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Worse than the Disease: Pitfalls of Medical Progress
... 4 This exclusive concern with clinical issues can be seen by the following brief summary of topics considered of interest to bioethics. The subject matter and questions asked are an extension of the biomedical definition and control of health, which include such issues as: the stress of diagnostic technology (Best, 1987;Daly, 1989;Green et al., 1993;Kearsley and Hirst, 1991;King, 1987;Lazarus and Leeder, 1989;Lerman et al., 1991;Lowe, 1989;Taylor, 1986;Walker et al., 1989), the use of drugs (Dutton, 1988;Kessler, 1991;Klein, 1992;McGrath, 1992;McGrath, 1993;McGrath and Kearsley, 1995;, the permanent vegetative state (King, 1987), artificial hearts (Dutton, 1988), genetic engineering (Dutton, 1988), Invitro Fertilisation (Donchin, 1989;Dunstan and Shinebourne, 1989;Lorber, 1989; defining death (Thomson, 1982) experimentation (Coney, 1988;Johnstone, 1994;Jones, 1989), transplantation (Johnstone, 1994;Shaw et al., 1991;Teo, 1991) technologised neonatal care (Dunstan and Shinebourne, 1989) Intensive Care Units (Fairman, 1992;Dunstan and Shinebourne, 1989;, the excessive costs of technology (King, 1987;Leeder, 1989;Lowe, 1989;Melski, 1992;Rutten and Bonsel, 1992;Williams, 1992) and treatment refusals or withdrawing treatment (Emanuel et. al., 1991;Edwards and Tolle, 1993;Evans and Brody, 1985;Devereux, Jones and Dickenson, 1993;Fisher and Raper, 1990;Johnstone, 1994;Kliever, 1989;Mclnerney, 1992;Sabatino, 1993;Scofield, 1991a;Tomlinson and Brody, 1988). ...
... 4 This exclusive concern with clinical issues can be seen by the following brief summary of topics considered of interest to bioethics. The subject matter and questions asked are an extension of the biomedical definition and control of health, which include such issues as: the stress of diagnostic technology (Best, 1987;Daly, 1989;Green et al., 1993;Kearsley and Hirst, 1991;King, 1987;Lazarus and Leeder, 1989;Lerman et al., 1991;Lowe, 1989;Taylor, 1986;Walker et al., 1989), the use of drugs (Dutton, 1988;Kessler, 1991;Klein, 1992;McGrath, 1992;McGrath, 1993;McGrath and Kearsley, 1995;, the permanent vegetative state (King, 1987), artificial hearts (Dutton, 1988), genetic engineering (Dutton, 1988), Invitro Fertilisation (Donchin, 1989;Dunstan and Shinebourne, 1989;Lorber, 1989; defining death (Thomson, 1982) experimentation (Coney, 1988;Johnstone, 1994;Jones, 1989), transplantation (Johnstone, 1994;Shaw et al., 1991;Teo, 1991) technologised neonatal care (Dunstan and Shinebourne, 1989) Intensive Care Units (Fairman, 1992;Dunstan and Shinebourne, 1989;, the excessive costs of technology (King, 1987;Leeder, 1989;Lowe, 1989;Melski, 1992;Rutten and Bonsel, 1992;Williams, 1992) and treatment refusals or withdrawing treatment (Emanuel et. al., 1991;Edwards and Tolle, 1993;Evans and Brody, 1985;Devereux, Jones and Dickenson, 1993;Fisher and Raper, 1990;Johnstone, 1994;Kliever, 1989;Mclnerney, 1992;Sabatino, 1993;Scofield, 1991a;Tomlinson and Brody, 1988). ...
... 4 This exclusive concern with clinical issues can be seen by the following brief summary of topics considered of interest to bioethics. The subject matter and questions asked are an extension of the biomedical definition and control of health, which include such issues as: the stress of diagnostic technology (Best, 1987;Daly, 1989;Green et al., 1993;Kearsley and Hirst, 1991;King, 1987;Lazarus and Leeder, 1989;Lerman et al., 1991;Lowe, 1989;Taylor, 1986;Walker et al., 1989), the use of drugs (Dutton, 1988;Kessler, 1991;Klein, 1992;McGrath, 1992;McGrath, 1993;McGrath and Kearsley, 1995;, the permanent vegetative state (King, 1987), artificial hearts (Dutton, 1988), genetic engineering (Dutton, 1988), Invitro Fertilisation (Donchin, 1989;Dunstan and Shinebourne, 1989;Lorber, 1989; defining death (Thomson, 1982) experimentation (Coney, 1988;Johnstone, 1994;Jones, 1989), transplantation (Johnstone, 1994;Shaw et al., 1991;Teo, 1991) technologised neonatal care (Dunstan and Shinebourne, 1989) Intensive Care Units (Fairman, 1992;Dunstan and Shinebourne, 1989;, the excessive costs of technology (King, 1987;Leeder, 1989;Lowe, 1989;Melski, 1992;Rutten and Bonsel, 1992;Williams, 1992) and treatment refusals or withdrawing treatment (Emanuel et. al., 1991;Edwards and Tolle, 1993;Evans and Brody, 1985;Devereux, Jones and Dickenson, 1993;Fisher and Raper, 1990;Johnstone, 1994;Kliever, 1989;Mclnerney, 1992;Sabatino, 1993;Scofield, 1991a;Tomlinson and Brody, 1988). ...
First published in 1997, this book contributes to our understanding of the way our society responds to issues of death and dying. The trans-disciplinary research which informs this discussion is situated in the disciplines of bioethics and palliative care. Postmodern notions of discourse and power are used to explore the organizational approach of one hospice (Karuna Hospice Service) to working with the dying. In modern, Western technological societies, biomedicine is the dominant discourse which underpins our care of the terminally ill. Bioethics has recently emerged as a discipline concerned with resolving the many ethical dilemmas arising from such a physiological, technologized approach to death. Rather than add to such studies, this research looks into the direction of alternative ways of responding to the dying in our community. KHS was chosen for this research as it presented the possibility of a holistic and spiritual alternative to the positivist, reductionist hegemony of scientific medicine. The research focus is on establishing and describing this difference, and exploring how such an organization could maintain resistance to mainstream medicine. The research findings are shared with the intent of using the material and insights gained to explore important issues presently arising in bioethics and palliative care, for example the recent critique of Principalism in bioethics and the methodological difficulties restricting research into spirituality for palliative care.
... At the same time, they may worry about encouraging the rapid diffusion of potentially ineffective or harmful interventions, and preventing recruitment to research already under way, by providing premature favorable recommendations for their use. The adverse consequences of recommendations to use diethylstilbestrol for the prevention of miscarriage [29] [30] highlight the risk of premature favorable recommendations (risks in the children of clear cell adenocarcinoma of the vagina and cervix, breast cancer, reproductive tract anomalies, infertility, and undescended testicles). When interventions have a large component of fixed costs such as equipment or facilities, an additional problem with premature recommendations in favor of an intervention is the risk of irretrievable allocation of resources that would be better spent elsewhere. ...
... At the same time, they may worry about encouraging the rapid diffusion of potentially ineffective or harmful interventions, and preventing recruitment to research already under way, by providing premature favorable recommendations for their use. The adverse consequences of recommendations to use diethylstilbestrol for the prevention of miscarriage [29,30] highlight the risk of premature favorable recommendations (risks in the children of clear cell adenocarcinoma of the vagina and cervix, breast cancer, reproductive tract anomalies, infertility, and undescended testicles). When interventions have a large component of fixed costs such as equipment or facilities, an additional problem with premature recommendations in favor of an intervention is the risk of irretrievable allocation of resources that would be better spent elsewhere. ...
... Udgangspunktet og begrundelsen for forskningsetiske overvejelser er først og fremmest at undgå, at deltagere i forskningsprojekter lider nogen former for fysisk eller psykisk overlast ved at deltage. Forskningslitteraturen om forskningsetik er nemlig fyldt med chokerende eksempler på massive kraenkelser af menneskerettigheder i videnskabens navn, som – blot for at naevne et par enkelte – The Tuskegee Syphilis Experiment (1932 – 1972), hvor mere end 400 maend smittet med syfilis forblev ubehandlede , så man kunne undersøge langtidsvirkningerne af sygdommen (Shamoo & Resnik 2009; Caplan 1992 ), eller DES-forsøgene (1950 – 1952), hvor flere hundrede gravide kvinder fik et syntetisk østrogentilskud (diethylstilbestrol) uden at vide det, og hvor hovedparten af dem efterfølgende fik børn med ekstrem høj forekomst af medfødte abnormaliteter og markant øget risiko for at udvikle cancer (Dutton 1988; Capron 1989 ). Den mest gentagne begrundelse for gennemgribende forskningsetiske refleksioner er imidlertid processen mod de laeger, som under 2. verdenskrig udførte raedselsvaekkende forsøg med mennesker interneret i de nazistiske koncentrationslejre. Denne proces udgør et internationalt referencepunkt for de efterfølgende udmøntninger af formaliseret videnskabsetik (cf. ...
Når man går i gang med et forskningsprojekt, vil der typisk være nogle forskningsetiske problemstillinger, man skal forholde sig til. Det kan fx være, at man skal have indhentet informeret samtykkeerklæringer fra de deltagere, der skal være med, eller man skal have indhentet forskningsetiske tilladelser og godkendelser fra uafhængige instanser. Det er altså overvejelser, som typisk dukker op ved begyndelsen af et forskningsprojekt. Der kan efterfølgende være en risiko for, at man forsømmer refleksioner over emergerende etiske problemstillinger, og at forskningsetik således reduceres til, at man som forsker har underskrevet og overholdt nogle prædefinerede retningslinjer for god forskningspraksis. Sådanne retningslinjer er naturligvis særdeles vigtige. Men det er pointen i denne artikel, at de ikke kan stå alene. Forskningsetiske dilemmaer er et epistemologisk vilkår gennem hele forskningsprocessen, og de må således overvejes og genovervejes, forhandles og genforhandles gennem hele forskningsprocessen. Den form for forskningsetik, der følger bestemte på forhånd fastlagte retningslinjer, som typisk er formuleret i standardiserede, kontekstuafhængige principper for god etisk adfærd, benævnes i artiklen procedural forskningsetik, mens en forskningsetik, der foretager en konkret og kontekstafhængig vurdering af de specifikke etiske problemstillinger og dilemmaer, som de viser sig i praksis gennem hele forskningsprocessen, benævnes kasuistisk forskningsetik. Distinktionen mellem disse to typer forskningsetik er udtryk for en teoretisk konstruktion, og de skal ikke betragtes som modsatrettede alternativer, men derimod som supplerende sider ved god forskningsetisk praksis. I artiklen diskuteres forholdet mellem dem for ad den vej at fremhæve enhver forskers pågående og kontinuerlige ansvar gennem hele forskningsprocessen.
Nøgleord: forskningsetik, procedural, kasuistisk, Leibniz
English summary: Dic cur hic – a casuistic research ethic
When embarking on a research project, researchers must customarily confront some ethical issues. To begin with, they may need informed consent from the participants, or research ethics permission and approval from an independent Research Ethics Committee. However, there is more involved than these legal requirements alone, for just complying with some pre-defined guidelines for good research practice is by no means enough. In fact, a number of ethical issues demanding thorough reflection may emerge during the research project. Far from being neglected, such questions deserve careful attention. Research ethical dilemmas are an epistemological condition throughout the whole research process, and must therefore be constantly considered and reviewed, negotiated and renegotiated. This article purports to categorize the ethical issues likely to arise during the course of an investigation into two main types, namely procedural and casuistic. The kind of research ethics following certain pre-established guidelines, which are typically expressed in standardized, context-independent principles of good ethical behavior, will be labeled as procedural research ethics, while the type of research ethics ensuing from the analysis and contextual assessment of the specific dilemmas arising in practice in the particular situation studied, will be named casuistic research ethics. A distinction between these two types of research ethics reflects a theoretical construct. Both types should not be regarded as opposing alternatives, but as complementary aspects of good ethical research practices. This article discusses the relationship between the two types in order to highlight the researcher’s ongoing and continuous responsibility throughout the research process.
... Die nachteiligen Auswirkungen einer voreiligen Empfehlung, Diethylstilbestrol für die Prävention von Fehlgeburten [30,31] anzuwenden, verdeutlichen das Risiko, frühzeitig Empfehlungen zu Gunsten von Interventionen auszusprechen (erhöhtes Risiko der Kinder, an einem Klarzellkarzinom der Vagina und der Zervix zu erkranken, darüber hinaus erhöhtes Risiko für die Entwicklung von Brustkrebs, Fehlbildungen der Fortpflanzungsorgane, Unfruchtbarkeit und Hodenhochstand). Ein zusätzliches Problem von voreiligen Empfehlungen stellt das Risiko dar, Ressourcen, die besser in einem anderen Bereich eingesetzt würden, unwiederbringlich für Interventionen zu binden, die hohe Fixkosten mit sich bringen, wie zum Beispiel für Geräte oder spezielle Einrichtungen. ...
... On the contrary , experts trying to convince the population that risk is low may contribute to overestimation of risk, especially if attention is drawn to the uncertainty of the risk estimate in situations that are potentially catastrophic, large-scale, and beyond personal control. Recent history abounds with examples of irrational response to epidemic threats: overreaction , such as with the swine-flu nonepidemic (Dutton 1988), or underestimation, as in case of AIDS. Epidemics are characterized by time-pressure and fear. ...
... The adverse consequences of recommendations to use diethylstilbestrol for the prevention of miscarriage [29,30] highlight the risk of premature favorable recommendations (risks in the children of clear cell adenocarcinoma of the vagina and cervix, breast cancer, reproductive tract anomalies, infertility, and undescended testicles). When interventions have a large component of fixed costs such as equipment or facilities, an additional problem with premature recommendations in favor of an intervention is the risk of irretrievable allocation of resources that would be better spent elsewhere. ...
In the GRADE approach, the strength of a recommendation reflects the extent to which we can be confident that the composite desirable effects of a management strategy outweigh the composite undesirable effects. This article addresses GRADE's approach to determining the direction and strength of a recommendation. The GRADE describes the balance of desirable and undesirable outcomes of interest among alternative management strategies depending on four domains, namely estimates of effect for desirable and undesirable outcomes of interest, confidence in the estimates of effect, estimates of values and preferences, and resource use. Ultimately, guideline panels must use judgment in integrating these factors to make a strong or weak recommendation for or against an intervention.
... As basic science undermined clinical research, increased demand for accountability in research (Strickland 1972;Steinfels 1976;Holton and Morison 1979;Dutton 1988;Rothman 1991) and shifting federal health priorities highlighted applied science. In the 1960s and 1970s, Congress entered the once restricted realm of health services financing and delivery, establishing Medicare and Medicaid, sponsoring planning, and engaging in regulation (Strickland 1972, ch. ...
For more than 20 years, clinical researchers have expressed alarm about the decline of their field, but they have failed to achieve a consensus on policies to revitalize and sustain it. Although they have traced the plight of clinical research to profound changes in science, medicine, and public expectations, their conservative vision and preference for short-term measures inhibit effective policy formulation. These trends are the outcome of historical developments, and they seem to mandate a new approach to public policy. A potential source for more viable and socially accountable policies lies in practitioners' notion that clinical research bridges basic and applied science (by translating scientific innovations into practical measures). Exploiting that idea, however, would require a major reorientation of the field toward health services research and the institutions that are struggling to support it.
... Alterations in Sertoli cell number have also been found following intrauterine exposure to BPA (Wistuba et al., 2003). In the 1940's, DES was developed as a chemotherapeutic agent for the treatment of metastatic prostate cancer (Huggins and Hodges, 1972) and was used as an off-label drug to prevent adverse pregnancy outcomes in women with a history of miscarriage (Dieckmann et al., 1953; Dutton, 1988). Since then, DES effects on the reproductive tract have been widely documented in both humans and experimental animals (Brouwers et al., 2006; Herbst et al., 1971; Klip et al., 2002; Newbold et al., 2009). ...
The objective of this study was to determine whether in utero exposure to Bisphenol A (BPA) induced reproductive tract abnormalities in the adult male testis. Using the C57/Bl6 mouse, we examined sex-organ weights, anogenital distance, and testis histopathology in adult males exposed in utero via oral gavage to sesame oil, 50 µg/kg BPA, 1000 µg/kg BPA, or 2 µg/kg diethylstilbestrol (DES) as a positive control from gestational days 10 to 16. No changes in sperm production or germ cell apoptosis were observed in adult testes after exposure to either chemical. Adult mRNA levels of genes associated with sexual maturation and differentiation, GATA4 and ID2, were significantly lower only in DES-exposed testes. In summary, the data indicate no gross alterations in spermatogenesis after in utero exposure to BPA or DES. At the molecular level, in utero exposure to DES, but not BPA, leads to decreased mRNA expression of genes associated with Sertoli cell differentiation.
... In particular, it examines the role of socioeconomic status, both of individuals, households and neighborhoods, in explaining the variance in mortality associated with the Spanish influenza pandemic which may have killed 50-100 million worldwide in 1918-19 (Johnson & Mueller, 2002). Indeed, socioeconomic differentials have also been reported for influenza and pneumonia combined, not only in the risk of dying (Kitagawa & Hauser, 1968, 1973Regidor, Calle, Navarro, & Domı´nguez, 2003;Singh & Siahpush, 2001), but also in the actual risk of contracting influenza (Dutton, 1988;Glezen, Paredes, & Taber, 1980). Moreover, the socioeconomic differences in mortality from influenza and pneumonia found in these studies, which include the United States in 1950, 1960and the period 1979-89, and Spain in 1996 were among the greatest compared to any other cause of death. ...
The Spanish influenza pandemic of 1918-19 was one of the most devastating diseases in history, killing perhaps as many as 50-100 million people worldwide. Much of the literature since 1918 has favored the view that mortality from Spanish influenza was class neutral. This view has prevailed, even though several contemporary surveys showed that there indeed were clear differences between the classes in disease incidence and that case fatality rates from influenza and pneumonia also varied according to socioeconomic status. Furthermore, studies of more recent influenza epidemics have also shown that there can be clear class differentials in mortality in this type of illness--is there any reason to believe that Spanish influenza was different? This paper is the first study in which individual- and household-level data which are unique for the period are utilized to test the conservative hypothesis that Spanish influenza was a socially neutral disease with respect to mortality. Through the use of Cox regressions in an analysis of two socially contrasting parishes in the Norwegian capital city of Kristiania, it is shown that apartment size as an indicator of wealth of a household, in addition to social status of place of residence, were the only socioeconomic variables that had an independent and significant effect on mortality after controlling for age, sex and marital status.
... Socioeconomic status differentials have also been reported for more recent influenza epidemics. Studies from the United States using data from the mid and late 1970s have shown that young children in low-income families are at greater risk of influenza infection than are pre-school children of middle-income families (Glezen et al. 1980), and that influenza was twice as common among poor adults as among the affluent (Dutton 1988). An individual level study of the white population in the United States in 1960 showed that male mortality from influenza and pneumonia amongst those with less than 8 years of schooling was 1.6 times that of those with one or more years at college; and among comparable women 1.7 times (Kitagawa and Hauser 1968). ...
The Spanish Influenza pandemic of 1918-19 was one of the most devastating diseases in history, killing perhaps as many as 50-100 million people worldwide. In addition to the high death toll and the high general lethality, the disease had a peculiar feature: the largest increase in death rates occurred among those between the age of 20 and 40 as opposed to the very young and the elderly, which is the more typical pattern of influenza epidemics. Furthermore, it appeared that it was the most robust population groups and the previously healthy that had highest mortality rates. Much of the literature favors the view that Spanish Influenza was class neutral with respect to mortality. This paper uses individual level data and applies Cox regressions to test the hypothesis that the blue-collar working class in 1918 suffered higher death rates from Spanish Influenza than the bourgeois and white-collar middle class in two parishes of the Norwegian capital of Kristiania (renamed Oslo in 1924).
Corruption is a word used loosely to describe many kinds of action that people find distasteful. We prefer to reserve it for the intentional misuse of the good offices of an established social entity for private benefit, posing as fair trading. The currency of corruption is not always material or financial. Moral corruption is all too familiar within churches and other ostensibly beneficent institutions, and it happens within medicine and the pharmaceutical industries. Corrupt behavior reduces trust, costs money, causes injustice, and arouses anger. Yet it persists, despite all efforts since the beginnings of societies. People who act corruptly may lack conscience and empathy in the same way as those with some personality disorders. Finding ways to prevent corruption from contaminating beneficent organizations is therefore likely to be frustratingly difficult. Transparency and accountability may go some way, but the determined corruptor is unlikely to feel constrained by moral and reporting requirements of this kind. Punishment and redress are complicated issues, unlikely to satisfy victims and society at large. Both perhaps should deal in the same currency-material or social-in which the corrupt dealing took place.
Stephen John has recently suggested that the ethics of communication yields important insights as to how values should be incorporated into science. In particular, he examines cases of “wishful speaking” in which a scientific actor (e.g. a tobacco company) endorses unreliable conclusions in order to obtain the consequences of the listener treating the results as credible. He concludes that what is wrong in these cases is that the speaker surreptitiously relies on values not accepted by the hearer, violating what he terms “the value-apt ideal”. I expand on this view by integrating into it Miranda Fricker’s account of testimonial injustice. I find testimonial injustice can arise in a manner unanticipated by Fricker, specifically that a credibility excess given to a speaker typically reduces the ability of others in the epistemic community to transmit knowledge, a phenomenon I term “collateral epistemic injustice”. I argue that this possibility entails that receivers have an ethical obligation to assign credibility judiciously. A further consequence of this view is that the value-apt ideal is insufficient. Because audience members have an obligation to assign credibility judiciously, a speaker cannot merely rely on shared values, they must also be open about the extent to which their conclusions depend on those values. Thus, both wishful speaking and obscuring the value-dependent nature of a conclusion makes one an unreliable source of information. Accordingly, other community members have an ethical obligation to ignore a speaker that frequently engages in either.
Auditing researchers have published over 24,000 academic articles (Google Scholar September 2016) since 1970. Auditing standard setters and regulators frequently describe an inability to engage with and utilize this research to make evidence‐informed standard setting and regulatory decisions. For society to benefit from the large investment in audit research, the knowledge needs to systematically and effectively transferred to auditing policymakers. We draw on the knowledge transfer literature to identify barriers to transferring academic knowledge and discuss how these concepts apply to audit standard setting. We then examine a paradigmatic example of academic knowledge transfer to policymaking: evidence‐based medicine. Based on this analysis, we propose a tentative strategy to address the barriers to transferring audit research knowledge to policymaking and sketch out potential avenues for research. We conclude with an illustrative example of how to implement a knowledge transfer strategy that is effective in systematically transferring knowledge in other policymaking settings to the context of a specific audit standard‐setting project: group audits.
This chapter focuses on the questions raised by the administration of DES to animals for food production, within the context of the DES medical affair and the public debates about the regulation of sex hormone prescription. The contrast in the development of this practice in the United States and France originates in the different roles public expertise played in each country. The chapter concludes that the different meanings thus given to human and animal enhancement — improvement versus augmentation — rest on a common ground. Agriculture and medicine are not two worlds apart: the same tools, techniques and sometimes personnel circulate between the two, thus making it possible to enhance both type of bodies at the boundary between the normal and the pathological.
Die politische Regulierung von Gefahren, die durch den Einsatz von Arzneimitteln entstehen können, ist nicht nur ein relevanter Teilbereich der politischen Risikoregulierung.1 Sie ist darüber hinaus in den umfassenderen Kontext des gesellschaftlichen Umgangs mit Krankheiten eingebettet. Die besonderen Bedingungen dieses Kontextes sind auch für den engeren Bereich der Arzneimittelregulierung von Bedeutung. Gerade hier - so die These - lassen sich tieferliegende Prozesse der Risikovergesellschaftung aufspüren. Diese Prozesse resultieren aus dem sukzessiven Übergang vom unmittelbaren Erleben einer Gefahr zur Entscheidungsabhängigkeit des Risikos. Das bedeutet jedoch nicht, daß nun technokratische Gestaltungsoptionen und Kontrollstrategien sich gleichsam ungebrochen im Hinblick auf den Umgang mit Krankheiten durchsetzen.2
The current high and escalating costs of medical care in the U.S. has prompted a renewed interest in how new treatments become part of established medical practice. Moreover, recent findings have raised serious questions concerning the efficacy of several commonly accepted treatments.1 As the related disciplines of medical technology assessment and adoption are fairly new, there is much controversy concerning underlying mechanisms and approaches to studying these phenomena.2 Essentially, three perspectives on treatment assessment and adoption have started to emerge.
Endocrine disruptors are exogenous natural or anthropogenic agents that produce adverse effects not only at the level of the individual, but also of the population and the community, by interfering with endogenous hormones in the body. Since these hormones are responsible for key processes in cellular control and communication as well as reproduction, development and behaviour, several severe impacts on ecosystems that occured during the last fifty years can now be explained by the presence of hormone mimics, acting as endocrine disruptors. Xenoestrogens such as DDT and PCBs are of special importance because they are leading to “feminized” wild life. Some of them are suspect of causing human sperm abnormalities, a decrease in sperm counts and a rise in hormone-related cancers. Since embryo development is particularly sensitive to estrogens, even small shifts in hormone levels experienced during the embryonic stage, e.g. by the presence of xenoestrogens, can cause malformations and cancer. The best known example is diethylstilbestrol (DES), a human “transplacental” carcinogen.
Since there are considerable structural differences between natural estrogens and xenoestrogens, the toxic potential cannot be derived from the chemical structure of individual substances, especially if xenoestrogens occur in complex mixtures and include yet unidentified compounds. Monitoring of effects takes advantage of the biological functions of estrogens, which act as signalling molecules. Components of the signal transduction chain can be used for effects monitoring, depending on the scope of the assay to be aimed at. The following options for detecting estrogen-like compounds are considered: receptor binding assays, DNA-binding tests of the receptor-ligand complex, and reporter gene assays measuring the estrogen-dependent modulation of gene activity. The perspectives for future biosensor approaches are discussed.
In this contribution, I wish to explore the potential of health technology assessment and ethics for increasing our capacity to pre-empt the shortcomings and undesired consequences of modern health care while maintaining its benefits. Central is the presumption that in case of some health problems this cannot be done unless we explicitly reconsider some features of the modern health care system, especially those related to its strong reliance on scientific rationality and the strong role played by medical professionals.
So as to both maintain the benefits of advanced health careand ensure that it produces less reason for concern, we need to reconsider our approach to rationality—and maybe even the way in which we build our health care system around that rationality. That is, we need to introduce an element of reflexivity. Two types of circumstances are being explored in which such reflexivity may prove worthwhile: controversies on side effects, and persistent problems encountered in optimising health care. Drawing on brief discussions of typical cases, we explore the potential of reflexive HTA and its methodical prerequisites.
We conclude that ethicists may contribute to reflexive HTA, if they combine a hermeneutic—and often also participative—methodology with a solid understanding of the relation between the health problem under scrutiny and more general critique of the health care system. Insights from the areas of science and technology studies, as well as from social philosophy may be critical items in their tool kit.
Care and treatment must as far as possible be designed and conducted in consultation with the patient, who must be informed of his state of health and of the treatment methods available. This is what the Swedish Health and Medical Services Act prescribes. This principle is in accordance with modern consumer policy, but for several reasons the patient is not an ideal “buyer.” Unquestionably, the system is characterized by professional dominance. The professions are supported by a cultural climate where formal complaints are exceptional. A unilateral liability insurance, the No Fault Patient Insurance, covers every patient. It pays standard amounts in the event of mishaps or malpractice without raising any questions as to who is to blame. There are 5,000 complaints per year, and roughly half of these result in payment to the patient. Lack of information about risks in diagnosis or therapy are mentioned in about 10 percent of the complaints.
IntroductionWestern medicine - the world-view of a professionThe body and the ‘gaze’Discourse - talking medicineThe dominant discourse of western medicineIatrogenesis and iatrogenic harmRecent evidence on iatrogenic harmConclusion
References
In Denmark, as elsewhere, electronic patient records are being presented as the solution to a multitude of problems in health care. However, in spite of these promises, the practical devel-opment and implementation of EPRs have consistently run into problems. I present material based on field studies in a Danish region, which have been working hard to develop and im-plement a standardized EPR. Meanwhile involved people have also been contemplating how the introduction of this new technology may affect hospital organization and work routines. Although development and implementation have run into a variety of problems, the ways of analyzing and reacting to these problems remain remarkably similar. I propose that patterns of envisioning and working with the EPR follow a techno-logic, which enables involved actors to imagine technical benefits of the new technologies while downplaying non-technical issues in developing and using them. This understanding constructs a persistent enigma of organiza-tion, because it is blind to the continuous intertwinements in practice between the technical and the organizational, the material and the discursive; or, between systems, signs, and action.
Medical technology assessment deals with the evaluation of novel or existing health care procedures. This paper addresses the interdependence between factual and normative issues, using the controversies about acceptability and desirability of reduced-size liver transplantations with living donors as example.
To make more responsible decisions regarding risk and to understand disagreements and controversies in risk assessments, it is important to know how and where values are infused into risk assessment and how they are embedded in the conclusions. In this article an attempt is made to disentangle the relationship of science and values in decision-making concerning the deliberate release of genetically modified organisms (GMOs) into the environment. This exercise in applied philosophy of science is based on Helen Longino's contextual empiricism which attempts to reconcile the objectivity of science with its social and cultural construction. Longino distinguishes different levels of research on which values apparently contextual with respect to a given research program can shape the knowledge emerging from that program. Her scheme is applied for locating and identifying the values that affect environment risk assessments of the field experiments with GMOs. The article concludes with some provisional suggestions for the decision process and the role of scientists in it.
Suppose we accept prenatal diagnosis and the selective abortion of fetuses that test positive for severe genetic disorders to be both morally and socially acceptable. Should we consider prenatal diagnosis and selective abortion (or other genetic interventions such as preimplantation diagnosis, genetic therapy, cloning, etc.) for nontherapeutic purposes to be acceptable as well? On the one hand, the social aims to promote liberty in general, and reproductive liberty in particular, provide reason for thinking that individuals should be free to make their own decisions about whether or not to employ whatever genetic services might be developed and offered by private enterprise. On the other hand, interventions aimed at enhancement would (in many cases) presumably only be available to those who are financially fortunate. A worry is that unequal access to enhancements that provide competitive advantages to offspring will further and more permanently increase existing unjust disparities between the haves and have-nots. The aim to promote liberty might thus conflict with the social aim of equality. An additional worry is that the development and provision of nontherapeutic genetic interventions would drain limited medical resources away from therapeutic purposes which would ultimately be more fruitful. The promotion of liberty might also thus conflict with the aim to promote aggregate utility. Assuming there is no reason to think that the promotion of liberty should be given absolute priority over both equality and aggregate utility, we need to think more about how to make trade-offs between these three legitimate social aims.
Clinical trials and other forms of evaluation of medical treatment are held to give an objective assessment of the ‘clinical effectiveness’ of the medical treatments under evaluation. This kind of evaluation is central to the evidence-based medicine movement, as it provides a basis for the rational selection of treatment. The ethical status of randomised clinical trials is widely agreed to depend crucially upon the state of equipoise regarding which of two (or more) treatments is more (or most) effective in a defined population. However, the meaning and nature of ‘clinical effectiveness’ are unclear. in this paper, I discuss the proposals to define clinical effectiveness as a relational property and as an intrinsic property, and the way effectiveness may supervene upon more fundamental physical properties of treatments. I discuss whether effectiveness is a single property or a family of properties; the types of outcome which can be explained by effectiveness properties; and the relationship between ‘objective’ and ‘preference’ outcomes. This paper suggests that while it may be possible to put clinical effectiveness on a proper metaphysical footing, in practice the language of clinical effectiveness is more properly a topic of the human sciences than of the natural sciences.
The catastrophic H1N1 pandemic of 1918, which killed tens of millions, is now legendary, and influenza policy has centered on preventing another such disaster. There is reason for concern about influenza A. It can rapidly alter its genetic makeup to increase virulence and can jump from other species to humans. Nonetheless, ignorance about influenza in 1918, the lack of effective vaccines or antibacterial and antiviral drugs, and the social disruption caused by World War I also contributed heavily to the lethality, and it is unlikely that influenza of similar destructiveness will recur. The stupefying publicity over the threat of influenza has been generated partly by those, such as the pharmaceutical industry and influenza researchers, who benefit from the increased expenditures the publicity provokes. It is, in effect, disease mongering, the promotion of disease or dread of disease for one's own gain. Huge expenditures on influenza preparedness have produced little demonstrable benefit and some harm, independent of the wasted resources. Disease mongering, including spreading fear of influenza, is widespread and unhealthy and should be vigorously opposed.
Under what conditions does an entire line of scientific work become controversial, and with what consequences? Nuclear physics, environmental studies, and sociobiology are familiar examples of controversial sciences. The case examined here is the development of American reproductive sciences over the past century, shaped by four domains of controversy: (1) association with sexuality and reproduction; (2) association with clinical quackery and hotly debated treatments; (3) association with controversial social movements; and (4) the capacity of reproductive sciences to create “Brave New Worlds.” Scientists' strategies for managing controversy are delineated.The framework used is arena analysis, and the paper concludes with rudiments of a conditional theory of status as a controversial “boundary world.”
This article reviews the history of smallpox and ethical issues that arise with its threat as a biological weapon. Smallpox killed more people than any infectious disease in history--and perhaps three times more people in the 20th Century than were killed by all the wars of that period. Following a WHO-sponsored global vaccination campaign, smallpox was officially declared eradicated in 1980. It has since been revealed that the Soviet Union, until its fall in the early 1990s, manufactured tens of tons of smallpox for military purposes. A worry is that some of this may have fallen into the hands of "rogue" nations or terrorists. Current U.S. debate questions whether smallpox vaccine should therefore be made available to the American public, which--like the rest of the world--now lacks immunity. Because the vaccine is considerably dangerous, public dialogue cannot resolve this matter if evidence material to the likelihood of attack is classified (i.e. secret). I conclude by recommending numerous future areas for ethics research related to the weaponization of smallpox.
Bakgrunn:
I denne artikkelen stilles det spørsmål om hvorfor influensapande-mien i 1918– 19 var forskjellig fra influ-ensaepidemier i nyere tid, som har større sosiale forskjeller i dødelighet enn de fleste andre dødsårsaker.
Materiale og metode:
Multivariat analyse og forløpsdata benyttes for første gang for å analysere variasjon i dødelighet av spanskesyken. Studien omfatter Frogner og Grønland-Wexels bydeler i Kristiania. Historisk-demografiske data for Norge er unike fordi det er mulig å rendyrke spanskesykens effekt på dødeligheten uavhengig av dødelighet som følge av den første verdenskrig ettersom Norge var et nøytralt land.
Resultat:
Dødeligheten i middelklassen og borgerskapet var 19 –25 % lavere enn i arbeiderklassen (ikke signifikant). De som bodde i leiligheter med 4– 6 rom hadde i gjennomsnitt 50 % lavere dødelighet enn de som bodde i ettroms leiligheter (signifikant). Innbyggerne på Grønland-Wexels hadde dessuten 50 % høyere dødelighet enn innbyggerne på Frogner justert for andre forskjeller (signifikant).
Fortolkning:
Funnene utfordrer myten om at spanskesyken tilfeldig plukket sine dødsofre. Studien har internasjonal relevans fordi data som sjelden er tilgjengelig for andre land er benyttet.
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