Complementary medicines advertising policy Part II: unethical conduct in the Australian market after July 2018.

Objective To assess the effects of Australian complementary medicines advertising policy after major changes in 2018. These included a legally enforceable advertising code, stronger investigative and compliance powers for the Therapeutic Goods Administration (TGA) and enhanced educational resources for industry. Methods Analysis of the TGA complaint outcome database from 1 July 2018 to 30 June 2019 and the new regulatory measures. Results Of 1821 complaint records analysed, 92% were classified as low priority and closed by sending the advertiser a Regulatory Obligation letter. For low priority complaints, no details of the product, advertiser or alleged Code violation were published, and no follow-up was undertaken. Of 121 higher priority complaints, 79% failed to meet their key performance indicator (KPI) time to closure (60-90 days). These included complaints about dangerous sports supplements and ineffective weight loss and hangover products, some of which had been submitted in July 2018. Conclusions Complaint classification and actions taken by the TGA were inconsistent. The TGA's new compliance powers were rarely applied. The new complaint system is less transparent than the one it replaced. There is a high rate of advertising complaints and a low rate of effective regulatory response. Time-based KPIs should be based on outcome measures, not when a case is closed by a process measure. An urgent review of the new system is required. Comment on Australia's 2018 Royal Commission into Misconduct in Banking is equally applicable to the TGA: 'Essentially a failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that.' It also encourages others to break the law, leading to a race to the bottom and consumer detriment. What is known about the topic? The previous co-regulatory system for complementary medicines was the subject of long-standing criticism and high levels of regulatory non-compliance. The new system, operated solely by the TGA, was meant to overcome these problems. What does this paper add? High levels of advertising complaints persist. The TGA was unable to close many higher-priority complaints within the time frame set by its KPIs. These complaints involved serious breaches of the Therapeutic Goods Act 1989 (Cwlth), which can attract both civil and (strict liability) criminal penalties. However, in most cases compliance was achieved by negotiation. The TGA met its KPIs for virtually all complaints it classified as low priority because these were closed by merely sending an obligations letter with no follow-up. What are the implications for practitioners? The persisting high levels of regulatory violation mean that practitioners cannot trust the claims made for complementary medicines or give good advice. In addition, consumers are wasting their money on useless products and are diverted from seeking more evidence-based remedies.

How Do We Combat Bogus Medicines in the Age of the COVID-19 Pandemic?

The COVID-19 pandemic has brought concurrent challenges. The increased incidence of fake and falsified product distribution is one of these problems with tremendous impact, especially in low- and middle-income countries. Up to a tenth of medicines including antibiotics and antimalarial drugs in the African market are considered falsified. Pandemics make this worse by creating an ecosystem of confusion, distraction, and vulnerability stemming from the pandemic as health systems become more stressed and the workload of individuals increased. These environments create opportunities for substandard and falsified medicines to be more easily introduced into the marketplace by unscrupulous operators. In this work we discuss some of the challenges with fake or falsified product distribution in the context of COVID-19 and proposed strategies to best manage this problem.

Mind the Information Gap: Quantifying the Courts' Role in Responding to Patient Harm, 1989 to 2013.

An empirical critique of Australia's medical indemnity crisis challenges assumptions about the role of the courts through determination of civil liability for medical negligence, occupational discipline and criminal liability. Courts were identified as a cause of a crisis in the 2000s that triggered extensive legislative reform of medical negligence law, absent adequate empirical data substantiating either criticisms of the courts or supporting the reforms. Changes to the occupational discipline framework for health practitioners were less controversial but have resulted in increasingly legalistic responses. Using a detailed longitudinal analysis across all jurisdictions this article examines the role of the courts in responding to patient harm across the relevant 25-year period encompassing these reforms, to determine whether the courts did cause the medical indemnity crisis, what effect the reforms had and what other roles the courts play in responding to patient harm.

Direct to consumer genetic testing and the libertarian right to test.

Loi recently proposed a libertarian right to direct to consumer genetic testing (DTCGT)- independent of autonomy or utility-reflecting Cohen's work on self-ownership and Hohfeld's model of jural relations. Cohen's model of libertarianism dealt principally with self-ownership of the physical body. Although Loi adequately accounts for the physical properties of DNA, DNA is also an informational substrate, highly conserved within families. Information about the genome of relatives of the person undergoing testing may be extrapolated without requiring direct engagement with their personal physical copy of the genome, triggering rights and interests of relatives that may differ from the rights and interests of others, that is, individual consumers, testing providers and regulators. Loi argued that regulatory interference with exercise of the right required justification, whereas prima facie exercise of the right did not. Justification of regulatory interference could include 'conflict with other people's rights', 'aggressive' use of the genome and 'harming others'. Harms potentially experienced by relatives as a result of the individual's exercise of a right to test include breach of genetic privacy, violation of their right to determine when, and if, they undertake genetic testing and discrimination. Such harms may justify regulatory intervention, in the event they are recognised; motives driving 'aggressive' use of the genome may also be relevant. Each of the above criteria requires clarification, as potential redundancies and tensions exist between them, with different implications affecting different groups of rights holders.

Beyond the corporeal: Extending propertisation of body parts to derivative information.

Jurisprudential consideration of property in the human body has typically conceptualised it as tangible, of finite lifespan, with limited end uses. This article offers an alternative conceptualisation: the body as information--intangible, infinite, and perpetual. Global markets in health "big data"--including population genomic data--trade this information. Emerging jurisprudence on source rights in this information are derived from jurisprudence based on the traditional, tangible, finite conceptualisation of the body--itself controversial--criticised in part for disregarding property rights vesting in the self, while recognising them in strangers. As such, it provides an uncertain foundation for extension to govern rights over derivatives, enabling disregard of legitimate concerns about health, commercialisation and genetic privacy, concerns compounded by the intergenerational nature of genetic information. A more nuanced approach, recognising that donors and strangers alike hold only weak custodial rights over access, use, and dissemination of tissues and derivative information, is required.

Physicians' Reflections on Death and Dying on Completion of a Palliative Medicine Fellowship.

CONTEXT: Patient and family dissatisfaction may result when they are not satisfied with the physician/patient interaction, although the physician may feel he/she worked hard to provide information to the patient and family. New approaches to visual analysis can (1) identify significant insights from physicians' personal and clinical experiences in providing compassionate palliative care and end-of-life care and (2) provide an effective and practical vehicle for communicating with patients, their families, and other professional caregivers. OBJECTIVES: To elucidate palliative physicians' core experiences with their patients' dying and death. METHODS: A qualitative visual analysis was conducted on 75 images created by physicians completing a one year palliative medicine fellowship. These images are part of a larger personal reflections narratives database of images, text, and auditory projects prepared by students, interns, and fellows completing training in palliative care at a large hospice provider. Participation in the personal reflections project is a required part of the training program, with the goal of blending clinical competencies with lived experiences of caring for the dying. RESULTS: Two categories of visual metaphors underlying the images were identified, with both expressing the relationship and transitional dynamics of life and death: portraits (n = 30, 40%) and nature (n = 45, 60%). Conventional images representing anxiety, pain, or other dimensions of suffering commonly associated with death and dying were virtually absent (n = 2, 0.03%). CONCLUSION: We propose the communication of positive, hopeful, even peaceful perceptions of death and dying was likely the result of effective personal and professional skills gained through physicians' clinical experiences during the fellowship.

Harnessing complex emergent metaphors for effective communication in palliative care: a multimodal perceptual analysis of hospice patients' reports of transcendence experiences.

Terminally ill patients can have unexpected, enigmatic, and profound cognitive shifts that significantly alter their perception of themselves, thereby eliminating their fear of death and dying. However, there are no systematic studies into these remarkable yet ineffable transcendence experiences. They therefore remain easily overlooked or viewed as isolated anomalies and therefore excluded from quality-of-life patient considerations. We use a multimodal methodology for identifying the prevalence and thematic properties of complex emergent metaphors patients use to report these experiences. Although previous research has pioneered the importance of understanding conventional or primary metaphors at the end of life, our findings indicate the considerable potential of more complex metaphors for reducing barriers to effective communication in palliative care.

Disclosure 'downunder': misadventures in Australian genetic privacy law.

Along with many jurisdictions, Australia is struggling with the unique issues raised by genetic information in the context of privacy laws and medical ethics. Although the consequences of disclosure of most private information are generally confined to individuals, disclosure of genetic information has far-reaching consequences, with a credible argument that genetic relatives have a right to know about potential medical conditions. In 2006, the Privacy Act was amended to permit disclosure of an individual's genetic information, without their consent, to genetic relatives, if it was to avoid or mitigate serious illness. Unfortunately, additional amendments required for operation of the disclosure amendment were overlooked. Public Interest Determinations (PIDs)-delegated legislation issued by the privacy commissioner-have, instead, been used to exempt healthcare providers from provisions which would otherwise make disclosure unlawful. This paper critiques the PIDs using documents obtained under the Freedom of Information Act-specifically the impact of both the PIDs and the disclosure amendment on patients and relatives-and confidentiality and the procedural validity of subordinate laws regulating medical privacy.

Shepherding a flock of different fleece: a historical and social analysis of the unique attributes of the African American pastoral caregiver.

Scholars researching and writing on the roles of pastor-caregivers in predominantly black congregations have done so using models originally designed to examine the roles of pastor-caregivers in primarily white churches. This study offers a revised model based on the historical development and present reality of black churches that more closely matches the historical and present roles of the black pastor who can trace his or her roots back to African spiritual traditions.

Mapping hospice patients' perception and verbal communication of end-of-life needs: an exploratory mixed methods inquiry.

BACKGROUND: Comprehensive "Total Pain" assessments of patients' end-of-life needs are critical for providing improved patient-clinician communication, assessing needs, and offering high quality palliative care. However, patients' needs-based research methodologies and findings remain highly diverse with their lack of consensus preventing optimum needs assessments and care planning. Mixed-methods is an underused yet robust "patient-based" approach for reported lived experiences to map both the incidence and prevalence of what patients perceive as important end of life needs. METHODS: Findings often include methodological artifacts and their own selection bias. Moving beyond diverse findings therefore requires revisiting methodological choices. A mixed methods research cross-sectional design is therefore used to reduce limitations inherent in both qualitative and quantitative methodologies. Audio-taped phenomenological "thinking aloud" interviews of a purposive sample of 30 hospice patients are used to identify their vocabulary for communicating perceptions of end-of-life needs. Grounded theory procedures assisted by QSR-NVivo software is then used for discovering domains of needs embedded in the interview narratives. Summary findings are translated into quantified format for presentation and analytical purposes. RESULTS: Findings from this mixed-methods feasibility study indicate patients' narratives represent 7 core domains of end-of-life needs. These are (1) time, (2) social, (3) physiological, (4) death and dying, (5) safety, (6) spirituality, (7) change & adaptation. The prevalence, rather than just the occurrence, of patients' reported needs provides further insight into their relative importance. CONCLUSION: Patients' perceptions of end-of-life needs are multidimensional, often ambiguous and uncertain. Mixed methodology appears to hold considerable promise for unpacking both the occurrence and prevalence of cognitive structures represented by verbal encoding that constitute patients' narratives. Communication is a key currency for delivering optimal palliative care. Therefore understanding the domains of needs that emerge from patient-based vocabularies indicate potential for: (1) developing more comprehensive clinical-patient needs assessment tools; (2) improved patient-clinician communication; and (3) moving toward a theoretical model of human needs that can emerge at the end of life.