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REPATRIATION MEDICAL AUTHORITY STATEMENT RE: INVESTIGATION INTO HELICOBACTER PYLORI INFECTION The Repatriation Medical Authority has decided not to make statements of principles under subsections 196B (2) or (3) in respect of Helicobacter pylori infection, following notice of an investigation to find out whether a Statement of Principles may be determined in respect of Helicobacter pylori infection gazetted on 10 September 1997 in the Commonwealth of Australia Gazette. Background to the Investigation The Repatriation Medical Authority of its own initiative under section 196B(4) of the Veterans’ Entitlements Act 1986 decided to investigate whether a Statement of Principles may be determined in respect of Helicobacter pylori infection. The investigation notice was signed by the Chairman of the Repatriation Medical Authority on 27 August 1997 and was gazetted in accordance with section 196G of the Act in the Commonwealth of Australia Gazette on 10 September 1997. Submissions were invited from persons and organisations wishing to make a submission by 31 October 1997. Helicobacter pylori infection has been determined to be a cause of some diseases, in some Statements of Principles previously made by the Repatriation Medical Authority. Submissions received by the Authority pursuant to section 196F (a) Repatriation Commission provided a detailed referenced submission, together with copies of the referenced articles, which were received by the Authority on 31 October 1997. (b) Mr Neil Rogers, Senior Pensions Officer and Advocate, RSL Queensland Branch, informed the Repatriation Medical Authority by letter faxed to the Secretariat on 1 December 1997 of an intention to provide a late submission, but on 2 December 1997 he informed the Secretariat he would not be doing so. (c) No other submissions were received pursuant to this section. Evidence/Information Available to the Repatriation Medical Authority a. b. c. d. Submission from Repatriation Commission received 31 October 1997. Literature search using Medline. Medical or scientific publications as set out in the bibliography hereto. Draft Submission prepared for presentation to the Authority by a medical officer from the Secretariat in conjunction with a member of the Authority. Reasons for the decision Page 1 of 14 Helicobacter pylori colonises the mucous layer overlying gastric or gastric-type metaplastic gut epithelium. Colonisation takes place largely in childhood. No environmental reservoir has been identified, suggesting a person-to-person method of transmission. The exact mode/s of transmission have not been determined, but it has been postulated that faeco-oral, oro-oral, gastro-oral modes of transmission are all possible. 1 Gastro-oral transmission appears to be the most likely mechanism from handling of achlorhydric vomitus of newly infected subjects (who are usually children) or saliva contaminated by gastric contents containing Helicobacter pylori bacteria. In most infected individuals, infection lasts lifelong develop gastric atrophy. 2 unless treated or the subjects The prevalence of Helicobacter pylori infection has shown an inverse relationship with socio-economic status. The prevalence of Helicobacter pylori infection has decreased in subsequent cohorts with improvement in the socio-economic status. A number of studies have shown an association with overcrowding particularly in childhood which is closely associated with socio-economic status. In the third world countries the prevalence of Helicobacter pylori infection may reach 70 percent or more. In Western populations from developed countries the prevalence is lower, rising with age to about 50% at 50 years of age. A decline in childhood infection rates with improving socioeconomic status is likely to be accompanied by an increase in the rate of newly acquired infections in adulthood, due to an increase in the number of susceptible adults. 3 4 5 6 7 Seroconversion rates indicative of newly acquired Helicobacter pylori infection among adults is very low. Reported figures are less than one percent per person-year, with developed countries reporting less than 0.5 percent per person-year. There is limited evidence that some gastroenterologists who perform upper endoscopies and institutionalised populations may be at higher risk of acquisition of Helicobacter pylori colonization. Person-to-person transmission between spouses does not seem to occur readily. Transmission of Helicobacter pylori by fibroscope and gastroduodenoscopies have been reported. 8 9 10 11 12 13 14 15 16 17 18 Vincent P (1995) Transmission and acquisition of Helicobacter pylori infection: evidences and hypothesis. Biomedicine & Pharmacotherapy. Vol 49 No 1 p 13. 2 NIH consensus development panel on Helicobacter pylori in Peptic Ulcer Disease (1994) Helicobacter pylori in peptic ulcer disease. JAMA Vol 272 pp 65-69. 3 Vincent P (1995) Transmission and acquisition of Helicobacter pylori infection: evidences and hypothesis. Biomedicine & Pharmacotherapy. Vol 49 No 1 pp 13-14. 4 The EUROGAST Study Group (1993) Epidemiology of, and risk factors for, Helicobacter pylori infection among 3194 asymptomatic subjects in 17 populations. Gut Vol 34 No 12 pp 1672-1676. 5 Mendall MA and Northfield TC (1995) Transmission of Helicobacter pylori infection. Gut Vol 37 No 1 pp 1-3. 6 Lindkvist P, Asrat D, Nilsson I, Tsega E, Olsson GL, Wretlind B and Giesecke J (1996) Age at acquisition of Helicobacter pylori infection: comparison of a high and a low prevalence country. Scandinavian Journal of Infectious Diseases Vol 28 No 2 pp 181-184. 7 Banatvala N, Mayo K, Megraud F, Jennings R, Deeks JJ and Feldman RA (1993) The cohort effect and Helicobacter pylori. J Infect Dis Vol 168 No 1 pp 219-221. 8 Vincent P (1995) Transmission and acquisition of Helicobacter pylori infection: evidences and hypothesis. Biomedicine & Pharmacotherapy. Vol 49 No 1 pp 13-14. 1 Page 2 of 14 Evidence does not support increased risk of acquisition of Helicobacter pylori infection in military personnel in recent times. 19 20 21 In the vast majority of subjects Helicobacter pylori infection does not cause any specific symptoms. However, it has been recognised as an important risk factor for gastritis, peptic ulcer disease and malignant neoplasm of the stomach. The National Institute of Health Consensus Development Conference on Helicobacter pylori in peptic ulcer disease concluded that the data are not sufficient to support prophylactic antimicrobial therapy to prevent ulcer disease or gastric neoplasia in asymptomatic patients. 22 23 24 25 Veldhuyzen van Zanten SJ, Pollak PT, Best LM, Bezanson GS and Marrie T (1994) Increasing prevalence of Helicobacter pylori infection with age: continuous risk of infection in adults rather than cohort effect. Journal of Infectious Diseases Vol 169 No 2 pp 434-437. 10 Perez-Perez GI, Witkin SS, Decker MD and Blaser MJ (1991) Seroprevalence of Helicobacter pylori in couples. J Clin Microbiol Vol 29 No 3 pp 642-644. 11 Parsonnet J, Blaser MJ, Perez-Perez GI, Hargrett-Bean N and Tauxe RV (1992) Symptoms and risk factors of Helicobacter pylori infection in a cohort of epidemiologists. Gastroenterology Vol 102 No 1 pp 41-46. 12 Goodman KJ and Correa P (1995) The transmission of Helicobacter pylori. A critical review of the evidence. International Journal of Epidemiology Vol 24 No 5 pp 875-887. 13 Cullen DJ, Collins BJ, Christiansen KP, Epis J, Warren JR, Surveyor I and Cullen KJ (1993) When is Helicobacter pylori infection acquired? Gut Vol 34 No 12 pp 1681-1682. 14 Berkowicz J and Lee A (1987) Person-to-person transmission of Campylobacter pylori. Lancet Vol 2 pp 680-681. 15 Langenberg W, Rauws EA, Oudbier JH and Tygat GNJ (1990) Patient-to-patient transmission of Campylobacter pylori infection by fibreoptic gastroduodenoscopy and biopsy. J Infect Dis Vol 161 pp 507-511. 16 Böhmer CJ, Klinkenberg-Knol EC, Kuipers EJ, Niezen-de Boer MC, Schreuder H, SchuckinkKool F and Meuwissen SG (1997) The prevalence of Helicobacter pylori infection among inhabitants and healthy employees of institutes for the intellectually disabled. American Journal of Gastroenterology, Vol.92(6), pp. 1000-4. 17 Harris AW, Douds A, Meurisse EV, Dennis M, Chambers S and Gould SR (1995). Seroprevalence of Helicobacter pylori in residents of a hospital for people with severe learning difficulties. European Journal of Gastroenterology & Hepatology 7 (1) pp 21-23. 18 Fawcett JP, Shaw JP, Cockburn M, Brooke M and Barbezat GO (1996). Seroprevalence of Helicobacter pylori in a birth cohort of 21 year old New Zealanders. European Journal of Gastroenterology & Hepatology 8 (4) pp 365-9. 19 Hyams KC, Taylor DN, Gray GC, Knowles JB, Hawkins R and Malone JD (1995) The risk of Helicobacter pylori infection among U.S. military personnel deployed outside the United States. American Journal of Tropical Medicine & Hygiene Vol 52 No 1 pp 109-112. 20 Hammermeister I, Janus G, Schamarowski F, Rudlolf M, Jacobs E and Kist M (1992) Elevated risk of Helicobacter pylori infection in submarine crews. Eur J Clin Microbiol Infect Dis Vol 11 pp 9-14. 21 Basso L, Beattie S, Lawlor S, Clune J and O'Morain C (1994) A descriptive follow-up study on Helicobacter pylori infection before and after exposition to a war area. European Journal of Epidemiology Vol 10 No 1 pp 109-111. 22 NIH consensus development panel on Helicobacter pylori in Peptic Ulcer Disease (1994) Helicobacter pylori in peptic ulcer disease. JAMA Vol 272 pp 65-69. 23 The EUROGAST Study Group (1993) Epidemiology of, and risk factors for, Helicobacter pylori infection among 3194 asymptomatic subjects in 17 populations. Gut Vol 34 No 12 pp 1672-1676. 24 Taylor DN and Blaser MJ (1991) The epidemiology of Helicobacter pylori infection. Epidemiologic Reviews Vol 13 pp 42-59. 25 Davis S (1996) Triple therapy and Helicobacter pylori. Aust Fam Phys Vol 25 No 1 pp 53-59. 9 Page 3 of 14 The Repatriation Medical Authority considered and had regard to the provisions of the Act and in particular, sections 5AB(2) (‘sound medical-scientific evidence’), 5D (‘disease’), 8 (‘war caused death’), 9 (‘war caused injuries or diseases’), and Part XIA. (i) The RMA considered the definition of ‘disease’ in s. 5D which is as follows: “(1) In this Act, unless the contrary intention appears: ‘disease’ means: (a) any physical or mental ailment, disorder, defect or morbid condition (whether of sudden onset or gradual development); or (b) the recurrence of such an ailment, disorder, defect or morbid condition; but does not include: (c) the aggravation of such an ailment, disorder, defect or morbid condition; or (d) a temporary departure from: (i) the normal physiological state; or (ii) the accepted ranges of physiological or biochemical measures; that results from normal physiological stress (for example, the effect of exercise on blood pressure) or the temporary effect of extraneous agents (for example, alcohol on blood cholesterol levels);” (ii) The RMA had regard to the definition of ‘disease’ for the purposes of the Safety Rehabilitation and Compensation Act 1988 , as follows: “disease means: (a) any ailment suffered by an employee; or (b) the aggravation of any such ailment; being an ailment or an aggravation that was contributed to in a material degree by the employee’s employment by the Commonwealth or a licensed corporation”. (iii) Whilst the RMA noted that the definitions are not the same, it considered that sufficient similarity existed to warrant regard to interpretations of the definition of ‘disease’ in the SRC Act. (iv) The RMA had regard to the consideration of the definition of disease for the purpose of the SRC Act in Comcare v Mooi (1996) 42 ALD 495. There Drummond J. of the Federal Court, held that particular facts and circumstances would only be caught by the statute if they fell within the defining phrase and also within the ‘connotations which the word defined by that phrase has in ordinary speech”. Page 4 of 14 (v) Accordingly, applying that reasoning to the definition of ‘disease’ in s. 5D, the RMA formed the opinion it would not be enough for a person to say that a condition they were suffering from was a ‘defect’ in one or more meaning of that word, or ailment, disorder, or morbid condition if there was otherwise no connotation of disease in its ordinary usage. Having regard to the definition, the RMA also formed the opinion that the definition was not intended to include those conditions as a disease that involve only a temporary departure from the normal range of measurements. Such exclusions provided a negative yardstick to assist in the interpretation of what is meant by ‘disease’ and the RMA acknowledged that in considering such exclusions it apply objective medical and scientific standards to its consideration. (vi) The RMA was familiar with the ordinary English meaning of ailment, disorder, defect or morbid condition, which terms are used in s.5D, and considered whether Helicobacter pylori infection was within the ordinary meaning of these terms and applied the ordinary meaning of those terms to its consideration of whether Helicobacter pylori infection is a disease. (vii) In considering whether Helicobacter pylori infection was a ‘disease’ for the purposes of the VEA, the RMA also relied upon its expert medical knowledge. Decision At its meeting on 3 March 1998, the Repatriation Medical Authority, decided not to make a Statement of Principles in respect of Helicobacter pylori infection for the purposes of subsection (2) or (3) of s.196B of the Act. Page 5 of 14 BIBLIOGRAPHY Ashorn M, Miettinen, Ruuska T, Laippala P and Maki M (1996). Seroepidemiological study of Helicobacter pylori infection in infancy. Archives of Disease in Childhood 74 (2) pp 141-142. Axon AT (1995) Review article: is Helicobacter pylori transmitted by the gastro-oral route?. Alimentary Pharmacology & Therapeutics Vol 9 No 6 pp 585-588. Axon ATR (1996). The transmission of Helicobacter pylori: which theory fits the facts? European Journal of Gastroenterology & Hepatology 8 (1) pp 1-2. Banatvala N, Mayo K, Megraud F, Jennings R, Deeks JJ and Feldman RA (1993) The cohort effect and Helicobacter pylori. J Infect Dis Vol 168 No 1 pp 219-221. 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