Innovation in Medical Technology: Ethical Issues and Challenges

Introduction: The Need to Ask Questions about Innovation

ready, resourceful man! Never without resources never an impasse as he marches on the future— only Death, from Death alone he will find no rescue but from desperate plagues he has plotted his escape Man the master, ingenious past all measure past all dreams, the skills within his grasp— he forges on, now to destruction now again to greatness. When he weaves in the laws of the land, and the justice of the gods that binds his oaths together he and his city rise high— but the city casts out that man who weds himself to inhumanity thanks to reckless daring. —Sophocles, Antigone (442 B.C.E.) 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 The Need to Ask Questions about Innovation introduction considered only when the harms of medical innovation outweigh the benefits. Recognizing in advance when harms are likely to predominate is never easy, but, as Sophocles suggests, it may help to consider the “laws of the land” and the “justice of the gods”—in other words, to acknowledge the social contracts and moral responsibilities that temper “reckless daring.” Exploring these wider implications of the way in which modern pioneering medical technologies are introduced in the real world is the purpose of this book. The choice of conduit for introducing medical advances—as research or as a new way to practice medicine—generates the fundamental ethical and social policy issues in this domain. Many other issues and conflicts flow from this choice, especially because the pace, sophistication, and power of medical technology innovation have been rapidly increasing. Yet, few recent or comprehensive e=orts have been made to address the ethical and social issues associated with this steady advance. Medical innovation is perhaps best exemplified by the following circumstance. A skillful physician-scientist encounters a patient with an unexpectedly challenging life-threatening condition. Treatments meeting the usual medical “standard of care” have proved unavailing, but the physician—possibly encouraged by the results of animal experiments conducted in his laboratory—believes that a di=erent kind of intervention could work. The novel treatment or procedure is applied, and the patient improves! Most practitioners and patients would applaud the physician for going forward—at least the first time. The level and persistence of approval might depend, of course, on just how far from standard the new intervention was and whether the physician intended to try the same thing again. In the interest of patients in general, most practitioners and most medical organizations (professional societies, hospital boards, and the like) support innovative medicine that preserves health and saves lives. At some point, however, the decision must be made as to whether an innovation is to be regarded as a practice variation, lying clearly within the scope of the physician’s initiative, or as something else. The “something else” would be research: clinical innovation conducted under a planned protocol, with its outcome carefully recorded, the process subject to a highly evolved system of oversight and rules designed to protect patients (read: human subjects) from the adverse consequences of premature use of a technology, of less than fully informed consent, and of overly enthusiastic recruitment .1 Thus it is that innovation sometimes proceeds and spreads with little oversight, whereas at other times it is called research and made subject to extensive controls. That constitutes something of a paradox. Regulated research on humans is defined as: a systematic investigation designed to develop or contribute to generalizable knowledge (Code of Federal Regulations). If an innovating 2 INNOVATION IN MEDICAL TECHNOLOGY physician is not using systematic methods or intending to advance general medical knowledge, the innovative activity is not subject to regulatory control and supervision . That has led one observing ethicist to wonder why it is that “we regulate only when we expect to learn something!” That charge is not entirely fair, because there is an intermediate condition: although healing a sick patient may be the primary motivation of physicians applying new treatment methods, they often use an orderly approach, carefully record conditions and results, and publish the results of their innovative techniques. That kind of overlap between these two activities has created a gray area, in which...