Moderator: Gary Roubin, MD
John Brumieve, Cook Medical
Jamie Jacobs, Abbott Vascular
Patricia Todd, Edwards Lifesciences
Max Muhs, Medtronic
Andrew Cragg, MD
Richard Shaw: While all the panelists are coming up to the stage I would like to take the opportunity to speak briefly. Gary Roubin was very generous in giving tribute to a lot of people who made this meeting happen but I think the person that really drives this society in terms of leadership and has always driven the society is Gary Roubin, and I want to make sure that we all acknowledge Gary for his contributions in making this all possible.
Gary Roubin: Thank you Dick. Allow me to frame the discussion of “How can Physicians and Industry be more effective in speeding product development and innovation?” by pointing out that this august society was founded on the principles set forth by Andreas Gruentzig. The father of Interventional Cardiology was an extremely talented physician and technician, an equally committed and rigorous clinical scientist, an effective innovator and entrepreneur who had from the outset close relationships with the device industry. In the end these collective talents were pivotal in his success in bringing PTCA to the medical community. In todays challenging compliance, economic and regulatory environment, what must physicians and industry do to continue the remarkable success this approach has offered our patients? The United States has provided leadership to the entire world in device development and rigorous scientific evaluation of cardiovascular therapies. This work has in no small way contributed to the dramatic improvement in cardiovascular mortality over the last two decades. Barry Katzen noted earlier in this meeting that in some respects, our profession and the device industry has brought additional regulation upon ourselves because of excesses from a minority in our community. I have always wondered if ongoing leadership from a strong and ethical individual such as Andreas may have modulated this behavior. Howard Cohen just pointed out there are many fine clinician scientists such as Richard Kuntz, the late Don Baim, Chuck Simonton, and Campbell Rogers to name a few, that have moved to work with industry and done a fabulous job. In this model of physician involvement there are of course clear boundaries. For physicians who prefer to maintain their clinical and academic focus, compliance with issues of conflicts of interest becomes much more complex and challenging. Bonnie Weiner is absolutely right that this problem is manifest on guideline-writing committees and cannot be simply addressed by Conflict Declarations. I believe the opportunity to be entrepreneurial and innovative with or without industry affiliation exists as long as we are absolutely transparent. And transparency goes beyond, in my view, beyond declaring your conflicts of interest. Essentially, such individuals must withdraw from the scientific podium. If you have direct business interests your role is clear at a business and analyst symposium but not at national scientific sessions. Teaching courses remains problematic, and while we cannot deny the audience the opportunity to learn from experienced operators (who may or may not have adequately declared their conflicts of interest), moderators must at the very minimum repeatedly point out the potential bias. And of course financial conflict is not limited to industry relationships. Those whose financial futures and those of their team depend on large extramural grants are always conflicted, and their scientific positions are potentially biased by financial realities. There is no room in this complex discipline of medicine for any of us to adopt “holier than thou” opinions. All of us are biased by our professional and personal experiences. Bias that can easily transcend our desire for evidence-based approaches to medicine.
A second important topic for the panel is the influence current regulations are having on delaying the availability of effective and safe therapies for patients in the US. Are patients that are receiving cardiovascular devices, for example in Western Europe or Australia, disadvantaged or put at greater risk than patients in the US? They don’t have the rigorous FDA machine controlling the access to devices! My observation back and forwards over the years has been that there is no evidence that they are worse off or that the US patients are better served with the current regulatory environment. The privatization of Notified Bodies in the EU has in my view provided an extraordinarily efficient and safe environment for device approval. So, I think that is a good place to start. Andy, why don’t you kick off this discussion.
Andrew Cragg: I have raised this question often with others in my profession. Gary and I have been fortunate to travel around and do cases around the world and I couldn’t agree more. I have not seen any evidence in the fine medical centers I have visited in Europe and South America that patients have been compromised. I do think our current regulatory process is an aberration that has grown out of our litigious environment and the economic problems we have, and somewhat from the excesses, but I don’t think it has made our American patients safer. I would like to focus on how physicians can work with industry and develop products. I spend half my time in practice and half my time developing medical devices. I’ve been in medical device development for 30 years and I am still optimistic. I think there are tremendous advances to be made in our field and they will happen because our patients are always going to demand new technology leading to better outcomes. I am optimistic that this will eventually prevail; and we will have a process where we can develop new products that will benefit patients. And, those that develop these devices will profit from their hard work and innovation. The current environment is challenging. I don’t have time to discuss all of the issues, but I deal with venture capitalists and corporate entities and it is a field in turmoil at present. But the pathway to get medical devices approved for physicians has changed dramatically in the last few years. In my view, investors are currently only interested in big market devices that require PMA approval, or alternatively, smaller niche devices only if approval can be accomplished with a 510K approval. Consequently, medium cap market devices requiring an arduous PMA pathway that may have great benefit for patients, languish for the need of essential investment.
John Brumieve: Where to begin? I think Nick Hopkins had a meeting a couple of years ago that really convinced me on how physicians should deal with conflicts of interest. He emphasized, always have a contract set up when you are working with a company if you get any remuneration whatsoever. The company will report the transaction and you must declare the relationship. From the European perspective, at a major radiology meeting this year, the leadership executive council was just gloating about the advantage they as physicians had over their American colleagues. Stating correctly “all the American companies are coming to Europe at the present time and introducing their products.” They look at our geographic location and how it is working for their business models, so I know that all of the industry representatives here are global companies and we are all looking at doing our signal arm studies in Europe and Asia. As global companies we all want simultaneous product introduction and first-to-market opportunities. Consequently a lot of technology is going offshore and the clinical studies are being conducted off shore. It is a fact of life and as a company, we find it very disturbing.
Gary Roubin: Any thoughts from Cook Inc. on what we might do to change this situation we are in?
John Brumieve: We are very vocal with the FDA and we often have one of our CEOs or Presidents speak to congress. We are on the record as being in favor of changing the system. You know there are ways to change the system. One is using a third party to undertake the mechanics and work of the approval process. There are checks and balances to ensure that they do a rigorous job. Many governments are going to these third party bodies for validation of safety and manufacturing compliance. This could be an avenue, it seems to work in Europe and it seems to work in other places.
Jamie Jacobs: Starting a foundational issue, I think one of the biggest problems we have is that the FDA is in this no win situation. I think we have talked about it many times. They feel this responsibility to protect the American population and there is really no incentive for the FDA to have new and better technologies coming through. If it is successful then industry and the medical community get the accolades. If it’s not, then the FDA shares the blame so they become hyper-conservative. Their best situation is to introduce nothing really. But there is a certain fundamental responsibility that the FDA is not bearing. If you think about these technologies not being available, how many patients are suffering worse disease, are dying, or having a lower quality of life? Yet the regulators seem to place less value on this side of the equation. That is a decrease in the state of American health because of overregulation and the lack of technology. There is only a penalty if something is brought forward and approved and it then has some sort of adverse effect. So there is a balance. Maybe we as a medical community need to point out some of the things that regulators are doing to actually damage the health of our society. This argument needs to be managed delicately and very carefully. We in industry and the medical community must not appear to be self-serving when we go to the government. Legislators must pay attention to their constituents. Patients in need of this technology can better make the point for us. Maybe we could have other organizations such as AARP help us make this important representation for the benefit of their members. Then there is the media, folks like Larry King, Oprah Winfrey and Jay Leno and a variety of other celebrities who can influence the constituents. Maybe there is some potential there.
As far as speeding innovation, there really is a desperate need to have collaboration with physicians and I don’t see that this collaboration is really all that inhibited when it comes to practice. We have a lot of advisory panels and as long as there is a contractual agreement, as long as it is clear and concise and you are comfortable with your remuneration being displayed under the Sunshine Act regulations, then it can all work. So we can move forward with that, I think the bigger problem is with regulators impeding progress in the US. I have a number of products that I just don’t plan on bringing to the US because of the high hurdle and it is a shame. As a responsibility to the shareholders I can’t justify that process.
Gary Roubin: Max what perspectives can you give us from the Asian Pacific region?
Max Muhs: Innovation in the medical device industry is vastly different from innovation in the pharmaceutical industry. In that industry, innovation is at the bench and is pushed down to the bedside through translational research. With medical devices, innovation in the main is almost always at the bedside. Concepts come from physicians who struggle to find a better way to do a procedure. Those concepts are taken to the bench where an engineer will prototype it and take it back to the bedside for further refinement. So I think bedside to bench defines innovation in the medical device world and it is critical that we have physicians as part of the interface in the innovation process. If you look at the major innovations that came from physicians the list is very long but to note a few: implantable pacemakers, ICDs, aortic endografts, percutaneous valves, coronary balloons, angioplasty, coronary and peripheral stents; I mean the list goes on and on. I think if government, if hospitals or universities try and stop physicians from interacting with industry, industry will face a major problem. So I think there needs to be a concerted effort to ensure that the government, medical centers and universities understand that these collaborative efforts must continue if we are going to see innovations that benefit patients.
Gary: Well said Max, thank you. Patricia.
Patricia Todd: I am Tricia Todd, I am here representing Edwards Life Sciences and first I want to say thank you for having us here as part of this meeting.
In previous session there was voiced some concern that innovation and collaboration between industry and clinicians might be in trouble. I can absolutely guarantee you that this is not the case and I think you have heard that from some of my colleagues. Edwards is a company that has been working proudly with clinicians the entirety of its existence from Drs. Star, Fogarty, Swan and Ganz and we continue to do that. One of the calls in today’s session was the need to be transparent when you work with companies. But frankly in the US, companies will be transparent for you. Consultation agreements will be laid bare by the companies themselves.
One point I would make concerning the role of clinicians in device approval is the commitment and willingness to not only participate in clinical trials but to actively recruit patients. If you are going to be a part of a clinical trial, if you are going to sign up, if you are going to take one of these slots in a clinical trial then be ready to randomize your patients. If you want products to continue to come to market on label in a timely manner in the United States be ready to randomize those patients. Secondly, physicians should push their professional societies to become involved since these organizations are a part of the conversations with CMS and the FDA.
Gary: Thank you. Any questions or comments from the floor?
Howard Cohen: One of the things that I find troublesome is that a lot of the technology and innovation that comes out of the United States is taken to Europe for assessment. Often these devices are evaluated with very good studies, rigorous, excellent studies. For some reason, these studies are not accepted by the FDA and the studies are reproduced again in the United States. There ought to be a way to somehow get the FDA to sign off on rigorous studies done in Europe and it would get things to market quicker in the US. One of the things that industry has to do and would maybe take some of the heat off of the FDA is to be responsible for very rigorous post-market surveillance of any device that is released. In addition, consider all the money that is going outside the US to do these trials. If we are trying to do something for the American Economy we should have some of that work done in the United States.
Gary Roubin: Allow me to reemphasize some important issues that have been discussed by the panel. First, innovation in the interventional cardiac and vascular space begins with thoughtful and creative, practicing clinicians identifying problems not addressed by current technology and therapies. These physicians working with engineers and scientists from multiple disciplines will formulate potentially effective solutions. There needs to be close collaboration with device manufacturers, finance and venture capital entities. Importantly, the exercise should begin with a clinical or technical problem that requires a solution. The alternative, beginning with technology looking for an application, is generally very inefficient and ineffective in terms of establishing better patient outcomes. Transparency as it applies to all elements of conflicts of interest is essential.
There exists an urgent need for the United States to “catch up” with our counterparts in the western world in terms of technology assessment and approval. We will, it appears, have to depend on our patients in need and our legislators to correct the current anomalies.