medical practitioner; and failing
to consider cases of maternal deaths when details become available.
Regulatory failure and conflict of interest.
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. Moreover, they failed to recognise the
limits of their expertise in relation to unconventional slow viruses.
4. RESPONSE BY DEPARTMENT AND OTHERS ON CESSATION OF PROGRAM
Terms of reference. The Inquiry was requested
to examine and report on actions taken by the Commonwealth Department
of Health and others, following cessation of the program, in response
to reports of deaths from CJD of patients on similar programs overseas
and subsequently of Australian patients.
Suspension and cessation of AHPHP. The Inquiry
found that the AHPHP was suspended on 29 May 1985 following a flurry of
activity from 2 April 1985 involving extraordinary meetings of HPAC and
its Subcommittees and regular contact with administrators of growth hormone
programs in the United States and the United Kingdom. who were in the
midst of making similar decisions to halt their programs. [paras 9.01-9.19]
From 1986-1988. When the news of the
suspension of the program was released, there was little information available
for recipients who made telephone enquiries to the Department. A study
was conducted by Dr Chapman and Professor Masters to test the capacity
of the Chapman fractionation process to eliminate CJD infective agent
by processing infected glands and inoculating mice with the hormone product.
The result, available in 1988, showed an extremely low risk of infectivity
in the final product but that did not exclude the possibility of cross-contamination
within the laboratory where the processing was done. However, the test
was not performed on the Ferguson method which was used throughout most
of the period of the AHPHP, until 1984.
An epidemiological study of pituitary hormone recipients was
commenced, but was gradually abandoned on account of lack of resources.
[paras 9.20-9.38]
From 1988 to May 1993. The first death of an
hPG recipient from CJD occurred in August 1988. The Department and former
members of HPAC became aware of the first case during the recipient's
illness. Although this first case was reported during 1989 at two professional
meetings of clinical pharmacists and possibly at a neuropathology meeting'
a proposed letter to The Lance' was never sent. and the case did
not become widely known in the medical community until its publication
in a journal in August 1990. Three more deaths of hPG recipients occurred
between May 1989 and January 1991. In the first and second cases of deaths.
the link between the CJD and the hormone treatment was made by medical
practitioners at the time of diagnosis. In the third and fourth cases
the link was made years later. Only the third and fourth cases were the
subject of news releases by the Department in early 1993.
As enquiries by recipients increased in response to media
attention to the issue, a CJD Unit was set up within the Department to
respond to telephone calls and written requests for confirmation as to
whether treatment had been received under the AHPHP. [paras 9.39-9.75]
Tracing by medical practitioners. When
the AHPHP was suspended in 1985, treating medical practitioners were notified
of the suspension. and requested to advise their current patients of the
deaths overseas. HPG treating medical practitioners were also requested
to verify a Departmental list of patients believed to have been treated
by them. In November 1990 treating medical practitioners received the
first request by the Department to trace and counsel their former patients.
Although many were initially reluctant to do so, medical practitioners
began to contact patients, particularly when they received advice from
the Department that patients should be advised not to donate blood or
tissue. The process of compiling mailing lists was slow. Medical practitioners
had no additional resources to perform the task. Some were retired. Some
took on the task on behalf of a deceased or departed colleague. They struggled
to devise their own tracing methodologies, Assistance through Medicare
records came too late. Many patients learned of the risk through the media
and contacted their former medical practitioners first. Some of the letters
sent contained incorrect information and were otherwise poorly drafted.
Some of the telephone calls received by recipients caused great shock.
[paras 9.76-9.134]
May 1993 to present: CJD Task Force. With
the establishment of the CJD Task Force within the Department in May 1993,
the pace of response improved markedly. A publication. CJD News, was
issued to provide further information to recipients and medical practitioners.
The out-dated Departmental database of recipients was replaced, enabling
the Task Force to gain a better picture of the progress of tracing as
medical practitioners advised the Department which patients had been contacted.
Counselling services were established in 1993 through Marriage Guidance
Australia and a National Advisory Group was established to assist in the
establishment of support groups. [paras 9.220-9.240]
Duty of Department. The Inquiry has found
that the Department had a moral duty to take steps to ensure that recipients
were made aware of the risk when the AHPHP was suspended in 1985. 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. The Inquiry has found that in circumstances such as these,
recipients should not have been left in the dark because they did not
request information. The Inquiry has also found that the Department should
have provided assistance in 1985 to medical practitioners through a coordinated
program of tracing in connection with the epidemiological study. [paras
9.132-9.134]
Duty of medical practitioners. The common
law duty has not yet recognised the extension of the duty of medical practitioners
to disclose risks to cover the situation where the person at risk is no
longer a patient. However, the Inquiry has taken the view that medical
practitioners ought to recognise that they have such a moral duty, and
has recommended accordingly a revision of NHMRC Guidelines, below at para
7(ii). [Chapter 13]
5. TRACING, IDENTIFICATION, COUNSELLING AND SUPPORT
Terms of reference. The Inquiry was requested
to make recommendations on further actions which the government might
take to identify people in Australia who received the pituitary derived
hormones and to provide counselling and support to them. The Inquiry has
recommended:
(i) That the CJD Task Force.
-
continue to trace recipients of pituitary derived hormones
and maintain its current staffing until that task nears completion.
-
continue to publish CJD News on
a regular basis.
-
develop the database so that it provides a useful resource
for recipients, subject to Information Privacy Principles.
-
subject to compliance with Information Privacy Principles,
within the next eight months administer a survey to recipients in
order to supplement the material in the database with further information
relevant to the needs of recipients.
-
ensure that an information evening about pituitary
hormones and CJD is held in each capital city in Australia at six
monthly intervals, with a review of the need for further evenings
after 12 months.
Medical records. The Inquiry found that
many recipients experienced serious difficulties in gaining access to
their medical records. The Inquiry has recommended:
(ii) That the Commonwealth Department of Health initiate
and coordinate the development of a uniform federal/state approach to
access to medical records and their disposal, which
-
applies not only to records held in public hospitals
but also to records held by private hospitals and private medical
practitioners; and
-
creates legally enforceable rights of patients with
regard to access and disposal of such records, either through the
extension of freedom of information legislation in each jurisdiction
or through the application of conditions to providers under the Medicare
scheme.
Secrecy provision in National Health Act.
The Inquiry found that Departmental officers were unduly guarded in
their responses 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 the responsiveness of Departmental
officers to members of the public was adversely affected by the fear officers
had of acting in breach of section 135A of the National Health Act, which
imposes severe penalties for disclosure of medical information to third
parties. This restrictive approach appeared unnecessary in the light of
the unproblematic procedures for access to information followed in many
state hospitals in accordance with the spirit of freedom of information
legislation. [paras 9.135-9.175]
The Inquiry has recommended:
(iii) That section 135A of the National Health Act 1953
(Cth) be amended; and
Counselling and support groups. Steps
have already been taken by the Task Force in this area.
The Inquiry has recommended:
(iv) That the counselling service for recipients provided
by Marriage Guidance Australia continue to be funded.
(v) That the National Advisory Group be replaced by an
Advisory Committee with the functions of providing advice to the Task
Force on:
-
how the Task Force may meet the needs of recipients;
-
fostering support groups;
-
the operation of the database;
-
the conduct of the survey; and
-
the conduct of research in which recipients are subjects.
6. REGULATION OF MEDICAL PROGRAMS
Terms of reference. The Inquiry was requested
to make recommendations on whether additional measures are necessary to
regulate medical programs in the light of the experience of the pituitary
hormone program and the current regulatory procedures. The Inquiry has
recommended:
(i) That section 100 of the National Health Act 1953 (Cth)
be repealed and replaced by a provision which specifies clearly the circumstances
where by reason of physical and similar factors associated with the distribution
of a pharmaceutical benefit "special arrangements" are appropriate.
(ii) That the NHMRC
it provides guidance with regard to decisions as to whether
treatment in a therapeutic setting constitutes an experiment;
a procedure is developed by which such decisions are
scrutinised and not left entirely to the treating medical practitioner.
registered with the Health Ethics Committee of the NHMRC;
and
approved by the institutional ethics committee of the
institution in which the procedure is carried out; and
consent is given on the basis of full information regarding
risks and outcomes as defined in the Supplementary Note 2 on Research
on Children, the Mentally Ill and Those in Dependent Relationships or
Comparable Situations.
7. CONSENT
Terms of reference. The Inquiry was requested
to make recommendations on any measures which should be taken to strengthen
the rules and guidelines relating to informed consent in similar medical
programs. The Inquiry has recommended:
(i) That the NHMRC Code of Practice for Transplantation
of Cadaveric Organs and Tissues be revised to set out the procedure
by which hospital authorities should obtain consent from relatives for
removal from cadavers of organs and tissue for therapeutic medical or
scientific knowledge including for the purposes of research and medical
education. The Code should include a consent form for signature by the
relatives, itemising the organs and tissue to be removed and the purpose
for removal in each instance.
(ii) That the NHMRC review the General guidelines
for medical practitioners on providing information to patients to
ascertain whether they are adequate in the light of the response made
by medical practitioners to the cessation of the Australian Human Pituitary
Hormone Program and the deaths of hormone recipients in Australia.
8. PRIORITIES FOR RESEARCH
Terms of reference. The Inquiry was requested
to make recommendations on priorities for research into matters related
to CJD and its transmission. The Inquiry has recommended:
(i) That research funds be allocated for:
-
provision of adequate laboratory facilities equipped
to conduct research into the infective CJD agent.
-
study of the nature of the infectious CJD agent, including
research into genetic susceptibility to CJD, within a broader context
of the study of a range of degenerative diseases.
-
extension of me period of retrospective analysis of
CJD cases by the CJD Registry to 1970 and prospectively to 2010, with
a review at that time.
-
an epidemiological study of hormone recipients in Australia
be commenced, and that it be coordinated with the work of the CJD
Case Registry.
-
development of an effective therapy for CJD.
-
development of improved methods of diagnosis of CJD.
(ii) That the Advisory Committee monitors the approval
and conduct of such research to ensure compliance with counselling procedures
and with ethical standards.
June 1994
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