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Friday, June 29, 2007

Session 5: Nanotechnology, Medicine, and Ethics

Mauro Ferrari, Ph.D.
Professor, Brown Institute of Molecular Medicine, and Chairman, Department of Biomedical Engineering, University of Texas Health Science Center at Houston, Professor of Experimental Therapeutics, University of Texas M.D. Anderson Cancer Center

CHAIRMAN PELLEGRINO:  Will the Council members be seated. We'll wait a minute or two. Thank you. We return. Our speaker is Professor Mauro Ferrari who is Professor at the Brown Institute of Molecular Medicine and Chairman of the Department of Biomedical Engineering at the University of Texas Health Sciences Center at Houston. He also a Professor of Experimental Therapeutics at the University of Texas MD Anderson Cancer Center. Professor Ferrari.

PROF. FERRARI: Good morning everybody. I am a practicing nanotechnologist and I come in peace. 


I find that the nanotechnology is the ultimate team sport on a number of different levels. On the scientific level because as you've heard with the very eloquent presentation that Dr. Maynard made, it brings together people from different disciplines and they are all required to make a functioning gadget that can solve a problem of interest. So in that sense, it is a team sport. It is also to me a great beauty of nanotechnology is in the fact that at the nanoscale, distinctions between academic fields which are, of course, by and large, human artifacts, that stand in the way of progress more than helping progress in my mind, those distinctions disappear and there is no biology, chemistry, mathematics, engineering. It's all pretty much the same. It's a bunch of items and work some way and we try to find a way to use these items and the way they work to solve problems of interest to the community.

But I also find, and again, here I find the dialogue of Dr. Maynard's perspectives and this will be probably the last time I do, because for the rest of the talk there's going to be a number of disagreements, which I think is healthy. So the other aspect that is really central for nanotechnology is that in order to be able to reap the full benefits of what nanotech can do for the community we need to work as a team, the scientists, but most importantly the stakeholders, the community in all of its aspects and with that in mind, I am profoundly honored and very, very grateful to have received an invitation to address you today and I'm really thankful for taking the time and picking up this issue. Dr. Pellegrino, thanks so much for the invite.

Now, when it comes to building teams, I find that a very important component of team building is for the potential team members to have the courage to show up in front of one another and declare their weaknesses. If you do that, building a team — I was in sports for a number of years, not with any consequence, but at least I know the philosophy. If you are able to declare your weaknesses to one another, that's how a team comes together. 

So in walking the walk after talking the talk, what I thought that I would [talk about] here is something that I'm terrified about. I've come here not to give you my regular lectures, I give many of those on nanotechnology and this medical application or the other medical application; cancer, heart disease, diabetes, whatever, we have many programs in my lab. But I thought I would come here and talk about something for which I have no academic credentials whatsoever, and that is bioethics. And I'm doing that in the hope that I will be of service to you, that will help at least understand the poor and incomplete perceptions that I personally have of the ethics world and that perhaps other members of the nanotechnology community share with me.

So let's start from the beginning. I have had the privilege of working with Dr. Smalley and to take his advice, especially when I was in service to the National Cancer Institute where we put together the world's largest program in nanotechnology applied to medicine that issued the year 2005, still remains the world's largest program. It was a great exercise, just the assembling of that, and I had the privilege of leading in that proposition. I was brought there for my academic role, part time to do that. It turned out to be one of the situations where you end up working 700 percent of your time if you put all the pieces together. So it was a great privilege. The best part of that was the fact that it gave me the opportunity to interact with a great number of wonderful people, very smart, very competent, very provocative, very different opinions, all the way from the Nobel laureates in medicine and biology to the Nobel laureates like Dick Smalley in chemistry to community leaders, community advocates, naked hippies and all sorts of different — great CEOs so that give us so we could actually refine a prospective that then could go out to the community and be embraced. And we have one representative of that theme here with us today. That would be Dr. Travis Harris who is now with the White House. He's sitting back there.

And I think that was a very successful exercise thanks to the work of Travis and others. So having spent some time with Rick, I think some of his philosophy clearly permeated through our thinking. When I was asked to provide the definition of nanotechnology for Nature Nanotech, the three pieces that I put in somehow echo as I realized for the first time today his definition of stuff doing stuff and being small, essentially the three components that I use again as my personal definition. I'm not arguing that it is better than anybody else's but that's what I go by.

Number one, you have to have a full device or as key fundamental crucial component of a device that has to be nanoscale in dimensions, 100 nanometer, 300, 500, I don't particularly care about being too specific on that. Second, the device has to be man-made, otherwise it's biologies, chemistry, we have all sorts of other disciplines that account for things that are small and everything is made of atoms and molecules anyways. That doesn't mean that nanotech is all of science, even though some are trying to kind of argue that.

Third, because of the smallness or that nanoscale nature of your device or the crucial component of your device, you have to have the property that you would not observe for the same thing at the microscale. Let's call that a new property or an emerging property and that can be chemical, physical, biological, whatever it may be, combination thereof.

So far I would think that most people in the nanoworld kind of agree, plus take or give a little bit with this definition. I add a fourth component that is a guiding principle of a lot of the work that we do in our lab, which is that you have to have a mechanistic explanation, a cause and effect type of explanation of what your new behavior is, why it takes place in a certain way, and usually the language in which his mechanistic understanding has to be expressed is the language of mathematics. 

So we kind of use the shorthand expression, "It ain't nano if you don't have the math to back it up," which is of course, a shorthand. It's an Italian slang, spaghetti western style, but I think it gets the point and the point is that unfortunately, a lot of what we call nanotechnology today is really observational science. It's taking pictures and describing them more than it is — which is a prerequisite first step towards doing a real nanoscale science which requires that understanding.

Well, nano, the best function in nanoscale devices anywhere in the universe, I think nobody would disagree that in biology, the dimensional realm between the 10 and the 100 nanometers, we have large biological molecules that do an absolute spectacular diversity of complex tasks. We are moving all the way into the domain where viruses live, which are also machinery of incredible complexity and the spectacular ability to multiple different functions. So now the fact that we are even talking about nanotech comes from the fact that at least I mentioned scales, now to have arrived to different techniques, it is possible to make human artifacts and control them and use them and assemble them. We've just scratched the surface but I think that is why we are here today.

Now, I will also make the comment that of the words I don't like nanotechnology is probably number one and one, I think, the great scourge that we have in nanotechnology is that the word was invented in the domain of science fiction and we continue to carry that connotation with us as we are doing science and as Nobel prizes are won pertaining to the domain of nanotechnology, several. So we continue to carry somehow in the back of our minds this notion of nanotechnology as that nanorobots so the nanogadgets, they really have no citizenship whatsoever in the field of science and have been proven to be impossible on solid scientific grounds. 

The nanosubmarines, that nanoboats that you see illustrated in covers of magazines and permeating discussions. Even today we saw some of that among this most learned group. They really have no citizenship in science whatsoever. They are, if you will, a consequence of the fact that the word nanotech originated in the domain of science fiction. 

So we all need to be cognizant of that as we filter out of the back of our mind some of these things that perhaps belong in Hollywood movies but they are certainly not what nanotech is operationally in the trenches, in the — for instance, in the clinic. So that we don't have the misunderstanding — of course I'm not blaming anybody for that. It's just a statement as to how the field has evolved and how, and of course, how certain words have a staying power and certain concepts have a staying power in everybody's mind is a natural development.

So I identified, again, these are my personal taxonomy, at least three classes of nanotechnologies. I will make quick reference to these three classes with a few examples and then from this slide on, I will just give you my chicken scratches of what my understanding of bioethical concerns are for you to correct me and to start a conversation.

So first, perhaps the most famous nanotechnological implements in medicine are nanoscale particles, particles on the order of say 10 to maybe 500 or perhaps even 1,000 nanometers for injection in the circulation so that they can deliver drugs or they can deliver imaging contrast agents selectively to sites of interest, to sites which are diseased, for instance. Think of a cancer lesion or a cancer metastateses. We call these things generally nanovectors and Dr. Maynard gave a very eloquent summary of some of the multiple functionalities that are built into these so let me not go over that again.

But I do want to say that I wouldn't want you to think of nanovectors as an object of the far future or even of an object that will come into play in the near future. We have had manmade nanoparticles not only research laboratories for 20 years plus but in the clinic for 10 years plus. Anybody that goes to a cancer clinic this day for say breast cancer, for ovarian cancer, certainly for Kaposi's sarcoma, as of two weeks ago for multiple myeloma, among the options that are offered is the option of treatment with liposoma (phonetic) formulations of otherwise very toxic drugs such as doxorubicin that carries tremendous cardio toxicity so if you package doxorubicin inside of a liposoma which is a little fat globule that mimics the essentials of a cell, of a biological cell, as a container, you put doxorubicin inside of that, you inject that in the general circulation, somehow these particles find their way to concentrate preferentially more in the tumor than they do in healthy tissue, and the reason for that is that the blood vessels of the tumor are leakier, they have little openings, little gaps, that these particles, if they are the right size, can penetrate whereas they cannot penetrate in other parts of the body. This is a very rough first order explanation but perhaps serves to make the point that these drugs have been in the clinic and they are actually front-line therapy for many different cancer types or different situations that arise in the continuation of the development of cancer for recurrent disease for metastatic disease, been with us 10 years already.

There is a second class of nanoparticles that has recently made quite a splash, quite an impact in the fight against breast cancer. It is a nanoparticle formulation of taxol and we're not going to use the trade name for that, but it is something that has really made a tremendous impact in the fight against breast cancer, especially recurrent and metastatic disease. There is a large number of nanoparticles that are being researched in many laboratories, mine is one of those, that are in different stages of the preclinical development pipeline and many of them are approaching or are already under consideration by the Food and Drug Administration. I an thankful that Dr. Sanhei (phonetic) is here from the FDA, that is a leading figure in FDA's involvement in nanotechnology. 

So these nanoparticles, that's a big part of the story. I will come back to them and I will discuss some of the things that we can hope to do with those. And some of these, you heard the famous names, is the of course, the lipizones, the quantum dose, the nanotubes, and there's many other different types, biologically derived nanoparticles, many different types. I think of the order of five to 10,000 different nanoparticle types being researched worldwide.

Second class implants that have nanocomponents. These are things that could be put under the skin or inside of the body to perform different functions. Let me give you a few examples of that, and these are really objects that are more near future or perhaps farther future than available right now. On the sensing side, you can imagine having sensors built, put under the skin that pick up simple physical variables such as acceleration, shock. The sensor could be used in a number of different context or perhaps temperature differences so you can respond to extreme emergent conditions. Or perhaps the sensors — the next generation of sensors that people are thinking about would be sensors of biological molecules, so molecules of biological significance, glucose for diabetes or certain narcotics that have to do, perhaps with cancer or with cardiovascular disease. Well, the notion of building sensors that can be implanted in the body and give reliable information about molecular concentrations in the body, that is a long-term proposition. There are technical hurdles even though this has been researched for many years, there are technical hurdles that make that very difficult, but physical sensors can be implanted. Pressure sensor, you know, flow sensors, that can be implanted and actually an ideal compliment for implants that we already put in the body everyday such as implants of course, of pacemakers, of stimulatory implants for cardiovascular function.

Another class of implants that may very well benefit from nanotechnology is that has to do with cell transplantations. Sometimes we think, and this thought has been going on historically for about 50 years, that it should be possible to use cell lines derived from animals to supplement diseased functions in a body and again, take diabetes for a moment, the islets of Langerhans inside of somebody's pancreas that produce insulin, if you could replace those with cells that come, for instance, from animals, wouldn't that be great? It would be self-regulating in their release of insulin. They would be essentially bringing back health, bringing back homeostasis. 

Now, the problem with that is that as you transplant the cells across different species, or across different individuals, but even more across different species, there is a very strong rejection response. Now what nanotechnology can help do is keep the molecules that govern this rejection response outside from being in contact with the transplant itself. So the potential notion there would be that of regenerating, if you would, that's a form of pretty elaborate tissue engineering, if you will, essentially reconstructing a distributive pancreas, if you will, or at least the endocrine part of that, the part that releases insulin when the glucose level triggers that release.

Now, what are ethical issues with that? Well, one is of course, the notion of is it ethically acceptable to use animal parts into humans? Of course, we use animal derived products in medicine and we have for many years. Insulin is a great example, porcine, pig derived insulin was always the mainstay until of course, we developed the recombinant DNA approach to obtain an insulin. There are many other examples of that. So it is not an ethical issue that is very novel. It is perhaps, made more intense by the fact that nanotechnology can help do things that perhaps, in order of magnitude, is more complex so it is intensified in its magnitude, but it's not enough of a concern. And if I can give you a sneak preview, I frankly, don't think that with nanotech we have no ethical concerns. I think we have increased, of course, the necessity to address some of the concerns that are pervasive throughout medicine but with my very limited understanding and ability, I cannot thing of truly novel concerns.

The third and then I promise that I will — oh, well, there's another example of implants that you may be interested in, implants for neuro-stimulation in the brain, for instance to give sight to the blind. And that is something that has been worked on, again, also for many years. That includes the use of probes that stimulate selectively certain parts of the brain so that you can get a signal that corresponds to a visual stimulation when necessary. That is something that really requires very specific stimulation that I think, by necessity, if it ever comes to bear, it would be through a nanotechnological device. Other type of stimulations for muscles, for wasted muscles, for muscles that are no longer capable of performing their functions. That is also something that can probably be done with something larger than nanotech, but in the same ballpark type of developments.

Will it be possible to ever develop brain implants that allow us to think faster, to think better, to make better decisions? That's sci-fi. For me that's sci-fi. There may be other people and I will stand corrected if I see a scientist that makes a good argument. Best I can do to you is speak my conscience. I don't believe that stuff. 

Next, laboratory devices and here is where nanotech is probably going to make a tremendous impact, already is very soon and the ethical issues with that I'm interested in discussing. Devices that we have in the lab that we don't put inside of people, that we don't inject, that we don't — that don't go up our nose into our brains, stuff that we keep in the laboratory, in the desk and that we use for processing biological samples so that we can find out as early as possible if somebody's got cancer or not, heart disease or not, so that we can intervene promptly with the best tool ever developed, for instance against cancer, and that will not be a magic drug. That will be the knife. If you catch cancer soon enough, today we have the tools to cure all of it by and large, and that is called the knife. So the notion of nanotech on the prevention and the screening side, I think that's something that we need to focus on.

Okay, and then let me show you again, let me show up naked here in my weaknesses and tell you, I've taken medical ethics in medical school and that's as far as I went and I actually participated and still do, in the medical board of institutions and sometimes I'm involved in discussions that have to do with ethical considerations and the life decisions and whatever, and I will say that I've been benefitted immensely from the works that came from this group and I thank you very much for them.

So my recollection from medical school, the way I was taught, and again, I'm not advocating this over any other framework, just telling you where I come from, as captured in my accent if you will. So my accent is I understand beneficence [as] "do most good," that's easy. I understand the non-maleficence, I think that means, "first do no harm," and I never learned to pronounce the word maleficence, and probably spell it, but you know what I mean. 

Number three, "respect," now what is respect? I understand respect. Again, I'm just telling you this so you can factor out my — the poverty of my understanding from my statements. "Autonomy," people make their own decisions as much as possible. We need to enhance the ability of people to make their own decisions. Self-determination, human nature and it was mentioned earlier and thanks for reminding us, that "human" and "humus" have the same root. The other word that's got the same root in my mind is "humor," which somehow I find that humans have this self-ironic nature to our existence. 

Human nature, going beyond human nature, I think is a question of respect for species and for all of us as members of the species, that would be my personal perspective. To meet the aspect of justice that I really want to focus on a little bit today, is that to have equal access. Okay, so considerations on beneficence, what good can medical nanotechnology do? I have made — already I've given you a few examples but just to make sure that we place the considerations in context, I work mostly in cancer and I have the privilege of working at the MD Anderson Cancer Center, which is a great medical center and the volume of cases that we see is absolutely unbelievable. I think it's the largest in the country by a factor of 10 or something like that. And so I'm reminded daily, even though I'm not a clinician, of the fact that one person every four minutes dies of cancer in the United States. Maybe I got the wrong — one person a minute dies of cancer in the United States, four persons a minute in Europe, 20 worldwide. So if you do the numbers, every week to 10 days the cancer casualties in the United States equal or exceed the casualties due to say 9/ll plus the war in Iraq. I think these are type of considerations that need to give us pause as we try to find a balance between the benefit, as was said earlier on, between the benefit and the risks that we embrace, of course, by bringing up different types of technologies and approaches.

So in my mind and I've already spilled my conclusion here, in my mind the most powerful tool that we need to develop against cancer is early detection through screening, through screening that can be applied to everybody many times during their lifetimes. The good news, which is, of course, also a very painful news, is that for a cancer to develop for a normal cell to develop into a cancer cell, it may take 10, 15 years, in multiple different mutations, so that makes us feel very bad that we are not able to catch it and people die because of it, but at the same time, it should make us feel very good, that if we play it right and we develop the tools, perhaps it will be possible to intervene early on in the trajectory, identify where the tumor — the nascent tumor or pre-tumor lesion is developing and intervene with it, with a knife or some equivalent to the knife. We don't need new magic drugs.

But how are you going to be doing this risk assessment or this mass screening? Well, imaging, you know, x-rays, MRIs, C scan, this sort of stuff, that's great technology, very useful indispensable actually when you come to doing a diagnostic work-up but there are technical hurdles, if you will, that keep me in my mind from thinking of imaging as a way to do screening for everybody all the time in the future. What are those hurdles? It's expensive. The logistics are a problem. There is a burden of radiation that you need to take and there is a burden of — there is a limit in the imaging contrast that you can get, can you pick up a single cell? How are you going to identify a cluster of cells, so maybe 100 cells, how are you going to identify the molecular markers? For — as you know, every cancer is different, so identifying the molecular makeup is a fundamental necessity. Different cancers respond differently and only by understanding the molecular makeup [can] we can select the right drug, which now is called "personalized medicine" and if you want, we can talk about that, too.

So to me the way to address mass screening is through — you cannot think of doing biopsies on everybody, cutting people open all the time. That doesn't work either. So to me, the notion is can we take advantage of biological fluids, sputum, saliva, blood, the air we exhale, urine, any number of biological fluids and look into the molecular contents inside of these fluids and look for signatures. Now, let me tell you the bad news. Number one, there used to be a time when people thought that there were magic markers that you could use to say, "This person's got cancer". We don't believe that any more. There is no single molecule.

You can get a bit more, get a bit less, but the typical is not cancer-specific to the extent that we want. We need to look at combinations for different molecules, perhaps, 10, perhaps 100, some of which over-express, some of which under-express and they form a partner that is really indicative. That is, I think, the direction that we need to go at.

Now, what does this have to do with nanotechnology? Well, nanotech, how many proteins do we have in the bloodstream, how many different proteins do we have in the bloodstream? You know, one would think 30,000 genes, so maybe 30,000 proteins. How about a million proteins, maybe a million and a half, nobody knows for sure and let's include in that number also the proteolytic fragment that comes from the degradation of the proteins that tell us about the disease process. So a huge number of different proteins, we need to monitor. We have to have many channels that address each of those quantitatively in real time, cheap so we need to have sensors that will be able to talk with these molecules one at a time.

It stands to reason that they should be molecular size, that is nanotechnological by definition. In addition, I'll make it even worse, some of these proteins are so concentrated that they are 100 billion times more concentrated than some of the signatures we are looking for. So it's an unbelievable problem of unbelievable complexity. I think the only way to address that, you have to have tools the data sizes that are comparable to the molecules that they are looking at, many, many of them with very controlled properties. That's an operational definition of nanotechnology. This is nanotech. This is what I think nanotech is going to do to change the world. And this does not go in the body. It's a tool that you use in the laboratory.

So with that, risk assessment, mass screening, early detection, personalized diagnostics, so that we can then develop treatment that are personalized or modifications for the individual or for the disease or the stage, wherever it is when we are treating it and these treatments can be non-nanotechnological even though nanotech can help convey the drugs and the agents locally, and I will talk a little bit about that in a moment, reduction — these are the side effects, reduction in cost of medical care.

This is the statement to the potential. This is the "I Wish" list. Now, of course, if doing the most good is something we are interested in, we should try to knock down the barriers to doing the most good. Let me just mention a few of those and I promise I will pick up the pace a little bit. Of course, the root cause of all problems sometimes is that the science is not sufficiently developed for this particular question of the protein based or the proteomic screening and any number of other screening, the fundamental science, is really lagging behind but is making good progress.

Multi-disciplinary, to solve these problems we need to find ways to get together and break down disciplinary barriers, very difficult to do that in academia, unless we are actively working on that, this type of teamwork approaches will never succeed. Delay in developing a regulatory framework, and again, and I'm not saying this because Dr. Sanhei is here, but actually the FDA, I think, is doing a magnificent job in picking up the new issues that come with nanotechnology.

Delay engagement of private sectors, as far as I know all the new approaches always come to the clinic through some sort of a product. So whether we like it or not, that's what we got, so we need to find a way to engage the private sector to have transition optimally these things into the clinic. Educational practitioner base, development or reimbursement protocols, these are all barriers. To me the biggest barrier of them all is insufficient or delayed engagement of the stakeholders, that is the general population, which is why I applaud so much your interest in discussing nanotechnology. I spend a lot of time in Europe. The Europeans are very active in looking at the bioethical issues that surround nanotech, sometimes even keeping their clothes on, and they have all sorts of different ways. It's very interesting.

But I really think that is the key, so a strategy that we start to develop in the National Cancer Institute and then now I apply in my life in Texas, is that of engaging the advocacy groups, the National Breast Cancer Coalition or the Prostate Cancer Coalitions, the people that see in themselves or in their close ones, the ravaging effects of disease and can argue on the benefits versus risk from a personal involvement perspective. I think that is very helpful, keep things honest and balanced.

Okay, let's go the" first do no harm." How do we do harm? Well, of course, there's an opportunity cost. Again, this echos what Dr. Maynard said earlier on, there's an opportunity cost is the argument. Look at the disastrous situation that we are in, in particular with cancer. In 50 years, from 1950 to 2002, the demographics in just the mortality rate for heart disease got cut in half. Cerebral problem, strokes, hemorrhagic stroke for instance, vascular diseases got cut by one-third. Infectious diseases got cut in half. Cancer remained the same. So we have an issue. We have an issue. It's a very hard disease to fight. And great progress in some subsets, but overall the great killers remain great killers. 

So the opportunity cost, we have a responsibility, if we can do something about that, my personal take, just myself speaking, is that we have a responsibility to make things happen. Of course, as is true for every other field of medicine, we have to make sure that the treatment, the benefits outweighs the suffering and the risk, there's nothing new to that, of course, in any of these. It is all stuff that we apply to all of course, considerations of medicine. There is always the risk of device and system malfunctions and there is always the concern about causing health problems in the health care provider or in the non-patient populations such as the people — the family, for instance, or the visitors or whatever, of somebody that could be treated with nano. So we need to focus very carefully on all four of these and probably more.

Let me just make a quick comment on the environmental impact of medical nanotechnologies. Dr. Maynard is the world's expert and has given a tremendous presentation on his perspective in general, environmental impact. When it comes to medical nanotechnologies, of course, remember we had talked about a laboratory nanotechnologies, the things that we keep on the desk. I frankly have a difficult time seeing much if it as tremendous environmental risk from devices such as these and when it comes to nanoparticles for directed therapy, we recognize that these are nanomedicine type of formulations. They are prepared in regulated fashions, administered, disposed in controlled environment. They are presented in very low volumes.

Sometimes people ask me, "How scary is your nanoparticles you guys are making to deliver drugs such as methotrexate or doxorubicin or sisplatinum (phonetic)", and my answer is, look if I spend the rest of my life trying to make my particle as toxic as methotrexate, I don't think that I could. You know, the levels of toxicity of the drugs that we are using, we use them because they are so toxic, so there is an argument here of a comparison and of course, these are subject to regulatory scrutiny by safety by the FDA. So in a sense, I personally am less concerned about — we always need to be very vigilant always, we're advocating for very strict vigilance on environmental impacts but frankly, where I get terrified at night is not so much for — I'll tell you something else in a moment, but not so much about the medical nanotechnologies and their environmental impact, industrial, yes, I'm worried about that. I am personally worried about that, low volumes, no regulations, we don't know what the heck is going on, and so I'm concerned about that and I'm delighted that people are working on this and the more they work in on it, the better it is. 

Now, the question was asked, biowarfare applications was asked of Dr. Maynard. He fielded it very well. Let me give you one example that comes from the other thing that I wake up at night, that I woke up at night at times in cold sweat and this helps address — now, let's look at what nanotechnologies can do for delivery of drugs in a localized fashion. I want to make sure that my drug goes to the tumor, not everywhere else. Right now, by contrast, even with the best medicines that we have the molecular targeted medicines, I have to inject 10 to 100,000 molecules to get one in the tumor and the rest goes in other places where it does different degrees of damage.

The problem with that is not only biological recognition, everybody talks about that, there has been biological guidance to get your particle to the right place. That is a consideration but it is not the dominant consideration. In my mind, my dominant consideration is the biological barrier that the body puts up. A reference was made earlier to one, the blood/brain barrier. So we are chocked full of all of these booby traps and the barbed wires and things that the body has and that has developed and of course refined over 4 billion years or plus or minus a few, and that's the stuff very difficult to penetrate. It's there for a reason. And the drugs that we inject or the foreign substance that we inject, nanoparticles as well as anything else, had to negotiate those barriers. They're there for protective reasons. So we need to be able to deal with them in a way that is very selective. That story, like a hammer, like the wrench, it can be used for good, it can be used for bad. 

How can it be used for bad? For instance, this is something that actually comes over the research program that we work on but not as intensely as we used to. These are particles that contain agents, biological agents. These represent the inside of the intestine. This is the wall of the intestine and this is the vasculature that supports all of this. As you see, the wall of the intestine comprises this basement — this mucosal layer. We have an epithelial layer, epithelial cells, which are connected by this gate type of things, they're represented here as gates. So to get my drugs, think of insulin, why can't we take insulin by mouth? From here to here, there's all these barriers, very difficult to negotiate. So wouldn't it be great if somebody can come up with a way to make a pill that inside of this micropills is got not only the drug but doses of some agents that open up the gates so the stuff can come through and then they close up again, shortly after that. Insulin by mouth, great. You don't have to inject your kid eight times a day any more. Fantastic. 

Right, then the next guy over picks them up and uses then to turn otherwise very difficult pathogens of biological origin, and turns them into something that are no longer blood borne but they can be sprinkled on a salad or distributed in the water or made for people to inhale, how scary is that? Terrifying and the bad folks that may want to do that, have one great advantage over the medicals. They don't need FDA approval. 


So one night literally I woke up and I said, "Holy cow," or something like that. What do we do now? And then I started having all these group meetings with all of our friends and advisers and whatever else and these are some of the options they came up and again, I'm just telling you our personal experience, but this carries through, I think, for essentially every piece of research that I can think about to different degrees. 

Well, we can stop everything, that's the Prince Charles approach. Prince Charles, as you may know, has advocated for a stop on nanomedical research until we figure something out. Well, that's an approach, and you know, the Europeans tend to have this notion, this concept of a "precautionary principle." I personally don't find that to be a principle but you know, this is a shorthand that is used to think that perhaps you shouldn't do anything until we know everything about that approach. And he's got good reasons, but to me, if you look at the four foundations of ethics, if you are the four pillars of the simple edifice that I was referring to, that has got all normal efficients without consideration for the other three. So I have a difficult time a little bit to accept that perspective, or we can continue research and just pretend we never thought about it. Or maybe we can tell everybody that there is a problem or that there is a risk or perhaps you don't tell everybody, just tell some people, the good guys.

And who? Or perhaps we say, okay, fine, but you know, in the back of the garage I'm also going to develop counter-tools if anybody comes up with bad ways to use this stuff. That is tricky, tricky. We have, of course, the U.S., who is signature to a treaty that says we don't do biowarfare research and to think of defensive measures, you have to think of offensive measures. And so we're in a bad position in certain circles, not far from this hotel. I was told very sternly, "I don't think that's a good idea." And that was a few years back. Maybe things have changed. But, you know, that's a real issue. And then let's have, okay, the other one that you're probably thinking about a little bit non-maleficence spelled yet a different way, unintended consequences. You may remember, some of you have seen this great development of a good friend of mine, Professor Carlos Montemagno. Now he is the Dean of the College of Engineering, University of Cincinnati. He's a great scientist. He took this piece of this biological enzyme, it's called FY NTPA, a fundamental enzyme for energy processing. It's got this rotatory motion in this piece of the molecule and he picked a piece of silicon made like you make out of — you know, when you make computer chips, I do a lot of those, I work in silicon myself. And so he was able to chop off this piece of the molecule, chop off — pick up a piece of silicon, put it in there and all of a sudden you have a nanopropeller, part biological, is an engine. They can use it to propel a submarine other than the physics doesn't support that. But this thing really spins and you can see it spinning water. It's exciting. Tremendous piece of science. So essentially here on a piece of silicon, manmade, computer type technology, you have been able to bring in biological capability. What is the bio-property? In this particular case the rotatory motion comes from a piece of biological molecules, great idea.

Can we extrapolate that to scary thoughts? Well, we can always do that. We can always think scary thoughts. I don't know if you read the book, the book "Prey." It's Michael Crightons' book that's got this self-assembling, autonomous, replicating nanoswarms and that attack people and end up eating people up and they have developed antangents (phonetic) of their own. So that's the doomsday scenario of nanotechnology.

Well, I don't think there's a chance that that will happen. We always need to be on guard. I don't think there is a chance that that will happen. So probably that's bad sci-fi, bad enough, it didn't even make it to Hollywood. And let me tell you I know about that a little bit. They were thinking about turning that into a Hollywood movie, but no, Hollywood movies like big scary monsters where you can have a lot of action. Nanoparticles, how are you going to visualize them? So where is the drama, where is the image of the nanoparticles are talking. The best that you can have is the guy, "Oh, I'm choking, I'm choking", which of course, we can do without the need for nanotechnology. Yet one more example of the fact that nano doesn't really bring anything new. It just brings some more heightened, if you will, degree of concern for things that you already had.

Respect, okay, to me respect has got a bunch of different components and again, excuse the power to my analysis. Informed consent is a fundamental component of respect, but you've got to know what you're talking about. So I mean, informed consent, how much harder is it to get the full informed consent with the respect for full knowledge of what is required for making decisions in nano. Perhaps there would be new angles that need to be looked into. Then the issue of performance enhancement was brought up already and I think some of the questions have already been mentioned. 

Okay, performance enhancement, I think we all agree what we should try to cure the sick but enhancing the normal, now what is normal? What is a tolerable risk? Can we decide, does the person decide, who decides what is acceptable? Having x-ray vision, is that acceptable? It's a trans-species type of thing that we should not accept. Who pays, who benefits? How is that nano different from coffee? You know, I take coffee all the time for enhancement of properties, and you know, steroids. I will not even mention the next one, plastic surgery, plastic surgery for cosmetic reasons. 

You know, the fact that you can get benefits from these is good and we are like that, but, of course, concerns come up. Let's talk about autonomy real quick, I'll come back to respect in a moment.

Right to make own decisions, now, let me tell you I've already given you a little bit

— a few items that come from the nano-world, that are already in clinical practice. Let me give you another one that is pervasive in every self-respecting biological laboratory around the country and probably the world. The microarray the DNA chip type of things for gene sequencing, that comes out. It is a straight up, brilliant application to biochemistry of a technology that has been used for making computer chips for about 50 years. That technology is called photolithography. 

So photolithography gives rise to the electronic chip which then gives rise somewhat in parallel to the micro-electro-mechanical systems which you may not know that you have but you have them in your car, for instance. These are the things that deploy the air bags if you hit something. There's many all over the place, sensors of that type which — and then the other generation is the microarray or the DNA which is called micro, you'll notice, it's not called nano. So why is it called micro? Because at the time these things were developed, about 15 years ago, close to 20 in the San Francisco Bay area, by a company called AFFYMETRIX together with Stanford, and I know because I was there, this little — this is a gene chip, one of the first ones that they put out. This little domains that you can use for sequencing the smallest you could make them was about 100 microns.

Now, with the technology evolution, it's kind of like the Morse law, the shrinking of all electronic components, the improvements in photolithography, the smallest you can make these domains is perhaps, 10 nano. Now, multiply out 100 micron, 10 nano, to get the image of surface area so what you're getting here is an enhancement of 100 million-fold worth of improvement and information density with respect to 15 years ago. That's a lot of million-fold. So now all of a sudden, the easy problem of genomics can be put in the context, different context, and we can start tackling the really hard problems of proteomics or all of the other omics that come on board and that is what people have been working on. 

So the notion is, nano is already pervasive in everything we do even in its early embodiment they were called micro because we weren't smart enough, it takes some time to develop these things, but the direction is that of mapping molecular signatures and... they can be gene products or they can be anything else but it's the same idea, to be able to pick up signatures that not only can tell us health and disease but it can also tell who we are, where we've been, who was sitting on this chair 10 minutes ago.  They are of course, I'm projecting now in terms of future developments, potentially. I'm looking at potential risks, or they can tell us what is the risk that I have of developing this disease, that disease, the other disease, which, of course, are issues that you have taken up already. But you know, these are a very fundamental enabling set of technologies. So who gets that information, a question of privacy? Who gets to make the decisions of what is the treatment that follows up in accordance with a certain risk profile?

What is the role of government in all of the above? Who is supposed to know these things? Who is supposed to know these profiles, the prognostics, the relevance of behavioral and environmental risk factors? Is it the person, is it the potential employer? Is it the insurance company? How do we treat? Again, I'm telling you things that you already discussed with great eloquence but allow me, just because they allow me to close the circle. 

Once we know the risk profiles, do we follow optimal care algorithms or do we have room for decision? What does this do with respect to autonomy of decision? Reimbursement, access to health care, employment discrimination, you may remember that there was a time to get married you needed to get a good health certificate including that you didn't have syphilis. I don't know if they did it in the country. They certainly did in Italy. 

Social interaction, are we going to have — do you see a society where I want your genome sequence before I marry you and I want to know the history of your entire [health] so that I can project what type of things you're going to get? Is that going to raise the spectrum of societal layering, those that have better chances and those that don't, and didn't mix. And perhaps those that have the better chance are also those that have the better resources to address whether problems may happen. Are we looking at societal layering? Now, I'm going out in the doomsday scenario myself. 

But I think I really resonate what Dr. Maynard was saying earlier, we kind of need to think these things out ahead of time a little bit and perhaps this is being very stupid. I'd be very happy if you do.

Justice, fair access to all. Will nanotech become yet another medical advance that will be of use only to the haves and inaccessible to have nots in the US and in the world? Now, that was the theme that I was given when I went to the Kyoto meeting on Science and Society in 2005. The other gentleman that was there to discuss these issues for the delegates there, it was a tremendous meeting, was Peter Singer, which I had never met before and I will confess I was a little bit tense about meeting. It turned out that it was an interesting set of discussions that we had.

So and the question that I was asked in the context of the society meeting was, "Tell us about the risk that nanotech will essentially contribute to the layering of the have and have nots by providing better healthcare only for the rich." And I said, "Well, of course, that's always a concern," but can't we for once rather than being defensive, think about — turn the argument around a little bit? Wouldn't it be part of our societal responsibility to turn the document around and rather than being defensive, focus on developing nanotech to specifically address healthcare injustices, healthcare disparities. There's a great opportunity for doing that. Single dose vaccines, you know, there are a large part of the population worldwide, if they see the doctor once, they are very happy. They may not have a chance to see a doctor again to get a booster shot for things that — for diseases that have all but disappeared from the developed world. 

Lower cost medication, I'll come back to that in a moment. Screening diagnostics, perhaps the biggest success that we have had in the fight against cancer is cervical cancer. Even before we get to the vaccines that are coming in now, because of what, because of the Pap smear. The Pap smear is a fantastic idea. It has reduced the incidence of the mortality of cancer in the developed world by orders of magnitude. Not so in under-developed countries. Why? You need to have a pathology lab to do a Pap smear. It doesn't do me any good if I don't have a team or trained technicians or trained doctors, the reagents that they need. It doesn't help me any. So for instance, I see points of light coming out this way and I'm very heartened by that. 

Some colleagues of mine at Rice University, Dr. Rebecca Richards-Kortum, is developing a colopscope (phonetic) that anybody can use, that lights up when you see something bad. You don't even have to know what it is, but it lights up and you can intervene directly. Portable system, but the ethical responsibility that we have is that we need to support these types of things. We can really change — nanotech can provide us with a set of tools that we can effectively use to address healthcare disparities but we have to get our act together and focus and really make it happen because this is, like all research, is expensive research, it's difficult research. It requires the environment, the organization, the skill, the priority, so I think that is an ethical consideration. 

Let me come back to this question of lower cost medication. As much as I'm trying to make a case for the positive things that nanotech can do, let me be honest with you, the one great example, the new nano drug that is coming to the market which I will not mention, but we talked about it earlier, it was the taxol, nanoparticle formulation, is so expensive, it's unbelievable how expensive it is. And frankly, that's yet another case of a drug that can really make a difference nano or no nano, which is priced with complete disregard, in my mind, for the cost of production. 

It's not how much it costs. I get asked all the time, "How much will your nanodrugs cost?" Well, if you look at the numbers, you know, the cost of the particle with respect to the drug, if you buy it on the open market, is minimal. It's small, it's pennies on the dollar, but that's not the point. That's not the price of drugs. These arguments that you hear, at least the way I read the arguments that I hear about how the prices of drugs is set and how much they have to do with the cost of production, the cost of exception, whatever else, are pretty thin arguments in my mind, than what I feel determines the cost of drugs and who gets and who doesn't is straight up market dynamics and I have a lot of respect for market dynamics, but perhaps, it is an ethical responsibility for us to find a way to balance the great strength of open market dynamics with ethical considerations and our societal responsibility, perhaps an in between type of an approach which of course, I'm not prepared to discuss. I wish I could but I think these are issues that perhaps this has to do also with the way we do research in universities, the way we do research in the pharmaceutical world.

We are getting products that cause this layering of haves and have nots because that's what we shoot for. Whether we do that consciously to subconsciously, I don't know but we are getting what we are getting up to do from the day one, perhaps developing different ways of setting priorities and directing research infrastructure can be — can address some of this. 

Well, you will be happy to hear that I've come to the end of my presentation. So let me give you a few summary points, at least the ones that I was not too afraid to put out in front of you and leave them there while we discussed some of the other ones that I mentioned, I left, of course, in the previous pages. So I think there are great opportunities for medical advances. I think that will happen. That's just my opinion but again, the best that I can do is speak my conscience to you. 

I think the environmental risks for medical nanotechnology are modest to very modest. However, for industrial nanotechnologies, I think that they need to be looked at with much greater enthusiasm than has been done so far. Military terror and risks in my mind are speculative and don't have any evidence that anybody is doing that of course, but that is something I do worry about and one reason for that is something Dr. Maynard said, that some of these things can be done in the back of the garage. It is not like putting together a nuclear power plant. The personalized medicine vision that we are all familiar with is really very much nanotech enabled both from the personalized diagnostics and the personalized delivery perspective so this then strengthens, should strengthen our concerns about the ethical questions of autonomy and privacy. I think there is a risk that nanotech will be available only to privileged societies, at least initially and there is one example that I mentioned I think should tell us a lot about that, that if we get our act together and act as a team should, I think we can direct nanotech specifically to address the questions of injustice and the question of underprivileged populations receiving a disproportionate low amount of healthcare. My personal take, and again, you ask, you know, somebody that's got a hammer, everything looks like a nail. I've been practicing nanotechnology, as I told you and there is a reason why I do that. So my last bullet point, perhaps, will not surprise you. I do think that the greatest risk in the nano medicine may be that of not taking advantage of risk for potential. And with that, I thank you very much for your very kind attention.


CHAIRMAN PELLEGRINO:  Thank you, Professor Ferrari for bringing some of the difficulties and complexities of nanotechnology down to the technical bioethical issues that we are concerned with. I'm sure that there are members of the Council who wish to comment and ask you questions. Do I see a hand? 

DR. FOSTER: Let me just make one comment. I, unfortunately, have got to go catch a plane. I'm actually going to get back to Dallas, but I want to say two things. One, I've been trying to understand what's happened to the climate in Dallas is this low pressure thing just sits there for 15 days with 8, 13 inches a day and I now think it's because this storm arrived in Houston and it's disturbed the whole atmosphere from Dr. Ferrari. 

Ben Carson and I were talking last night about the fact that there's an old biblical statement that without vision the people perish but the vision that you've brought is very interesting and touching and I just — particularly in medicine, I just — there's so many potentials for using this. How is a person like yourself as a leader in this, going to prioritize what one does first? And I'll let you answer that for the group, because I have to run. But I think almost everything that you brought up was both interesting, potentially exciting and then we also have all the things. I thought that it was really an excellent presentation.

But in your own mind, what do you think we do next? Are the vectors the main thing that we're going to start with?

PROF. FERRARI: Well, Dr. Foster, first of all, thanks for keeping the bed wet in Dallas, because in Houston, we are very happy that you are volunteering to keep that there. 

Yes, again, my personal answer has to do with I wish I could ascribe it to philosophical considerations but probably it's more contingency. I really — I am very strongly dedicated to breast cancer research and it is one of the primary focuses in my groups. And that, I think, evolved over the years because of opportunities and personal interest and also personal experience, but also opportunities. And this is a very important point about the community leadership that I would like to make on this.

However, a brief comment is that in my group we have — half of my group works in early detection systems and the other half works in targeting therapeutics. So that, I've told you, the walk that we walk. That is what we believe in. That's why we spend all of our time and energy and resources doing exactly these two things. There are many other things that one can do but that happens to be our focus specifically for breast cancer even though the developments — of course, the beauty of technology is, once you develop it for one branch of medicine, then it becomes pretty easy to apply to other branches of medicine. 

Now, why is breast cancer a particularly attractive area to work in, in terms of the contingencies of like everyday life? Well, you may remember that there is a great community group, the National Breast Cancer Coalition, which in years past, was able to harness — I think 12 years ago was the first year and bring down from the Hill something on the order of $150 million to be dedicated to breast cancer research through a mechanism that will really be controlled by the community itself. There was a tremendous paradigm shift. Rather than the traditional NIH mode, which a lot of us subscribe to, which is governed by scientists, this notion here it's going to be co-governed by community leaders with input from scientists and of all people, it's going to be administered by the Department of Defense, through the Army which had to do a little bit with the origin of the funds. 

Now, that program that has given way to — given the rise to —the Congressionally mandated Breast Cancer Research Program, which has grown to, I think, in excess close to $500 million a year. I think it's the biggest program that we have in cancer research, perhaps, even bigger than the NCI's, has also now spawned a program embraced prostate cancer and a few other things. Now, those guys, or those ladies, I should say, most not all, I was on the board for a couple of years, have a patient focus that allows them to push for taking great risks with respect to what the NIH typically does, so I found that to be a very suitable environment to direct our own programs because what we are doing really swings for the fences more than looking for a base hit. So as a result of that, you know, it's — we need to have a funding environment that is more prone to accepting risks. 

So by and large, the reason why we are focused on the breast cancer program is because the community has spoken, these million women have come together initially with a million women march, as it was called. It's always a million this, a million that. I think in that case it probably was a million people, and actually have made it happen for themselves and for the community that they care for. Initially, I'll be honest with you, I was terrified going in as a scientist into this environment, being on their board, being other things because I couldn't believe — I couldn't see how a group of ladies, 99 percent ladies, most of which with no scientific background, could be of any help in leading the fight against cancer. Now I've been five years with them, I've learned so much from them it's unbelievable. They help us keep on this and remember that our job is not to write books, it's not to give grants, it's not to do work on our careers. Our job is to work on improving healthcare and the ultimate objective to everything we do, is with a lady that's got breast cancer or that could get breast cancer and shouldn't get it. That's the reason.

DR. FOSTER: Thank you very much. Very moving statement.


DR. GÓMEZ-LOBO: Thank you. It's very encouraging to have two Italians presiding this meeting. I am glad that you brought up the topic of justice, distributive justice and on a global scale. In fact, in my mind this ties in with our discussions — with the discussions we had yesterday about minimal healthcare in universal insurance and how — to what an extent it is a violation of justice that there be so many people without that kind of protection in the US. But my more specific question to you is the following: I personally don't understand the complex interactions between science, public funding, private funding, et cetera, but is there something like a dynamism that could really lead research into lower cost medication research in this area? I think what you said towards the end was extremely interesting, that there are a number of things that could be done for say, third world countries' populations if certain things were done.

Now, is there any hope in the, again, the dynamics of research as you see it, that would lead us in that direction?

PROF. FERRARI: Well, yes, thanks so much for a wonderful question again. Again, bringing things back to our laboratory, what we have done in my lab, we have hired as Director of our Breast Cancer Laboratory, a lady who by her day job she's a Reverend. She's not a scientist, and so her job is to review all the papers that we write before we send them out to make sure we are honest to our mission, to review all of our media communications, to review all of our patent applications, and to help us participate in guidance. She mentors everyone who is involved in breast cancer research and our work. Of course, she's got technical support but, you know, so that is a paradigmatic shift, if you will, bringing the community truly in an executive position in a control seat as opposed to being a boundary condition.

Frankly, my perspective has always been that unfortunately even, not only community involvement but in general there's always been a boundary condition to things we do in the lab. I think it is high time that that becomes the driving force, not a boundary condition. So in keeping with that philosophy, you're asking is there any dynamic that allows you to do that? Frankly, I don't think so. I think as usual, as many times as happened in the history of this great country, it really comes down to citizens taking life in their own hands and for instance in the case of the National Breast Cancer Coalition, in doing that philanthropy has been fantastic and again great efforts towards underdeveloped countries is spearheaded by the Melinda and Bill Gates Foundation. There are a number of other foundations. Michael Milken is doing great work with prostate, looking at things, approaches that can help address healthcare crisis in this country and internationally.

Now, in terms of I think that those mechanisms need to be enhanced and formalized. I think there is a policymaking aspect to that. That I think we need to come together and make the argument for formalizing approaches that will allow research, that will allow medical development to be directed specifically to those considerations. And that at this moment we are working on a policy document with somebody that I trust many of you know, Goran Hermeren from the University of Lund in Sweden. Again, the Europeans have been very aggressively considering bioethical issues, essentially a statement of responsibilities that have to do with what we as a society can do to help make sure that we channel resources in a way that will address the disparities and the inequities. Now, this gets a bit technical and I promise I will stop here, but there are very clear technical aspects for how we do research in the academic setting and in the industrial setting and they are very similar and they're mutually reinforcing that at the end, will always give us something that perpetuates the system that we have. So my perspective is, perhaps we can think out of the box and say a few stupid things and perhaps, over time, we will develop a way to engender a way of doing research and product development that does not bring us to this almost unavoidable conclusion of healthcare disparities.

Now, the notion of universal healthcare if very appealing, having been raised in Italy, there was ways in which that does not work, too. So I don't know that the reimbursement by itself is a solution. The way we bring healthcare, the mechanism of providing healthcare, above and beyond — together with reimbursement strategies, are also phenomenally important. There are types of medical products that regardless of the credible reimbursement policies that we can put in place, will never be available. So we need to focus on putting out things that people can use. That is my perspective.

DR. GÓMEZ-LOBO: Thank you.


PROF. DRESSER: A couple of points. One is priority setting which is not, certainly, pertinent only to nanotechnology but is a broad issue problem in science. I'm a big fan of ordinary people getting involved in that discussion but there are a lot of problems, for example the National Breast Cancer Coalition, I think they're an excellent group, I agree with you. But of course, they're advocating for investment in a certain area and most of the advocacy organizations have their stakeholders. So — and everybody has a good cause. So how do we, from a broader level, make choices?

The NIH has some priority setting criteria such as promise and number of people effected by disease, number of years of average life span lost and so forth. But we haven't done a very good job of doing that thoughtfully. And then it depends a lot on lobbying. And so many poor people don't have the wherewithal to have an advocacy group and certainly in other countries. So there's a lot of unfairness there. And there are a lot of difficult moral questions such as what do we in wealthy countries owe in terms of investing our resources into the health problems of poor countries? 

I don't think we've done a good job of examining our consciences about that. So I agree with you that we should be involved in this but it is very complicated and I hope it can be done in a more thoughtful way and with awareness of the ethical complexities.


PROF. DRESSER: And the second point is, maybe I'm jaded but you know, whenever a new area of science comes up, there's what I think it's Renee Fox calls Ritualized Optimism. So you know, we've seen this in so many different areas, genetics and stem cells and artificial hearts and everything. So we see it here. I guess I would plead for truth-telling and honesty about the uncertainty, whether the benefits will be achieved and openness and honesty about the downsides, the risks. 

One of your issues was shall we keep it secret, the risks or shall we disclose only to certain people? I think that the public is owed honesty in terms of what we have possibly to gain, but also what we have possibly to lose. So I would hope that the field would adopt that as a guiding principle.

PROF. FERRARI: Absolutely. Thanks so much. This was of course very wise and very inspiring words. And now, going backwards in the order of the presentations, or the items that you made, I certainly, I advocate, I agree with you in full that we need to be very open and truth-telling is absolutely necessary. Actually, in my earlier version of the talk, there was a slide that said cause for actions and then I didn't think it was my role to put out cause for actions and so I took that out. 

I had, perhaps, the strongest term of them all that I used today was scientists obliged to educate. You know, and so we can't oblige anybody to do anything but, you know, that is kind of the philosophy. I completely agree with you. We need to have forums or fora, whatever the plural might be, where we actually tell, and we need to be held accountable for our statements, somehow. I don't know how. The reality is that the word mechanism, you know, the word mechanism works against us. Let's be honest about this.

The word "mechanism," such as in all sorts of walks of professional life, the media, whatever else, I think it is true and I think nanotech suffers from a little bit of a tendency to sensationalism. I will also speak in defense, if you will, of the field a little bit. There have been many times that I've spoken to the media and I've been speaking in the most conservative ways that I could. The ones that I took were the ones that got everybody. And then I get every week phone calls, e-mails, letters from people that are in desperate situations that say, "You said that in the newspaper. You got this for this person, for me, for my father, for my daughter, for my wife," and those are heartbreaking stories. And every time I go through all of them and I listen to all them personally because they're so difficult to hear, and that has really put a great damper on my enthusiasm for speaking in general, you know, because then, you know, I'm called to the task.

That's one form of accountability. It's very painful from accountability, but I agree with you, we need to be — let's say one more thing, you cannot be a scientist if you're not an optimist. That is something I learned from Rick Smalley. He said, "Hey, come on. You can't fault me for being an optimist because if I wasn't, I couldn't be doing experiments. You know, why would I do that? Am I crazy? I do something that isn't going to work."

You know, so society, I think that interface needs to be monitored a little bit keeping this in mind. In terms of all we need to do, what our responsibilities are with respect to the rest of the world, I tend to be — again, that's just my personal take. I am not, I don't like institutionalizing things too much. I kind of like the personal charity that we model. Everyone in accordance with their own conscience and things. Just my take.

However, we can put together, because we're doing all sorts of other works, of our policy making without infringing on the individual liberties, but we can put together institutional developments, what I'm looking for, that will allow for the right results to come out. So let me put it this way, rather than having our research establishment work in a certain way, we can have our research establishment work in a different way. That is not mandating charity. I don't like mandating charity. That's doing the right thing. That is we're living up to our responsibilities in a great country. That's a different story. And I think that is the ethical choices we would prefer. We revamp in a sense, the entire edifice of our research and development in the country which is the most powerful on earth, in a way that we take into proper account the balance of the community.

Working solo doesn't work in the long haul, so you can even make a utilitarian argument for the country itself.


PROF. GEORGE: Thank you, Doctor. I think Professor Dresser has raised such an important issue about truth telling and I think the issue is not so much about outright lying or misrepresenting to the public. It's spinning, exaggerating a little bit, hyping, encouraging, more than is justified and I wonder if there's a deep problem here, perhaps unavoidable. The temptation to engage in those sins against truth telling may be just built into the fact that there is inevitably competition for scarce resources in the sciences for funding. 

And to sell the funding sources on my line of research, my area, rather than the other guy's, the temptation to say, "Well, there's greater hope here, perhaps than is justified," is just there. Now, is this an area where anything can be done? Is this an area where science can police itself? Is this an area where it's dangerous for any external bodies or institutions to attempt to police science? Is there any way within the scientific world that people can be held accountable for the hyping and exaggeration that goes on? Do you have any thoughts about this? I think it's just profoundly important.

PROF. FERRARI: It is profoundly important, I agree with you. It's — and you're right, it has to do with Darwinian dyanmics. It's Darwinian revolutionary privilege and advantages the scientists pursue because the reality is the bigger your name, the easier it is to get your grants, to get your promotions, to get those things. So it is very hard, it is very hard and I certainly, I don't mean for the nano or for everybody now, as was mentioned. It is difficult to make — to negotiate and I never would want anybody to police themselves on anything including scientists on their own, media communication approaches which is why, you know, knowing that the spirit is strong and the flesh is weak, whatever the expression may be, which is why I brought in the Reverend to make sure that she interfaces with every media communication that we make. It's very difficult.

So I think to have some sort of an external sounding board or I don't know, I think that would be very important. I would not know how to set it up. You also reminded me of another point that the Professor made, this question of setting priority, how do we set priority and man, I don't have a clue. The system, I think, the method that the NIH has put in place, I think is very strong and is very defensible, it's objective. It is based on numbers that anybody can control, go verify and so I think it's got great merit. However, you know, I'd like to think that perhaps, a way to avoid the disease wars, as we call them, you know, the breast cancer against prostate cancer against heart disease, against diabetes, everybody's got a great cause. But the way to avoid the disease wars is again, to restructure the research establishment to look at the things in common not at the differences. If you look, the case of cancer is dramatic in this — if you look at the fundamental mechanisms of cancer, you know, we think we bin cancers into place of origin just because that's the way we started looking at cancer a long time ago and we didn't know enough, so we're talking about breast as opposed to prostate as opposed to pancreas, as opposed to lung, but if you look at the fundamental science mechanisms, they are very similar. 

So the question is, can we redo the binning, very difficult to redo the binning because we are all protective of our turfs. Any time you redraw district lines, you know what brings, not far from here. So it's the same, the same, scientific redistricting is also very difficult and it's a very contentious proposition but I think that's an example of the things that we, as a community can do, which do not have anything to do with mandating charity or mandating people's conscience. It's just a better way to be addressing channeling everybody's resources to solve everybody's problems.

CHAIRMAN PELLEGRINO:  Thank you. I have time for one more question and one more response. Thank you. Leon?

DR. KASS: Thank you very much and thank you for this presentation. This is perhaps, not a question that should be addressed to you but I'd make a comment, because I'm trying to sort out given the presentations we've had this morning, what nanotechnology is such that we should give it separate treatment. I mean, what makes this a topic of special interest, let's say to a bioethics Council? 

And let me preface by making, perhaps, two philosophicalistic — more conceptual comment about where you begin, move to a comment you make in the middle and then in a way invite you to address a question. When you offer a definition of nanotechnology, the definition is confined to the device. I mean, the three parts really deal with the device. But — and a hammer is a device and these microscopic, less than microscopic things can be — there can be devices at that scale and they're manmade, et cetera. But a device makes certain powers available and those powers, then have multiple uses. The internal combustion engine is a device. Automobility is the power, the ability of people to move themselves around and you could use it to transport goods, to take yourself on vacation and to drive explosives into somebody else's buildings.

But still thinking further about what is technological, there are also attitudes and dispositions about problem solving and these things find their way into the larger socioeconomic and cultural context and ultimately with political and other kinds of notions governing, so that it seems to me there is partly a question of whether we are rightly understanding what we're about here if we're simply thinking about the devices without sort of elaborating, the larger possible meanings of what it is to be technological in general and technological on a nanoscale. 

In the middle of your presentation and several times and I don't disagree with this at all, you say there's a hammer and there's a wrench and they, like nanodevices, have their better and worse uses, et cetera. On the other hand, from the earlier presentation and from the comments made before, the very molecular scale of this, at least invites some people to want to group nanotechnologies together as a special source of concern. I mean, somebody said in the discussion afterwards, there's something insidious about this because it's sort of beneath detection and it can be spread around without people knowing it. 

I don't mean in the medical context but I mean — and I guess what I — with this sort of long-winded preface, do you really think that apart from gathering certain kinds of headlines, news support, galvanizing, the collaboration of physicists, chemists, physicians, engineers and so on, that from the point of view of thinking about the social issues or the ethical issues, that there's something unique about nanotechnology or is this simply a new wrinkle of the sorts of things about equal access, about privacy and things of this sort? Is there something special here and if so, what is it?

PROF. FERRARI: Thank you, Dr. Kass. My answer is that I don't think there is anything special about nanotechnology in terms of creating new chapters our consideration from a bioethical perspective keeping in mind the limitations on the bioethical understanding, I don't see there is anything new. I see for instance stem cells, there are truly different biological perspectives that were never discussed before, even though they have reference, of course, to millennia questions. For nanotechnology, I don't think so.

I think that what nanotechnology does, is whatever that is, is — heightens some concerns in areas that have already pretty well been understood and researched and studied so, perhaps puts greater priority for additional discourse and engagement of the community in certain areas because, for instance, there's matters of privacy and the acquiring of other data. Now all of a sudden this is happening today. It's happening tomorrow. We thought it would happen 10 years from now. We have to get our acts together in terms of the right say HIPAA laws or whatever modifications there are. 

So there's some policy making consequences that come from the fact that certain targets, I wouldn't reach that we did not think would be within reach very soon. So I think that is all nanotechnology. That accelerates the concern, the rate at which the concern must be addressed and sometimes, perhaps, heightens and intensifies the concern but I don't see anything that is conceptually another chapter in the great book of bioethics.

Something else that I would like to comment and I don't like the word nanotechnology I said earlier, not only because it has its roots in science fiction but also because you may have heard the expression, the nano is really a Greek prefix that means apt to bring in dollars from Washington DC. 


That's what nano really means. And so now essentially the vast majority of what people are calling now nanotechnology is that we are — there is a lot of recycling going on, let me put it that way, and all sorts of other domains of science. All of a sudden they become nano and nano has become this big tent. I like tents, I like a lot of people. I'm a community type of guy, but it really has become on one side somewhat deceptive and I don't say that in a negative fashion but of course, it creates confusion because everybody is nano and everybody is not when it comes to getting considerations that actually come with that. So I think there is a little bit of three cards going on.

DR. KASS: Mr. Chairman, first of all, thank you for that, but I wonder — the time is out so we can't really do this now, but I would be very interested, after having heard this — these two presentations this morning, if Council members might be invited to write to you to see what answers they might, in fact, give in response to this question because it seems to me it bears upon what's at stake for this Council if we were to go further in this area. Bill Hurlbut in the previous session, I thought, spoke rather eloquently about the kind of consideration that might be unique to this.

I'm not sure that everyone would agree but if you would encourage that, I think it would be helpful.

CHAIRMAN PELLEGRINO:  I think that would be a splendid suggestion. We'd much like to hear from that because I think we're into a new area and I think the breadth of it has been exhibited here and the kinds of questions that Bill raised and you've raised need to be looked at in light of the practical suggestions that were put here before us. So I would welcome it. I think it's an excellent presentation. And with that, I would like to thank Professor Ferrari for his presentation and now we move into another aspect, the last aspect of our meeting, which usually is a time allowed for public discussants who many wish to say a word or two. They are required to register beforehand and I have before me only one person who registered. If there are others, they might rise later. The time is limited to the presentation. 

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