Innovation in Medical Technology: Ethical Issues and Challenges

7. Questions, Issues, and Recommendations Going Forward

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 bene fited from the boldness of countless physicians who have innovated on their behalf. Physicians who succeed as innovators are often esteemed by their peers, and they reap justifiable professional and personal rewards for their achievements . Given all of these benefits, it is not surprising that some physicians believe they have a duty to innovate and should be accorded the freedom to do so as a professional prerogative. On the other hand, despite its benefits, medical innovation deployed outside of a research environment often occurs haphazardly and may be implemented without producing generally useable data regarding the consequences. Ideally, medical innovations originate from a sound theoretical base, but some are also supported by little more than hopeful guesswork. Empiricism also supports the development of new treatments, which again can be solid or based only on the fact that a treatment seems to work, without an understanding of how or why it works. This lack of consistency or standard practice in how innovations come about has led to recommendations that most medical innovation should be subject to research requirements. Rather than relying on trial and error, the argument goes, carefully controlled and executed studies will produce the most reliable information about the benefits and risks of new therapies and procedures. Innovation based on research allows physicians to move beyond inference to a greater certainty (depending on the trustworthiness of the data) that a treatment or practice is beneficial. Questions, Issues, and Recommendations Going Forward chapter seven These divergent views were discussed at the Lasker Foundation Forum that led to this book. The forum’s participants identified four core questions and issues that should guide any consideration of how new medical technologies should be deployed. 1. Should medical innovation be deployed as research or as medical practice? 2. What are the thresholds and models for oversight? 3. What information should be disclosed to patients? 4. Is there a professional duty to learn and to educate other practitioners? should medical innovation be deployed as medical research or as medical practice? All of those who have addressed this question have faced the di;culty of distinguishing between medical research and medical practice. Despite their seeming di=erences, the dividing line can be hard to find. The distinction can depend on the context in which an innovation takes place. For instance, a change in surgical technique intended to reduce the chance of cutting a nerve seems more like adaptive practice and unlike using a drug for a disease for the first time, which seems more like research. But there are many times when it is di;cult to distinguish between changes that should be researched before general implementation and changes that are merely innovation “creep,” where physicians are changing therapy or technique to fit the needs of patients. Despite its attempt at clarification, the Belmont Report leaves many questions on the distinction between research and practice open for further discussion. Much research is conducted with a reasonable belief that human subjects will benefit medically, and plenty of physicians and surgeons would disagree about what constitutes a “radical” departure from standard practice and thus requires a research protocol. Because change in medical practice is often characterized by a continuous stream of small innovations, the attendant incremental progress crosses no bright line into agreed definitions of formal research. So how is one to distinguish between the two? Despite a professional and academic dialogue that began more than thirty years ago in the United States, there still seems to be no consistent opinion. The range of views on the subject is typified by the account relayed by a surgeon at the Lasker Forum. He described an innovative practice that resulted when a colleague attempted to improve the postoperative results of balloon angioplasty followed by the insertion of a coronary stent.1 Surgeons generally had been in favor of using the stents but were frustrated by the fact that stent patients expeQUESTIONS , ISSUES, AND RECOMMENDATIONS GOING FORWARD 95 rienced an unacceptably high rate of potentially fatal blood clots, despite the use of a blood thinner, warfarin. Although it was counterintuitive, this particular surgeon suspected that the blood thinner...