How to distinguish medicalization from over-medicalization?

Is medicalization always harmful? When does medicine overstep its proper boundaries? The aim of this article is to outline the pragmatic criteria for distinguishing between medicalization and over-medicalization. The consequences of considering a phenomenon to be a medical problem may take radically different forms depending on whether the problem in question is correctly or incorrectly perceived as a medical issue. Neither indiscriminate acceptance of medicalization of subsequent areas of human existence, nor criticizing new medicalization cases just because they are medicalization can be justified. The article: (i) identifies various consequences of both well-founded medicalization and over-medicalization; (ii) demonstrates that the issue of defining appropriate limits of medicine cannot be solved by creating an optimum model of health; (iii) proposes four guiding questions to help distinguish medicalization from over-medicalization. The article should foster a normative analysis of the phenomenon of medicalization and contribute to the bioethical reflection on the boundaries of medicine.

Analysing the ethics of breast cancer overdiagnosis: a pathogenic vulnerability.

Breast cancer screening aims to help women by early identification and treatment of cancers that might otherwise be life-threatening. However, breast cancer screening also leads to the detection of some cancers that, if left undetected and untreated, would not have damaged the health of the women concerned. At the time of diagnosis, harmless cancers cannot be identified as non-threatening, therefore women are offered invasive breast cancer treatment. This phenomenon of identifying (and treating) non-harmful cancers is called overdiagnosis. Overdiagnosis is morally problematic as it leads to overall patient harm rather than benefit. Further, breast cancer screening is offered in a context that exaggerates cancer risk and screening benefit, minimises risk of harm and impedes informed choice. These factors combine to create pathogenic vulnerability. That is, breast cancer screening exacerbates rather than reduces women's vulnerability and undermines women's agency. This paper provides an original way of conceptualising agency-supporting responses to the harms of breast cancer overdiagnosis through application of the concept of pathogenic vulnerability.

Left Of Bang Interventions in Trauma: ethical implications for military medical prophylaxis.

Advances in medical capability should be accompanied by discussion of their ethical implications. In the military medical context there is a growing interest in developing prophylactic interventions that will mitigate the effects of trauma and improve survival. The ethics of this novel capability are currently unexplored. This paper describes the concept of trauma prophylaxis (Left Of Bang Interventions in Trauma) and outlines some of the ethical issues that need to be considered, including within concept development, research and implementation. Trauma prophylaxis can be divided into interventions that do not (type 1) and those that do (type 2) have medical enhancement as an unintended side effect of their prophylactic action. We conclude that type 1 interventions have much in common with established military medical prophylaxis, and the potentially enhancing qualities of type 2 interventions raise different issues. We welcome further debate on both interventions.

On the personal utility of Alzheimer's disease-related biomarker testing in the research context.

Many healthy volunteers choose to take part in Alzheimer's disease (AD) prevention studies because they want to know whether they will develop dementia-and what they can do to reduce their risk-and are therefore interested in learning the results of AD biomarker tests. Proponents of AD biomarker disclosure often refer to the personal utility of AD biomarkers, claiming that research participants will be able to use AD biomarker information for personal purposes, such as planning ahead or making important life decisions. In this paper, the claim that AD biomarkers have personal utility for asymptomatic individuals is critically assessed. It demonstrates that in the absence of clinical validity, AD biomarkers cannot have personal utility and do not serve research participants' autonomy. Over the next few years, many research groups will be confronted with participants' preferences to learn the results of AD biomarker tests. When researchers choose to make results available upon explicit request, they should ensure adequate information provision and education, notably on the uncertain clinical significance of AD biomarker information. Routine disclosure of AD biomarkers to cognitively unimpaired individuals in research settings cannot be justified with an appeal to the personal utility of AD biomarker information.

A mobile revolution for healthcare? Setting the agenda for bioethics.

Mobile health (mHealth) is rapidly being implemented and changing our ways of doing, understanding and organising healthcare. mHealth includes wearable devices as well as apps that track fitness, offer wellness programmes or provide tools to manage chronic conditions. According to industry and policy makers, these systems offer efficient and cost-effective solutions for disease prevention and self-management. While this development raises many ethically relevant questions, so far mHealth has received only little attention in medical ethics. This paper provides an overview of bioethical issues raised by mHealth and aims to draw scholarly attention to the ethical significance of its promises and challenges. We show that the overly positive promises of mHealth need to be nuanced and their desirability critically assessed. Finally, we offer suggestions to bioethicists to engage with this emerging trend in healthcare to develop mHealth to its best potential in a morally sound way.

The Ethics of General Population Preventive Genomic Sequencing: Rights and Social Justice.

Advances in DNA sequencing technology open new possibilities for public health genomics, especially in the form of general population preventive genomic sequencing (PGS). Such screening programs would sit at the intersection of public health and preventive health care, and thereby at once invite and resist the use of clinical ethics and public health ethics frameworks. Despite their differences, these ethics frameworks traditionally share a central concern for individual rights. We examine two putative individual rights-the right not to know, and the child's right to an open future-frequently invoked in discussions of predictive genetic testing, in order to explore their potential contribution to evaluating this new practice. Ultimately, we conclude that traditional clinical and public health ethics frameworks, and these two rights in particular, should be complemented by a social justice perspective in order adequately to characterize the ethical dimensions of general population PGS programs.

[Exists an Obligation to be Healthy? Ethical Limits of Medical Prevention]. / Gibt es eine Pflicht zur Gesundheit? Zu den ethischen Grenzen medizinischer Prävention.

An obligation to be healthy in the sauce of a categorical imperative "You shall change your life!" (P. Sloterdijk) does not exist. There is however a moral responsibility to shape ones own life in such a way that the resulting potentials for development can be realized within one owns possibilities (I. Kant). The example of predictive medicine illustrates, why the right not to know can be a responsible way of self governance when dealing with the knowledge of modern biomedicine. This allows the setting of limits within prevention, which preserve the quality of life of the exposed as well as enabling the individual the "acceptance of self" (R. Guardini).

Participant selection for preventive Regenerative Medicine trials: ethical challenges of selecting individuals at risk.

The innovative field of Regenerative Medicine (RM) is expected to extend the possibilities of prevention or early treatment in healthcare. Increasingly, clinical trials will be developed for people at risk of disease to investigate these RM interventions. These individuals at risk are characterised by their susceptibility for developing clinically manifest disease in future due to the existence of degenerative abnormalities. So far, there has been little debate about the ethical appropriateness of including such individuals at risk in clinical trials. We discuss three main challenges of selecting this participant model for testing RM interventions: the challenge of achieving a proportional risk-benefit balance; complexities in the trial design in terms of follow-up and sample size; and the difficulty of obtaining informed consent due to the many uncertainties. We conclude that selecting the model is not ethically justifiable for first-in-man trials with RM interventions due to the high risks and uncertainties. However, the model can be ethically appropriate for testing the efficacy of RM interventions under the following conditions: interventions should be low risk; the degenerative abnormalities (and other risk factors) should be strongly related with disease within a short time frame; robust preclinical evidence of efficacy needs to be present; and the informed consent procedure should contain extra safeguards with regard to communication on uncertainties.

["Emergency measures"]. / "Les mesures d'urgence".

This article deals with the impact of health crisis on governance of public health. It tries to show that, in accordance with the thought of Michel Foucault, emergency measures issued during health crisis are akin to those issued during wartime.

The perils of the imperfect expectation of the perfect baby.

Advances in modern medicine invite the assumption that medicine can control human biology. There is a perilous logic that leads from expectations of medicine's control over reproductive biology to the expectation of having a perfect baby. This article proposes that obstetricians should take a preventive ethics approach to the care of pregnant women with expectations for a perfect baby. We use Nathaniel Hawthorne's classic short story, "The Birthmark," to illustrate the perils of the logic of control and perfection through science and then identify possible contemporary sources of the expectation of the perfect baby. We propose that the informed consent process should be used as a preventive ethics tool throughout the course of pregnancy to educate pregnant women about the inherent errors of human reproduction, the highly variable clinical outcomes of these errors, the limited capacity of medicine to detect these errors, and the even more limited capacity to correct them.

Twentieth-century science education and 21st-century genetic engineering technologies: A toxic mix.

I challenge the "convenient consensus" that He Jiankui is a "bad apple" in order to consider alternative explanations for why He may have ventured down the ill-considered path in his research that he did. The answer I want to proffer is that He was ill-equipped by his education and training in biomedical research to appropriately weigh the competing goods he encountered and thus was not able to be swayed by the clear guidance that basic ethical considerations would have provided. If true, this shows us why, much as we would like to take solace in him being a bad apple, we should be prompted by this episode to focus instead on systems level contributors to He's decisions that, if left unaddressed, will surely lead to similarly reckless episodes by other researchers in the future.

Integrating anticipated nutrigenomics bioscience applications with ethical aspects.

Nutrigenomics is a subspecialty of nutrition science which aims to understand how gene-diet interactions influence individuals' response to food, disease susceptibility, and population health. Yet ethical enquiry into this field is being outpaced by nutrigenomics bioscience. The ethical issues surrounding nutrigenomics face the challenges of a rapidly evolving field which bring forward the additional dimension of crossdisciplinary integrative research between social and biomedical sciences. This article outlines the emerging nutrigenomics definitions and concepts and analyzes the existing ethics literature concerning personalized nutrition and presents "points to consider" over ethical issues regarding future nutrigenomics applications. The interest in nutrigenomics coincides with a shift in emphasis in medicine and biosciences toward prevention of future disease susceptibilities rather than treatment of already established disease. Hence, unique ethical issues emerge concerning the extent to which nutrigenomics can alter our relation to food, boundaries between health and disease, and the folklore of medical practice. Nutrigenomics can result in new social values, norms, and responsibilities for both individuals and societies. Nutrigenomics is not only another new application of "-omics" technologies in the context of gene-diet interactions. Nutrigenomics may fundamentally change the way we perceive human illness while shifting the focus and broadening the scope of health interventions from patients to healthy individuals. In resource- and time-limited healthcare settings, this creates unique ethical dilemmas and distributive justice issues. Ethical aspects of nutrigenomics applications should be addressed proactively, as this new science develops and increasingly coalesces with other applications of genomics in medicine and public health.

[Defining an ethics for preventive trials]. / Quelle éthique pour les essais de prévention?

Preventive trials (to prevent from infection) or prophylaxis trials (to avoid consequences of the disease) differ from other clinical trials as they apply to healthy subjects or subjects considering themselves as such: the latter do not ask for intervention even less for trial. Moreover, it is generally an experiment which aims at validating a public health intervention, the individual character of which could appear as secondary regarding the collective interest. It concerns many tools or methods: preventive or prophylactic vaccines and drugs, condoms, impregnated bed nets, etc. The field of implementation of preventive trials is large and covers routine immunization (EPI), large-scale control or eradication of endemic diseases or epidemics, for which the concept of individual risk is generally better understood. Preventive trials imply ethical obligations (high individual or collective benefits and absence of risks as there is no immediate therapeutic compensation), methodological adaptations (because the number of subjects is considerably larger than for therapeutic trials) and a sensitive valorization towards a large population who is not asking for the recommended intervention. As regard the benefits, it is also necessary to consider the costs in comparison with the expected efficacy The methodological constraints are important because the demonstration of both safety and efficacy requires a very large number of subjects to validate the product. It is often necessary to use indirect or substitutive markers and indicators (title of protective antibodies rather than definite clinical protection) which need a preliminary validation. Before carrying out a preventive or prophylactic trial, it is advisable to specify the objectives in order to assess the real profits and absence of risks during the trial and after the implementation of the tested product. Preventive trials require a phase of technological transfer to guarantee the application of the validated tools for the benefit of the population at stake. In this respect, if trials for prevention are now well codified both on ethical and methodological aspects, trials for prophylaxis (filariasis with ivermectin, schistosomiasis with praziquantel, malaria with intermittent "preventive" treatment or HIV with antiretroviral treatment, for example) still remain a difficult issue at both ethical and methodological levels.

Preventive misconception: its nature, presence, and ethical implications for research.

BACKGROUND: Ethical aspects of prevention trials, as they differ from therapeutic trials, have not been fully explored. This article aims to define and demonstrate the existence of "preventive misconception" (PM), a misunderstanding in which research participants in prevention trials make an "overestimate in probability or level of personal protection that is afforded by being enrolled in a trial of a preventive intervention." METHODS: A rating tool was developed to evaluate PM, using data collected between August 2000 and July 2002 as part of a nationwide study of the quality of informed consent in a trial of a shingles vaccine. During 2005-2006, two pair of raters assessed the responses of 50 participants to questions asked after the participants had given consent to participate in the shingles trial. Two pair of raters evaluated the response for the presence and type of PM. Each pair of raters adjudicated their responses and inter-rater reliability was assessed. RESULTS: Adjudicated pairs of raters agreed that 32% (CI: 20.7%-45.9%) of participants showed evidence of PM (kappa=0.71, CI: 0.52-0.90); that 12% (CI: 5.2%-24.2%) of participants underestimated the probability of receiving placebo (kappa=0.53, CI: 0.24-0.83); and that 24% (CI: 14.2%-37.6%) overestimated the likely personal effectiveness of the experimental intervention (kappa=0.42, CI: 0.08-0.76). CONCLUSIONS: This study newly describes the concept of preventive misconception and empirically demonstrates its existence in trials of prevention. Study participants may overestimate the protection that they receive by being enrolled in a trial of prevention, which poses ethical challenges for research.

Prevention in Halakhah.

Preventive medicine is taking an increasingly central place in modern clinical practice, at least in primary care. What, if anything, does the Jewish rabbinic tradition have to say about keeping healthy? The delayed response of contemporary rabbis to the dangers of smoking, in particular, raises questions about the underlying principles that Halakhah employs to approach health promotion. As is often the case in Halakhah, we may detect different streams of thought in the classical sources, which may be felt in the way contemporary issues are handled. Three approaches will be discussed. First, Maimonides, famous for the practical preventive approach in his medical writings, makes his philosophy clear both in his halakhic works and in his Guide for the Perplexed. For him, a healthy body is a prerequisite for a healthy soul. We must be free of physical suffering in order to be able to do the work of perfecting our souls. Second, the view that health is the reward for goodness and illness a punishment for sin as expounded or implied in the writings of Nahmanides, and of Ibn Ezra: the way to good health is to lead a good life. Third, an early midrashic source picked up again much later by Rabbi Israel Meir Kagan (the Hafetz Hayim) gives the argument from custodianship--since the body is divine property we have a duty to look after it well. So for Maimonides there is a prior duty to keep healthy, while for Nahmanides the prior requirement is to repent of sin. For the Hafetz Hayim, keeping the body healthy is an independent duty in its own right. These then are the differences in basic approach that may affect the emphases that different rabbis today place on health maintenance and promotion.

[Ethical and practical problems of secondary prevention. Two paediatrics examples]. / Problemas prácticos y éticos de la prevención secundaria. A propósito de dos ejemplos en pediatría.

The concept of prevention is surrounded by a halo of optimism that can sometimes confuse, since it is not always borne out by the facts. The saying, "An ounce of prevention is worth a pound of cure", is not always true. Moreover, preventive activities should be based on a much more solid scientific basis than curative activities, since we offer the former as an option, whereas we are required to provide the latter. This article reviews two examples of paediatric screening instruments-one for neuroblastoma, and the other for hip dysplasia-which provide an opportunity to evaluate the practical problems of secondary prevention. These two instruments are used to examine a few general but important issues in screening, such as the need to know the natural history of the disease, and the "point of no return" (the moment past which early diagnosis and early intervention are no longer so effective in improving the course of the disease). In conclusion, only sometimes "an ounce of cure is worth a pound of prevention", and regardless of the value of a given screening instrument, clinicians should use the same level of scientific rigor to judge preventive activities as they use for curative activities.