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Statement of Principles

concerning

CARDIOMYOPATHY

No. 23 of 2007

for the purposes of the

Veterans’ Entitlements Act 1986

and

Military Rehabilitation and Compensation Act 2004

Title

This Instrument may be cited as Statement of Principles concerning cardiomyopathy No. 23 of 2007.

Determination

2. The Repatriation Medical Authority under subsection 196B(2) and (8) of the Veterans’ Entitlements Act 1986 (the VEA):

(a) revokes Instrument No. 19 of 1998, as amended by Instrument No. 22 of 2002, concerning cardiomyopathy; and

(b) determines in its place this Statement of Principles.

Kind of injury, disease or death

3. (a) This Statement of Principles is about cardiomyopathy and death from cardiomyopathy.

(b) For the purposes of this Statement of Principles, "cardiomyopathy" means a disease that involves the myocardium directly, and results in dilatation, restriction or hypertrophy of the heart, but is not due to hypertension or congenital, valvular, coronary, arterial or pericardial abnormalities. This definition excludes all heritable forms of hypertrophic cardiomyopathy.

Basis for determining the factors

4. The Repatriation Medical Authority is of the view that there is sound medical-scientific evidence that indicates that cardiomyopathy and death from cardiomyopathy can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces under the VEA, or members under the Military Rehabilitation and Compensation Act 2004 (the MRCA).

Factors that must be related to service

5. Subject to clause 7, at least one of the factors set out in clause 6 must be related to the relevant service rendered by the person.

Factors

6. The factor that must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting cardiomyopathy or death from cardiomyopathy with the circumstances of a person’s relevant service is:

(a) being a prisoner of war of Japan before the clinical onset of cardiomyopathy; or

(b) for males only, drinking at least 250 kilograms of alcohol within any ten year period before the clinical onset of cardiomyopathy; or

(c) for females only, drinking at least 200 kilograms of alcohol within any ten year period before the clinical onset of cardiomyopathy; or

(d) having a hypersensitivity reaction of the myocardium to a drug at the time of the clinical onset of cardiomyopathy; or

(e) being treated with an anthracycline before the clinical onset of cardiomyopathy; or

(f) being treated with chemotherapeutic agents for cancer or being treated with immunosuppressive drugs following transplantation, within the 30 days before the clinical onset of cardiomyopathy; or

(g) being treated daily with chloroquine sulphate, chloroquine phosphate or hydroxychloroquine for at least the one year before the clinical onset of cardiomyopathy; or

(h) being treated with a drug from Specified List 1 within the seven days before the clinical onset of cardiomyopathy; or

(i) being treated with corticosteroids, other than topical or inhaled corticosteroids, at doses equivalent to at least 7.5 milligrams per day of prednisolone for at least the three months before the clinical onset of cardiomyopathy; or

(j) using cocaine, amphetamines or amphetamine derivatives, at the time of the clinical onset of cardiomyopathy; or

(k) having carbon monoxide poisoning within the 24 hours before the clinical onset of cardiomyopathy; or

(l) being infected with human immunodeficiency virus (HIV) at the time of the clinical onset of cardiomyopathy; or

(m) having infection-related myocarditis before the clinical onset of cardiomyopathy; or

(n) having a specified endocrine disorder at the time of the clinical onset of cardiomyopathy; or

(o) having generalised lipodystrophy at the time of the clinical onset of cardiomyopathy; or

(p) having a catecholamine-secreting tumour at the time of the clinical onset of cardiomyopathy; or

(q) having a specified autoimmune disease at the time of the clinical onset of cardiomyopathy; or

(r) having infiltration of the myocardium due to a specified disorder at the time of the clinical onset of cardiomyopathy; or

(s) undergoing a course of therapeutic radiation involving the mediastinum before the clinical onset of cardiomyopathy; or

(t) having clinically apparent thiamine deficiency (beriberi) before the clinical onset of cardiomyopathy; or

(u) being peripartum at the time of the clinical onset of cardiomyopathy; or

(v) having morbid obesity for at least the five years before the clinical onset of cardiomyopathy; or

(w) having severe chronic renal failure at the time of the clinical onset of cardiomyopathy; or

(x) being envenomated by a scorpion, a specified spider or carybdeid box jellyfish within the 24 hours before the clinical onset of cardiomyopathy; or

(y) having a heart transplant before the clinical onset of cardiomyopathy; or

(z) having selenium deficiency at the time of the clinical onset of cardiomyopathy; or

(za) for males only, drinking at least 250 kilograms of alcohol within any ten year period before the clinical worsening of cardiomyopathy; or

(zb) for females only, drinking at least 200 kilograms of alcohol within any ten year period before the clinical worsening of cardiomyopathy; or

(zc) having a hypersensitivity reaction of the myocardium to a drug at the time of the clinical worsening of cardiomyopathy; or

(zd) being treated with an anthracycline before the clinical worsening of cardiomyopathy; or

(ze) being treated with chemotherapeutic agents for cancer or being treated with immunosuppressive drugs following transplantation, within the 30 days before the clinical worsening of cardiomyopathy; or

(zf) being treated daily with chloroquine sulphate, chloroquine phosphate or hydroxychloroquine for at least the one year before the clinical worsening of cardiomyopathy; or

(zg) being treated with nonsteroidal anti-inflammatory drugs (NSAIDS) for at least the 30 days before the clinical worsening of cardiomyopathy; or

(zh) being treated with a drug from Specified List 1 within the seven days before the clinical worsening of cardiomyopathy; or

(zi) being treated with corticosteroids, other than topical or inhaled corticosteroids, at doses equivalent to at least 7.5 milligrams per day of prednisolone for at least the three months before the clinical worsening of cardiomyopathy;

(zj) using cocaine, amphetamines or amphetamine derivatives, at the time of the clinical worsening of cardiomyopathy; or

(zk) having carbon monoxide poisoning within the 24 hours before the clinical worsening of cardiomyopathy; or

(zl) being infected with human immunodeficiency virus (HIV) at the time of the clinical worsening of cardiomyopathy; or

(zm) having infection-related myocarditis before the clinical worsening of cardiomyopathy; or

(zn) having a specified endocrine disorder at the time of the clinical worsening of cardiomyopathy; or

(zo) having generalised lipodystrophy at the time of the clinical worsening of cardiomyopathy; or

(zp) having a catecholamine-secreting tumour at the time of clinical worsening of cardiomyopathy; or

(zq) having a specified autoimmune disease at the time of the clinical worsening of cardiomyopathy; or

(zr) having infiltration of the myocardium due to a specified disorder at the time of the clinical worsening of cardiomyopathy; or

(zs) undergoing a course of therapeutic radiation involving the mediastinum before the clinical worsening of cardiomyopathy; or

(zt) having clinically apparent thiamine deficiency (beriberi) before the clinical worsening of cardiomyopathy; or

(zu) being peripartum at the time of the clinical worsening of cardiomyopathy; or

(zv) having morbid obesity for at least the five years before the clinical worsening of cardiomyopathy; or

(zw) having severe chronic renal failure at the time of the clinical worsening of cardiomyopathy; or

(zx) being envenomated by a scorpion, a specified spider or carybdeid box jellyfish within the 24 hours before the clinical worsening of cardiomyopathy; or

(zy) having selenium deficiency at the time of the clinical worsening of cardiomyopathy; or

(zz) inability to obtain appropriate clinical management for cardiomyopathy.

Factors that apply only to material contribution or aggravation

7. Paragraphs 6(za) to 6(zz) apply only to material contribution to, or aggravation of, cardiomyopathy where the person’s cardiomyopathy was suffered or contracted before or during (but not arising out of) the person’s relevant service.

Inclusion of Statements of Principles

8. In this Statement of Principles if a relevant factor applies and that factor includes an injury or disease in respect of which there is a Statement of Principles then the factors in that last mentioned Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.

Other definitions

9. For the purposes of this Statement of Principles:

"a course of therapeutic radiation" means one or more fractions (treatment portions) of ionising radiation administered with the aim of achieving palliation or cure with gamma rays, x-rays, alpha particles or beta particles;

"a drug from Specified List 1" means one of the following:

(a) amphotericin B;

(b) bromocriptine;

(d) interleukin 2;

(e) lithium;

(f) rosiglitazone, pioglitazone or troglitazone;

(g) tumour necrosis factor-alpha (TNF-α) antagonists; or

(h) trastuzumab;

"a hypersensitivity reaction of the myocardium to a drug" means an inflammation of the myocardium due to an allergic reaction, as indicated by symptoms and signs of skin rash, fever, eosinophilia, ECG changes, tachycardia, elevated cardiac enzymes or endomyocardial biopsy appearing after drug treatment in reasonable temporal relation;

"a specified autoimmune disease" means one of the following:

(a) ankylosing spondylitis;

(b) dermatomyositis;

(d) polyarteritis nodosa;

(e) polymyositis;

(f) rheumatoid arthritis;

(g) Sjogren’s syndrome;

(h) systemic lupus erythematosus;

(i) systemic sclerosis;

(j) Takayasu’s arteritis; or

(k) Wegener’s granulomatosis;

"a specified disorder" means one of the following:

(a) amyloidosis;

(b) sarcoidosis;

(d) iron overload;

"a specified endocrine disorder" means one of the following:

(a) acromegaly;

(b) adrenal insufficiency;

(d) hypoparathyroidism;

(e) hypothyroidism; or

(f) thyrotoxicosis;

"a specified spider" means a funnel web spider or a spider belonging to the genus Latrodectus;

"alcohol" is measured by the alcohol consumption calculations utilising the Australian Standard of 10 grams of alcohol per standard alcoholic drink;

"being peripartum" means being in the last month of pregnancy or being within the five months immediately postpartum;

"beriberi" means a state of thiamine deficiency which may be due to decreased thiamine intake, impaired thiamine absorption and storage, and/or accelerated destruction of thiamine diphosphate in the body;

"carybdeid box jellyfish" means the group of box jellyfish which causes Irukandji syndrome;

"death from cardiomyopathy" in relation to a person includes death from a terminal event or condition that was contributed to by the person’s cardiomyopathy;

"ICD-10-AM code" means a number assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, 10th revision, Australian Modification (ICD-10-AM), Fifth Edition, effective date of 1 July 2006, copyrighted by the National Centre for Classification in Health, Sydney, NSW, and having ISBN 1 86487 772 3;

"immunosuppressive drugs" means drugs or agents administered orally, intravenously or intramuscularly for the purpose of suppressing the immune responses, but does not include inhaled or topical steroids;

"iron overload" means an accumulation of excess iron in tissues and organs which has been confirmed by elevated ferritin or transferrin saturation levels. Causes include haemochromatosis and blood transfusions;

"relevant service" means:

(a) operational service under the VEA;

(b) peacekeeping service under the VEA;

(d) warlike service under the MRCA; or

(e) non-warlike service under the MRCA;

"selenium deficiency" means having a plasma or serum selenium level of less than 50 nanograms per millilitre;

"severe chronic renal failure" means a glomerular filtration rate which is consistently less than 30 millilitres per minute;

"terminal event" means the proximate or ultimate cause of death and includes:

(a) pneumonia;

(b) respiratory failure;

(d) circulatory failure; or

(e) cessation of brain function.

Application

10. This Instrument applies to all matters to which section 120A of the VEA or section 338 of the MRCA applies.

Date of effect

11. This Instrument takes effect from 7 March 2007.

Dated this twenty-second day of February 2007

The Common Seal of the )

Repatriation Medical Authority )

was affixed to this instrument )

in the presence of: )

KEN DONALD

CHAIRPERSON