Alex Faulkner

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.

Practitioner Evaluation at Work.

Practitioner involvement in evaluation, research, development, and other forms of disciplined inquiry that are small scale, local, grounded, and carried out by professionals who directly deliver those services is embraced across a wide range of professions as essential to good professional practice. However, little is known about the character, homogeneity or diversity, outcomes, motives, and practice of this activity. This article explores practitioner evaluation in social work, with an eye toward plausible connections with professional work across the public sector. The authors first explore the experience of doing practitioner evaluation, including its solitary or collaborative character, insider and outsider ascriptions and achievements, reflective moments regarding competence and capacity, and occasional glimmers of fascination with the work. The authors then explore contextualizing practitioner evaluation within its practice, agency, and professional cultures. Their third focus is through the lens of shifting practice and evaluation borderlines. The authors conclude with some provisional discussion of the implications for good practitioner evaluation.

Technology identity: The role of sociotechnical representations in the adoption of medical devices

This study explored the sociotechnical influences shaping the naturally-occurring adoption and non-adoption of device technologies in the UKs National Health Service (NHS), amid increasing policy interest in this area. The study was informed by Science and Technology Studies and structuration and Actor Network Theory perspectives, drawing attention to the performative capacities of the technology alongside human agentic forces such as agendas and expectations, in the context of structural and macro conditions. Eight technologies were studied using a comparative ethnographic case study design and purposive and snowball sampling to identify relevant NHS, academic and industry participants. Data were collected between May 2009 and February 2012, included in-depth interviews, conference observations and printed and web-based documents and were analysed using constructivist grounded theory methods. The study suggests that while adoption decisions are made within the jurisdiction of healthcare organisations, they are shaped within a dynamic and fluid adoption space that transcends organisational and geographic boundaries. Diverse influences from the industry, health care organisation and practice, health technology assessment and policy interact to produce technology identities. Technology identities are composite and contested attributes that encompass different aspects of the technology (novelty, effectiveness, utility, risks, requirements) and that give a distinctive character to each. We argue that it is these socially constructed and contingent heuristic identities that shape the desirability, acceptability, feasibility and adoptability of each technology, a perspective that policy must acknowledge in seeking to intervene in health care technology adoption.

Innovation and regulation in human implant technologies: developing comparative approaches.

Human implant technologies are subject to continual innovation and proliferation, raising important issues for technology testing, healthcare sciences, clinical performance and risk assessment, and regulation. The regulatory environment of medical devices is being shaped by harmonisation of standards in the European Union. The aim of this paper is to compare the histories and current regulatory environment of two technologies, breast implants and artificial hips, and to consider the implications of this comparison for a sociological healthcare research agenda to investigate the issues raised. The main focus is upon developments in the United Kingdom. Major points of contrast between the two technologies include the institutional contexts in which clinical evidence has been marshalled for government attention; the relative importance of strategic alliances between clinicians and manufacturers in the innovation process; the degree of public controversy evident; the varying definitions of an adverse incident within medical device vigilance systems; and in the UK the presence of a national register for breast implants but not for hip implants. Inter-national contrasts in these dimensions are noted. The analysis suggests that improved understanding is required of the institutional, organisational and professional processes involved in implant technology innovation and regulation. A comparative research agenda is proposed, focusing upon: innovativeness and proliferation; safety and technological standards; clinical and social outcomes; and consumer/user information and choice. It is concluded that research in these areas will enhance the evidence-base for the evaluation of human implant technologies in the context of their innovatory and regulatory environments.

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

n Abstractn n 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.n n

Non-aspirin, non-steroidal anti-inflammatory drugs for osteoarthritis of the knee.

OBJECTIVESnTo determine whether there is a difference in the relative efficacy of individual non-steroidal anti-inflammatory drugs (NSAIDs) when used in the management of osteoarthritis (OA) of the knee.nnnSEARCH STRATEGYnWe searched Medline (1966-1995) and Bids Embase (Jan-Dec, 1980-1995). The searches were limited to publications in the English language, and were last perfomed in November 1996. We used modified Cochrane Collaboration search strategy to identify all randomised controlled trials. The MeSH heading osteoarthritis was combined with the generic names of the 17 non-aspirin NSAIDs licensed in the UK for the management of OA in general practice. The search of Embase used the term osteoarthritis if present in the abstract, title or keywords, and was combined with the generic names of the 17 non-aspirin NSAIDs, only if they were mentioned in the title, abstract or keywords.nnnSELECTION CRITERIAnAll double blind, randomised controlled trials, in the English language, comparing the efficacy of two non-aspirin NSAIDs in the management of osteoarthritis of the knee, were selected. Only trials with subjects aged 16 years and over, with clinical and/or radiological confirmation of the diagnosis of OA knee were included. Studies which compared one trial NSAID with one reference NSAID were included provided they were non-aspirin NSAIDs available in the UK and were licensed for the treatment of OA by general practitioners. Trials which were placebo-controlled and which also involved the comparison of two NSAIDs were also included.nnnDATA COLLECTION AND ANALYSISnThe methodological design of each study was scored according to a pre-determined system. The three main outcome measures of pain, physical function and patient global assessment were chosen based on the core set agreed upon by OMERACT (Outcome Measures in Rheumatology Clinical Trials). These were used to determine the power of each trial. The equivalency of NSAID doses was calculated using the percentage of the recommended maximum daily dose. Sample size estimates for the detection of clinically relevant changes in outcome measures used in the assessment of OA knee were used for power calculations. These calculations were performed to determine whether the trials were of a sufficient size to detect clinically relevant differences which were statistically significant. The calculations incorporate estimates of standard deviation, and minimum, median and maximum differences (delta) between drugs which are deemed to be clinically important. The number of withdrawals due to lack of efficacy was also selected as an outcome measure for this review. The Peto odds ratio and 95% confidence intervals were calculated where possible. The results of studies which compared the same trial and reference NSAIDs were combined where possible.nnnMAIN RESULTSnOf the 1151 trials identified by the search strategy, 22 involved knee osteoarthritis only. Sixteen of these trials fulfilled the inclusion criteria and were entered in the review. Eight NSAIDs were represented in these trials. Etodolac was represented in 11 trials. The reference NSAID in these trials was piroxicam (n=3), naproxen(n=3), diclofenac (n=3), indomethacin (n=1), and, nabumetone (n=1). The reported methodological design of the trials was poor, with a median score of 3 (out of a maximum of 8). The results of the trials comparing the same trial and reference NSAIDs were pooled for the outcome withdrawal due to lack of efficacy. For the comparison, etodolac vesus piroxicam, the odds ratio favoured etodolac i.e. patients receiving etodolac were less likely to withdraw due to lack of efficacy. The dose of etodolac used in each of these three studies, however, was greater than the corresponding dose of piroxicam (based on percentage maximum daily dose). The significance of these results is therefore questionable. For the comparisons etodolac versus diclofenac, and etodolac versus naproxen, there were no clear differences betw

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.

Regulating human implant technologies in Europe--understanding the new era in medical device regulation

It has been suggested that we are entering a new era in medical device regulation in Europe. This paper discusses the implementation of the European Medical Devices Directive (EMDD) in EU member states with a particular focus on the UK. Case studies are then presented of two models of implant technologies--Trilucent breast implants and the 3M Capital hip prosthesis. Both have been withdrawn from the marketplace recently in controversial circumstances. Different aspects of regulatory activity are outlined with a bearing upon benefits and safety from national health services and consumers perspectives, and a number of issues concerned with the ability of regulatory mechanisms and practices to serve public health and safety are identified. Our analysis of the case studies draws parallels with studies of drug regulation, and explores the construction of risk and public participation in policy making. We argue that there are weaknesses in the regulation of medical devices and that commercial interests have dominated regulatory policy. Our case studies, however, suggest a shift towards a more user-oriented shaping of regulation.

Are there specific translational challenges in regenerative medicine? Lessons from other fields

There is concern that translation from bench to bedside within regenerative medicine (RM) will fail to materialize, or will be dismally slow, due to various challenges arising from the highly novel and disruptive nature of RM. In this article, we provide a summary of these challenges, and we critically engage with the notion that such challenges are specific to RM. It is important, we argue, not to overstate the exceptional nature of RM, as valuable lessons can be learned from elsewhere in medicine. Using several examples of technology adoption, we suggest that emerging RM products and procedures will have to work hard to find or create an adoption space if translation into the clinic is to be successful.

Tissue-Engineered Technologies: Scientific Biomedicine, Frames of Risk and Regulatory Regime-Building in Europe

Abstract Tissue engineering is one potential arm of the much-heralded regenerative medicine. We use the concepts of technological zone, risk framing and regulatory jurisdiction to analyse what risks are formulated in the zone of tissue engineering and whether those risks are reflected in emerging regulatory policy in Europe. In the regulatory jurisdictions of the European Union, public health risks have become increasingly important. Tissue engineering challenges pre-existing regulatory frameworks. Scientific–industrial actors formulate the risks of tissue engineering in three primary frames: technological safety risk; therapeutic efficacy risk; and economic risk. Study of the prevailing configuration of European Commission institutions and the EU process of regulatory regime-building for tissue engineering shows that risk frames are mobilized selectively. Whilst the technological safety frame and the economic frame are strongly mobilized, therapeutic efficacy—especially comparative efficacy—is not. Additionally the regime avoids any Europe-level position on the so-called ethics of sourcing and engineering tissues and cells. Efficacy and ethics are defined as the jurisdiction of national authorities, underpinned by the subsidiarity principle. Outcomes include the likely banning of certain therapeutic technologies by European countries that have objections to products deriving from controversial materials and processes, and the prevention of adoption of products due to efficacy concerns, so creating new imbalances in the European therapeutic marketplace. Consequently, the tissue-engineered medical products that European societies consume, at least in the near term, will reflect the medically defined needs of the European population to a limited and patchy extent.