New surgical devices and ethical challenges
Promoting swift, safe, and smart innovation
By Thomas H. Murray, PhD
After listening to previous speakers at this conference, I am coming away with the message that we want a system for surgical innovation that is swift, safe, and smart.
In his keynote address, Dr. Thomas Fogarty, who will join us in this session’s panel discussion, mentioned that people who want to develop a new technology need to actually talk with those who are working in and familiar with the field. That observation is a fundamental insight behind the interdisciplinary methodology at the Hastings Center, where we identify issues in bioethics, develop relevant questions, and seek out people with various kinds of knowledge and insight to provide as comprehensive an understanding of those issues as possible.
The Hastings Center draws from people who make public policy, from people who interpret policy (such as those at the FDA), and from innovators. Two members of our board are biotech entrepreneurs who have created companies that make products that they hope will help many people. I have never found a shortage of people willing to talk to you. The real shortage is of people who are actually willing to listen. So we try to encourage that as well.
In his keynote, Dr. Fogarty also brought up some controversial issues surrounding conflict of interest. The Association of American Medical Colleges (AAMC) report7 that he criticized was written by a committee that included me as well as leaders from the pharmaceutical and device industries, researchers who were developing new drugs and surgical devices, medical school deans, legal scholars, and ethicists. I stand behind that report and believe that it made a fundamental distinction between drug development and device development. This distinction—which has been pointed out earlier in this conference—is that drug development involves a lot of preclinical and clinical work but results in a product that can simply be given to a patient with simple instructions, whereas device development involves continuous innovation and improvement even after preclinical and clinical testing, and typically requires special expertise and training for proper clinical use.
WHAT DOES INNOVATION REALLY COME DOWN TO?
I see the challenge of innovation as a challenge to balance a number of things that we value: innovation itself, access to that innovation, respect for the human subjects who are part of the testing process, and regard for the patients who will ultimately benefit.
We also need to acknowledge the realities of how innovative surgical devices and procedures are created and to foster a culture of innovation that incorporates every bit of wisdom we can gather. This includes insight into what motivates inventors, such as royalties, with which there is nothing wrong in principle. It also includes insight into how to bring helpful innovations to patients. For instance, what do investors look for before they put money into a company or a particular development? We also need insights into how institutions and bureaucracies work—including the dreaded committees, to allude again to Dr. Fogarty’s keynote. I think we can all agree with the widely held insight, “Among democracy’s many virtues, efficiency is not high.”
A PERSONAL TAKE ON SUCCESSFUL INNOVATION
Last month marked the 25th anniversary of my Starr-Edwards valve, which replaced a Hancock porcine valve that calcified about 8 years after it was sewn into my heart. I would like to thank prior panelist Michael Mussallem of Edwards Lifesciences for his company’s product, which has extended my life and the lives of many others. I am grateful to innovators and determined to ensure a healthy and vigorous culture of innovation in this country.
And I want that innovation to be swift, safe, and smart, though there are always tensions between these three values. The first two—swiftness and safety—are fairly straightforward: we should encourage creativity and innovation as much as possible, and we must respect the human subjects in whom we test new devices and the patients in whom we ultimately use them. But how can we ensure that innovation is smart? We must insist on a base of evidence that is as solid as possible while still being flexible. We also must learn which devices are the best matches for each patient.
Newborn screening is an example of one area that I have recently examined where innovation is fast proceeding in a way that might not be very smart. Recently we have seen a sudden and rapid expansion of the conditions for which newborns are screened. In many cases we do not know what action to take if test results are positive, and in some cases we have no known effective therapies. I have criticisms of the process by which this expansion was decided upon, but most experts—even those supportive of the expansion— agree that we need to become much smarter about systematically studying the new conditions being screened for. Similarly, we need to make our system of surgical innovation as smart as we can in terms of how we gather evidence.
Dr. Joseph Fins opened this conference by declaring, “Let the conversation begin.” I will conclude it by saying, “Let the conversation continue, and let it be vigorous, candid, and respectful, with unfailing regard for evidence.”
