Volume 167 Issue 7

Local impact of the NHMRC early breast cancer guidelines: where to from here? Jeanette E Ward, John Boyages and Leena Gupta Subsequently cited in Dwyer P. Legal implications of clinical practice guidelines. MJA 1998; 169: 292-293. Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Abstract - Introduction - Methods - Results - Sample characteristics - Recall of and reactions to the guidelines - Self-reported use and views of impact on clinical practice and patient outcomes - Discussion - Acknowledgements - References - - ©MJA1997 Abstract Obj ectives: To determine clinicians' recall of the National Health and Medical Research Council's (NHMRC) Clinical practice guidelines for the management of early breast cancer six months after publication, and their reactions to its content and potential dissemination and implementation strategies. Setting: Greater Western Region of Sydney, May 1996. Method: Self-administered survey of clinicians with an involvement or interest in the management of women with breast cancer. Results: Of the 69 respondents to the questionnaire (77% response rate), 20% did not recall ever seeing the guidelines. Although most agreed with the defined parameters of potential strengths of the guidelines, there was less agreement as to their medicolegal implications. The four treatment sections of the guidelines were the most highly rated, followed by the sections on communication skills and investigations. Education programs, including college-based programs, as well as endorsement of the guidelines by the learned colleges and respected colleagues, were rated highly as dissemination strategies, far outranking Internet availability. Local revision of the guidelines was considered important as an implementation strategy by three-quarters of respondents. Only 20% indicated that the guidelines had influenced clinical practice, although 46% agreed that they would improve outcomes for women with early breast cancer. Conclusions: The NHMRC early breast cancer guidelines have been relatively well received in the Greater Western Region of Sydney, although local activities within public institutions and private practice will be needed to achieve implementation . MJA 1997; 167: 362-365 Introduction Evidence-based clinical guidelines have been advocated by overseas1-3 and local4 authorities to support more effective health care and enhance patient outcomes. However, publication of guidelines alone is insufficient to ensure improvements in clinical practice because dissemination and implementation of guidelines must follow if patient outcomes are to improve.5 Although there is evidence of increased activity in the development of evidence-based guidelines in Australia, dissemination and implementation of such guidelines have received less emphasis.6 Dissemination refers to activities which encourage positive attitudes toward specific guidelines and raise awareness of the need to change. Strategies appropriate to disseminate guidelines include medical seminars about the guidelines and endorsement by recognised peers.7 Implementation refers to activities which aim to achieve and maintain changes in actual practice. Strategies to implement guidelines include audit and feedback, prompts for clinicians, checklists for patients, and financial sanctions and incentives.7,8 The Clinical practice guidelines for the management of early breast cancer9 were the first guidelines produced by the National Health and Medical Research Council (NHMRC) using an explicit evidence-based process.10 The guidelines, published in 1995, were designed "to assist in decision-making by women and their doctors, educate all involved in the care of women with breast cancer, assess and assure the quality of care, reduce the risk of legal liability by improving care and bring the issue of cost-effectiveness into the public arena".10 A consumer guide was also published at the same time.11 We wished to determine clinicians' recall of the guidelines six months after national distribution as well as their reactions to its content, and potential dissemination and implementation strategies. Methods In May 1996, we mailed an eight-page questionnaire and a copy of the guidelines, after an advance telephone prompt, to all members of the Western Areas Breast Group in the Greater Western Region of Sydney, encompassing the Western, Wentworth and Southwestern area health services (n = 52), all other clinicians known to have managed women with breast cancer in 1992 in the region12 (n = 27), and surgical and oncology registrars (n = 11). Non-respondents were followed up with reminder letters a fortnight later and a telephone call 26 days later by one of us (J E W) and 70 days later by an eminent peer. The questionnaire was designed to assess recall and recent use of both the guidelines and consumer guide and the impact of the guidelines to date. We asked respondents to rate eight potential strengths of the guidelines and seven potential criticisms using a five-point scale (strongly agree, agree, unsure, disagree, strongly disagree). To assess content relevance, we asked respondents to rate the usefulness of information in 12 sections of the guidelines using five categories (very, somewhat useful, not useful, unsure, not applicable). To assess the influences on clinicians' decisions whether to follow the guidelines, we asked respondents (using the same response options) to rate the relative importance of each of four features of the development process, one current and five potential dissemination strategies, and three implementation strategies. The latter consisted of a regional implementation strategy designed around revision of the guidelines by all western Sydney specialists to enhance its local application as well as two other implementation strategies drawn from the international literature7,8 (namely, an interactive computerised system to provide clinicians with individualised feedback about patterns of care, and patient checklists provided directly to women). Eight questions ascertained respondents' sociodemographic and professional characteristics. Results Sample characteristics We obtained a 77% response rate (90 clinicians received questionnaires and 69 returned them). Of the 69 respondents, 59 (85%) were men and 10 were women (14%), and ages ranged from 26-67 years. The sample consisted of 35 general surgeons (51%), 10 breast surgeons (14%), five medical oncologists (7%), seven radiation oncologists (10%), and nine registrars (13%) (a further three did not specify). The number of new patients with breast cancer seen per respondent per month ranged from 0-20 (mode, 1; median, 2). Involvement in teaching and research was reported by 52 (75%) and 29 (42%), respectively. Over half the respondents had Visiting Medical Officer appointments (n = 39; 56%), and 18 (26%) were full-time staff specialists in public hospitals. Eight breast surgeons (80%) and 16 general surgeons (46%) were associated with the Royal Australasian College of Surgeons Breast Section. Recall of and reactions to the guidelines Fifty-five respondents (80%) indicated they had seen the guidelines before receiving a copy with our survey, while 12 (17%) had commented on the earlier draft circulated for consultation in June 1995. Only 35 (51%) were aware of the Consensus Statement on the Management of Breast Cancer, published by the Clinical Oncological Society of Australia.13 Fifty-one respondents (74%) were familiar with the consumer guide, but only 12 (17%) always recommended it to women; 20 (29%) sometimes and five (7%) rarely. A further 25 (36%) did not recommend it at all. Of the 37 who recommended the consumer companion, only two would document this always in their medical records; two sometimes and one rarely. The rest never recorded it. Box 1 shows that at least three-quarters of respondents had positive views (strongly agree or agree) for five out of eight statements about potential strengths of the guidelines. More than half disagreed or strongly disagreed with five of seven potential criticisms of the guidelines. While 32% were unsure if the guidelines could be used to sue doctors, 45% agreed or strongly agreed that they could. Box 2 summarises respondents' ratings of specific sections of the guidelines. The four sections listed in the questionnaire about treatment decisions were the most highly rated, followed by the section on communication skills, which outranked the seven sections concerning investigations and other pretreatment decisions. All four features of the guidelines development process were very or somewhat important for almost all of the respondents in deciding whether to follow their recommendations (Box 3). To disseminate the guidelines, most respondents rated educational programs conducted by learned colleges (84%) as well as their endorsement of the guidelines (86%) as very or somewhat important strategies. Other educational programs and recommendation by a respected colleague were rated as very or somewhat important by nearly three-quarters of respondents and outranked Internet availability (the only dissemination strategy in place at the time of the survey). To implement the guidelines, local revision by specialists to make the guidelines more practical was ranked by 76% as being either very or somewhat important in deciding whether to follow the guidelines, contrasting with respondents' ratings of an interactive computer system (50%) and patient checklists (34%). Self-reported use and views of impact on clinical practice and patient outcomes Forty-one (59%) respondents had not referred to the guidelines at all in the previous month of practice, 20 (29%) had referred to them between one and four times, and seven (10%) more than four times. Of the 38 respondents who indicated they saw at least one new patient each month, 34 (90%) had not referred to the guidelines at all in the previous month. Forty-two (61%) respondents indicated that the guidelines had had no influence on their clinical practice, 14 (20%) indicated that they had, and three (4%) were unsure (data missing or the guidelines had not been seen by the remainder). In response to the question Will the guidelines improve outcomes for women with early breast cancer?, 32 (46%) indicated "yes", while 11 (16%) indicated "no", and 25 (36%) were unsure. Discussion Our study assessed the initial reactions of a multidisciplinary group of clinicians to the first evidence-based clinical practice guidelines produced by the NHMRC. Most respondents (80%) had seen the guidelines six months after publication. This compares well against previous surveys showing much lower recall of other national guidelines (e.g., among general practitioners),14 and exceeds the proportion recalling earlier guidelines produced by the Clinical Oncological Society of Australia.13 Even clinicians who recalled the guidelines appear not to have been substantially influenced by them. However, it is possible that clinical practice was already consistent with evidence-based best practice. However, this explanation is inconsistent with the fundamental premise underpinning initiation of the guidelines9 and other, indirect, evidence of an unacceptable variation in practice.12,15 In addition, the guidelines (and a parliamentary report16 ) recommend that clinicians advise their patients about the availability of the consumer companion and recommend them as a reference to be used in cooperation with their doctor.9 However, more than a third of respondents did not recommend the consumer guide at all. Guidelines will not change practice unless clinicians have access to them when needed. Our study shows that use of the guidelines at the local level appears limited. A planned approach to dissemination and implementation is needed. Respondents' ratings of potential strategies have identified useful priorities. Their views on potential dissemination strategies ought to be used to find ways to encourage positive attitudes toward the guidelines and, through their preferred implementation strategies, to change behaviour. Respondents' interest in educational programs conducted by learned colleges, as well as colleges' endorsement of the guidelines, suggests the use of these strategies to create a greater interest in the guidelines. To achieve full implementation, however, local adaptation will be critical.18 Local adaptation will engender a stronger sense of ownership of the guidelines, but mechanisms to enssure the methodological integrity of the evidence-based elements of the guidelines throughout the process of local adaptation will need to be developed. As implementation strategies shown to be effective in overseas research received low ratings in our survey, they should be replicated in controlled trials before being given wider advocacy. Given the relative lack of experience in Australia to date in disseminating, implementing and monitoring use of evidence-based guidelines,17 documentation of the process of local implementation of the guidelines is needed. Finally, as measurement of improved patient outcomes represents the "gold standard" of guidelines evaluation,4,19 we recommend such an approach at local, State and national levels. Acknowledgements We thank all who completed the questionnaire; Professor Allan Langlands and staff of the Breast Cancer Institute for commenting on draft questionnaires; Dr Kate George for telephone prompts; Ms Josette Banks and Mrs Nancy Harding for survey administration; Emeritus Professor Tom Reeve for generous contribution to telephone follow-up; and Mr Md Moniruzzaman for data analysis. References Field M, Lohr K. Guidelines for clinical practice: from development to use. Washington: National Academy Press, 1992. Grimshaw J, Russell I. Achieving health gain through clinical guidelines: 1. Developing scientifically valid guidelines. Qual Hlth Care 1993; 2: 2432-2438. Hayward RSA, Laupacis A. Initiating, conducting and maintaining guidelines development programs. Can Med Assoc J 1993; 148: 507-512. National Health & Medical Research Council. Guidelines for the development and implementation of clinical practice guidelines. Canberra: AGPS, October 1995. Grimshaw J, Russell I. Achieving health gain through clinical guidelines II: ensuring guidelines change medical practice. Qual Hlth Care 1994; 3: 45-52 Holt P, Wilson A, Ward J. Clinical practice guidelines and critical pathways: a status report on national and NSW development and implementation activity. Sydney: NSW Health Department, 1996: 106. Grimshaw J, Russell I. Effect of guidelines on medical practice: a systematic review of rigorous evaluations. Lancet 1993; 342: 1317-1322. Davis D, Thomson M, Oxman A, Haynes RB. Changing physician performance: a systematic review of the effect of CME. JAMA 1995; 274: 700-705. National Health and Medical Research Council. Clinical practice guidelines for the management of early breast cancer. Canberra: AGPS, 1995. Smallwood R. President's letter. RACP Fellowship Affairs 1996; 15: 3. National Health and Medical Research Council. Early breast cancer. A consumer's guide. Canberra: AGPS, 1995. Western Areas Breast Group. Breast cancer patterns of care in the Greater Western Region of Sydney in 1992. Sydney: NSW Breast Cancer Institute, 1997: 1-98. Breast Cancer Consensus Report. Med J Aust 1994; 161 (Suppl): S1-S16. Gupta L, Ward J, Hayward R. Clinical practice guidelines in general practice: a national survey of recall, attitudes and impact. Med J Aust 1997; 166: 69-72. Adelson P, Lim K, Churches T, Nguyen R. Surgical treatment of breast cancer in NSW, 1991-1992. Aust N Z J Surg 1997; 67: 9-14. 16. House of Representatives Standing Committee on Community Affairs. Report on the management and treatment of breast cancer in Australia. Canberra: AGPS, February 1995: 133. Ward J. Best practice guidelines implementation -- implications for patient outcomes. Proceedings of the Second Conference of the Australian Health Outcomes Clearing House. Integrating health outcomes measurement in routine health care; 1996 Aug 13-14; Canberra. Canberra: AHOCH, 1997: 78-83. Browman G, Levine M, Mohide E, et al. The practice guidelines development cycle: a conceptual tool for practice guidelines development and implementation. J Clin Oncol 1995; 13: 502-512. Thompson R, Lavender M, Madhok R. How to ensure that guidelines are effective. BMJ 1995; 311: 237-242. (Received 8 Jan, accepted 3 July, 1997) Author's Details Needs Assessment & Health Outcomes Unit, Central Sydney Area Health Service, NSW. Jeanette E Ward, PhD, FAFPHM, Director; Leena Gupta, MPH, FAFPHM; formerly, Clinical Epidemiologist (Cancer Outcomes). NSW Breast Cancer Institute, Western Sydney Area Health Service, NSW. John Boyages, FRACR, PhD, Director. Reprints: Dr J E Ward, Needs Assessment & Health Outcomes Unit, Central Sydney Area Health Service, Locked Bag 8, Newtown, NSW 2042. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Jeanette E Ward · John Boyages · Leena Gupta

How the NHMRC got its fingers burnt Konrad Jamrozik, Simon Chapman and Alistair Woodward MJA 1997; 167: 372-374 On 20 December 1996, Justice J Finn of the Federal Court of Australia handed down his judgment in the case of the Tobacco Institute of Australia (TIA) Ltd and others v the National Health and Medical Research Council (NHMRC) and others. Justice Finn concluded that, in developing its recommendations for control of environmental tobacco smoke, the NHMRC's Working Party on Passive Smoking erred significantly in regard to the consultative procedures that it employed. As the following discussion shows, the legal decision has profound implications for the NHMRC and the provision of expert advice to Australian governments on matters of health and health policy. The discussion has been prepared by three members of the NHMRC Working Party, but reflects their personal views and not necessarily those of the Working Party as a whole or those of the NHMRC. Introduction - The judgment - Implications of the judgment for the NHMRC - References - Authors' details Make a comment - - ©MJA1997 Introduction The action brought by the Tobacco Institute of Australia (TIA) Ltd and others against the National Health and Medical Research Council (NHMRC) and others was concerned with matters of process, not of science. In his Reasons for Judgment statement,1 Justice Finn said, "My concern is not with the science of the Draft Report nor with the public policy recommendations made" (p2). He ruled that the Working Party "failed to have regard to the submissions received" (p38) from the TIA, in that it was obliged to but failed "to give positive consideration to their contents as a fundamental element in its decision making" (p31). Early in its deliberations the Working Party had decided that, in responding to its term of reference requiring it "to review the relevant scientific evidence linking passive smoking to disease in adults and children",2 it would only consider evidence that had been published in the peer-reviewed scientific literature. It then applied transparent processes in making an extremely conservative calculation of the impact of passive smoking on the health of Australians. Next, it considered the present situation with regard to public policy and public opinion in relation to smoke-free policies. Finally, it produced a series of recommendations which proposed that, given the increasing amount of peer-reviewed scientific evidence of harm from environmental tobacco smoke and significant public concern and support for change, all workplaces and confined public places should become smoke-free. The judgment There were two major issues in the judgment. 1. What emphasis should be placed on different types of evidence? Section 12 of the National Health and Medical Research Council Act 1992 (Cwlth) provides that, whenever the NHMRC proposes to develop guidelines or recommendations, it must publish a notice to that effect, seek submissions from the public and interested bodies on the matter, publish the draft recommendations and seek further submissions on these before issuing a definitive report. In the first phase of consultation initiated by the Working Party on Passive Smoking, in April 1994, the TIA submitted a large volume of material, much of which fell into three broad categories: Reports on aspects of passive smoking. These were openly acknowledged as having been prepared at the request of the tobacco industry and as not being peer-reviewed. Articles from the scientific literature that were readily identifiable as having been written by people known to have been associated with tobacco companies at some time (as judged by criteria developed by Bero and Glantz3). A considerable proportion of these consisted of critiques of previous original, peer-reviewed research on passive smoking rather than independently produced new research. The tobacco industry has been quite successful in pursuing advice received from consultants in 1978 that it should have as much material published as possible that casts doubt on the scientific evidence that passive smoking is harmful to health.4,5 This dissident opinion then gains a life of its own by being repeatedly cited in peer-reviewed literature, often, but not always, by authors with known links to the tobacco industry. Published proceedings of apparently reputable scientific meetings. However, these were, in fact, meetings convened by the tobacco industry and allegedly attended by invitation only.6 The Working Party was faced with the question of how to define "relevant scientific evidence". Errors may result from excluding material from non-peer-reviewed literature. However, in this instance, inclusion of reports from outside the peer-reviewed domain could produce a bias of another kind, as the volume of material generated by the tobacco industry far outweighs that sponsored by other interest groups.7 The Working Party judged that the literature on a long-defined and closely investigated topic such as the effects of passive smoking on health was likely to be relatively unaffected by orthodox publication bias, which favours early, false positive reports.8,9 Accordingly, the Working Party chose to restrict its description of the scientific evidence to that available from peer-reviewed literature. This is the same position as that adopted by the International Agency for Research on Cancer in its regular reviews of the causes of human cancer.10 However, Justice Finn found that the NHMRC Act did not provide for the Working Party to apply a selective standard of whether the material it received was peer reviewed, and rejected the argument that application of such a standard was justified by its wide acceptance by the professional community in reviewing scientific evidence. 2. What constitutes proper consideration of submissions made to the NHMRC or one of its committees or working parties? Justice Finn found fault with a mechanism adopted by the Working Party on Passive Smoking of having research officers summarise the individual submissions received and, in the first instance, circulate these summaries to members of the committee (with full submissions available to all members on request). The summaries were an aid to identifying efficiently to which of the evolving chapters of the Working Party's report submissions might be most pertinent (notwithstanding that no weight was given to non-peer-reviewed material). Justice Finn did not overturn the Working Party's conclusion that passive smoking poses a significant risk to the health of Australians, but he stated that:1 ". . .'positive consideration' of a submission (i) would preclude the adoption of an a priori criterion which itself excluded a part or parts of that submission from actual consideration; and (ii) would involve 'an active intellectual process directed at that . . . submission'." (p31). Justice Finn did not say explicitly what evidence of "proper consideration" or "an active intellectual process" would have satisfied him, nor did he limit or define a submission. Not defining these terms opens the door for any organisation with sufficient resources to forward excessive amounts of material for "active intellectual processing". The lack of a definition of "proper consideration" is significant. A close reading of the judgment suggests that its strongest defence would have been for each member of the Working Party to have prepared a written critique on all of the four books, 122 scientific papers and other supporting documents sent to the NHMRC by the TIA, for those critiques to have been tabled and discussed at full meetings of the Working Party, for the minutes of those meetings to have recorded those discussions and their outcomes in detail, and for all members of the Working Party to have been prepared to have taken the witness stand to answer questions about the whole process and every document. This extremely onerous standard would stretch the present NHMRC and its system of committees to their very limits. While it is possible that in future a court might accept a less demanding standard, it is predictable that those appealing against the NHMRC would seek evidence of "consideration" in its widest sense. Implications of the judgment for the NHMRC Given that the 1992 NHMRC Act obliges the Council to embark upon a process of public consultation whenever it is proposing to issue regulatory recommendations (recommendations that require responses from relevant Australian governments) or guidelines on any matter falling within its charter, we now have a situation in which any party with a vested interest and sufficient resources can effectively slow down the NHMRC's provision of independent expert advice on important matters of public health policy, simply by submitting an overwhelming number of opinions and commissioned, non-peer-reviewed reports on the matter at issue. There would appear to be nothing stopping any manufacturer or other group involved in the production, sale or distribution of any possibly hazardous product from doing exactly the same thing. The NHMRC Secretariat has a limited budget (approximately $5.5 million, half of which is for staff salaries)11 and only a very small permanent workforce of 96 people that it supplements by temporary secondments from the Department of Health and Family Services. A very large proportion of its work is undertaken by academic and other experts who, while being mindful of the honour of being invited to serve the Australian public in this way, also feel duty-bound to accept the responsibility and to give their time and effort to providing the best possible advice to the community and its various governments. The recent case on passive smoking shows that, as the law stands, this rather unsophisticated arrangement is not adequate for dealing with potentially far-reaching questions of health and health policy where large vested interests are involved. One response would be for the Federal Government to expand the Secretariat and budget of the NHMRC to the point where dedicated, in-house experts would be permanently available to consider any matter that was referred to the Council for consideration. Alternatively, the NHMRC Act might be changed to define more closely the requirements and mechanisms for consultation to prevent the process of formulating policy becoming unworkably bogged down. The NHMRC should not retreat to a professionally dominated model that excludes participation by the wider community. The challenge is to create processes that are open, inclusive and democratic, in the sense that all interests are treated fairly. The NHMRC must juggle efficiency, equity and scarce resources -- not an easy task. One practical suggestion is that, in future, it should restrict the length of submissions to ensure that the Council, with limited resources, can give fair consideration to all. A third alternative is suggested by the history of tobacco control in the United Kingdom, where expert reports from the Royal College of Physicians have driven the debate on public policy.12-15 In the present circumstances, the Federal Government might do well to commission outside expert groups such as the universities or the medical colleges to produce reports. The government would get its advice, but the process of providing it would not be held up by legal challenges. References Federal Court of Australia. Tobacco Institute of Australia Ltd & Ors v National Health & Medical Research Council & Ors [1996] 1150 FCA 1 (20 December 1996). Full text decisions of the Federal Court of Australia from 1977 on the Internet at: < URL: http://www.austlii.edu.au/au/cases/cth/federal - ct/ > >. National Health and Medical Research Council Working Party. The health effects of passive smoking. Canberra: NHMRC, 1995: 3. Bero LA, Glantz SA. Tobacco industry response to a risk assessment of environmental smoke. Tobacco Control 1993; 2: 103-113. Roper Organization Inc. A study of public attitudes towards cigarette smoking and the tobacco industry. Vol 1. New York: Roper Organization Inc., 1978. Chapman S. Tobacco industry memo reveals passive smoking strategy. BMJ 1997; 314: 1569. Bero LA, Galbraith A, Rennie D. Sponsored symposia on environmental tobacco smoke. JAMA 1994; 271: 612-617. Bero LA, Glantz SA, Rennie D. Publication bias and public health policy on environmental tobacco smoke. JAMA 1994; 272: 133-136. Begg CB, Berlin JA. Publication bias: a problem in interpreting medical data. J Roy Stat Soc A 1988; 151: 419-463. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR. Publication bias in clinical resarch. Lancet 1991; 337: 867-871. O'Neill IK, Chen J, Bartsch H, editors. Relevance to human cancer of N -nitroso compounds, tobacco smoke and mycotoxins. Lyon: International Agency for Research on Cancer, 1991. (IARC Scientific Publications No. 105.) National Health and Medical Research Council. Review of the Implementation of the Strategic Plan 1994-1996. Document tabled in Federal Parliament, 26 August 1997. Royal College of Physicians. Smoking and health. London: Pitman, 1962. Royal College of Physicians. Smoking and health now. London: Pitman, 1971. Royal College of Physicians. Smoking or health. London: Pitman Medical, 1977. Royal College of Physicians. Health or smoking. London: Pitman Medical, 1983. Authors' details University of Western Australia, Perth, WA. Konrad Jamrozik, DPhil, FAFPHM, Associate Professor in Public Health. University of Sydney, Sydney, NSW. Simon Chapman, PhD, Associate Professor in Public Health and Community Medicine. Wellington School of Medicine, Wellington, NZ. Alistair Woodward, PhD, FAFPHM, Professor of Public Health. Reprints will not be available from the authors. Correspondence: Associate Professor K Jamrozik, Department of Public Health, University of Western Australia, Nedlands, WA 6907. E-mail: konrad AT talbot.epidem.uwa.edu.au Make a comment - - To top of article - ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments.

Konrad Jamrozik · Simon Chapman · Alistair Woodward

Letter Ultrarapid opiate detoxification. What's all the fuss about? MJA 1997; 167: 393 To the Editor: In the past few months, the Australian electronic and print media have hailed ultrarapid opiate detoxification (UROD) as being able to "cure" 60%-100% of heroin addicts. These claims were initially made as part of a professionally organised media campaign by CITA/ATT, a Spanish-Israeli organisation, but have been repeated by opponents of harm-minimisation addiction treatments.1 While there is no conclusive evidence as to the efficacy of UROD, CITA/ATT has attempted to patent and franchise what it considers to be "its" treatment. In UROD, opioid addicts are anaesthetised for several hours and given naltrexone to precipitate withdrawals. Naltrexone is a long-acting, opioid antagonist with little or no agonist activity that is effective orally. It has not been approved for use in Australia. While there are benefits in terms of speed and reduced suffering, there are no published reports comparing the long-term outcome after UROD with other methods of rapid opioid detoxification. UROD is expensive and has obvious risks; a patient died during treatment in the United Kingdom.2 After UROD, patients are given up to a year's maintenance treatment with naltrexone, usually 100 mg on Mondays and Wednesdays and 150 mg on Fridays. While the available evidence is contradictory, there is a suggestion that socially stable addicts with no psychiatric comorbidity may benefit from postdetoxification naltrexone treatment. In two randomised, placebo-controlled, double-blind trials the treated group tended to use less heroin, but the differences were not statistically significant.3,4 CITA claimed UROD was discovered by a Spanish psychologist, Dr Juan Legarda.5 However, rapid opiate detoxification was first described by researchers working at Vienna University in a series of papers published in the international peer-reviewed literature between 1988 and 1991.6 Dr Legarda's first and only published account dates from 1994 and refers to the work of the Vienna group and others.7 CITA/ATT sought to franchise "its" treatment (international patent application PCT/ES94/100108),5 and has threatened to sue a British and American physician who offer patients similar services. CITA/ATT has also attempted to issue national franchises for the "CITA Method". A United Kingdom version of the franchise agreement stipulated "the Method" must remain secret. A minimum 240 detoxifications had to be performed in the first six months and one-quarter of all payments were to be paid to the parent company. The British licensee would have been obliged to spend no less than US$50 000 in the first year and US$25 000 in subsequent years marketing and advertising "the Method".2 The CITA/ATT marketing campaign represents a corruption of the scientific process and is unethical. The profession should condemn this and similar attempts to use the mass media to bypass the peer-reviewed literature. However, despite the concerns raised by the CITA/ATT media campaign, a local, randomised trial of UROD versus another form of rapid, antagonist-assisted detoxification is warranted.5 Such a study should include a double-blind, placebo-controlled trial of postdetoxification naltrexone maintenance. John R M Caplehorn PhD Student, Department of Public Health and Community Medicine University of Sydney, NSW 2006 E-mail: johncATpub.health.su.oz.au Ackerman P. Aim must be abstinence when it comes to drugs. Sunday Telegraph 1997 March 23; 143. Tyaransen O. The strange and terrible saga of Brendan Woolhead. Hot Press (Dublin) 1997 May 14; 12, 13, 62. National Research Council Committee on Clinical Evaluation of Narcotic Antagonists. Clinical evaluation of naltrexone treatment of opiate-dependent individuals. Arch Gen Psychiatry 1978; 35: 335-340. Shufman EN, Porat S, Witzum E, et al. The efficacy of naltrexone in preventing reabuse of heroin after detoxification. Biol Psychiatry 1994; 35: 935-945. Brewer C. Ultra-rapid, antagonist-precipitated opiate detoxification under general anaesthesia or sedation. Addiction Biol 1997; 2: 291-302. Loimer N, Schmid R, Presslich Q, Lenz K. Continuous naloxone administration suppresses opiate withdrawal symptoms in human opiate addicts during detoxification treatment. J Psychiatr Res 1988; 23: 81-96. Legarda J, Gossop M. A 24-h inpatient detoxification treatment for heroin addicts: a preliminary investigation. Drug Alcohol Depend 1994; 35: 91-93.