Julie Kent

Respiratory viruses and exacerbations of asthma in adults.

OBJECTIVE--To study the role of respiratory viruses in exacerbations of asthma in adults. DESIGN--Longitudinal study of 138 adults with asthma. SETTING--Leicestershire Health Authority. SUBJECTS--48 men and 90 women 19-46 years of age with a mean duration of wheeze of 19.6 years. 75% received regular treatment with bronchodilators; 89% gave a history of eczema, hay fever, allergic rhinitis, nasal polyps, or allergies; 38% had been admitted to hospital with asthma. MAIN OUTCOME MEASURES--Symptomatic colds and asthma exacerbations; objective exacerbations of asthma with > or = 50 l/min reduction in mean peak expiratory flow rate when morning and night time readings on days 1-7 after onset of symptoms were compared with rates during an asymptomatic control period; laboratory confirmed respiratory tract infections. RESULTS--Colds were reported in 80% (223/280) of episodes with symptoms of wheeze, chest tightness, or breathlessness, and 89% (223/250) of colds were associated with asthma symptoms. 24% of 115 laboratory confirmed non-bacterial infections were associated with reductions in mean peak expiratory flow rate > or = 50 l/min through days 1-7 and 48% had mean decreases > or = 25 l/min. 44% of episodes with mean decreases in flow rate > or = 50 l/min were associated with laboratory confirmed infections. Infections with rhinoviruses, coronaviruses OC43 and 229E, influenza B, respiratory syncytial virus, parainfluenza virus, and chlamydia were all associated with objective evidence of an exacerbation of asthma. CONCLUSIONS--These findings show that asthma symptoms and reductions in peak flow are often associated with colds and respiratory viruses; respiratory virus infections commonly cause or are associated with exacerbations of asthma in adults.

Risk factors for lower respiratory complications of rhinovirus infections in elderly people living in the community: prospective cohort study

Abstract Objective: To assess the role of rhinoviruses in elderly people living in the community. Design: Prospective community based surveillance of elderly people, without intervention. Subjects were telephoned weekly to identify symptomatic upper respiratory tract infections. Symptoms and impact of illnesses were monitored, and specimens were collected for diagnostic serology and human rhinovirus polymerase chain reaction. Setting: Leicestershire, England. Subjects: 533 subjects aged 60 to 90. Main outcome measures: Symptoms, restriction of activity, medical consultations, and antibiotic use during 96 rhinovirus infections. Adjusted odds ratios for lower respiratory syndromes with respect to smoking and health status. Results: A viral cause was established in 211 (43%) of 497 respiratory illnesses; rhinoviruses were identified in 121 (24%) and as single pathogens in 107. The median duration of the first or only rhinovirus infection in the 96 people with 107 rhinovirus infections was 16 days; 18 of the 96 patients were confined to bed and 25 were unable to cope with routine household activities. Overall, 60 patients with rhinovirus infections had lower respiratory tract syndromes; 41 patients consulted their doctor, 31 of them (76%) receiving antibiotics. One patient died. Logistic regression analysis showed that chronic medical conditions increased the estimated probability of lower respiratory rhinovirus illness by 40% (95% confidence interval 17% to 68%) and smoking by 47% (14% to 90%). There were almost six times as many symptomatic rhinovirus infections as influenza A and B infections. Conclusions: Rhinoviruses are an important cause of debility and lower respiratory illness among elderly people in the community. Chronic ill health and smoking increase the likelihood of lower respiratory complications from such infections. The overall burden of rhinovirus infections in elderly people may approach that of influenza. Key messages Rhinoviruses are responsible for more colds in elderly people living in the community than are other respiratory pathogens combined Almost two thirds of elderly people with rhino- virus infections can be expected to develop lower respiratory illness More than 40% of rhinovirus infections in elderly people are seen by medical practitioners, and three quarters of those consulting are prescribed antibiotics Risk factors for lower respiratory rhinovirus illness include chronic medical conditions and cur- rent smoking; past smoking is not an independent risk factor and stopping smoking is the only factor identified thus far that could reduce the severity of rhinovirus illness in elderly people

Regulating hybrids: 'Making a mess' and 'cleaning up' in tissue engineering and transpecies transplantation

This paper explores the institutional regulation of novel biosciences, hybrid technologies that often disturb and challenge existing regulatory frameworks. Developing a conceptual vocabulary for understanding the relationship between material and institutional hybrids, the paper compares human tissue engineering (TE) and xenotransplantation (XT), areas of innovation which regulators have sought to govern separately and in isolation from one another. Contrasting definitional boundaries and regulatory mechanisms partition them socio-institutionally. But despite these attempts at purification, TE and XT have proven increasingly difficult to tell apart in practical and material terms. Human and animal matters, cell cultures and tissue products have much greater corporeal connection than has been institutionally recognized, and are therefore a source of acute instability in the regulation of implants and transplants. This paper tells the story of how the messy worlds of TE and XT have leaked into one another, calling into question the abilities of regulation to adequately control hybrid innovations.

The fetal tissue economy: From the abortion clinic to the stem cell laboratory

This paper examines the exchange relationships between women undergoing abortion, the clinicians who procure fetal tissue and stem cell scientists in Britain, and argues that the fetal tissue economy is an important dimension of the gendered bioeconomy that underpins stem cell science. In so doing it suggests that the path from the abortion clinic to the stem cell laboratory differs from the route taken by pre-implantation embryos from the in vitro fertilisation clinic in important ways. It reports on a study which included 29 in-depth, semi-structured interviews with stem cell scientists, policymakers, clinicians, activists and sponsors of stem cell research. The paper explores the meanings attached to aborted fetuses and how womens relationship to fetal tissue is constructed in the interviews, the law and official guidance on the use and disposal of fetal tissue. This is linked to variability in consent procedures and procurement practices.

Routine administration of Anti-D: the ethical case for offering pregnant women fetal RHD genotyping and a review of policy and practice

BackgroundSince its introduction in the 1960s Anti-D immunoglobulin (Anti-D Ig) has been highly successful in reducing the incidence of haemolytic disease of the fetus and newborn (HDFN) and achieving improvements to maternal and fetal health. It has protected women from other invasive interventions during pregnancy and prevented deaths and damage amongst newborns and is a technology which has been adopted worldwide. Currently about one third of pregnant women with the blood group Rhesus D (RhD) negative in the UK (approximately 40,000 women per year in England and Wales), receive antenatal Anti-D Ig in pregnancy when they do not require it because they are carrying a RhD negative fetus. Since 1997, a test using cell free fetal DNA (cffDNA) in maternal blood has been developed to identify the genotype of the fetus and can be used to predict the fetal RhD blood group.DiscussionThis paper considers whether it is ethically acceptable to continue administering antenatal Anti-D Ig to all RhD negative women when fetal RHD genotyping using maternal blood could identify those women who do not need this product.SummaryThe antenatal administration of Anti-D Ig to a third of RhD negative pregnant women who carry a RhD negative fetus and therefore do not need it raises important ethical issues. If fetal RHD genotyping using maternal blood was offered to all RhD negative pregnant women it would assist them to make an informed choice about whether or not to have antenatal Anti-D Ig.

Purity and the dangers of regenerative medicine : Regulatory innovation of human tissue-engineered technology

Abstract This paper examines the development of innovation in human tissue technologies as a form of regenerative medicine, firstly by applying ‘pollution ideas’ to contemporary trends in its risk regulation and to the processes of regulatory policy formation, and secondly by analysing the classificatory processes deployed in regulatory policy. The analysis draws upon data from fieldwork and documentary materials with a focus on the UK and EU (2002–05) and explores four arenas: governance and regulatory policy; commercialisation and the market; ‘evidentiality’ manifest in evidence-based policy; and publics’ and technology users’ values and ethics. The analysis suggests that there is a trend toward ‘purification’ across these arenas, both material and socio-political. A common process of partitioning is found in stakeholders’ attempts to define a clear terrain, which the field of tissue-engineered technology might occupy. We conclude that pollution ideas and partitioning processes are useful in understanding regulatory ordering and innovation in the emerging technological zone of human tissue engineering.

Children's consent to research participation: social context and personal experience invalidate fixed cutoff rules.

David Wendler and Seema Shah (2003) offer an interesting proposal concerning children’s assent to participation in nontherapeutic biomedical research. They argue that children should be considered competent to consent to such participation provided they have attained a level of cognitive and prosocial development such that they are able to understand the nature and point of altruistic decisions and actions. On the basis of psychological evidence they argue that this develops between the ages of 10 and 14. They argue on practical and moral grounds for an agebased cutoff for assent to research participation at 14 years old. Other commentators on Wendler and Shah’s paper draw attention to a number of moral and practical challenges to this proposal. We would like to draw attention to what we regard as weaknesses in the scientiac basis of the paper. It is important to note that Wendler and Shah start with U.S. federal guidelines, move on to identify the underlying moral principles (drawing heavily on the standard “Four Principles” approach), and only then seek to identify a psychological foundation for the means to apply these principles in practice. Their argument turns on a psychological account of the development of the capacity for altruism as the basis for capacity to assent to participation in nontherapeutic biomedical research. Although there is some analytical interest in the proposition that capacity for altruism is a necessary condition for capacity to assent to participation in nontherapeutic research, had they approached the issue of children’s capacity to consent or assent more directly, they might well have obtained a different result. Most work on research ethics commences, as do Wendler and Shah, with a theoretical and legal analysis of the requirements for ethical research. Occasionally, empirical work is conducted to determine the acceptability of guidelines or policy in the aeld of research ethics. Yet we have found almost no research that seeks to analyze in any detail research participants’ reasoning and values concerning the ethical issues in research, or to understand how far the ethical issues identiaed by research participants are consistent with the issues raised by ethicists or ethical

Framing Women, Framing Fetuses: How Britain Regulates Arrangements for the Collection and Use of Aborted Fetuses in Stem Cell Research and Therapies

This article engages with the frequently made claim that the UK has a transparent, accountable and strict but permissive regulatory approach to research using pre-implantation human embryos created in vitro and that this approach provides reassurance to the public in a particularly emotive area, has the full confidence of the scientific and medical research communities, and gives the UK a competitive advantage in the international field of stem cell research. Aborted fetuses are another controversial source of stem cells although their use is less widely known. The paper uses Jasanoffs conceptual tool of framing to analyse the history of the legislative and governance arrangements for the collection of aborted fetuses for use in stem cell research and therapies in Britain. We argue that the arrangements are confused, lack transparency, are out of line with current good practice on seeking consent, and that non-compliance with regulations is condoned. Furthermore, in our view, the separation of legal and governance arrangements for collection and use of pre-implantation human embryos and aborted fetuses will increasingly become problematic, and we conclude by proposing that there is increasingly a potential for conflict between them.

Culturing Cells, Reproducing and Regulating the Self

The emergence of a new tissue economy raises issues for the governance of risk and concepts of the body and self. This article explores the development of autologous cell therapies as a form of tissue engineering and considers how and why autologous applications are seen as less risky and more socially and politically acceptable. In a careful analysis of contemporary debates around the need for new international policies to regulate these technologies, we critically assess the discursive strategies employed to support ideas of the body as a natural entity. Central to these debates are assumptions that autologous applications do not threaten the moral or corporeal integrity of the individual and that they are ‘an ethics-free zone’. Analysis reveals that concepts such as intercorporeality need to be refined if they are to assist our understanding of these cell-based therapies. We consider the biopolitics of Autologous Chondrocyte Implantation (ACI) in order to show the linkages between the culturing of cells, regulation and the reproduction of the self.

Social Science Gets the Ethics Treatment: Research Governance and Ethical Review

The paper examines the current provision for ethical review within the social sciences and considers how existent structures could be improved to protect human research subjects in accordance with international guidelines and regulation. This paper examines the current regulation of social science in the form of professional guidelines, peer review, funding application procedures and steering/advisory groups, and compares these processes with the independent ethical review currently required for health research. This paper also addresses the concepts of ‘risk’ and regulation by comparing the provision of review processes for health and non-health based research. The authors question the distinctions made between different types of medical research which represent epidemiological research, for example, as non-intrusive thus creating a hierarchy of research which results in social science researchers slipping through the ethical review net.