Ethical issues in using a cocaine vaccine to treat and prevent cocaine abuse and dependence

A cocaine vaccine'' is a promising immunotherapeutic approach to treating cocaine dependence which induces the immune system to form antibodies that prevent cocaine from crossing the blood brain barrier to act on receptor sites in the brain. Studies in rats show that cocaine antibodies block cocaine from reaching the brain and prevent the reinstatement of cocaine self administration. A successful phase 1 trial of a human cocaine vaccine has been reported. The most promising application of a cocaine vaccine is to prevent relapse to dependence in abstinent users who voluntarily enter treatment. Any use of a vaccine to treat cocaine addicts under legal coercion raises major ethical issues. If this is done at all, it should be carefully trialled first, and only after considerable clinical experience has been obtained in using the vaccine to treat voluntary patients. There will need to be an informed community debate about what role, if any, a cocaine vaccine may have as a way of preventing cocaine addiction in children and adolescents.

Genetic screening for susceptibility to depression: can we and should we?

Objective: To summarize current knowledge about genetic susceptibility to mood disorders and examine ethical and policy issues that will need to be addressed if robustly replicated susceptibility alleles lead to proposals to screen and intervene with persons at increased genetic risk of developing mood disorders. Method: Empirical studies and reviews of the genetics of unipolar and bipolar depression were collected via MEDLINE and psycINFO database searches. Results: A number of candidate genes for depression have been identified, each of which increases the risk of mood disorders two- or threefold. None of the associations between these alleles and mood disorders have been consistently reported to date. Conclusions: Screening the population for genetic susceptibility to mood disorders is unlikely to be a practically useful policy (given plausible assumptions). Until there are effective treatments for persons at increased risk, screening is arguably unethical. Screening within affected families to advise on risks of developing depression would entail screening children and adolescents, raising potentially serious ethical issues of consent and stigmatization. Genetic research on depression should continue under appropriate ethical guidelines that protect the interests of research participants.

The contribution of research to Australian policy responses to heroin dependence 1990-2001: a personal retrospection

Periodic public concern about heroin use has been a major driver of Australian drug policy in the four decades since heroin use was first reported. The number of heroin-dependent people in Australia has increased from several hundreds in the late 1960s to around 100000 by the end of the 1990s. In this paper I do the following: (1) describe collaborative research on heroin dependence that was undertaken between 1991 and 2001 by researchers at the National Drug and Alcohol Research Centre: (2) discuss the contribution that this research may have made to the formulation of policies towards the treatment of heroin dependence during a period when the policy debate crystallized around the issue of whether or not Australia should conduct a controlled trial of heroin prescription; and (3) reflect on the relationships between research and policy-making in the addictions field, specifically on the roles of investigator-initiated and commissioned research, the interface between researchers, funders and policymakers: and the need to be realistic about the likely impact of research on policy and practice.

The policy and ethical implications of genetic research on attention deficit hyperactivity disorder

Objective: To review the policy and ethical implications of recent research on the molecular genetics of attention deficit hyperactivity disorder (ADHD). Method: MEDLINE and psycINFO database searches were used to identify studies on the genetics of ADHD. The implications of replicated candidate genes are discussed. Results: The findings for most genes have been inconsistent but several studies have implicated the genes in the dopaminergic pathway in the aetiology of ADHD. Conclusions: The current evidence on the genetics of ADHD is insufficient to justify genetic screening tests but it will provide important clues as to the aetiology of ADHD. Genetic information on susceptibility to ADHD has the potential to be abused and to stigmatize individuals. Researchers and clinicians need to be mindful of these issues in interpreting and disseminating the results of genetic studies of ADHD.

Using pharmacogenetics and pharmacogenomics in the treatment of psychiatric disorders: some ethical and economic considerations"

Current pharmacotherapies for psychiatric disorders are generally incompletely effective. Many patients do not respond well or suffer adverse reactions to these drugs, which can result in poor patient compliance and poor treatment outcome. Adverse drug reactions and non-response are likely to be influenced by genetic polymorphisms. Pharmacogenetics holds some promise for improving the treatment of mood disorders by utilising information about genetic polymorphisms to match patients to the drug therapy that is the most effective with the fewest side effects. Pharmacogenomics promises to facilitate the development of new drugs for treatment. However, these technologies raise many ethical, economic and regulatory issues that need to be addressed before they can be integrated into psychiatry, and medicine more generally. We discuss ethical and policy issues arising from pharmacogenetic testing and pharmacogenomics research, such as informed consent, privacy and confidentiality, research on vulnerable persons and discrimination; and economic viability of pharmacogenetics and pharmacogenomics. We conclude with recommendations for the regulation and distribution of pharmacogenetic testing services and pharmacogenomic drugs.

To marry or not to marry: marital status and the household division of labour

Data from an Australian national survey (1996 to 1997) are used to examine domestic labor patterns among de facto and married men and women. The results show that women spend more time on housework and do a greater proportion of housework than men. However, the patterns are most traditional among married men and women. Women in de facto relationships spend less time doing housework and do a smaller proportion of indoor activities than married women. Men in de facto relationships do a larger proportion of indoor activities and a lower proportion of outdoor tasks than married men. The data also show that couples who have cohabited prior to marriage have more egalitarian divisions of labor than those who have not cohabited prior to marriage. This article concludes by arguing that the incompleteness of the de facto relationship provides a period of relative freedom in which to negotiate more equal roles.

Marriage breakdown in Australia - The social correlates of separation and divorce

Marriage breakdown through separation and divorce is a pervasive feature of Australian society. But little research investigates the social factors associated with marital breakdown in Australia. This study builds on and extends Australian research by using survival analysis models to examine patterns of association among temporal, life-course, attitudinal and economic factors associated with marital breakdown. Using data from the Household Income and Labour Dynamics in Australia (HILDA) survey, we find marital breakdown in Australia is socially patterned in similar ways to other Western countries. But our findings point to several directions for future research into marriage breakdown in Australia, and we identify certain unique features of Australian marriage breakdown that warrant a more detailed investigation, such as the relationship between ethnic origin and the risk of marital breakdown.

Effectiveness of screening for risk of medical emergencies in the elderly

Study objective: UK government policy mandates the introduction of 'intermediate care services' to reduce emergency admissions to hospital from the population aged 75 years or more. We evaluated one of these initiatives-the Keep Well At Home (KWAH) Project-in a West London Primary Care Trust. Design: KWAH involves a two-phase screening process, including a home visit by a community nurse. We employed cohort methods to determine whether KWAH resulted in fewer emergency attendances and admissions to hospital in the target population, from October 1999 to December 2002. Results: estimated levels of coverage in the two phases of screening were 61 and 32%, respectively. The project had not maintained records of which additional health and social care services had been delivered following screening. The rates of emergency admissions to hospital in the 9 months before screening were similar in practices that did and did not join the project (rate ratio (RR) = 1.05; 95% CI 0.95-1.17), suggesting absence of volunteer bias. Over the first 37 months of the project, there was no significant impact on either attendances at Accident & Emergency departments (RR = 1.02; 95% CI 0.97-1.06) or emergency admissions of elderly patients (RR = 0.98; 95% CI 0.93-1.05). Conclusion: the KWAH Project has been ineffective in reducing emergency admissions among the elderly. Significant questions arise in relation to selection of the screening instruments, practicality of achieving higher coverage of the eligible population, and creation of a new postcode lottery.

General practitioners with special interests: risk of a good thing becoming bad?

There is a long tradition of some general practitioners developing areas of special interest within their mainstream generalist practice. General practice is now becoming increasingly fragmented, with core components being delivered as separate and standalone services (eg, travel medicine, skin cancer, women's health). Although this fragmentation seems to meet a need for some patients and doctors, potential problems need careful consideration and response. These include loss of generalist skills among GPs, fewer practitioners working in less well-remunerated areas, such as nursing home visits, and issues related to standards of care and training.

Perceptions of the influence of prescription medicine samples on prescribing by family physicians

Background: The provision of free prescription medicine samples is a common and traditional marketing strategy used by pharmaceutical companies, but concerns have been raised about their influence on physician prescribing behavior and patient safety. Objective: We sought to investigate the knowledge, attitudes, and behaviors of Australian family physicians regarding the use of sample prescription medications. Methods: Qualitative and quantitative techniques were used, including (1) mailed questionnaires to family physicians, (2) semistructured interviews with family physicians, and (3) sample cupboard inventories. Results: A number of issues about samples were identified by the questionnaires (208) and interviews (17 doctors), including insufficient labeling, poor record keeping, diversion of stock (personal use by doctors.. their families, practice staff and pharmaceutical representatives), and wasting of expired stock. Prescription medicine samples also influenced prescribing behavior. Australian doctors were less likely to provide samples to patients on financial grounds compared with a previous study in the United States on medical residents. Six sample cupboards were inventoried. Median wholesale value of sample cupboards was AUD $4959 (range $2395-$8709), with 6% of stock expired. Very little generic medicine was included in the sample cupboards. Conclusions: Better methods are needed to meet legislative requirements and to ensure quality use of medicines (and optimal public health) with respect to prescription medicine samples. Doctors and practice staff require training on the appropriate handling and storage of prescription medications. Alternative ways for distribution of sample medications need to be investigated.

Effectiveness of topical skin care provided in aged care facilities

Background The 2001 Australian census revealed that adults aged 65 years and over constituted 12.6% of the population, up from 12.1% in 1996. It is projected that this figure will rise to 21% or 5.1 million Australians by 2031. In 1998, 6% (134 000) of adults in Australia aged 65 years and over were residing in nursing homes or hostels and this number is also expected to rise. As skin ages, there is a decreased turnover and replacement of epidermal skin cells, a thinning subcutaneous fat layer and a reduced production of protective oils. These changes can affect the normal functions of the skin such as its role as a barrier to irritants and pathogens, temperature and water regulation. Generally, placement in a long-term care facility indicates an inability of the older person to perform all of the activities of daily living such as skin care. Therefore, skin care management protocols should be available to reduce the likelihood of skin irritation and breakdown and ultimately promote comfort of the older person. Objectives The objective of this review was to determine the best available evidence for the effectiveness and safety of topical skin care regimens for older adults residing in long-term aged care facilities. The primary outcome was the incidence of adverse skin conditions with patient satisfaction considered as a secondary outcome. Search strategy A literature search was performed using the following databases: PubMed (NLM) (1966–4/2003), Embase (1966–4/2003), CINAHL (1966–4/2003), Current Contents (1993–4/2003), Cochrane Library (1966–2/2003), Web of Science (1995–12/2002), Science Citation Index Expanded and ProceedingsFirst (1993–12/2002). Health Technology Assessment websites were also searched. No language restrictions were applied. Selection criteria Systematic reviews of randomised controlled trials, randomised and non-randomised controlled trials evaluating any non-medical intervention or program that aimed to maintain or improve the integrity of skin in older adults were considered for inclusion. Participants were 65 years of age or over and residing in an aged care facility, hospital or long-term care in the community. Studies were excluded if they evaluated pressure-relieving techniques for the prevention of skin breakdown. Data collection and analysis Two independent reviewers assessed study eligibility for inclusion. Study design and quality were tabulated and relative risks, odds ratios, mean differences and associated 95% confidence intervals were calculated from individual comparative studies containing count data. Results The resulting evidence of the effectiveness of topical skin care interventions was variable and dependent upon the skin condition outcome being assessed. The strongest evidence for maintenance of skin condition in incontinent patients found that disposable bodyworn incontinence protection reduced the odds of deterioration of skin condition compared with non-disposable bodyworns. The best evidence for non-pressure relieving topical skin care interventions on pressure sore formation found the no-rinse cleanser Clinisan to be more effective than soap and water at maintaining healthy skin (no ulcers) in elderly incontinent patients in long-term care. The quality of studies examining the effectiveness of topical skin care interventions on the incidence of skin tears was very poor and inconclusive. Topical skin care for prevention of dermatitis found that Sudocrem could reduce the redness of skin compared with zinc cream if applied regularly after each pad change, but not the number of lesions. Topical skin care on dry skin found the Bag Bath/Travel Bath no-rinse skin care cleanser to be more effective at preventing overall skin dryness and most specifically flaking and scaling when compared with the traditional soap and water washing method in residents of a long-term care facility. Information on the safety of topical skin care interventions is lacking. Therefore, because of the lack of evidence, no recommendation on the safety on any intervention included in this review can be made.

A community nurse referral system for HMRs: Can it work?

The HMR model contains a mechanism whereby anyone who is concerned about the risk of medication misadventure can request a HMR from the patient's GP. Since nurses are widely involved in a range of triage and gatekeeping roles, utilising their primary care skills to identify patients for a HMR is a logical extension of this role. Furthermore, community nurses visit their clients in the home situation and see many difficulties the client may be experiencing at first hand. They are therefore well placed to request specialist assistance for the client. Blue Care in Brisbane, a community nursing service, approached its local Division of General practice to determine how best to request HMRs for its clients. The Division contacted The University of Queensland which initiated this study to engage the health care team to tailor the established HMR request process to the needs of community nurses and test the system developed. (non-author abstract)

Introduction of routine outcome measures: staff reactions and issues for consideration

The aim of this study was to explore clinician reactions to (i) the introduction of routine outcome measures and (ii) the utility of outcomes data in clinical practice. Focus group discussions (n = 34) were conducted with mental health staff (n = 324) at approximately 8 months post implementation of routine outcome measures. A semi-structured interview schedule was used to collect data on two key issues; reactions to the introduction of outcome measures and factors influencing the utility of outcomes data in clinical practice. Data from the discussion groups were analysed using content analysis to isolate emerging themes. While the majority of participants endorsed the collection and utilization of outcomes data, many raised questions about the merits of the initiative. Ambivalence, competing work demands, lack of support from senior medical staff, questionable evidence to support the use of outcome measures, and fear of how outcomes data might be used emerged as key issues. At 8 months post implementation a significant number of clinical staff remained ambivalent about the benefits of outcome measurement and had not engaged in the process. The shift to a service model driven by outcomes and case-mix data will take time and resources to achieve. Implications for nursing staff are discussed.