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Wednesday, 16 October 2002
Page: 5345


Senator Greig asked the Minister for Health and Ageing, upon notice, on 12 September 2002:

(1) (a) Is the Minister aware of a Dutch report regarding a man who developed Creutzfeldt-Jakob disease (CJD) 38 years after receiving human derived growth hormone (hGH); and (b) given that the 47 year old Dutch man who died from iatrogenic CJD 38 years after treatment, was given only low dose of hGH as part of a diagnostic procedure rather than being given full treatment: does the Minister intend any further action warning Australians who were given low doses of hGH.

(2) With reference to the fact that, when this patient was 9 years old, a nitrogen retention test with 6 IU hGH was performed to exclude growth hormone deficiency: Does the department know which batches or batch numbers were used during these `diagnostic' tests.

(3) (a) Is the Minister aware that the authors of the journal paper (J Neurol Neurosurg Psychiatry 2002; 72: 792-793) reporting on this case concluded: `This case indicates that still more patients with iatrogenic CJD can be expected in the coming years. Another implication of our study is that CJD can develop even after a single low dose of human growth hormone'; and (b) given this, to what extent was the diagnostic use of hGH considered.

(4) With reference to the statement in the journal paper that, `If low doses presented a risk I would have thought that other cases would have come to light before now'. Given that this deceased patient is believed to be the first treated with `diagnostic hGH': (a) is the department expecting other cases of iatrogenic CJD in the coming years; (b) what advice has the Minister been given on this matter; (c) what action does the department intend to take to deal with the increase in CJD cases; (d) will all unofficial patients who were treated with `diagnostic infusions' of hGH during GH stimulation tests be notified of this new risk; and (e) what, if any, action does the Government intend for people who are expected to suffer iatrogenic CJD through the diagnostic test who are now confirmed `at risk'.

(5) Were all children treated in clinical trials registered with the department at the time of their treatment with hGH.

(6) How many low dose `one-off infusion' recipients of hGH, as part of a diagnostic procedure, were involved.

(7) What is the Government doing to track the missing 5 per cent of the hGH recipients.


Senator Patterson (Minister for Health and Ageing) —The answer to the honourable senator's question is as follows:

(1) (a) Yes. The article has been brought to my attention.

(b) At this stage I do not intend any further action warning Australians who were given low doses of human Growth Hormone (hGH) as a diagnostic test.

(2) It is unlikely that the batch numbers were recorded for every diagnostic procedure using hGH.

(3) (a) Yes.

(b) The Australian National CJD Case Registry did not record any new iatrogenic cases of CJD during the period January 2002 to June 2002. There is little evidence of an increase in the number of iatrogenic cases due to hGH treatment. The Inquiry into the Use of Pituitary Derived Hormones in Australia and Creutzfeldt-Jakob Disease (“The Inquiry”) did report on diagnostic uses of hGH and the diagnostic use of hGH was considered during The Inquiry.

(4) (a) The Australian National CJD Case Registry did not record any new iatrogenic cases of CJD during the period Jan 2002 to June 2002. There is little evidence of an increase in the number of iatrogenic cases due to hGH treatment. Given that the use of hGH for diagnostic purposes in Australia is small, the number of potential cases that may occur in the coming years is expected to be very low.

(b) My Office is advised on all relevant matters relating to hGH and CJD Programs.

(c) The number of iatrogenic cases in Australia as a result of hGH therapy is one, suggesting that this group is at `low risk' for developing CJD. There is little evidence of an increase in the number of iatrogenic cases, due to hGH treatment. The article has been referred to the members of the National Health and Medical Research Council's Special Expert Committee on Transmissible Spongiform Encephalopathies.

(d) The “Diagnostic infusion” of hGH for nitrogen retention testing (referred to in Australia as `Stage III acute metabolic testing') was discussed during the The Inquiry, though the Department does not hold records of its use in Australia. Such records will be kept at the specialist centres (eg. the Children's Hospital in Melbourne and Sydney) in which the test was carried out.

(e) The number of people in Australia expected to develop iatrogenic CJD through the use of the diagnostic test is likely to be small. The supportive mechanisms in place for the monitoring, care and treatment of iatrogenic cases of CJD can be used in the unlikely event of a case in Australia following diagnostic hGH use.

(5) Ninety-four per cent of patients treated with hGH were registered with the Department at the time of their treatment with hGH, by virtue of being treated under the Australian Human Pituitary Hormone Program (AHPHP). The AHPHP was not a clinical trial.

(6) The Inquiry indicates that 50 patients underwent acute metabolic testing. The use of hGH for diagnostic testing ceased in 1971 when the procedure was replaced by more reliable, cost effective tests to assess growth hormone deficiency.

(7) The Department of Health and Ageing has endeavoured since 1992 to trace recipients via the print and electronic media, through the Department of Immigration and Multicultural Affairs, the Health Insurance Commission, various statutory and private organisations and more recently through the Australian Electoral Commission. As a result of these efforts 94 per cent of all recipients of human-derived pituitary hormones in the Australian community have been traced and, where possible, counselled on their slight increased risk of contracting CJD. The former Minister for Health, Dr Michael Wooldridge approved the ceasing of tracing activities in May 2000.