Good morning. I’m Amy Gutmann, and I’m President of the University of Pennsylvania and Chair of the Presidential Commission for the Study of Bioethical Issues. This is the Commission’s third public meeting and I thank you all for joining us. I extend my deepest thanks to Vice Chair, Jim Wagner, President of Emory University, who is hosting us today and also to each of our Commission members for their truly exemplary service. I’d also like to take note of the presence of our designated federal officer, Valerie Bonham, who makes this meeting legal, thank you, Valerie. Valerie is also the Executive Director of the Presidential Commission. Let me give you a very quick overview of where we are in our deliberations.
Nearly six months ago, President Barack Obama asked our Commission to recommend how the developing field of synthetic biology and related biotechnologies can maximize public benefit, minimize risks, and operate within appropriate ethical boundaries. In addressing our charge from the President, we made a conscious effort to be an inclusive and deliberate body. Much stands to be gained from taking an open approach to decision making. From the outset, our Commission has encouraged the exchange of perspectives, with the goal of making recommendations that will aid President Obama and, above all, serve the public good.
At the Commission’s first two meetings we heard from more than thirty invited experts and public representatives who explored essential territory from multiple perspectives: the science, the risks, the benefits, the concerns of public stewardship, and more. Some guests presented information about recent and ongoing achievements in the science of synthetic biology, as well as current and future applications. Others shared their perspectives on possible benefits and anticipated risks.
At each meeting, we welcomed questions from the public, as well as from our Commission members, and that’s a format that’s proved to be highly interactive and we’ve had some very valuable sessions. We plan today to continue, this time, presenting you with a provisional set of our recommendations and opening up discussion among the Commission members and among those of you who have come to be part of our deliberation.
We’ve tried to build solid ethical and philosophical analysis to our work, while remaining firmly rooted in the practical realities that are an integral part of our Commissions charge. So, our power is to influence policy through the persuasiveness of our recommendations. We do not have legislative authority. We have advisory authority. We’ve attempted to take into account all the facts, contexts, and perspectives presented to us. So what we will do today is begin the important task of formulating our recommendations.
I’m going to present to you now, and you see them projected here, a draft framework for our report that consists of five principles that we take to be important in the area of synthetic biology and biotechnology more broadly understood. I’ll say something very briefly about each one of these principles and then, through our sessions, we will expand on how these principles have formed our recommendations in synthetic biology. Each one of the Commissioners today and tomorrow will present one or more recommendations. After I give a very quick overview of the principles, I’m going to turn to President Wagner to give us a very quick, but very essential, sense of what we take synthetic biology to be and the context in which these principles are operating.
So, our framework for evaluating emerging technologies, we think, can have a direct impact on future policymaking and public consciousness of bioethical issues more generally, because synthetic biology represents only the next link in a long chain of scientific innovation to relatively new field. The principles that we’re going to discuss are very relevant to synthetic biology, but they’re equally relevant to recombinant DNA research, for example. Just as the Belmont Report many years ago, decades ago, in fact, created an important framework for the discussion of ethical treatment of research subjects, this Commission’s work can spur the creation of a common vocabulary to discuss biotechnological advances. We also think we can help advance national and international conversations about this rapidly changing area of science.
So, the first principle is one that should be familiar to everybody who has read the Belmont Report or has been influenced by it. It is the principle of Public Beneficence. As others and we have understood the principle, the core of that principle is to maximize public benefits, while minimizing potential possible harm. We begin with that principle.
The second principle is new to presidential Commission work and very relevant to synthetic biology and biotechnology and that is the principle of Responsible Stewardship. Interestingly, several of our presenters gestured toward this principle. One actually recommended to us to have a principle of stewardship. Responsible Stewardship is a charge to scientists and public bodies and individuals alike, to be trustees of the interests of those who can’t represent themselves. We are stewards of the interest of children of future generations, the environment, and of present and future interests that are not represented in the democratic process itself, so that’s responsible stewardship. It’s very relevant to the concerns, as well as the promise, of synthetic biology. Many of our presenters talked about how important it is for our recommendations to attend to the needs of stewarding the environment and biodiversity as we look forward.
The third principle, again, none of these principles should strike people as idiosyncratic, this is a principle that not been explicitly articulated in many reports by previous presidential Commissions, but it’s an incredibly important principle for the work of science and that is the principle of Intellectual Freedom and its corresponding Intellectual Responsibility. We will have recommendations on that.
The fourth principle — which you won’t be surprised that I stand behind, but I actually am not the first to suggest this principle to this Commission — is that of Democratic Deliberation. There are many issues that we take up — indeed, there’s almost no issue that we would take up that doesn’t have some controversy at its base — otherwise if we took these truths to be self evident then we wouldn’t have to discuss them so much, right? Democratic Deliberation tells us basically to have open and inclusive forums with reasonable debate and discussion over issues of difference and commonality and come to some understanding, and, when possible, a consensus, and if not possible, then a respect for the differences that continue.
Fifth is the principle of Justice and Fairness. That is also common to the Belmont Report and that principle asks us to be responsible in attending to the distribution of benefits and harm so that people do not unfairly either gain benefits, or are subject to harm disproportionately.
Those are our five principles. I’ve just laid them out in whirlwind fashion, but we will come back to them when each commissioner presents the recommendations in draft as we’re considering them. I’ll just say that we have, as of this minute, we’re thinking of nineteen recommendations that fall under these five principles. And there is more … you will hear about each one of them in the course of these two days proceeding.
I will now turn it over to Jim Wagner to say a little bit more about synthetic biology, since I said almost nothing about it.
It will be just a little bit more. First of all, Amy, thank you for the leadership of the Commission. This has been a really remarkable and productive process on this first topic and I imagine the other topics we address will go equally well in great measure to your leadership. Welcome to the Commission and to Emory University. Welcome to those in the audience and those in the extended audience, the electronic audience, we’re pleased to have you join us as well. While I’m doing welcomes and thanks, Val, thank you and your team for the extraordinary work that you’re doing to help the Commission to display the fruits of its labors. At Emory, in particular Michael Kloss and Gary Hauk, thank you folks for helping us to put this particular session together.
It is a good thing for the Emory community to see deliberations of this committee in part because, explicitly declared in the documents that guide us are references to us being ethically engaged and to addressing the frontiers of science and technology. This is certainly exactly what this Commission is about, so I’m delighted for Emory’s sake to welcome you here.
To talk a little about synthetic biology — and it’s interesting that in our very first meeting in July, we asked for a definition and I guess we were rebuffed because they couldn’t give us one definition — I will guide you. Perhaps, we can be guided by the incident that brought the topic to the Commission in the first place. The Commission was not created to address synthetic biology; the Commission was broadly established on the study of bioethical issues. It was in May, most of you in the audience recall, that the Craig Venter Labs announced what could be described by everyone to be a milestone activity, a feat of genetic engineering, a triumph of genetic engineering in some ways, where the process that he went through is one that permitted the DNA — the entire genome, in fact, from one bacterial species, after it was read, to be then discarded — it existed then only in information and data — and recreated out of laboratory chemicals, synthetically and then reinserted into another chassis, if you will, of another bacterium or another species and shown to be able to have converted the second species to the genetic behaviors and the process behaviors the first species had. Okay? So, it was a transcription process, but at the end of the day, the entire genome that was transferred had been manufactured on a laboratory bench.
Obviously, there was some pretty swift reaction to this. The fact that from data … It seems to me that one of the Commission’s issues about how one manages intellectual property of synthetic biology is complicated — not any more difficult necessarily — but complicated by the notion that the coin of the realm of synthetic biology may be nothing more than bits and bytes of information. From data and laboratory chemicals, the prospect of engineering controllable and reliable properties in organisms, such that they would behave in ways that they do not naturally behave in nature. It got a lot of attention, and it should get a lot of attention. Imagine programmable biological micro factories, if you will, producing fuels, pharmaceuticals, fertilizers, foods, materials, hormones, and enzymes. Imagine the prospects even for genetic vaccination based on the activities of being able to controllably and reliably reprogram, or add programmed functions to, biology synthetically.
And of course, in addition to the excitement, there are a good deal of concerns. What if what is produced is more robust than exists in nature and are we concerned about that? What if this new technology could be applied for malevolent purposes? In exercising this, to what degree could we be … could we risk interfering with the natural order of life, some have asked.
The process that our chair, President Gutmann, outlined over the course of the first two meetings in July and September, we have the opportunity here to hear from thirty-four experts. We’ll have a couple more experts in the sessions today and tomorrow to guide us in helping us to address the charge President Obama gave us to ensure the maximum benefits for society while doing the best we can to obviate the risks. To try to articulate what is marvelous about the technology of synthetic biology and how best to pursue it. What are the threats that we can know or can imagine and how should we avoid them? And to acknowledge that there may be — there certainly are — opportunities that we can’t even imagine now and sooner or later may be some risks that we can’t imagine, that are unknowable, but how is it that we would advise society to be best prepared when we ultimately encounter those kind of risks.
We’ll discuss today a set of recommendations that are intended to provide our best guidance, and we’ll be open to the thoughts of those who are with us today and to others who can log in later and e-mail us. Thoughts that we hope, what we expect and have been told, will address public policy. We have some thoughts, in fact, about private action. To take all of this — to take best advantage of the promise, and to take responsible precautions, to preclude suffering negative consequences of accidents and malicious intent — is a wonderful challenge, and I am in awe of the group that’s been assembled to do this and have been learning wonderfully, at some point I’ll get back to them. But in the mean time, we need to hear from our people, so I’ll turn the microphone back to our chair.
Thanks, Jim. I feel blessed by having a wonderful vice chair and great commission, and now everybody will have chance, as we all will, to deliberate about our recommendations as they are in our minds at the present and will, no doubt, have some revisions as we take advantage of these two days.
Let me say first that one of our Commission members can’t be here in person, but is here over the speakerphone. I’m going to go around and have all of our Commission members introduce themselves, so Raju, let me begin with you.
Amy, thank you. I apologize for not being there. I’m Raju Kucherlapati and Professor of Genetics and Medicine at Harvard Medical School.
I’m Nita Farahany; I’m an Associate Professor of Law and Philosophy at Vanderbilt University.
Good morning. I’m John Arras; I teach Philosophy and Bioethics at the University of Virginia in Charlottesville.
Hi, I’m Anita Allen, I’m happy to be here in my hometown of Atlanta and I’m a Professor of Law and Philosophy at the University of Pennsylvania.
I’m Dan Sulmasy from the University of Chicago, Department of Medicine, the MacLean Center for Clinical Medical Ethics, and the Divinity School.
Good morning. Steve Hauser, Department of Neurology, University of California in San Francisco, I’m a neurologist and a neuroscientist.
I’m Barbara Atkinson; I’m the Executive Vice Chancellor and the Executive Dean School of Medicine at the University of Kansas in Kansas City, Kansas.
Hi, I’m Lonnie Ali, I have an MBA from UCLA, and I’m married to Muhammad Ali.
Good morning, I’m Dr. Alex Garza; I’m the Assistant Secretary for the Office of Health Affairs and Chief Medical Officer for the Department of Homeland Security.
Good morning everyone, I’m Christine Grady from the Department of Bioethics at The Clinical Center at the National Institutes of Health.
I’m Nelson Michael from the Walter Reed Army Institute of Research.
Thank you all, and let me reintroduce Valerie Bonham, who is our Executive Director. Valerie, would you stand up, so people can recognize you? Thank you.