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Books on the topic 'Non-clinical studies'

Author: Grafiati

Published: 25 May 2024

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1

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. and Canada Therapeutic Products Directorate, eds. Timing of non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals. Ottawa, Ont: Therapeutic Products Directorate, Health Canada, 1997.

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2

Bartu, Anne. Evaluation of a preventative intervention strategy in a non-clinical setting using computerised screening. [Perth, W.A.]: Western Australian Alcohol & Drug Authority, 1991.

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3

Giffney, Noreen. Developing Clinical Insight Using Non-Clinical Case Studies in Psychoanalysis and Psychotherapy. Taylor & Francis Group, 2021.

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4

Giffney, Noreen. Developing Clinical Insight Using Non-Clinical Case Studies in Psychoanalysis and Psychotherapy. Taylor & Francis Group, 2021.

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5

Food and Drug Administration Staff. Compact Regs - Good Laboratory Practice for Non-Clinical Laboratory Studies. Taylor & Francis Group, 2004.

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6

Beckett, Ronald G., Gerald J. Conlogue, and Andrew J. Nelson. Case Studies for Advances in Paleoimaging and Other Non-Clinical Applications. CRC Press, 2020. http://dx.doi.org/10.4324/9780429318597.

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Nelson, Andrew, Ronald G. Beckett, and Gerald J. Conlogue. Case Studies for Advances in Paleoimaging and Other Non-Clinical Applications. Taylor & Francis Group, 2020.

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8

Nelson, Andrew, Ronald G. Beckett, and Gerald J. Conlogue. Case Studies for Advances in Paleoimaging and Other Non-Clinical Applications. Taylor & Francis Group, 2020.

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9

Beckett, Ronald G., Andrew J. Nelson, and Gerald J. Conlogue. Case Studies for Advances in Paleoimaging and Other Non-Clinical Applications. Taylor & Francis Group, 2020.

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10

Nelson, Andrew, Ronald G. Beckett, and Gerald J. Conlogue. Case Studies for Advances in Paleoimaging and Other Non-Clinical Applications. Taylor & Francis Group, 2020.

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11

Nelson, Andrew, Ronald G. Beckett, and Gerald J. Conlogue. Case Studies for Advances in Paleoimaging and Other Non-Clinical Applications. Taylor & Francis Group, 2020.

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12

Peacock, Martin. Correction for non-linearity due to small objects in clinical PET studies. 1996.

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13

Hoberman. Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practices for Juvenile Toxicology Studies. Wiley & Sons, Limited, John, 2023.

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14

Ibritumomab Tiuxetan (Zevalin) in Non-Hodgkin's Lymphoma: Clinical Background, Practical Considerations, and Case Studies. Oncology Group, 2003.

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15

Administration, Food and Drug. Compact Regs Part 58: CFR 21 Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies. Taylor & Francis Group, 2002.

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16

Administration, Food and Drug. Compact Regs Part 58: CFR 21 Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies. Taylor & Francis Group, 2002.

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17

Administration, Food and Drug. Compact Regs Part 58: CFR 21 Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies. Taylor & Francis Group, 2002.

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18

Administration, Food and Drug. Compact Regs Part 58: CFR 21 Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies. Taylor & Francis Group, 2002.

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19

Compact Regs Part 58: CFR 21 Part 58 Good Laboratory Practice for Non-clinical Laboratory Studies (10 Pack). 2nd ed. Informa Healthcare, 2003.

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20

McCaul, Thomas Russell *. The use of clinical supervision for enhancing teacher reflections on the teaching of non-academic students: two case studies. 1991.

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21

Interpharm. Compact Regs Part 58: CFR 21 Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies 10 Pack, Second Edition. Taylor & Francis Group, 2013.

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22

Interpharm. Compact Regs Part 58: CFR 21 Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies 10 Pack, Second Edition. Taylor & Francis Group, 2013.

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23

Dickey, Lore M., and Marsha Botzer. Case Studies in Clinical Practice With Trans and Gender Non-binary Clients: A Handbook for Working With Children, Adolescents, and Adults. Jessica Kingsley Publishers, 2021.

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24

dickey, lore m., and Marsha Botzer. Case Studies in Clinical Practice with Trans and Gender Non-Binary Clients: A Handbook for Working with Children, Adolescents, and Adults. Kingsley Publishers, Jessica, 2021.

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25

Elwood, Mark. Critical Appraisal of Epidemiological Studies and Clinical Trials. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199682898.001.0001.

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This book presents a system of critical appraisal applicable to clinical, epidemiological and public health studies and to many other fields. It assumes no prior knowledge. The methods are relevant to students, practitioners and policymakers. The book shows how to assess if the results of one study or of many studies show a causal effect. The book discusses study designs: randomised and non-randomised trials, cohort studies, case-control studies, and surveys, showing the presentation of results including person-time and survival analysis, and issues in the selection of subjects. The system shows how to describe a study, how to detect and assess selection biases, observation bias, confounding, and chance variation, and how to assess internal validity and external validity (generalisability). Statistical methods are presented assuming no previous knowledge, and showing applications to each study design. Positive features of causation including strength, dose-response, and consistency are discussed. The book shows how to do systematic reviews and meta-analyses, and discusses publication bias. Systems of assessing all evidence are shown, leading to a general method of critical appraisal based on 20 key questions in five groups, which can be applied to any type of study or any topic. Six chapters show the application of this method to randomised trials, prospective and retrospective cohort studies, and case-control studies. An appendix summarises key statistical methods, each with a worked example. Each main chapter has self-test questions, with answers provided.

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26

Ghaemi, Nassir. Clinical Psychopharmacology. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780199995486.001.0001.

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Clinical Psychopharmacology offers a comprehensive guide to clinical practice that explores the science and art of clinical research and its individualized application. Content is primarily based on clinical research and pharmacological studies, unlike most texts that rely on inferences from biological mechanisms. The text consists of 49 chapters, organized into 6 sections, focusing on disease-modifying versus symptomatic effects of available treatments, careful differential diagnosis including non-DSM diagnostic concepts, key clinical research studies, essential facts about the most common drugs, and more. Four appendices address key diagnostic controversies. This innovative book advocates a scientific and humanistic approach to practice and examines not only the benefits, but also the harms of psychotropic drugs. Providing a solid foundation of knowledge and a great deal of practical information, this book is a valuable resource for psychiatrists, nurse practitioners, medical students, trainees in psychiatry, pharmacists, and other mental health professionals.

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27

Pereira, Mark A. Nutrition and Type 2 Diabetes: Etiology and Prevention. Taylor & Francis Group, 2013.

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28

Pereira, Mark A. Nutrition and Type 2 Diabetes: Etiology and Prevention. Taylor & Francis Group, 2013.

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29

Nutrition and Type 2 Diabetes. Taylor & Francis Group, 2013.

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30

Pereira, Mark A. Nutrition and Type 2 Diabetes. Taylor & Francis Group, 2019.

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31

Pereira, Mark A. Nutrition and Type 2 Diabetes: Etiology and Prevention. Taylor & Francis Group, 2013.

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32

Katumbay, Desire Tshala. On the Site of the Lesion in Konzo: Clinical and Neurophysiological Studies on a Non-Progressive Upper Motor Neuron Disorder (Comprehensive Summaries of ... from the Faculty of Medicine, 1092). Uppsala Universitet, 2001.

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33

Gray, Nathan A., and Thomas W. LeBlanc. Early Palliative Care for Patients with Metastatic Non-Small Cell Lung Cancer (DRAFT). Edited by Nathan A. Gray and Thomas W. LeBlanc. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190658618.003.0001.

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This chapter provides an overview and commentary on the 2010 study by Temel and colleagues regarding early palliative care for patients with non-small cell lung cancer. It describes the trial design and findings while also providing a concise critique of the study and a brief review of relevant subsequent studies. The chapter describes the basics of the study, including funding, year study began, year study was published, study location, who was studied, who was excluded, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, gives a summary and discusses implications, and concludes with a relevant clinical case.

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34

Lhatoo, Samden D., Philippe Kahane, and Hans O. Lüders, eds. Invasive Studies of the Human Epileptic Brain. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198714668.001.0001.

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No other neurological condition allows the same opportunities for intracranial electrophysiological study of the human brain as epilepsy does. What ensues is exponentially expanding knowledge of the human epileptic brain, as well as windows into the physiology of the normal human brain itself. In Invasive Studies of the Epileptic Human Brain, some of the most renowned epilepsy experts of the twentieth and twenty-first centuries provide their expertise and insights into the identification and mapping of intracranial epileptiform and non-epileptiform activity, mapping of human brain function, and approaches to the use of invasive electroencephalography in a variety of clinical situations. It is an essential read for neurologists and neurosurgeons involved in epilepsy surgery, as well as neuroscientists and clinician researchers interested in the epileptic brain. It is organized in an easily readable series of chapters that will also appeal to trainees and students of these fields. Many of the chapters are brilliantly illustrated with case studies, and each provides an intuitively comprehensive approach to invasive brain studies. A burgeoning, worldwide, interest in stereotactic electroencephalography (SEEG), the use of sophisticated, cutting edge, multimodal imaging and other ancillary techniques, and the increasing complexity of epilepsy surgery cases makes this a timely publication, and a likely classic.

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35

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Clinical trial supplies: investigational medicinal products (IMPs). Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0017.

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This chapter describes the procedures and records associated with accountability of investigational and non-investigational medicinal products (IMP and NIMP) used in clinical trials, to show that the drug has been labelled according to the regulations, stored in conditions to keep it stable, prepared and administered to the correct subjects in accordance with the protocol, has been fully accounted for and destroyed if unused. Manufacture of IMP is discussed together with methods of blinding. The role of the Qualified person (QP) is reviewed. The need for study drug accountability is discussed in context with the regulatory requirements (Clinical Trial Directive 2001/20/EC and in particular, GMP Directive 2003/94/EC Annex 13). The chapter explains what needs to be accounted for and describes the types of records including: labelling records, delivery and transportation, receipt, storage, preparation, dispensing and administration, unblinding records, reconciliation, returns and destruction. Discussions are included on protocol compliance, management of excursions resulting from incorrect storage conditions, management of dosing errors and documentation errors, expiry date re-labelling, drug recall and re-supply. Sections are included on considerations for non-commercial studies, GMP requirements for UK Phase I clinics and sites requiring a MIA (IMP) license.

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36

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Setting the scene and ICH GCP in clinical and healthcare research. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0008.

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This chapter looks at the purpose and history of the development of good clinical practice (GCP). The international conference on harmonisation (ICH) GCP is the international quality standard for conducting clinical research to ensure the rights and well-being of patients are protected and the resulting data are valid. The cornerstone of ethics in research stems from the Declaration of Helsinki and the chapter looks at the changes in the Declaration and the impact on clinical trials. The development of the ICH process is described and the E, S, Q and M guidelines are discussed, The efficacy guidelines affect the practical aspects of trials and the efficacy guideline number 6 (E6) is on GCP. The content of the E6 guidelines is reviewed including the responsibilities of ethics committees, investigator and sponsor. Documentation requirements including the Protocol and Investigator Brochure as well as all the other documents are outlined. The guidelines are written to be interpreted and companies and institutions have to document their interpretation using standard operating procedures (SOPs). Although ICH GCP is regarded as the world-wide standard it sits alongside countries' legislation. In Europe CTIMPs have to follow the EU Directives and Regulation. Non pharmaceutical/non interventional healthcare research has no legal requirements to adhere to ICH GCP and is carried out under different research governance frameworks (RGF), however they all have their principles based on ICH GCP. The chapter also discusses the definition of an IMP and the decisions and processes that have to be followed when conducting non CTIMP studies.

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37

Gross, Wolfgang L., and Julia U. Holle. Clinical features of ANCA-associated vasculitis. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780199642489.003.0131.

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The primary ANCA-associated vasculitides are granulomatosis with polyangiitis (Wegener's, GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss syndrome, CSS). They predominantly affect small (and medium-sized) vessels and share a variable association with ANCA (anti-neutrophil cytoplasm antibody) directed against neutrophil proteinase 3 (PR3, mainly in GPA) and myeloperoxidase (MPO, mainly in MPA and CSS). Crescentic necrotizing glomerulonephritis and alveolar haemorrhage due to pulmonary capillaritis represent classical (vasculitic) organ manifestations of the ANCA-associated vasculitides (AAV). MPA occurs as a 'pure' small (to medium-size) vessel vasculitis, whereas GPA and CSS are characterized by additional distinct clinical and pathological features. In GPA, granulomatous lesions of the upper and/or lower respiratory tract are a hallmark of the disease. Granulomatous lesions may be large in appearance and occur as space-consuming, infiltrating, and destructive inflammatory masses. GPA is believed to follow a stagewise course with an initial localized form, restricted granulomatous lesions of the upper and/or lower respiratory tract without clinical signs of vasculitis, and a consecutive generalization to systemic vasculitis which may be either non-organ-threatening (early systemic) or organ- and life- threatening (generalized GPA). Rarely, patients arrest in the localized stage and do not progress to systemic disease. In EGPA asthma, hypereosinophilia and eosinophilic organ infiltration (e.g. eosinophilic myocarditis) are typical features of the disease apart from vasculitis. Similarly to GPA, EGPA follows a stagewise course: asthma and eosinophilia may precede full-blown disease for several months or years. Recent cohort studies suggest different phenotypes in EGPA (predominantly vasculitic and MPO-ANCA-positive and predominantly with eosinophilic organ infiltration, usually ANCA-negative). This chapter focuses on the clinical features of the primary AAV and their outcome.

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38

Farhood, Laila Faris. WAR AND NON-WAR STRESSORS, FAMILY RESOURCES, COPING AND FAMILY ADAPTATION AMONG LEBANESE FAMILIES. 1993.

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39

Bliss, Alison. Paediatric pain epidemiology. Edited by Paul Farquhar-Smith, Pierre Beaulieu, and Sian Jagger. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198834359.003.0055.

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The landmark paper discussed in this chapter reviewed 51 epidemiological studies looking at the incidence and prevalence of both acute pain and chronic pain in children and adolescents. The paper divided the studies they reviewed into two broad categories: those which examined pain in non-clinical populations, such as school children or general population samples, and those which examined pain in clinical settings, such as inpatients, outpatients from specific clinics, or special populations. In the clinical studies assessed, back pain in athletes and overuse injury syndrome in musicians were also included as studies from special populations. The non-clinical studies included head, stomach/abdominal, and back pain, as well as further studies focusing on oral/dental and limb pain, dysmenorrhoea, and multiple pain problems. The authors concluded that the epidemiology of pain in children and adolescents remained relatively undocumented.

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40

Brunoni, Andre Russowsky, Bernardo de Sampaio Pereira Júnior, and Izio Klein. Neuromodulatory approaches for bipolar disorder: current evidences and future perspectives. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780198748625.003.0028.

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Bipolar disorder is a prevalent condition, with few therapeutic options and a high degree of refractoriness. This justifies the development of novel non-pharmacological treatment strategies, such as the non-invasive techniques of transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), as well as the invasive techniques of deep brain stimulation (DBS) and vagus nerve stimulation (VNS). In this chapter, we provide a summary of the development of the techniques as well as the studies carried out with patients with bipolar disorder. Although many promising results regarding the efficacy of theses techniques were described, the total number of studies is still low, highlighting the need of further studies in larger samples as to provide a definite picture regarding the use of clinical neuromodulation in bipolar disorder.

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41

Polanczyk, Guilherme V. Epidemiology. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198739258.003.0013.

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This chapter initially reviews the main methodological aspects of ADHD prevalence studies, specifically study design, case definition, and ascertainment to subsequently address meta-analyses summarizing the prevalence of the disorder on children, adolescents, and adults. Results of meta-regression in the context of meta-analysis have investigated the effect of year of publication, sample location, and methodological characteristics of studies on heterogeneity of results. Studies on the course of the disorder, following up clinical and community samples, are discussed, as well as cultural influences on epidemiological findings. Large-scale cross-national studies and longitudinal studies following non-referred samples are necessary to further advance the knowledge on the epidemiology of ADHD.

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42

Abhishek, Abhishek, Adrian Jones, and Michael Doherty. Topical pharmacological treatments. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199668847.003.0028.

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Topical pharmacological agents such as non-steroidal anti-inflammatory drugs (NSAIDs) and capsaicin are widely recommended as first-line analgesics in the treatment of osteoarthritis (OA) of the knee, hand, and potentially other peripheral joints in view of their safety and efficacy. Although initial studies were short in duration (2–4 weeks), recent randomized controlled trials have confirmed the efficacy of topical NSAIDs over longer (12-week) study periods. Systematic reviews demonstrate that their efficacy can be equivalent to oral NSAIDs for OA pain, but they have a significantly better systemic toxicity profile than the corresponding oral formulations. Topical capsaicin is less well studied than topical NSAIDs but has been demonstrated to be effective in several placebo-controlled clinical trials. Local warming and an uncomfortable burning sensation is a common problem with initial applications, but this subsides with continued treatment and can be minimized by using a low-strength preparation (e.g. 0.025%) initially. Several other topical treatments such as drug-free transfersome gel and local lignocaine patches have been shown to be effective in controlling pain due to OA. However, they have been studied in relatively few studies and currently are not recommended for general use.

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43

Zaiwalla, Zenobia, and Roo Killick. Sleep disorders. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199688395.003.0035.

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As sleep medicine advances, there is increasing demand on services including neurophysiology to investigate sleep disorders. This chapter classifies the sleep disorders according to the main symptom presenting to the clinician, including excessive daytime sleepiness, insomnia, patients sleeping at the wrong times due to a circadian rhythm disorder, and movements or behaviours in sleep. The clinical presentation of common sleep disorders in each category are outlined, including obstructive sleep apnoea, narcolepsy, restless leg syndrome, periodic leg movements disorder, circadian rhythm disorders, and non-rapid eye movement and rapid eye movement parasomnias. The chapter discusses the overlap of symptoms in different sleep disorders, and the importance of selecting appropriate sleep studies, and recognizes the pitfalls, both clinical and in interpretation of sleep studies. The difficulties in diagnosing narcolepsy and differentiating from other causes of excessive daytime sleepiness, and when to investigate parasomnias is explained.

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44

Nilipour, Reza. Neurolinguistics. Edited by Anousha Sedighi and Pouneh Shabani-Jadidi. Oxford University Press, 2018. http://dx.doi.org/10.1093/oxfordhb/9780198736745.013.18.

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This chapter summarizes some first neurolinguistic studies conducted in Persian, using patholinguistic data taken from monolingual and bilingual brain-damaged patients, as well as five first neuroimaging studies in healthy native speakers of Persian. The patholinguistic data are extracted from formal clinical linguistic assessments of a heterogeneous group of brain-damaged patients with different etiologies and brain lesion sites. The data are indicative of general agrammatic features of ‘syntactic simplification’ and ‘morphological regression’ reported in cross-language studies, along with language-particular agrammatic features in spoken and written modalities for Persian consequent to brain damage. The present patholinguistic data are also suggestive of a ‘non-unitary’ model of aphasia as a symptom complex phenomenon with disruptions of independent linguistic levels consequent to different lesion sites. The data are not supportive of independent production and comprehension language centres claimed in ‘classical model’ of brain and language but in support of new non-narrow localization brain–language models.

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45

Schnider, Armin. Types of confabulation. Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780198789680.003.0003.

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When the term ‘confabulation’ entered the medical literature, it referred to the emergence of memories of events and experiences that never happened. However, its Latin root—meaning ‘to gossip, to chat’—allowed for a broader use of the term. This chapter gives the classic and the present-day definitions of confabulations and proposes a distinction between memory-related (mnestic) and non-memory-related (non-mnestic) confabulations. Early clinical observations already suggested the distinction between different forms of mnestic confabulations. Based on the literature and our own studies, I propose to distinguish four forms of confabulations, which partially or completely dissociate, and suggest ways to explore them.

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46

Sabharwal, Nikant, Parthiban Arumugam, and Andrew Kelion. Radionuclide ventriculography. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780198759942.003.0005.

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Radionuclide ventriculography (RNV) was the first reliable non-invasive method of assessing left ventricular (LV) function, and established nuclear cardiology as a clinical discipline. The subsequent development of other imaging modalities, particularly echocardiography, has led to a sharp decline in the number of studies performed, but RNV still has a role in situations where reproducible serial assessments of LV ejection fraction are required. Equilibrium RNV (ERNV) is the most straightforward and commonly performed style of RNV, and this chapter therefore focuses on ERNV, covering blood-pool labelling, principles of electrocardiogram (ECG) gating, acquisition, processing and interpretation, and clinical value in relation to ERNV. A section on first-pass radionuclide ventriculography is also included.

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47

Cummings, Jeffrey, Jefferson Kinney, and Howard Fillit, eds. Alzheimer's Disease Drug Development. Cambridge University Press, 2022. http://dx.doi.org/10.1017/9781108975759.

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Alzheimer's Disease (AD) is a growing global public health challenge. The development of new therapies is urgently needed, and a complex ecosystem of organizations has grown to facilitate AD drug discovery and development. Masterfully collating information on the drug development ecosystem, this book emphasizes the contributions of each aspect in the pipeline with a uniform approach to chapters, enabling readers to access relevant information quickly. Topics covered include the use of non-clinical laboratory studies, biomarker development, artificial intelligence, design and management of clinical trials, and funding and financing models. Also discussed is the critical role of advocacy fundraising for drug development. With the approval of aducanumab, the function of the ecosystem has become apparent. This is a definitive overview of how the ecosystem works in transferring an AD drug from its discovery in the laboratory through clinical trial testing to regulatory review and eventual marketing.

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48

Burrell, James R., and John R. Hodges. Dementia. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199658602.003.0010.

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Cognitive neurology has exploded over the last century, and especially over the last 20 years. From the distinction of dementia as a pathological entity, rather than just ‘normal’ ageing, to more sophisticated sub-classification of dementia syndromes, much has been learned, though great challenges remain. From an incredible array of worthy research studies, ten landmark papers in the field of dementia are presented in this chapter. With regard to Alzheimer’s disease, the following are discussed: the initial description of the disease, both clinically and pathologically; the development of meaningful clinical assessment measures; the early clinical manifestations and genetic causes; the precursors to symptomatic treatment; the use of neuroimaging to identify amyloid pathology in vivo; and the staging of Alzheimer’s pathology. The clinical features and genetic causes of frontotemporal dementia, an important non-Alzheimer’s primary dementia syndrome seen especially in younger patients, are also discussed.

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49

Sullivan, Mark D. Patient-Centered Health Is Produced by Patients. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780195386585.003.0012.

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More fundamental than the patient’s capacity to perceive and value health is the capacity of the patient to produce health. Population and individual health do not originate from health care. Health care is not just inefficient at producing health; it can produce significant iatrogenic harm in clinical, social, and cultural ways. Patients may be overtreated. Non-patients may be overdiagnosed. Our culture is seduced into the belief that all death and disease can be controlled. Iatrogenesis transforms into expropriation as we become confused and forgetful about the sources of health itself. We have gradually strengthened our clinical safety net and weakened our social safety net. Yet, international studies suggest social spending improves population health more than clinical spending. The right to health is usually approximated as the right to health care. But this is inadequate and counterproductive. A better policy is a right to health capability.

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50

Biloshytsky, Vadym, and Roman Cregg. Pioneering use of gene therapy for pain. Edited by Paul Farquhar-Smith, Pierre Beaulieu, and Sian Jagger. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198834359.003.0083.

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The landmark paper discussed in this chapter is ‘Gene therapy for pain: Results of a Phase I clinical trial’, published by Fink et al. in 2011. In this study, the first of its kind, researchers studied the efficacy and safety of a modified herpes simplex virus (HSV) vector used to deliver PENK, which encodes proenkephalin, which is cleaved into the enkephalin peptides Met-enkephalin and Leu-enkephalin, which induce analgesia by acting on opioid receptors. The development of the HSV vector was based in part on results studies in which adenovirus, adeno-associated virus, or non-viral vectors were used to overexpress genes. Overexpression of a variety of large molecules leads to a reduction in pain-related behaviour in animals. Gene therapy in the treatment of chronic pain seems to offer a promising alternative to systemic or highly invasive therapies. However, additional research is needed to determine the safety, effectiveness, and cost-efficiency of this approach.

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