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Author: Jon Jureidini
Publisher:
ISBN: 9781743057247
Category :
Languages : en
Pages : 330
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Book Description
An exposé of the corruption of medicine by the pharmaceutical industry at every level, from exploiting the vulnerable destitute for drug testing, through manipulation of research data, to disease mongering and promoting drugs that do more harm than good. Authors, Professor Jon Jureidini and Dr Leemon McHenry, made critical contributions to exposing the scientific misconduct in two infamous trials of antidepressants. Ghostwritten publications of these trials were highly influential in prescriptions of paroxetine (Paxil) and citalopram (Celexa) in paediatric and adolescent depression, yet both trials (Glaxo Smith Kline's paroxetine study 329 and Forest Laboratories' citalopram study CIT-MD-18) seriously misrepresented the efficacy and safety data. The Illusion of Evidence-Based Medicine provides a detailed account of these studies and argues that medicine desperately needs to re-evaluate its relationship with the pharmaceutical industry. Without a basis for independent evaluation of the results of randomised, placebo-controlled clinical trials, there can be no confidence in evidence-based medicine. Science demands rigorous, critical examination and especially severe testing of hypotheses to function properly, but this is exactly what is lacking in academic medicine.
Author: Jon Jureidini
Publisher:
ISBN: 9781743057247
Category :
Languages : en
Pages : 330
Get Book Here
Book Description
An exposé of the corruption of medicine by the pharmaceutical industry at every level, from exploiting the vulnerable destitute for drug testing, through manipulation of research data, to disease mongering and promoting drugs that do more harm than good. Authors, Professor Jon Jureidini and Dr Leemon McHenry, made critical contributions to exposing the scientific misconduct in two infamous trials of antidepressants. Ghostwritten publications of these trials were highly influential in prescriptions of paroxetine (Paxil) and citalopram (Celexa) in paediatric and adolescent depression, yet both trials (Glaxo Smith Kline's paroxetine study 329 and Forest Laboratories' citalopram study CIT-MD-18) seriously misrepresented the efficacy and safety data. The Illusion of Evidence-Based Medicine provides a detailed account of these studies and argues that medicine desperately needs to re-evaluate its relationship with the pharmaceutical industry. Without a basis for independent evaluation of the results of randomised, placebo-controlled clinical trials, there can be no confidence in evidence-based medicine. Science demands rigorous, critical examination and especially severe testing of hypotheses to function properly, but this is exactly what is lacking in academic medicine.
Author: George Everly, Jr.
Publisher:
ISBN: 9781943001149
Category :
Languages : en
Pages :
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Book Description
Psychological Crisis Intervention: The SAFER-R Model is designed to provide the reader with a simple set of guidelines for the provision of psychological first aid (PFA). The model of psychological first aid (PFA) for individuals presented in this volume is the SAFER-R model developed by the authors. Arguably it is the most widely used tactical model of crisis intervention in the world with roughly 1 million individuals trained in its operational and derivative guidelines. This model of PFA is not a therapy model nor a substitute for therapy. Rather it is designed to help crisis interventionists stabile and mitigate acute crisis reactions in individuals, as opposed to groups. Guidelines for triage and referrals are also provided. Before plunging into the step-by-step guidelines, a brief history and terminological framework is provided. Lastly, recommendations for addressing specific psychological challenges (suicidal ideation, resistance to seeking professional psychological support, and depression) are provided.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
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Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309253187
Category : Medical
Languages : en
Pages : 248
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Book Description
There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.
Author: Edward H. Ahrens
Publisher: Oxford University Press, USA
ISBN: 9780195051568
Category : Medical
Languages : en
Pages : 270
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Book Description
The current crisis in clinical research cannot be fully appreciated unless the underlying economic, sociological and motivational problems in American medicine are fully understood. Accordingly, this important book describes the evolution of biomedical research in relation to changes in institutional perceptions of the importance of each of the three roles that U.S. medical schools play--teaching, research and service to patients. Ahrens meticulously analyzes seven very different kinds of research activity that are included under the term "clinical research." He describes the profound shift in emphasis from patient-oriented research to research at the cellular and molecular level. This shift has created an imbalance between two contrasting research approaches to the problems of human disease--reductionism and integrative research. In searching out the reasons for this change, Ahrens carefully examines institutional supports for clinical research--the medical school environment in which the research is carried out and the main funding source, the National Institutes of Health. This timely work identifies the fundamental differences between reductionism and integrative research and provides clear evidence that if both modes are to prosper in the future, as they must, then patient-oriented research must receive far stronger support from U.S. medical schools and the N.I.H. Ahrens masterfully argues that changes must be made in the special training of clinical investigators and in their funding requirements, and that new working partnerships between clinically skilled M.D.s and technically trained Ph.D.s are urgently needed in order to restore patient-oriented research to full productivity and to accomplish a re-balancing that most effectively assures quality research in the future.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309046289
Category : Medical
Languages : en
Pages : 337
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Book Description
Europe's "Black Death" contributed to the rise of nation states, mercantile economies, and even the Reformation. Will the AIDS epidemic have similar dramatic effects on the social and political landscape of the twenty-first century? This readable volume looks at the impact of AIDS since its emergence and suggests its effects in the next decade, when a million or more Americans will likely die of the disease. The Social Impact of AIDS in the United States addresses some of the most sensitive and controversial issues in the public debate over AIDS. This landmark book explores how AIDS has affected fundamental policies and practices in our major institutions, examining: How America's major religious organizations have dealt with sometimes conflicting values: the imperative of care for the sick versus traditional views of homosexuality and drug use. Hotly debated public health measures, such as HIV antibody testing and screening, tracing of sexual contacts, and quarantine. The potential risk of HIV infection to and from health care workers. How AIDS activists have brought about major change in the way new drugs are brought to the marketplace. The impact of AIDS on community-based organizations, from volunteers caring for individuals to the highly political ACT-UP organization. Coping with HIV infection in prisons. Two case studies shed light on HIV and the family relationship. One reports on some efforts to gain legal recognition for nonmarital relationships, and the other examines foster care programs for newborns with the HIV virus. A case study of New York City details how selected institutions interact to give what may be a picture of AIDS in the future. This clear and comprehensive presentation will be of interest to anyone concerned about AIDS and its impact on the country: health professionals, sociologists, psychologists, advocates for at-risk populations, and interested individuals.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309157870
Category : Medical
Languages : en
Pages : 317
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Book Description
The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.
Author: Bruce Jennings
Publisher: Oxford University Press
ISBN: 0190270748
Category : Medical
Languages : en
Pages : 321
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Book Description
Leading scholars in bioethics and public health ethics clarify the key values and norms of emergency planning and response and address ethical issues relating to the allocation of scarce resources, research in the context of emergencies, community participation in preparedness planning, the protection of those with special needs, and the duties public health professionals.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309285526
Category : Medical
Languages : en
Pages : 217
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Book Description
Disasters and public health emergencies can stress health care systems to the breaking point and disrupt delivery of vital medical services. During such crises, hospitals and long-term care facilities may be without power; trained staff, ambulances, medical supplies and beds could be in short supply; and alternate care facilities may need to be used. Planning for these situations is necessary to provide the best possible health care during a crisis and, if needed, equitably allocate scarce resources. Crisis Standards of Care: A Toolkit for Indicators and Triggers examines indicators and triggers that guide the implementation of crisis standards of care and provides a discussion toolkit to help stakeholders establish indicators and triggers for their own communities. Together, indicators and triggers help guide operational decision making about providing care during public health and medical emergencies and disasters. Indicators and triggers represent the information and actions taken at specific thresholds that guide incident recognition, response, and recovery. This report discusses indicators and triggers for both a slow onset scenario, such as pandemic influenza, and a no-notice scenario, such as an earthquake. Crisis Standards of Care features discussion toolkits customized to help various stakeholders develop indicators and triggers for their own organizations, agencies, and jurisdictions. The toolkit contains scenarios, key questions, and examples of indicators, triggers, and tactics to help promote discussion. In addition to common elements designed to facilitate integrated planning, the toolkit contains chapters specifically customized for emergency management, public health, emergency medical services, hospital and acute care, and out-of-hospital care.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309124999
Category : Computers
Languages : en
Pages : 334
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Book Description
In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
