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Thursday, March 12, 2009

Session 3: National Ethics Commissions:
Future Agendas

Mark Frankel, Ph.D., Director, Scientific Freedom, Responsibility and Law Program, American Association for the Advancement of Science

Nancy Kass, Sc.D., Phoebe R. Berman Professor of Bioethics and Public Health, Berman Institute, Johns Hopkins University


CHAIRMAN PELLEGRINO: Thank you. I think we're ready to go. A few more coming in. Despite all that discussion about lunch before lunch, we really did not have a big lunch. So I want to assure you that being late had to do with processing our payment, not overeating.

This afternoon we will turn to our next topic, which is that of national ethics commissions' future agendas, looking at how these kinds of organizations we've been looking at would look or should look or might look in the future.

I'll repeat for our two speakers, we don't give long curriculum vitae. That does in no way demean your extensive record of accomplishment, but only to save a little bit of time because you'll find that this council is eager to ask questions. But we will simply give you a title, so please bear with us. The first speaker this afternoon is Dr. Mark Frankel, who is the Director of Scientific Freedom Responsibility and Law program of the American Association for the Advancement of Science. Dr. Frankel.

DR. FRANKEL: I'm here. Can I be heard?

CHAIRMAN PELLEGRINO: Yes, we can hear you here. How about the rest of you?

DR. FRANKEL: No, they raised their hands. It's nice to have agreement at the beginning before I've said anything. Dr. Pellegrino, thank you.


DR. FRANKEL: It is both scintillating and somewhat daunting to be part of this day given the breadth of issues that you have been and will continue to discuss, but I do want to thank you and the council and the staff for giving me the opportunity to share some of my thoughts regarding looking forward and what future commissions might want to take a look at when they develop their agendas.

I have a couple of preliminary comments. I want to make clear that my remarks today are in no way representative of an official or unofficial position of AAAS. They're simply my thoughts on the issues. And I do want to acknowledge the research assistance of a couple of my staff who helped me put this together and who happen to be in the audience. I also want to give Professor Schneider a heads-up. There is one place in my talk when I use the acronym IRB.

PROF. SCHNEIDER: Abandon all hope.

DR. FRANKEL: While I think science and engineering are alive and well, there's a lot of creativity going on out there, a lot of interesting things being done, all of which probably have some ethical issues that we could think about and consider, but my time is limited with you, so I've chosen four that I would like to suggest are worth considering in terms of bioethics.

And I'll — if I get this right — we'll begin — that's a play on words, by the way — with personalized medicine. William Osler, who is often described as the father of modern medicine, wrote in 1892 that if it were not for the great variability among individuals, medicine might as well be a science, not an art. And it may be that medicine will soon approach that time when it can take on successfully the complexity of variability and enter a new era of science-driven medical practice.

I suspect that many of you have encountered the term "personalized medicine." This is a slide, I think, which really gets to the heart of it. And I don't want to be terribly technical about it, but the idea behind personalized medicine is to use the kind of variability referred to by Dr. Osler to develop new treatments and to identify subgroups of patients who are likely to benefit from them the most so that the one-size-fits-all medicine is likely to be tailored to individual patients, taking advantage, if you will, of those pesky variations.

And although doctors have long incorporated personal features and traits and characteristics of individuals, personalized medicine in the contemporary form holds the possibility of perhaps changing medicine dramatically by developing more powerful diagnostic techniques to go along with the knowledge that we gain about our genetic and neurological makeup.

The expectation is, for example, that it will lead to more successful therapies by targeting the right treatments to the right people and that it will also improve patient's safety by selecting drugs in their proper dosages to reduce adverse side effects, as well as improve the participation of clinical trial participants. Now, all of this according to its proponents is going to also lower the cost of health care.

Well, whether it does any or all of those things remains to be seen, but I do think it's very promising and based on my conversations with people and reading in the field and our own project, the AAAS, dealing with personalized medicine, I think it's worth exploring. It's beginning to emerge, and it's clear that there are a lot of scientists in collaboration with the medical profession who are heading in that direction.

Let me give you a few examples of things that are being done now that might come under the rubric of personalized medicine. Patients diagnosed with early stage invasive breast cancer can now be tested for the likelihood of recurrence as well as how well they will respond to chemotherapy. Very recently patients diagnosed with advanced colon cancer were advised by the American Society of Clinical Oncology to get a genetic test before undergoing two of the leading treatments. The advice is based on the discovery that the two drugs won't work for four in ten people and those patients can be identified through the test.

Now, what that information will do to the psyche of those patients is something that we need to think about, both in ethical and policy terms, but the science is moving along, if not gradually, certainly in drips here and drops there. Based on genome-wide association studies, which are studies which involve gathering massive amounts of data to compare people who have the genetic components of people who have a disease against those who don't, it's rarely a week that goes by that you don't see something in the literature, perhaps even in the newspaper, that scientists have been able to show an association between this gene and this disease. And you can almost fill in the blank as to what disease it might be.

In fact, last year researchers found that there were nine genes linked to Type 2 diabetes. Now, the difficulty with all of this is twofold. One, we're not sure what to do with the information; and, two, we're really not quite sure how to interpret it in the context of health, not only because genes will vary, if you will, in their penetration — and, in fact, the effect that genes have are likely to be of an interplay or an interaction between various genes — it's also missing any connection to lifestyle and environment.

But these limitations, I don't think, should obscure the very real possibilities that lie ahead. And neither should they obscure the very critical role that information technology is playing in the push towards personalized medicine. We will not have personalized medicine if that is the goal of the country without very powerful IT, information technology, that can take, collect, store, analyze, et cetera large amounts of information.

And while these kinds of studies the genome-wide association studies are building databases and trying to draw connections between genes and diseases or between genes and responsiveness to certain treatments, some scientists are actually developing approaches that try to combine this valuable genetic information, if you will, with patients' electronic health records.

This is a slide of a project funded in part by NIH, basically at Vanderbilt University, which is an attempt to see whether or not data collected from electronic health records where names are not identifiable can be matched to the genetic data that is being collected. Potentially, of course, if we're able to link genetic data with electronic health records of people, we'll probably be able to zone in more on the diseases and the possible treatments than we can do now.

And then there's one additional role for IT and personalized medicine that I want to bring to your attention, and that is the emergence of technology companies, like Google and Microsoft, who are beginning to look at the possibility of playing a very critical role, if you will, in holding on to patient information, organizing it in such a way that patients, if you will, will want to see all of their data available in one place and readily accessible to them, but not accessible to anybody else without their permission.

So you have something called Microsoft Health Vault, one of the companies involved. The business plan behind all of this, of course, is that Microsoft will be able to claim that it is able to provide to patients all they need to know about all of their health information going back to the extent that they have access to it, as well as in the future. Whenever they have a drug test, whenever they have a scan of some sort — all of this information could be sent to their personal vault at Microsoft. And the idea, of course, is that then others will pay to have access to that information with, of course, the patient's permission.

So clearly what you see is a blending, if you will, with powerful information technology and knowledge about genetics, neurology, et cetera, to the point where personalized medicine may well someday be a reality and it seems to me it's worth taking a look at some of the ethical issues that arise in that context.

Let me begin with a point that I just made, and that is the notion that commercial enterprises will begin to enter the picture, will become major health care players, if you will, to the extent that they do become major repositories of information, information that would be very valuable to use for research purposes.

The question we might ask from both an ethical point of view and as a researcher is what are the responsibilities of those entities, if you will, to make that information available to researchers and under what conditions.

Another issue that comes to the fore is this notion of linking these large genetic databases to personal health records. It sounds like a good idea, but it raises lots of questions about the integrity of the data that is collected. If decisions are going to be made on the basis of this information, then we'd like the data to be as solid as possible. But as you well know, I'm sure, simply as patients, the way physicians manage the health records of patients differs from physician to physician and certainly in broader scale from the point of state to state, health care entity to health care entity, so forth and so on.

They may have this difference because there are real and genuine differences in their interpretation of their diagnosis of the patient or they may well be playing the insurance game and providing a diagnostic code that may just not be right or another physician would apply, but in this case, the first physician is using a different code simply because of insurance purposes.

So surely there's some sort of ethical responsibility here to ensure as much as possible that that data is, indeed, as accurate as possible in order to use it for research purposes, but whose responsibility it is to ensure the accuracy and how that can be discharged are really questions that we haven't begun to pose.

There are issues also for clinical trials with personalized medicine. Pharmaceutical companies will indeed apply the principles of personalized medicine selecting research subjects and they will group these subjects perhaps because of genotype or some sort of neuro bio-marker in order to either maximize the efficacy of the drug they're using or to minimize safety risks.

The very fact that you are recruited for such a clinical study may well create feelings of stigma, perhaps lead to discrimination in some fashion, as we've already faced in terms of the current way of analyzing and having access to genetic data. It also may mean the under-representation of some population groups. We now have a policy, as I'm sure you know, that many of our clinical trials have to have some diversity across the board. That may not be the case in personalized medicine clinical trials. We may well want to simply focus on that population where we think that drug is, one, going to be safe, and, two, is going to be most effective.

Moreover being — there are likely to be people in the larger population who while not in the subject cohort that you choose, may still be able to benefit from that drug. It's not clear how we will know that in terms of the initial trial and the results that are produced and translating that into health care. So that is another problem associated with personalized medicine that we'll need to think about as we move forward.

The second issue that I want to talk with you about is synthetic biology. What is synthetic biology? Well, it refers to the design and fabrication of biological components and systems that do not already exist in the natural world or to redesigning and fabricating existing biological systems. The goal is to try to build, if you will, new biological systems that are able to process information, manipulate chemicals, produce energy, provide food, and maintain and enhance human health and the environment.

In the traditional recombinant DNA with which we're all familiar there is an organism that you start with, and scientists are interested, if you will, in modifying that organism. In this case scientists and engineers are interested in starting from scratch and producing something very new, presumably with the kind of outcomes and benefits that I mentioned a moment ago.

Now, there does remain a critical gap between what we know and what we think we can do. We certainly have a long way to go, but clearly the opportunities are there really to create something new and also to create a different kind of life form than we've ever experienced before — that is, we are creating that kind of life form.

We had an indication of where we might be going in 2002 when scientists announced that they basically built from scratch the polio virus. They basically bought various strands of DNA and other chemicals from suppliers here and there, they put it altogether, and they were able to create the polio virus in a synthetic fashion. For science that was a rather important proof of principle, if you will, but for the public there was a great deal of uneasiness about where we were going and where we are going with this science.

The familiar ethical issues, which others are dealing with, have to do with the safety of these kinds of — these synthetic entities that are created. There is a lot of concern about whether or not they will produce hazards for those working with them or perhaps be used by others for reasons that will not bode well for us, such as terrorist activity. Apparently it — while, again, we're far from doing it, the feeling is that ultimately if people know what to do, it won't be difficult to get these kinds of materials and put them altogether.

There are a number of credible groups in and outside government that I think are examining the issues with regard to security and safety, but I think there are other issues that need to be examined, and for the most part, there's nobody focusing on those, and it may well be that a commission, a successor commission to your body, would be just the right entity to do that.

So let me raise a couple of those issues. We are going to be, in a sense, creating new life forms. That is, they will be able to replicate themselves. And, in fact, that's what we want them to do in some cases. And this does — it seems to me, raises some very interesting questions, including what will we view as our relationship, if you will, with nature if we are able, as humans, to create new life forms; to what extent any of those life forms require or demand respect; to what extent in terms of religious views will we be in some fashion intruding on what might be perceived as the role of The Creator.

It's going to limit us — I think it's going to force us to think a little bit about our responsibilities and the limits of our abilities, as well as the limits of our intentions and what our expectations might be. I think when the public really figures out what the potential might be with synthetic biology that there's going to be a lot of debate about the ethics of moving forward in this direction, and I think the scientific community needs to be prepared. And, again, a bioethics commission, such as this council, could play an important role, if you will, in sort of organizing those kinds of debates.

A second possibility is blurring the boundary between living organisms and machines. These organisms are really seen as engineered machines that can do something, whatever that might be — take care of the oil spill, for example, in the oceans. And so since a lot of ways that we think ethically is we make distinctions between living things and things that are not living. What is this that we're creating in the sense that we are combining, if you will, the essence of life in terms of genetics with some sort of engineering that enables it to do whatever it is to do. It may well be that we'll have to think a little bit differently about these kinds of entities when we we're able to create them.

And then there's the possibility of using synthetic biology in human beings — that is, if you will, to insert these new machines into humans in order to create some sort of change. That change may be for health reasons, but that change may also be for reasons concerning, let's say, human enhancement, a topic that I know that this council is already familiar with.

It also raises, of course, issues regarding human subjects research that we have to think through as to whether or not there are any real differences between working with this kind of synthetic material that we have created as opposed to the way we do things now, which will probably look very cumbersome in the years ahead.

In 2006 38 various organizations throughout the world issued an open letter calling for international discussion and review of the social, ethical, and economic implications of synthetic biology. It seems to me that a successor body to this council would be an appropriate public forum in which to have that larger global discussion, which I think is missing now.

The next topic that I want to talk with you about is something called virtual communities. Virtual communities are sort of computer-based simulated environments. They're basically physical environments. They have multiple users for the most part — at least, those are the ones that we are concerned with — and people actually interact in those communities with avatars — that is, they are computer representations of themselves tailored to reflect their desires, whatever they might be. And at the same time you can do all of this and remain — presumably remain anonymous, if you wish.

People enter these worlds, of course, with the same baggage they have in the real world, at least in terms of their values, in terms of their beliefs, in terms of their ethics, but they don't necessarily enter those worlds with the same kind of illness or disability. There are numbers of people with disabilities who are using these kind of virtual communities to sort of escape the real world that they live in, in which is so difficult for them to maneuver in order to have a different kind of life, if you will, in these virtual worlds.

During the past few years, the number of virtual worlds and the number of people participating in them has increased. One of the more well-known of these virtual worlds is Second Life, which has twelve million subscribers whose average age is 25. So our future physicians, our future health care providers, and our future patients are flocking, if you will, to these kinds of virtual communities. And if you don't have your own avatar yet, there you go. There's some examples. I leave you to decide which one is the real person and which one is the avatar.

So what does all this have to do bioethics, you ask. Well, it seems that these virtual communities and their residents have become the target of increased research, as well as the delivery of health care. For many scientist these kinds of communities have opened new areas of research, which have been funded by credible organizations, like the NIH, and published in peer-reviewed literature.

Just a few days ago perhaps many in this room realize that NIH announced its challenge grant applications for 2009. They were alerting the community what their priorities would be if they chose to take advantage of this extra money through the president's stimulus package.

Let me read to you what one of the priority targets is. "Improving compliance with diabetic regimen: Despite often intensive educational efforts, patients with diabetes commonly mismanage or under-manage their illness, despite the known ability of optimal management to reduce complications and morbidity. Interactions between avatars" — when was the last time you saw that word in a NIH announcement — "Interactions between avatars in virtual reality environments, such as Second Life, are known to influence behavior. Studies" — now speaking to the community — "Studies should explore the effectiveness of periodic physician/nurse interaction with diabetic patients via virtual reality environments in improving diabetic control as compared to standard practices."

Given the source, NIH, it seems to me that virtual worlds and research in health care delivery have — if you will, are the real thing. Now, some of the ongoing research is being used by researchers in various creative ways. This is a virtual community where we're having a virtual therapy session.

And this was published in a rather distinguished journal, Science, in December of 2007. In writing about, if you will, group therapy, the author stated that, and I quote, "Online virtual worlds provide the remote user or patient with a feeling of embodiment that has the potential to facilitate the clinical communication process. In the virtual world setting of the therapy session presented by this graphic, the therapist can remotely monitor the patient's psychological, physiological, and emotional responses with the use of biomonitoring systems and can modify the intervention, if needed."

So we're far along, if you will, in attempting to manipulate these virtual communities for purposes of research and delivery of health care.

And as you can see on this next slide from 2008, both of them, virtual reality therapy is being used to try to help PTSD patients, as well as autistic kids. In the first item dealing with PTSD, the director of the study covered by the article is quoted as saying, "I'm very optimistic. We think that aided by medications, virtual reality is going to be useful in ways to help people haunted by an experience confront their fears in a more complete and therapeutic way."

And with regard to the second report on autistic children, the researcher states that "a particularly convincing virtual reality system can help an autistic child transfer new skills back to a real situation. New technology can provide an in-between setting, particularly in a virtual world, that's not moving as quickly and doesn't have as many cues that might distract you."

There are lots of other studies in the literature that have demonstrated success in treating people with phobias that have left them psychologically and physically debilitated, but which have greatly improved after virtual therapy. And for patients who are living in remote areas, access to a virtual world may well substitute for a real world therapist who is simply not available. Even the CDC has a place in Second Life.

So as with any emerging technology, as you might imagine, we still have much to learn, but I think it's instructive the following quote from an NSF scientist and administrator just in 2007. He said, "We're at a major technical and social transition with this technology. It has very recently started to become a very big deal, and we haven't by any means digested what the implications are."

So that suggests to me a couple of things. One, it's becoming quite important, but the other thing is, what is the extent of our empirical data to show whether any of this is working beyond these kinds of anecdotal studies. And the evidence so far really is based on a lot of small N's, if you will, and anecdotal studies, but nevertheless it does seem to bring results.

The fact is we don't really know what feature of the virtual world environment actually has a positive effect on therapy or health care, more generally, or what features might be detrimental or have no effect at all. We need to learn that.

We don't know how much of what is happening related to health interventions is being done within the confines of a closely monitored and well-designed experiment. The question of what are the ethical standards that should govern the exposure of patients and/or research subjects to virtual worlds is not, as far as I can tell, on anyone's radar screen, which leads me to mention informed consent.

Studies that have been done on virtual communities and behavior generally have found rather consistently that users treat these interpersonal encounters as having the same depth as face-to-face relationships. Well, does this mean that the ethical imperative to respect others will obligate researchers to obtain consent from the avatar?

Now, before you think this is a trivial matter, remember, in many cases these therapists or researchers do not know who is behind the avatar. They do not have the identity of that person if he or she wishes, if you will, to remain anonymous. So this raises the question, of course, of what do I need to get informed consent in a virtual community setting. And I have here a note to myself, "I wonder how the IRB would handle that one."

Now, there are also issues related to anonymity, security, confidentiality, and authenticity. Remember that virtual worlds work under the assumption that people behind the avatars are anonymous. And this has benefits because it may well lead some people who are uncomfortable in having their identity known participate in research or clinical care, all else being equal.

But it also has a downside because of identity deception, which is widely practiced on the internet and just as widely practiced in the virtual communities. So is the research subject today the same one as it was last week? Are two brothers operating the same avatar? And unless precautions are taken, people who roam virtual communities can roam free. They're free to roam anywhere they want to roam and there's nothing to stop anybody from dropping in on one of these therapy sessions and having a seat.

Needless to say that wouldn't happen in the real world. It's the kind of disruption that might well have adverse affects on the kind of therapeutic intervention, as well as the research that you might be doing.

And, of course, there's the issue of surveillance. Surveillance is probably much more likely, more easily achieved, and much harder to spot in this kind of environment than in the real world, and when you're dealing with health care issues, that's clearly something that you have to pay attention to.

And one other point I'll mention very briefly is that these virtual worlds pop up and down — that is, they may exist for years or they may exist for a few weeks or months. It doesn't take much for somebody who basically has set up the infrastructure to simply turn off the switch and the virtual community is no more. If you started a research project on that community, you realize some problems right away.

And then there's the final issue that I wanted to bring to your attention, and that's neuroscience. Now, I realize that the council has had neuroscience on its agenda in the past, although I couldn't find anything since 2004, and the science has moved on since then, as well as the way in which the science is presented to the public. Moreover there's a vacuum in the public discussion of ethical issues associated with neuroscience that's not true with its close cousins genetics and nano.

So let me say a few words about why I think neuroscience should rise up on the agenda again with regard to any new commission. There are areas of neuroscience that have made considerable strides since 2004. One of the exciting areas, if you will, is known as sort of brain/computer interface. Here you have a couple of reports. I'm sure many of you have seen the videos of people who simply by thinking are able to move a limb that they were unable to move even hours or days before. Again, it's sort of one subject at a time. It's not a revolution, but it's happening. We also find that people with Parkinson's disease, if they receive deep brain stimulation, results are produced which have had very positive effects on their ability to cope with the disease.

What happens in these cases is a computer chip is implanted in the brain or back here, if you will, and it monitors brain activity, it sends signals, and when the patient sends the signal that it intends to do something, the computer helps make it happen.

In fact, researchers in Japan have even tested a brain computer system that lets the user walk an avatar through the streets of Second Life while relying solely on the power of thought. Perhaps that's transferable to humans, as well. I suspect it probably will be at some point in time.

Now, while it's very satisfying to see some real change with people who suffer from these kinds of disabilities, the brain/computer interface also raises some interesting questions about where the boundaries are between the machine and the human brain. For example, if electrical stimulations in the brain can trigger conscious movement, as we're seen in the past with these different subjects, might it also be able to cause changes to one's behavior, memory, or judgment?

Families of some Parkinson's disease patients treated with deep brain stimulation have reported that the patient experienced significant personality changes, yet remained unaware of them despite the fact that they were highly disruptive to family functioning. How should we view informed consent in such cases?

There have also been some new findings in neuroscience about how people make moral judgments. The studies, granted, involving very few people suggest that there are specific regions of the brain that when damaged change the way people make moral judgments. So does that mean, if you will, that neurons affect how we form our beliefs and our values? Clearly these kinds of findings at least raise the intriguing question of the relative influences of brain circuitry, culture, and the environment on ethical decision-making.

One of the interesting ways that neuroscience has also changed is the way it interfaces with the public. The world-wide web makes it quite easy to directly reach the public whether to recruit research subjects or to promote products for the mind. Here's a company called Northstar, and it claims that it is a medical device company focused on developing and commercializing innovative neuro-modulation therapies to restore function and quality of life for people suffering from neurological diseases and disorders.

Well, that's all well and good except for the following. This news article reports on the demise of that company. It starts off with ominous words, "Northstar Neuroscience is Toast." Basically the headline conveys the issue. Northstar Neuroscience shuts down ending experimental depression trial. If you read a little bit further in the article it says that the company has a plan, which will involve paying off remaining liabilities, like its lease and its clinical trial obligations.

Now, I have no interest in thinking about the moral implications of paying off its lease, but it does seem fair to ask what those clinical trial obligations are and how the plan deals with them. What's happening to all of those patients? How does the company define its obligations to them? And were the patients initially informed that completion of the trial depended, in part, on the success of a company to attract adequate venture capital.

Clearly the increasing connection between research and commercial issues are raising questions about the integrity of science, the treatment of human subjects, and how the public perceives neuroscience. And all of this is happening when the public is exposed to headlines such as these, yet there's no coordinated national effort to explore these issues.

Nano has its ELSI program, genetics has its ELSI program. What about neuroscience? I think that while these issues are not unique to neuroscience, they're worth exploring in a more public way and suggest that a future council would want to take them on.

So, finally, let me conclude with one last statement, and that is the world is increasingly becoming global. Certainly that's true of science and engineering, and I would like to see any future body such as this spend some time to take a look at some of the international implications of the kinds of things that they are focusing on.

It probably will do us all better if both we learn from others, as well as we contribute to the thinking and work of others in these areas. Ethics is not the domain of the U.S., and more and more research being done internationally suggests that we have to have a better understanding of how different ethical perspectives might affect the advancement of science and technology and its uses, as well. And that seems to me to be something that any future council ought to have as a regular part of its assessment and analysis, whatever the issues might be.

Thanks very much.

CHAIRMAN PELLEGRINO: Thank you very much, Dr. Frankel. Our next speaker is Dr. Nancy Kass, who is the Phoebe Berman Professor of Bioethics and Public Health at the Berman Institute of the Johns Hopkins University. Dr. Kass.

PROF. KASS: Thank you. I'm very pleased to be invited here and to have a few minutes, and I look forward to the part of — the part of the meeting where we can get feedback and discussion going. Let me give you two disclaimers before I really get going on the slides. The first is a logistical one. I've tinkered a little bit with the slides since they were handed to the staff here and distributed, so you'll notice a few changes. The substance is really the same, but it really is tinkering.

The second, I feel a responsibility to say to this group that I'm no relation to Leon Kass, even though I'm asked that all the time. And as a matter of fact only a month ago I was at an event in my neighborhood and there was a man there who had traveled there for some coincidental reason and he spent about five minutes telling me all the ways he'd known my father over the years, only at the end for us to discover that it was not my father at all; it was Leon Kass. So with that, let me move forward.

So I'm not only always personally grateful when I'm invited to speak before any group like this, but I guess I also feel like I want to thank you for including public health on the agenda. I have a tremendous bias here and that maybe is evident from my background. I did my doctoral training in a school of public health, and when I arrived at that school of public health — and this may be true for all professional schools; it's just the only one I've ever been through — I was struck by how many people there were there who were just tremendously idealistic.

Public health schools are full of people who want to save the world, and they want to save the world in part because of their commitments to the under-served. And when I started to learn about bioethics — in great part from Ruth Faden, who's in the audience — it became clear that bioethics is significantly interested in the well-being of the under-served. And obviously my own path gravitated much more toward bioethics, but I think that the conceptual clarity and agility that people in bioethics have could be a tremendous contribution to the fundamental goals of public health.

So I'm going to — I was challenged to think through, really to limit myself, to a number of issues that could be discussed in half an hour. Here's the laundry list of things I'm going to talk about. In my mind I actually can draw some connections of one to the other, but that's not really my goal. My goal is to just throw out a bunch of issues, and I think these are issues that could all stand to have more both conceptual clarity through a bioethics lens and ideally some public policy guidance that would be particularly relevant to this context of public bioethics.

So the first is public health research. And obviously presidential, national, public commissions in this country have devoted probably more attention to the area of research ethics than any other topic. Some extraordinary work that has led to regulations, to foundational thinking about how we should approach human subjects research has come thanks to the work of national commissions.

What perhaps deserves additional attention building on this work are some of the questions raised through what I'm going to call public health research. So let me tell you a few of the issues that I think are at stake and then I'm just going to walk us through one example as an example of the kind of research that goes on in public health where I think there are some questions that deserve more attention.

So in general in public health research, first of all, we have this complication that researchers sometimes think of the subject of their research as a population, rather than an individual, and yet our guidance assumes that we have an individual in front of us when we're thinking about consent and autonomy and benefits and all of that kind of thing.

As an example, there is a method in public health research called cluster randomization. We're probably all familiar with randomized controlled trials in what I'll call the traditional sense where patient A may be randomized to one drug and patient B might be randomized to another. Cluster randomization means that an entire group is randomized to one intervention and an entire other group — it could be one managed care organization and another managed care organization — the other group receives something different or receives no intervention.

A couple of examples that I put on the slide — I've worked a little bit with a tuberculosis prevention trial in South Africa that involves hundreds of thousands of gold miners. But the way that they allocate this TB preventive intervention that they are testing the efficacy of is an entire shaft of ten thousand gold miners either gets this preventative intervention or an entire shaft doesn't.

Another kind of example, there could mass media campaigns where one city would get a mass media campaign related to something in health education or something that people think will promote the public's health; another city wouldn't. There's evaluations later across the entire population in aggregate of what the health benefits are or aren't.

So, of course, this raises really interesting questions with regard to consent, which, again, is this foundational assumption we've bring in to public health, to human subjects' protection policy. So what kinds of permissions are needed for either of those kinds of studies. Who has authority? Right? One city is going to get all these billboards and radio announcements and one city is not. Does that mean that people in the city where they are not getting the intervention need to know that another city is getting them and they're not? Is individual awareness of that needed? That's the informed part. Who, if anyone, needs to provide permission for this kind of thing happening, the consent part, and is the answer to any of these questions relevant to the level of individual — now, getting back to the individual — risk or identifiability at stake in any of these designs?

There's a lot of work in public health research, which is probably also to some degree true in clinical research, where there's an intertwining of practice and research — lots of possible examples here. There's been a lot of attention recently to quality improvement. Again, some examples I'm familiar with close to my home is, for example, the city health department might decide to do a new innovative program. It could be an outreach program to try to reach hard-to-reach populations who have some particular public health need, but as a component of their outreach program they want to evaluate it, they want to publish it, they want to treat it both as a practice intervention, a program that comes out of public health funds, and they want to evaluate it so that other cities can learn from it.

Well, again, there's all these questions of is it research, what are the oversight requirements, are there any consent requirements? Just some interesting questions that I think deserve more attention.

So I want to talk about another flavor, another category of public health research that has caused a lot of angst in the bioethics world and where I think more guidance remains needed. So I'm going to call this type of approach community-based prevention trials, although you'll see as I walk us through it that there's a particular context in which these community-based prevention trials exist where I think some of the particular ethics challenge emerge.

So here are some of the assumptions. Public health, generally, not yet in the research world, has a mandate, a legal mandate to intervene where major public health problems exist. And, of course, we learn through research and through data that have been collected for more than 100 years that major public health problems often exist where there are bad social conditions and generally where there is evidence of societal inequity.

So here's another piece of the context to bring into thinking through proposing a research trial. There are a lot of contexts where there's bad public health outcomes and there are interventions that we already know would make a difference for improving the health of those people. It's not that we need more science there. It's that for some reason the people in Africa don't have clean water yet. It's not that we're not sure if clean water would make a difference for them, but they don't have the clean water.

And so interventions that are effective are not being implemented due to costs, due to feasibility, due to different priorities, whatever. So ethically there's this question, can researchers go in and test the effectiveness of an intervention that they think will be what I will call a harm-reduction intervention, will, for example, ameliorate what happens when those kids in a poor country get diarrhea, tests of very feasible, you-don't-need-much-training, education, or-refrigeration-way to do oral rehydration.

Can you test interventions that ameliorate the public health problem, but that aren't addressing the fundamental problem? And, again, there are many kinds of examples of this: bed nets, oral rehydration. Many of you will be familiar with the perinatal AZT trial controversy of about ten years ago. And I'm going to walk us through one that, again, happened in my home city of Baltimore.

So I'm going to talk about the Baltimore lead study, not because I want us to get into a distraction about what happened there, but as an example of something that where this kind of question of trying to propose — of proposing a study that looked at the effectiveness of an intervention that might reduce the public health harm when other strategies already existed but were not being implemented when this kind of study was proposed. And not in a very poor country; it happened in Baltimore City.

So here's the background for this particular study — again, just to be an example. It's been known for close to 100 years now that lead is dangerous for children. In 1931 the use of new lead paint was banned in Europe. It actually didn't happen until the 1970's in the United States clearly due to policy decisions that were different, not because the data weren't available.

Okay, so it's been outlawed in Europe since 1931. Fast forward to the 1990's in Baltimore. This is 15 years ago. And unfortunately in the City of Baltimore here in the United States of America, 90 percent of the houses were old and therefore had lead paint in them somewhere. My house that I live in has lead paint. It just happens to be covered up by many, many, many other layers of non-lead paint.

There were, however, in some sections of the city that were not at all affluent many homes with peeling paint and a lot of lead dust that was routinely around for a variety of reasons, including old windows that every time they were opened and closed scraped and generated dust. And 60 percent of the children in certain neighborhoods in Baltimore 15 years ago had highly elevated lead levels.

So the logical conclusion, because we know lead is bad, is that we need to change public health policy. This is not a situation that automatically screams for research. In my mind this is a situation that screams for policy change. Well, there's a little research that happens as part of this story.

There's research that looks at how abatement methods were done in the seventies and eighties and, lo and behold, demonstrates that the way they used to be done of scraping off all the paint and scraping off the windows turns out to generate a lot of risk through the generation of dust. Okay.

So they do another set of studies and demonstrate a very different way to do abatement with both approved personnel and covering up the lead, rather than scraping off the lead. Highly effective studies shows that makes a big difference. Again, this should lead to the logical conclusion — a lot of kids are getting sick and having brain damage — bad thing. We now know how to intervene. Okay. Logical conclusion, we've got the science. We should intervene.

Well, it doesn't happen. There's no policy action in the same way that the use of new paint wasn't banned in this country from the thirties to the seventies — it took forty years — there's still a lot of policy action that should have happened that hasn't happened.

So that led a group of public health researchers to say, "Maybe what we should do out of this duty to improve the health of these kids is try to find some other strategies that could make a difference, where maybe the policy world would accept a requirement that landlords have to intervene if it's only going to cost them $1,000 rather than $12,000, which is what abatement would otherwise have cost them.

So there was a research study proposed that was a randomized trial where different houses in these neighborhoods in Baltimore where the housing stock was of pretty poor quality and there was a lot of lead risk, were randomized to three different kinds of interventions of different amounts of money doing part of these kinds of effective things, like replacing the windows or putting mats down on the floor, and there were two control arms.

And the control arms were not houses that got no abatement, but they were new houses or houses that had been completely abated for other purposes. And the kids were monitored regularly. And lo and behold all three of the interventions of doing just part of the total abatement reduced the lead levels in the house by more than 90 percent. They were shown to be — in the context of research, thinking as a scientist, highly effective interventions.

Lawsuits were brought against the investigators because they didn't do all that they could have, because they took what I'll call this public health approach of harm reduction rather than doing everything possible. And specifically not only were they told they should have done full abatement, the alternative is they should have moved the families outside of Baltimore.

So it leads to some perennial questions for people who do this kind of research. There's often unjust background conditions that prompt public health people to seek interventions, but there's this conceptual tension. Does testing interventions in these settings promote justice by identifying strategies that will improve these kids' health or improve the public's health, more generically, or does testing in this kind of way, does designing a study in this way, exploit the poor or condone the injustices there or suggest that public health will accept substandard approaches for people who are disadvantaged.

Important conceptual work needs to be done there, and, obviously, practical guidance for, for example, all my colleagues at the school of public health, who I really believe want to do right thing and come to us and say, "So what are we supposed to do now."

So I'm going to move on to another area that I'd love to see a future council or commission provide some guidance. And, again, in my mind there is possibly some link to the last set of examples. So one solution that actually was proposed as at least being relevant and maybe having a voice for the kind of study like the Baltimore study was getting community input. How does the community view this and do they want that kind of study done at least in the interim until there is more policy action?

And as it turns out this idea of having community engagement as at least a strategy in responding to a bunch of tough issues seems to be popping up everywhere I go in bioethics circles. So those of you familiar with the regulatory guidance about emergency research know that it's a requirement now that there's some kind of community consultation.

In international research, like that gold mine trial and a bunch of other public health trials, there's now sort of a — not a ethical mandate, but it's becoming more normative for there to be some kind of community engagement, community input in planning or at least executing a trial.

Obviously this urban research, like the Baltimore example — there's this notion of public engagement which is becoming more popular in health care decisions and in bioethics-relevant decisions. Health policy decisions — now there's probably a lot more attention to health reform. The Oregon Medicaid decision strategy was an example of public engagement. Preparedness allocation has taken on this idea of community engagement, public engagement, getting members of the public together and saying if there's scarce vaccines, who should get them, what do you think.

So this leads to a whole bunch of really interesting questions. First of all, what is community engagement? Again, all these circles seem to say, "Ah, ha, part of the solution is community engagement." Well, are they all talking about the same thing? And why is it relevant to bioethics? Are people saying it's helpful because it's an input, it's another source of information, or are people saying that it's actually determinative, that if we hear from the public that they think these people should get vaccines and these people shouldn't that we somehow have a responsibility to follow it.

Now, what's the authority of communities or the public in determining what is right. And if they think it's right for them, can we override their preferences out of paternalism? I mean, I remember doing a study years ago, a very different context, where a bunch of drug users and HIV infected women had very different views about what should happen with regard to drug use and pregnancy and reproduction, but there were some members who said basically, "Lock people up, sterilize them. Don't let them do this stuff." And these are women talking about themselves. And so does that mean that the right answer is to do that? Is that the only input that's relevant, or are there other ways we can think about what's right, separate from what people themselves say is right for their own community.

So that just leads me to another specific example where this idea of community engagement has emerged as a strategy, which is preparedness. And a lot of the work that's been going on in preparedness by health departments in every state and certainly federally has been related to pandemic influenza, but there's also been a lot of work related to disaster preparedness or bioterrorism, more broadly.

So there are already groups that have taken on this question of preparedness and allocation and justice. The Institute of Medicine has looked at it. The CDC has looked at it. Every state is required to have a plan. The plans are remarkably different, and there remain some foundational questions for bioethics here that in certain ways are reminiscent of the early questions that animated bioethics sort of when it got its start in the seventies in terms of allocation of scarce resources, in terms of who should be saved, who was important, is age relevant?

And while we have dealt with this issue of allocation of scarce resources before, the context is a little bit different. We're not simply saying whose lives do we want to save, but we may be saying that the emergency nature here is a little bit relevant or potentially could be relevant to who should be saved.

So is one's role in society relevant? Ought we to give special priority for people who I'm calling are instrumental to the well-being of others? If giving a vaccine to me would mean that I could go out and help 100 other people, ought that give me higher priority than just randomly distributing it with no attention to that kind of thing? And if we do give special priority in any way that's not random, ought we then also to have special safeguards for those who most vulnerable, who in no way are in a position either to help themselves or certainly to help others.

Okay. So I'm going to now raise a very different kind of issue that leads into all three — that for me is related in certain ways, again, by this chain of events to the last three issues I want to talk about.

Environmental ethics is at least in my opinion an area where we in the bioethics community have been relatively silent. I don't mean to suggest that there is no work in this area by any means, but I think compared to a lot of other issues that we've taken on with great gusto and with a huge depth of literature, there is relatively little in the area of environmental ethics.

Part of it perhaps is in all of us not being clear on what the boundaries of bioethics are. And I don't mean to suggest necessarily that there's a clear answer, but if we think of bioethics as in some way being related to science or health, how is it that environmental concerns are related to this.

I have a colleague who often says, "Part of the problem is that when we say work in environmental issues, people think of the salmon floating upstream and they don't think of it as the environment in which people live, the context in which we are surrounded," which is obviously a very different picture of environment.

So if we think of the health effects of war or the health effects of radiation exposure or the health effects of pesticides in food or climate change and its domino effects or deforestation, which people do sometimes as a response to poverty, as a response to the tragic circumstances in which they find themselves. But those behaviors in turn lead to effects on the environment and on animal health and on human health. Arguably these start to crossover into areas that probably most people would agree are related to the kinds of topics people in bioethics think about.

So within environmental ethics there's a particular set of questions that people say are related to something called — that they label environmental justice. And this is, again, this perennial theme in bioethics of justice, social justice. Environmental justice, I think, means we get concerned when there are inequities in the distribution of environmental hazards. And since we know environmental hazards — by definition, that word — can lead to bad health consequences, it means we are then witness to inequities in the distribution of the health consequences of these different environmental hazards.

And then there's sort of salt in the wound, if you will, further injustice if that chain of events happens and then the people who are exposed disproportionately to these negative health consequences from this unequal distribution of hazards are the kinds of people who happen to have less ability to navigate the health care system due to limited knowledge, disenfranchisement, under insurance, lack of insurance, et cetera. And these issues are relevant domestically; they're relevant globally.

And I just put up here I think there may be what I'm going to call some bioethics anxiety that is not a question of are these important issues, but are these our issues? Is this the kind of thing we're supposed to take on, or is somebody else supposed to take this on?

So this is, in part, going to be related to this broader issue, which is social determinants of health. It seems like, you know, what goes around, comes around. I'll have a slide in a few minutes that in certain ways public health got its start thinking about social determinants of health. I think in ways some of what the early commissions looked at, the president's commission, was, in part, related to social determinants of health.

There is a resurgence of interest in social determinants of health, is all that I can say, and there are plenty of issues that remain unaddressed. So it's currently a new huge initiative at the CDC. Some of you are familiar with a report that was just released by the World Health Organization — I'll have a slide on that in a minute.

Mark McClellan, former FDA commissioner, former head of CMS, co-chairs the Robert Johnson commission to build a healthier America. He said in one of their reports on children's health that was released a few months ago, "Most of our efforts to improve health have focused on improving quality, access to, and affordability of care. While these are important, support for better health that is associated with resources and community matters as well."

So here's a few quotes from this WHO commission, which, again, also just came out. This WHO commission — and I will just put in an editorial comment, I think from my reading this is just more a cultural norm of Europe than it is cultural norm of the United States. The language is stronger, and it says things like, "Inequities are killing people on a grand scale. The toxic combination of bad policies, economics, and politics is in large measure responsible for the fact that a majority of people in the world do not enjoy the good health that is biologically possible." Again, this idea we have the science; somehow there's not access.

And then finally they say, "Social justice is a matter of life and death. It affects the way people live, their consequent chance of illness, and their risk of premature death. We watched in wonder as life expectancy and good health continue to increase in parts of the world and in alarm as they fail to improve in others."

So why is this part of public health ethics? The Institute of Medicine defines public health as what we as a society do to collectively assure the conditions in which people can be healthy. And as I was saying earlier, if you go back to the roots of public health, a lot of it is about social determinants.

The school where I've spent most of my career, Johns Hopkins, recently changed its name to the Bloomberg School for obvious reasons related to philanthropy, but before that was called the Johns Hopkins School of Hygiene and Public Health. Right. There's real reason why when it started as the first school of public health in this country it was related to social conditions.

So in the 1800's Edward Chadwick in England showed this relationship between class and life expectancy. He demonstrated that there was more than a twofold difference in life expectancy between the upper and lower classes. Also in the 1800's there were maps created of housing conditions and of garbage heaps and those were linked to disease and health status which were directly correlated.

At the end of the 1800's in this country there were state and local boards that were created and they were required to enforce sanitary regulations and that was in the name of improving the health of the public. So that's the — environment, social conditions, and equity have all received the attention of what I'm calling the public health pioneers.

And, again, a lot of other evidence — I'll go through this really quickly because probably everybody here knows it, but there are a lot of important research studies that remind us that even among people who all have jobs and all have access to health insurance, inequities lead to differences in health. The way health studies, which is sort of the landmark studies in the United Kingdom, show that occupational status was directly linked to health outcome among people who all were employed and insured.

The MRFIT trials showed an inextricable link between income and death. And individual risk factors we learn — you know, when we say, "Well, there are a lot of health outcomes that are really sort of our own fault — smoking and obesity and lack of exercise" — it becomes more complex when we look at the data and realize that those are also deeply correlated. They cluster by social position.

So that becomes a little more complicated and at least deserves attention in a discussion of social determinants. Dan Beauchamp, one of the people I think of as, again, a pioneer in this area of justice and public health said that "If we continue to devote our attention to individual interests and individual behaviors, we will plague our attempts to protect the public's health. And the community is not simply insuring non-interference from others. It also means a shared interest in the developing conditions for health and safety." Again, an idea that the conditions of social determinants are going to be highly determinative for the welfare of our society with regard to health.

So how can bioethics contribute or how can public bioethics play a role? There is in bioethics deep expertise in the area of justice. There's deep expertise in different conceptions of justice, different theories of justice, and different duties of justice. And we can build on that important work that was done earlier.

Bioethics at its core wants to ensure arrangements that are both respectful and just. And the challenge is that sometimes, once we see all this data that says, "Social determinants make a difference, inequities make a difference," sometimes the way that we would best intervene are also in areas that I would say cross sectors that are not really related to what the health department does, but what other groups do.

So the person who was just named the interim head of the CDC said that one of the things they're going to try to do is work with other people in public infrastructure sectors to make sure that when there's roads built, they always build sidewalks. Okay, so that's not something we usually think of as part of a health department concern. Commerce, the availability of fresh foods, and a few people know that I'm starting to increasingly say whenever I think about this issue that I think if we could do one thing to improve the public's health, we should put more money in this country into public education.

And probably if we took half the budget of health and half the budget devoted to new business or advertising and put it into public education, we would probably have better health outcomes and certainly more qualified people to populate our jobs and professions.

It is a public policy land mine, however, of considering the effects of different forms of governance and different economic strategies that may be at stake here, and I'm fully aware of that.

The last thing I'm going to talk about and then I will end is the idea of global justice. So I see that Dr. Frankel also ended with this plea for us to start thinking globally and not only domestically, and I feel that very deeply. Partly it is because it just gets harder and harder to think in a vacuum because the world doesn't work like that anymore. The links related to social determinants are, if anything, more profound when you look globally. And arguably U.S. bioethics thus far has devoted less attention to global concerns.

These are critically important questions, but they are also important symbolically. And, again, this just echoes completely what Dr. Frankel said. It is important for us to contribute and it's important for us to show the rest of the world that we care. There's a lot of really important work to be done out of bioethics in defining what are just arrangements and what are the justifications for the United States making this part of American policy.

There is different work that's being done in this arena. It's interesting that I sort of only realized after I made the slide that even though I think of these people now as Americans in terms of working here, both of these people [slide mentions Peter Singer and Thomas Pogge] have their roots — neither of them was born in the United States, which, you know, who knows what that's about, but there are different justifications that are emerging for why it's important to work on global justice.

I'm not going to go through them here, but the point is there's a lot of room for a group of thoughtful people to take on these issues and think it through. Is there a duty? Are we simply being compassionate or is there a stronger duty than that? And what is the extent of some kind of duty?

So then my last slide is really how we translate scholarship and important conceptual contributions into action. There's a real difference between a public bioethics body and a group of bioethics scholars in terms of their mandate. And it's important to think through how justice scholarship, which is, I think, in its nuance and sophistication breathtaking — how that can translate within the confines and constraints of real-life public policy that, again, deals with multiple sectors and multiple interests and multiple agendas that aren't always rational.

So how do we work with public policy for public bioethics to identify strategies that are realistic and we think based on data could lead to public health improvement. We need work that is both conceptual and strategic, and when you bring together boards like this, you have the luxury of finding the best people and they can do both of those kinds of tasks.

How can we think about furthering justice in a world that right now when we look around it has human rights violations and injustices left and right? What can be learned from regions who actually have made headway with regard to reducing inequities. We have to have positive role models and maybe we can learn some things there.

The boundaries between local and global are disappearing and, you know, just this final slide, which, I think, is maybe part of what being part of a U.S. presidential or national bioethics commission is all about. As is true probably for most of us in the room, we are the privileged, the responsibilities of the privileged to take on these issues in order to serve those who can't have a voice themselves is enormous. Thank you.

CHAIRMAN PELLEGRINO: Thank you very much, Dr. Kass, for opening up a whole new area, issues, and problems, and certainly, I think, appealing to our sense of community responsibility and what bioethics might do for it.

Rebecca Dresser has agreed to open the discussion on the part of the council.

DR. DRESSER: Well, thank you two for a rich review of interesting topics. I would like to ask a meta question. We can think about national bodies like this as having to allocate resources — limited time, limited energy and ability to look at different topics. So when a group does not have a specific policy directive, how do you think the group should decide what to address?

Our executive order actually has a number of criteria, which I haven't memorized, but I think were pretty good. They said things like look at whether other groups are adequately addressing the topic. I can't remember what they were, but I guess I'm interested in your view.

Obviously there are issues about when something is right to consider, when it's premature, when it might be at the point where something — a report might gain some traction, because a lot of times these documents come out and they go into a black hole and no one ever sees them or reads them. You know, when should you revisit an old topic, when should you highlight a topic that you think is under-addressed, should the process of decision-making be somewhat systematic, so should you survey people, experts, ordinary people about what they think the important issues are, should it be more flexible.

I know often for us we've talked about different possibilities and it's been more of a deliberative decision about what we should go forward with. So if you have any thoughts on that, I'd be interested. Thank you.

PROF. KASS: Rebecca, you give us too much credit in thinking we might have the answers to that. I mean, obviously I have a few thoughts on it, but I don't want to suggest that my thoughts are any wiser than anybody else's around the table.

Some of the things that occur to me are a lot of what you touched on. It seems like picking issues that both involve some paradigmatic cases that maybe have prompted some public interest in the last couple of years, but that also are tied into much larger issues that could have relevance beyond those cases that sparked a lot of attention is one type of criterion that could be helpful, that there's sort of — there's interest, everybody is excited, we can get — we can get our hands around why it's important, but when this particular question dies down, the conceptual thinking behind it will have relevance to a lot of other topics.

Where a commission or council is at that moment in time and what's going on outside of it, of course, is relevant. What's going on with the politics here, what's going on with the politics globally is going to be really relevant to whether this is the right time to take on environmental ethics or global justice or anything else. So that seems to be relevant.

I think the question of how much other bodies are taking on a similar issue is an interesting one. Certainly if it seems sort of what I'll call directly duplicative of what another body in U.S. government is doing, that seems like a waste of resources. But if, for example, a group in Europe has decided to take this on, it could be that it's very complementary for us to take on the issue. So I think having an awareness of the external landscape ends up being helpful aside from the importance of the issue.

DR. FRANKEL: Rebecca, you had a very good list, and Nancy has added to that. I would only add that councils, public bodies like this, should be sure to have mechanisms built into them whereby they can — and I use the words in quotes — "survey" the public. Now, that doesn't necessarily mean a social science survey. It may well be. It may well be that, but have a variety of different strategies and mechanisms for listening and you'll get a lot of information.

A great deal of it, of course, will be in conflict, but it might be useful for the next commission, depending upon the breadth of its charter, if you will, to sit down very early in the game and deal with that issue before you get too further along. It seems to me it's a really important one.

CHAIRMAN PELLEGRINO: Thank you. I'll call Schneider and Bill.

PROF. SCHNEIDER: You have confirmed — this is really directed to Dr. Kass. You have confirmed my already deep belief that there is a lot of really, really important work to do in public health. What mystifies me is why you think that anything good is going to happen by creating another commission or asking the commission to look at these things.

I think the reverse is as surely likely to be the truth in at least one of the areas that you talked about — that's the Kennedy, Krieger, Grimes lead paint study. There are actually already — as you, I'm sure, know, has been a very, very, very elite commission which looked at it. It was, I think, an NRC/IOM commission that looked at it. And it issued one of these reports and it said you may not do this kind of research. It is wicked and criminal and cruel to do this kind of research unless you have all kinds of things, particularly including the consent of the community.

I've read the literature written by the people who actually tried to get consent of the community for informed waiver cases, and it's a joke. It's a joke because the community is an entirely artificial construct. There is no such thing as "the community." The community gets defined as everything between a neighborhood and the State of Mississippi.

When you try to get hold of the community to get them interested, nobody shows up. You have more people from the IRB and from the research groups than you do from the actual community. And why not? Who wants to spend his time sitting and listening to somebody talk about these sorts of things? One reason you have elected officials is so that they can make these kinds of decisions if the community really needs to be consulted. That's what democracy is supposed to be about.

If I were giving advice to one of my students who was a joint degree candidate in public health and law, I would say the last thing that you should do if you want to help the world is get into an area where you're going to be stopped from doing good research like the research that was done in the Kennedy Krieger case by another commission that wants to find more ways of stopping research.

PROF. KASS: So thank you. It's an important question. So clearly there's an assumption there that we already know what the commission would say.

PROF. SCHNEIDER: Well, we've seen the commission's statement.

PROF. KASS: Well, so one — so we can quibble over exactly what the conclusions of that IOM committee were, but the fact that one group with one kind of charge makes one conclusion and a public commission that might weigh in with certain kinds of concepts or certain kinds of general goals to be preserved that might not look exactly consistent. So there's a consistency problem that always has to be dealt with when there's a bunch of federal groups.

But I don't think to me that's yet a convincing argument that we don't need to go there, but let me say something about the way in which I could imagine there being a role for a national council or commission. I actually don't in any way think that it's the right role of a national council or commission to weigh in on specific cases.

I think that doing — part of it you get into the "he said, she said," what were really the facts, what were people's intent, but partly I think it's a distraction and I think from doing a lot of research ethics in this case often the devil is in the details.

What I think is far more helpful is establishing certain kinds of conceptual goals — for example, when one does public health research — and examining this whole idea, this whole question of is it ever going to be ethically acceptable to test an intervention that provides some health — that ameliorates public health problems when we know that there's a whole variety of other public policy interventions that could make more of a difference. And again, the paradigmatic example is bad water and oral rehydration.

I think that providing general conceptual goals and general conceptual recommendations is a very important role for a commission, whereas weighing in on individual cases I think is not. And let me give you an example of that. In another one of these public health research quandaries, the perinatal AZT studies, which I'm sure you also quite familiar with — it was very telling that both the people who thought that those studies were completely unethical by virtue of using a placebo and the people who thought that the studies were justifiable in using a placebo invoked the same tenet from the Declaration of Helsinki in justifying their views.

And for some people the conclusion was Helsinki needs to be revised, it's a terrible declaration, what help is it anyway. And I had completely the opposite view. And it may be that I'm misguided — and we're all entitled to our opinion — but for me Helsinki lays out general goals and concepts that are important for us to live by. And in certain ways they're general enough that most people can live by them.

And once we start to get too specific — which we have to do in individual determinations — then I think we get ourselves into difficulties. So I could imagine taking on this new piece of human research challenges and thinking through the ethical concerns and ethical goals related to that, but I would hate to see us start to weigh in on any specific examples because it's going to be different from the next example.

CHAIRMAN PELLEGRINO: Thank you. Dr. Hurlbut.

DR. HURLBUT: I just want to add a voice of appreciation for what you've said to us. I think it's a very compelling general domain and important, and we — several times in our work I thought we could have been extended some of what we said on other subjects to include some of what you've alluded to. And let me just give one example.

Specifically, when we did our report called "Beyond Therapy," we talked about not just the human questions and basic issues of what human goods are, but some of the dangers of the biotechnologies that people have exaggerated schemes in their minds for how they're going to transform their children or themselves to make superior human beings.

And I think there's a way to connect this in with what you were talking about because there's a very fragile balance operating between natural human biology and the natural environment of our evolution and adaption. We should take that deeply seriously, not just as a sort of public health issue, but as a personal issue and as a professional issue in medicine.

Anybody who is a doctor after awhile, if they don't start out this way, realizes that the best policy is to do as little as possible by way of interventions in human life. Even seemingly simple drugs like Tylenol have an amazing number of effects. Hundreds of genes can be up-regulated or down-regulated by simple drugs.

And this has all come home to me that at least one good thing that's coming out of the financial world's meltdown and that is if we can't even understand how credit default swaps work, then we should be a lot more humble about how biology works, genetics works, and so forth.

And one arena that — I want to just underscore this — one arena that we've really, really neglected and it's just staring us in the face is the damaging — potentially damaging effects of alterations in our — what you might call the biochemical milieu in which our new members of the species are gestating. I think we're going to find out with great regret that some among the 80 to 100,000 industrial chemicals in our modern world are affecting embryogenesis in subtle, and in some cases not so subtle ways.

There's a huge — I don't want to use too bad a word for it, but there's a huge rethinking of this due and it connects very well with what you said. And if a future bioethics group takes up issues in this way, at the very least it will the alert the general public to take this more seriously.

CHAIRMAN PELLEGRINO: Thank you, Bill. Dr. Frankel, did you want to get in on this aspect at all?


CHAIRMAN PELLEGRINO: Thank you. I have to revise the schedule again. Let me tell you what it will be. I have the next speaker, Paul McHugh coming up, but we can carry this discussion to 3:45 and then we're going to have a break and reassemble at 4:00 o'clock. I'll try to handle this as gracefully as I can. Paul.

DR. McHUGH: I'll try to be brief then, Pellegrino, but I, too, want to thank you both for your wonderful presentations. And I want to concentrate on the issue of public health and global public health because I'm also a member of the faculty of the Johns Hopkins School of Public Health, and it's a wonderful place, just as Dr. Kass described, full of eager, positive-thinking, committed, willing-to-do-without people.

But as I teach over there and engage in these very happy conversations, I'm always having the same argument, and the argument is we want to do great things, but very often we are very naive about the issues that need to be dealt with and we're very naive also about our own biases.

And I wanted to just talk a little bit about that because I want to make a point different from you, Dr. Kass, that I believe, in fact, specific examples are exactly where we have to work in public health in order to improve on ourselves and particularly on our naivete. And I'll give you two examples where I think that the commitment to a particular point of view or a particular viewpoint overlooked the underpinnings that led to disaster.

The first one was described by Helen Epstein in her book, The Invisible Cure, where she showed that the World Health Organization, which is after all the major organization that deals with issues of global health — because of their commitment to the idea of harm avoidance and condom distribution led to a neglect of the discovery amongst the women of Uganda that the issues in the transmission of AIDS amongst the African people were related to aspects of behavior and if they could encourage the reduction in partners, rather than the distribution of condoms, they would promptly reduce, as they did, the incidence and prevalence of HIV amongst the Ugandans, whereas at the same time the World Health Organization, knowing of this data, but burying it, continued a policy of condom distribution in Botswana Land and all where the HIV conditions continued and soared.

This was an issue related to the way we're thinking about how to manage human sexuality and the knowledge that fundamentally it's partner reduction that does most to protect from sexual transmitted disorders was neglected. This point — I make this point now because our school of public health in its recent alumni journal devoted to sexuality — and made a lot about it — had article after article saying how brave we were to fight the taboo against sex, but neglected to mention anything about this important public health disaster, really.

The other thing is specific examples are terribly important, and we should be looking at particular places where public health goes in relation exactly to what you're saying about impoverishment and particularly the way government might play a role in making things more equitable.

I think, for example, the suffering of Palestinian people in the West Bank, for example — if you visit there, it's quite clear that all the monies that the American people are giving to help the Palestinian people is going right into some Swiss bank account of the leaders of those countries, rather than to the health of those people, who continue to suffer from the poor water supply and the dusty conditions there.

And I wonder whether we in the schools of public health are telling people how much importance it's going to be to back the development of a more democratic, equitable society before real health will be given, and that is perhaps as important as the health supply themselves. So it's specific examples that I think are going to help generate — help direct this wonderful enthusiasm that you and I find and love in our school.


PROF. KASS: Thank you. I appreciate those comments, Dr. McHugh, and I want to clarify what I meant by that. I agree with you 100 percent that there's no way to really delve deeply into what I think conceptually without specific examples. So I think specific examples are invaluable. All that I meant was that I hate to see — and the truth is I can't imagine this happening — a commission formed in order to respond to a specific example — and, for example, public health research as its mandate.

To use examples to help clarify its thinking and say, okay, here's the data on condoms from here and here's the data on condoms from here and here's the data on condoms from here and here's the data on interventions in democracies and here's the data on interventions in human-rights-compromised places — those are, of course, are the kinds of thinking that both help us get clear and help us move forward. So I agree with you completely.

CHAIRMAN PELLEGRINO: Thank you very much. If there are no further questions on this topic, let's reassemble at ten minutes of the hour for the last session of the afternoon.

  - The President's Council on Bioethics -  
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