Proposal to extend toddler vaccine program causes concern. NSW - Vaccine irresponsible - vaccination lobbyist.

Free jab against deadly brain bug. Free jabs for 1 million. Parents warned of false vaccine. Letters UPDATE 1-Australia plans mass meningococcal vaccinations. NSW - Meningococcal vaccination program prompts mixed reactions. Pain a small price to pay - Vaccination push for tots. Meningococcal vaccine warning. Pain a small price to pay - New vaccination shots. Australia plans mass meningococcal vaccinations. Letters

2 3 4 5 6 8 27 29 31 33 35 37 39

P

r

o p o s a l

t

o

e x t

e n d

t

o d d l

e r

v a c c i

n e

p r

o g r

a m

c a u s e s

c o n c e r

n .

Proposal to extend toddler vaccine program causes concern. 147 words 7 June 2002 Australian Broadcasting Corporation (ABC) News ABCNEW English (c) 2002 Australian Broadcasting Corporation Concerns have been raised the Federal Government may expand its national immunisation program to include three new vaccines for toddlers. Professor George Rubin from the immunisation advisory group says they are considering whether to recommend adding immunisations for chicken pox, meningococcal and pneumococcal disease to the free vaccination schedule. However Australian Vaccination Network president Meryl Dorey says the Australian Government should independently test the vaccines before they are used on the population. "We just rely on what happens overseas and most of the vaccine research that takes place overseas has been funded in full or in part by the pharmaceutical companies," Ms Dorey said. But Professor Rubin says they assess all scientific data available. "The vaccine manufacturers know they've got to through this process and pass all the tests to demonstrate that the vaccine is safe," he said. Document abcnew0020020607dy67000b5

Page 2 of 40

© 2012 Factiva, Inc. All rights reserved.

N

S

W

-

V

a c c i

n e

i

r

r

e s p o n s i

b l

e

-

v a c c i

n a t

i

o n

l

o b b y i

s t

.

NSW - Vaccine irresponsible - vaccination lobbyist. 211 words 20 August 2002 18:43 Australian Associated Press General News AAP English (c) 2002 AAP Information Services Pty Ltd. All rights reserved. Available for personal use but not for sale or redistribution for compensation of any kind without the prior written permission of AAP. SYDNEY, Aug 20, AAP - A mass vaccination program against the deadly meningococcal disease was irresponsible, a pro-choice vaccination lobbyist said today. The $41 million scheme was approved yesterday by the federal government and will begin early next year. Federal Health Minister Kay Patterson said high-risk babies and teenagers would be targeted by the program, which will vaccinate against the meningococcal C strain. There is no vaccine available for meningococcal B. Australian Vaccination Network (AVN) president Meryl Dorey said the vaccine had never been tested for effectiveness. AVN is a lobby group dedicated to ensuring parents have the right to choose whether or not to vaccinate their children. Ms Dorey said the vaccine is now the subject of an inquiry in the UK. "When it was introduced in the United Kingdom they had so many adverse reactions reported that they've actually had a government inquiry into this," she told Channel Seven's Sunrise program. "To introduce this vaccine while there is an inquiry ongoing overseas, while there have been this huge number of reactions reported is irresponsible and does not mean that the government is performing its duty of care." So far this year, more than 20 Australians have died from the killer bug. Document aap0000020020820dy8k0018h

Page 3 of 40

© 2012 Factiva, Inc. All rights reserved.

F

r

e e

j

a b

a g a i

n s t

d e a d l

y

b r

a i

n

b u g .

Free jab against deadly brain bug. 218 words 20 August 2002 MX (Australia) EMMEXX 7 English (c) 2002 Nationwide News Pty Limited MENINGOCOCCAL C The federal government hoped to introduce vaccinations for the deadly C strain of meningococcal disease for all ages. One million Australian children and teenagers will have free vaccinations against the deadly C strain of meningococcal disease from next year. Cabinet yesterday approved a national program which will cost $41 million in 2003, and $20 million each year for the next 14 years. Health Minister Kay Patterson said vaccinations would begin with young children and teenagers, but the government's aim was to vaccinate all age groups. So far this year more than 20 Australians have died from the killer bug. There is no vaccine available for meningococcal B, another deadly strain of the disease. The Meningococcal Association of Australia today said while the move would help save lives, it was a Band-Aid solution and more was needed. Opposition health spokesman Stephen Smith also welcomed the move, but said the government could do more to promote the lifestyle changes needed to minimise the risk of the disease to children. Australian Vaccination Network president Meryl Dorey said the vaccine had never been tested for effectiveness, and was the subject of an inquiry in the UK. "To introduce this vaccine while there have been this huge number of reactions reported is irresponsible." Document emmexx0020020820dy8k0000f

Page 4 of 40

© 2012 Factiva, Inc. All rights reserved.

F

r

e e

j

a b s

f

o r

1

m

i

l

l

i

o n .

Free jabs for 1 million. 209 words 21 August 2002 Northern Territorian NORTHT 3 English (c) 2002 Plans for a national meningococcal vaccination program yesterday received a mixed response from doctors, victims' families and anti-vaccination lobby groups. One million Australian children and teenagers will get free vaccinations against a deadly strain of meningococcal disease from next year, after federal Cabinet approved a targeted program costing $41 million in its first year, and $20 million each year for the next 14 years. Australian Medical Association vice-president Trevor Mudge said the plan to vaccinate against meningococcal C strain would reassure the public, but had serious limitations. Dr Mudge said the real answer lay in boosting funding for medical research into the deadly and frightening disease. "I think vaccination really is the only strategy we have at the moment, but unfortunately it has its limitations," he said. Dr Mudge said the vaccine would be effective only against the C strain of the bacteria, which accounted for only 30 per cent of cases. The Meningococcal Associ ation of Australia (MAA) described vaccination as a band-aid solution, saying more education was the answer. MAA general manager Joe Mac Manamon said the government must focus on education. Meanwhile, Australian Vacci nation Network president Meryl Dorey said the vaccine had never been tested for effectiveness. Document northt0020020820dy8l000gu

Page 5 of 40

© 2012 Factiva, Inc. All rights reserved.

P

a r

e n t

s

w

a r

n e d

o f

f

a l

s e

v a c c i

n e .

Parents warned of false vaccine. By MARY PAPADAKIS. 463 words 29 September 2002 Sunday Herald Sun SUHERS 17 English (c) 2002 Herald and Weekly Times Limited THOUSANDS of Victorian children are at risk because parents are choosing homeopathic remedies over traditional vaccines, according to medical experts. Health authorities fear the children are not being protected against killer diseases as parents opt for alternatives to medically sanctioned vaccines. Department of Human Services prevention and perinatal health manager Dr Rosemary Lester said parents were misled about homeopathic remedies. "There's no scientific evidence that these so-called homeopathic vaccines work at all," she said. "Parents are putting their kids at risk." Royal Children's Hospital pediatrician Dr Jenny Royle said parents who did not vaccinate their children or relied on homeopathic remedies were flirting with disaster. "Having a homeopathic vaccine for any childhood illness is false reassurance," she said. "This worries us enormously because there is no evidence these supposed vaccines work." But Australasian College of Hahnemannian Homeopathy director Isaac Golden said vaccine alternatives were effective. "Parents are not putting their child at any risk," he said. "Over 200 years of evidence suggests the level of protection is about 80 per cent to 90 per cent. "The homeopathic option is not perfect; neither is vaccination." Remedies marketed as homeopathic "vaccines" have been recently criticised and the Therapeutic Goods Administration cracked down on a purported meningococcal "vaccine". But Mr Golden, a homeopath for 17 years in Daylesford, said homeopaths offered "preventative remedies", not vaccines. "We don't have homeopathic vaccines. We offer a form of immunisation," he said. Page 6 of 40 © 2012 Factiva, Inc. All rights reserved.

Mr Golden, who also supports conventional vaccines, said there had been a big increase in parents choosing not to vaccinate or instead using oral homeopathic alternatives. He plans to write to state and federal politicians urging acceptance of homeopathic remedies. There are no official figures on the number of Victorian children who use homeopathic alternatives to vaccines, but Australian estimates are in the tens of thousands. Ninety-one per cent of Victorian children are medically vaccinated by age one year and 88.8 per cent by two years old. Whooping cough, diphtheria, polio and measles vaccines are 80 per cent to 95 per cent effective. Australian Homeopathic Association secretary Peter Torokfalvy said homeopathic remedies worked despite not provoking an antibody response like vaccines. Overseas studies showed severely diluted homeopathic remedies, often using plants and minerals, prevented disease. "There's strong vested interest that objects to anything that pushes the status quo," he said. Australian Medical Association Victorian president Dr Mukesh Haikerwal said homeopathic vaccine alternatives should be avoided. "The only effective means of protecting our kids is through a proven vaccine, not a hopeful therapy," he said. Australian Vaccination Network president Meryl Dorey said homeopathic remedies were a legitimate alternative. "We all want healthy children. The only question is how best to achieve that," she said. Document suhers0020020928dy9t000hf

Page 7 of 40

© 2012 Factiva, Inc. All rights reserved.

L e t

t

e r

s

Letters 8,056 words 6 July 2002 British Medical Journal BMDJ International edition 41 Volume 325, Issue 7354; ISSN: 0959-8146 English Copyright (c) 2002 ProQuest Information and Learning. All rights reserved. Copyright BMJ Publishing Group Jul 6, 2002 Website: bmj.com Email: letters@bmj.com Randomised controlled trials for homoeopathy Providers have much to gain from homoeopathy being accepted EDITOR-Debates generated by the lack of evidence of benefit of screening for breast and prostate cancer are similar to the argument for lack of effectiveness of homoeopathy. How does one show a lack of benefit in the face of wishful thinking by both customers and providers, particularly when the providers have a financial interest in a positive outcome? And, as an anaesthetist and non-user of any of these services, why should I care? The answer is given by Feder and Katz, who point out that patients can be referred to homoeopathic specialists in the NHS or general practitioners who prescribe homoeopathically.1 Consumers of these resources should have a duty to show a benefit from any consultations or treatments provided, and the fundholders should have a duty to withhold funds in the absence of such evidence. If the customers then wish to purchase treatment that is not beneficial they will of course be free to do so and the homoeopaths, iridologists, colonic irrigationists, and the rest can flourish. As the editorial points out, meta-analysis of results of trials of homoeopathic treatments suggest benefit greater than placebo in some cases, but this can easily be discounted by publication bias. Statistically, some trials of homoeopathic treatments will show some benefit even when the real effect of the treatment is zero, and these are the trials that are most likely to be published. Homoeopaths argue that their treatments are not amenable to statistical analysis in the same way as conventional medicine is, in part because most trials of homoeopathic medicines do not individualise treatment. I can give an example from my own practice: anaesthesia for coronary artery surgery. In this, treatment is tailored to individuals, whose coronary anatomy is unique, yet statistical analysis shows an aggregate beneficial effect from treatment. This is how medicine works; patients are individuals yet patterns can be recognised, and this allows us to base our diagnostic and therapeutic interventions on these patterns. Why should homoeopathy be allowed to hide behind a smokescreen that is denied to conventional medicine, and why should the NHS fund such treatment in the absence of any evidence of useful effect The answer Page 8 of 40 © 2012 Factiva, Inc. All rights reserved.

is that the providers have a lot to gain, in terms of financial reward and intellectual acceptance; quacks will always be with us. Michael Foley consultant anaesthetist James Cook University Hospital, Middlesbrough TS4 3BW mikefoley@doctors.org.uk 1 Feder G, Katz T Randomised controlled trials for homoeopathy. BMJ 2002;324A98-9.(2 March.) Studies comparing homoeopathy and placebo are unhelpful EDITOR-Why do we need another study comparing homoeopathy with placebo?1 The word placebo is a language construct for an apparently inert product, just as the word homoeopathy is a language construct for treatment with an apparently active product. We know that both may have positive effects on an illness, and occasionally one of the interventions will be more effective than the other. But when both are studied against an effective active treatment no difference is found between them.2 3 Clinicians must decide whether to prescribe effective active treatment that is significantly better than placebo or homoeopathy. For mild illness, where the active treatment leads to small benefits or high risks, a placebo or homoeopathy can be chosen. For severe illness, where the active treatment leads to large benefits, the active treatment can be chosen. There will be a grey zone. Our debate should really be about the extent of this grey zone. It is certainly different in Australia from that in the United Kingdom, where five times more general practitioners are involved with ho homoeopathy.4 5 Why is this? Differences in health funding? Availability and costs of active treatments? Cultural differences? These are some of the questions worth studying, rather than spending our resources on further trials of homoeopathy versus placebo. John Weiner visiting allergist St Vincent's Hospital, Fitzroy, Victoria 3065, Australia jmweiner@allergynet.com.au 1 Lewith GT, Watkins AD, Hyland ME, Shaw S, Broomfield JA, Dolan G, et al. Use of ulutramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double-blind randomised controlled clinical trial. BMJ 2002;324:520-3.(2 March.). 2 Fisher P, Scott DL. A randomised controlled trial of homeopathy in rheumatoid arthritis. Rheumatology 2001;40: 1052-5. 3 Cialdella P, Boissel JP, Belon P, Groupe de recherche ASTRHO. [Homeopathic specialties as substitutes for benzodiazepines: double-blind vs placebo study.] Therapie 2001;56:397-402. (In Page 9 of 40 © 2012 Factiva, Inc. All rights reserved.

French.) 4 Pirotta MV, Cohen MM, Kotsirilos V, Farish SJ. Complementary therapies: have they become accepted in general practice? Med J Aust 2000;172:102-3. 5 Perry R, Dowrick C. Homeopathy and general practice: an urban perspective. Br Homeopath J 2000;89:13-6. Language is being distorted EDITOR-The conclusion in the abstract to Lewith et al's paper states: "Homoeopathic immunotherapy is not effective in the treatment of patients with asthma."1 The last sentence of the paper itself states: "In conclusion, in this double blind, randomised controlled trial of homoeopathic immunotherapy we have failed to confirm that this treatment is therapeutically efficacious in allergic asthma." These two conclusions are not the same. The conclusion of the paper is a reasonable one to make. "In this trial we have failed to confirm" captures the point exactly. To extrapolate that to the conclusion quoted in the abstract suggests that no homoeopathic immunotherapy is ever effective in patients with asthma; this is not logical. What if a different potency or different frequency of dosing were to show a difference? This trial only used three doses of 30c over 24 hours. Many other different regimens are used in practice. This trial doesn't show that those other regimens don't work. Sadly, this loose use of language then generates front page headlines like the one on the cover of the 2 March issue, which says: "Homoeopathy for dust mite allergies? No, it's a waste of time." This further extrapolates from the conclusion of the abstract to claim that any use of homoeopathy in treating dust mite allergies is a waste of time. This is an even less defensible position So, from article to conclusion, to conclusion of the abstract, to front page headline we lose the truth and develop generalisations that are not only wrong but unscientific. Robert W Leckridge associate specialist Glasgow Homoeopathic Hospital, Glasgow G12 0XQ bob.leckridge@virgin.net 1 Lewith GT, Watkins AD, Braouffield J A Dolan G, Holgate ST. Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial. BMJ 2002;324:520-3. (2 March.) Study is in effect trying to compare apples with oranges EDITOR-Homoeopathy is a system of healing that has been around for over 200 years. It does not operate in the way that allopathic medicine does. Page 10 of 40 © 2012 Factiva, Inc. All rights reserved.

Allopaths treat symptoms. They say that if patient A has a certain set of symptoms then a specific drug will be used for treatment. All patients are treated on the basis of their symptom picture. Sometimes a history is taken to ensure that patients are not allergic to a certain drug; if they are, then another one will be substituted. But, generally, allopathy will treat symptoms rather than the whole person. Homoeopathy treats the person. If a person has asthma a homoeopath will generally spend at least one hour on a first visit, getting an idea of the person's history and lifestyle. What is his/her diet like? What other problems has s/he been treated for in the past? Are there any emotional issues? Then, and only then, will a remedy be prescribed, based not on the symptoms that the patient has but on what the homoeopath thinks is causing those symptoms. Only then can someone truly be cured. Lewith et al's study does not compare homoeopathic and allopathic treatments of asthma.1 It sets out with the intention of proving that homoeopathy does not work. To accomplish this it is using non-homoeopathic treatments and methods. I have never heard of a homoeopath using potentised allergens to treat an allergy, although possibly in some cases this might be an effective treatment Certainly, if you took 242 people with asthma and treated them homoeopathically you might well find that they would require 242 different remedies. How is it possible that something as ill constructed and ill conceived as this study could be published in the BMJ? Where were the peer reviewers when the paper was submitted? Does the BMJ have any homoeopaths as reviewers, or was the paper looked at by people who are as ignorant of homoeopathy as the authors obviously are? When I read something of this nature in the BMJ I truly wonder what other studies make it through the peer review process for absolutely no good reason. Meryl Dorey national president Australian Vaccination Network Inc, PO Box 177, Bangalow NSW 2479, Australia meryl@avn.org.au 1 Lewith (GT, Watkins AD, Broomfield JA, Dolan G, Holgate ST. Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial. BMJ 2002;324:520-3. (2 March.) When is useful improvement a waste of time? Double positive paradox of negative trials EDITOR-Lewith et al report a pilot study of the use of homoeopathic immunotherapy,1 complementing but differing from Reilly et al's earlier study.2 The table accompanying this letter is published on bmj.com, as is a rapid response from me.3 The table lists some of the fundamental differences between the two trials that may have determined their Page 11 of 40 © 2012 Factiva, Inc. All rights reserved.

different results, and my rapid response may also clarify matters. Lewith et al's data show day to day effectiveness but leave a question mark over the efficacy issue of "more than placebo." Taylor et al's series suggested efficacy more than placebo in homoeopathy but did not tackle effectiveness.4 In Reilly et al's trial only the active group improved; in Lewith et al's both the placebo and active groups improved. The cover of the 2 March issue of the BMJ has an italic headline saying that homoeopathic immunotherapy is a waste of time. But the graphs of subjective and objective variables in both groups in Lewith et al's paper show the effectiveness of homoeopathy in an everyday context for a common and serious disease. We have created a curious intellectual and clinical absurdity here-useful improvement that is a waste of time. Perhaps it is now time to ask of a negative study whether it is a "double positive" study (both groups improving) or a "double negative" study (neither group improving). This question is important because each scenario calls for different conclusions, debate, and treatment in systematic reviews. If we reject double positive trials without due care we risk the paradox of throwing out treatments with efficacy exactly because they also show high effectiveness-when the real problem is that our studies lack the power to see the baby of efficacy in its bath water of "context/non-specific/placebo" effectiveness. In a double negative study there is neither baby nor bath water. Le,with et al's study may well have obtained false negative results, finding it hard to show additional activity over excellent context induced improvements-rather like the failure of sertraline and St John's wort (Hypericum perforatum) to better placebo facilitated improvement in depression5; that study was another double positive study (or triple positive in that case) that has been reported in the media as yielding a negative result The BMJ'sclassification of homoeopathy as a negative treatment is premature. David Reilly lead consultant physician Glasgow Homoeopathic Hospital, Glasgow G12 0XQ davidreilly1@compuserve.com The table is published on bmj.com 1 Lewith GT, Watkins AD, Broomfield JA, Dolan G, Holgate ST Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial. BMJ 2002:324:520-3. (2 March.) 2 Reilly DT, Taylor MA, Campbell J, Beattie N, McSharry C, Aitchison T, et al. Is evidence for homoeopathy reproducible? Lancet 1994;344:1601-6. 3 Reilly D. A pilot design of diluted power. It might prove effectiveness, but it does not disprove efficacy. bmj.com/ cgi/eletters/324/7336/520#20216 (accessed 26 June 2002).

Page 12 of 40

© 2012 Factiva, Inc. All rights reserved.

4 Taylor MA, Reilly D, Llewellyn Jones RH, McSharry C, Aitchison TC. Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series. BMJ 2000;321:471-6. 5 Hypericum Depression Trial Study Group. Effects of Hypericum perforatum (St John's wort) in major depressive disorder. A randomized controlled trial. JAMA 2002;287:1807-14. Authors' reply EDITOR-Homoeopathy arouses strong emotions among believers and nonbelievers, as the extent of responses to our article suggests; our letter encompasses the points made electronically and above. Homeopathy is a "waste of time," states the front cover of the BMJ. This type of response to our scientific paper is inaccurate and unhelpful. We tested the model of homoeopathic immunotherapy as suggested and defined by Reilly et al and observed no clinical effect? However, as pointed out in our paper, we recognise that this model is not generalisable into current homoeopathic practice. It was used to investigate the different effects of ultramolecular potencies compared with placebo rather than pragmatic homoeopathy. Feder and Katz suggest that the mechanisms underpinning homoeopathy are best understood through laboratory experimentation. We believe that clinical investigations in humans offer insights that are impossible to achieve in a laboratory. We have suggested some hypotheses that might explain our observed oscillatory effects of homoeopathy, but these require further work2; they may be a type I error. We hope that Feder and Katz's suggestion about pragmatic studies does not represent a retreat from rigour. One reason for conducting our study was that we were concerned by fl-the small size and potential for statistical error and the atypical lack of improvement over time for placebo in the asthma study of Reilly et al.1 Our study owes much to the design of this earlier work, but it was not a mere duplication. We rigorously rediagnosed asthma in each patient, and before the study we communicated with Reilly to check that we were following the same protocol in relation to inclusion criteria, dosage regimen, and primary outcome (visual analogue scale).1-3 Reilly suggests that he used repeated doses of homoeopathic immunotherapy but does not report this in his asthma study.4 We were also not aware that each patient was subjected to an individual case conference with, possibly, unreproducible inclusion criteria.1 It has been suggested that a hospital based study would select a different population of patients from those in general practice. There is no evidence that this is the case; many high quality asthma effectiveness studies have been conducted in primary care. We selected a group of asthmatic patients in two neighbouring counties who had variable asthma so we could measure change. We cannot understand Reilly's hypothetical differentiation between an effectiveness and efficacy study in this context. Like us, Taylor et al avoided the pollen season and used potencies of house dust mite while not avoiding the house dust mite season.4 The use of Reilly's visual analogue scale on alternate weeks avoided patient data recording fatigue and produced greater compliance over a 20 week study. Our process of randomisation entailed minimisation, thus balancing the treatment groups. Both nurses and patients were unable to guess trial allocation, therefore we are clear that our blinding allocation was completely secure. Had we used a different time point for analysis we might have obtained different (false positive) results. Page 13 of 40 © 2012 Factiva, Inc. All rights reserved.

We analysed response to homoeopathic immunotherapy over 4 months and as a consequence our conclusions are less open to misinterpretation. The only major methodological difference between our study and that of Reilly et al is the lack of a placebo run-in period; an unlikely cause of a significant difference in outcome.1 Homoeopathic immunotherapy may be effective in rhinitis,3 4 but independent investigations have failed to confirm this.5 Reilly may have overinterpreted one small such study on asthma. We accept that no two clinical trials are exactly the same, but we believe our study is comparable.4 It comes to different conclusions about the differences between homoeopathy and placebo and about treatment effect, reporting that homoeopathy and placebo are significantly different. The robustness of these observations requires careful further work rather than more debate. George T Lewith senior research fellow Complementary Medicine Research Unit, Mail Point OPH, Royal South Hants Hospital, Southampton SO14 0YG Michael Hyland professor of health psychology Department of Psychology, University of Plymouth, Plymouth PL4 BAA Stephen Holgate clinical professor of immunopharmacology Respiratory, Cell and Molecular Biology Division, Mailpoint 810, Southampton General Hospital, Southampton SO 16 6YD 1 Reilly D, Taylor MA, Beattie NGM, Campbell JH, McSharry C, Aitchison TC, et al. Is evidence for homoeopathy reproducible? Lancet 1994;344:1601-6. 2 Hyland ME, Lewith GT Oscillatory effects in a homeopathic clinical trial: an explanation using complexity theory, and implications for clinical practice. Homeopathy (in press). 3 Reilly DT, Taylor MA, McSharry C, Aitshison T. Is homoeopathy a placebo response? Controlled trial of homoeopathic potency, with pollen in hayfever as model. Lancet 1986;ii:881-6. 4 Taylor MA, Reilly D, Llewellyn-Jones RH, McSharry C, Aitchison TC, Lancaster T, et al. Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series. BMJ 2000;321:471-6. 5 Aabel S. No beneficial effect of isopathic prophylactic treatment for birch pollen allergy during a low-pollen season: a double-blind, placebo-controlled clinical trial of homeopathic Betula 30c. Br Homeopath J 2000;89:169-73.

Page 14 of 40

© 2012 Factiva, Inc. All rights reserved.

Evidence based leaflets in maternity care Compliance, coercion, and power have huge effect in maternity services EDITOR-The midwives from Sheffield show the insight that a qualitative study can provide when coupled with a more controlled empirical investigation.1 2 Both the studies and the accompanying editor's choice suggest that inequalities in power and status in the maternity services have a greater influence on what happens to women giving birth than either their hopes and dreams or the choices they feel informed to make.3 These studies are a powerful reminder that the physiological birth process without some degree of technological interference and tampering is rare. Midwives are portrayed in this hierarchical system as having little effect on the outcome of care. The authors suggest that when women can form a trusting relationship with a midwife they are more likely to ask questions and feel that they can make choices about their care, rather than simply being compliant As members of a national consumer movement in Australia, we consider it to be a violation of human rights for women to continue to be subjected to routine hospital maternity care that is demonstrably not backed by research evidence on what is best for most mothers and babies. Far from being an illness, childbirth is a healthy, normal, and important event in women's lives. Women deserve to receive the model of care backed by research evidence-namely, one on one care from a known competent midwife throughout pregnancy, birth, and postnatally, with obstetric back up for the minority of women (10-15%) who need it. Yet for most women now this model of care is unavailable. We implore all women everywhere to take heed of the options available to them and call for reforms to the maternity services in their countries so that all women have the choice of being cared for by their own midwife. In Australia we have proposed a national maternity action plan (www.communitymidwiferv.iinet.net. au/nmap.html) to inform governments and policy makers of the need for change. Barbara Vernon national president Maternity Coalition, PO Box 269, Lyneham ACT 2602, Australia vernon@webone.com.au Sally Tracy research midwife Centre for Family Health and Midwifery, University of Technology Sydney, PO Box 123 Broadway, Sydney NSW 2007, Australia Tracy Reibel administrator Community Midwifery Program, East Fremantle

Page 15 of 40

© 2012 Factiva, Inc. All rights reserved.

WA 6158, Australia 1 O'Cathain A, Walters SJ, Nicholl JP, Thomas KJ, Kirkham M. Use of evidence based leaflets to promote informed choice in maternity care: randomised controlled trial in everyday practice. BMJ 2002;324:643-6. (16 March.) 2 Stapleton H, Kirkham M, Thomas G. Qualitative study of evidence based leaflets in maternity care. BMJ 2002;324:639-43. (16 March.) 3 Editor's choice. BMJ 2002;324 (7338). (16 March.) Provision of information is only one component of informed choice EDITOR-Stapleton et al highlight the fact that provision of information is only one of the necessary conditions-and not a sufficient condition-for informed choice in the context of health care.1 Competence (of patients to understand choices), voluntariness (freedom from constraints and coercion), and decision making ability (making an actual choice) are also necessary. Most antenatal patients are competent, but in the context of pregnancy care in the United Kingdom it is doubtful whether any decision is voluntary, given the attitudes and behaviour of some staff described in this study. In addition, patients are often not expected to make any decisions themselves but, as highlighted in this paper, are simply expected to comply with the policy of the obstetric unit, whatever that might be. It is thus not surprising that Stapleton et al found that their leaflet made little difference to the percentage of women reporting that they made informed choices. Diane Reeves honorary clinical senior lecturer Department of General Practice, University of Birmingham, Birmingham B 17 0SN diane.reeves@medgp1.bham.ac.uk 1 Stapleton H, Kirkham M, Thomas G. Qualitative study of evidence based leaflets in maternity care. BMJ 2002;324:639-43.(16 March.) Voluntariness must be ensured in prenatal screening EDITOR-Prenatal screening for Down's syndrome has largely developed as a consequence of advances in technology and the presumption that the NHS would provide it as a health related service. Whether the NHS should fund a test (or combination of tests) for this condition is questionable. But what is perhaps more worrying is a second presumption-the presumption of acceptance, the expectation of compliant behaviour. Despite any intended neutrality the very act of offering screening for the syndrome intrinsically suggests that having information relating to the risk will-be beneficial and empowering.1 Making the offer of a test mandatory can seem to a mother to be compulsion. Women have come to perceive screening for Down's syndrome as an integral part of antenatal care and may feel a responsibility to have it. Page 16 of 40 © 2012 Factiva, Inc. All rights reserved.

Skrabanek has suggested that screening can be achieved only through coercion and deception and that it is invariably an infringement of personal liberty.2 Certainly in the antenatal setting issues of voluntariness and informational manipulation are raised. The observation that health professionals promote normative patterns of care and thus ensure informed compliance rather than informed choice has recently been given further credence.3 4 Clearly, the decision as to whether or not to be screened should rest on knowledge of potential benefits and remain free from social pressures and coercions. A woman may fear covertly expressed suggestions of rejection by her carers at a time when she wants to be seen to be doing the best for her baby. She may simply acquiesce to meet the terms of the service provided, her resistance having been weakened by her desire for the complete antenatal care package-almost entirely organised around the provision of prenatal screening tests, which in itself is a presumption of acceptance. When considering issues of consent for prenatal screening most commentators concern themselves with adequacy of disclosure. It is, however, increasingly clear that the real issue in this situation is whether the "informed" choice is freely made.5 James B Robins consultant obstetrician and gynaecologist Inverclyde Royal Hospital, Greenock PA 16 0XN James.Robins@irh.scot.nhs.uk 1 Hunt LM. Routine prenatal genetic screening in a public clinic: informed choice or moral imperative? Medical Humanities Report 2000;22(2):fall. (www:bioethics.msu.edu/ mhr/01w/prenataiscreening.htm.) 2 Skrabanek P. Preventive medicine and morality. Lancet 1986;i:143. 3 Stapleton H, Kirkham M, Thomas G. Qualitative study of evidence based leaflets in maternity care. BMJ 2002;324:639-43.(16 March.) 4 O'Cathain A, Walters SJ, Nicholl J P, Kirkham M. Use of evidence based leaflets to promote informed choice in maternity care: randomised controlled trial in everyday practice. BMJ 2002; 324:643-6. (16 March.) 5 Bowater v Rowley Regis Corpn. [1944] KB 476 at 479. Domestic violence It's not only men who commit domestic violence EDITOR-I am disappointed by Jewkes's editorial on domestic violence.1 The clear implication is that men are the oppressors and women suffer. Sadly this is often true, but it is far from being the whole picture. The 1996 British crime survey asked a representative sample of 16 Page 17 of 40 © 2012 Factiva, Inc. All rights reserved.

500 adults in England and Wales directly about their experiences of crime, and whether it was reported to the police. The survey included a computer assisted self interviewing questionnaire, designed to give findings on the extent of domestic violence in England and Wales. The results found that 4.2% of women and 4.2% of men said that they had been physically assaulted by a current or former partner in the past year.2 Many studies have found similar results. The work of Straus (a good example of which can be found at www.vix.com/ menmag/straus21.htm) is particularly authoritative. Indeed, when one considers that most violence against children is committed by women, in terms of gender it is women who are most likely to be perpetrators of domestic violence. Does this manner of presentation matter? I think it does. On a personal level it leads to the situation I encountered recently in my local police station. A man with quite severe injuries after an attack by his former (female) partner was in the cells for breach of the peace. On a broader level it adds to the negative image of men that is so widespread in parts of our popular culture. This does nothing to help the forging of a masculine identity in certain vulnerable young men, which Jewkes says is a risk factor for violence. Why, I wonder, is domestic violence so often portrayed in such a partisan and unscientific way? Mark S Horner general practitiner Felton, Northumberland NE65 9PR ylw14@dial.pipex.com 1 Jewkes R. Preventing domestic violence. BMJ 2002;324:253-4. (2 February.) 2 Home Office. British crime survey. London: HMSO, 1998. Literature is biased as studies rarely look at female-to-male violence EDITOR-Several papers in the BW have looked at domestic violence.1 2 3 Although this problem has been well documented, in the movement to expose it properly there is a gender bias that, ironically, betrays the underlying concern with gender equality. The language of domestic violence reporting often makes a bold assumption by speaking exclusively of violence by men against women. The title of Richardson et al's paper is misleading.2 It implies that they are reporting a cross sectional study, but what the authors actually looked at was 50% of the population-namely, women. The title of Jewkes's editorial is gender neutral, yet the subtitle shows the exclusion, lamenting that women are not consistently asked about the possibility of domestic violence. This is not necessarily more misleading than the early studies of coronary artery disease, which were presumed to be inclusive though in fact studied only men. The justification for this slant in the domestic violence Page 18 of 40 © 2012 Factiva, Inc. All rights reserved.

literature has been that female victims vastly outnumber male victims. Many data, however, suggest otherwise. Cascardi et al found that 86% of marital aggression was reported as reciprocal between husbands and wives.4 Schafer et al reported lower and upper bounds on intimate partner violence of 5.21% and 13.61% for male-to-female partner violence and 6.22% and 18.21% for female-to-male partner violence.5 Interestingly, female-to-- male violence was reported to be higher than male-to-female. These data force a recognition that female-to-male violence must be included in any discussion. Bradley et al note that "there is generally no universally agreed method of defining and measuring domestic violence."1 A simple first step would be for the authors to recognise that, regardless of the precise percentages, this is a bi-directional, bi-gender issue. The authors lament that women are inconsistently asked about domestic violence, but they ignore the even greater lack of inquiry into men's potential victim status. This reporting bias may partly explain the disparity in the limited literature that attempts to include data on bi-directional violence. None of the three articles in the BMJ even allude to female-to-male domestic violence. This reflects a literature bias that will undoubtedly influence future work. Such bias ignores many thousands of male victims and alienates those who demand a more balanced presentation. Let's keep working to get better data, but let's recognise the bi-gender nature of this societal ill. That way, all of us can become involved in research, advocacy, and teaching and be part of the solution. In other words, "it is now time for the medical establishment to embrace the issue of gender."3 Chris Carlsten resident in internal medicine Department of Medicine, Box 356421, University of Washington, Seattle, WA 98195, USA Bradley F, Smith M, Long J, O'Dowd T. Reported frequency of domestic violence: cross sectional survey of women artending general practice. BMJ 2002;324:271-4.(2 February.) 2 Richardson J, Coid J, Petruckevitch A, Wai SC, Moorey S, Feder G. Identifying domestic violence: cross-sectional study in primary care. BMJ 2002:324:274-7.(2 February.) 3 Jewkes R. Preventing domestic violence. BMJ 2002;324:253-4. (2 February.) 4 Cascardi M, Larighintichsen J, Vivian D. Marital aggression. Impact, injury, and health correlates for husbands and wives. Arch Intern Med 1992; 152:1178-84. 5 Schafer J, Caetano R, Clark CL, Rates of intimate partner violence in the United States. Am J Public Health 1998;88:1702-4. European sentinel network of practices has been established EDITOR-Two studies on domestic violence highlighted the lack of routine involvement of primary care practitioners1 and the Page 19 of 40 © 2012 Factiva, Inc. All rights reserved.

difficulties in screening for domestic violence in general practice.2 These two studies are of great importance as European data on domestic violence are scarce. Richardson et al concluded that the introduction of screening for domestic violence in healthcare settings is premature because of its limited acceptability (20% of women said that they would mind being asked about it by their general practitioner), whereas Bradley et al observed that only 7% of women would mind such routine inquiry by their doctor. Unlike Richardson et al, we find this rate of spontaneous acceptability high, and favourable for the adoption of this type of screening. After all, it is not done at present; other types of screening, such as that for breast, cervical, or prostate cancer, were probably greeted with similar views initially. Other authors report good sensitivity and good specificity from primary care questionnaires regarding severe violence by intimate partners.3 Why do doctors find it so difficult to recognise marital violence, even in cases of visible physical violence? A study in 2000 among 235 general practitioners in the Paris area showed that in only 7.7% of the cases of domestic violence finally recognised as such had the doctor raised the question of domestic violence. It also showed that most general practitioners do not know how to cope with this problem: 76% did not know of any structure or other professional able to help their patient, 60% declared themselves insufficiently trained to detect and provide follow up for domestic violence, 47%judged themselves unable to do so, and 21% declared that they had too little time to raise this question. In view of these findings, a multilingual internet site was created in 2001 with the support of the European Union's Daphne initiative. It provides health professionals with information and recommendations for detecting female victims of domestic violence and providing follow up for them (www.sivic.org). In addition, a European surveillance network of primary care practices (the Vigil network) now brings together health professionals (general practitioners, staff of emergency services, gynaecologists) and associations that help female victims of domestic violence in eight European countries. For each case recognised the volunteer doctors are questioned about how the violence was detected, their intervention, and the difficulties encountered. The female victims are also questioned about their contacts with health professionals (or why there were none) and the proposals that were made. Cecile Morvant director Institut de I'Humanitaire, 75014 Paris, France Jacques Lebas specialist Department of Internal Medicine, Hopital Saint-Antoine, 75012 Paris Pierre Chauvin public health researcher Research Unit on Epidemiology and Information Page 20 of 40 © 2012 Factiva, Inc. All rights reserved.

Sciences (INSERM U444), 75012 Paris pierre.chauvin@u444jussieu.fr 1 Richardson J, Coid J, Petruckevitch A, Chung WS, Moorey S, Feder G. Identifying domestic violence: cross sectional study in primary care. BMJ 2002;324:274-7. (2 February.) 2 Bradley F, Smith M, Long J, O'Dowd T. Reported frequency of domestic violence: cross sectional survey of women attending general practice. BMJ 2002;324:271-4.(2 February.) 3 McNutt LA, Carlson BE, Rose IM, Robinson DA. Partner violence intervention in the busy primary care environment. Am J Prev Med 2002;22:84-91. Screening can be made acceptable to women EDITOR-We wish to highlight outcomes of the Queensland health domestic violence initiative, which incorporated screening for domestic violence into routine history taking protocols as a component of core clinical practice.1 The provider asks the client two or three additional questions relating to domestic violence during the history taking procedure. This small change has improved diagnosis and the provision of health services and information to women who experience domestic violence. Respondents in the studies by Richardson et al2 and Bradley et al3 completed a self report questionnaire, but many had never been asked directly about domestic violence in a screening process. Only 12% of women in Bradley et al's study reported that their doctor had asked about domestic violence. In our study 83% of women presenting to the antenatal or gynaecology outpatient services were screened for domestic violence, with roughly 6.5% disclosing that some form of domestic violence had occurred. Of those women who were positive on screening, about 10% accepted help. Clients thought that screening women for domestic violence was a good idea, with 97% of those surveyed supporting it This is higher than the figures reported in the BMJ (77% by Bradley et al and 80% by Richardson et al). Richardson et al report that at least 20% of women objected to screening. To determine the extent of acceptability more accurate conclusions can be drawn from research that reports on the views of women who have experienced personalised screening. Richardson et al report that 42% of women would find it easier to discuss issues concerning domestic violence with a female doctor. Issues of gender, power, and interpersonal sensitivity must be considered when assessing people for domestic violence. Neither Richardson et al nor Bradley et al identified whether certain contexts were described in the questionnaire when investigating women's attitudes to screening. For example, a woman's attitude to screening about domestic violence might alter if the questions were asked in private with no family member present, if they were asked by a female health professional, if the woman perceived the health professional to be genuinely concerned about her, and if the woman was offered access to information and referral. Such issues need to be considered when investigating attitudes of service users. The papers also report on the low rate of documentation of domestic Page 21 of 40 © 2012 Factiva, Inc. All rights reserved.

violence-for example, only 17% of cases were documented in Richardson et al's paper. Our work identified that quick, simple, routine screening can be effective, with documented compliance of around 88% and 97% acceptability to women. Joan Webster director Nursing and Women's Health Research Centre, Royal Brisbane and Royal Women's Hospital, Post Office Herston 4029, Queensland, Australia joan_webster@health.qld.gov.au Debra K Creedy professor of nursing and health Griffith University, Brisbane 4305, Queensland, Australia 1 Webster J, Stratigos S, Grimes K. Women's responses to screening for domestic violence in health care settings. Midwifery 2001;17:289-94. 2 Richardson J, Coid J, Petruckevitch A, Chung W, Moorey S, Feder G. Identifying domestic violence: a cross sectional study in primary care. BMJ 2002;324:274-7. (2 February.) 3 Bradley F, Smith M, Long J, O'Dowd T. Reported frequency of domestic violence: cross sectional survey of women attending general practice. BMJ 2002;324:271-4. (2 February.) Sexual behaviour and its medicalisation Many (especially economic) forces promote medicalisation EDITOR-The subject of the medicalisation of sexual behaviour requires an even larger perspective than that offered by Hart and Wellings,1 one specifically identifying socioeconomic trends and agents. For example, the addition of sexual dysfunctions to the American psychiatric nomenclature in 1980 came at a time when psychiatry needed to become more biological and quantitative to participate in new American insurance reimbursement plans. The Masters and Johnson list of disorders, focusing on dissatisfaction with genital arousal and orgasm but omitting "soft" problems of pleasure or intimacy, fitted these quantitative and biological needs but popularised standards for sexual satisfaction that are overly genital and performance oriented.2 The involvement of urologists in male sexual problems in the 1980s came about because of specialists' needs for new topics and patients, the encouragement of newly interested industries, and shifts in relations between academics and these industries.3 It was widely promoted in the press, creating heightened expectations about medical sexual expertise. When Hart and Wellings cite epidemiological statistics for sexual problems they inadvertently contribute to the problems of medicalisation by citing weak research and failing to discuss how definitions of a problem play a part in market-driven medicalisation. American studies of the prevalence of sexual problems use overinclusive definitions-not surprising given the extent of drug company involvement in the research.4 Page 22 of 40 © 2012 Factiva, Inc. All rights reserved.

A discussion of medicalisation needs to examine the fit between models of sexuality and the medical model.5 Hart and Wellings conclude that the problems of medicalisation are really those of overmedicalisation, but I believe that that is superficial. Sexuality is a social construction, and medicalisation is the new social construction. Excessive medicalisation may be malpractice, but we must question the fundamental model of sexuality as a biological rather than a sociocultural and political entity. Hart and Wellings's final sentence ("The last century saw a considerable increase in acceptance of diversity of sexual expression-it would be a shame if this century saw diversity replaced by uniform expectations of performance and desire") is their strongest, but their analysis needs to be more comprehensive. I would direct readers to a new feminist campaign that has emerged to resist the for-profit medicalisation of women's sexual problems (www.fsdalert.org). Leonore Tiefer clinical associate professor of psychiatry New York University School of Medicine, New York, NY 10003, USA LTiefer@mindspring.com 1 Hart G, Wellings K. Sexual behaviour and its medicalisation: in sickness and in health. BMJ2002;324:896-900. 2 Tiefer L. Historical, scientific, clinical, and feminist criticisms of "the human sexual response cycle" model. Annual Review of Sex Research 1991;2:1-23. 3 Tiefer L. In pursuit of the perfect penis: the medicalization of male sexuality. American Behavioral Scientist 1986;29:579-99. 4 Tiefer L. Sexology and the pharmaceutical industry: the threat of co-optation. J Sex Research 2000;37:273-83. 5 Tiefer L The medicalization of sexuality: conceptual, normative, and professional issues. Annual Review of Sex Research 1996;7:252-82. HIV-AIDS prevention efforts deserved greater mention EDITOR-In their account of the medicalisation of sexual behaviour Hart and Wellings do not pay sufficient attention to the HIV-AIDS prevention efforts that were undertaken during the mid-1980s.1 They can be considered to be the most important effort to medicalise sexuality in the 20th century. The enormous amount of social, scientific, medical, and public health responses generated are evidence of the complex and multiple dimensions of such a process. In the absence of a vaccine and a magic bullet against HIV and the disease it engenders, public health authorities had to develop a comprehensive prevention strategy. This included, firstly, national surveys on sexual behaviour in most industrial and developing countries to collect information on the sexual practices of the populations, to an extent never before achieved; secondly, a dramatic change of sexuality-related values and meanings (heterosexual intercourse becoming a major risk behaviour; Page 23 of 40 © 2012 Factiva, Inc. All rights reserved.

masturbation considered to be a low risk practice, etc); and, thirdly, a global strategy of behaviour modification to promote behaviour change (systematic use of condoms, reducing the number of partners, etc). Ar overall evaluation of the response to AIDS today shows, on the one hand, an insufficient response by public health authorities, as evidenced by the increasing numbers of HIV carriers in developing countries and among vulnerable groups in industrialised countries. On the other hand, it represents the most important and comprehensive effort at controlling sexual activity and changing its meaning on the global level. In conclusion, Hart and Wellings would have given a more balanced analysis of the process of medicalisation of sexuality if they had included the responses to HIV infection and AIDS in their article. Alain Giami director of research INSERM U 569, 94276 Le Kremlin Bicetre Cedex, France giami@vjf.inserm.fr 1 Hart G, Wellings K. Sexual behaviour and its medicalisation: in sickness and in health. BMJ 2002;324:896-900. (13 April.) Insulin pumps are still debatable for type 1 diabetes EDITOR-We have three comments about Pickup et al's meta-analysis comparing insulin infusion with injection, which may cast a different light on their main conclusion.1 Firstly, the results of the largest study in the meta-analysis, the so called Dusseldorf study, needs careful interpretation. The authors have estimated this study to show a positive result for continuous subcutaneous insulin infusion, with an advantage in percentage of glycated haemoglobin of 0.68%. This figure will be an estimation made from a graph, as exact data are not given in the original paper. This seems to be a correct interpretation of the six month data of this study, but the total duration of the study was two years. At 12, 18, and 24 months the "advantage" of continuous subcutaneous insulin infusion can be estimated to be 0.35%, -0.1%, and -0.2%, respectively. Thus another interpretation of this one study, representing 918 months of the meta-analysis's total of 2522 patient months of pump treatment, will have a substantial impact on the overall outcome of the metaanalysis. Secondly, the authors did not include the study of Reeves et al in their analysis. This study, albeit small, did not show a difference in glycated haemoglobin between intensified injection therapy and insulin pump therapy.2 Thirdly, modified rapid acting insulins have recently been shown to be advantageous with respect to glycated haemoglobin.3 4 The most relevant comparison is therefore between continuous subcutaneous insulin infusion and multiple injection therapy, both using rapid acting insulin analogues. Only two such studies have been published. The first, by Hanaire-Broutin et al and included in the meta-analysis, found a 0.35% lower glycated haemoglobin with insulin pump therapy than with Page 24 of 40 © 2012 Factiva, Inc. All rights reserved.

injection therapy in 41 patients using a crossover design. However, patients had been receiving insulin pump therapy with human regular insulin for a mean of 5.5 years before entering the trial, which limits the external validity of this study. The second study, by Tsui et al, was published too recently to be included in the meta-analysis but did not show a difference in glycated haemoglobin over nine months in 21 patients.5 We consider that the case for insulin pump treatment in type 1 diabetes has still to be decided. Two large multicentre trials comparing this treatment with optimised injection schemes with rapid acting analogues have been recently completed and should provide clinically useful information. J Hans DeVries endocrinologist hans.devries@vumc.nl Robert J Heine Professor of diabetology VU Medical Centre, Diabetes Centre, PO Box 7057, 1007 MB, Amsterdam, Netherlands 1 Pickup J, Mattock M, Kerry S. Glycaemic control with continuous subcutaneous insulin infiision compared with intensive insulin injections in patients with type 1 diabetes: meta-analysis of randomised controlled trials. BMJ 2002;324:705-8. (23 March.) 2 Reeves ML, Seigler DE, Ryan EA, Skyler JS. Glycemic control in insulin-dependent diabetes mellitus. Comparison of outpatient intensified conventional therapy with continuous subcutaneous insulin infusion. Am J Med 1982;72:673-- 80. 3 Raskin P, Guthrie RA, Leiter L, Riis A,Jovanovic L. Use of insulin aspart, a fast-acting insulin analog, as the mealtime insulin in the management of patients with type 1 diabetes. Diabetes Care 2000;23:583-8. 4 Home PD, Lindholm A, Riis A. Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial. European Insulin Aspart Study Group. Diabetes Med 2000;17:762-70. 5 Tsui E, Barnie A, Ross S, Parkes R, Zinman B. Intensive insulin therapy with insulin lispro: a randomized trial of continuous subcutaneous insulin infusion versus multiple daily insulin injection. Diabetes Care 2001;24:1722-7. Tourists travelling to Kilimanjaro do need advice EDITOR-As Bellis's letter confirms, many tourists attempting the ascent of Kilimanjaro come ill prepared for the climb.1 We have treated tourists on the mountain for a range of conditions, including high altitude cerebral and pulmonary oedema. In one instance we chanced on a traveller who was both frankly cyanotic and ataxic at an altitude of 3500 in and treated him with the last spare course of dexamethasone. We insisted that he descend, to the chagrin of his guide, who was encouraging him to continue his ascent As some guides receive incentives to get tourists to the summit, this type of incident will undoubtedly recur. Page 25 of 40 © 2012 Factiva, Inc. All rights reserved.

Guides are generally drawn from the local population and have little training in first aid or the emergency management of altitude sickness. A helpful measure might be to set up basic training for guides that encompasses basic first aid and indications for descent. This initiative would, we believe, have to come from the travel industry. We support the contention that tour operators and travel agents must issue the necessary warnings. Some tour operators do, providing printed material, referral to a travel clinic, and orientation lectures to travellers before departure; others, however, exercise less responsibility. Unfortunately, there seems to be little enforcement of the common law requirement for tour operators and travel agents to fulfil their admonitory obligations. Inquiry at the Kilimanjaro Christian Mission Hospital at the base of Kilimanjaro confirmed that it regularly treats tourists with severe altitude sickness. Until a high profile claim is brought against negligent operators and agents we expect that it will continue to receive such patients. We suspect that the solution to this problem will ultimately come from the legal and not the medical profession. Stephen Toovey medical director Netcare Travel Clinics, PO Box 786692, Sandton, 2146, South Africa toovey@travelclinic.co.za Andrew Jamieson medical director Netcare Travel Clinics, South Africa and Mozambique, PO Box 573, Sunninghill, 2157, South Africa 1 Bellis F. Tour operators should tell clients about potential risks of adventure holidays. BMJ 2002;324:1040.(27 April.) Rapid responses Correspondence submitted electronically is available on our website Document bmdj000020020719dy7600012

Page 26 of 40

© 2012 Factiva, Inc. All rights reserved.

U

P

D

A

T

E

1 -

A

u s t

r

a l

i

a

p l

a n s

m

a s s

m

e n i

n g o c o c c a l

v a c c i

n a t

i

o n s .

UPDATE 1-Australia plans mass meningococcal vaccinations. 476 words 20 August 2002 15:16 Reuters News LBA English (c) 2002 Reuters Limited CANBERRA, Aug 20 (Reuters) - Over one million Australian children will receive free vaccinations against a deadly form of meningitis after the government on Tuesday bowed to public pressure following a spate of deaths from meningococcal disease. Australia is one of the first countries to introduce a mass vaccination programme for one strain of the deadly brain disease, following Britain's lead three years ago. The vaccination programme was triggered by a public outcry after a campaign in the Australian media highlighting the tragic stories of some children who recently died of the disease. But Health Minister Kay Patterson said a global shortage of vaccine meant the campaign would not start until 2003, with only one registered supplier of the vaccine in Australia - U.S. drug maker Wyeth - and a current supply of 100,000 doses. "The shortages are a global problem," Patterson said in a statement. Two other drug companies, Australia's CSL Ltd and U.S.-based Baxter International Inc , currently have vaccines for the meningococcal type-C strain before Australia's drug authority, the Therapeutic Goods Administration, awaiting approval. "We are fast-tracking these and expect a decision within a month so that the government can get into negotiations with the companies to start the vaccine programme next year," a spokesman from the Health Department told Reuters. So far this year 24 Australians have died from the disease, which is on par with the average with 31 Australians dying of meningococcal last year when 671 cases were reported. Patterson said initially 12-month-old babies and children aged 15 will be vaccinated in a programme expected to cost A$41 million (US$22.5 million) in its first year. Britain was the first country to introduce a mass vaccination programme against C-type meningococcal in 1999, and medical experts say the vaccine has cut the number of cases among British younsters by 80 percent to under 150 a year. But some medical lobby groups said the limited vaccination programme was a band-aid solution and questioned its potential effectiveness, with only 32 percent of the 600 or so cases of meningococcal in Australia each year of Page 27 of 40 © 2012 Factiva, Inc. All rights reserved.

the type-C strain. The majority, or 62 percent, of meningococcal cases seen in Australia are type-B for which there is presently no vaccine. "This is a knee-jerk reaction that has not been thought through properly," president of the Australian Vaccination Network, Meryl Dorey,told Reuters. Meningococcal disease is a rare brain illness that usually infects about 500,000 people worldwide a year, killing 50,000. The bacteria is spread by coughing, kissing, and sneezing. Fevers, headaches and vomiting are early symptoms of the illness but they can be mistaken for flu. A stiff neck and a purplish rash are signs of the disease. (US$1=A$1.82). Document lba0000020020820dy8k00a6z

Page 28 of 40

© 2012 Factiva, Inc. All rights reserved.

N

S

W

-

M

e n i

n g o c o c c a l

v a c c i

n a t

i

o n

p r

o g r

a m

p r

o m

p t

s

m

i

x e d

r

e a c t

i

o n s .

NSW - Meningococcal vaccination program prompts mixed reactions. By Judy Skatssoon, National Medical Writer 565 words 22 August 2002 03:27 Australian Associated Press General News AAP English (c) 2002 AAP Information Services Pty Ltd. All rights reserved. Available for personal use but not for sale or redistribution for compensation of any kind without the prior written permission of AAP. SYDNEY, Aug 20 AAP - Plans for a national meningococcal vaccination program today received a mixed response from doctors, victims' families and anti-vaccination lobby groups. One million Australian children and teenagers will get free vaccinations against a deadly strain of meningococcal disease from next year, after federal cabinet approved a targeted program costing $41 million in its first year, and $20 million each year for the next 14 years. Australian Medical Association (AMA) vice-president Trevor Mudge said the plan to vaccinate against meningococcal C strain would reassure the public, but had serious limitations. Dr Mudge said the real answer lay in boosting funding for medical research into the deadly and frightening disease. "I think vaccination really is the only strategy we have at the moment, but unfortunately it has its limitations," he said. Dr Mudge said the vaccine would only be effective against the C strain of the bacteria, which accounted for only 30 per cent of cases. He also warned that even if all the high risk groups - young children and teenagers - were vaccinated as proposed, the disease could still strike low risk groups. "For both of those reasons, while this will provide a degree of reassurance for the population at large, it's not going to make meningococcal disease go away." Dr Mudge said there needed to be more incentives for the commercial development of vaccines. Sue-Anne Sanig, whose seven-year-old son Stephen died of the type B strain last year, called for routine blood tests and antibiotic treatment of all children with high temperatures. "Let's have the hospitals do a blood test straight up if a child presents with a fever that doesn't respond straight away," she said. Page 29 of 40 © 2012 Factiva, Inc. All rights reserved.

"If we have a bacteria we can give it broadband antibiotics, slow it down so septicaemia doesn't develop. "It gives us time to find out whether it is (meningococcal). Let's look to the worst case scenario and work back." The Meningococcal Association of Australia (MAA) described vaccination as a band-aid solution, saying more education was the answer. MAA honorary general manager Joe Mac Manamon (Mac Manamon) said the government must focus on education. "It's about getting people to recognise the symptoms so they can get to our wonderful hospitals, where we have the finest professionals in the world," he said. "Give those professionals the best chance possible of treating these meningococcal diseases. "You can only do that with information." The president of the "right to choose" Australian Vaccination Network (AVN), Meryl Dorey, said the vaccine had never been tested for effectiveness. Ms Dorey said the vaccine was now the subject of an inquiry in the United Kingdom. "When it was introduced in the United Kingdom they had so many adverse reactions reported that they've actually had a government inquiry into this," she told Channel Seven's Sunrise program. "To introduce this vaccine while there is an inquiry ongoing overseas, while there have been this huge number of reactions reported, is irresponsible and does not mean that the government is performing its duty of care." Vaccinations will begin with young children and teenagers, but the government's aim is to vaccinate all age groups. Twenty-four Australians have died from meningococcal this year; eight from type B and 14 from type C. Document aap0000020020820dy8l003ea

Page 30 of 40

© 2012 Factiva, Inc. All rights reserved.

P

a i

n

a

s m

a l

l

p r

i

c e

t

o

p a y

-

V

a c c i

n a t

i

o n

p u s h

f

o r

t

o t

s .

Pain a small price to pay - Vaccination push for tots. By SUE DUNLEVY. 625 words 1 November 2002 Daily Telegraph DAITEL 20 English (c) 2002 Nationwide News Proprietary Ltd THE trauma of subjecting tiny infants to three injections at once should not deter parents from vaccinating their children under a proposed new scheme. The head of the working party proposing an overhaul of the nation's immunisation program says introducing a third needle for babies as young as two months is a good idea. Dr Geoffrey Hanna of Queensland Health heads the working party that has called for the new vaccine to be included in the official schedule. The new pneumococcal vaccine recommended for babies could prevent deafness, middle ear infections and surgery to insert grommets to drain the ear canal, he says. He says the vaccine is already being delivered to Aboriginal children and parents in northern Australia have had no difficulty with three injections at once, he said. In the US babies of this age were sometimes subjected to four needles, he said. He said he did not anticipate the three injections deterring parents or undermining the Government's achievements in lifting the national immunisation rate. Australian Medical Association vice president Dr Trevor Mudge said yesterday modern needles were not painful and the only discomfort came from the acidity of the fluid injected. The Federal Government is considering the recommendation to add pneumococcal vaccine to the nation's immunisation schedule. It would be delivered to babies aged two months, four months and six months under the proposed new schedule. And it would add a third injection to these immunisation visits which currently involve two needles to protect against hepatitis B, diphtheria, tetanus, whooping cough and HIB. It is one of a number of proposed changes to the schedule reported by The Daily Telegraph this week. Page 31 of 40 © 2012 Factiva, Inc. All rights reserved.

Other changes would see children receive a dose of chicken pox vaccine at 18 months and another between the ages of 10 and 13 years. Although the disease is not usually life threatening, it causes significant economic loss, with parents staying home to care for sick children. And, for the first time, adolescents between 15 and 17 may be immunised against whooping cough in a bid to stop the spread of the disease, which is dangerous to babies. There were around 9000 cases notified last year, even though around 90 per cent of children are immunised against it. Also, the oral polio vaccine would be replaced by an injection. The Australian Vaccination Network is opposing the introduction of the pneumococcal vaccine claiming it has never been tested in Australia. Network president Meryl Dorey says children injected with the pneumococcal vaccine in combination with other vaccines are more likely to suffer fevers, drowsiness and decreased appetite. New schedule WHAT is the standard vaccination schedule? It is a list of vaccinations a committee of experts believes children and adults should have to protect them against serious diseases. Will the schedule change? Yes, from next year the Federal Government will fund vaccinations against meningococcalC for children aged 12 months and 15 years. What is meningococcalC? An infection caused by bacteria invading the blood or infecting the outer lining of the brain and spinal cord. It causes fever, joint and muscle pains and a rash that starts as tiny spots and spreads to look like fresh bruises. What other changes have the experts proposed? Replacing the oral polio vaccine with an injection to prevent rare side effects; immunising young babies against meningococcal disease; and giving 15-year-olds a whooping cough, tetanus and diptheria booster. How many vaccinations will a young baby need at each vaccination visit? Young babies aged 2, 4 and 6 months will require three injections each time they visit their doctor for immunisation under the proposed new schedule, up from the current two injections. Document daitel0020021031dyb10019h

Page 32 of 40

© 2012 Factiva, Inc. All rights reserved.

M

e n i

n g o c o c c a l

v a c c i

n e

w

a r

n i

n g .

Meningococcal vaccine warning. By DANIELLE CRONIN,. 559 words 21 August 2002 Canberra Times CANBTZ 2 English (c) 2002 The Canberra Times Health Reporter About six in 10 people who contracted the potentially deadly meningococcal disease would not benefit from the Federal Government's $321 million vaccination scheme, organisations warned yesterday. Health Minister Kay Patterson announced that the Government would provide free vaccinations for all Australian children aged 12 months and between 15 and 17 years under the program due to start in early 2003. But Meningitis Foundation general manager Elizabeth Watling warned against complacency, saying the vaccine would protect people only against type-C meningococcal disease - the more deadly but less common strain. More than 60 per cent of cases were of the type-B version. No vaccine was available for this strain but the University of Auckland and New Zealand health authorities had started clinical trials on a possible medication. The Meningitis Foundation and the Australian Medical Association supported the Government's scheme but called for more research into vaccines for the B strain. AMA vice-president Trevor Mudge said the strategy had limitations because low-risk groups would not get the vaccine and it was effective only against type C. 'For both of those reasons, while this will provide a degree of reassurance for the population at large, it's not going to make meningococcal disease go away,' he said. Health Department figures show 322 people have contracted the disease and 24 have died from it between January 1 and August 2 this year. There have been four cases but no deaths in the ACT this year. It is one of the rarest communicable diseases in the ACT, five people contracting it in 2000 compared with 232 cases of hepatitis C, 206 of whooping cough, 17 of malaria, 11 of tuberculosis, nine of HIV and five of legionella. One in five people who develops meningococcal disease will suffer other medical problems such as the loss of a limb, brain damage and hearing loss. Babies, children and people aged between 15 and 24 are most at risk. The disease is spread through saliva - coughing, kissing and sharing food or drinks. The first symptoms are similar to the common cold, but a tell-tale rash develops. Australian Vaccination Network president Meryl Dorey said the scheme was irresponsible. 'To introduce this vaccine while there is an inquiry ongoing overseas [in Britain], while there have been this huge number of reactions reported, is irresponsible and does not mean that the Government is performing its duty of care,' she told Sunrise on Channel Seven. Senator Patterson said the program - which would cost $41 million in the first year and about $20 million annually for the next 14 years - was a responsible and pro-active approach to managing the disease. The Government hoped that eventually enough vaccine would be available to extend the program to everybody aged up to 19. Opposition health spokesman Stephen Smith said children exposed to tobacco smoke in the home were four times as likely to develop the disease. Prime Minister John Howard said, 'Parents who are concerned about the possibility of their children contracting meningococcal disease and who smoke might think for a moment tonight about the contribution they personally could make towards reducing the likelihood of their children contracting this absolutely abhorrent disease. 'They continue to do these absolutely irresponsible things and expose their children to quite unnecessary risks.' (Endstory) (Story #24277 ). Document canbtz0020020820dy8l00010 Page 33 of 40 © 2012 Factiva, Inc. All rights reserved.

Page 34 of 40

© 2012 Factiva, Inc. All rights reserved.

P

a i

n

a

s m

a l

l

p r

i

c e

t

o

p a y

-

N

e w

v a c c i

n a t

i

o n

s h o t

s .

Pain a small price to pay - New vaccination shots. By SUE DUNLEVY. 621 words 1 November 2002 Daily Telegraph DAITEL 20 English (c) 2002 Nationwide News Proprietary Ltd THE trauma of subjecting tiny infants to three injections at once should not deter parents from vaccinating their children under a proposed scheme. The head of the working party proposing an overhaul of the nation's immunisation program said introducing a third needle for babies as young as two months is a good idea. Dr Geoffrey Hanna of Queensland Health heads the working party that has called for the new vaccine to be included in the official schedule. The new pneumococcal vaccine re-commended for babies could prevent deafness, middle ear infections and surgery to insert grommets to drain the ear canal, he said. He said the vaccine was being delivered to Aboriginal children and parents in northern Australia had had no difficulty with three injections at once. In the US babies of this age were sometimes subjected to four needles, he said. He said he did not anticipate the three injections deterring parents or undermining the Government's achievements in lifting the national immunisation rate. Australian Medical Association vice president Dr Trevor Mudge said yesterday modern needles were not painful and the only discomfort came from the acidity of the fluid injected. The Federal Government is considering the recommendation to add pneumococcal vaccine to the nation's immunisation schedule. It would be delivered to babies aged two months, four months and six months under the proposed new schedule. And it would add a third injection to these immunisation visits which currently involve two needles to protect against hepatitis B, diphtheria, tetanus, whooping cough and HIB. It is one of a number of proposed changes to the schedule reported by The Daily Telegraph this week. Page 35 of 40 © 2012 Factiva, Inc. All rights reserved.

Other changes would see children receive a dose of chicken pox vaccine at 18 months and another between the ages of 10 and 13 years. Although the disease is not usually life threatening, it causes significant economic loss, with parents staying home to care for sick children. And, for the first time, adolescents between 15 and 17 may be immunised against whooping cough in a bid to stop the spread of the disease, which is dangerous to babies. There were around 9000 cases notified last year, even though around 90 per cent of children are immunised against it. Also, the oral polio vaccine would be replaced by an injection. The Australian Vaccination Network is opposing the introduction of the pneumococcal vaccine claiming it has never been tested in Australia. Network president Meryl Dorey said children injected with the pneumococcal vaccine in combination with other vaccines were more likely to suffer fevers, drowsiness and decreased appetite. New schedule WHAT is the standard vaccination schedule? It is a list of vaccinations a committee of experts believes children and adults should have to protect them against serious diseases. Will the schedule change? Yes, from next year the Federal Government will fund vaccinations against meningococcalC for children aged 12 months and 15 years. What is meningococcalC? An infection caused by bacteria invading the blood or infecting the outer lining of the brain and spinal cord. It causes fever, joint and muscle pains and a rash that starts as tiny spots and spreads to look like fresh bruises. What other changes have the experts proposed? Replacing the oral polio vaccine with an injection to prevent rare side effects; immunising young babies against meningococcal disease; and giving 15-year-olds a whooping cough, tetanus and diptheria booster. How many vaccinations will a young baby need at each vaccination visit? Young babies aged 2, 4 and 6 months will require three injections each time they visit their doctor for immunisation under the proposed new schedule, up from the current two injections. Document daitel0020021101dyb1000cv

Page 36 of 40

© 2012 Factiva, Inc. All rights reserved.

A

u s t

r

a l

i

a

p l

a n s

m

a s s

m

e n i

n g o c o c c a l

v a c c i

n a t

i

o n s .

Australia plans mass meningococcal vaccinations. 474 words 20 August 2002 12:48 Reuters News LBA English (c) 2002 Reuters Limited CANBERRA, Aug 20 (Reuters) - Over one million Australian children will receive free vaccinations against a deadly form of meningitis after the government on Tuesday bowed to public pressure following a spate of deaths from meningococcal disease. Australia is one of the first countries to introduce a mass vaccination programme for one strain of the deadly brain disease, following Britain's lead three years ago. The vaccination programme was triggered by a public outcry after a campaign in the Australian media highlighting the tragic stories of some children who recently died of the disease. But Health Minister Kay Patterson said a global shortage of vaccine meant the campaign would not start until 2003, with only one registered supplier of the vaccine in Australia - U.S. drug maker Wyeth - and a current supply of 100,000 doses. "The shortages are a global problem," Patterson said in a statement. Health officials said two other drug companies, who could not be named for commercial reasons, currently had vaccines for the meningococcal type-C strain before Australia's drug authority, the Therapeutic Goods Administration, awaiting approval. "We are fast-tracking these and expect a decision within a month so that the government can get into negotiations with the companies to start the vaccine programme next year," a spokesman from the Health Department told Reuters. So far this year 24 Australians have died from the disease, which is on par with the average with 31 Australians dying of meningococcal last year when 671 cases were reported. Patterson said initially 12-month-old babies and children aged 15 will be vaccinated in a programme expected to cost A$41 million (US$22.5 million) in its first year. Britain was the first country to introduce a mass vaccination programme against C-type meningococcal in 1999, and medical experts say the vaccine has cut the number of cases among British younsters by 80 percent to under 150 a year. But some medical lobby groups said the limited vaccination programme was a band-aid solution and questioned its potential effectiveness, with only 32 percent of the 600 or so cases of meningococcal in Australia each year of Page 37 of 40 © 2012 Factiva, Inc. All rights reserved.

the type-C strain. The majority, or 62 percent, of meningococcal cases seen in Australia are type-B for which there is presently no vaccine. "This is a knee-jerk reaction that has not been thought through properly," president of the Australian Vaccination Network, Meryl Dorey,told Reuters. Meningococcal disease is a rare brain illness that usually infects about 500,000 people worldwide a year, killing 50,000. The bacteria is spread by coughing, kissing, and sneezing. Fevers, headaches and vomiting are early symptoms of the illness but they can be mistaken for flu. A stiff neck and a purplish rash are signs of the disease. (US$1=A$1.82). Document lba0000020020820dy8k00590

Page 38 of 40

© 2012 Factiva, Inc. All rights reserved.

L e t

t

e r

s

News And Features; Letters Letters 457 words 1 March 2002 Sydney Morning Herald SMHH 12 English Copyright of John Fairfax Group Pty Ltd Tax break leaves the books unbalanced The prospect of not having to fill in a tax return will bring a smile to most salary and wage earners (``Goodbye to tax returns'', Herald, February 28). However, the suggestion that bank account details will prove annual income and tax liability misses the other half of the equation, namely allowable deductions. It is going to bedifficult to claim such deductions if a return is not lodged. I suspect that this so-called radical proposal will merely squeeze ordinary taxpayers from being able to claim even simple employment-related expenses. Michael Blissenden, Senior lecturer in tax law, UWS, Blacktown, February 28. Not cured just yet Regarding Mark Robinson's article (``Measles on the way out as vaccine hits the spot'', Herald, February 26) on the low reporting of measles cases: it should be understood that it is very rare for there to be a blood test taken when measles is suspected especially when a patient is vaccinated against it. In 1997, the British journal Pulse published an article stating that 97.7 per cent of all doctor-diagnosed measles turned out, upon further testing, to be something else. So, if doctors don't recognise measles when they see it, how are we supposed to trust that when they actually do see a case of measles, they have not diagnosed it as something else? In addition, measles is a cyclical disease so just because there are fewer cases now does not mean that the illness has disappeared. Meryl Dorey, President, The Australian Vaccination Network, Inc, Bangalow, February 28. More than one opinion Regarding Miranda Devine's article (``Plain truth is we are failing kids'', Herald, February 28): the reference to the teacher education textbook Re-Viewing English completely distorts the thrust of the book. The section singled out occupies some eight pages in a volume whose 349 pages present a range of views from about 30 contributors, many of whom Page 39 of 40 © 2012 Factiva, Inc. All rights reserved.

hold quite different positions from the one quoted. Ken Watson, Co-editor, Re-Viewing English, Rozelle, February 28. Obvious solution Peter Dare (Letters, February 26) seeks to hold the Government blameless for its inaction over David Hicks's confinement. He seeks a ``workable solution'' to charging Mr Hicks under deficient Australian law. I seek a different workable solution. If there is a case against Hicks I'd like evidence, and a trial, and decent lawyers on both sides. I'd like an open court and habeas corpus, and the right of reply. I'd like the presumption of innocence, and trial by jury, not media. In Australia. Just the kind of civil rights our PM accords the Governor-General would do nicely. Peter Walker, Marsfield, February 28. Document smhh000020020228dy3100013

Page 40 of 40

© 2012 Factiva, Inc. All rights reserved.