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This volume covers a wide range of topics concerning methodological, epistemological, and regulatory-ethical issues around pharmacology. The book focuses in particular on the diverse sources of uncertainty, the different kinds of uncertainty that there are, and the diverse ways in which these uncertainties are (or could be) addressed. Compared with the more basic sciences, such as chemistry or biology, pharmacology works across diverse observable levels of reality: although the first step in the causal chain leading to the therapeutic outcome takes place at the biochemical level, the end-effect is a clinically observable result—which is influenced not only by biological actions, but also psychological and social phenomena. Issues of causality and evidence must be treated with these specific aspects in mind. In covering these issues, the book opens up a common domain of investigation which intersects the deeply intertwined dimensions of pharmacological research, pharmaceutical regulation and the related economic environment. The book is a collective endeavour with in-depth contributions from experts in pharmacology, philosophy of medicine, statistics, scientific methodology, formal and social epistemology, working in constant dialogue across disciplinary boundaries.
Introduction : The Challenge of Uncertainty in Medicine -- The Nature and Etiology of Uncertainty -- The Anatomy of Uncertainty -- The Natural History of Uncertainty -- The Management of Uncertainty -- A Way Forward : Systematizing Uncertainty Tolerance.
This work provides a thought-provoking account of how medical treatments can be tested with unbiased or 'fair' trials and explains how patients can work with doctors to achieve this vital goal. It spans the gamut of therapy from mastectomy to thalidomide and explores a vast range of case studies.
Uncertainty is the norm in medical practice, yet often gives rise to distress in clinicians, who fear they will make shameful or guilt inducing errors. This book offers a succinct method to clinicians for classifying uncertainty and finding the right skills to manage different types of uncertainty successfully. Every clinician experiences moments when 'they don't know what to do'. Modern medicine is increasingly complex and training has also become more complicated. The days of 'see one, do one, teach one' are over. Yet, both younger clinicians and senior practitioners describe uncertainty as one of the most challenging and stressful aspects of clinical work. If uncertainty is uncomfortable or threatening to individual practitioners, it also provides complex educational challenges. How can we learn to cope with uncertainty effectively ourselves? How can we teach others to understand and manage uncertainty? In this ground breaking book, the authors propose ways to cut through uncertainty, which is explored as an inevitable (and even desirable) component of clinical practice. A Map of Uncertainty in Medicine (MUM) is used to classify uncertainty and to define the skills that will help find a way though practical difficulties. It is always good to have your MUM with you in a tricky situation!
What makes a good doctor? It's not what you think. A doctor willing to face their own uncertainty in the face of illness and treatment might just be the best medicine. Too often we choose the wrong doctor for the wrong reasons. It doesn't have to be that way. In The Good Doctor, Ken Brigham, MD, and Michael M.E. Johns, MD, argue that we need to change the way we think about health care if we want to be the healthiest we can be. Counterintuitive as it may seem, uncertainty is integral to medicine, and you want a doctor who knows that: someone who sees you as the unique case you are, someone who knows that data isn't everything, someone who is able to change her mind as the information changes. For too long we've clung to the myth of the infallible doctor--one who assuredly tells us this is what's wrong and here is how I will cure you--and our health has suffered for it. Brigham and Johns propose a new model of medicine, one that is comfortable with ambiguity and that centers on an equal partnership between patient and doctor. Uncertainty, properly embraced, opens a new universe of possibilities.
"Will ever-more sensitive screening tests for cancer lead to longer, better lives? Will anticipating and trying to prevent the future complications of chronic disease lead to better health? Not always, says Robert Aronowitz. In fact, it often is hurting us... Drawing on such controversial examples as HPV vaccines, cancer screening programs, and the cancer survivorship movement, Aronowitz demonstrates that patients and their doctors have come to believe, perilously, that far too many medical interventions are worthwhile because they promise to control our fears and reduce uncertainty." -- Taken from book flyleaf.
This book offers a philosophically-based, yet clinically-oriented perspective on current medical reasoning aiming at 1) identifying important forms of uncertainty permeating current clinical reasoning and practice 2) promoting the application of an abductive methodology in the health context in order to deal with those clinical uncertainties 3) bridging the gap between biomedical knowledge, clinical practice, and research and values in both clinical and philosophical literature. With a clear philosophical emphasis, the book investigates themes lying at the border between several disciplines, such as medicine, nursing, logic, epistemology, and philosophy of science; but also ethics, epidemiology, and statistics. At the same time, it critically discusses and compares several professional approaches to clinical practice such as the one of medical doctors, nurses and other clinical practitioners, showing the need for developing a unified framework of reasoning, which merges methods and resources from many different clinical but also non-clinical disciplines. In particular, this book shows how to leverage nursing knowledge and practice, which has been considerably neglected so far, to further shape the interdisciplinary nature of clinical reasoning. Furthermore, a thorough philosophical investigation on the values involved in health care is provided, based on both the clinical and philosophical literature. The book concludes by proposing an integrative approach to health and disease going beyond the so-called "classical biomedical model of care".
Set against the unexplained stroke of the author's newborn daughter, this stunning, unflinchingly honest memoir is a thought-provoking reflection on uncertainty in medicine and in life. Growing up as the daughter of a dedicated surgeon, Elizabeth L. Silver felt an unquestioned faith in medicine. When her six-week-old daughter, Abby, was rushed to the Neonatal Intensive Care Unit with sudden seizures, and scans revealed a serious brain bleed, her relationship to medicine began to change. The Tincture of Time is Silver's gorgeous and haunting chronicle of Abby's first year. It's a year of unending tests, doctors' opinions, sleepless nights, promising signs and steps backward, and above all, uncertainty: The mysterious circumstances of Abby's hospitalization attract dozens of specialists, none of whom can offer a conclusive answer about what went wrong or what the future holds. As Silver explores what it means to cope with uncertainty as a patient and parent and seeks peace in the reality that Abby's injury may never be fully understood, she looks beyond her own story for comfort, probing literature and religion, examining the practice of medicine throughout history, and reporting the experiences of doctors, patients, and fellow caretakers. The result is a brilliant blend of personal narrative and cultural analysis, at once a poignant snapshot of a parent's struggle and a wise meditation on the reality of uncertainty, in and out of medicine, and the hard-won truth that time is often its only cure. Heart-wrenching, unflinchingly honest, and beautifully written, The Tincture of Time is a powerful story of parenthood, an astute examination of the boundaries of medicine, and an inspiring reminder of life's precariousness.
Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.