Surgical innovation and ethical dilemmas: A panel discussion
ETHICAL DILEMMAS ARISING FROM NEW OPTIONS
Question from audience: In my specialty, we have a non-life-threatening condition with a well-established 25% recurrence rate after traditional surgery with sutures, and a 25% rate of reoperation. A device comes along and it improves the outcomes so that the recurrence rate declines to 10%, but along with the extra costs of doing the procedure with the device, there is also a complication rate of about 10% that requires reoperation with the device, and a few of those patients actually end up worse. Ethically, how should the clinician proceed in this situation? The old way, or the new way that improves outcomes but at a higher cost and risk?
Dr. Fins: Based on the size of the populations, is the difference in the combined rates of recurrence and complications between the traditional and new methods (25% vs 20%) statistically significant?
Response from questioner: The difference is probably not statistically significant.
Dr. Fins: Okay, so you are saying that the numbers are basically equal. That is the first consideration, but there is a nuance to one of the variables, and that is an improvement in quality of life with one of the treatments. Measuring its significance is subjective. A patient may place greater emphasis on quality of life than would somebody who is not a beneficiary of the operation. That is why I said before that biostatistical input that goes beyond crude measures of mortality or reoperation rates can be very helpful. The risk of reoperation may be one that the patient is willing to take for a chance at an improvement in quality of life.
There is a wonderful book by Howard Brody called The Healer’s Power6 in which he writes about the physician’s power to frame a question so as to engineer outcomes. While that is not something that Brody endorses, he does endorse the use of the physician’s power to guide patients using good informed consent, providing direction without being so determinative that patients feel compelled to choose the physician’s recommendation. Patients should be able to decline your recommendation while still having the benefit of your counsel. And in a case like this, your counsel should include variables that may seem “softer” or more difficult to quantify than crude measures such as mortality or reoperation rates.
Dr. Rezai: You have to compare multiple outcomes between the two approaches—surgical time, recovery time, patient quality of life (as assessed by scales), family quality of life, time to return to work, etc. I think it is important to try new technologies because the failure rate or the complication rate may be reduced over time, but only if you evaluate the failures and then restrategize. Only in doing so can you reduce risk, and if the benefit profile and the risk profile prove to be good, then the new technology should be pushed forward.
Dr. Herndon: If the volume of procedures performed by the surgeon is important with respect to outcomes with either one of these two procedures, that should be taken into account. Also, if a new procedure carries a higher complication rate than the traditional procedure, I think that more cohort studies from large centers are needed to gauge the true complication rate before the new technology enters the general market. Continued surveillance, such as with a postmarket registry of outcomes with these procedures, would also be helpful to make adjustments in the future if necessary.
Dr. Hahn: If you looked at the early experience of Med tronic with pacers, you would be amazed at the number of deaths and complications that occurred during the first 3 years. But we do not even think about that now.
CAN INNOVATION HAPPEN WITHOUT INCENTIVES?
Question from audience: Dr. Hahn alluded earlier to the infl uence of money. All of you on the panel are institutionally based, and you are used to practicing with colleagues. I would suggest that surgery today is really not an individual sport, but that is the way it is practiced in much of the nation. Would we be better off if we developed a system that removed us from direct financial influence? Can we get the money out of the equation so that people have motives other than direct personal gain?
Dr. Hahn: I went to an institutional review board (IRB) retreat that included, of course, some IRB members who were not clinicians. They asked the same question that you just did: Why would you even expect to get anything for what you invent? I think that is naïve. People who work hard and invent things deserve to reap a reward. The challenge lies in working with industry, which may try to convince us to use its innovations without our input, as opposed to working with us to identify a clinical problem and trying to solve it together. In that way, the end product and the logic behind its use will be better.
I will give you an example from when I was head of surgery here. A company made a voice-activated table that would obey the surgeon’s commands, such as “left,” “right,” “up,” or “down.” I asked the representative why such a product was needed, and he responded that the surgeon wants to be in total control of the operating room. I told him we do not change the position of the table very often. After a 2-week trial, the table was a dud. He fired the entire group that was working on the project. It was a case of a company simply trying to come up with a product it could sell.
The opposite scenario is if I invent the latest and greatest stent for the carotids and I want to use it. The question becomes how to strike a balance: how to protect the patients while at the same time rewarding the inventor. Another challenge is that device companies want you to stay on their scientific advisory board and they will pay you for it.
These questions are a big concern, and we have spent a lot of time on these issues at Cleveland Clinic. In fact, we held our own conference on biomedical confl icts of interest in September 2006 with attendees from around the country to discuss the necessary firewalls for ensuring that data are not contaminated, that the surgeon-inventor does not fudge data so that his innovation will make it to the marketplace, etc. At that conference, a number of people spoke about Vioxx. I am a surgeon, and my take on the COX-2 inhibitors is that a lot of my patients take these drugs and think they are wonderful, but there are some problems and risks. What is wrong with explaining to patients the risks and complications of these drugs, making your own recommendation about their use (unless you are receiving money from their manufacturers, which you would need to disclose to patients), and then letting patients make their own informed decisions? Personally, I was on Bextra for 3 years and was furious when it was pulled from the market because nobody gave me a choice whether or not to continue using it.
Dr. Lieberman: Let’s explore this concept a little deeper. We know that innovation is so important, but how do we encourage clinicians to innovate in this environment? Dr. Hahn, you served as chairman of CC Innovations, which is Cleveland Clinic’s technology commercialization arm. What were some of the strategies you came across in that role?
Dr. Hahn: We look for creative staff. We tell them up front that we want them to come to Cleveland Clinic and invent things. Our mission is literally to work on problems and take solutions to our patients. The culture here is meant to be creative. As a part of that culture, we welcome working with industry, as opposed to industry thrusting its innovations on us.
We are averaging more than 200 invention disclosures per year. More than 500 of our staff are involved with various industrial partners, and we are not going to hide that. In fact, we are going to make it public. The thought is that we owe it to our patients to work on their problems. At the same time, we owe it to our patients to say when we are working with industry on a particular product and explain to them why we think it would work in their case, if we think it would. While doing so, we need to make it clear that we will be happy to refer them for a second opinion if they would like. If I have a patient who wants a second opinion, I will offer to make the phone call for them and get them in. I think that is an advantage of the model we have here.
The reality is that there are some procedures that can only be done by one surgeon here, a surgeon who may have helped develop the procedure or some technology involved in it. Are we going to tell that surgeon that he or she cannot perform the procedure on anyone? That does not make sense. So you need to have a management plan that puts in place firewalls to protect the data on that procedure from any possible contamination.
So yes, we do reward staff who are doing innovation, and we do work with industry, and we do tell our patients we are doing it, and we do build firewalls to protect the data.
Dr. Lieberman: How about the rest of the panel? What are your thoughts on providing incentives for innovation?
Dr. Fins: Money is a key issue. The way the landscape is now structured, collaborations with industry are part of the mix. Under the Bayh-Dole Act of 1980, institutions are granted intellectual property rights to ideas or inventions developed by their researchers, and then the institutions can enter into contracts with industry to move the innovations forward. If industry support of research were removed, we would have to double the budget of the National Institutes of Health to compensate.
On the other hand, industry support can sometimes prove to be a disincentive to innovation in that it may engineer certain kinds of research or deprive investigators of tools they may need to do more basic science types of research. It is an academic freedom issue. At a translational level, industry may be helpful and catalytic. But sometimes it pushes an investigator to work for a short-term innovative application at the expense of a more speculative, riskier innovation.
We need to acknowledge that industry collaborations are part and parcel of the universe and focus on working with industry to moderate its influences. At the same time, we must use our leverage on the investigative side of the equation to pursue academic freedom and to leverage industry resources to perhaps pay for some of the care that innovative devices make possible. For example, contracting agreements could be drawn up so that money came back to the populations that participated in a clinical trial, or to a community that otherwise may need the device but cannot afford it. I think we have to create some type of charitable impulse to moderate the excesses of the profits and use them for the common good.
Dr. Herndon: I would like to touch on disclosure. The orthopedic implant industry has been required by law to disclose its relationships with orthopedic surgeons, including the amount of money that surgeons may be getting from industry. This requirement has had unintended consequences that underscore the importance of disclosure. First, some of the monetary awards, whether market-driven or not, are quite excessive. Second, reviewing the contracts for royalties has led to the discovery that many are not supported by patents or intellectual property rights. Third, these disclosures have revealed that certain surgeons who work at major US institutions, and who thus have an obligation to pay the institution some of the monies from their research, have not disclosed their relationships for years and have kept those monies solely for themselves. So this disclosure requirement has brought many things to light.
Dr. Rezai: As long as there is human disease and suffering, innovation will continue. It has in the past and it will in the future. Most innovators have it in their genes and in their blood. They can be taught to innovate, but they have to have the intrinsic curiosity and the creative mind to be an innovator. Institutional support of innovation is important, as is respect for the process that must be followed, including transparency and disclosure. If you put all these together, then innovation can be facilitated.
