Informed choice and immunisation programmes ppt

women’s health update Women’s Health Update features women’s health news, policy and scientific findings, to enable health care professionals and community-based workers to be at the forefront in women’s health. Women’s Health Update is published by the Women’s Health Action Trust Women’s Health Update is produced by Women’s Health Action Trust • Edited by Jo Fitzpatrick To receive copies of Women’s Health Update, make suggestions about future contents or send items for publication please contact: Women’s Health Action Trust • PO Box 9947, Newmarket, Auckland, NZ 2nd Floor, 27 Gillies Avenue • Ph (09) 520 5295 • Fax (09) 520 5731 • email: info@womens-health.org.nz Internet address: http://www.womens-health.org.nz • Women’s Health Update is published with the assistance of the Ministry of Health Women's Health Action Trust celebrating 20 years 1989-2009 The school-based phase of the HPV (human papillomavirus) immunisation programme that will provide Gardasil vaccine for girls from 12 years old is about to start. Given the debate on the failure of informed consent processes with the MeNZB immunisation programme, and a troubling start to the national HPV immunisation programme launched in September last year, it is timely to raise concerns about the fate of informed choice and consent in the school-based phase of the programme. Christy Parker looks at some of the ethical issues surrounding mass immunisation programmes targeting children and young people and argues that the principles of informed choice and consent must not be compromised by population health objectives. During the last 50 years mass immunisation programmes have been effective in protecting people against infectious diseases alongside other public health measures. However, while successful, these programmes have remained controversial often with fierce debate over both the context and their implementation (Verweij & Dawson, 2004). There are two major groups of ethical issues which cause controversy. The first relate to the development, introduction, and availability of new vaccines. There is much debate about the principles that should be applied in deciding which programmes are funded, about how these decisions are made, and by whom (Verweij & Dawson, 2004). The role of pharmaceutical companies who stand to make millions, or even billions, in decisions Inside ● Menopause,Midlifeand Metabolism ● M¯aoriWomenand Breastfeeding ● NewWomen’sHealth ActionWebsite ● Resourcesandonline supportgroupfor women continued on page 2 vol13 no1•February2009 Informed choice and immunisation programmes Informed choice and consent are not niceties in New Zealand; they are enshrined in law through the Code of Health and Disability Services Consumers’ Rights. The Code of Rights, which became law in 1996 confers a number of rights on all consumers of health and disability services in New Zealand, and arose out of the Cartwright Inquiry with its damning findings about the treatment of women with cervical cancer at National Women’s Hospital, a scandal termed the “Unfortunate Experiment”. Rights six and seven of the code define health and disability services consumers’ rights to full information to enable them to make an informed choice and give their informed consent for any proposed health intervention. Right six is the right to be fully informed. The consumer can expect an explanation of the options available including an assessment of the expected risks, side effects, benefits, and costs of each option. Right six also stipulates: Before making a choice or giving consent, every consumer has the right to the information that a reasonable consumer, in that consumer’s circumstances, needs to make an informed choice or give informed consent. Right seven outlines the right to make an informed choice and give informed consent. about national vaccination programmes is particularly contentious. Broader debates about the safety and efficacy of vaccines also continue to be very active. The second major group of ethical issues, and the ones which are the focus of this article, concern the implementation of vaccination programmes: the means used to achieve high vaccination uptake, and the information and communication processes involved (Verweij & Dawson, 2004). When extraordinarily high immunisation targets, aggressive marketing campaigns, and one sided information resources are employed, they risk undermining consumers’ rights to informed choice and informed consent (See Box). There is an inherent tension between these rights, and the objectives of population health which seek the highest uptake of interventions (such as screening or immunisations) to reduce the incidence of a disease across the whole population. The tension is further complicated when an intervention is aimed at children and young people and the right to informed choice and informed consent includes their parents. continued from page 1 International research has explored this tension and the ways that the communication and implementation of childhood immunisation programmes, aimed at maximising uptake, can undermine consumers’ (or their parents) rights to make an informed choice. Offering practitioners financial incentives to meet high uptake targets works to undermine informed consent processes, especially when practitioners also believe that it is their “moral responsibility” to ensure children are immunised. Alderson et al (1997) asked primary health care practitioners in the United Kingdom about their views on childhood immunisation and how targets with financial incentives might affect parent’s choice. They found that ‘official’ targets and guidelines, as well as one-sided information resources, had a significant impact on how these practitioners approached informed choice and informed consent in vaccination programmes. Almost all of the practitioners which included GPs, practice nurses and health visitors felt obliged to carry out government policy even if they felt this was damaging to their patient relationships. One GP stated: I feel angry about targets. My relationship with patients is becoming increasingly damaged. I think, increasingly, things like coercive consent will become a problem; they’ll see me more as a policeman, not a doctor (Alderson et al, 1997: 96) Many practitioners also described a special moral duty to children which superseded the rights of parents to make an informed choice. It was apparent that policies encouraging high uptake leant institutional support to these attitudes. The comments of one GP were particularly concerning: My duty is to the child, and not to have the child immunised because of grandmother’s prejudice is unacceptable as far as I’m concerned…If a child comes in and I notice the child hasn’t had them, I sometimes will do them opportunistically. I think targets have improved rates. There’s no doubt that money talks, and it’s meant a lot of GPs have got themselves sorted out. The reluctance to provide full information and facilitate discussion about the risks and benefits of immunisation for fear that parents would not make the “right” choice was reported by many practitioners, leading one practitioner to state rather revealingly ‘consent is about compliance, we need to do more work on how to get them to comply, to take it up’. Parents who chose not to have their children immunised tended to be seen as irresponsible and/or irrational. The recent MeNZB immunisation programme was a worrying local example of the fate of informed choice and consent when the goal of childhood immunisation programmes is to achieve the highest possible uptake and fast. When the $220 million dollar campaign finished in May last year, parents were shocked to discover that few of the children immunised during the campaign remained immune to Meningococcal B. Uncertainties about how long immunity would last were not adequately communicated to parents in the rush to achieve high uptake targets, and many parents thought that their children would be immune for life. The failure of informed choice and consent processes is not just a violation of health consumer’s rights as enshrined in law, it is dangerous. Parents, believing their children are immunised against Meningococcal B, are less likely to be alert to signs of this deadly disease. Claims that fear-mongering and bullying tactics were used to intimidate parents into having their children immunised were reported throughout the MeNZB campaign, and many parents reported a lack of reliable and unbiased information to assist their decision making process. The approach to informed choice and consent during the school-based phase of the programme was particularly concerning to many parents. An October 2007 study published in the New Zealand Medical Journal found that parents had a ‘largely unfulfilled desire for reliable, valid and balanced information about the MeNZB vaccine’ (Watson et al, 2007). Parents – whether they decided to immunise or not – frequently described the Ministry of Health media publicity as ‘scare mongering’, ‘controlling people through fear’, ‘fear driven’, ‘not balanced’, and ‘one sided’. Even parents with a more positive view made comments such as ‘presenting the Government’s received view’ and ‘needing in some way to twist it to force people to immunise’. Those parents with school aged children reported concerns about the graphic nature of information given to children at school, in most cases without parental consent; the use of child-based incentives; and the short time frame given to parents to sign consent forms, all of which left parents feeling like they were being pressured into giving their consent (Watson et al, 2007). The roll out of the HPV immunisation programme since September 2008 has also raised concerns that the approach to its implementation undermines health consumers’ ability to make an informed choice about the vaccine. The Gardasil vaccine, which targets four types of the human papillomavirus associated with cervical cancer, some vulval and vaginal cancers, and genital warts, is being offered to all women aged 9-26, and is controversial for a number of reasons. These include the vaccines’ infancy and the suspicion that it was rushed to the market ahead of competitors for commercial gain with inadequate evidence of its efficacy and safety. Once again there are unanswered questions around how long the vaccine will offer immunity. HPV vaccination programmes are also solely targeting girls and women when HPV infection is present in boys and men and is associated with other cancers and genital warts. HPV is thus a sexual health issue, not a women’s health issue and young women should not have to bear the burden for reducing the incidence of HPV related diseases. Further we risk sending young women the message that they alone are responsible for sexual health. Gardasil is also one of the most expensive vaccines ever sold and the programme will cost hundreds of millions of dollars- prompting questions about the gains given that women still need regular cervical smears with or without the vaccine. The HPV immunisation programme is being introduced in two phases, the first phase introduced in September last year through GPs and primary health care practices for women born in 1990 and 1991, and the second school based phase late in term one of this year for girls aged 12 to 18. Concerns about the implementation and communication of the HPV immunisation programme echo those of the MeNZB campaign and centre around the marketing of the vaccine; the one-sided nature of the information resources available to young women and their parents; and the involvement of the pharmaceutical company- CSL Biotherapies- in delivering the programme. The decision to market the HPV vaccine as the “cervical cancer vaccine” is factually incorrect and obstructs consumers’ ability to understand the relationship between HPV, cervical cancer and Gardasil. The information resources are also woefully inadequate and fail to communicate uncertainties about how long the vaccine will confer protection, and that 90% of HPV infections are cleared by the body naturally within two years. The ethics of aggressive marketing campaigns selling vaccines as “cool” to young women are questionable- peer pressure should not be used as a strategy to encourage vaccine uptake. The Auckland District Health Boards ‘One ForTheGirls’ “information” website about the HPV programme is an example of the emphasis on marketing over clear and honest evidence- based information to assist decision making. CSL’s biotherapies “remind me” compliance programme alerts young women by email or text when their follow up vaccines are due. It is unethical for pharmaceutical companies with major financial interests in vaccine uptake to have this role, and the resulting direct contact with young health consumers. Ethical issues aside, safety is a major issue if aggressive one-sided marketing campaigns and poor information resources reduce young women’s ability to make a meaningful informed choice about Gardasil. Young women must understand that they will still need to have regular cervical smears because Gardasil does not offer “lifetime protection from cervical cancer” (as parents believed with meningococcal B). Gardasil does not protect against all cancer causing types of HPV and it is unknown how long immunity will last- experience tells us the duration of immunity is likely to be shorter than first thought. If young women do not understand the limitations of Gardasil there is a major risk 2 • Women’s Health Update • vol 13 no 1 • February 2009 Menopause, Midlife and Metabolism Women’s Health Update • vol 13 no 1 • February 2009 • 3 The 12th Australasian Menopause Society (AMS) conference held in Melbourne in October last year explored the issues of midlife and the many changes that women experience at this time. Jo Fitzpatrick gives us a brief overview. Women’s Health Action doesn’t attend AMS conference every year but this one promised a wider look at common and uncommon midlife problems not often discussed. It focused on the impact and emergence of diseases such as diabetes, depression, heart disease, osteoporosis, metabolic disorder, and lupus at the time of menopause; and included a full session on vulval disorders. Interesting points from the sessions on obesity and metabolic syndrome include: Most weight gain occurs pre and peri- menopausally rather than at the time of menopause and is particularly marked around the midriff where it is also most dangerous in terms of future health implications. Low calorie diets, and particularly Mediterranean diets, are useful for weight control at this time and they are most useful when combined with exercise. Exercise needs to be varied and include weight bearing and aerobic exercise and, to be effective, should last for at least an hour a day. Lifestyle changes, including fitness, change of food habits and behaviours, remain the bedrock of all medical strategies to manage obesity. These changes include self-monitoring with the doctor and the woman negotiating agreed changes. Drugs for other conditions may increase weight and there are few effective drugs for the management of obesity available. Surgery - lap banding – results in major positive changes but needs to be permanent as small changes ‘easing-off’ the lap band have resulted in rapid and dramatic weight gain. Lifestyle related metabolic diseases are now a primary cause of chronic disease in Australian women and they are underpinned by a lack of physical activity and excess food intake. They include obesity; polycystic ovarian syndrome; diabetes (including gestational and pre- diabetes); and cardiovascular disease. The vulval disorders section was extremely useful in throwing light on these troubling and troublesome midlife problems. It also confirmed that this is a complex area which is not well understood and may be difficult to treat. An in- depth look at hot flushes identified 620 drugs and 337 known drug interactions which were known to cause ‘hot flushes’ and outlined ways of determining whether hot flushes were menopausal or indicative of other more serious conditions. Many of the papers were useful and fascinating which made this conference worth attending. This conference as always, was heavily sponsored by drug companies and they were well in evidence – as sponsors and advertisers in the conference materials; as session sponsors and as principal providers of food – served surrounded by their stands on a mezzanine floor. References: http://en.wikipedia.org/wiki/Mediterranean_ diet http://www.mayoclinic.com/health/ mediterranean-diet/CL00011 A recently launched report brings to completion qualitative research on factors that influence breastfeeding for M ¯aori women: the decision to breastfeed; the choice and quality of breastfeeding advice; and the factors influencing breastfeeding – both positively and negatively. Sixty women and their whanau were interviewed and the results shine a useful light on M ¯aori breastfeeding today. The depth of analysis has enabled the researchers to make useful recommendations. Particularly useful is a new model for understanding how M ¯aori women are diverted from breastfeeding. Five influencers were indentified : breakdown in the breastfeeding norm within the whanau, early interruptions to or difficulties establishing breastfeeding, negative or insufficient maternity support for breastfeeding, lack of knowledge about how breastfeeding changes over time and returning to work. The recommendation in this report, for the promotion of breastfeeding to M¯aori, would be wisely taken heed of. “… focus on re-establishing breastfeeding as a tikanga (right cultural practice) rather than a perceived lifestyle choice.” The published report of Marewa Glover, Haarangi Manaena-Biddle, John Waldon and Chris Cunningham was launched on Tuesday the 3rd of February at the University of Auckland. For a copy of the full report send an $18 cheque made out to: ‘Auckland Uniservices Ltd’ to Marewa Glover, Social & Community Health, The University of Auckland, Private Bag 92019, Auckland Mail Centre 1142. Shining a light: te whaangai uu – te reo o te aratika M¯aori Women and Breastfeeding that they may not participate in New Zealand’s excellent cervical screening programme. Given the uncertainties about the duration of immunity, there is a real risk that by the time many of the very young women who have the vaccine are sexually active they may no longer be protected from any of the strains of HPV. In the worst case scenario, if these young women do not have regular smears believing that they are protected from cervical cancer we could actually see an increase in the incidence of cervical cancer. Good information when it comes to health choices is a serious business. As we prepare to launch the HPV programme in our schools, it is timely that we look seriously at the level of education and the information resources we provide to the huge numbers of young women we plan to vaccinate in the course of these prgrammes. Consumers must have easy access to full information and the opportunity to make an informed choice about vaccines, especially when a vaccine is controversial. Consumers’ rights to do so are fundamental to health service delivery in this country. Verweij and Dawson (2004) argue that analysis and discussion of the ethical issues should be part of any justification of mass immunisation programmes, perhaps especially for those targeting children and young people. Alderson et al (1997) urge policy makers to take parents’ concerns and questions about vaccination seriously and to include them in these discussions, acknowledging them as the experts in caring for their children. We must remember that parents are the first to see the impact of vaccines on their children’s health. Alderson et al (1997) also urge the development of detailed information booklets with clear summaries of research reviews, statistics and suggested questions to discuss rather than relying on marketing resources that appeal to parent’s guilt and fear, or to the culture of “cool”. Finally, serious questions need to be asked about how we measure ‘success’ in immunisation programmes. It’s too easy and extremely dangerous to set high targets for uptake and to see this as ‘success’ or ‘good practice’ by health professionals. Best practice should be measured by the number of people who have been given enough information, time to discuss this information, and who make a meaningful informed choice, whether this be to accept or decline the intervention. Despite laudable objectives, we shouldn’t be bullied into accepting anything less. The full article, including references, can be accessed from our website www.womens- health.org.nz women’s health update Women’s Health Update features women’s health news, policy and scientific findings, to enable health care professionals and community-based workers to be at the forefront in women’s health. Women’s Health Update is published by the Women’s Health Action Trust Women’s Health Update is produced by Women’s Health Action Trust • Edited by Jo Fitzpatrick To receive copies of Women’s Health Update, make suggestions about future contents or send items for publication please contact: Women’s Health Action Trust • PO Box 9947, Newmarket, Auckland, NZ 2nd Floor, 27 Gillies Avenue • Ph (09) 520 5295 • Fax (09) 520 5731 • email: info@womens-health.org.nz Internet address: http://www.womens-health.org.nz • Women’s Health Update is published with the assistance of the Ministry of Health Women's Health Action Trust celebrating 20 years 1989-2009 Noticeboard ● Well Child Week “listening and talking” 2nd - 8th March For further information please go to www.wellchild.org.nz ● 2nd hdC MediCo-legal ConferenCe Wednesday 4 March 2009 Wellington For more information please contact Julia Phillips on 04 494 7900 ● UnifeM, international WoMen’s day Breakfast 8th March For more information please contact: Liz Brown, Breakfast Co-coordinator Ph: 04 977 8783 or E-mail: liz.brown@paradise.net.nz ● ViCtiM sUpport Week 11th - 18th March For events please see www.victimsupport.org.nz ● pUBliC leCtUres “Who Cares? Narratives of People Who are Dying and Their Families” 16th March For more information on these lectures please go to http:// www.compassioninhealthcare.org ● neW Zealand laCtation ConsUltants assoCiation Walking toUr 2009 Auckland - Monday 23 March The Conference Centre, AUT Tech Park Wellington - Wednesday 25 March Terrace Conference Centre Christchurch - Friday 27 March Russley Golf Course For more information please go to: http://www.workz4u. co.nz/LinkClick.aspx?fileticket=72RH6F2lIGI%3d&tabi d=3925 ● 15th international CritiCal and feMinist perspeCtiVes in health & soCial jUstiCe ConferenCe 16 – 19 April 2009 Auckland Conference themes are: Health care system and practice interplay, Social justice and challenges for society Cultural challenges within health care, Power and practice challenges, Indigenous peoples and health care For more information or to register go to contact Debbie Payne at debbie.payne@aut.ac.nz ● Working With Child sexUal aBUse Strengthening and Informing Practice 14th and 15th of May For more information please see http://www.safenz.org/ Downloads/SymposiumDetails2009.pdf Our newly developed Women’s Health Action website was launched at our Women’s Suffrage Breakfast on the 19th September. The new website contains over 300 pages of up-to-date information and research on women’s health issues, policy, service developments and events. It has been built on a database structured template which will allow our staff members to add pages to the site ensuring a site that is regularly updated. It is an excellent resource for health consumers; health care providers; women’s and community health organisations; and health policy makers and researchers alike. Our submissions, newsletters and papers on a wide range of women’s and consumer health issues can be down-loaded directly from the site as they become available. We welcome comment and feedback on these. Also available on the site are a range of gender-based analysis tools for policy development; Women’s Health Action press releases; quick reference hot topics; upcoming events related to women’s health and breastfeeding; and links to other women’s organisations in New Zealand and around the world. Along with hundreds of pages of current women’s health research and information, the site includes a facility for making queries from the site. WHA has a 24 hour Monday to Friday turnaround policy on enquiries. Another useful site feature is the down-loadable order form for our women’s health resources and we hope to have an electronic order form available in the near future. We welcome any feedback or comments on the new site and how it can be improved further. The website address is www.womens-health. org.nz. New Women’s Health Action Website Launched Women who are battling with mental health or drug and alcohol problems as a result of domestic violence now have a safe place to go for on-line support. There are a number of ‘domestic violence’ websites about but this is the first specifically for people who feel that domestic violence has driven them mad. www.hedrovememad.com is for people to share experiences, discuss issues of concern, ask and answer questions, provide information on what helps and what doesn’t, advertise local and national events and share information. The website provides contact with people who not only understand, but who have been in similar situations and will provide support usually found in face-to-face and group situations. The site is secure; pseudonyms are used and there is clear information on how to use the site so that abusers are unable to trace and track usage. For health professionals and support services working with these people, a CD and teaching package is also available. Flyers on the website for distribution and display are available from debbie.neil@paradise. net.nz. Debbie also has more information on the DVD and teaching package. Resources and online support group for women . 2 vol13 no1•February2009 Informed choice and immunisation programmes Informed choice and consent are not niceties in New Zealand; they are enshrined in. circumstances, needs to make an informed choice or give informed consent. Right seven outlines the right to make an informed choice and give informed consent. about