Statement of Principles concerning hypothyroidism (Balance of Probabilities) (No. 4 of 2022) (Cth)

Statement of Principles concerning HYPOTHYROIDISM (Balance of Probabilities) (No. 4 of 2022) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986.

Dated 24 December 2021

The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of:

Professor Terence Campbell AM Chairperson

Contents 1 Name 2 Commencement 3 Authority 4 Repeal 5 Application 6 Definitions 7 Kind of injury, disease or death to which this Statement of Principles relates 8 Basis for determining the factors 9 Factors that must exist 10 Relationship to service 11 Factors referring to an injury or disease covered by another Statement of Principles Schedule 1 - Dictionary 1 Definitions

1 Name This is the Statement of Principles concerning hypothyroidism (Balance of Probabilities) (No. 4 of 2022). 2 Commencement This instrument commences on 31 January 2022. 3 Authority This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning hypothyroidism No. 30 of 2013 (Federal Register of Legislation No. F2013L00730) made under subsections 196B(3) and (8) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004 applies. 6 Definitions The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument. 7 Kind of injury, disease or death to which this Statement of Principles relates (1) This Statement of Principles is about hypothyroidism and death from hypothyroidism. Meaning of hypothyroidism (2) For the purposes of this Statement of Principles, hypothyroidism: (a) means a functional disorder in which there is deficiency of thyroid hormone that produces clinical symptoms and signs or warrants medical treatment; and (b) includes: (i) primary hypothyroidism due to dysfunction of the thyroid gland; and (ii) central hypothyroidism due to decreased secretion of thyroid hormone from a functionally normal thyroid gland as a result of hypothalamic or pituitary disease; and (iii) peripheral hypothyroidism due to inactivation of thyroid hormone; and (c) excludes: (i) congenital hypothyroidism; (ii) congenital iodine-deficiency syndrome; (iii) Hashimoto thyroiditis; (iv) sick euthyroid syndrome; (v) subclinical hypothyroidism; and (vi) transient hypothyroidism during recovery from non-thyroidal illness. Note 1: Hypothyroidism typically presents with low serum concentrations of the thyroid hormones thyroxine (T4) and/or triiodothyronine (T3), and with an increased concentration of thyroid-stimulating hormone. However, in central hypothyroidism, the thyroid-stimulating hormone concentration may be low to normal. Note 2: Clinical symptoms and signs of hypothyroidism are nonspecific and typically include fatigue, lethargy, cold intolerance, weight gain, constipation, change in voice and dry skin. Note 3: In the circumstance where hypothyroidism is a clinical manifestation of Hashimoto thyroiditis, it is covered by the Statements of Principles concerning Hashimoto thyroiditis. Note 4: Hypothyroidism may be acute or chronic. The acute form may present as myxoedema coma. Note 5: myxoedema coma is defined in the Schedule 1 - Dictionary. Death from hypothyroidism (3) For the purposes of this Statement of Principles, hypothyroidism, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's hypothyroidism. Note: terminal event is defined in the Schedule 1 - Dictionary. 8 Basis for determining the factors On the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that hypothyroidism and death from hypothyroidism can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the MRCA. Note: MRCA, relevant service and VEA are defined in the Schedule 1 - Dictionary. 9 Factors that must exist At least one of the following factors must exist before it can be said that, on the balance of probabilities, hypothyroidism or death from hypothyroidism is connected with the circumstances of a person's relevant service: (1) having iodine deficiency within the 3 months before the clinical onset of hypothyroidism; Note: iodine deficiency is defined in the Schedule 1 - Dictionary. (2) having iodine excess within the 3 months before the clinical onset of hypothyroidism; Note 1: Iodine excess may be due to consuming foods, dietary supplements or medications with a high content of iodine. Note 2: iodine excess is defined in the Schedule 1 - Dictionary. (3) being administered an iodine-containing radiographic contrast agent within the 3 months before the clinical onset of hypothyroidism; (4) taking a drug from the specified list of drugs within the 3 months before the clinical onset of hypothyroidism; Note: specified list of drugs is defined in the Schedule 1 - Dictionary. (5) taking a drug containing at least 10 milligrams of iodine daily for a continuous period of at least 4 weeks within the 3 months before the clinical onset of hypothyroidism; (6) taking amiodarone for a continuous period of at least 2 weeks within the 1 year before the clinical onset of hypothyroidism; (7) being pregnant or within the 12 months postpartum at the time of the clinical onset of hypothyroidism; (8) having a form of thyroiditis from the specified list of forms of thyroiditis at the time of the clinical onset of hypothyroidism; Note: specified list of forms of thyroiditis is defined in the Schedule 1 - Dictionary. (9) undergoing a course of therapeutic radiation for cancer, where the thyroid gland was in the field of radiation, before the clinical onset of hypothyroidism; (10) having received iodine-131 (radioactive iodine) treatment before the clinical onset of hypothyroidism; (11) having subtotal or total thyroidectomy, or neck surgery involving the thyroid gland, before the clinical onset of hypothyroidism; (12) having a disease involving the thyroid gland from the specified list of diseases at the time of the clinical onset of hypothyroidism; Note: specified list of diseases is defined in the Schedule 1 - Dictionary. (13) having a primary or secondary malignant neoplasm of the thyroid gland at the time of the clinical onset of hypothyroidism; (14) having a type 3 deiodinase-overexpressing neoplasm before the clinical onset of hypothyroidism; (15) having hypopituitarism involving deficiency of thyroid-stimulating hormone at the time of the clinical onset of hypothyroidism; (16) being obese for at least 5 years before the clinical onset of hypothyroidism; Note: being obese is defined in the Schedule 1 - Dictionary. (17) for hypothyroidism first presenting as myxoedema coma only, having an acute precipitating event within the 48 hours before the clinical onset of hypothyroidism; Note: acute precipitating event and myxoedema coma are defined in the Schedule 1 - Dictionary. (18) having iodine deficiency within the 3 months before the clinical worsening of hypothyroidism; Note: iodine deficiency is defined in the Schedule 1 - Dictionary. (19) having iodine excess within the 3 months before the clinical worsening of hypothyroidism; Note 1: Iodine excess may be due to consuming foods, dietary supplements or medications with a high content of iodine. Note 2: iodine excess is defined in the Schedule 1 - Dictionary. (20) being administered an iodine-containing radiographic contrast agent within the 3 months before the clinical worsening of hypothyroidism; (21) taking a drug from the specified list of drugs within the 3 months before the clinical worsening of hypothyroidism; Note: specified list of drugs is defined in the Schedule 1 - Dictionary. (22) taking a drug containing at least 10 milligrams of iodine daily for a continuous period of at least 4 weeks within the 3 months before the clinical worsening of hypothyroidism; (23) taking amiodarone for a continuous period of at least 2 weeks within the 1 year before the clinical worsening of hypothyroidism; (24) taking a drug that increases the requirement of thyroid hormone replacement therapy at the time of the clinical worsening of hypothyroidism; Note: Examples of drugs that may increase the requirement for thyroid hormone replacement therapy include 5-fluorouracil, antiretroviral drugs, clofibrate, raloxifene and tamoxifen. (25) being pregnant or within the 12 months postpartum at the time of the clinical worsening of hypothyroidism; (26) having a form of thyroiditis from the specified list of forms of thyroiditis at the time of the clinical worsening of hypothyroidism; Note: specified list of forms of thyroiditis is defined in the Schedule 1 - Dictionary. (27) undergoing a course of therapeutic radiation for cancer, where the thyroid gland was in the field of radiation, before the clinical worsening of hypothyroidism; (28) having received iodine-131 (radioactive iodine) treatment before the clinical worsening of hypothyroidism; (29) having subtotal or total thyroidectomy, or neck surgery involving the thyroid gland, before the clinical worsening of hypothyroidism; (30) having a disease involving the thyroid gland from the specified list of diseases at the time of the clinical worsening of hypothyroidism; Note: specified list of diseases is defined in the Schedule 1 - Dictionary. (31) having a primary or secondary malignant neoplasm of the thyroid gland at the time of the clinical worsening of hypothyroidism; (32) having a type 3 deiodinase-overexpressing neoplasm before the clinical worsening of hypothyroidism; (33) having hypopituitarism involving deficiency of thyroid-stimulating hormone at the time of the clinical worsening of hypothyroidism; (34) being obese for at least 5 years before the clinical worsening of hypothyroidism; Note: being obese is defined in the Schedule 1 - Dictionary. (35) for myxoedema coma only, having an acute precipitating event within the 48 hours before that clinical worsening of hypothyroidism; Note: acute precipitating event and myxoedema coma are defined in the Schedule 1 - Dictionary. (36) inability to obtain appropriate clinical management for hypothyroidism. 10 Relationship to service (1) The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person. (2) The factors set out in subsections 9(18) to 9(36) apply only to material contribution to, or aggravation of, hypothyroidism where the person's hypothyroidism was suffered or contracted before or during (but did not arise out of) the person's relevant service. 11 Factors referring to an injury or disease covered by another Statement of Principles In this Statement of Principles: (1) if a factor referred to in section 9 applies in relation to a person; and (2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(3) of the VEA; then the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.