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Innovation in Medical Technology

Ethical Issues and Challenges

Margaret L. Eaton, Pharm.D., J.D., and Donald Kennedy, Ph.D.

Publication Year: 2007

This thought-provoking study examines the ethical, legal, and social problems that arise with cutting-edge medical technology. Using as examples four powerful and largely unregulated technologies—off-label use of drugs, innovative surgery, assisted reproduction, and neuroimaging—Margaret L. Eaton and Donald Kennedy illustrate the difficult challenges faced by clinicians, researchers, and policy makers who seek to advance the frontiers of medicine safely and responsibly. Supported by medical history and case studies and drawing on reports from dozens of experts, the authors address important practical, ethical, and policy issues. They consider topics such as the responsible introduction of new medical products and services, the importance of patient consent, the extent of the duty to mitigate harm, and the responsibility to facilitate access to new medical therapies. This work's insights into the nature and consequences of medical innovation contribute to the national debate on how best to protect patients while fostering innovation and securing benefits.

Published by: The Johns Hopkins University Press


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p. v

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pp. vii-xii

Early in the current millennium, the Lasker Foundation1 determined that it was time to examine the landscape of innovation in modern medical technology, to look at how new, unproved medical technologies are being deployed, and to identify ethical issues associated with this rapidly advancing arena of medical practice. This exploration began with a forum, the Lasker Forum on Ethical Challenges ...

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p. xiii

As described above, this book grew out of the Forum on Ethical Challenges in Biomedical Research and Practice, initiated and sponsored by the Albert and Mary Lasker Foundation with additional and very welcome support from the Walter and Elise Haas Fund, the Robert Wood Johnson Foundation, the Greenwall Foundation, and the American Association for the Advancement of Science. ...

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Introduction: The Need to Ask Questions about Innovation

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pp. 1-22

What is admirable about human abilities? Should limits be placed on human ability and action? How does a daring person get into trouble? Constantly and confidently innovating with the goal of conquering disease and injury is one of mankind’s most admirable activities. Limiting this endeavor should perhaps be ...

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1. Distinguishing Innovative Medical Practice from Research

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pp. 23-36

Before we address any of the ethical issues associated with innovation in medical technology and whether it should proceed as practice or as research, we must ask a fundamental definitional question: What is innovative medical practice and what is research? The problem of distinguishing the two was thoroughly considered in the United States more than thirty years ago. In 1974, Congress, reacting ...

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2. The Modern History of Human Research Ethics

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pp. 37-46

Just as it is instructive to understand the history of medical practice innovations and the attempts to distinguish it from medical research, it is likewise helpful to be acquainted with the modern history of research on humans and how it led to the formalized ethics obligations of researchers and to the protections currently afforded to human subjects. Knowing this history enhances one’s ability to ...

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3. Innovation in the Off-Label Use of Drugs

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pp. 47-56

Innovation in drug therapy often occurs in the unregulated “off-label” use of drugs. The term off-label comes from the FDA’s regulation of what uses a drug is approved for and what claims a pharmaceutical company is allowed make about any approved drug. Because all of this information is included in the drug’s labeling, using a drug for an unapproved purpose has come to be called “off-label ...

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4. Innovative Surgery

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pp. 57-71

Innovations in the way surgeries are performed often occur with little or no advance oversight. If supervision is present, it is most likely done by medical-credentialing or peer review staff, who aim to assure that physicians are sufficiently skilled to perform a particular surgery at that hospital, or by the FDA if there is an innovative device involved, for the FDA tries to assure that surgical devices ...

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5. Innovation in Assisted Reproduction

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pp. 72-83

Assisted reproductive technology (ART) had its start in the 1970s and, according to estimates by the Centers for Disease Control and Prevention (CDC), since 1978 approximately 0.9 percent of all U.S. births and more than one million children worldwide have been conceived with ART procedures. Until the late 1980s, assisted reproductive technology was successful only 10 percent of ...

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6. Innovation in Neuroimaging

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pp. 84-93

Functional magnetic resonance imaging (fMRI) is a new medical tool that is being used to understand diseases of the brain and nervous system and also the neural basis for human behavior. Findings from fMRI and other neuroimaging techniques produce real-time images that show which parts of the brain are active at that time. For instance, fMRI images can detect when parts of the brain ...

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7. Questions, Issues, and Recommendations Going Forward

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pp. 94-113

Many people believe that innovators are medicine’s heroes—men and women who are not resigned in the face of impending death or disability but instead look for ways to improve treatment options for their patients. Many patients have benefited from the boldness of countless physicians who have innovated on their behalf. Physicians who succeed as innovators are often esteemed by their peers, ...

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Conclusion: Final Thoughts on the Landscape of Innovation

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pp. 114-118

Shortly before this book went to press, the New York Times reported on an operation performed on Vice President Dick Cheney (Altman 2005). The procedure involved the placement of stent-grafts to repair aneurysms in the arteries behind both knees. One day after the surgery, the vice president was reportedly doing well. However, surgeons and interventional radiologists were debating the wisdom ...

Appendix A. Directives for Human Experimentation: Nuremberg Code

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pp. 119-120

Appendix B. World Medical Association Declaration of Helsinki

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pp. 121-126

Appendix C. Description of Department of Health and Human Services Regulations for the Protection of Human Subjects

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pp. 127-129

Appendix D. Participants in Lasker Forum on Ethical Challenges in Biomedical Research and Practice

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pp. 130-134


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pp. 135-142


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pp. 147-150


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pp. 151-155

E-ISBN-13: 9780801891946
E-ISBN-10: 0801891949
Print-ISBN-13: 9780801885266
Print-ISBN-10: 0801885264

Page Count: 176
Publication Year: 2007

OCLC Number: 310353957
MUSE Marc Record: Download for Innovation in Medical Technology

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Subject Headings

  • Medical technology -- Moral and ethical aspects.
  • Medical innovations -- Moral and ethical aspects.
  • Medical ethics.
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