The use of human pituitary hormones in Australia and Creutzfeldt-Jakob disease
Creutzfeldt-Jakob disease (CJD) is a rare disease of the central nervous system, which results in death after a relatively rapid course of muscle weakness and dementia. There is no definitive diagnostic test and no known cure.
CJD occurs sporadically in the community with an incidence of one case per million population per year and may have a symptom free incubation period of more than 30 years. CJD is also known to have been transmitted as a result of certain medical interventions, such as human pituitary hormone treatment. This iatrogenic form is similar clinically to sporadically occurring CJD. The symptom free incubation period of this form of CJD ranges from 4 to 30 years with an average of 15 years based on international experience.
History of pituitary hormone treatment in Australia
Between 1967 and 1985 cadaver derived pituitary hormones were officially supplied to 1,976 Australians as treatment for infertility and short stature. In addition, 187 people are known to have been treated with human pituitary derived hormones in Australia as part of special projects associated with metabolic growth problems, and between 1972 and 1978 on some IVF programs. A number of people also received treatment outside these programs, as early as 1963. A total of 2,163 people were treated with human pituitary derived hormones in Australia during this time.
In Australia, human pituitary hormones were supplied as a Pharmaceutical Benefit (under Section 100(1)(a)(b) of the National Health Act 1953) and were manufactured by the Commonwealth Serum Laboratories (CSL). Hormones were also supplied under Section 9(1)(d) of the National Health Act 1953 for projects approved by the Human Pituitary Advisory Committee (HPAC). The Australian Human Pituitary Hormones Program (AHPHP) was overseen by the HPAC and its expert subcommittees supported by the then Commonwealth Department of Health. About 130 batches of Human Pituitary Gonadotrophin and 100 batches of Human Growth Hormone were manufactured by the CSL between the late 1960's and 1985. It is suspected that some batches were contaminated with the infective agent of CJD.
The AHPHP ceased in May 1985 after overseas reports of deaths from CJD in people who received treatment with human growth hormone. The Department of Health was advised of the first case of CJD in a pituitary hormone recipient in 1988, a second case in 1990, discovered the third and fourth cases in 1993 and the fifth case in 1995. All five individuals died between 1988 and 1991. Of these five cases, three were confirmed at autopsy as having died of CJD. One case has been classified by the then CJD Case Registry as probable and the other was assessed as a possible case. In these cases there was no autopsy.
There have been no further cases reported to date.
Symptoms, transmission and precautions
The symptoms of someone with CJD may include difficulty in balance while walking, changes in behaviour and mental capacity, loss of muscle coordination and jerky movements, slurred speech, failing vision, rigidity or stiffness. The symptoms of CJD are unmistakably severe and increase progressively and rapidly. Therefore, mild clumsiness, irritability or forgetfulness should not be a cause for worry.
There is no evidence that CJD can be transmitted through normal social contact, sexual intercourse or by transmission from mother to child.
While it is theoretically possible that CJD can be transmitted by blood, there is no confirmed epidemiological or clinical evidence to support such claims. There are documented cases of transmission of CJD through transplants of neurological tissue such as corneas and dura mater grafts and through contaminated instruments used in these procedures.
A list of hospitals that perform neurosurgical and ophthalmological procedures (PDF 19 KB) is available (note this list has been derived from the Australian Hospitals Directory 8th Edition 2002, with permission from Alex Tymson ATA Professional Services Pty Ltd.)
To avoid any potential risk pituitary hormone recipients are asked not to donate blood and tissues.
Request for Medical-in-Confidence letters
A ‘Medical-in-Confidence letter’ (MICL) signed by the Commonwealth Chief Medical Officer is available for pituitary hormone recipients who require admission to hospital for a surgical procedure. The MICL may also be used to inform health care workers that a risk of CJD transmission to surgical instruments exists, as the result of certain medical procedures.
To request a MICL, please contact the Department of Health via email (firstname.lastname@example.org) or by telephone, to the dedicated telephone line for pituitary hormone recipients on 1800 802 306 (free call).
Review into the public health response to CJD and the AHPHP (2021)
In the first half of 2021, PricewaterhouseCoopers Consulting (Australia) (PwC) undertook an independent review of several initiatives supported by the Australian Government, focussed on the public health response to CJD, and the historic Australian Human Pituitary Hormones Program (AHPHP).
The review included an evaluation of the Australian National Creutzfeldt-Jakob Disease Registry (ANCJDR), CJD Support Group Network (CJDSGN), and the ongoing support needs of AHPHP participants and their families.
As part of the review, more than 20 AHPHP participants and one relative were consulted, each providing valuable insights into the Review. The Department thanks all AHPHP participants for volunteering their time.
Additionally, over 30 consultations occurred with Australian and international stakeholders including CJD surveillance units, clinical peak body representatives, professional bodies, consumer representatives, research organisations and other support groups. The ANCJDR, the CJDSGN and representatives from State and Territory health departments (through the Communicable Disease Network Australia) also contributed to the review.
As at 2021, the CJD Review found that the ANCJDR and the CJDSGN provide valuable services to the Australian community and are well respected both domestically and internationally. The Review also confirmed the need for continued Australian Government support for the AHPHP participant cohort.
The CJD Review Final Report is available here:
The Australian National CJD Registry
The National CJD Case Registry was established in 1993 (now known as the Australian National CJD Registry), as a result of discussions between the Department and the University of Melbourne, in response to the risk of iatrogenic transmission of CJD from treatment under the AHPHP. The Registry is funded by the Department to:
- undertake research;
- monitor new cases of CJD and other transmissible spongiform encephalopathies (TSEs) in Australia and overseas;
- examine risk factors such as blood transfusions;
- produce quarterly and annual reports; and
- provide advice to the Department and other health authorities on request.
The Registry includes a comprehensive epidemiological database on CJD and provides expertise to various committees and working groups on TSEs and infection control.
Inquiry into the use of human pituitary derived hormones in Australia and CJD
On 11 May 1993 the Government announced an independent inquiry into the use of human pituitary derived hormones in Australia and CJD. The inquiry was headed by Associate Professor Margaret Allars of the University of Sydney Law School. The Government's response to the findings of the inquiry was announced in November 1994 and included a range of initiatives to address the ongoing needs of human pituitary hormone recipients. The finding announced:
- provides for ongoing counselling and support services for human pituitary hormone recipients and their families;
- allows for medical and other care needs to be met if any further human pituitary hormone recipients contract CJD;
- provided over $1 million over four years to fund commissioned research in Australia to assist in developing a diagnostic test and treatment for the disease, and for further epidemiological research; and
- provides funding to continue the information activities including a free call 1800 number, medical advice, and to publish the HPH Newsletter.
In March 1998, the Government released its response to the report on the CJD settlement offer by the Senate Community Affairs References Committee (PDF 31 KB). The Government agreed to implement the majority of the recommendations of the report.
The National Pituitary Hormones Advisory Council
The National Pituitary Hormones Advisory Council (NPHAC) was established in December 1994 to advise the then Minister for Health and Family Services on broad national issues affecting the recipient community. The ten members of the Council included experts drawn from fields including law, psychology and research science, the National coordinator of the CJD Support Group Network Inc and five members of the pituitary hormone recipient community. The Council met on average three times each year. In December 1999 the Minister for Health and Aged Care requested that the Council develop a strategy to complete the implementation of the Government's Response and to place the Council into abeyance. This was formalised in December 2000.
The strategy that the Council developed were mechanisms by which measures were established to support and advise the recipient community to be maintained by the Department of Health and Ageing. These mechanisms will:
- inform the CJD Support Group Network and recipients of any revised administrative arrangements that are put in place;
- continue to provide a central contact point, via a free call 1800 number for hormone recipients who wish to contact the Department seeking information until 2010;
- keep hormone recipients informed of relevant issues via the HPH newsletter and the departmental web-site with both to be maintained until 2010; and
- ensure a clear procedure is in place to notify hormone recipients as quickly as possible in the event of any further deaths from CJD among people treated under the AHPHP.
CJD Support Group Network
The CJD Support Group Network (CJDSGN) provides an environment of self-help in which recipients of human pituitary derived hormones and their families can share experiences and information. The CJDSGN also provides a source of independent information for recipients.
The coordinators are either recipients themselves or family members. For further information about support groups, please contact Suzanne Solvyns on 1800-052-466.
Human pituitary hormone counselling service
Due to the diminished demand for counselling services from human pituitary hormone recipients and their families, both the Department of Health and Ageing and the human pituitary hormone (HPH) counselling panel formally closed the HPH counselling service on the 31 December 2005. Both the Department and the panel discussed the principles and options for the panel to review current administrative arrangements for funding these services.
It was never intended that the HPH counselling service provide long-term therapy. As recommended in Professor Margaret Allars Report on the inquiry into the use of pituitary derived hormones in Australia and Creutzfeldt-Jakob disease, the HPH counselling service was scheduled for closure in 2002-03.
A recipient or family member may seek special consideration for funded HPH counselling services and each case will be decided on its merits. Applicants will be required to explain why they are unable to use mainstream counselling services through state or territory government health services or through current general practice initiatives.
Should you wish to submit an application to access funding for HPH counselling services or obtain further information on the closure of the HPH counselling service please call the Department’s free call number 1800 020 103 or (02) 6289 1555.
Human Pituitary Hormone Newsletter
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