Access to new cancer medicines in Australia: dispelling the myths and informing a public debate

Despite the high level of spending on cancer medicines in Australia, consumer organisations and the pharmaceutical industry often make claims of delayed or lack of access to new cancer medicines—claims that are frequently supported by prominent coverage in the Australian media. These claims, while morally and psychologically compelling, tend to ignore the complexity of medicines funding decisions. In this commentary we summarise the current situation regarding the registration and funding of cancer medicines in Australia, elucidate the main challenges associated with access to cancer medicines in the Australian context, and describe some of the steps that have been taken to address these challenges. Keywords: Cancer medicines, Funding, High prices, Consumer engagement, Transparency, Public debateNHMRC project grant, App 108067

Financial motives drive some doctors’ decisions to offer IVF

Around one in 25 Australian babies are conceived using assisted reproductive technologies (ART), including in-vitro fertilisation (IVF). These interventions are almost all offered in private fertility clinics, backed by a thriving fertility industry. Women who are deemed eligible for IVF can have an unlimited number of cycles subsidised by Medicare, but out-of–pocket costs can range from several hundred to several thousand dollars per cycle. Our research, published today in the journal Human Fertility, suggests the money being made from IVF could be subtly changing the advice doctors give. Informed consent Although IVF is a well-established procedure, it is not without its risks. These include ovarian hyperstimulation syndrome, where hormone levels rise too much (causing abdominal swelling, nausea, vomiting and diarrhoea); obstetric complications such as premature delivery; and psychological distress, especially if the process fails. Although long-term outcomes for children conceived using IVF appear to be similar to non-IVF children, questions remain about possible harmful impacts, including developmental abnormalities and cancer. Given the financial, physical and psychological burdens of IVF, patients must be able to make informed decisions about whether to pursue these treatments in the first place, and when to stop. So it’s concerning that couples are often oversold the likelihood of success

Ethics as an act of listening

Over the past fifty years concerns regarding ethical and human rights abuses arising from biomedical research have led to the establishment of sophisticated processes for ethical oversight of research and to increasing regulation of many aspects of the research endeavour. Research using human tissue collections (tissue banking research) is no exception, with evermore stringent regulations emerging in response to concerns about consent, privacy and commercialisation. These measures are perfectly compatible with central bioethical concerns such as the need to ensure autonomy and the right to control one’s body and personal information, and the need to protect vulnerable research subjects from harm. So why, one might ask, are scientists so resentful of these regulations and so concerned about their potential adverse impact (e.g. Furness 2004)? Does this mean that the scientific community is dangerously insensitive to the public’s mistrust and desire for autonomy? Or are they more aware of public values? It is possible to theorise endlessly about such matters, but at some point it is necessary to carry out empirical research into public attitudes and values. While the ‘empirical turn’ in bioethics has its limitations and is primarily descriptive, rather than normative (Sugarman 2004), as Chandros Hull et al remind us, if bioethics does not accurately reflect community values may impede science and misrepresent the needs of “vulnerable” populations

An empirical reappraisal of public trust in biobanking research: rethinking restrictive consent requirements

Collections of human tissue removed from patients in the course of medical diagnosis or therapy are believed to be an increasingly important resource for medical research (biobank research). As a result of a number of tissue-related "scandals" and increasing concern about ownership and privacy, the requirements to obtain consent from tissue donors are becoming increasingly stringent. The authors' data show that members of the general public perceive academic biobank researchers and their institutions to be highly trustworthy and do not see the need for recurrent, project-specific consent. They argue, on the basis of their empirical findings, that we should question the trend, at least in some settings, toward ever more stringent consent requirements for the use of tissue in research. They argue that this approach, while perhaps counterintuitive in the current regulatory environment, can be both ethically and legally sound so long as channels of communication are maintained and third-party relationships are tightly controlled

Don’t dismiss conflict-of-interest concerns in IVF, they have a basis

It’s estimated over 5 million children have been born worldwide as a result of assisted reproductive technology treatments. Assisted reproductive technology, an umbrella term that includes in vitro fertilisation (IVF), is a highly profitable global industry, and fertility clinics are increasingly regarded as an attractive investment option. In 2014, two major IVF clinics - Virtus and Monash IVF — floated on the stock exchange. Excited financial analysts observed at the time that: people will pay almost anything to have a baby. Over the past 12 months, there have been numerous critical media analyses of the IVF industry in Australia, including Monday night’s ABC Four Corners program, The Baby Business. The episode suggested IVF doctors are recommending treatments that are expensive, unsafe and likely to be futile. The following morning the Fertility Society of Australia rejected these assertions, saying: Four Corners presented no evidence to support these claims. One of the claims made in the program was that IVF doctors have a financial incentive to treat women with the more invasive practice of IVF. The program suggested this financial incentive conflicts with the doctor’s duty of care towards the patient. Four Corners highlighted the conflicted nature of commercialised IVF, where some IVF doctors are more concerned about their own interests (making money for themselves or their clinics) than they are about their patients. Not surprisingly, the Fertility Society of Australia strongly denied such conflicts of interest exist. It argued that the profession is both highly ethical and highly regulated

The Medical Innovation Bill: Still more harm than good

The Medical Innovation Bill continues its journey through Parliament. On 23 January 2015, it was debated for the final time in the House of Lords and with one final amendment, the House moved to support the Bill, which then moved to the House of Commons on 26 January. It will be debated again on 27 February 2015. The Bill’s purpose is to encourage responsible innovation in medical treatment. Although this goal is laudable, it is argued that the Bill is unnecessary and has the potential to undermine the very cause it aims to advance. More useful for encouraging responsible innovation is the continued education of health-care professionals on how the law already supports practitioners who look to improve care through responsible innovation

Is Gly16Arg β₂ Receptor Polymorphism Related to Impulse Oscillometry in a Real-Life Asthma Clinic Setting?

PURPOSE: We evaluated whether Gly16Arg beta2-receptor genotype relates to impulse oscillometry (IOS) in a real-life clinic setting. METHODS: Patients with persistent asthma taking inhaled corticosteroid ± long-acting beta-agonist (ICS ± LABA) were evaluated. We compared genotype groups comprising either no Arg copies (i.e. GlyGly) versus one or two Arg copies (i.e. ArgArg or ArgGly). IOS outcomes included total airway resistance at 5 Hz (R5), central airway resistance at 20 Hz (R20), peripheral airway resistance (R5–R20), reactance at 5 Hz, area under reactance curve (AX) and resonant frequency (RF). In addition, we recorded ACQ-5 and salbutamol use. RESULTS: One hundred and twelve ICS-treated asthmatic patients (mean ICS dose 1238 µg/day), mean age 43 years, ACQ 2.34, FEV1 82 %, R5 177 % were identified—89 were also taking LABA. 61 patients were GlyGly, while 14 were ArgArg and 37 were ArgGly. There were no significant differences in IOS outcomes, ACQ or salbutamol use between the genotypes. The allelic risk (as odds ratio) for less well-controlled asthma (as ACQ > 1.5) was 1.1 (95 % CI 0.72–1.68) in relation to each Arg copy with a corresponding odds ratio for abnormal R5–R20 > 0.07kPA/l.s being 0.91 (95 % CI 0.57–1.44). 71 % of patients had an ACQ > 1.5 in the GlyGly group, versus 67 % in GlyArg/ArgArg group, with corresponding figures for abnormal R5–R20 > 0.07 kPa/l.s being 69 versus 73 %. CONCLUSION: In a real-life clinic setting for patients with poorly controlled persistent asthma taking ICS ± LABA, we found no evidence of any relationship of Gly16Arg to IOS, ACQ or salbutamol use

Cancer As Rubbish: Donation of tumor tissue for research.

Tissue banking (or biobanking), thought by many to be an essential form of medical research, has raised a number of ethical issues that highlight a need to understand the beliefs and values of tissue donors, including the motivations underlying consent or refusal to donate. Data from our qualitative study of the legal, social and ethical issues surrounding tumor banking in New South Wales, Australia, shows that participants’ attitudes to donation of tumor tissue for research are partially captured by theories of weak altruism and social exchange. However, we argue that the psychological rewards of value transformation described by Thompson’s rubbish theory provide additional insights into participants’ attitudes to tumor donation. We believe our data provides sufficient justification for an approach to regulation of tumor banking that is aimed at fostering a relationship based on the notions of virtuous reassignment and social exchange. Keywords Ethics; genetics; research participation; risk perceptionsUniversity of Sydney Cancer Research Fun

Views of health journalists, industry employees and news consumers about disclosure and regulation of industry-journalist relationships: An empirical ethical study

Bioethicists and policymakers are increasingly concerned about the effects on health journalism of relationships between journalists and private corporations. The concern is that relationships between journalists and manufacturers of medicines, medical devices, complementary medicines, and food can and do distort health reporting. This is a problem because health news is known to have a major impact on the public’s health-related expectations and behaviour. Commentators have proposed two related approaches to protecting the public from potential harms arising from industry-journalist interactions: greater transparency and external regulation. To date, few empirical studies have examined stakeholders’ views of industry-journalist relationships and how these should be managed. We conducted interviews with 13 journalists and 12 industry employees, and two focus groups with consumers. Our findings, which are synthesised here, provide empirical support for the need for greater transparency and regulation of industry-journalist relationships. Our findings also highlight several likely barriers to instituting such measures, which will need to be overcome if transparency and regulation are to be accepted by stakeholder and have their intended effect on both the quality of journalism and the actions of news consumers.NHMR