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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 of what had been done. The stent-grafts had not been approved by the FDA for use in knee vessels, and their use for this purpose was therefore considered o=-label and innovative. No one knew, for instance, if these devices could withstand the constant knee motion to which they would be subjected. In addition, the intent initially was to operate on only one knee, but during the surgery the surgeons had decided to do both, which doubled the operative time to six hours and created unknown risks of complications. Presumably, if the operating surgeons had been allowed to speak to the press, they would have supported their work. Other surgeons who did speak to the Times reporter, however, expressed concern about both choices, to use the devices in the knees and to operate on both knees at once. The fact that these issues about an innovative surgery appeared in this article is evidence that they have risen in the public interest. It is also an indication , we think, of the timeliness of addressing the topic of how to deploy innovative medical technology. The ethical challenge in this area is one with which one of us (DK) became familiar as commissioner of the Food and Drug Administration in the late 1970s. On the one hand, new technologies and new procedures o=er the possibility of dramatic short-term benefit—even rescue—for the patient under treatment. On Final Thoughts on the Landscape of Innovation conclusion the other hand, premature introduction of those technologies or procedures presents real risks of iatrogenic illness; they may damage more than they cure. So the purpose of regulation, whether in the form of patient protection systems or of restraints on the approval of new drugs and devices, is to slow the deployment of technology until it has been thoroughly examined for risk. That e=ort can lead to lively arguments. FDA commissioners are often asked, as a challenge, whether the process of approving new drugs at the FDA might not slow the progress of innovation. The answer is, “of course.” Regulation seeks to find a public policy position that balances the costs of premature introduction against the costs of forgone innovation. Those responsible for health policy constantly face a cross- fire of charges: that they are not doing enough to protect patients and that they are doing harm to patients by forestalling innovation. This is an old dilemma in medicine, and it will be with us for some time. This book and the Lasker Forum on Ethical Challenges in Biomedical Research and Practice on which the book is based are attempts to address this dilemma, in the process sketching the landscape of the current ethical and social issues associated with innovative medical technology. The medical literature, the lay press, and the forum discussions indicate that views on the topic of medical innovation range widely, from great optimism to extreme caution. Despite this disparity, there is agreement that innovative medical technology should be viewed in a social and ethical context. Some issues have been classified as valleys in the landscape, receiving little attention. For instance, access to new technology and social justice have received relatively less attention, perhaps because, as one forum participant put it, “we can’t do anything about them in today’s medical system, so why even discuss them?” Other issues rise up unavoidably, like peaks in the landscape, having more importance or being more amenable to resolution. These issues tend to receive the bulk of the attention. They include the main question, whether medical innovation should be deployed as research or as medical practice, and subsidiary questions like what oversight might be appropriate for unregulated technology, what disclosure duties exist when patients are first exposed to unproven medical technologies, and whether physicians have a duty to learn about the benefits and risks of their innovations and to pass this learning on to their colleagues. On the overarching question of whether research or medical practice settings best serve medical innovation, the general assessment seems to be that not unless a particular new technology poses an unacceptable risk is deployment...

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