Regulation of medicines and medical devices Books

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Book SynopsisCovering areas of drug toxicity which address the major issues including registration requirements of new drugs and pharmacovigilance, this book provides an overview of the methodology and requirements of pre-clinical safety assessment of new medicines. It discusses mechanisms by which drugs cause toxic effects in living organisms.Trade Review'The text is well written, concise and easy to understand with informative and helpful illustrations, figures and tables...it serves as an excellent companion to pharmacology textbooks, dealing with the issues relevant for assessing the safety of new drugs...a good starting point for the novice toxicologist, ambitious undergraduate student or graduate students working in the pharmaceutical sciences.' Irish Pharmacy Journal, November 2006, p418 * Irish Pharmacy Journal *'...this is a great little book...the text is aimed primarily at new PHD students in the pharmaceutical and related sciences but could equally well serve taught postgraduate students on toxicology, clinical pharmacology, drug development and safety or similar courses. The book 'does exactly what it says on the tin' and will definitely whet the appetite of enthusiastic young researchers for toxicology.' Heather M Wallace, Summer 2007 issue of the British Toxicology Society Newsletter -- Heather M Wallace * British Toxicology Society Newsletter *Table of Contents1. General toxicology; 2. Drug metabolism: inactivation and bioactivation of xenobioptics; 3. Molecular and cellular mechanisms of toxicity; 4. Teratology; 5. Genotoxicity; 6. Carcinogenicity of drugs; 7. Liver toxicity; 8. Kidney toxicity; 9. Toxicology in the respiratory system; 10. Immunotoxicity; 11. Clinical toxicology; 12. Safety assessment of pharmaceuticals: regulatory aspects; 13. Pharmacovigilance.

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Book SynopsisOpening with a detailed account of the historical development of Irish pharmacy and medicines law, this practical textbook covers all aspects of current pharmacy and medicines law in Ireland, including the landmark Pharmacy Act of 2007.Trade Review"Irish pharmacists, pharmacy students and those coming to practice in Ireland from other countries, this new text will also be a valuable reference source for lawyers, government bodies and anyone who wants to know more about the regulatory framework for pharmacists and medicinal products in Ireland." Evening Echo, Monday May 23, 2011 * Evening Echo *Table of Contents1. Introduction 2. Sources of Irish Law 3. Historical development of medicines and pharmacy law 4. Placing medicines on the market 5. Manufacturing and wholesaling of medicines 6. Advertising of medicines 7. Prescription and control of supply of medicines 8. Misuse of Drugs Acts and Regulations 9. Poisons Acts and Regulations 10. Veterinary medicines 11. Methylated spirits legislation 12. The Pharmacy Act 13. Pharmacy Act-regulations and rules 14. The pharmacy disciplinary system 15. Liability of community pharmacists in negligence and for defective products

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Book SynopsisConsidering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination.Trade Review'In sum, the book is well written, interesting and very topical. It is written by very knowledgeable lawyers, which is reflected in the high quality of the articles. . . I recommend this book, not only for academics but for practicing lawyers as well. Many of the contributions contain valuable ''take home messages'', which should be taken into account in the discussions.' --Marcus Norrgard, International Review of Intellectual Property and Competition Law'This is an intriguing selection of topical essays addressing fundamental questions of pharmaceutical innovation. It is comprised of a high-profile list of contributors, including academics, judges and practitioners from the U.S., Europe and Japan, who ''explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicines and health care''. . . This is an enjoyable, readable and interesting book containing thorough studies of ''hot'' legal issues in the pharma sector converging in an decisive era for pharmaceutical innovation. It ought to be found in any library that has reserved space for pharma-, IP- or competition law-related literature.' --Jur. Dr. Timo Minssen, European Competition Law Review Table of ContentsContents: Introduction Nari Lee and Josef Drexl PART I: PATENT PROTECTION FOR PHARMACEUTICAL METHODS 1. The Patentability of Genetic Diagnostics in US Law and Policy Rochelle C. Dreyfuss 2. Patentability of Pharmaceutical Innovations: The European Perspective Rainer Moufang 3. Patentability of Medical Methods in Japan Nari Lee PART II: DATA EXCLUSIVITY AND PATENT TERM EXTENSION: CONVERGENCE OR DIVERGENCE 4. Patent Term Restoration and Non-Patent Exclusivity in the US Margo A. Bagley 5. Clinical Data, Data Exclusivity and Private Investment Protection in Europe Christian R. Fackelmann 6. Patent Term Extension in Japan: An Academic and Comparative Perspective Ryoko Iseki 7. Recent UK Case Law on Supplementary Protection Certificates Richard Arnold 8. Patent Term Extension in Japan: Focusing on the Pacif Capsule Decision Toshiaki Imura PART III: BALANCING INCENTIVES AND COMPETITION IN EUROPE 9. Strategic Patenting by the Pharmaceutical Industry: Towards a Concept of Abusive Practices of Protection Hanns Ullrich 10. Anticompetitive Marketing in the Context of Pharmaceutical Switching in Europe Bengt Domeij 11. AstraZeneca and the EU Sector Inquiry: When Do Patent Filings Violate Competition Law? Josef Drexl Index

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Book SynopsisThis accessible guide to advanced medical technologies and methodologies for monitoring, diagnosing, and predicting cardiovascular diseases addresses sensor technologies and non-invasive monitoring methods and looks at the growing integration of machine learning and AI.The authors guide readers from an introduction to the cardiovascular system and a review of traditional and modern diagnostic methods before explaining recent advances in medical technology, such as wearable smart devices and their sensor types (namely, pressure, photoelectric, and ultrasonic), and how these advances have been applied to cardiovascular disease diagnosis and detection. Key topics include pulse wave analysis, sensor technology for radial blood pressure monitoring, and the integration of artificial intelligence to enhance predictive accuracy. With a focus on continuous monitoring solutions, this book highlights groundbreaking research on non-invasive detection methods and the development of intelligent health systems for real-time patient evaluation. The authors also discuss how the widespread implementation of machine learning and deep learning techniques have influenced the field and propose new methods for enhancing continuous monitoring and risk prediction systems. The information within this book will help to bridge the gap between research and clinical practice.This short guide is a valuable resource primarily for academic readers in the fields of biomedical engineering, physics, computer science, and medical imaging. Clinicians will also benefit from the discussions of applications and future research and clinical trends.

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Book SynopsisMany companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation.This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful.After a review of the challenges that any medical device company faces in the world of todaythe multiple sources of QMS requirementsthe book poses a question: are we satisfied with the QMS we have now, or could we do beTable of ContentsChapter 1 The Challenge Chapter 2 The Path Chapter 3 Key Decisions Chapter 4 A Quality Plan Chapter 5 Documentation, the Big Picture Chapter 6 Level 1 Documentation Chapter 7 Level 2 Documentation Chapter 8 Level 3 Documentation Chapter 9 Level 4 Documentation Chapter 10 Fully Incorporating Risk Management Chapter 11 Implementation Chapter 12 Maintenance (and Improvement)

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Book SynopsisThe FDA is responsible for overseeing the safety and effectiveness of medical devices sold in the United States. New devices are generally subject to FDA review via the 510(k) process, which determines if a device is substantially equivalent to another legally marketed device, or the more stringent pre-market approval process, which requires evidence providing reasonable assurance that the device is safe and effective. This book examines whether the FDA is sufficiently meeting the performance goals and whether devices are reaching the market in a timely manner.

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Book SynopsisHeroin is an illustrated history of Canadian heroin regulation over two centuries. Susan Boyd points to our failure to address the overdose death epidemic caused by criminalizing drug users and to the decades of resistance to harm-reduction policies. Heroin, discovered in 1898, was heralded as an important medicine and successfully marketed as a pain reliever and cough suppressant. Until the early 1950s, heroin was prescribed for therapeutic use in Canada. Yet, illegal heroin use became the focus of drug prohibition advocates and law enforcement, who painted it as highly addictive and destructive. Systemic racism was the impetus for our first anti-heroin laws; the race, gender and class of users influenced drug control, which, by the 1930s, became the focus of law enforcement. Flawed ideas about heroin and people who use the drug have shaped drug law and policy for decades. This book is informed by documentary evidence and the experiences of people who use/used heroin, drug user unions and harm-reduction advocates. These sources highlight the structural violence of drug policy that uses prohibition and criminalization as the main response to drug use.

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Book SynopsisThis new volume provides an abundance of information on new biomedical applications being used today. The book covers a wide range of concepts and technologies, discussing such modern technological methods as the Internet of Things, e-pills, biomedical sensors, support vector machines, wireless devices, image and signal processing in e-health, and machine learning. It also includes a discussion on software implementation for the devices used in biomedical applications. The different types of antennas, including antennas using RF energy harvesting for biomedical applications, are covered as well.

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Book SynopsisEmbryo research, cloning, assisted conception, neonatal care, saviour siblings, organ transplants, drug trials - modern developments have transformed the field of medicine almost beyond recognition in recent decades and the law struggles to keep up.In this highly acclaimed and very accessible book, now in its sixth edition, Margaret Brazier and Emma Cave provide an incisive survey of the legal situation in areas as diverse as fertility treatment, patient consent, assisted dying, malpractice and medical privacy. The book has been fully revised and updated to cover the latest cases, from assisted dying to informed consent; legislative reform of the NHS, professional regulation and redress; European regulations on data protection and clinical trials; and legislation and policy reforms on organ donation, assisted conception and mental capacity. Essential reading for healthcare professionals, lecturers, medical and law students, this book is of relevance to all whose perusal of the daily news causes wonder, hope and consternation at the advances and limitations of medicine, patients and the law.Trade Review‘In this book the authors provide an incisive survey of the legal situation surrounding the areas of fertility treatment, patient consent, assisted dying, malpractice and medical privacy. This 6th Edition has been fully revised and updated to cover the latest cases from assisted dying to informed consent, legislative reform of the NHS, professional regulation and redress, European regulations on data protection and clinical trials, and legislation and policy reforms on organ donation, assisted conception and mental capacity.’ The Lamp, March 2017 -- .Table of ContentsIntroductionPart I Medicine, law and society1 The practice of medicine today2 Doctors' responsibilities: patient's rights 3 Medicine, moral dilemmas and the law4 A relationship of trust and confidencePart II: Medical malpractice5 Agreeing to treatment6 Capacity, consent and compulsion7 Clinical negligence8 Medical litigation9 Complaints and redress10 Medical products liabilityPart III: Matters of life and death11 Pregnancy12 Assisted conception13 Abortion and embryo research14 Doctors and children15 Healthcare research16 Defining death17 Organ & tissue transplantation18 Human body and parts19 End of lifeIndex

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Book SynopsisThis timely Research Handbook offers significant insights into an understudied subject, bringing together a broad range of socio-legal studies of medicine to help answer complex and interdisciplinary questions about global health - a major challenge of our time. Interdisciplinary chapters explore both how the terrain of medicine can generate new questions about law, regulation and the state, and how the law intersects with health and medicine at every level. Bringing together leading international scholars, the Research Handbook assembles concrete case studies to suggest avenues for further research on socio-legal inquiries, such as the construction of disorders by law, the reparation of injuries, and how race and gender impact justice. The Research Handbook for Socio-Legal Studies of Medicine and Health will be an inspiring read for researchers, academics and graduate students in the fields of health law, socio-legal studies, and gender and sexuality. Contributors include: P. Arcidiácono, J. Barbot, L. Barrera, E. Bernheim, E. Brennan, B. Can, E. Chiarello, É. Cloatre, V. De Greef, N. Dodier, A. Doll, J. Edwards, A.-M. Farrell, J.A. Hamilton, R. Harding, J. Harrington, H.R. Hlavka, C.W.-L. Ho, K. Hoeyer, I. Iyioha, M.-A. Jacob, V. Karavas, A. Kirkland, J. Metzl, D. Moore, C. Morrill, L. Mulcahy, S. Mulla, T. Phillips, J. Piemonte, R. Singh, M. Suchman, M. Thomson, S. WestwoodTrade Review'Wide-ranging and thoughtfully curated, this collection demonstrates just how far the tentacles of healthcare and law extend into social life. Taken together, though, these chapters suggest that the epistemic reach of both law and medicine ultimately exceed their grasp, a conclusion that practitioners and scholars alike will both rue and applaud. With such provocative and carefully researched pieces, this volume is sure to foster a deep rethinking of socio-legal studies of medicine and health. --Carol A. Heimer, Northwestern University, US'Handbooks are often conceived to tie together already-established research fields. With the Research Handbook on Socio-Legal Studies of Medicine and Health, Anna Kirkland and Marie-Andreé Jacob have in fact inaugurated an important new field of study while generously acknowledging its diverse ancestries. I've always thought that STS should instead have been dubbed TLS (technoscience, law and society) whether in studies of health, climate change, migration, inequality or their interconnections. Through an empirically rich set of chapters, handbook contributors perceptively show how socio-legal problems (from femicide to alternative medicine, genetic ancestry testing and gun violence) in highly (bio)medicalized societies throughout the world are always historically and ethnographically situated. This Handbook will be of equal interest to legal scholars, anthropologists, sociologists, bioethicists, philosophers and STS scholars.' --Ayo Wahlberg, University of Copenhagen, Denmark'One of the strengths of socio-legal studies is to show how seemingly mundane and technical practices and artifacts, such as clinical protocols or bureaucratic procedures, shape social realities: how they include and exclude people, and redistribute duties and entitlements. This fantastic volume gives a flavour of the breath and diversity of this lively (inter-)discipline, and also pushes its boundaries into new topics and methodological terrains.' --Barbara Prainsack, University of Vienna, AustriaTable of ContentsContents: Preface Linda Mulcahy 1. Introduction Part I Beyond Healthcare 2. Trapped in limbo: effects of a medical perspective on the education of children with disabilities P. Arcidiácono and L. Barrera 3. Mental disorders and work V. De Greef 4. Challenging capacity: Shifting paradigms of intellectual disability across law, medicine and society R. Harding 5. Genetic Ancestry Tests: Materializing Race and Indigeneity Across Law, Medicine, and Society J.A. Hamilton Part II Ways In Through Terrains 6. Work, facts, and the textual organization of psychiatric involuntary psychiatric admission: Methodological insights from institutional ethnography A. Doll 7. Provincializing the clitoris J. Edwards and M. Thomson 8. The Bearable Lightness of Relationality: Actor-Network-Theory as a Mode of Comparative Law C.W.-L. Ho Part III Ways In Through Models 9. A multi-field logics approach to theorizing relationships between healthcare and criminal justice E. Chiarello and C. Morrill 10. Law and technology in healthcare organizations E. Brennan and M.C. Suchman 11. What role for the state in global health law? A nodal governance perspective from Kenya J. Harrington 12. Substantive Effectiveness, Women’s Health and the Limits of International Human Rights Law I.O. Iyioha Part IV The Meeting Point of Injury 13. Thinking forensically: Law, medicine and the nomos of sexual violence H.R. Hlavka and S. Mulla 14. Proof, probability and the plaintiff: epistemological challenges in the medico-legal field T. Phillips 15. The normative work of victims of medical injuries J. Barbot and N. Dodier 16. Bare death: femicide, forensics and the necropolitics of the corpse R. Singh and D. Moore 17. The (non)denial of torture, human rights and medical expertise B. Can Part V Ethical pluralisms 18. Doctors and global health security: What role for ethics and regulation? A.-M. Farrell 19. Ethics as a form of regulation in relation to data and bodily materials K. Hoeyer 20. Regulating at the boundaries of healthcare: the case of alternative and traditional medicine E. Cloatre 21. Biomedical collective labour: politics, sovereign subjects, and empowerment in biobank research V. Karavas, Vagias Part VI Health as Pretext 22. Justice, power and intersectionality: beyond psychiatry, the social issue in question E. Bernheim 23. Gun violence and mental health: Myths and strategies for socio-legal research J.L. Piemonte and J. Metzl 24. Older lesbian, gay and bisexual people: socio-legal perspectives on healthcare inequalities in later life S. Westwood Index

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Book SynopsisThis timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research. This thought-provoking book provides new perspectives on the regulation of health research by demonstrating how RECs and other regulatory actors seek to fulfil these two functions by performing a role of 'regulatory stewardship'. This involves guiding researchers through stages of research approval, as well as seeking to maximise benefits for participants and society while minimising risks. Arguing that participant protection and research promotion should rightly be treated as twin objectives for health research regulators, this book asserts that there is a need for more overt recognition of the importance and function of the deliberative space in which RECs can negotiate the risks relevant to a research application. This book is a key resource for academics and students interested in health research and regulation, and the dynamic interaction of ethics and the law. Regulators and policy-makers will also find it to be an insightful and illuminating text for the practical insights that it reveals about research governance in action.Trade Review'This excellent book presents an original and intriguing insight into the ''black box'' of decisions made by Research Ethics Committees (RECs). Put simply, if you want to understand the changes that ethics review and research governance has undergone over the past ten to fifteen years, then this book is required reading. In its intense empirical approach to a topic normally addressed in rather more theoretical terms Regulatory Stewardship of Health Research lays down a challenge to socio-legal studies of regulation, pushing debates towards what he calls an ''anthropology of regulation'', drawing explicit attention to processes, passages, and change inherent in the regulation of modern medical research.' --Adam Hedgecoe, Cardiff University, UK'Dove's careful and detailed analysis of the regulatory system for health research is a refreshing and valuable contribution to theory and practice of ethics review committees - and not just for the UK, but for any jurisdiction thinking seriously about the twin goals of protecting research participants while promoting research. Researchers, research ethics committees, regulators and the public will each find insights about the ways society can make research better for all.' --Eric M. Meslin, Council of Canadian Academies, CanadaTable of ContentsContents: 1. Introduction 2. Conceptual framework—setting the scene for ‘protection’ and ‘promotion’ 3. The making of RECs as health research regulators 4. Anthropology of regulation 5. Operationalising ‘next-generation’ health research regulation—what is happening in practice? 6. Charting a framework for regulatory stewardship 7. Conclusion Index

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Book SynopsisOffering a novel and pragmatic perspective, this timely book critically examines the development of a culture of machinist regulation and questions whether this approach is appropriate in an era of rising biological technologies. Adopting an ontological approach, James Griffin considers how current regulatory frameworks favour digital technology and how this may change in the future.Griffin adeptly investigates how regulation can impact the nature of new technologies, especially as biological computing is becoming more commonplace. Chapters provide a wealth of critical analysis, considering cutting-edge technologies such as AI, prosthesis, and biological computing. Griffin outlines a proposed reformative system which focuses on the biological substrate in the creation of cultural works. The book serves to highlight the ever-increasing need for awareness of the importance of biological substrates and for a regulatory system which reflects this.The State of Cultural Biology will be an essential read for academics and students interested in intellectual property law, law and technology, legal philosophy and law’s role in society. It will also prove invaluable to policymakers and professionals looking to broaden their knowledge on the regulation of modern technology.Trade Review‘Dr James Griffin presents a ground-breaking and visionary exploration into the fascinating world of biological computing, which sets this book apart. Through a captivating blend of rigorous research and real-world examples, Dr James Griffin skilfully showcases the profound impact of cultural context on our genetic expression and cognitive development, unearthing the insights that challenge conventional thinking on traditional (binary) computing. Dr James Griffin delivers an unparalleled examination of biological computing’s regulatory mechanisms that underpin this intricate interdependence of culture and biology. This book paves the way for a revolutionary advancement in various disciplines, from psychology to artificial intelligence. I found myself continuously inspired and enlightened by the fresh perspectives offered in this book.’ -- Hing Kai Chan, University of Nottingham Ningbo China, ChinaTable of ContentsContents: Preface 1 Introduction to the State of Cultural Biology 2 The machinic State 3 The biological State 4 The biology of legal nothingness (the invisible hand of biology) 5 The false turn of digital technology 6 The wider view: New Technologies 7 Reform 8 Conclusions on the State of Cultural Biology Bibliography Index

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Book SynopsisThis timely book discusses the application of the EU competition rules to pharmaceuticals, covering the prohibitions on anticompetitive agreements and abuse of dominance, and merger control.The author team comprises academic experts and private practitioners who analyse recent case law at both EU (and UK) and Member State levels – in the context of current issues and future trends, including those related to COVID-19 – and examine the impact of competition law on the behaviour of the pharmaceutical industry. The book carefully considers the balance between competition and innovation, as well as between competition and regulation. It concludes that competition and regulation are not alternatives, but complementary, and that novel ways of taking into account risk and real innovation through competition assessments have been developed.Integrating an overview of competition law, IP law and pharmaceutical regulation, this book will be an ideal read for scholars and graduate students, as well as private and public practitioners interested in pharmaceutical and European law.Trade Review‘Pharmaceutical and vaccine markets are highly complex. In European healthcare systems, the state is the major purchaser, and so ordinary rules of competition law are insufficient in themselves to respond to the various dynamics at play: cost-effective innovation; access to medicines; burden on the public purse. But competition law is one of the aspects of the relevant regulatory toolkit, so it’s crucial to understand how it applies. This cross-disciplinary and timely book goes well beyond the superficial, in its analysis and critique of contemporary developments and the direction of travel of European competition law as it applies to pharmaceuticals.’ -- Tamara Hervey, City, University of London, UKTable of ContentsContents: Foreword xiv PART I INTRODUCTION, LEGAL AND ECONOMIC CONTEXT 1 Introduction 2 Marcel Canoy, Jotte Mulder and Wolf Sauter 2 Excessive pricing doctrine in the pharmaceutical sector: the space for reform 16 Frederick M Abbott 3 Evergreening exclusive rights in pharmaceutical products: the case of SPCs, paediatric extensions and orphan drugs 33 Frantzeska Papadopoulou 4 The economics of patents and innovation in pharma 48 Marcel Canoy and Matthijs Versteegh PART II THE COMPETITION CASES SECTION IIA PAY FOR DELAY AND PATENT STRATEGIES 5 Settlement agreements acknowledging patent validity in the United Kingdom 62 Okeoghene Odudu 6 Anticompetitive pharmaceutical patent settlements: the EU cases on pay-for-delay 79 Jotte Mulder and Wolf Sauter SECTION IIB EXCESSIVE PRICING 7 The Aspen case of the Italian Competition Authority 98 Claudia Desogus 8 Unfair pricing: policy considerations and recent experience in the pharmaceutical sector 113 Andrew Groves and Lourenço Ventura 9 Temporary dominance and excessive pharmaceutical pricing – CD Pharma (Denmark) 124 Behrang Kianzad 10 Excessive pricing for pharmaceuticals in the Netherlands: the Leadiant case 138 Freek Bruggert and Clara Ceulemans 11 The EU Aspen decision: the European Commission’s first excessive pricing decision in the pharmaceutical market 151 Harald Mische SECTION IIC DISPARAGEMENT AND MISLEADING INFORMATION 12 Disparagement: the European Union and France 175 Adrien Giraud, Juliette Raffaitin and Constance Dobelmann 13 The dissemination of misleading information in the pharmaceutical market: the Italian experience 199 Margherita Colangelo SECTION IID MERGERS AND PARALLEL TRADE 14 EU merger control in the pharmaceutical sector: an overview 213 Jan Truijens Martinez 15 Taking stock of the single market imperative in the Court’s case law on parallel trade in pharmaceuticals: are matters as settled as they seem? 229 Jotte Mulder PART III FUTURE DIRECTIONS 16 Towards responsive enforcement of EU antitrust in pharmaceuticals 248 Wolf Sauter 17 Excessive pricing in pharmaceuticals: perspectives from EU antitrust and regulation 264 Giorgio Monti and Leigh Hancher 18 Tackling grand challenges with competition law: lessons from the pandemic 281 Ioannis Lianos, Timo Minssen and Christy Kollmar Index

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Book SynopsisA TELEGRAPH BOOK OF THE YEAR. An undercover investigation into the synthetic-drug epidemic. A new group of chemicals is radically transforming the recreational-drug landscape. Known as novel psychoactive substances (NPS), they range from so-called ‘legal highs’ like Spice, to synthetic opioids – most famously, the deadly fentanyl. Designed to replicate the effects of established drugs like cocaine, ecstasy, marijuana, and heroin, NPS are synthesised in laboratories. They are cheap to produce and easy to transport. They are also extremely potent and often deadly. Originally developed for medicinal purposes, and then hijacked by rogue chemists, who change their molecular structures to stay ahead of the law, these chemicals’ effects can be impossible to predict. What we do know is that they have triggered the biggest drug epidemic that America has ever seen, and which is now spreading internationally. In Fentanyl, Inc., award-winning journalist Ben Westhoff goes undercover to investigate the shadowy world of synthetic drugs — becoming, in the process, the first journalist to infiltrate a Chinese fentanyl lab. He tracks down the drug baron in New Zealand who unintentionally helped to start the synthetic-drug revolution; prowls St. Louis streets with a former fentanyl dealer to understand how the epidemic started; and chronicles the lives of addicts and dealers, families of victims, law enforcement officers, and underground drug-awareness organisers in the US and Europe. Fentanyl, Inc. is essential reading on a global calamity we are only just beginning to understand.Trade Review‘It’s a sucker-punch of a read … Westhoff exposes, with cinematic scope and reams of data, a new epidemic.’ -- Harriet Alexander * The Daily Telegraph *‘Groundbreaking.’ -- Eleanor Halls * The Telegraph *‘An eye-opening work of journalism, informed on the legal and pharmaceutical aspects without losing sight of the human cost.’ -- Alastair Mabbott * The Herald *‘A fascinating book.’ -- Seán Moncrieff * The Moncrieff Show *‘Through his courageous reporting, Ben Westhoff takes us to the heart of the problem. In Fentanyl, Inc. he shines a light on the human wreckage and damage caused by the most powerful and dangerous of the opioids, fentanyl, and its derivatives. He shows us how addiction, mislabeling, purposefully or mistakenly mixed drugs lead to tragic ends. The drug is often created out of factories operating with the permission of the Chinese government. To solve this epidemic, we must understand it. Make no mistake; the fentanyl problem is a global issue. Fentanyl, Inc. is a must-read, pulling the curtain back and showing us how this human tragedy occurs and how insidious and addictive a drug can be.’ -- Katherine Tobin, PhD, Former Member of the U.S.-China Economic & Security Review Commission‘A necessary and sobering look at the opioid crisis and how it is not as simple as it appears on the surface. Well-researched and user-friendly for all readers. An important book.’ -- Debra Ginsberg * Bay Books *‘Drawing material from official reports, drug databases, scores of interviews, and years of personal research, Westhoff presents an unflinching, illuminating portrait of a festering crisis involving a drug industry that thrives as effectively as it kills. Highly sobering, exemplary reportage delivered through richly detailed scenarios and diversified perspectives.’ STARRED REVIEW * Kirkus Reviews *‘This is an exceptionally useful and well-timed book. I hope anyone concerned about this era’s new addiction epidemic will read it and put its messages to use. Ben Westhoff very skilfully combines pharmacology, politics, law enforcement, and gripping international intrigue in his account of America’s number-one public health problem. I hope Fentanyl, Inc. is widely read and influential.’ -- James Fallows, award-winning journalist and author of China Airborne‘In Fentanyl, Inc., Ben Westhoff lays bare the twisted history that led to opioids wreaking havoc on twenty-first century America. If you want to understand the bloody cycle of addiction and death gripping the nation, you need to read this book.’ -- Ioan Grillo, author of El Narco and Gangster Warlords‘An information-packed work of reporting that traces the rise of designer drugs, including synthetic and/or more dangerous versions of weed, acid, and heroin, the last of which gives the book its title. Fentanyl, a synthetic opioid that’s chemically similar to morphine and heroin, is the top cause of fatal drug overdoses in the United States. The most illuminating parts of the book are those that reveal the business practices of Chinese labs that supply illicit fentanyl to U.S. dealers. These labs are a source of death and destabilisation for our country, American officials say, while Chinese leaders contend that it’s on us to deal with Americans’ appetite for the stuff.’ -- Francie Diep * Pacific Standard *‘Westhoff explores the many-tentacled world of illicit opioids, from the streets of East St. Louis to Chinese pharmaceutical companies, from music festivals deep in the Michigan woods to sanctioned ‘shooting up rooms’ in Barcelona, in this frank, insightful, and occasionally searing exposé ... Offers a truly multifaceted view of the landscape of fentanyl use and abuse. The disparate narrative strands he weaves together — including tragic stories of drug users, straightforward analysis of the history of opioid use, tension-filled episodes of drug runs and supplier meet-ups, and the humane and hopeful work of the ‘harm reduction’ movement—all come together to provide a more complex understanding of the rise of, and response to, the opioid epidemic. Westhoff’s well-reported and researched work will likely open eyes, slow knee-jerk responses, and start much needed conversations.’ * Publishers Weekly *‘Excellent’ -- Mary Wakefield * The Spectator *‘Will assist policymakers, activists, and general readers in understanding better how to respond to the drug crisis that is only more intractable now.’ * Library Journal *‘So many substance abuse books are a mix of hysterical in tone and a disappointing ‘paint by numbers’ in their execution, but [Fentanyl, Inc.] really stands out for its research, journalism, and overall analysis ... It is also a great book on China, and how China and the Chinese chemicals industry works, backed up by extensive original investigation ... Definitely recommended.’ -- Tyler Cowen * Marginal Revolution *‘Timely and agonising … [Westhoff’s] book is the product of a four-year deep-dive into the world of designer drugs, and it’s an impressive work of investigative journalism. He interviewed 160 people and visited laboratories all over the world; he even infiltrated a pair of Chinese drug operations.’ * USA Today *‘A history lesson on American drug use and drug laws, a crash course in chemistry and neuroscience, a multifaceted portrait of addiction, and a look at how harm reduction programs can atone for the failures of the War on Drugs … A finely woven and accessible analysis of the connection between university chemistry professors, dark web sales, drug cartels, law enforcement, and the dealers and addicts dependent on it … Westhoff is a skilled and empathetic biographer, and this gift serves the composite of the dealers, users, and bereaved of Fentanyl, Inc. … It’s in this focus on the human cost of the crisis, of empathy over criminalisation, that this accomplished book feels most urgently important.’ * St. Louis Post-Dispatch *‘The most frightening book of the year, and it’s mandatory reading … Epic … This is a story about people, and Fentanyl, Inc. features a roster of villains and victims who stray far from movie archetypes.’ * Dig Boston *‘Setting Fentanyl, Inc. apart from most other books that focus on the supply-side of illegal drugs, Westhoff smartly avoids pro-drug-war narratives that push for an intensified law-and-order response to the proliferation of more potent synthetic drugs … The War on Drugs and misguided law enforcement efforts have not stemmed the spread of fentanyl, but instead have contributed to its takeover, Westhoff carefully explains.’ * Filter *‘Extensively reported and vividly written … Westhoff elevates his impressive examination of the opioid epidemic by reporting on the US government’s failed war on drugs and the promise of innovative ‘harm reduction’ policies that recognise that ‘Just Say No’ is a losing proposition.’ * National Book Review *‘Westhoff looks at the new wave of synthetic drugs that are taking the opioid epidemic to a whole new deadly level. He managed to go undercover into one of the many labs in China where these drugs are being manufactured, and the results of his research there and elsewhere are terrifying … Anyone who is interested in learning more about the opioid crisis, or has read Dopesick, is going to want to check this out.’ * Omnivoracious, the Amazon Book Review *‘A detailed and far-ranging investigation into the production, marketing, and usage of fentanyl reveals an intertwined business network that spans continents and kills thousands.’ * Shelf Awareness *‘In this gripping investigation, Westhoff recounts the deadly consequences of synthetically made drugs and how this phenomenon is beginning spread internationally.’ * Happy Mag *‘The way [Fentanyl, Inc.] looked at every aspect of the novel psychoactive substance trade was unique. From chemists manipulating chemical structures of precursors to fentanyl before countries can ban them, to the dealers, end users and those who want to change the way addiction is treated, Westhoff details it all ... this book is an eyeopener to anyone who reads it of just how coordinated and advanced the illicit drug trade is in aiming to get new highs to market at any cost.’ * Sam Still Reading *‘Fentanyl, Inc. is a wake-up call to us all. Shocking and unnerving.’ -- Judith Baragwanath * Noted *‘The information uncovered by Westhoff, an investigative reporter, will no doubt prove useful to lawmakers, addiction counsellors, and anyone else who is dealing with opioid addiction ... But where the book really shines is in Westhoff’s ability to get inside the lives of his characters, from addicts like Henke and Schwandt, to the scientists who initially developed opioids, to the Chinese chemists who are manufacturing fentanyl knockoffs — and profiting hugely off the global rise of opioid addiction ... a feat of reporting, to be sure. And while the many details Westhoff uncovered are likely to leave some readers enraged, Fentanyl, Inc. is an important book that arrives at a key juncture in the opioid crisis.’ -- Arlene Weintraub * The New York Journal of Books *‘[E]pic ... like Breaking Bad, sure — meets Night of the Living Dead meets New Jack City, Gummo, Kids and Gremlins, with a cast from a lot of the places on President Donald Trump’s ‘shithole’ list ... Westhoff includes ample relevant history.’ -- Chris Faraone * Little Village *‘A really fascinating book on a terrifying subject.’ * Joe Rogan *‘Excellent … Readable and alternately engaging and chilling in its account of the development, deployment, and devastating consequences of NPS … Politicians, police, and the public continue to debate how to handle the use of psychoactive substances in our culture and legal system. Westhoff’s Fentanyl, Inc. should be required reading for anyone who wishes to contribute to a knowledgeable discussion.’ * Winnipeg Free Press *‘A fascinating look into how China is playing a major role in the spread of fentanyl across the US. The book connects the dots between the pharmaceutical companies and their role in the opioid crisis with the Chinese labs manufacturing the illicit fentanyl and manoeuvring it through Mexico to get it into the US. Highly recommend it!’ * Yahoo Finance *Praise for Original Gangstas ‘I trust Ben Westhoff. I trust him to report a story and I trust him to tell a story, and that's exactly what he's done here in Original Gangstas. He's taken what's always felt like an almost impossibly knotted string of storylines and plot points in gangsta rap, the most turbulent version of the most popular music on the planet, and turned them into an airtight and unflinching book. Original Gangstas is as resolute as the people and ideas it sets out to profile, and that is no small feat.’ -- Shea Serrano, New York Times bestselling author of The Rap Year BookPraise for Original Gangstas ‘A provocative, multifaceted portrait of essential rap pioneers who ushered the hip-hop music scene to greatness … As raw, authoritative, and unflinching as the music his narrative chronicles, Westhoff comprehensively uncovers the factual roots of the gangsta rap movement and admirably credits those whose footprints paved the way for the younger rappers emerging today … An elaborately detailed, darkly surprising, definitive history of the LA gangsta rap era.’ STARRED REVIEW * Kirkus *Praise for Dirty South ‘Packed with lively reporting and colourful social history … doesn't shy away from the bigger questions. Westhoff grapples with Southern rap's troubling racial politics and takes on the critics.’ * Rolling Stone *

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