Alex Faulkner
Dados Biográficos
| ID | 247428 |
|---|---|
| NOME | Alex Faulkner |
| PRENOMES | Alex |
| SOBRENOME | Faulkner |
| ASSINATURA | FAULKNER A |
| AFILIAÇÕES | University of Sussex |
| ORCID | 0000-0002-0492-6316 |
| VERIFICADO | Sim |
| TOTAL DE OBRAS | 35 |
| TOTAL DE CITAÇÕES | 133 |
| TOTAL COMO AUTOR | 35 |
| TOTAL COMO EDITOR | 0 |
| PRIMEIRO ANO DE PUBLICAÇÃO | 1993 |
| ANO MAIS RECENTE DE PUBLICAÇÃO | 2021 |
| ÍNDICE H | 8 |
Definitely Maybe
States that claim responsibility for citizens’ healthcare try to deal with knowledge uncertainties while preserving a duty of care. Production of clinical guidelines in disputed medical conditions or where uncertainty is high, is difficult. Patient groups may advocate non-credentialed evidence, contribute to debates and form alliances with established policy actors. In this context, Lyme disease, especially highly contested ‘chronic’ Lyme disease…
Sociotechnical alignment in biomedicine
Promissory and protective imaginaries of regenerative medicine
This article draws upon recent scholarship on technoscientific imaginaries and the sociology of technology expectations to reveal the mediating roles played by a number of disease-focused research charities in the United Kingdom. We examine the expectations they deal with about regenerative medicine research, and how they develop strategies to support and ‘protect’ potential medical scenarios for new therapies for dread diseases. In so doing, we …
Knowledge and uncertainty in Lyme disease detection
There are increasing levels of concern about policy and practice related to Lyme disease testing and diagnosis in the UK. A complex debate has emerged, with patient groups challenging clinical and testing practices. This paper focuses on four dimensions of diagnostic testing: accuracy, types of test, clinical application and test interpretation, to illustrate the divergence amongst and between official and patient group views. We explore these is…
Software, risks, and liabilities
The growing use of software in biomedicine has enlarged the capacities of researchers and clinicians. This, one might expect, would enhance the precision and safety of biomedicine. However, it has been recognized that software can bring about new risks to the field of medicine and medical devices, requiring at least some degree of caution from the different players responsible for technology governance and risk management. This phenomenon is focu…
Beyond the orthodox/CAM dichotomy
Elite athletes face extreme challenges to perform at peak levels. Acute and chronic musculoskeletal injuries are an occupational hazard while pressures to return to play post-injury are commonplace. Therapeutic options available to elite athletes range from novel 'cutting edge' biomedical therapies, established biomedical and surgical techniques, and physiotherapy, to a variety of non-orthodox therapies. Little is known about how different treatm…
The politics of valuation and payment for regenerative medicine products in the UK
The field of regenerative medicine (RM) faces many challenges, including funding. Framing the analysis in terms of institutional politics, valuation studies and “technologies of knowledge”, the paper highlights growing debates about payment for RM in the UK, setting this alongside escalating policy debates about “value”. We draw on interviews and publicly available material to identify the interacting and conflicting positions of institutional st…
Bioinformatics imaginaries in the engine-room of genomic health policy
Bioinformatics comprises a diffuse field of technologies, knowledges, databases and software for medical and pharmaceutical innovation. It is becoming a major target of policymaking for global health goals, but experiences conflicts including over ownership and access; national versus commercial agendas; disease targeting; genomic versus clinical data. The paper draws on the political economy of states, and the performativity of policy and ‘socio…
Special Treatment? Flexibilities in the Politics of Regenerative Medicine’s Gatekeeping Regimes in the UK
Emerging flexibilities are apparent in gatekeeping regimes applicable to regenerative medicine products, raising issues about the extent to which and forms in which such flexibilities might promote emerging products as a sector warranting special treatment, in the context of recent policy developments in the UK and wider European Union. Concepts of ‘gatekeeping’, ‘gatekeeping regimes’ and ‘gateways’ can point to the ways in which regulatory insti…
Stretching and Challenging the Boundaries of Law
Where biomedicalisation and magic meet
Promissory identities
Comparing national home-keeping and the regulation of translational stem cell applications
A very large grey area exists between translational stem cell research and applications that comply with the ideals of randomised control trials and good laboratory and clinical practice and what is often referred to as snake-oil trade. We identify a discrepancy between international research and ethics regulation and the ways in which regulatory instruments in the stem cell field are developed in practice. We examine this discrepancy using the n…
Technology identity
Tissue engineered technologies
Human tissues and cells, and tissue engineered (TE) therapies, have been the object of attempts at regulatory regime-building in Europe since the late 1990s. As a sector-in-the-making, or technological zone, TE has been beset by multiple uncertainties. The 2007 Regulation on Advanced Therapy Medicinal Products, expands the legal scope of EU pharmaceutical jurisdiction to cover tissue engineering as “unconventional medicine”. This paper outlines t…
Steering biomedicine
Law’s performativities
The paper undertakes a textual and documentary analysis of the Advanced Therapy Medicinal Products Regulation, which was passed into law in the European Union (EU) in 2007. This law is significant for the development of regenerative medicine in the EU and globally. Regulatory texts such as this one provide significant material for addressing key concerns in recent theorising about innovative technologies in socio-legal studies, innovation studies…
The Legal Landscape for Advanced Therapies
In 2007, the European Union adopted a lex specialis , Regulation (EC) No. 1394/2007 on advanced therapy medicinal products (ATMPs), a new legal category of medical product in regenerative medicine. The regulation applies to ATMPs prepared industrially or manufactured by a method involving an industrial process. It also provides a hospital exemption, which means that medicinal products not regulated by EU law do not benefit from a harmonized regim…
Introduction
‘Material’ : n. The substance or substances out of which a thing is or can be made. adj. Being both relevant and consequential; crucial; ‘testimony material to the inquiry’
Resisting the screening imperative
The introduction of mass screening programmes in the UK has been controversial. It is instructive to examine medical conditions for which screening has been actively considered but not introduced, such as prostate cancer. Incidence of the disease has escalated during the last 20 years, partly due to the upsurge in use of PSA (prostate-specific antigen) detection technology. The controversy is moving into a new phase, associated with the developme…
State strategies of governance in biomedical innovation
BACKGROUND: 'Innovation' has become a policy focus in its own right in many states as they compete to position themselves in the emerging knowledge economies. Innovation in biomedicine is a global enterprise in which 'Rising Power' states figure prominently, and which undoubtedly will re-shape health systems and health economies globally. Scientific and technological innovation processes and policies raise difficult issues in the domains of scien…
The Artificial Ear
The Artificial Ear: Cochlear Implants and the Culture of Deafness Blume, S. . Piscataway : Rutgers University Press . 2010 . x+226 pp. $25–95 (pbk) ISBN 978-0-8135-4660-5 The history of cochlear implants dates from the 1960s. When the US Food and Drug Administration (FDA) approved the first cochlear implant device for use, in 1984, President Reagan wrote to congratulate the company and the experimentalist surgeon involved. The FDA decision receiv…
Tissue-Engineered Technologies
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 ch…
Medical devices into healthcare
Regulating Hybrids
Promoting stability and continuity of care for looked after children
This paper reports on a two-pronged research study: a critical review of reported research concerning continuity and stability for children looked after away from home, and a telephone survey of UK managers responsible for looked after children. The review found limited research in this specific field that met the criteria of the critical review, but reports some evidence in favour of sibling co-placement, kinship care, parental participation, pr…
Technology identity
Law’s performativities
The paper undertakes a textual and documentary analysis of the Advanced Therapy Medicinal Products Regulation, which was passed into law in the European Union (EU) in 2007. This law is significant for the development of regenerative medicine in the EU and globally. Regulatory texts such as this one provide significant material for addressing key concerns in recent theorising about innovative technologies in socio-legal studies, innovation studies…
Resisting the screening imperative
The introduction of mass screening programmes in the UK has been controversial. It is instructive to examine medical conditions for which screening has been actively considered but not introduced, such as prostate cancer. Incidence of the disease has escalated during the last 20 years, partly due to the upsurge in use of PSA (prostate-specific antigen) detection technology. The controversy is moving into a new phase, associated with the developme…
Innovation and regulation in human implant technologies
Strange bedfellows' in the laboratory of the NHS? An analysis of the new science of health technology assessment in the United Kingdom
Comparing national home-keeping and the regulation of translational stem cell applications
A very large grey area exists between translational stem cell research and applications that comply with the ideals of randomised control trials and good laboratory and clinical practice and what is often referred to as snake-oil trade. We identify a discrepancy between international research and ethics regulation and the ways in which regulatory instruments in the stem cell field are developed in practice. We examine this discrepancy using the n…
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 pract…
Promissory identities
Introduction
‘Material’ : n. The substance or substances out of which a thing is or can be made. adj. Being both relevant and consequential; crucial; ‘testimony material to the inquiry’
Regulating Hybrids
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 technol…
Purity and the dangers of regenerative medicine
Tissue-Engineered Technologies
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 ch…
Where biomedicalisation and magic meet
Special Treatment? Flexibilities in the Politics of Regenerative Medicine’s Gatekeeping Regimes in the UK
Emerging flexibilities are apparent in gatekeeping regimes applicable to regenerative medicine products, raising issues about the extent to which and forms in which such flexibilities might promote emerging products as a sector warranting special treatment, in the context of recent policy developments in the UK and wider European Union. Concepts of ‘gatekeeping’, ‘gatekeeping regimes’ and ‘gateways’ can point to the ways in which regulatory insti…
Stretching and Challenging the Boundaries of Law
Steering biomedicine
Obstacles on the path to a primary-care led National Health Service
Tissue engineered technologies
Human tissues and cells, and tissue engineered (TE) therapies, have been the object of attempts at regulatory regime-building in Europe since the late 1990s. As a sector-in-the-making, or technological zone, TE has been beset by multiple uncertainties. The 2007 Regulation on Advanced Therapy Medicinal Products, expands the legal scope of EU pharmaceutical jurisdiction to cover tissue engineering as “unconventional medicine”. This paper outlines t…
The Legal Landscape for Advanced Therapies
In 2007, the European Union adopted a lex specialis , Regulation (EC) No. 1394/2007 on advanced therapy medicinal products (ATMPs), a new legal category of medical product in regenerative medicine. The regulation applies to ATMPs prepared industrially or manufactured by a method involving an industrial process. It also provides a hospital exemption, which means that medicinal products not regulated by EU law do not benefit from a harmonized regim…
Sociotechnical alignment in biomedicine
Outpatients and their doctors
Outpatients revisited
STUDY OBJECTIVE--To assess the scope for reducing unnecessary outpatient reattendances, using a benchmark an acute specialty at a site recognised to have an especially low ratio of repeat to new attendances. DESIGN--This was a survey of the re-attendance workload at general surgery outpatient clinics over a three month period. Patient re-booking and discharge rates for different grades of staff; clinicians' perception of the ability of the GP to …
Strange bedfellows' in the laboratory of the NHS? An analysis of the new science of health technology assessment in the United Kingdom
Obstacles on the path to a primary-care led National Health Service
Innovation and regulation in human implant technologies
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 circumsta…
Promoting stability and continuity of care for looked after children
This paper reports on a two-pronged research study: a critical review of reported research concerning continuity and stability for children looked after away from home, and a telephone survey of UK managers responsible for looked after children. The review found limited research in this specific field that met the criteria of the critical review, but reports some evidence in favour of sibling co-placement, kinship care, parental participation, pr…
Regulating Hybrids
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 pract…
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 technol…
Purity and the dangers of regenerative medicine
Tissue-Engineered Technologies
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 ch…
Medical devices into healthcare
State strategies of governance in biomedical innovation
BACKGROUND: 'Innovation' has become a policy focus in its own right in many states as they compete to position themselves in the emerging knowledge economies. Innovation in biomedicine is a global enterprise in which 'Rising Power' states figure prominently, and which undoubtedly will re-shape health systems and health economies globally. Scientific and technological innovation processes and policies raise difficult issues in the domains of scien…
The Artificial Ear
The Artificial Ear: Cochlear Implants and the Culture of Deafness Blume, S. . Piscataway : Rutgers University Press . 2010 . x+226 pp. $25–95 (pbk) ISBN 978-0-8135-4660-5 The history of cochlear implants dates from the 1960s. When the US Food and Drug Administration (FDA) approved the first cochlear implant device for use, in 1984, President Reagan wrote to congratulate the company and the experimentalist surgeon involved. The FDA decision receiv…
Tissue engineered technologies
Human tissues and cells, and tissue engineered (TE) therapies, have been the object of attempts at regulatory regime-building in Europe since the late 1990s. As a sector-in-the-making, or technological zone, TE has been beset by multiple uncertainties. The 2007 Regulation on Advanced Therapy Medicinal Products, expands the legal scope of EU pharmaceutical jurisdiction to cover tissue engineering as “unconventional medicine”. This paper outlines t…
Steering biomedicine
Law’s performativities
The paper undertakes a textual and documentary analysis of the Advanced Therapy Medicinal Products Regulation, which was passed into law in the European Union (EU) in 2007. This law is significant for the development of regenerative medicine in the EU and globally. Regulatory texts such as this one provide significant material for addressing key concerns in recent theorising about innovative technologies in socio-legal studies, innovation studies…
The Legal Landscape for Advanced Therapies
In 2007, the European Union adopted a lex specialis , Regulation (EC) No. 1394/2007 on advanced therapy medicinal products (ATMPs), a new legal category of medical product in regenerative medicine. The regulation applies to ATMPs prepared industrially or manufactured by a method involving an industrial process. It also provides a hospital exemption, which means that medicinal products not regulated by EU law do not benefit from a harmonized regim…
Introduction
‘Material’ : n. The substance or substances out of which a thing is or can be made. adj. Being both relevant and consequential; crucial; ‘testimony material to the inquiry’
Resisting the screening imperative
The introduction of mass screening programmes in the UK has been controversial. It is instructive to examine medical conditions for which screening has been actively considered but not introduced, such as prostate cancer. Incidence of the disease has escalated during the last 20 years, partly due to the upsurge in use of PSA (prostate-specific antigen) detection technology. The controversy is moving into a new phase, associated with the developme…
Technology identity
Comparing national home-keeping and the regulation of translational stem cell applications
A very large grey area exists between translational stem cell research and applications that comply with the ideals of randomised control trials and good laboratory and clinical practice and what is often referred to as snake-oil trade. We identify a discrepancy between international research and ethics regulation and the ways in which regulatory instruments in the stem cell field are developed in practice. We examine this discrepancy using the n…
Bioinformatics imaginaries in the engine-room of genomic health policy
Bioinformatics comprises a diffuse field of technologies, knowledges, databases and software for medical and pharmaceutical innovation. It is becoming a major target of policymaking for global health goals, but experiences conflicts including over ownership and access; national versus commercial agendas; disease targeting; genomic versus clinical data. The paper draws on the political economy of states, and the performativity of policy and ‘socio…
Special Treatment? Flexibilities in the Politics of Regenerative Medicine’s Gatekeeping Regimes in the UK
Emerging flexibilities are apparent in gatekeeping regimes applicable to regenerative medicine products, raising issues about the extent to which and forms in which such flexibilities might promote emerging products as a sector warranting special treatment, in the context of recent policy developments in the UK and wider European Union. Concepts of ‘gatekeeping’, ‘gatekeeping regimes’ and ‘gateways’ can point to the ways in which regulatory insti…
Political science (28 obras) · Sociology (22 obras) · Law (21 obras) · Biomedical Ethics and Regulation (20 obras) · Medicine (18 obras) · Economics (15 obras) · Law (15 obras) · Business (14 obras) · Public relations (13 obras) · Computer Science (12 obras)