Conflict Of Interest And Medical Innovation

Scientific advances such as the sequencing of the human genome have created great promise for improving human health by providing a greater understanding of disease biology and enabling the development of new drugs, diagnostics, and preventive services. However, the translation of research advances into clinical applications has so far been slower than anticipated. This is due in part to the complexity of the underlying biology as well as the cost and time it takes to develop a product. Pharmaceutical companies are adapting their business models to this new reality for product development by placing increasing emphasis on leveraging alliances, joint development efforts, early-phase research partnerships, and public-private partnerships. These collaborative efforts make it possible to identify new drug targets, enhance the understanding of the underlying basis of disease, discover novel indications for the use of already approved products, and develop biomarkers for disease outcomes or directed drug use. While the potential benefits of collaboration are significant, the fact that the relationships among development partners are often financial means that it is vital to ensure trust by identifying, disclosing, and managing any potential sources of conflict that could create bias in the research being performed together. Conflict of Interest and Medical Innovation is the summary of a workshop convened by the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health in June 2013 to explore the appropriate balance between identifying and managing conflicts of interest and advancing medical innovation. A wide range of stakeholders, including government officials, pharmaceutical company representatives, academic administrators and researchers, health care providers, medical ethicists, patient advocates, and consumers, were invited to present their perspectives and participate in discussions during the workshop. This report focuses on current conflict of interest policies and their effect on medical innovation in an effort to identify best practices and potential solutions for facilitating innovation while still ensuring scientific integrity and public trust.

For millennia, human survival depended on our innate abilities to fight pathogens and repair injuries. Only recently has medical science prolonged longevity and improved quality of life. Physicians and academic researchers contribute to such progress, but the principal contributor is private industry that produces the tools – drugs and medical devices – enabling doctors to prevent and cure disease. Heavy regulation and biology’s complexity and unpredictability make medical innovation extremely difficult and expensive. Pharmaphobia describes how an ideological crusade, stretching over the last quarter century, has used distortion and flawed logic to make medical innovation even harder in a misguided pursuit of theoretical professional purity. Bureaucrats, reporters, politicians, and predatory lawyers have built careers attacking the medical products industry, belittling its critical contributions to medical innovation and accusing it of non-existent malfeasance: overselling product value, flaunting safety and corrupting physicians and academics who partner with it. The mania has imposed “conflict-of-interest” regulations limiting or banning valuable interactions between industry and physicians and researchers and diverting scarce resources from innovation to compliance. The victims are patients suffering from cancer, dementia, and other serious diseases for which new treatments are delayed, reduced, or eliminated as a result of these pointless regulations. With breathtaking detail, Thomas Stossel shows how this attack on doctors who work with industry limits medical innovation and inhibits the process of bringing new products into medical care.

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

In the context of a growing criticism on the influence of the pharmaceutical industry on physicians, scientists, or politicians, Conflict of Interest and Medicine offers a comprehensive analysis of the conflict of interest in medicine anchored in the social sciences, with perspectives from sociology, history, political science, and law. Based on in-depth empirical investigations conducted within different territories (France, the European Union, and the United States) the contributions analyze the development of conflict of interest as a social issue and how it impacts the production of medical knowledge and expertise, physicians’ work and their prescriptions, and also the framing of health crises and controversies. In doing so, they bring a new understanding of the transformations in the political economy of pharmaceutical knowledge, the politicization of public health risks, and the promotion of transparency in science and public life. Complementing the more normative and quantitative understandings of conflict of interest issues that dominate today, this book will be of interest to researchers in a broad range of areas including social studies of sciences and technology, sociology of health and illness, and political sociology and ethics. It will be also a valuable resource for health professionals, medical scientists, or regulators facing the question of corporate influence.

While plenty can be said about the dysfunction of our health care system, rarely do business and private players in health care innovation get a good rap. This book takes on skeptics of the partnership between the medical community, political groups, and private businesses, by illustrating how such cooperation can result in world-class innovation and health care delivery.

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

Medical Innovation: Concept to Commercialization is a practical, step-by-step approach on how to move a novel concept through development to realize a commercially successful product. Real-world experience cases and knowledgeable contributors provide lessons that cover the practices of diverse organizations and multiple products. This important reference will help improve success and avoid innovation failure for translational researchers, entrepreneurs, medical school educators, biomedical engineering students and faculty, and aspiring physicians. Provides multiple considerations and comprehensive lessons from varied organizations, researchers and products Designed to help address topics that improve success and avoid the high cost of innovation failure Recommends the practical steps needed to move a novel, non-developed concept into a tangible, realistic and commercially successful product

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.